chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blister, Diarrhoea, Nausea, Oropharyngeal blistering
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old female with hypertension, depression and thyroid disorder and no history of drug reactions or allergies who on 21-APR-2008 was vaccinated in the left arm with one dose of ZOSTAVAX (Oka/Merck) subcutaneously (lot#: 658605/1089U).  Concomitant therapy included ADVIL, SYNTHROID, PAXIL and NEXIUM.  Within days after the vaccine the patient severely broke out with blisters in her mouth, throat, GI tract and rectum, along with nausea, vomiting and diarrhea.  This episode lasted for about a week.  One week later, on 23-MAY-2008 she experienced another episode that was less severe and lasted just less than a week.  During the second episode, the patient's blood pressure medication was stopped because her blood pressure was so low.  On 05-JUN-2008 the patient had another less severe episode which started out as sore throat, blisters to throat, mouth and lips, and diarrhea and vomiting.  The patient had fever of 105F and chills.  The patient's right node in her neck was huge.  The patient was prescribed VALTREX and MOTRIM.  This episode lasted for a week.  The patient sought medical attention with a physician office visit.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old female with hypertension, depression and thyroid disorder and no history of drug reactions or allergies who on 21-APR-2008 was vaccinated in the left arm with one dose of ZOSTAVAX (Oka/Merck) subcutaneously (lot#: 658605/1089U).  Concomitant therapy included ADVIL, SYNTHROID, PAXIL and NEXIUM.  Within days after the vaccine the patient severely broke out with blisters in her mouth, throat, GI tract and rectum, along with nausea, vomiting and diarrhea.  This episode lasted for about a week.  One week later, on 23-MAY-2008 she experienced another episode that was less severe and lasted just less than a week.  During the second episode, the patient's blood pressure medication was stopped because her blood pressure was so low.  On 05-JUN-2008 the patient had another less severe episode which started out as sore throat, blisters to throat, mouth and lips, and diarrhea and vomiting.  The patient had fever of 105F and chills.  The patient's right node in her neck was huge.  The patient was prescribed VALTREX and MOTRIM.  This episode lasted for a week.  The patient sought medical attention with a physician office visit.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Hypotension, Lip blister, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old female with hypertension, depression and thyroid disorder and no history of drug reactions or allergies who on 21-APR-2008 was vaccinated in the left arm with one dose of ZOSTAVAX (Oka/Merck) subcutaneously (lot#: 658605/1089U).  Concomitant therapy included ADVIL, SYNTHROID, PAXIL and NEXIUM.  Within days after the vaccine the patient severely broke out with blisters in her mouth, throat, GI tract and rectum, along with nausea, vomiting and diarrhea.  This episode lasted for about a week.  One week later, on 23-MAY-2008 she experienced another episode that was less severe and lasted just less than a week.  During the second episode, the patient's blood pressure medication was stopped because her blood pressure was so low.  On 05-JUN-2008 the patient had another less severe episode which started out as sore throat, blisters to throat, mouth and lips, and diarrhea and vomiting.  The patient had fever of 105F and chills.  The patient's right node in her neck was huge.  The patient was prescribed VALTREX and MOTRIM.  This episode lasted for a week.  The patient sought medical attention with a physician office visit.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Oropharyngeal blistering, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old female with hypertension, depression and thyroid disorder and no history of drug reactions or allergies who on 21-APR-2008 was vaccinated in the left arm with one dose of ZOSTAVAX (Oka/Merck) subcutaneously (lot#: 658605/1089U).  Concomitant therapy included ADVIL, SYNTHROID, PAXIL and NEXIUM.  Within days after the vaccine the patient severely broke out with blisters in her mouth, throat, GI tract and rectum, along with nausea, vomiting and diarrhea.  This episode lasted for about a week.  One week later, on 23-MAY-2008 she experienced another episode that was less severe and lasted just less than a week.  During the second episode, the patient's blood pressure medication was stopped because her blood pressure was so low.  On 05-JUN-2008 the patient had another less severe episode which started out as sore throat, blisters to throat, mouth and lips, and diarrhea and vomiting.  The patient had fever of 105F and chills.  The patient's right node in her neck was huge.  The patient was prescribed VALTREX and MOTRIM.  This episode lasted for a week.  The patient sought medical attention with a physician office visit.  Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 77 year old female with allergic to Amoxicillin/ampicillin, hypertension, hyperlipidemia, hypothyroid who on 09-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). (Dose, route of administration and lot number were not provided). There was no illness at the time of vaccination. On 13-JUN-2008 the patient sought medical attention and returned the office. The reporter indicated that the patient developed a painful rash following a dermatome of about T3 to T4 on the right. The rash did not appear to be typical for Shingles, but the pain and the recurrence following the vaccine suggested perhaps it was a form crust of Shingles. The patient was given VALTREX 500mg tid and VICODIN for pain. The outcome of the patient was unknown. Follow up information also indicated the patient experienced urinary incontinence and caruncle (end of July 2008). No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Urethral caruncle, Urinary incontinence
Clinical narrative: Information has been received from a physician concerning a 77 year old female with allergic to Amoxicillin/ampicillin, hypertension, hyperlipidemia, hypothyroid who on 09-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). (Dose, route of administration and lot number were not provided). There was no illness at the time of vaccination. On 13-JUN-2008 the patient sought medical attention and returned the office. The reporter indicated that the patient developed a painful rash following a dermatome of about T3 to T4 on the right. The rash did not appear to be typical for Shingles, but the pain and the recurrence following the vaccine suggested perhaps it was a form crust of Shingles. The patient was given VALTREX 500mg tid and VICODIN for pain. The outcome of the patient was unknown. Follow up information also indicated the patient experienced urinary incontinence and caruncle (end of July 2008). No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Blister, Pruritus, Rash, Rash vesicular
Clinical narrative: Information has been received from a 60 year old female consumer with osteoporosis and allergic to penicillin and azithromycin, who on 24-MAY-2008 was vaccinated with 0.65 mL of a dose of ZOSTAVAX (Lot # is not provided). Concomitant therapy included alendronate sodium (+) cholecalciferol (MSD). On approximately 27-MAY-2008 (also reported as "3 or 4 days later"), the patient developed blood blister on her chest. At time of the report, patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood blister
Clinical narrative: Information has been received from a 60 year old female consumer with osteoporosis and allergic to penicillin and azithromycin, who on 24-MAY-2008 was vaccinated with 0.65 mL of a dose of ZOSTAVAX (Lot # is not provided). Concomitant therapy included alendronate sodium (+) cholecalciferol (MSD). On approximately 27-MAY-2008 (also reported as "3 or 4 days later"), the patient developed blood blister on her chest. At time of the report, patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old female with diabetes who on 27-JUL-2008 was vaccinated with a dose of ZOSTAVAX (lot #658859/0411X) subcutaneously. Concomitant therapy included PREVACID, and unspecified medication for cholesterol and thyroid. On approximately  02-AUG-2008 (some time over the weekend) the patient developed 10 clear filled blisters on her face, head and behind her ear after administration of ZOSTAVAX (Oka/Merck). The patient sought medical attention via telephone call. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old female with diabetes who on 27-JUL-2008 was vaccinated with a dose of ZOSTAVAX (lot #658859/0411X) subcutaneously. Concomitant therapy included PREVACID, and unspecified medication for cholesterol and thyroid. On approximately  02-AUG-2008 (some time over the weekend) the patient developed 10 clear filled blisters on her face, head and behind her ear after administration of ZOSTAVAX (Oka/Merck). The patient sought medical attention via telephone call. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 64 year old pre-diabetic female with hypercholesterolaemia, osteoporosis, coronary artery disease, hypertension and penicillin allergy and a history of constipation who on 25-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/MERCK) "laterally" in her arm rather than her deltoid. Concomitant therapy included metoprolol succinate  (TOPROL XL TABLETS), simvastatin (ZOCOR), ibuprofen, ezetimibe (ZETIA), risedronate sodium (ACTONEL), and lansoprazole (PREVACID). The patient initially developed pain on 30-JUN-2008. On 03-JUL-2008 the patient developed a low-grade fever. The rash started on 04-JUL-2008 and the patient had a zoster rash on her right buttock which had spread into her vagina and into her anus. On 04-JUL-2008 the patient went to the emergency room, no laboratory diagnostics studies were performed. The patient was diagnosed shingles and treated with valacyclovir hydrochloride (VALTREX) and releases. The patient also had a scattered  papules on both arms which had not had much progression but the patient felt uncomfortable. The physician stated that the biggest problem was that the patient can not take narcotics for the pain because of her history of constipation. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug administered at inappropriate site, Herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 64 year old pre-diabetic female with hypercholesterolaemia, osteoporosis, coronary artery disease, hypertension and penicillin allergy and a history of constipation who on 25-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/MERCK) "laterally" in her arm rather than her deltoid. Concomitant therapy included metoprolol succinate  (TOPROL XL TABLETS), simvastatin (ZOCOR), ibuprofen, ezetimibe (ZETIA), risedronate sodium (ACTONEL), and lansoprazole (PREVACID). The patient initially developed pain on 30-JUN-2008. On 03-JUL-2008 the patient developed a low-grade fever. The rash started on 04-JUL-2008 and the patient had a zoster rash on her right buttock which had spread into her vagina and into her anus. On 04-JUL-2008 the patient went to the emergency room, no laboratory diagnostics studies were performed. The patient was diagnosed shingles and treated with valacyclovir hydrochloride (VALTREX) and releases. The patient also had a scattered  papules on both arms which had not had much progression but the patient felt uncomfortable. The physician stated that the biggest problem was that the patient can not take narcotics for the pain because of her history of constipation. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 64 year old pre-diabetic female with hypercholesterolaemia, osteoporosis, coronary artery disease, hypertension and penicillin allergy and a history of constipation who on 25-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/MERCK) "laterally" in her arm rather than her deltoid. Concomitant therapy included metoprolol succinate  (TOPROL XL TABLETS), simvastatin (ZOCOR), ibuprofen, ezetimibe (ZETIA), risedronate sodium (ACTONEL), and lansoprazole (PREVACID). The patient initially developed pain on 30-JUN-2008. On 03-JUL-2008 the patient developed a low-grade fever. The rash started on 04-JUL-2008 and the patient had a zoster rash on her right buttock which had spread into her vagina and into her anus. On 04-JUL-2008 the patient went to the emergency room, no laboratory diagnostics studies were performed. The patient was diagnosed shingles and treated with valacyclovir hydrochloride (VALTREX) and releases. The patient also had a scattered  papules on both arms which had not had much progression but the patient felt uncomfortable. The physician stated that the biggest problem was that the patient can not take narcotics for the pain because of her history of constipation. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Body temperature normal, Erythema, Herpes zoster, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 63 year old female with arthritis, bronchitis, blood pressure high, cardiac disorder, sinusitis, hay fever, bad knee, PENICILLIN allergy, CODINE allergy, drug hypersensitivity and SULFONAMIDE allergy and a history of measles, mumps, chickenpox, infectious mononucleosis, hives, cancer, back discomfort, anemia, ulcer, hemorrhoids, bladder infection and hernia who on 04-MAR-2008 was vaccinated subcutaneously into left deltoid with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659759/1873U). Concomitant therapy included ALENDRONATE SODIUM (MSD), ZANTAC, INDERAL, NORTRIPTYLINE, CABBAGE PALM, ZYRTEC, WELLBUTRIN XL, DIOVAN HCT, FLUTICASONE FUROATE, METFORMIN, KLOR-CON, DYAZIDE, SIMVASTATIN (manufacturer unknown), METOPROLOL,  DILTIAZEUM HCL, CECLOR, DILTIAZEM HCL, DOXYCYCLINE, NITROLINGUAL and "other medications". On 07-AUG-2008 the patient was diagnosed with shingles. the patient had rash on upper left leg which was painful and blistering redness. The patient had no other symptoms. The patient was treated with TYLENOL. On 11-AUG-2008 the patient was in office with draining lesions located on left upper thigh The physical examination was done. Blood pressure was 108/64. Pulse was 66. Respiratory rate was 18. Body temperature was 97.1 F. There was no abnormal discovery with the patient. The patient was well health and well nourish. Heart rate and rhythm. Lungs were clear to auscultation and no wheeze. there were multiple patches of painful. erythatous; vesicular erythema within the L2 dermatome of the left leg It was diagnosed that the rash was probably shingles infection. The patient was treated with VALTREX 1000 mg. three times per day for 7 days; triamcinolone cream 1%, VICODIN; 1-2 tablets, four times per day as needed for pain. The patient would be followed up in 2 weeks. At the time of this report, patient's shingles persisted. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a licensed practical nurse concerning a 63 year old female with arthritis, bronchitis, blood pressure high, cardiac disorder, sinusitis, hay fever, bad knee, PENICILLIN allergy, CODINE allergy, drug hypersensitivity and SULFONAMIDE allergy and a history of measles, mumps, chickenpox, infectious mononucleosis, hives, cancer, back discomfort, anemia, ulcer, hemorrhoids, bladder infection and hernia who on 04-MAR-2008 was vaccinated subcutaneously into left deltoid with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659759/1873U). Concomitant therapy included ALENDRONATE SODIUM (MSD), ZANTAC, INDERAL, NORTRIPTYLINE, CABBAGE PALM, ZYRTEC, WELLBUTRIN XL, DIOVAN HCT, FLUTICASONE FUROATE, METFORMIN, KLOR-CON, DYAZIDE, SIMVASTATIN (manufacturer unknown), METOPROLOL,  DILTIAZEUM HCL, CECLOR, DILTIAZEM HCL, DOXYCYCLINE, NITROLINGUAL and "other medications". On 07-AUG-2008 the patient was diagnosed with shingles. the patient had rash on upper left leg which was painful and blistering redness. The patient had no other symptoms. The patient was treated with TYLENOL. On 11-AUG-2008 the patient was in office with draining lesions located on left upper thigh The physical examination was done. Blood pressure was 108/64. Pulse was 66. Respiratory rate was 18. Body temperature was 97.1 F. There was no abnormal discovery with the patient. The patient was well health and well nourish. Heart rate and rhythm. Lungs were clear to auscultation and no wheeze. there were multiple patches of painful. erythatous; vesicular erythema within the L2 dermatome of the left leg It was diagnosed that the rash was probably shingles infection. The patient was treated with VALTREX 1000 mg. three times per day for 7 days; triamcinolone cream 1%, VICODIN; 1-2 tablets, four times per day as needed for pain. The patient would be followed up in 2 weeks. At the time of this report, patient's shingles persisted. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Heart rate normal, Herpes zoster, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 63 year old female with arthritis, bronchitis, blood pressure high, cardiac disorder, sinusitis, hay fever, bad knee, PENICILLIN allergy, CODINE allergy, drug hypersensitivity and SULFONAMIDE allergy and a history of measles, mumps, chickenpox, infectious mononucleosis, hives, cancer, back discomfort, anemia, ulcer, hemorrhoids, bladder infection and hernia who on 04-MAR-2008 was vaccinated subcutaneously into left deltoid with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659759/1873U). Concomitant therapy included ALENDRONATE SODIUM (MSD), ZANTAC, INDERAL, NORTRIPTYLINE, CABBAGE PALM, ZYRTEC, WELLBUTRIN XL, DIOVAN HCT, FLUTICASONE FUROATE, METFORMIN, KLOR-CON, DYAZIDE, SIMVASTATIN (manufacturer unknown), METOPROLOL,  DILTIAZEUM HCL, CECLOR, DILTIAZEM HCL, DOXYCYCLINE, NITROLINGUAL and "other medications". On 07-AUG-2008 the patient was diagnosed with shingles. the patient had rash on upper left leg which was painful and blistering redness. The patient had no other symptoms. The patient was treated with TYLENOL. On 11-AUG-2008 the patient was in office with draining lesions located on left upper thigh The physical examination was done. Blood pressure was 108/64. Pulse was 66. Respiratory rate was 18. Body temperature was 97.1 F. There was no abnormal discovery with the patient. The patient was well health and well nourish. Heart rate and rhythm. Lungs were clear to auscultation and no wheeze. there were multiple patches of painful. erythatous; vesicular erythema within the L2 dermatome of the left leg It was diagnosed that the rash was probably shingles infection. The patient was treated with VALTREX 1000 mg. three times per day for 7 days; triamcinolone cream 1%, VICODIN; 1-2 tablets, four times per day as needed for pain. The patient would be followed up in 2 weeks. At the time of this report, patient's shingles persisted. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Respiratory rate
Clinical narrative: Information has been received from a licensed practical nurse concerning a 63 year old female with arthritis, bronchitis, blood pressure high, cardiac disorder, sinusitis, hay fever, bad knee, PENICILLIN allergy, CODINE allergy, drug hypersensitivity and SULFONAMIDE allergy and a history of measles, mumps, chickenpox, infectious mononucleosis, hives, cancer, back discomfort, anemia, ulcer, hemorrhoids, bladder infection and hernia who on 04-MAR-2008 was vaccinated subcutaneously into left deltoid with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659759/1873U). Concomitant therapy included ALENDRONATE SODIUM (MSD), ZANTAC, INDERAL, NORTRIPTYLINE, CABBAGE PALM, ZYRTEC, WELLBUTRIN XL, DIOVAN HCT, FLUTICASONE FUROATE, METFORMIN, KLOR-CON, DYAZIDE, SIMVASTATIN (manufacturer unknown), METOPROLOL,  DILTIAZEUM HCL, CECLOR, DILTIAZEM HCL, DOXYCYCLINE, NITROLINGUAL and "other medications". On 07-AUG-2008 the patient was diagnosed with shingles. the patient had rash on upper left leg which was painful and blistering redness. The patient had no other symptoms. The patient was treated with TYLENOL. On 11-AUG-2008 the patient was in office with draining lesions located on left upper thigh The physical examination was done. Blood pressure was 108/64. Pulse was 66. Respiratory rate was 18. Body temperature was 97.1 F. There was no abnormal discovery with the patient. The patient was well health and well nourish. Heart rate and rhythm. Lungs were clear to auscultation and no wheeze. there were multiple patches of painful. erythatous; vesicular erythema within the L2 dermatome of the left leg It was diagnosed that the rash was probably shingles infection. The patient was treated with VALTREX 1000 mg. three times per day for 7 days; triamcinolone cream 1%, VICODIN; 1-2 tablets, four times per day as needed for pain. The patient would be followed up in 2 weeks. At the time of this report, patient's shingles persisted. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Nausea, Pain, Skin warm
Clinical narrative: Initial and follow-up information has been received from a physician and healthcare provider, concerning a 65 year old patient with penicillin and DARVON allergy and a history of chickenpox as a child, who on 19-AUG-2008 was vaccinated with 0.65 mL dose of ZOSTAVAX (Oka/Merck) (Lot #658859/0411X) in the right arm SQ. Concomitant medications included VALTREX, fexofenadine hydrochloride, verapamil, DYAZDIDE, K-DUR, NAPROSYN, hydrochlorothiazide - triamterene, estradiol and pantoprazole. Twelve hours after ZOSTAVAX (Oka/Merck) was given, the patient experienced rash near the injection site. The patient went to see the physician on 22-AUG-2008 who reported the rash now appeared as vesicles and the patient had shingles on the right arm 5x7 cm reaction. The patient was warm but did not have fever, other systemic symptom reported was skin tightness. At the time of reporting the patient had not recovered. The patient sought medical attention with the physician. There was no product quality complaint. The patient was enrolled in the varicella zoster identification program to identify if VZV is present and if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the vesicle was collected on 25-AUG-2008. VZV DNA was not amplified. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicle was adequate specimen-negative. Additional inform is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Herpes zoster, Injection site rash, Injection site vesicles, Skin tightness
Clinical narrative: Initial and follow-up information has been received from a physician and healthcare provider, concerning a 65 year old patient with penicillin and DARVON allergy and a history of chickenpox as a child, who on 19-AUG-2008 was vaccinated with 0.65 mL dose of ZOSTAVAX (Oka/Merck) (Lot #658859/0411X) in the right arm SQ. Concomitant medications included VALTREX, fexofenadine hydrochloride, verapamil, DYAZDIDE, K-DUR, NAPROSYN, hydrochlorothiazide - triamterene, estradiol and pantoprazole. Twelve hours after ZOSTAVAX (Oka/Merck) was given, the patient experienced rash near the injection site. The patient went to see the physician on 22-AUG-2008 who reported the rash now appeared as vesicles and the patient had shingles on the right arm 5x7 cm reaction. The patient was warm but did not have fever, other systemic symptom reported was skin tightness. At the time of reporting the patient had not recovered. The patient sought medical attention with the physician. There was no product quality complaint. The patient was enrolled in the varicella zoster identification program to identify if VZV is present and if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the vesicle was collected on 25-AUG-2008. VZV DNA was not amplified. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicle was adequate specimen-negative. Additional inform is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Viral DNA test negative
Clinical narrative: Initial and follow-up information has been received from a physician and healthcare provider, concerning a 65 year old patient with penicillin and DARVON allergy and a history of chickenpox as a child, who on 19-AUG-2008 was vaccinated with 0.65 mL dose of ZOSTAVAX (Oka/Merck) (Lot #658859/0411X) in the right arm SQ. Concomitant medications included VALTREX, fexofenadine hydrochloride, verapamil, DYAZDIDE, K-DUR, NAPROSYN, hydrochlorothiazide - triamterene, estradiol and pantoprazole. Twelve hours after ZOSTAVAX (Oka/Merck) was given, the patient experienced rash near the injection site. The patient went to see the physician on 22-AUG-2008 who reported the rash now appeared as vesicles and the patient had shingles on the right arm 5x7 cm reaction. The patient was warm but did not have fever, other systemic symptom reported was skin tightness. At the time of reporting the patient had not recovered. The patient sought medical attention with the physician. There was no product quality complaint. The patient was enrolled in the varicella zoster identification program to identify if VZV is present and if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the vesicle was collected on 25-AUG-2008. VZV DNA was not amplified. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicle was adequate specimen-negative. Additional inform is expected.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Groin pain, Herpes zoster, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a 77 year old female with allergy to codeine and a history of heart attack in December 2007, who on 02-Jul-2008 was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. The patient reported that on  09-JUL-2008, she developed a "big rash in her groin and down the side of her leg". The patient sought medical attention seeing the physician who diagnosed shingles and prescribed VALTREX. At the time of the report patient the patient was recovering. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a 77 year old female with allergy to codeine and a history of heart attack in December 2007, who on 02-Jul-2008 was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. The patient reported that on  09-JUL-2008, she developed a "big rash in her groin and down the side of her leg". The patient sought medical attention seeing the physician who diagnosed shingles and prescribed VALTREX. At the time of the report patient the patient was recovering. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 03-MAY-2007 was vaccinated with the first dose of GARDASIL, on 17-JUL-2007 was vaccinated with the second dose of GARDASIL and on 25-OCT-2007 was vaccinated with the third dose of GARDASIL (lot#: 658560/1062U).  Two or three months after she received the third dose her mother reported that she had been having seizures at night while she was sleeping.  She also began experiencing headaches and dizziness.  It was not known if this also occurred after the first two doses.  The mother told the physician that the patient's sister went into her room a few times and noticed that she was very pale and had white saliva dripping out of her mouth.  She was currently seeing a neurologist but it was not known if she had recovered.  Electroencephalogram (EEG) and computed axial tomography (CAT) scan was performed (results not reported).  Upon internal review the patient's seizures were determined to be an other important medical event.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion, Dizziness, Drooling, Electroencephalogram
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 03-MAY-2007 was vaccinated with the first dose of GARDASIL, on 17-JUL-2007 was vaccinated with the second dose of GARDASIL and on 25-OCT-2007 was vaccinated with the third dose of GARDASIL (lot#: 658560/1062U).  Two or three months after she received the third dose her mother reported that she had been having seizures at night while she was sleeping.  She also began experiencing headaches and dizziness.  It was not known if this also occurred after the first two doses.  The mother told the physician that the patient's sister went into her room a few times and noticed that she was very pale and had white saliva dripping out of her mouth.  She was currently seeing a neurologist but it was not known if she had recovered.  Electroencephalogram (EEG) and computed axial tomography (CAT) scan was performed (results not reported).  Upon internal review the patient's seizures were determined to be an other important medical event.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pallor
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 03-MAY-2007 was vaccinated with the first dose of GARDASIL, on 17-JUL-2007 was vaccinated with the second dose of GARDASIL and on 25-OCT-2007 was vaccinated with the third dose of GARDASIL (lot#: 658560/1062U).  Two or three months after she received the third dose her mother reported that she had been having seizures at night while she was sleeping.  She also began experiencing headaches and dizziness.  It was not known if this also occurred after the first two doses.  The mother told the physician that the patient's sister went into her room a few times and noticed that she was very pale and had white saliva dripping out of her mouth.  She was currently seeing a neurologist but it was not known if she had recovered.  Electroencephalogram (EEG) and computed axial tomography (CAT) scan was performed (results not reported).  Upon internal review the patient's seizures were determined to be an other important medical event.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Incorrect route of drug administration, Inflammation, Local reaction, Pain, Skin warm
Clinical narrative: Pt was (assumed) to have been given 0.1mL Anthrax vaccine intradermally, inadvertently (instead of PPD skin test). Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth). Will follow-up to see if reaction subsides. Unknown which vaccine was given.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Swelling
Clinical narrative: Pt was (assumed) to have been given 0.1mL Anthrax vaccine intradermally, inadvertently (instead of PPD skin test). Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth). Will follow-up to see if reaction subsides. Unknown which vaccine was given.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Inflammation, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Pt was (assumed) to have been given 0.1mL Anthrax vaccine intradermally, inadvertently (instead of PPD skin test). Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth). Will follow-up to see if reaction subsides. Unknown which vaccine was given.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Wrong drug administered
Clinical narrative: Pt was (assumed) to have been given 0.1mL Anthrax vaccine intradermally, inadvertently (instead of PPD skin test). Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth). Will follow-up to see if reaction subsides. Unknown which vaccine was given.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Incorrect route of drug administration, Inflammation, Local reaction, Pain, Skin warm
Clinical narrative: Pt was (assumed) to have been given 0.1 ml Anthrax vaccine intradermally, inadvertently (instead of PPD skin test).  Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth) will follow up to see if reaction subsides.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Swelling
Clinical narrative: Pt was (assumed) to have been given 0.1 ml Anthrax vaccine intradermally, inadvertently (instead of PPD skin test).  Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth) will follow up to see if reaction subsides.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Inflammation, Local reaction, Pain, Skin warm, Swelling
Clinical narrative: Pt was (assumed) to have been given 0.1 ml Anthrax vaccine intradermally, inadvertently (instead of PPD skin test).  Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth) will follow up to see if reaction subsides.
Age: 29.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Wrong drug administered
Clinical narrative: Pt was (assumed) to have been given 0.1 ml Anthrax vaccine intradermally, inadvertently (instead of PPD skin test).  Pt has local reaction to left arm resembling Anthrax reaction (localized inflammation, swelling, mild pain, warmth) will follow up to see if reaction subsides.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Asthenia, CSF culture negative, Computerised tomogram, Decreased appetite, Fatigue
Clinical narrative: Pt was 'floppy' per parents starting the evening on the day he received vaccines.  He was not walking as before.  Looking tired.  No fever.  Poor appetite.  Pt more weak after 3 days -> obtained CT & MRI.  MRI showed findings suggestive of acute demyelinating encephalomyelitis. 10/20/08-records received for DOS 9/30-10/5/08-Acute disseminated encephalomyelitis. Evening of vaccinations seemed dazed and had poor oral intake. Temperature 100.4, developed ataxia. Presented to Ed with mental status change and weakness. 1/27/2010 Patient continues with significant speech delays.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Gait disturbance, Hypotonia, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pt was 'floppy' per parents starting the evening on the day he received vaccines.  He was not walking as before.  Looking tired.  No fever.  Poor appetite.  Pt more weak after 3 days -> obtained CT & MRI.  MRI showed findings suggestive of acute demyelinating encephalomyelitis. 10/20/08-records received for DOS 9/30-10/5/08-Acute disseminated encephalomyelitis. Evening of vaccinations seemed dazed and had poor oral intake. Temperature 100.4, developed ataxia. Presented to Ed with mental status change and weakness. 1/27/2010 Patient continues with significant speech delays.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: Pt describes swelling from shoulder to elbow.  Seen in ER where she lives.  Resolved slowly over 2 weeks.  No sequelae.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site rash
Clinical narrative: Rash to injection site next day after receiving vaccines.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Amniotic fluid index abnormal, Drug exposure during pregnancy, Foetal disorder, Foetal non-stress test, Premature labour
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female, with asthma and an allergy to shellfish and iodine, who on approximately 08-JAN-2008 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. The patient was 4 weeks and 3 days pregnant when vaccinated. The patient sought medical attention. As of 01-FEB-2008, the patient was 7 weeks 6 days gestation. In follow-up, the nurse reported that the patient delivered a preterm, where the baby had some sort of "loss of amniotic fluid" and that had needed surgery. Subsequently, the patient whose estimated delivery date was 15-SEP-2008, delivered a vaginally on 06-AUG-2008 at 34 week estimated gestational age. The nurse reported that the patient was last seen in the office at her 32 week prenatal visit on 23-JUL-2008. The nurse was able to access the patient's chart information. On 05-AUG-2008, the patient had called the practice to report a significant decrease in fetal movement. She was sent to the hospital for a non-stress test (NST) and a biophysical profile (BPP) by ultrasound. The result of the BPP were that the patient scored only a 4 out of 8 and had amniotic fluid index (AFI) of 3.6, which is the diagnostic for oligohydramnios, and subsequently needed to be induced. She did not specify the results of the NST. It was also noted on the ultrasound at that time that the baby had a distended bladder with bilateral hydronephrosis and had an obstructed bladder outlet. And would require surgery after delivery. The patient was then sent to a major medical center where she delivered on 06-AUG-2008 and the baby had subsequent surgery (exact date of surgery not specified). According to the nurse, the mother was seen last week (week of 23-SEP-2008) and she was doing quite well at her postpartum visit and the baby was doing well and was at home with her. The nurse reported that she would offer the patient the informed consent sheet at her next visit. Upon internal review, premature baby, distended bladder, obstructed bladder outlet and bilateral hydronephrosis were determined to be other important medical events. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female, with asthma and an allergy to shellfish and iodine, who on approximately 08-JAN-2008 was vaccinated with her first dose of GARDASIL. There was no concomitant medication. The patient was 4 weeks and 3 days pregnant when vaccinated. The patient sought medical attention. As of 01-FEB-2008, the patient was 7 weeks 6 days gestation. In follow-up, the nurse reported that the patient delivered a preterm, where the baby had some sort of "loss of amniotic fluid" and that had needed surgery. Subsequently, the patient whose estimated delivery date was 15-SEP-2008, delivered a vaginally on 06-AUG-2008 at 34 week estimated gestational age. The nurse reported that the patient was last seen in the office at her 32 week prenatal visit on 23-JUL-2008. The nurse was able to access the patient's chart information. On 05-AUG-2008, the patient had called the practice to report a significant decrease in fetal movement. She was sent to the hospital for a non-stress test (NST) and a biophysical profile (BPP) by ultrasound. The result of the BPP were that the patient scored only a 4 out of 8 and had amniotic fluid index (AFI) of 3.6, which is the diagnostic for oligohydramnios, and subsequently needed to be induced. She did not specify the results of the NST. It was also noted on the ultrasound at that time that the baby had a distended bladder with bilateral hydronephrosis and had an obstructed bladder outlet. And would require surgery after delivery. The patient was then sent to a major medical center where she delivered on 06-AUG-2008 and the baby had subsequent surgery (exact date of surgery not specified). According to the nurse, the mother was seen last week (week of 23-SEP-2008) and she was doing quite well at her postpartum visit and the baby was doing well and was at home with her. The nurse reported that she would offer the patient the informed consent sheet at her next visit. Upon internal review, premature baby, distended bladder, obstructed bladder outlet and bilateral hydronephrosis were determined to be other important medical events. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site urticaria, Pruritus, Skin warm
Clinical narrative: Redness, warmth, itching, wheal at injection site. Treated with XYZAL 5mg daily.
Sex: F
Vaccine: HPV4
Symptoms: Amniorrhoea, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician from the Pregnancy Registry for GARDASIL concerning a female who was vaccinated with GARDASIL.  The patient became pregnant and went into labor.  On an unknown date, the patient experienced loss of amniotic fluid and had to undergo surgery.  No information is available on the outcome of both, mother and child.  Loss of amniotic fluid was considered to be immediately life-threatening.  No further information is available.
Age: 12.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Heart rate increased
Clinical narrative: Increased heart rate approximately 2 hour after injection- lasted app 30 minutes-resolved after treatment.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: 10/06/2007 2nd HPV; 11/26/2007-Left leg pain- no injury; 01/09/2008-shoulder pain; 01/30/2008 Ortho referral; 02/09/2008-3rd HPV vaccination; 04/11/2008 and 04/12/2008 -shoulder pain.  She has had MRI of shoulder pain. Normal injection and physical therapy.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Immediate post-injection reaction, Injection site pain, Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 15 year old female with a history of fainting twice in the past who on 25-SEP-2008 was vaccinated with the first dose of GARDASIL (LOT# 661530/0575X). The patient also received MENACTRA at the same visit. The patient said that the injection was painful. She went into a seizure immediately after the injection and passed out for about 30 seconds. The physician pulled her hair back and she came to. The physician thought that this was a vasovagal reaction. Subsequently, the patient recovered from the events in the same day. An electrocardiogram was scheduled for the patient as follow-up. The patient sought medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Swelling
Clinical narrative: Erythema of left arm(at place of IPV) appeared on 10/01/2008, 12 PM (23 hours after vaccine) and resolved on 10/02/2008 7 AM (only minuscule swelling, no ab given. No pain, no fever
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dyspnoea, Immediate post-injection reaction, Syncope vasovagal
Clinical narrative: Information has been received from a nurse practitioner concerning a female with extremely anxiety about receiving vaccine who was administered her first dose of GARDASIL, 0.5 ml, IM.  The patient experienced severe vasovagal reaction, seizure like activity and difficulty in breathing within seconds of administration.  The patient was given oxygen and transported to the hospital via ambulance.  It was unknown if the patient was hospitalized.  On an unspecified date, the patient recovered from all symptoms.  Severe vasovagal reaction, seizure-like activity and difficulty breathing were considered to be other important medical events because oxygen was given.  No further information is available.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Immunizations given in bilateral thighs.  Redness and slight edema noted within 30 seconds of administering MMR subQ to right thigh and VARICELLA SubQ to the left thigh.  Doctor notified.  Orders received for Benedryl PO X1.  Pt received dose at 1220.  Tolerated well.  Parent contacted by phone at 1416 states "both legs are back to normal"
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in February 2008, was vaccinated with the third dose of GARDASIL, 0.5 milliliter intramuscular. In "August 2008", the patient developed a seizure.  The patient sought medical attention, she contacted the doctor.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested. 11/11/08-records received-seen in office 8/20/08-after ER visit for seizure.Assessment questionalbe seizures.Gardasil #3 given on 2/21/08. UA showed blood at time of sports physical, also trying to loose weight.
Age: 57.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Rash on arms, back and chest- small, red, itchy, pimple like
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Gaze palsy, Immediate post-injection reaction, Tremor, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no pertinent medical history and no drug reactions/allergies who on 02-OCT-2008 was vaccinated with the first dose of GARDASIL (Lot# reported as 660557/0072X), 0.5 milliliter intramuscular in left deltoid. Concomitant therapy included DTaP, varicella virus vaccine (MSD), hepatitis A vaccine (inactive) and MENACTRA, all these vaccines were received at the same office visit as GARDASIL. The patient developed a seizure within 3 minutes of receiving the first dose of GARDASIL on 02-OCT-2008. The seizure was described as follows: "The patient's limbs shook, the eyes rolled back, and the patient was unresponsive for about one minute". Subsequently the patient recovered from the seizure. The patient sought medical attention at physician's office. No other symptoms or treatment was reported. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Lichenoid keratosis, Pruritus, Rash erythematous, Rash macular
Clinical narrative: Approx 1d after vaccine, begin with pruritis & erythematous macular rash spredding from b/l thighs & forearms to entire trunk (front & back), extremities x4   .  Rash was pruritic but non-tender.  Symptoms well controlled with benadryl.  As this body rash resolved over 4-5d, developed lichenoid drug rash on b/l hands (L>R) (this lichenoid rash present (x2d) at time of this report)