chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Autism, Childhood disintegrative disorder, Inappropriate schedule of drug administration, Regressive behaviour, Staring
Clinical narrative: Within days, patient lost language and began to verabalize completely differently than he had been. Also began staring and avoiding eye contact. From age 12 1/2 months on until present, at age 18 months. Seemed to worsen further after last months shots as well and physician finally referred us to a speech pathologist for an analysis, of which patient scored 50's and 60's on the questions we were asked and was deemed language delay, receptive delay and probably autistic tendancies. Awaiting referral for a treatment plan to begin. We are military and will have to wait until we relocate this month and once there, the pathologist said she would recommend for us daily in home therapy for patient.  07/14/2008 MR received for OVs 2/13/2008-7/10/2008.  Seen for 12 mon WCC 2/13/08. PE WNL. Vocab of 5 words. Failed gross motor questionaire-to be referred to Easter Seals. Seen again 6/23/08 for 15 mon WCC. PE WNL. Not using words to communicate. Assessment: Normal routine H&P. Delayed Milestones-Language/Speech.  Parents concerned about only saying 2 words. Refered for speech tx. Speech/Language eval  with Assessment -Development Disorder-Language (Mixed Receptive-Expressive). (+) Screen on 1st level of PDDST-II which warrants further f/u.  Unable to fully test due to age. 1/25/2010 Follow-up: Autism, specifically Regressive Austim, abnormal brain function for learning skills/retaining ability for speech.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Anorexia, Blood alkaline phosphatase increased, Blood ketone body, Crying, Lethargy
Clinical narrative: 3/17 8pm - found lethargic & vomiting taken to E.R.  3/17 11pm IV fluids & ZOFRAN discharged.  3/19 10pm starts petit mal seizures.  3/20 3am hospital admitted.  3/23 6pm Discharged.  Symptoms vomiting, anorexia, lethargy, inconsolably crying, petit mal seizures. 8/4/08-records received for DOS 3/20-3/23/08-DC DX: Acute gastroenteritis. Dehydration, improved. Metabolic acidosis, improved. Diet refusal for previous 24 hours, vomiting, diarrhea. Initial diagnosed with viral infection and treated with antibiotics. Crying inconsolable.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Lymphocyte percentage decreased, Vomiting
Clinical narrative: 3/17 8pm - found lethargic & vomiting taken to E.R.  3/17 11pm IV fluids & ZOFRAN discharged.  3/19 10pm starts petit mal seizures.  3/20 3am hospital admitted.  3/23 6pm Discharged.  Symptoms vomiting, anorexia, lethargy, inconsolably crying, petit mal seizures. 8/4/08-records received for DOS 3/20-3/23/08-DC DX: Acute gastroenteritis. Dehydration, improved. Metabolic acidosis, improved. Diet refusal for previous 24 hours, vomiting, diarrhea. Initial diagnosed with viral infection and treated with antibiotics. Crying inconsolable.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Anorexia, Back pain, Blindness, Chills
Clinical narrative: Pale skin, Daily headaches, blurred to no vision, fatigue, loss of appetite, severe back pain, nausea, fever, chills, increased urination, loss of memory.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Nausea, Pallor, Pollakiuria
Clinical narrative: Pale skin, Daily headaches, blurred to no vision, fatigue, loss of appetite, severe back pain, nausea, fever, chills, increased urination, loss of memory.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Pale skin, Daily headaches, blurred to no vision, fatigue, loss of appetite, severe back pain, nausea, fever, chills, increased urination, loss of memory.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: Large local reaction began 1 day after varicella vaccine given.  10cm ring of erythema with darker center L arm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Fatigue, Injection site erythema, Injection site rash
Clinical narrative: Pt presented 4 days after immunization with a 5cm area of redness, warmth, and swelling.  A slightly erythematous macular rash extended from the injection site down the arm to the L hand.  Pt also had low grade temp. of 99.2 degrees F and fatigue.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Rash macular, Skin warm, Swelling
Clinical narrative: Pt presented 4 days after immunization with a 5cm area of redness, warmth, and swelling.  A slightly erythematous macular rash extended from the injection site down the arm to the L hand.  Pt also had low grade temp. of 99.2 degrees F and fatigue.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose decreased, Blood potassium decreased, Immediate post-injection reaction, Loss of consciousness, Tonic clonic movements
Clinical narrative: Pt passed out immediately after getting GARDASIL.  She was unresponsive for <1 minute.  She did have tonic clonic movements for 15-20 seconds.  Pt was fasting with glucose 64.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt passed out immediately after getting GARDASIL.  She was unresponsive for <1 minute.  She did have tonic clonic movements for 15-20 seconds.  Pt was fasting with glucose 64.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Dyskinesia, Local swelling, Pyrexia, Wheezing
Clinical narrative: Three hours after receiving vaccines, she developed anterior neck swelling, tongue protruding from mouth "like she couldn't keep it in her mouth" and wheezing per parental report. All symptoms resolved by time she was seen in ER, though there had rectal temp of 100.7 (also resolved).
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site abscess, Pyrexia, Upper respiratory tract infection
Clinical narrative: injection site abscess, URI possible OM fever of 102.5 A  Tx Keflex 250 BID x 10 days, heat to area
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash papular, Scab
Clinical narrative: Seen by another provider in our office 6/24/08 without herpes zoster (10 crusted papules in a linear cluster r side of abdomen) per provider documention
Age: 20.0
Sex: M
Vaccine: JEV
Symptoms: Hypoaesthesia oral, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: Client experienced tingling and numbness along sides of tongue within 15 minutes of receiving vaccine. The sensation continued (but did not worsen) for about 3 hours after vaccination was given. No other symptoms.
Sex: F
Vaccine: HEP
Symptoms: Cough, Eye disorder, Renal failure, Renal transplant, Viral infection
Clinical narrative: Information has been received for a case in litigation from information obtained from a published article concerning a female who was vaccinated with a dose of RECOMBIVAX HB.  It was reported that patient had developed eye trouble and in mid-April (year not reported) the patient developed a cough which was a manifestation of a viral infection.  Subsequently the patient developed Wegener's granulomatosis and kidney failure, eventually requiring a kidney transplant.  At the time of the report, the patient's outcome was unknown.  Upon internal review, kidney failure, eventually requiring a kidney transplant was considered to be an other important medical event.  The reporter felt that Wegener's granulomatosis and kidney failure caused by RECOMBIVAX HB.  It was reported that although the patient could have suffered from a virus, the patient had "other signs, such as eye trouble, that existed before the cough in April.  Therefore, the virus which allegedly caused the cough, could not have caused these problems."  No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Wegener's granulomatosis
Clinical narrative: Information has been received for a case in litigation from information obtained from a published article concerning a female who was vaccinated with a dose of RECOMBIVAX HB.  It was reported that patient had developed eye trouble and in mid-April (year not reported) the patient developed a cough which was a manifestation of a viral infection.  Subsequently the patient developed Wegener's granulomatosis and kidney failure, eventually requiring a kidney transplant.  At the time of the report, the patient's outcome was unknown.  Upon internal review, kidney failure, eventually requiring a kidney transplant was considered to be an other important medical event.  The reporter felt that Wegener's granulomatosis and kidney failure caused by RECOMBIVAX HB.  It was reported that although the patient could have suffered from a virus, the patient had "other signs, such as eye trouble, that existed before the cough in April.  Therefore, the virus which allegedly caused the cough, could not have caused these problems."  No further information is available.
Age: 60.0
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received form a 60 year old female consumer with sulfonamide and codeine allergies and no pertinent medical history who on 11C-DEC-2007 was vaccinated with one dose of ZOSTAVAX. Concomitant therapy included estrogens, conjugated (PREMARIN) and progesterone (PROMETRIUM). On the morning of 13-DEC-2007 the patient stated she broke out into little cluster of hives. She was getting about 6 or 8 a day. On 8-JAN-2008 it stated progressing and getting worse. Medical attention was sought with her dermatologist, there were no lab studies performed. The patient was prescribed XYZAL and TOPICORT. The patient stated it didn't help me. The patient also stated on 22-JAN-2008, it looked like I had a very bad case of hives on my chest, face, and scalp. On 24-JAN-2008, the patient saw the dermatologist again and was told she could be breaking out for up to one year and was given a prescription for PREDNISONE. The patient stated she finished on 16-FEB-2008 and it worked like a charm. On 25-FEB-2008 the hives started popping up again, but it's not too terrible. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information was received from the Dermatologist. In medical records from 23-JAN-2008 it was noted that the patient developed hives shortly after getting ZOSTAVAX. The patient had a rash on her right arm, left forearm, right thigh, left leg, back, left thigh, right knee, chest and abdomen showing urticarial plaques. There were no tests to report. The patient was treated with OTC antihistamines but she continued to get new hives. The patient was given XYZAL 5 mg a day which helped but when she stopped talking them on vacation she developed a generalized eruption. The patient has been using TOPICORT 0.05% gel for the new areas. The dermatologist suggested that the patient go back to the XYZAL, consider ALLEGRA 180 mg a day if no better with XYZAL, continue with TOPICORT gel and if she got much worse to start a PREDNISONE taper 30 mg x 3 days, 20 mg x 4 days, 10 mg x 4 days, 10 mg QOD x 4 days. In medical records dated 29-FEB-2008 it was noted that the patient did better, off of PREDNISONE for 9 days. The patient would develop 1-2 new lesions that would go away. The patient was to use TOPICORT on the new lesions and only if she got much worse she was to start a PREDNISONE taper 30 mg x 3 days, 20 mg x 4 days, 10 mg x 4 days, 10 mg QOD x 4 days. At the time of the report the patient had not recovered completely. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TTOX, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received form a 60 year old female consumer with sulfonamide and codeine allergies and no pertinent medical history who on 11C-DEC-2007 was vaccinated with one dose of ZOSTAVAX. Concomitant therapy included estrogens, conjugated (PREMARIN) and progesterone (PROMETRIUM). On the morning of 13-DEC-2007 the patient stated she broke out into little cluster of hives. She was getting about 6 or 8 a day. On 8-JAN-2008 it stated progressing and getting worse. Medical attention was sought with her dermatologist, there were no lab studies performed. The patient was prescribed XYZAL and TOPICORT. The patient stated it didn't help me. The patient also stated on 22-JAN-2008, it looked like I had a very bad case of hives on my chest, face, and scalp. On 24-JAN-2008, the patient saw the dermatologist again and was told she could be breaking out for up to one year and was given a prescription for PREDNISONE. The patient stated she finished on 16-FEB-2008 and it worked like a charm. On 25-FEB-2008 the hives started popping up again, but it's not too terrible. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information was received from the Dermatologist. In medical records from 23-JAN-2008 it was noted that the patient developed hives shortly after getting ZOSTAVAX. The patient had a rash on her right arm, left forearm, right thigh, left leg, back, left thigh, right knee, chest and abdomen showing urticarial plaques. There were no tests to report. The patient was treated with OTC antihistamines but she continued to get new hives. The patient was given XYZAL 5 mg a day which helped but when she stopped talking them on vacation she developed a generalized eruption. The patient has been using TOPICORT 0.05% gel for the new areas. The dermatologist suggested that the patient go back to the XYZAL, consider ALLEGRA 180 mg a day if no better with XYZAL, continue with TOPICORT gel and if she got much worse to start a PREDNISONE taper 30 mg x 3 days, 20 mg x 4 days, 10 mg x 4 days, 10 mg QOD x 4 days. In medical records dated 29-FEB-2008 it was noted that the patient did better, off of PREDNISONE for 9 days. The patient would develop 1-2 new lesions that would go away. The patient was to use TOPICORT on the new lesions and only if she got much worse she was to start a PREDNISONE taper 30 mg x 3 days, 20 mg x 4 days, 10 mg x 4 days, 10 mg QOD x 4 days. At the time of the report the patient had not recovered completely. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Rash
Clinical narrative: Information has been received from a physician concerning a 67 year old male who in 30-Jan-2008, was vaccinated with a dose of ZOSTAVAX.  On 30-JAN-2008 the patient complained of pain and was referred to an urologist who determined that the patent experienced shingles.  The patient received ZOSTAVAX at a facility.  The reporting physician was not the treating physician.  Subsequently, the patient recovered from shingles on an unknown date.  Unspecified medical treatment was sought.  No product quality complaint.  Additional information has been requested. This is in follow-up to report(s) perviously submitted on 6/24/2008. Follow-up information has been received from a physician concerning a 68 year old white retired male who on 23-JAN-2008 was vaccinated intramuscularly with a dose of ZOSTAVAX (lot # 658867/1413U). Concomitant therapy included pneumococcal 23v polysaccharide vaccine (MSU). On 29-JAN-2008, the patient developed herpes zoster. Subsequently, the patient recovered from herpes zoster. Additional information is not expected
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 67 year old male who in 30-Jan-2008, was vaccinated with a dose of ZOSTAVAX.  On 30-JAN-2008 the patient complained of pain and was referred to an urologist who determined that the patent experienced shingles.  The patient received ZOSTAVAX at a facility.  The reporting physician was not the treating physician.  Subsequently, the patient recovered from shingles on an unknown date.  Unspecified medical treatment was sought.  No product quality complaint.  Additional information has been requested. This is in follow-up to report(s) perviously submitted on 6/24/2008. Follow-up information has been received from a physician concerning a 68 year old white retired male who on 23-JAN-2008 was vaccinated intramuscularly with a dose of ZOSTAVAX (lot # 658867/1413U). Concomitant therapy included pneumococcal 23v polysaccharide vaccine (MSU). On 29-JAN-2008, the patient developed herpes zoster. Subsequently, the patient recovered from herpes zoster. Additional information is not expected
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Diagnostic procedure, Granuloma, Musculoskeletal chest pain
Clinical narrative: Information has been received from a 66 year old female consumer with glaucoma and allergic reaction to bee stings who on 20-JUN-2007 was vaccinated with her left arm with 0.65ml of ZOSTAVAX (Oka/Merck) (lot # 656395/0290u) expiration date 02-AUG-2008. Concomitant therapy included dorzolamide HCl (MSD) and LUMIGAN. "Every since then" the patient developed a red ringer under her right breast and around her side. The patient stated she had huge, itchy blisters and had piercing pain. Patient stated if she took a deep breath, she had sharp pain. For the first seven months the pain was severe, and not it's a throbbing pain. The patient also stated she had very bad headaches. She said she had the shot in her left arm and her arm was hard, red and swollen for two days. The patient was prescribed LYRICA. Medical attention was sought. The patient had a chest x-ray, mammogram, CT scan, bone scan, and an "Upper GI thing," the results were not provided. On 08-OCT-2007 the patient was diagnosed with shingles. At the time of the report the patient  had not recovered. There was no product quality complaint involved. Follow-up information from the patient indicated no new information.  Follow-up information from the nurse indicated no new information. Additional information requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Ultrasound scan
Clinical narrative: Information has been received from a 66 year old female consumer with glaucoma and allergic reaction to bee stings who on 20-JUN-2007 was vaccinated with her left arm with 0.65ml of ZOSTAVAX (Oka/Merck) (lot # 656395/0290u) expiration date 02-AUG-2008. Concomitant therapy included dorzolamide HCl (MSD) and LUMIGAN. "Every since then" the patient developed a red ringer under her right breast and around her side. The patient stated she had huge, itchy blisters and had piercing pain. Patient stated if she took a deep breath, she had sharp pain. For the first seven months the pain was severe, and not it's a throbbing pain. The patient also stated she had very bad headaches. She said she had the shot in her left arm and her arm was hard, red and swollen for two days. The patient was prescribed LYRICA. Medical attention was sought. The patient had a chest x-ray, mammogram, CT scan, bone scan, and an "Upper GI thing," the results were not provided. On 08-OCT-2007 the patient was diagnosed with shingles. At the time of the report the patient  had not recovered. There was no product quality complaint involved. Follow-up information from the patient indicated no new information.  Follow-up information from the nurse indicated no new information. Additional information requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chest X-ray, Musculoskeletal chest pain, Rash, Ultrasound scan
Clinical narrative: Information has been received from a 66 year old female consumer with glaucoma and allergic reaction to bee stings who on 20-JUN-2007 was vaccinated with her left arm with 0.65ml of ZOSTAVAX (Oka/Merck) (lot # 656395/0290u) expiration date 02-AUG-2008. Concomitant therapy included dorzolamide HCl (MSD) and LUMIGAN. "Every since then" the patient developed a red ringer under her right breast and around her side. The patient stated she had huge, itchy blisters and had piercing pain. Patient stated if she took a deep breath, she had sharp pain. For the first seven months the pain was severe, and not it's a throbbing pain. The patient also stated she had very bad headaches. She said she had the shot in her left arm and her arm was hard, red and swollen for two days. The patient was prescribed LYRICA. Medical attention was sought. The patient had a chest x-ray, mammogram, CT scan, bone scan, and an "Upper GI thing," the results were not provided. On 08-OCT-2007 the patient was diagnosed with shingles. At the time of the report the patient  had not recovered. There was no product quality complaint involved. Follow-up information from the patient indicated no new information.  Follow-up information from the nurse indicated no new information. Additional information requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Bone scan, Chest X-ray, Computerised tomogram, Erythema
Clinical narrative: Information has been received from a 66 year old female consumer with glaucoma and allergic reaction to bee stings who on 20-JUN-2007 was vaccinated with her left arm with 0.65ml of ZOSTAVAX (Oka/Merck) (lot # 656395/0290u) expiration date 02-AUG-2008. Concomitant therapy included dorzolamide HCl (MSD) and LUMIGAN. "Every since then" the patient developed a red ringer under her right breast and around her side. The patient stated she had huge, itchy blisters and had piercing pain. Patient stated if she took a deep breath, she had sharp pain. For the first seven months the pain was severe, and not it's a throbbing pain. The patient also stated she had very bad headaches. She said she had the shot in her left arm and her arm was hard, red and swollen for two days. The patient was prescribed LYRICA. Medical attention was sought. The patient had a chest x-ray, mammogram, CT scan, bone scan, and an "Upper GI thing," the results were not provided. On 08-OCT-2007 the patient was diagnosed with shingles. At the time of the report the patient  had not recovered. There was no product quality complaint involved. Follow-up information from the patient indicated no new information.  Follow-up information from the nurse indicated no new information. Additional information requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a 66 year old female consumer with glaucoma and allergic reaction to bee stings who on 20-JUN-2007 was vaccinated with her left arm with 0.65ml of ZOSTAVAX (Oka/Merck) (lot # 656395/0290u) expiration date 02-AUG-2008. Concomitant therapy included dorzolamide HCl (MSD) and LUMIGAN. "Every since then" the patient developed a red ringer under her right breast and around her side. The patient stated she had huge, itchy blisters and had piercing pain. Patient stated if she took a deep breath, she had sharp pain. For the first seven months the pain was severe, and not it's a throbbing pain. The patient also stated she had very bad headaches. She said she had the shot in her left arm and her arm was hard, red and swollen for two days. The patient was prescribed LYRICA. Medical attention was sought. The patient had a chest x-ray, mammogram, CT scan, bone scan, and an "Upper GI thing," the results were not provided. On 08-OCT-2007 the patient was diagnosed with shingles. At the time of the report the patient  had not recovered. There was no product quality complaint involved. Follow-up information from the patient indicated no new information.  Follow-up information from the nurse indicated no new information. Additional information requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Mammogram, Pain, Pruritus, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a 66 year old female consumer with glaucoma and allergic reaction to bee stings who on 20-JUN-2007 was vaccinated with her left arm with 0.65ml of ZOSTAVAX (Oka/Merck) (lot # 656395/0290u) expiration date 02-AUG-2008. Concomitant therapy included dorzolamide HCl (MSD) and LUMIGAN. "Every since then" the patient developed a red ringer under her right breast and around her side. The patient stated she had huge, itchy blisters and had piercing pain. Patient stated if she took a deep breath, she had sharp pain. For the first seven months the pain was severe, and not it's a throbbing pain. The patient also stated she had very bad headaches. She said she had the shot in her left arm and her arm was hard, red and swollen for two days. The patient was prescribed LYRICA. Medical attention was sought. The patient had a chest x-ray, mammogram, CT scan, bone scan, and an "Upper GI thing," the results were not provided. On 08-OCT-2007 the patient was diagnosed with shingles. At the time of the report the patient  had not recovered. There was no product quality complaint involved. Follow-up information from the patient indicated no new information.  Follow-up information from the nurse indicated no new information. Additional information requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Chest pain, Erythema, Groin pain
Clinical narrative: Information has been received from a 69 year old female consumer with no known allergies with breast cancer since 09-MAY-2007 who on 27-DEC-2007 was vaccinated with one dose of ZOSTAVAX.  Concomitant vaccinations included PNEUMOVAX and FLUZONE (unspecified) on 18-DEC-2007.  Concomitant therapy included atenolol, and "aromansin."  Subsequently, on 20-JAN-2008 the patient stated she got a very red, itchy rash on her right shoulder and right chest area.  After a few days, it turned yellow and continued to itch.  Another large patch broke out on 27-JAN-2008 on the right side below the first patch.  On 01-FEB-2008 she had an upper respiratory tract infection.  On 04-FEB-2008 she had a very sharp shooting pain in the center of her chest between her breasts.  On 09-FEB-2008 she had an extremely sharp pain in her groin area and the next day (10-FEB-2008) she felt a huge blister in the left vulva area, it did not itch but it burned.  That cleared up about ten days later.  Unspecified medical attention was sought, there were no lab studies performed.  At the time of the report the patient was recovering.  She still had the upper respiratory tract infection, but the rashes were clearing up.  The patient stated she is not on chemotherapy and is taking oral medication for cancer.  There was no product quality complaint involved.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a 69 year old female consumer with no known allergies with breast cancer since 09-MAY-2007 who on 27-DEC-2007 was vaccinated with one dose of ZOSTAVAX.  Concomitant vaccinations included PNEUMOVAX and FLUZONE (unspecified) on 18-DEC-2007.  Concomitant therapy included atenolol, and "aromansin."  Subsequently, on 20-JAN-2008 the patient stated she got a very red, itchy rash on her right shoulder and right chest area.  After a few days, it turned yellow and continued to itch.  Another large patch broke out on 27-JAN-2008 on the right side below the first patch.  On 01-FEB-2008 she had an upper respiratory tract infection.  On 04-FEB-2008 she had a very sharp shooting pain in the center of her chest between her breasts.  On 09-FEB-2008 she had an extremely sharp pain in her groin area and the next day (10-FEB-2008) she felt a huge blister in the left vulva area, it did not itch but it burned.  That cleared up about ten days later.  Unspecified medical attention was sought, there were no lab studies performed.  At the time of the report the patient was recovering.  She still had the upper respiratory tract infection, but the rashes were clearing up.  The patient stated she is not on chemotherapy and is taking oral medication for cancer.  There was no product quality complaint involved.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a 69 year old female consumer with no known allergies with breast cancer since 09-MAY-2007 who on 27-DEC-2007 was vaccinated with one dose of ZOSTAVAX.  Concomitant vaccinations included PNEUMOVAX and FLUZONE (unspecified) on 18-DEC-2007.  Concomitant therapy included atenolol, and "aromansin."  Subsequently, on 20-JAN-2008 the patient stated she got a very red, itchy rash on her right shoulder and right chest area.  After a few days, it turned yellow and continued to itch.  Another large patch broke out on 27-JAN-2008 on the right side below the first patch.  On 01-FEB-2008 she had an upper respiratory tract infection.  On 04-FEB-2008 she had a very sharp shooting pain in the center of her chest between her breasts.  On 09-FEB-2008 she had an extremely sharp pain in her groin area and the next day (10-FEB-2008) she felt a huge blister in the left vulva area, it did not itch but it burned.  That cleared up about ten days later.  Unspecified medical attention was sought, there were no lab studies performed.  At the time of the report the patient was recovering.  She still had the upper respiratory tract infection, but the rashes were clearing up.  The patient stated she is not on chemotherapy and is taking oral medication for cancer.  There was no product quality complaint involved.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Chest pain, Genital pain, Pain
Clinical narrative: Information has been received from a 69 year old female consumer with no known allergies with breast cancer since 09-MAY-2007 who on 27-DEC-2007 was vaccinated with one dose of ZOSTAVAX.  Concomitant vaccinations included PNEUMOVAX and FLUZONE (unspecified) on 18-DEC-2007.  Concomitant therapy included atenolol, and "aromansin."  Subsequently, on 20-JAN-2008 the patient stated she got a very red, itchy rash on her right shoulder and right chest area.  After a few days, it turned yellow and continued to itch.  Another large patch broke out on 27-JAN-2008 on the right side below the first patch.  On 01-FEB-2008 she had an upper respiratory tract infection.  On 04-FEB-2008 she had a very sharp shooting pain in the center of her chest between her breasts.  On 09-FEB-2008 she had an extremely sharp pain in her groin area and the next day (10-FEB-2008) she felt a huge blister in the left vulva area, it did not itch but it burned.  That cleared up about ten days later.  Unspecified medical attention was sought, there were no lab studies performed.  At the time of the report the patient was recovering.  She still had the upper respiratory tract infection, but the rashes were clearing up.  The patient stated she is not on chemotherapy and is taking oral medication for cancer.  There was no product quality complaint involved.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Upper respiratory tract infection, Vulval disorder
Clinical narrative: Information has been received from a 69 year old female consumer with no known allergies with breast cancer since 09-MAY-2007 who on 27-DEC-2007 was vaccinated with one dose of ZOSTAVAX.  Concomitant vaccinations included PNEUMOVAX and FLUZONE (unspecified) on 18-DEC-2007.  Concomitant therapy included atenolol, and "aromansin."  Subsequently, on 20-JAN-2008 the patient stated she got a very red, itchy rash on her right shoulder and right chest area.  After a few days, it turned yellow and continued to itch.  Another large patch broke out on 27-JAN-2008 on the right side below the first patch.  On 01-FEB-2008 she had an upper respiratory tract infection.  On 04-FEB-2008 she had a very sharp shooting pain in the center of her chest between her breasts.  On 09-FEB-2008 she had an extremely sharp pain in her groin area and the next day (10-FEB-2008) she felt a huge blister in the left vulva area, it did not itch but it burned.  That cleared up about ten days later.  Unspecified medical attention was sought, there were no lab studies performed.  At the time of the report the patient was recovering.  She still had the upper respiratory tract infection, but the rashes were clearing up.  The patient stated she is not on chemotherapy and is taking oral medication for cancer.  There was no product quality complaint involved.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Erythema, Lacrimation increased, Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old white female with no history of drug reactions or allergies who on 21-FEB-2008 was vaccinated subcutaneously into the left arm with 0.65 ml of ZOSTAVAX (lot # 659325/1823U).  On 21-FEB-2008 the patient developed chills, achiness all over, watery eyes, fever, stiff neck and tight breathing within 8 hours of vaccination with ZOSTAVAX.  The pharmacist reported that the patient developed a local reaction at the injection site 30 hours after vaccination, described as red, swollen, itchy and warm with fever.  The patient called the pharmacy on 23-FEB-2008 to report the events, and visited the pharmacy on 25 FEB 2008.  The pharmacist reported that the 25 FEB 2008 patient still had the local injection site reaction, chills and general malaise.  The pharmacist described the injection site reaction as red and swollen, about 4 inches around.  The pharmacist spoke with her a few more times, and she did not contact a physician or visit the ER.  She was still having symptoms on 25-FEB-2008.  On 05-MAR-2008 the patient recovered.  There was no product quality complaint.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local swelling, Musculoskeletal stiffness, Pain, Pruritus, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old white female with no history of drug reactions or allergies who on 21-FEB-2008 was vaccinated subcutaneously into the left arm with 0.65 ml of ZOSTAVAX (lot # 659325/1823U).  On 21-FEB-2008 the patient developed chills, achiness all over, watery eyes, fever, stiff neck and tight breathing within 8 hours of vaccination with ZOSTAVAX.  The pharmacist reported that the patient developed a local reaction at the injection site 30 hours after vaccination, described as red, swollen, itchy and warm with fever.  The patient called the pharmacy on 23-FEB-2008 to report the events, and visited the pharmacy on 25 FEB 2008.  The pharmacist reported that the 25 FEB 2008 patient still had the local injection site reaction, chills and general malaise.  The pharmacist described the injection site reaction as red and swollen, about 4 inches around.  The pharmacist spoke with her a few more times, and she did not contact a physician or visit the ER.  She was still having symptoms on 25-FEB-2008.  On 05-MAR-2008 the patient recovered.  There was no product quality complaint.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old white female with no history of drug reactions or allergies who on 21-FEB-2008 was vaccinated subcutaneously into the left arm with 0.65 ml of ZOSTAVAX (lot # 659325/1823U).  On 21-FEB-2008 the patient developed chills, achiness all over, watery eyes, fever, stiff neck and tight breathing within 8 hours of vaccination with ZOSTAVAX.  The pharmacist reported that the patient developed a local reaction at the injection site 30 hours after vaccination, described as red, swollen, itchy and warm with fever.  The patient called the pharmacy on 23-FEB-2008 to report the events, and visited the pharmacy on 25 FEB 2008.  The pharmacist reported that the 25 FEB 2008 patient still had the local injection site reaction, chills and general malaise.  The pharmacist described the injection site reaction as red and swollen, about 4 inches around.  The pharmacist spoke with her a few more times, and she did not contact a physician or visit the ER.  She was still having symptoms on 25-FEB-2008.  On 05-MAR-2008 the patient recovered.  There was no product quality complaint.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Lacrimation increased, Local reaction, Malaise, Musculoskeletal stiffness
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old white female with no history of drug reactions or allergies who on 21-FEB-2008 was vaccinated subcutaneously into the left arm with 0.65 ml of ZOSTAVAX (lot # 659325/1823U).  On 21-FEB-2008 the patient developed chills, achiness all over, watery eyes, fever, stiff neck and tight breathing within 8 hours of vaccination with ZOSTAVAX.  The pharmacist reported that the patient developed a local reaction at the injection site 30 hours after vaccination, described as red, swollen, itchy and warm with fever.  The patient called the pharmacy on 23-FEB-2008 to report the events, and visited the pharmacy on 25 FEB 2008.  The pharmacist reported that the 25 FEB 2008 patient still had the local injection site reaction, chills and general malaise.  The pharmacist described the injection site reaction as red and swollen, about 4 inches around.  The pharmacist spoke with her a few more times, and she did not contact a physician or visit the ER.  She was still having symptoms on 25-FEB-2008.  On 05-MAR-2008 the patient recovered.  There was no product quality complaint.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old white female with no history of drug reactions or allergies who on 21-FEB-2008 was vaccinated subcutaneously into the left arm with 0.65 ml of ZOSTAVAX (lot # 659325/1823U).  On 21-FEB-2008 the patient developed chills, achiness all over, watery eyes, fever, stiff neck and tight breathing within 8 hours of vaccination with ZOSTAVAX.  The pharmacist reported that the patient developed a local reaction at the injection site 30 hours after vaccination, described as red, swollen, itchy and warm with fever.  The patient called the pharmacy on 23-FEB-2008 to report the events, and visited the pharmacy on 25 FEB 2008.  The pharmacist reported that the 25 FEB 2008 patient still had the local injection site reaction, chills and general malaise.  The pharmacist described the injection site reaction as red and swollen, about 4 inches around.  The pharmacist spoke with her a few more times, and she did not contact a physician or visit the ER.  She was still having symptoms on 25-FEB-2008.  On 05-MAR-2008 the patient recovered.  There was no product quality complaint.  Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Rash, Varicella zoster virus serology positive
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 64 year old female consumer with sulfonamide allergy, osteopenia and menopause who on 29-FEB-2008 at 09:57 was vaccinated SQ in the left arm with zoster vaccine live (Oka/Merck) (lot # 659324/1835U). There was no illness at the time of vaccination and no concomitant medication. On 04-MAR-2008, the patient reported a blotchy red rash on her buttock and posterior thigh which started on 02-MAR-2008. The patient was examined on 05-MAR-2008 and had a classic zoster rash left S1 distribution, left arm normal. A Rapid Culture from the buttock area was obtained and reported as positive for varicella zoster. The patient was put on Valtrex 1gm three times a day X 7 days. On 11-MAR-2008, the physician spoke to the patient and the patient was doing well. It was reported that the rash "dried up." There was no product quality complaint involved. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Culture positive, Herpes zoster, Rash erythematous, Rash macular, Varicella zoster virus serology positive
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 64 year old female consumer with sulfonamide allergy, osteopenia and menopause who on 29-FEB-2008 at 09:57 was vaccinated SQ in the left arm with zoster vaccine live (Oka/Merck) (lot # 659324/1835U). There was no illness at the time of vaccination and no concomitant medication. On 04-MAR-2008, the patient reported a blotchy red rash on her buttock and posterior thigh which started on 02-MAR-2008. The patient was examined on 05-MAR-2008 and had a classic zoster rash left S1 distribution, left arm normal. A Rapid Culture from the buttock area was obtained and reported as positive for varicella zoster. The patient was put on Valtrex 1gm three times a day X 7 days. On 11-MAR-2008, the physician spoke to the patient and the patient was doing well. It was reported that the rash "dried up." There was no product quality complaint involved. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: Information has been received from a physician concerning a 74 year old male who on 18-MAR-2008 was vaccinated with a dose of ZOSTAVAX SQ in the left arm (lot# 659762/1874U).  Concomitant therapy included CELEBREX, warfarin, lisinopril and metoprolol.  On 19-MAR-2008 the patient experienced shingles on the trunk above the belly but below the chest.  Patient had no itching or pain but only had a rash.  Regarding medical treatment the patient only spoke to the pharmacist.  No product quality complaint.  Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 74 year old male who on 18-MAR-2008 was vaccinated with a dose of ZOSTAVAX SQ in the left arm (lot# 659762/1874U).  Concomitant therapy included CELEBREX, warfarin, lisinopril and metoprolol.  On 19-MAR-2008 the patient experienced shingles on the trunk above the belly but below the chest.  Patient had no itching or pain but only had a rash.  Regarding medical treatment the patient only spoke to the pharmacist.  No product quality complaint.  Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Eye swelling, Rash, Scab
Clinical narrative: Information has been received from an 85 year old male consumer who on 20-MAR-2008 at 12:58 pm was vaccinated in the left deltoid with ZOSTAVAX (Oka/Merck).  Subsequently, on 24-MAR-2008 at 08:00 am the patient's right eye was very swollen and later his left eye became swollen.  The patient had red spots, then scabs on his chest, his back and also on his legs.  The patient was seen by a physician and diagnosed with shingles.  On 28-MAR-2008 the patient was
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Scab
Clinical narrative: Information has been received from an 85 year old male consumer who on 20-MAR-2008 at 12:58 pm was vaccinated in the left deltoid with ZOSTAVAX (Oka/Merck).  Subsequently, on 24-MAR-2008 at 08:00 am the patient's right eye was very swollen and later his left eye became swollen.  The patient had red spots, then scabs on his chest, his back and also on his legs.  The patient was seen by a physician and diagnosed with shingles.  On 28-MAR-2008 the patient was
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash erythematous
Clinical narrative: Information has been received from an 85 year old male consumer who on 20-MAR-2008 at 12:58 pm was vaccinated in the left deltoid with ZOSTAVAX (Oka/Merck).  Subsequently, on 24-MAR-2008 at 08:00 am the patient's right eye was very swollen and later his left eye became swollen.  The patient had red spots, then scabs on his chest, his back and also on his legs.  The patient was seen by a physician and diagnosed with shingles.  On 28-MAR-2008 the patient was
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Eye swelling, Herpes zoster, Scab
Clinical narrative: Information has been received from an 85 year old male consumer who on 20-MAR-2008 at 12:58 pm was vaccinated in the left deltoid with ZOSTAVAX (Oka/Merck).  Subsequently, on 24-MAR-2008 at 08:00 am the patient's right eye was very swollen and later his left eye became swollen.  The patient had red spots, then scabs on his chest, his back and also on his legs.  The patient was seen by a physician and diagnosed with shingles.  On 28-MAR-2008 the patient was
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from physician concerning a 67 year old female with allergies to penicillin and sulfonamides who on 09-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneously in the left arm (Lot #659759/1873U). On 09-APR-2008 at 8:00 PM, the patient noticed a rash at the site of injection. By 10-Apr-2008 PM, the rash extended from the site of the injection to the elbow. The rash was red warm itchy and painful. The rash remained the same through 12-Apr-2008. On 13-Apr-2008, the patient reported that the rash was improving and not painful. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain, Rash pustular
Clinical narrative: Information has been received from a 73 year old male retired dentist with no known allergies and hypertension who on 26-JUL-2007 was vaccinated SQ with zoster vaccine live (Oka/Merck) (lot # 656859/0357u). Concomitant therapy included lisinopril, Felodipin, hydrochlorothiazide, iron (unspecified) and omega fish oil. The patient reported he developed a rash with pustules and numbness of the right thigh on 03-APR-2008. He was examined in the emergency room. There were no lab studies performed. The patient was initially diagnosed with contact dermatitis. The patient was prescribed hydrocortisone ointment. On 12-APR-2008, the patient was examined by a dermatologist and was diagnosed with shingles. It was reported that the rash extended from the right thigh to the right buttock and into the right groin area. At the time of the report the rash was improving without requiring treatment. There was no product quality complaint involved. Follow-up information from the patient indicated that the lesions are drying up, but he was in considerable pain and was experiencing a numbness of the skin on his right thigh, where the lesions erupted. Follow information from the nurse indicated no new information. additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Herpes zoster, Hypoaesthesia, Pain, Rash pustular
Clinical narrative: Information has been received from a 73 year old male retired dentist with no known allergies and hypertension who on 26-JUL-2007 was vaccinated SQ with zoster vaccine live (Oka/Merck) (lot # 656859/0357u). Concomitant therapy included lisinopril, Felodipin, hydrochlorothiazide, iron (unspecified) and omega fish oil. The patient reported he developed a rash with pustules and numbness of the right thigh on 03-APR-2008. He was examined in the emergency room. There were no lab studies performed. The patient was initially diagnosed with contact dermatitis. The patient was prescribed hydrocortisone ointment. On 12-APR-2008, the patient was examined by a dermatologist and was diagnosed with shingles. It was reported that the rash extended from the right thigh to the right buttock and into the right groin area. At the time of the report the rash was improving without requiring treatment. There was no product quality complaint involved. Follow-up information from the patient indicated that the lesions are drying up, but he was in considerable pain and was experiencing a numbness of the skin on his right thigh, where the lesions erupted. Follow information from the nurse indicated no new information. additional information is not expected.