chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: Information has been received from a physician concerning a 68 year old female with no known allergies who on 29-DEC-2006 was vaccinated SC with a 0.5 ml dose of varicella-zoster vaccine.  "Within 24 hours", on 30-DEC-2006 the patient developed an injection site reaction. The patient's symptoms included local heat, redness, pain and itching. Unspecified medical attention was sought.  At the time of the report the symptoms continued and the patient had not recovered.  There was no product quality complaint involved.  No further information was available.  Additional information has been requested. The patient had allergies to losartan potassium (WAES # 073USA00372)and hydrochlorothiarde (+) losartan potassium (WAES #0703USA00373).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a female consumer who on 22-DEC-2006 was vaccinated IM with one 0.65 ml dose of varicella-zoster virus vaccine.  On 22-DEC-2005 the patient developed a rash at the injection site which lasted "about 24-36 hours." The patient recovered.  There was no product quality complaint involved.  No further information was available.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of varicella-zoster virus vaccine.  Subsequently the patient developed a rash around the injection site.  Unspecified medical attention was sought.  Subsequently, the patient recovered. There was no product quality complaint involved.  Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male who on an unspecified date was vaccinated with a dose of varicella-zoster virus instead of varicella virus vaccine.  The nurse stated that this was "probably an error on their end", she felt that the two vaccines were "clearly marked" with the vaccine names.  The patient had not had any adverse experiences.  There was no product quality complaint involved. No further information was provided.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from an 81 year old female consumer with a prolapse heart valve and a history of hysterectomy (45 years ago) who on 18-DEC-2006 at 14:30 was vaccinated SC in the "fat part" of the left deltoid with a first dose of ZOSTAVAX vaccine (Merck).  Concomitant therapy included MSD, DIOVAN HCT, TOPROL XL, ECOTRIN, CENTRUM SILVER, CALTRATE 600 PLUS VITAMIN D, beta carotene and cyanocobalamin.  On 19-DEC-2006 the patient developed a rash which "has gotten worse". The rash started in the forearms and spread to the top of her hands and "now" the rash is in the ankle and going up the leg into the torso. She mentioned that at the site of injection there was a 0.5 inch x 2 inch "strip like area" that was discolored, sore and red. The consumer went to see a dermatologist on 27-DEC-2006 and was prescribed triamcinolone topical lotion. She used the lotion until it was gone and saw the dermatologist again on 08-JAN-2007.  The lotion was not working and the dermatologist told the patient that the rash would have to run its course through the body. The patient will go back to the dermatologist in three to four weeks if needed.  At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 02/13/2007. Additional information from the registered nurse who reported that on 26-DEC-2006 the patient called the physician's office to report her rash. She was seen on 27-DEC-2006 and had a 1 cm X 2 cm lesion at the site of injection which the physician did not feel was problematic. On the ventral aspect of each forearm the patient had erythema multiforme which looked like small little red dots the size of "push pin heads" from the elbow to the wrist. The physician thought that this reaction was a problem so she referred the patient to the dermatologist. On 28-DEC-2007 she was seen by the dermatologist and the derm consult was drug reaction and the patient was treated with triamcinolone. The nurse reported that the patietn had a significant reaction, however it wasn't something of imminent doom". The patient's experience was not life threatening, the patient never went to ER, was not hospitalized and is not disabled. She felt that it was 7 on a scale of 1-10. The patient was seen at the dermatologist again 10 days later on 08-JAN-2007 and had since recovered. No further information is expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from an 81 year old female consumer with a prolapse heart valve and a history of hysterectomy (45 years ago) who on 18-DEC-2006 at 14:30 was vaccinated SC in the "fat part" of the left deltoid with a first dose of ZOSTAVAX vaccine (Merck).  Concomitant therapy included MSD, DIOVAN HCT, TOPROL XL, ECOTRIN, CENTRUM SILVER, CALTRATE 600 PLUS VITAMIN D, beta carotene and cyanocobalamin.  On 19-DEC-2006 the patient developed a rash which "has gotten worse". The rash started in the forearms and spread to the top of her hands and "now" the rash is in the ankle and going up the leg into the torso. She mentioned that at the site of injection there was a 0.5 inch x 2 inch "strip like area" that was discolored, sore and red. The consumer went to see a dermatologist on 27-DEC-2006 and was prescribed triamcinolone topical lotion. She used the lotion until it was gone and saw the dermatologist again on 08-JAN-2007.  The lotion was not working and the dermatologist told the patient that the rash would have to run its course through the body. The patient will go back to the dermatologist in three to four weeks if needed.  At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 02/13/2007. Additional information from the registered nurse who reported that on 26-DEC-2006 the patient called the physician's office to report her rash. She was seen on 27-DEC-2006 and had a 1 cm X 2 cm lesion at the site of injection which the physician did not feel was problematic. On the ventral aspect of each forearm the patient had erythema multiforme which looked like small little red dots the size of "push pin heads" from the elbow to the wrist. The physician thought that this reaction was a problem so she referred the patient to the dermatologist. On 28-DEC-2007 she was seen by the dermatologist and the derm consult was drug reaction and the patient was treated with triamcinolone. The nurse reported that the patietn had a significant reaction, however it wasn't something of imminent doom". The patient's experience was not life threatening, the patient never went to ER, was not hospitalized and is not disabled. She felt that it was 7 on a scale of 1-10. The patient was seen at the dermatologist again 10 days later on 08-JAN-2007 and had since recovered. No further information is expected.
Age: 16.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 16-year-old female who on 08-JAN-2007 was vaccinated SC with a dose of varicella-zoster virus vaccine (lot # 652966/0722F) instead of her second dose of varicella vaccine. Unspecified medical attention was sought.  It was reported that the patient was not experiencing any known symptoms.  The patient was vaccinated with her first dose of varicella vaccine on 22-JAN-1996, at 5 years of age. No product quality complaint was involved.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a physician concerning a 60 year old female with diabetes who on 05-JAN-2007 was vaccinated SC in the left arm with a first dose of varicella-zoster virus vaccine (Merck) (lot # 652925/0621F). There was no illness at the time of vaccination. Subsequently later in the day on 05-JAN-2007, the patient's injection site was red, tender, itching and swollen. On 10-JAN-2007 the patient was seen in the doctor's office and was treated with Benadryl topical cream and cool compresses.  At the time of the report, the patient had not recovered. There was no product quality complaint involved.  Additional information has been requested. Additional information indicated that on 06-JAN-2007 (previously reported as 05-JAN-2007) the patient developed pain, itching, redness and swelling at the site of injection involving most of the upper arm. The patient's experiences resolved completed on 17-JAN-2007. No laboratory tests were performed. The patient had no adverse events following prior vaccinations. No further information is expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 76 year old female with no known allergies, asthma, diabetes, hypothyroidism and hyperlipidemia who on 04-JAN-2007 was vaccinated in the left arm with a 0.65 ml dose of Zostavax (lot#654604/1406F). Concomitant therapy included SYNTHROID, ZOLOFT, alendronate sodium, LIPITOR, PROVENTIL, XANAX, AMBIEN, diclofenac Na, ADVAIR, aspirin, calcium (unspecified), vitamin D (unspecified), DECONEX. The next day, on 05-JAN-2007, the patient called the office complaining of slight redness and itchiness at the injection site. By the next morning, on 06-JAN-2007, the injection was more irritated, dry, and red. Unspecified medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality was not involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old female with no known allergies, hyperlipidemia, and osteoporosis who on 19-DEC-2006 was vaccinated in the left arm with a 0.65 ml dose of Zostavax (lot#654604/1406F0. Concomitant therapy included simvastatin, lisinopril, alendronate sodium, estrogens, conjugated (PREMARIN), and multivitamins (unspecified). Within 24 hours, on 21-DEC-2006, the patient presented to the office with a localized site reaction of the left arm that swelled from her left elbow to the shoulder and was red. No treatment was received and the patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 75 year old female with hyperlipidaemia, anaemia and hypothyroid who on 15-DEC-2006 was vaccinated in the right arm with a 0.65 ml dose of Zostavax (lot#654604/1406F). Concomitant therapy included atenolol (manufacturer unknown), NASONEX, TRICOR, ALTACE, RELAFEN and SYNTHROID. At a visit to the doctor's office on 03-JAN-2007 the patient mentioned that post vaccination she experienced redness at the injection site and her entire body felt itchy. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated SC with a single dose of Zostavax. Subsequently the patient experienced swelling in the arm with a blister after receiving the injection. At the time of the report the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a "between 60 and 65 year old" male consumer who on unspecified date was vaccinated with one dose of Zostavax. There was no concomitant medication. The patient noticed red spots on his arm after vaccine administration, it was reported that the red spots were not at the injection site. Unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently, the patient developed a mild case of shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient developed localized cellulitis at the injection site and swelling in the arm. Unspecified medical attention was sought. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning an 84 year old female with an allergy to sulfa medications who on 05-JAN-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Three days after vaccination, on 08-JAN-2007, the patient developed herpes zoster. Unspecified medical attention was sought. At the time of the report, the patient had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous stomatitis, Blister, Herpes simplex, Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a 52 year old female licensed practical nurse with a penicillin allergy and no other medical history who on 27-NOV-2006 at 10:00 am was vaccinated SC in the left deltoid with a 0.5 mL dose of ZOSTAVAX (Merck) (lot # 652925/0621F). There was no concomitant medication. There was no illness at the time of vaccination. Since November 2006, she has had two incidents or oral herpes simplex lesions. On 16-JAN-2007, she also developed a single vesicular lesion on her forehead that is starting to crust over. No other symptoms were noted. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. Follow-up information from the licensed practical nurse indicated that on 03-DEC-2006 at 7:00 am the patient developed her first herpes simplex on the lip. The patient developed 3 cold sores" on the lip, on canker sore in the mouth, one sore in the nostril, and a blister like lesion on her forehead all within a two month period. It was reported that the patient had no prior problems before ZOSTAVAX (Merck) (lot # 652925/0621F). It was reported that the patient required a doctor visit. She recovered on 30-JAN-2007. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Skin lesion
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a 52 year old female licensed practical nurse with a penicillin allergy and no other medical history who on 27-NOV-2006 at 10:00 am was vaccinated SC in the left deltoid with a 0.5 mL dose of ZOSTAVAX (Merck) (lot # 652925/0621F). There was no concomitant medication. There was no illness at the time of vaccination. Since November 2006, she has had two incidents or oral herpes simplex lesions. On 16-JAN-2007, she also developed a single vesicular lesion on her forehead that is starting to crust over. No other symptoms were noted. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. Follow-up information from the licensed practical nurse indicated that on 03-DEC-2006 at 7:00 am the patient developed her first herpes simplex on the lip. The patient developed 3 cold sores" on the lip, on canker sore in the mouth, one sore in the nostril, and a blister like lesion on her forehead all within a two month period. It was reported that the patient had no prior problems before ZOSTAVAX (Merck) (lot # 652925/0621F). It was reported that the patient required a doctor visit. She recovered on 30-JAN-2007. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a male patient who on 26-DEC-2006 was vaccinated with a first dose of Zostavax. Concomitant therapy included VIAGRA, vitamins (unspecified), LOPID, and ACTONEL. On approximately 31-DEC-2006, the patient developed a rash all over his body. The physician prescribed MEDROL dose pads to help, however, the patient has not recovered and is due to see the physician for a follow-up visit. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the physician who reported that the "rash was not from the vaccine as originally thought." There was "no reaction." No further information is expected.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a physician and physician assistant concerning a 1 year old male patient who on 18-JAN-2007 was vaccinated IM in the thigh with a dose of Zostavax (Merck) (lot # 652947/1411F) instead of Varivax (Merck). Concomitant vaccination included a dose of MMR II (lot # 651803/0631F) given IM in the thigh and PROHIBIT (manufacturer unknown) (lot # UE976AE) given IM in the thigh. The physician reported that there was no product confusion, "it was human error." No adverse reaction noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information indicated there were no adverse symptoms. No further information is expected.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Influenza like illness
Clinical narrative: Information has been received from a 58 year old male consumer with no known medical history or allergies who in "early" January 2007, was vaccinated with a 0.5 ml dose of Zostavax. There was no concomitant medication. Subsequently the patient experienced flu-like symptoms. Unspecified medical attention was sought. No laboratory tests were performed. At the time of the report, the patient had not recovered. There was no product complaint involved. No further information is available.
Age: 13.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a physician and registered nurse concerning a 13 year old female patient who on 19-JAN-2007 was vaccinated IM in the right deltoid with a dose of Zostavax (lot#652947/1411F) instead of Gardasil. Concomitant vaccination on 19-JAN-2007 included influenza virus vaccine (unspecified). No adverse experiences were related to this event. On 20-JAN-2007 the patient returned and was vaccinated in the left deltoid with a dose of Gardasil (yeast) (lot#654510/0962F). The nurse reported that the vaccines were stored in separate bins which were clearly labeled and the wrong vaccine was selected by a new nurse. There was no product quality compliant involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/13/2007. Information has been received from a physician and a medical assistant concerning a 12 year old female patient with no allergies or medical history who on approximately 28-DEC-2006 at 11:00 AM was mistakenly vaccinated in the left arm by a medical assistant with a first dose of Zostavax (Merck) (lot # 652925/0621F) instead of a dose of Varivax (Merck). This was to be a booster dose of Varivax (Merck). The first dose was given at 5 years of age. There was no illness at the time of vaccination. As of 05-JAN-2007, the child had not experienced an adverse events. No medical attention was sought and no diagnostic laboratory tests were performed. It was noted that because the Zostavax (Merck) and the Varivax (Merck) are stored in the refrigerator and the packages look the same, she inadvertently grabbed the wrong vaccine. At the time, they had no more Zostavax (Merck), but they planned on keeping the Zostavax (Merck) and Varivax (Merck) vaccinees in separate boxes in the future. It was noted that the patient had no adverse events following prior vaccination. No further information is expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Rash erythematous, Urticaria
Clinical narrative: Information has been received from a physician concerning an adult male who on approximately 08-JAN-2007 was vaccinated SC with a 0.5 ml dose of Zostavax. There was no concomitant medication. Three days after his vaccination, on approximately 11-JAN-2007, the patient was swimming in an area with jellyfish and developed a red rash on both legs shortly after leaving the water. Unspecified medical attention was sought and the patient was treated with Zyrtec for itching. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/13/2007. Additional information has been received from the physician who reported that on 14-Jan-2007, the patient noticed the onset of hives on the lower extremities in an area below his shorts after canoeing in brackish water containing a lot of dead jellyfish. It was unknwon if the patient recovered but he did self-refer to dermatology. No further information is epected.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 15-JAN-2007 was vaccinated with a dose of Zostavax. Two days after vaccination, on approximately 17-JAN-2007, the patient developed a rash on the lower extremities. It was a very specific rash, not blisters, more like a round, red circle rash. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 77 year old male with hypertension, hyperlipidemia and a history of cerebrovascular accident who on 16-OCT-2006 was vaccinated SC in the left arm with a first dose of Zostavax (Merck) (lot # 652965/0622F). On 03-DEC-2006, six weeks after vaccination the patient developed shingled over his face and scalp. Medical attention was sought. It was reported that the patient had no prodrome and minimum neuropathic pain. At the time of the report the patient was recovering but not well yet. No further information was provided. Additional has been requested.  This is in follow-up to report(s) previously submitted on 2/13/2007. Additional information from the physician indicated that on an unspecified date the patient recovered. It was reported that the patient had no neuralgia, either prodromal or post infection. The patient felt that the vaccine "made his shingles better" No further information was provided. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a female who on 19-JAN-2007 was vaccinated with Zostavax. On 23-JAN-2007, the patient experienced shingles on her buttocks. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 73 year old female with no known allergies who on 21-JAN-2007 was vaccinated SC with a dose of Zostavax (lot#656412/1476F). Subsequently, the patient developed redness with a little bit of pink around the injection site about the size of a half dollar. The area was slightly hard and tender. No laboratory tests were performed and medical attention was not sought. As of 24-JAN-2007 the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 02/13/2007. Information has been received from a physician concerning a 73 year old female with no known allergies who on 20-JAN-2007 at 17:45 was vaccinated SC with a first dose of Zostavax (lot # 656412/1476F). Subsequently, in the evening on 20-JAN-2007, the patient developed redness with a little bit of pink around the injection site about the size of a half dollar. The area was slightly hard and tender. It was also reported that the site was warm tot ouch. The patient's adverse events lasted approximately 4 days. No laboratory tests were performed and medical attention was not sought. The patient recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Hypoaesthesia, Pain, Skin burning sensation
Clinical narrative: Information has been received from a health professional concerning a patient who on 04-JAN-2007 was vaccinated with Zostavax. Subsequently the patient experienced blisters which were located near her ankles. The symptoms were burning, stinging and numbness. The reporter did not think that the blisters were due to the vaccine. No additional information was provided. Additional information has been requested. Follow-up information indicated that the patient was exposed to shingles for two weeks prior to vaccination. She was the caregiver to her husband. Twenty three days after the vaccines on approximately 27-JAN-2007, the patient broke out. This lasted just a few days and the patient "seems fine". She had no pain. The reporter indicated that there was "no reaction to the vaccine". Additional inforamtion has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a child who was vaccinated with a dose of Zostavax. The pharmacist did not know why nurse picked up Zostavax and vaccinated the patient. No additional information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Conjunctivitis, Eye infection
Clinical narrative: Information has been received from a 71 year old male consumer with no known allergies and hypertension who on 12-DEC-2006 was vaccinated SC with a single dose of Zostavax. Concomitant therapy included Lipitor and atenolol. On 13-DEC-2006 the patient experienced conjunctivitis. Unspecified medical attention was sought. There were no lab tests performed. On 14-DEC-2006 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Follow up information received from the registered nurse indicated that on the night of the injection (also reported as 16-DEC-2006) the patient developed pus in one eye and was seen by an ophthalmologist. At the time of the report the patient had recovered. It was unknown if the patient had any adverse events following prior vaccination. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from a physician concerning a 68 year old female with controlled diabetes who was vaccinated with a dose of Zostavax. On 29-JAN-2007 the physician reported that the patient "recently" developed shingles within four to five days of vaccination. The physician felt that it could be transmission from the patient's spouse who received his vaccination on an earlier unspecified date. Unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/13/2007.  Information has been received from a physician concerning a 68 year old female with controlled diabetes who on 10-JAN-2007 was vaccinated with a dose ZOSTAVAX (Merck).  On 29-JAN-2007 the physician reported that the patient "recently" developed shingles within four to five days of vaccination.  The physician felt that it could be transmission from the patient's spouse who received his vaccination on an earlier unspecified date.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  There was no product quality complaint involved.  Additional information from the physician indicated on 18-JAN-2007 the patient contacted the physician's office with complaints of itchy, painful lesions on her back.  She was seen in the office on 23-FEB-2007 and diagnosed with shingles in an unspecified thoracic dermatome.  At that time the lesions and pain remained, however the itching had improved.  The patient continued to improve after that visit with the majority of lesions resolving.  On 02-FEB-2007 the lesions returned and the patient was seen in the office on 06-FEB-2007 again with shingles.  She was started on an unspecified antiviral therapy.  No further information was available.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pustular, Secondary transmission
Clinical narrative: Information has been received from a registered nurse concerning a child whose grandparents were vaccinated with a dose of Zostavax on an unspecified date. The patient was in contact with the grandparents several days after they were vaccinated. The patient developed pustules after the contact. A product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Diabetes mellitus, Fatigue, Pollakiuria, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 60 year old male with no known medical history or allergies who on 12-JAN-2007 was vaccinated with a first dose of Zostavax (lot#652947/1212F). Concomitant therapy included amoxicillin, Valtrex, Triglide, Diovan. The patient showed symptoms of diabetes one day after vaccination on 13-JAN-2007. The patient's sugar levels were "A1C" 10.6 and sugars 355. The patient experienced fatigue, blurred vision and frequent urination. The patient previously showed sugars of 132 in December 2005 and 109 in December 2004. Unspecified medical attention was sought. Addition information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician assistant concerning an 83 year old female who on approximately 17-JAN-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included Synthroid, Celebrex, LESCOL, Flonase, Zyrtec, Prozac, Avapro. Subsequently shortly after receiving the vaccine, the patient developed shingles and rash on the right side of her back. At the time of the report, the patient had not recovered. Unspecified medial attention was sought. There was no product complaint involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a health professional concerning a 71 year old female with hypothyroidism and a history of gastroesophageal reflux disease who on 25-JAN-2007 was vaccinated IM with a 0.5 ml dose of Zostervax (lot #656412/1476F). Concomitant therapy included Synthroid. On 30-JAN-2007 the patient developed itching, pain and a rash, which was located on the left back. The patient was seen in the office on 31-JAN-2007 and diagnosed with shingles. There was no change in the rash from 30-JAN-2007 to 31-JAN-2007. The patient was given prescriptions for prednisone, FAMVIR and VICODIN. No laboratory tests were performed. The patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever, 102.9 Axilary, Vomiting. He is still running a temp of 101.5 in the morning of 2-18-07. Contacted the Dr. @ 1AM. Administering Tylenol.
Age: 0.2
Sex: M
Vaccine: HIBV
Symptoms: Dysphonia, Dyspnoea, Food allergy, Gastrooesophageal reflux disease, Heart rate increased
Clinical narrative: 2 hours after administration of HIB vaccine, my son demonstrated high fever (103), hoarseness, rapid heart rate and some difficulty breathing.  Upon calling doctor on call (Saturday) I was told it is not a reaction to the vaccine.
Age: 0.2
Sex: M
Vaccine: HIBV
Symptoms: Hypersensitivity, Milk allergy, Pyrexia
Clinical narrative: 2 hours after administration of HIB vaccine, my son demonstrated high fever (103), hoarseness, rapid heart rate and some difficulty breathing.  Upon calling doctor on call (Saturday) I was told it is not a reaction to the vaccine.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: developed mild chickenpox 2/2007, rash began 2-3 wks after varicella case at school
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Intensive care, Intestinal perforation, Intubation, Intussusception
Clinical narrative: Patient developed GI symptoms (vomiting) on 2/3/2007  (31 days after receiving 3rd Rotateq).  Was diagnosed with intussception on 2/7/2007.  Suffered perforation of intestine during attempt to reduce by Barium enema, requiring emergent laparotomy and reanastomosis of small bowel.  Suffered a 2nd bowel perforation on 2/12/2007.  Illness resulted in ICU admission, intubation, probable sepsis.  3/15/07 Received partial medical records from hospital which reveal patient admitted 2/7/07 after experienced +IS s/p perforation x 2 w/OR repair who developed fever, elevated WBC, increasing discomfort & irritability.  Returned to OR on 2/15 for transverse colon perforation. FINAL DX: none at present as patient still hospitalized.  Peritonitis, either resistant bacteria such as MRSA or fungal were considered likely. T/C to hospital to determine D/C status of patient & to request D/C Summary if available.  Patient d/c to home 3/14.  No D/C Summary dictated yet.  Will request later. 4/10/07 Received D/C summary from hospital which reveals patient admitted from 2/7/07-3/14/07.  Admitted w/abdominal pain & emesis x approx 5 days w/lethargy & dehydration.  Treated at outlying hospital w/IVF prior to transfer for surgery on 2/7/07 was exp lap w/ileocecectomy w/primary anastomosis; then, lysis of adhesions & repair of transverse colon perforation on 2/12/07.  Condition was critical & worsened prior to second surgry w/patient remaining intubated & in PICU.  After second surgery & continued IVF, antibiotics & TPN, had gradual improvement & was successfully extubated.  Despite treatment, continued to have intermittent fevers & multiple w/ups were done, all were neg for source of infection.  Transitioned from TPN to NJ feeds & was transferred to regular peds floor.  Gradually, oral feeds were introduced & tolerated & NJ feeds were d/c.  Patient had become accustomed to MSO4 pain med & had extensive wean w/ativan & methadone.  Bowel function had returned to normal by d/c to home w/f/u w/PCP & surgery. FINAL DX: Intussusception complicated by small bowel perforation & transverse colon perforation. Per information received from the annual follow up patient did have the complication of intestinal perforation twice after diagnosis of intussusception, was hospitalized for greater than 1 month.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Laparotomy, Sepsis, Small intestinal anastomosis, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Patient developed GI symptoms (vomiting) on 2/3/2007  (31 days after receiving 3rd Rotateq).  Was diagnosed with intussception on 2/7/2007.  Suffered perforation of intestine during attempt to reduce by Barium enema, requiring emergent laparotomy and reanastomosis of small bowel.  Suffered a 2nd bowel perforation on 2/12/2007.  Illness resulted in ICU admission, intubation, probable sepsis.  3/15/07 Received partial medical records from hospital which reveal patient admitted 2/7/07 after experienced +IS s/p perforation x 2 w/OR repair who developed fever, elevated WBC, increasing discomfort & irritability.  Returned to OR on 2/15 for transverse colon perforation. FINAL DX: none at present as patient still hospitalized.  Peritonitis, either resistant bacteria such as MRSA or fungal were considered likely. T/C to hospital to determine D/C status of patient & to request D/C Summary if available.  Patient d/c to home 3/14.  No D/C Summary dictated yet.  Will request later. 4/10/07 Received D/C summary from hospital which reveals patient admitted from 2/7/07-3/14/07.  Admitted w/abdominal pain & emesis x approx 5 days w/lethargy & dehydration.  Treated at outlying hospital w/IVF prior to transfer for surgery on 2/7/07 was exp lap w/ileocecectomy w/primary anastomosis; then, lysis of adhesions & repair of transverse colon perforation on 2/12/07.  Condition was critical & worsened prior to second surgry w/patient remaining intubated & in PICU.  After second surgery & continued IVF, antibiotics & TPN, had gradual improvement & was successfully extubated.  Despite treatment, continued to have intermittent fevers & multiple w/ups were done, all were neg for source of infection.  Transitioned from TPN to NJ feeds & was transferred to regular peds floor.  Gradually, oral feeds were introduced & tolerated & NJ feeds were d/c.  Patient had become accustomed to MSO4 pain med & had extensive wean w/ativan & methadone.  Bowel function had returned to normal by d/c to home w/f/u w/PCP & surgery. FINAL DX: Intussusception complicated by small bowel perforation & transverse colon perforation. Per information received from the annual follow up patient did have the complication of intestinal perforation twice after diagnosis of intussusception, was hospitalized for greater than 1 month.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Gastrointestinal disorder, Intestinal perforation, Intubation, Intussusception
Clinical narrative: Patient developed GI symptoms (vomiting) on 2/3/2007  (31 days after receiving 3rd Rotateq).  Was diagnosed with intussception on 2/7/2007.  Suffered perforation of intestine during attempt to reduce by Barium enema, requiring emergent laparotomy and reanastomosis of small bowel.  Suffered a 2nd bowel perforation on 2/12/2007.  Illness resulted in ICU admission, intubation, probable sepsis.  3/15/07 Received partial medical records from hospital which reveal patient admitted 2/7/07 after experienced +IS s/p perforation x 2 w/OR repair who developed fever, elevated WBC, increasing discomfort & irritability.  Returned to OR on 2/15 for transverse colon perforation. FINAL DX: none at present as patient still hospitalized.  Peritonitis, either resistant bacteria such as MRSA or fungal were considered likely. T/C to hospital to determine D/C status of patient & to request D/C Summary if available.  Patient d/c to home 3/14.  No D/C Summary dictated yet.  Will request later. 4/10/07 Received D/C summary from hospital which reveals patient admitted from 2/7/07-3/14/07.  Admitted w/abdominal pain & emesis x approx 5 days w/lethargy & dehydration.  Treated at outlying hospital w/IVF prior to transfer for surgery on 2/7/07 was exp lap w/ileocecectomy w/primary anastomosis; then, lysis of adhesions & repair of transverse colon perforation on 2/12/07.  Condition was critical & worsened prior to second surgry w/patient remaining intubated & in PICU.  After second surgery & continued IVF, antibiotics & TPN, had gradual improvement & was successfully extubated.  Despite treatment, continued to have intermittent fevers & multiple w/ups were done, all were neg for source of infection.  Transitioned from TPN to NJ feeds & was transferred to regular peds floor.  Gradually, oral feeds were introduced & tolerated & NJ feeds were d/c.  Patient had become accustomed to MSO4 pain med & had extensive wean w/ativan & methadone.  Bowel function had returned to normal by d/c to home w/f/u w/PCP & surgery. FINAL DX: Intussusception complicated by small bowel perforation & transverse colon perforation. Per information received from the annual follow up patient did have the complication of intestinal perforation twice after diagnosis of intussusception, was hospitalized for greater than 1 month.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Laparotomy, Sepsis, Small intestinal anastomosis, Ultrasound abdomen, Vomiting
Clinical narrative: Patient developed GI symptoms (vomiting) on 2/3/2007  (31 days after receiving 3rd Rotateq).  Was diagnosed with intussception on 2/7/2007.  Suffered perforation of intestine during attempt to reduce by Barium enema, requiring emergent laparotomy and reanastomosis of small bowel.  Suffered a 2nd bowel perforation on 2/12/2007.  Illness resulted in ICU admission, intubation, probable sepsis.  3/15/07 Received partial medical records from hospital which reveal patient admitted 2/7/07 after experienced +IS s/p perforation x 2 w/OR repair who developed fever, elevated WBC, increasing discomfort & irritability.  Returned to OR on 2/15 for transverse colon perforation. FINAL DX: none at present as patient still hospitalized.  Peritonitis, either resistant bacteria such as MRSA or fungal were considered likely. T/C to hospital to determine D/C status of patient & to request D/C Summary if available.  Patient d/c to home 3/14.  No D/C Summary dictated yet.  Will request later. 4/10/07 Received D/C summary from hospital which reveals patient admitted from 2/7/07-3/14/07.  Admitted w/abdominal pain & emesis x approx 5 days w/lethargy & dehydration.  Treated at outlying hospital w/IVF prior to transfer for surgery on 2/7/07 was exp lap w/ileocecectomy w/primary anastomosis; then, lysis of adhesions & repair of transverse colon perforation on 2/12/07.  Condition was critical & worsened prior to second surgry w/patient remaining intubated & in PICU.  After second surgery & continued IVF, antibiotics & TPN, had gradual improvement & was successfully extubated.  Despite treatment, continued to have intermittent fevers & multiple w/ups were done, all were neg for source of infection.  Transitioned from TPN to NJ feeds & was transferred to regular peds floor.  Gradually, oral feeds were introduced & tolerated & NJ feeds were d/c.  Patient had become accustomed to MSO4 pain med & had extensive wean w/ativan & methadone.  Bowel function had returned to normal by d/c to home w/f/u w/PCP & surgery. FINAL DX: Intussusception complicated by small bowel perforation & transverse colon perforation. Per information received from the annual follow up patient did have the complication of intestinal perforation twice after diagnosis of intussusception, was hospitalized for greater than 1 month.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Barium enema, Gastrointestinal disorder, Intensive care, Intestinal anastomosis, Intestinal perforation
Clinical narrative: Patient developed GI symptoms (vomiting) on 2/3/2007  (31 days after receiving 3rd Rotateq).  Was diagnosed with intussception on 2/7/2007.  Suffered perforation of intestine during attempt to reduce by Barium enema, requiring emergent laparotomy and reanastomosis of small bowel.  Suffered a 2nd bowel perforation on 2/12/2007.  Illness resulted in ICU admission, intubation, probable sepsis.  3/15/07 Received partial medical records from hospital which reveal patient admitted 2/7/07 after experienced +IS s/p perforation x 2 w/OR repair who developed fever, elevated WBC, increasing discomfort & irritability.  Returned to OR on 2/15 for transverse colon perforation. FINAL DX: none at present as patient still hospitalized.  Peritonitis, either resistant bacteria such as MRSA or fungal were considered likely. T/C to hospital to determine D/C status of patient & to request D/C Summary if available.  Patient d/c to home 3/14.  No D/C Summary dictated yet.  Will request later. 4/10/07 Received D/C summary from hospital which reveals patient admitted from 2/7/07-3/14/07.  Admitted w/abdominal pain & emesis x approx 5 days w/lethargy & dehydration.  Treated at outlying hospital w/IVF prior to transfer for surgery on 2/7/07 was exp lap w/ileocecectomy w/primary anastomosis; then, lysis of adhesions & repair of transverse colon perforation on 2/12/07.  Condition was critical & worsened prior to second surgry w/patient remaining intubated & in PICU.  After second surgery & continued IVF, antibiotics & TPN, had gradual improvement & was successfully extubated.  Despite treatment, continued to have intermittent fevers & multiple w/ups were done, all were neg for source of infection.  Transitioned from TPN to NJ feeds & was transferred to regular peds floor.  Gradually, oral feeds were introduced & tolerated & NJ feeds were d/c.  Patient had become accustomed to MSO4 pain med & had extensive wean w/ativan & methadone.  Bowel function had returned to normal by d/c to home w/f/u w/PCP & surgery. FINAL DX: Intussusception complicated by small bowel perforation & transverse colon perforation. Per information received from the annual follow up patient did have the complication of intestinal perforation twice after diagnosis of intussusception, was hospitalized for greater than 1 month.