chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Aspartate aminotransferase increased
Clinical narrative: Info has been received from a pharmacist concerning a 27 y.o. male PT w/NKDA, who on unspecified date, was vax'd w/Hep B vax recombinant. There was no concomitant medication. Subsequently, 4 days post vax, lab work showed the PT developed "AST and LST" levels at 3 times their normal value. Unspecified medical attention was sought. Add'l info has been requested.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Influenza, Nausea, Nuchal rigidity
Clinical narrative: Info has been received from a health prof'l concerning a 52 y.o. female w/Hep C, and NKA who on 8/22/02 was vax'd w/Hep B vax recombinant. There was no concomitant medication. On 8/22/02 the PT developed "flu-like Sx's", nausea, light-headedness, stiff neck and fatigue w/in 1 hr post vax. The PT recovered from the Sx's of nausea, light-headedness, stiff neck and fatigue 12 hrs later and was reported to have been fine since then. Unspecified medical attention was sought. Add'l info has been requested.
Age: 78.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Balance disorder, CSF test abnormal, Difficulty in walking, Hypoaesthesia
Clinical narrative: Info has been received from a physician concerning a 78 year old white male physician with a history of a stable abdominal aortic aneurysm and high cholesterol, who on 7/9/02 was vaccinated, in the left deltoid, with a 1st dose of Hep-B (invalid lot 06555) and on 9/5/02 was vaccinated, in the right deltoid, with a 2nd dose of Hep-B vaccine. On 9/15/02, the pt developed distal leg numbness described by the pt as a "sensation that my left foot was asleep". Over the next few days, this "feeling moved up the leg" and at the same time, the "same process started in the right foot and moved up the leg". On 9/20/02, the sensation had "risen to the waist" and it "felt like I had tights on constricting the lower half of my body". On 9/20/02, the pt 1st noticed some difficulty walking and on 9/21/02 he "could not walk unassisted". On 9/21/02, the pt also had trouble initiating micturition and "felt like I had crashed". On 9/22/02, the pt went to the ER and was admitted to the hospital. The pt's LP on admission, revealed WBC-14, neutrophil-18, protein-183 and normal glucose. Tests for West Nile Virus and Lyme's Disease were negative. The pt's computed tomography showed hyper-density at T10-T11. Transverse myelitis was reported and the pt was treated with IV steroids. On 9/27/02, the pt was discharged from the hospital. On 9/30/02, it was reported by the treating physician that the pt was walking and recovering. Follow-up info from the pt indicated that he "started to improve" with the IV steroids while in the hospital. but he has not recovered. The pt also reported he still had "sensory changes which were marked from the waist down", there was a "loss of strength in both legs", his "balance continued to be lousy", he walks with a cane, he was going to a rehabilitation center 3 X a week and he has noted "some improvement". The pt considered his adverse experiences to be a life-threatening illness, to have resulted in a persistent or significant disability/incapacity and to be an "Other Important Medical Event". Additional info has been requested.
Age: 78.0
Sex: M
Vaccine: HEP
Symptoms: Micturition disorder, Myelitis transverse
Clinical narrative: Info has been received from a physician concerning a 78 year old white male physician with a history of a stable abdominal aortic aneurysm and high cholesterol, who on 7/9/02 was vaccinated, in the left deltoid, with a 1st dose of Hep-B (invalid lot 06555) and on 9/5/02 was vaccinated, in the right deltoid, with a 2nd dose of Hep-B vaccine. On 9/15/02, the pt developed distal leg numbness described by the pt as a "sensation that my left foot was asleep". Over the next few days, this "feeling moved up the leg" and at the same time, the "same process started in the right foot and moved up the leg". On 9/20/02, the sensation had "risen to the waist" and it "felt like I had tights on constricting the lower half of my body". On 9/20/02, the pt 1st noticed some difficulty walking and on 9/21/02 he "could not walk unassisted". On 9/21/02, the pt also had trouble initiating micturition and "felt like I had crashed". On 9/22/02, the pt went to the ER and was admitted to the hospital. The pt's LP on admission, revealed WBC-14, neutrophil-18, protein-183 and normal glucose. Tests for West Nile Virus and Lyme's Disease were negative. The pt's computed tomography showed hyper-density at T10-T11. Transverse myelitis was reported and the pt was treated with IV steroids. On 9/27/02, the pt was discharged from the hospital. On 9/30/02, it was reported by the treating physician that the pt was walking and recovering. Follow-up info from the pt indicated that he "started to improve" with the IV steroids while in the hospital. but he has not recovered. The pt also reported he still had "sensory changes which were marked from the waist down", there was a "loss of strength in both legs", his "balance continued to be lousy", he walks with a cane, he was going to a rehabilitation center 3 X a week and he has noted "some improvement". The pt considered his adverse experiences to be a life-threatening illness, to have resulted in a persistent or significant disability/incapacity and to be an "Other Important Medical Event". Additional info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Nonspecific reaction
Clinical narrative: Info has been received from a pharmacist concerning a PT who was vax'd "many yrs ago" w/a dose of Hep B vax recombinant. Subsequently, the PT "reported a reaction". The PT's vax records were unavailable and the "exact reaction was never documented". Add'l info has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Erythema nodosum, Oedema
Clinical narrative: Info has been received from a registered nurse concerning an 18 y.o. female who was vax'd w/a 1st and 2nd dose of Hep B vax recombinant on 6/21/01 and 8/6/01, respectively. On 10/9/01 the PT presented to the MD's office w/swelling and redness of her lower right leg and was diagnosed w/Erythema Nodosum. The PT was treated w/prednisone. Subsequently, the PT refused her 3rd dose of Hep B vax recombinant. Add'l info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Injection site pain, Multiple sclerosis, Paraesthesia
Clinical narrative: Info has been been received from a registered nurse concerning a female PT who in approx 9/01 was vax'd w/a dose of Hep B vax recombinant. Concomitant therapy included hormones (unspec'd). Subsequently, the PT developed "multiple sclerosis type reactions" that were "probably not related to the vax", which included tingling and generalized weakness. The PT also developed pain in the inject site. The hormones (unspec'd) were changed to another hormone (unspec'd) and unspec'd medical attention was sought. As of 9/25/02 the adverse experiences had not abated. Upon internal review "multiple sclerosis type reaction" was determined to be an other important medical event (OMIC). Add'l info has been requested.
Age: 6.0
Sex: M
Vaccine: HEP
Symptoms: Alopecia areata, Medication error
Clinical narrative: Info has been received from an MD concerning a 6 y.o. male PT w/asthma and down's syndrome, who in 96 and 98 was vax'd w/a 1st and 2nd dose of Hep B vax recombinant, respectively. Concomitant therapy included nebulizer treatments for asthma. Subsequently, the PT developed alopecia areata. Unspecified medical attention was sought. Add'l info has been requested.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased
Clinical narrative: Info has been received from a registered nurse concerning a 27 y.o. male employee w/a PCN allergy and a history of serum exposure to Hep B in his eye who was vax'd w/Hep B vax recombinant. There was no concomitant medication. Subsequently the PT developed an elevated serum alanine aminotransferase (ALT) of 530. The registered nurse reported that the PT had labwork done twice (dates unreported), and was negative for viral Hep B both times. The outcome of the PT's elevated ALT was unknown. It was reported that the PT sought unspecified medical attention. Add'l info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a female who in the AM of either 9/30/02 or 10/1/02 was vaccinated with the first dose of hpe B vaccine recombinant. That evening, the pt developed a diffuse full body rash. It was reported that the pt was afebrile and was not admitted to the hospital. Unspecified medical attention was sought. No further details were provided and at the time of this report, the outcome of the rash was unknown. Conflicting follow-up was received from a physician who stated that the info was obtained as a history from the pt. The pt had reported that the event happened 6 years ago. Neither the pt nor her attending physician could provide any further details. No further info is expected.
Sex: M
Vaccine: HEP
Symptoms: Alpha 1 foetoprotein increased
Clinical narrative: Information has been received from a Pharm. D. concerning a male with cancer who was vaccinated with hep B vaccine recombinant. Subsequently the pt developed a slightly elevated alpha-fetoprotein (value not reported). The outcome of the pt's elevated serum alpha-fetoprotein was unknown. It was unknown if the pt sought medical attention. Additional info has been requested.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 52 year old female who was believed to have been vaccinated with a complete series of hep B vaccine recombinant. On 8/15/02, the pt donated blood, and subsequently, was found to be anti-HBs positive, anti-HBc ositive and HBaAg positive. The outcome of the pt's experience was unknown. It was reported that the pt sought unspecified medical attention. Follow-up info has been received from a health professional. The health professional reported that the pt did not have a reaction to hep B vaccine recombinant. The health professional also reported that, according to the physician, the pt had hep B in the past and was now immune. No additional info is expected.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 45 year old white female pt with no allergies and no past medical history, who on 10/7/02 at approximately 14:00 was vaccinated with a dose of hep B vaccine recombinant (642095/1536L). Approximately three hours later at 17:00, the pt had a "bad reaction to hep B vaccine recombinant" that started with a severe headache and later included fever, chills, fatigue, body aches, leg pain and vomiting for two days. The pt's daughter had the "flu" at the same time. Subsequently, the pt recovered. The pt did not experience adverse events following prior vaccination. The reporter stated that they will "try to re-vaccinate." Additional info is not expected.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 45 year old white female pt with no allergies and no past medical history, who on 10/7/02 at approximately 14:00 was vaccinated with a dose of hep B vaccine recombinant (642095/1536L). Approximately three hours later at 17:00, the pt had a "bad reaction to hep B vaccine recombinant" that started with a severe headache and later included fever, chills, fatigue, body aches, leg pain and vomiting for two days. The pt's daughter had the "flu" at the same time. Subsequently, the pt recovered. The pt did not experience adverse events following prior vaccination. The reporter stated that they will "try to re-vaccinate." Additional info is not expected.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician's assistant concerning a 19 year old female pt, who in approximately October 2000 was vaccinated with a first dose of hep B vaccine recombinant. A few hours later, the pt developed lower abdominal cramping that resolved after a few hours. Unspecified medical attention was sought, but no intervention was required. No further info is available.
Sex: F
Vaccine: HEP
Symptoms: Skin disorder
Clinical narrative: Information has been received from a registered pharmacist for a nurse concerning a one day old female who on 10/16/02 was vaccinated with a 5UG dose of hep B vaccine recombinant. On 10/16/02 the nurse noted blood in the "hub" of the needle after injecting the vaccine. She was concerned that she may have nicked the pt's vein and some may have been administered IV. It was also noted that the pt had a "bleb" on her skin that was not there previously. It was also noted that there was no hypersensitivity reaction apparent. Unspecified medical attention was sought. No additional info was available.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old student pt with a latex sensitivity, who on 9/11/02 at 11:45am was vaccinated in the left arm with a first dose of hep b vaccine (642927/0196M). There was no concomitant medication. There was no illness at the time of vaccination. In approximately October 2002, the pt developed a "red rash" at the injection site, which spread from the pt's elbow to shoulder. The pt was treated with an unspecified amount of Benadryl. On approximately 10/17/02 the pt was "doing fine," and the injection site was reported to be "a little warm." Follow-up received from initial reporter indicated details are not known, and no additional info is available. Additional follow-up info from a nurse practitioner indicated that on 10/16/02 at 11:15am, also reported as 2 months after injection, the pt's left arm began to ache and swell at the site. The pt took Tylenol and did not report to the clinic. The reporter indicated that four months after injection, the pain and swelling increased from her shoulder to her elbow. The pt reported that "it looked like a rash or hives." The pt was prescribed Benadryl, Tylenol, and an ice pack with relief. The rash disappeared but returned in 2 days, and was relieved each time with Benadryl. It was reported that on 10/17/02 the pt recovered. No diagnostic tests or lab data were known.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 month old female who on 10/28/02, was vaccinated with her third dose of hep B vaccine. On 10/28/02, one hour following the vaccination, the pt developed a rash around the injection site. This rash spread to her legs, arms, trunk, palms of her hands and soles of her feet. The pt did not have a fever and was not hospitalized. The registered nurse reported that the pt was "fine." Unknown medical attention was sought. Additional info has been requested.
Age: 0.2
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Laboratory test abnormal, Urticaria
Clinical narrative: Info has been received from a physician concerning a 60 day old pt with "underlying mastocytosis" who was vaccinated by injection with a dose of Hep-B vaccine. Concomitant therapies received included injected doses of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, Haemophilus B conjugate vaccine and poliovirus vaccine. The pt developed urticaria, which covered the entire body, 4 days post vax, at the injection site, and had eventual dx of mastocytosis. Unspecified medical attention was sought. This was originally reported by a consumer. Follow-up info indicated that the pt was being treated with Hep-B vaccine (MSD) and not (mfr unk) as previously reported. Additional info has been requested.
Age: 0.6
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Info has been received from a consumer concerning an approx. 7 month old male with Down's Syndrome who in approx. November, 2002, at 2 months of age, was vaccinated with a 1st, 2nd and 3rd dose of Hep-B. The pt "had bad reactions to his Hep-B vaccinations." Unspecified medical attention was sought. Subsequently, on 10/14/02, the pt was vaccinated with a dose of MMRII and a dose of Varivax and experienced adverse events (WAES 0211USA00174). Follow-up info from the physician stated that "the child received Hep-B alone not (Hib (+) Hep-B at the visit where a possible reaction occurred". It was also noted that the immunization associated with the reaction was given on 4/26/02. Additional info is not expected.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Muscular weakness, Musculoskeletal stiffness, Oedema peripheral, Pain
Clinical narrative: Info has been received from a physician and an RN concerning a 21 year old male employee, who on 10/28/02 was vaccinated with a 1st dose of Hep-B. Nine days, post vax, on 11/6/02, the pt developed swelling and weakness of his left wrist and shoulder pain and stiffness. Unspecified medical attention was sought. As of 11/6/02, the pt's experience had not abated. The physician noted that there was no previous history of an adverse reaction. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Colitis, Haematochezia
Clinical narrative: Info has been received from a physician concerning an overweight female pt with hypertension who was vaccinated with Hep-B. The pt had recently returned from a business trip. The reporter stated that 48 hours after administration of the Hep-B vaccine, the pt developed bloody stools and was treated with unknown antibiotics. The pt was later dx'd with ischemic colitis. Additional info has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash pustular
Clinical narrative: Info has been received from a health professional concerning a 46 year old female nurses aide who on 11/1/02 was vaccinated with a 1st dose of Hep-B, IM in the deltoid. On 11/1/02, at 15:00, the pt developed an itchy head and pustules on the scalp. Unspecified medical attention was sought. On 11/2/02, the pt recovered from pustules on the scalp and itchy head. No further info is expected.
Age: 30.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Arthritis, Back pain
Clinical narrative: Info has been received from an RN concerning a 30 year old female who on 8/13/02 and 9/18/02 was vaccinated with the 1st and 2nd doses of Hep-B. Concomitant therapy, on 8/13/02, included a dose MMRII. On 8/26/02, the pt experienced pain in the fingers of both hands which progressed to her wrists. On 9/26/02, the pain got worse and traveled into her back. On that same date, the pt went to her physician. The pt had tests performed which showed a positive arthritis panel. The pt was treated with anti-inflammatories and was scheduled to see a rheumatologist. The pt sought unspecified medical attention. Additional inform has been requested.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Hypersensitivity, Influenza like illness, Mononucleosis syndrome
Clinical narrative: Info has been received from a mother concerning her approx. 15 year old son who in approx. 1996 was vaccinated with the 3rd dose of Hep-B. Following vaccination, in approx. 1996, the pt developed flu-like symptoms which were dx'd as infectious mononucleosis. Every 2 weeks since his vaccination, the pt has had allergy symptoms including difficulty breathing. It was recently found that the pt has an allergy to yeast. The pt sought unspecified medical attention. Additional info has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Liver function test abnormal, Myalgia, Pyrexia
Clinical narrative: Info has been received from a registered pharmacist concerning a 20 year old female with no known drug allergies or past medical history who was vaccinated with a 2nd dose of Hep-B. There was no concomitant medication. The pharmacist reported that the pt received 3 doses of Hep-B vaccine but the 1st dose was not recorded. The pharmacist further reported that the 3rd dose was given 6 months following the prior dose. Subsequently, in 2002, the pt developed a fever for 1 day and muscle aches on another day which had both resolved. In approx. 11/02, a lab test revealed the pt had elevated liver enzymes. The outcome was not reported. The pt sough unspecified medical attention. Additional info has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Info has been received from a 42 year old female pt with allergies to gluten and antibiotics and a history of a spinal injury who on 11/15/02 was vaccinated with a dose of Hep-B. There was no concomitant medication. On 11/17/02, the pt experienced abdominal pain and a fever. The pt's abdominal pain persisted. No medical attention was sought.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Dermatitis, Extravasation blood, Hypersensitivity, Pruritus, Rash maculo-papular
Clinical narrative: Info has been received from a health care professional concerning a 13 year old female pt with a neurogenic bladder and no known drug allergies who was vaccinated with a 2nd dose of Hep-B. The pt developed a rash 3-4 days after administration of the vaccine. The rash was located on her hands, arms, legs and trunk. The rash was described as a monomorphus, 2-3mm, generalized papular eruption, non-blanching and pruritic. A skin biopsy was performed to rule out Giacotti-Crosi and vasculitis. No vasculitis was identified. The pt was treated with Triamcinolone cream and Camphor + Menthol + Phenol (Sarna) lotion. The pt's condition did improve and the physician thought it could be related to the vaccine. Additional info has been requested.
Sex: U
Vaccine: HEP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of hep B vaccine recombinant in a foreign country. The reporter was "not sure of exact hep B vaccine the pt had." Subsequently, the pt developed Guillain-Barré Syndrome and "returned home due to this." Upon internal review, Guillain-Barré Syndrome was considered an other important medical event (OMIC). Additional info has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia, Syncope
Clinical narrative: Info has been received from an LPN regarding a 22 year old female who on 10/3/02 was vaccinated with a 1st dose of Hep-B, in the left deltoid, (lot 642096/0069M). Subsequently, the pt experienced a syncopal reaction. The pt was lightheaded and felt numb on the left side. Unspecified medical attention was sought. The nurse had requested a lot check to be performed on lot 642096/0069M. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested. Follow up on 03/09/04: "Information has been received from a LPN regarding a 22 year old Filipino female with a blood pressure of 110/70, a regular pulse rate of 80/m, a respiratory rate of 16/m and no known drug allergies, relevant medical history or illness at time of vaccination who on 10/03/02 was vaccinated IM in the left deltoid with a first dose of hepatitis B vaccine recombinant (yeast) in the left deltoid (Lot # 642096/0069M).  On 10/03/02 at 15:45 the pt experienced a syncopal reaction. The pt was light headed and felt numb on the left side. It was noted that the pt had "no L.O.C." and rested for 20 minutes, drank ice water and was able to move arms and legs. She returned to work after approximately 1 hour of rest and observation.  The nurse had requested a lot check to be performed on Lot 642096/0069M.  No additional information is expected."
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Info has been received from an LPN concerning several pts/50 to 60% who were vaccinated with the 3 dose series of Hep-B vaccine and failed to sero-convert (had negative titers) since 7/02 and a few others were weakly positive. The LPN also reported that in 11/02, the Hep-B vaccine temperature was 35F for 25% of the days. The LPN reported that pts will be revaccinated with a repeat of the 3 dose series. Follow-up info was received from the LPN who reported that she recently discovered that for the past 14 months, the temperature in the refrigerator that stored the Hep-B vaccine had been out of range and no action was taken to rectify the situation. Subsequently, the "problem" was fixed. The LPN reported that any employees that failed to sero-convert would be re-immunized because the staff were mostly laboratory and housekeeping personnel. Additional info was received from the LPN concerning 1 of the pts, a 49 year white female RN, with no illness at the time of vaccination who was vaccinated with a 1st, 2nd and 3rd dose of Hep-B vaccine (lot 641072/1047L), (lot 641692/1458L), (lot 642096/0069M), in the left deltoid on 11/7/01, 12/19/01 and 5/31/02, respectively. On 7/17/02, the pt's serum Hep-B surface antibody screen was "weak" positive. On 8/20/02, the pt received a 4th dose of Hep-B vaccine (lot 643396/0497M). On 9/27/02, the pt's serum Hep-B surface antibody screen was positive. The LPN reported on 4 other pts (WAES0212USA009137, WAES0211USA01804, WAES0212USA00941 and 0212USA00942). No further info is available.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Info has been received from an LPN concerning several pts/50 to 60% who were vaccinated with the 3 dose series of Hep-B and failed to sero-convert (had negative titers) since 7/02 and a few others were weakly positive. The LPN also reported that in 11/02, the Hep-B vaccine temperature was 35F for 25% of the days. The LPN reported that the pts will be revaccinated with a repeat of the 3 dose series. Follow-up info was received from the LPN who reported that she recently discovered that for the past 14 months, the temperature in the refrigerator that stored the Hep-B vaccine had been out of range and no action was taken to rectify the situation. Subsequently, the "problem" was fixed. The LPN reported that any employees that failed to sero-convert would be re-immunized because the staff were mostly laboratory and housekeeping personnel. Additional info was received from the LPN concerning 1 of the pts, a 31 year white female, who on 12/14/01, was vaccinated with the 1st dose of Hep-B (ENG3369B6), in the right deltoid. The pt was vaccinated with a 2nd and 3rd dose of Hep-B (631281/0575J) and (642096/0069M), in the left deltoid, on 1/14/02 and 6/15/02, respectively. On 7/16/02, the pt's serum Hep-B surface antibody screen was weak positive. On 7/29/02, the pt received a 4th dose of Hep-B (642096/0069M). On 9/3/02, the pt's serum Hep-B surface antibody screen was positive. The LPN reported on 4 other pts (WAES0212USA00937, WAES0212USA00939, WAES0212USA00941 and 0211USA01804). No further info is available.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactoid reaction, Loss of consciousness, Pallor
Clinical narrative: Info has been received from a health professional concerning a 53 year old female who in 2/2002, was vaccinated with a dose of Hep-B (lot not reported). Post vax, the pt had an "anaphylactic-like reaction", where she reportedly passed out and turned white. The pt was treated with epinephrine and "everything seems okay". Unspecified medical attention was sought. Upon internal review, anaphylactic-like reaction was determined to be an "Other Important Medical Event". Additional info has been requested.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Info has been received from a health professional concerning a 56 year old female pt who on 12/7/02 was vaccinated with the 1st dose in a series of Hep-B vaccine. On 12/10/02, the pt presented to her internist with Bell's Palsy. It was noted that the pt was being treated with corticosteroids. Follow up non 03/09/04: "On the morning of 12/10/02, approximately 72 hours after vaccination, the pt presented to the internist with Bell's Palsy.  The pt was referred to a neurologist and was subsequently treated with Prednisone and physical therapy.  It was unknown if the pt underwent any testing. At the time of this report, the pt was "improved" but had not yet recovered from the Bell's palsy. The pt was still being followed.  Bell's palsy was considered to be disabling. Additional information has been requested."
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Asthenia, Cardiovascular disorder, Chest pain, Dyspnoea, Erythema
Clinical narrative: Acute myopericarditis c pleuritic chest pain occurring 8 days p vaccination; On exam, afebrile, VSS; Heart and lungs wnl; no pericardial friction rub. + 8 mm Jennerian scab c ~ 7 cm rim of erythema, CPK elevated to 512, Troponin I level 36.40 ng/mL  (nl 0.3-2.0) ESR 6, CBC, chemistries otherwise wnl. CXR wnl; EKG: diffuse 1mm ST elevations.  Echocardiogram c sl global hypokinesis, LVEF 50-55%.  Complete clinical recovery, resolution of echocardiographic abnormalities c rest, ibuprofen.  Nurse follow up on 07/27/04 states: "Short of breath, epicarditis, pericarditis, decreased stamina, decreased strength."
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myocarditis, Pericarditis
Clinical narrative: Acute myopericarditis c pleuritic chest pain occurring 8 days p vaccination; On exam, afebrile, VSS; Heart and lungs wnl; no pericardial friction rub. + 8 mm Jennerian scab c ~ 7 cm rim of erythema, CPK elevated to 512, Troponin I level 36.40 ng/mL  (nl 0.3-2.0) ESR 6, CBC, chemistries otherwise wnl. CXR wnl; EKG: diffuse 1mm ST elevations.  Echocardiogram c sl global hypokinesis, LVEF 50-55%.  Complete clinical recovery, resolution of echocardiographic abnormalities c rest, ibuprofen.  Nurse follow up on 07/27/04 states: "Short of breath, epicarditis, pericarditis, decreased stamina, decreased strength."
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Laboratory test abnormal, Unintended pregnancy
Clinical narrative: The pt was vaccinated with vaccinia and it was later determined that she was pregnant. LNMP: 1/31/03
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: The pt was vaccinated with vaccinia and it was later determined that she was pregnant. LNMP: 1/31/03
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Chills, Cough, Erythema multiforme, Fatigue
Clinical narrative: On March 5th client felt run down flue like symptoms, nauseous, feeling achy, fatigued chilled with joint pains and a temp fo 101.  This continued for 5 days.  On day 6 the client started coughing, felt warm with under arm glands felling swollen and arm was itchy.  On day 7 arms were really sore and swollen.  There is a rash around vaccination site, similar to erythema multiforme.  Client is taking benadryl.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Feeling hot, Influenza like illness, Lymphadenopathy, Nausea, Oedema
Clinical narrative: On March 5th client felt run down flue like symptoms, nauseous, feeling achy, fatigued chilled with joint pains and a temp fo 101.  This continued for 5 days.  On day 6 the client started coughing, felt warm with under arm glands felling swollen and arm was itchy.  On day 7 arms were really sore and swollen.  There is a rash around vaccination site, similar to erythema multiforme.  Client is taking benadryl.
Age: 37.0
Sex: F
Vaccine: SMALL
Symptoms: Pain, Pruritus, Pyrexia, Rash
Clinical narrative: On March 5th client felt run down flue like symptoms, nauseous, feeling achy, fatigued chilled with joint pains and a temp fo 101.  This continued for 5 days.  On day 6 the client started coughing, felt warm with under arm glands felling swollen and arm was itchy.  On day 7 arms were really sore and swollen.  There is a rash around vaccination site, similar to erythema multiforme.  Client is taking benadryl.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: 10 days post vaccine, developed papular rash upper back and posterior neck, only 3 pustules developed
Age: 36.0
Sex: F
Vaccine: SMALL
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Pt with hives, pruritic, raised rash over extensive surface's arms and legs, neck, and back and face with response to benadryl.
Age: 1.3
Sex: M
Vaccine: DTAPH, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Mother reports-marked swelling entire left thigh - redness and heat-beginning 2-27-03 am-child afebute-tylenol given for inflammation-no restriction of ambulation-painful to touch-inflammationsubsiding-saw doctor on 2-28-03.
Age: 1.3
Sex: M
Vaccine: DTAPH, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site warmth
Clinical narrative: Marked inflammation left thigh- detected by babysitter-area of injection edematous-marked redness and heat-2x3 area child afebrile-no restriction of movement-motrin given to reduce inflammation-by 03-07-03 reduced edema-redness fading.
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Dizziness, Headache, Somnolence
Clinical narrative: Smallpox vaccine 3-4-03-started with N/V, dizziness, severe headache, excessive sleep-mid cycle BCP but that night started menses. All symptoms started 8 hours after vaccination.
Age: 41.0
Sex: F
Vaccine: SMALL
Symptoms: Dermatitis bullous, Pruritus, Pyrexia
Clinical narrative: on day "10" post vaccine developed a pimple-like rash (about 10 lesion) on trunk and left lower arm, some not itchy, some mildly itchy. low grade fever 99.8-100. Patient cleansed all lesions with rubbing alcohol, applied neosporin and took chlortrimeton.  All blemishes were markedly decreased by the next day and resolved completely by day 14.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Oedema peripheral
Clinical narrative: Patient presented with bilateral lower extremity pitting edema. Hospitalized for lower leg elevation and compresses. All labs within normal limits. Edema resolved with elevation. Patient discharged on hospital day 3.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site infection
Clinical narrative: Mild cellulitis around vaccine site, L arm, day #9. Pt had prior history of MRSA cellulitis.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Approx 7 days post small pox immunization, pt experienced generalized maculopapular and mildly pruritic rash to ant/post trunk, upper and lower extremities.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Feeling abnormal, Headache, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Sore L arm and L Axilla, local redness, bump, whitish blister, local itching, local rash, headache, fever, muscle aches, feeling lousy, swollen lymph nodes.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Myalgia, Pruritus, Pyrexia, Rash
Clinical narrative: Sore L arm and L Axilla, local redness, bump, whitish blister, local itching, local rash, headache, fever, muscle aches, feeling lousy, swollen lymph nodes.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Headache, Injection site erythema, Injection site hypersensitivity, Injection site rash
Clinical narrative: Local redness, bump, reddish blister, local itching, headache, itchy all over, fever 101F, muscle aches, swollen lymph nodes, severe chest discomfort across entire chest and into arm and both sides of neck and lower jaws, decreased with Motrin, benadryl and tylenol. Became worse with movement, even worse next night, could not lie down had to sleep sitting up. Pt went to ER that AM. Tx with Vicodin for pain, motrin. Pt was told had Pericarditis, Vicodin helped, decreased sleep. Much better this AM. No short of breath.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site vesicles, Myalgia, Oedema, Pain, Pericarditis
Clinical narrative: Local redness, bump, reddish blister, local itching, headache, itchy all over, fever 101F, muscle aches, swollen lymph nodes, severe chest discomfort across entire chest and into arm and both sides of neck and lower jaws, decreased with Motrin, benadryl and tylenol. Became worse with movement, even worse next night, could not lie down had to sleep sitting up. Pt went to ER that AM. Tx with Vicodin for pain, motrin. Pt was told had Pericarditis, Vicodin helped, decreased sleep. Much better this AM. No short of breath.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Pyrexia
Clinical narrative: Local redness, bump, reddish blister, local itching, headache, itchy all over, fever 101F, muscle aches, swollen lymph nodes, severe chest discomfort across entire chest and into arm and both sides of neck and lower jaws, decreased with Motrin, benadryl and tylenol. Became worse with movement, even worse next night, could not lie down had to sleep sitting up. Pt went to ER that AM. Tx with Vicodin for pain, motrin. Pt was told had Pericarditis, Vicodin helped, decreased sleep. Much better this AM. No short of breath.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Satellite lesions, approx 10 surrounding primary lesion due to auto-innoculation. No Tx needed. Pt's primary innoc.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox
Clinical narrative: Generalized vaccinia
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Facial palsy, Neuropathy peripheral
Clinical narrative: L sided facial paralysis
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cow pox, Erythema, Skin ulcer
Clinical narrative: Disseminated, non-systemic vaccinia. Multiple round erythematous lesions varying in size from 1 cm to 4 cm on legs, arms and trunk.
Age: 0.0
Sex: F
Vaccine: SMALL
Symptoms: Rash erythematous, Rash macular, Rash pustular
Clinical narrative: diffuse erythematous macules numbering 20-30 <1cm scattered on torso, some with 1-2mm central pustules
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Cow pox, Pruritus, Rash maculo-papular
Clinical narrative: Smallpox vaccine received on 2/5. Take assessment done on 3/4/03. Has a good take. On 3/12/03, called nurse to report a "rash" which itched. Stated it had started on 3/8, first appearing on her left leg. Also reported that the rash had now spread to ankles, across back and arms. Rash is macular-papular with no pruritus or vesicles and no drainage. Monitor closely for any progression or resolution. No further treatment prescribed at this time. She is off work until Monday 3/17/03 and to be seen by doctor before returning to work. On 3/14/03, tried to contact client at home, not available, message left.
Age: 56.0
Sex: M
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: Vaccinated for smallpox on L-Deltoid on 2/25/2003.  Awoke this morning (day 15) with vesicles scattered on L-arm.  No c/o itching, burning or pain.  Temperature 96 degrees.  Questionable zoster or vaccinia reaction.  Lab sample to be taken tomorrow morning.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Rash
Clinical narrative: Patient received vaccine on 3/10 in the morning.  This morning (3/11)noted red flat rash-face, neck and chest. S/S decreased in 24 hours at time he was brought in for check.
Age: 56.0
Sex: M
Vaccine: SMALL
Symptoms: Back pain, Chills, Fatigue, Pyrexia
Clinical narrative: 3/7/2003 Day 11 after smpx vaccination on 2/24/2003 reported temp 102-severe chills--severe fatigue and back pain--left work early 3/8/3003 day 12--temp 101-mod chills--mod fatigue--planned day off (Sat) 3/9/2003--Day 13--temp 100-mild fatigue-planned day off (Sun) 3/10/2003-Day 14--No symptoms noted 3/11/2003-Day 15--Called to report
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Red warm area on (L) thigh beginning @ injection site measuring 21cm in width.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Rash pustular
Clinical narrative: Patient returned to clinic following vaccination of smallpox. Diagnosed as secondary bacterial cellulitis with generalized pustular rash; unresponsive to Keflex. Sent to ER; placed inpatient with IV antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site reaction, Pain
Clinical narrative: Local reaction left upper thigh 8 cm circular area-erythemia and heat painful to touch-afebrile-T 97.8-no restriction of ambulation-tylenol to reduce inflammation
Age: 32.0
Sex: F
Vaccine: SMALL
Symptoms: Oedema, Throat tightness
Clinical narrative: 13:40 roof of mouth became swollen-returned to office and told supervisor-by this time throat felt tight and this worsened and was taken to clinic and given Benadryl and tegaderm removed.
Age: 58.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Feeling hot, Injection site reaction, Lymphadenopathy, Nausea
Clinical narrative: Deltoid area swollen, red, warm to touch-much tenderness and pain in area surrounding vaccination site-Tenderness/swelling in lymph nodes(armpit)-lasted 4 days. general nausea, intense at times - 5 days. Symptoms started 8th-9th day after vaccination.
Age: 58.0
Sex: F
Vaccine: SMALL
Symptoms: Oedema, Pain
Clinical narrative: Deltoid area swollen, red, warm to touch-much tenderness and pain in area surrounding vaccination site-Tenderness/swelling in lymph nodes(armpit)-lasted 4 days. general nausea, intense at times - 5 days. Symptoms started 8th-9th day after vaccination.
Age: 40.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash pustular, Skin ulcer
Clinical narrative: 3-12-03:Small red bump 2 inches below vaccination site and one small bump on right arm.   3-13-03: One more lesion on right arm, 2 on left arm, 3 on neck and 1 on right hip.  Complains of itching.  No fever or adenopathy.  Saw ER physician and sent home with benadryl. 3-14-03: Has 24 total lesions that appear to be pustular. MD at the medical center is in contact with another MD at CDC.  Samples being taken today (3-14-03).
Age: 35.0
Sex: F
Vaccine: SMALL
Symptoms: Disturbance in attention, Fatigue, Lethargy, Loss of consciousness, Visual disturbance
Clinical narrative: Client c/o feeling "lethargic and fatigued" starting the evening of 3/13/03.  States she was talking to her husband and "went out of consciousness" and he had to shake her awake.  Presents this morning feeling tired and is having trouble concentrating. No c/o pain, headache, irritability, mood changes.  States her vision is different and she is seeing colors more vibrant.  Client unable to drive home d/t fatigue so had her husband take her home.  T/C to Dr to inform him of clients condition. He suggests that I call Dr the hospital and inform her of client's condition.  T/C to Dr .  She will call client at home and have her come to the hospital for clinical consult and evaluation.
Age: 54.0
Sex: F
Vaccine: SMALL
Symptoms: Atrial fibrillation, Chest discomfort, Enzyme abnormality, Heart rate increased, Heart rate irregular
Clinical narrative: Discomfort in chest, rapid irregular pulse on carrying bags of groceries up flight of steps Thursday evening (3/13).  BP 150/110, P 150, not relieved by rest.  At local ED around 7 or 8 pm that same evening, CPK MB and Troponin I rose, and EKG showed changes consistent with a subendocardial MI and Atrial Fibrillation, with AF resolving after treatment. Echocardiogram and catheterization results pending.  Impression: Myocardial infarction due to longstanding serious cardiac risk factors of hypertension, elevated lipid levels, and Type II AODM. No fever, no leukocytosis.
Age: 54.0
Sex: F
Vaccine: SMALL
Symptoms: Hypertension, Myocardial infarction
Clinical narrative: Discomfort in chest, rapid irregular pulse on carrying bags of groceries up flight of steps Thursday evening (3/13).  BP 150/110, P 150, not relieved by rest.  At local ED around 7 or 8 pm that same evening, CPK MB and Troponin I rose, and EKG showed changes consistent with a subendocardial MI and Atrial Fibrillation, with AF resolving after treatment. Echocardiogram and catheterization results pending.  Impression: Myocardial infarction due to longstanding serious cardiac risk factors of hypertension, elevated lipid levels, and Type II AODM. No fever, no leukocytosis.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Influenza like illness, Injection site reaction, Vaccination complication
Clinical narrative: Robust reaction at site-flu like symptoms 2-28/3-07. Lesion in pubic area 3-07-03 to 3-14-03.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Herpes zoster, Malaise, Nausea, Pyrexia
Clinical narrative: A 44 year old male re-vaccinee was vaccinated on 2/20 and had subsequent symptoms of a low grade fever, malaise, nausea and vomiting. On 2/28, he noticed a small red patch on his upper left forehead with two small "pimples", which he rubbed open. Instead of healing, the lesion expanded during the subsequent days. On 3/4, he noticed 1-2 "bumps" on his left eyebrow and on his upper left eyelid, with some additional lesions over the next few days. He had no ocular symptoms. He visited his physician on 3/7 and was also seen by a dermatologist and an ophthalmologist. The forehead lesion was described as a 1.5 x 2.5 cm deep red plaque. It was significant for two confluent black eschars approximately .6 x 1.0 cm in total diameter. There were no vesicles. His left brow and upper eyelid contained approximately 5 faint pink macules and patches with superimposed vesicles that were less than 1 mm in diameter, appeared superficial and were in the same stage of development. Many were grouped though not in the typically florette pattern of herpetic vesicles. None were eroded or crusted. Very small vesicles were also present on his upper left eyelid but did not involve the lash margin. His ophthalmological exam was negative for keratitis, blepharitis, or conjunctival involvement. His vaccination site revealed a major reaction. The scab on his forehead and the eyelid vesicles were unroofed, and swabs for viral culture, DFA, and PCR were obtained from these sites and from his vaccination site. He was placed on valcyclovir and trifluoridine eye drops with close outpatient follow-up.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash macular, Vaccination complication, Vomiting
Clinical narrative: A 44 year old male re-vaccinee was vaccinated on 2/20 and had subsequent symptoms of a low grade fever, malaise, nausea and vomiting. On 2/28, he noticed a small red patch on his upper left forehead with two small "pimples", which he rubbed open. Instead of healing, the lesion expanded during the subsequent days. On 3/4, he noticed 1-2 "bumps" on his left eyebrow and on his upper left eyelid, with some additional lesions over the next few days. He had no ocular symptoms. He visited his physician on 3/7 and was also seen by a dermatologist and an ophthalmologist. The forehead lesion was described as a 1.5 x 2.5 cm deep red plaque. It was significant for two confluent black eschars approximately .6 x 1.0 cm in total diameter. There were no vesicles. His left brow and upper eyelid contained approximately 5 faint pink macules and patches with superimposed vesicles that were less than 1 mm in diameter, appeared superficial and were in the same stage of development. Many were grouped though not in the typically florette pattern of herpetic vesicles. None were eroded or crusted. Very small vesicles were also present on his upper left eyelid but did not involve the lash margin. His ophthalmological exam was negative for keratitis, blepharitis, or conjunctival involvement. His vaccination site revealed a major reaction. The scab on his forehead and the eyelid vesicles were unroofed, and swabs for viral culture, DFA, and PCR were obtained from these sites and from his vaccination site. He was placed on valcyclovir and trifluoridine eye drops with close outpatient follow-up.