chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Arthralgia, Arthritis, Cough, Headache, Pain
Clinical narrative: One week after immunizations at 6 p.m. in the evening both shoulders felt like arthritis pain.  During the night the pain left the shoulders and went to both hips.  Took Ibuprofin, helped to sleep.  Pain decreases during the day, increases at night. At approx. 2 weeks after immunizations along with the traveling joint pain, started coughing, headache, and sore throat.  Lasted for 3 days, then came back about one week later.  Three weeks after immunizations went to visit MD.  Exam was done, and Vioxx was given.  Reports helped for 1-2 days then stopped.  Fourth week went back to Dr. blood tests where done no other meds given  All blodds tests results were negative.  One week after MD visit, returned to MD with continue complaint of traveling joint pain, headache, sore throat  MD did Strep test, X-rays of both hips and more blood work.  All tests were negative.  Perscription Ibup. and Zithromax was given.  Voices compliance to meds, continues to have above symptoms, startes "I'm still the same."  Today reports stiffness, pain in left hand and left ankle, sore throat.  Planning on seeing a specialist.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Pharyngolaryngeal pain
Clinical narrative: One week after immunizations at 6 p.m. in the evening both shoulders felt like arthritis pain.  During the night the pain left the shoulders and went to both hips.  Took Ibuprofin, helped to sleep.  Pain decreases during the day, increases at night. At approx. 2 weeks after immunizations along with the traveling joint pain, started coughing, headache, and sore throat.  Lasted for 3 days, then came back about one week later.  Three weeks after immunizations went to visit MD.  Exam was done, and Vioxx was given.  Reports helped for 1-2 days then stopped.  Fourth week went back to Dr. blood tests where done no other meds given  All blodds tests results were negative.  One week after MD visit, returned to MD with continue complaint of traveling joint pain, headache, sore throat  MD did Strep test, X-rays of both hips and more blood work.  All tests were negative.  Perscription Ibup. and Zithromax was given.  Voices compliance to meds, continues to have above symptoms, startes "I'm still the same."  Today reports stiffness, pain in left hand and left ankle, sore throat.  Planning on seeing a specialist.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Urticaria
Clinical narrative: Urticaria since smallpox vaccination.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Skin reaction
Clinical narrative: 1. super skin reaction to smallpox vaccination 2. cellulitis to upper arm  Referral to Dermatology Clinic
Age: 19.0
Sex: U
Vaccine: SMALL
Symptoms: Rash, Viral infection
Clinical narrative: Probably viral exanthema (grouped nodules over flexor surface of both hands and elbows
Age: 33.0
Sex: U
Vaccine: SMALL
Symptoms: Skin ulcer, Vaccination complication
Clinical narrative: satellite lesions on trunks and chest since leaving smallpox site unbandaged; suspect self innoculation; referral to Dermatology Clinic
Age: 57.0
Sex: F
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Pruritus, Rash erythematous, Rash papular
Clinical narrative: Patient's husband received smallpox inj. on approx 2/1/03 on his left arm. No other information about vaccination is available to obtain. She was with him on 2/14-15 and then again on 2/21. On 2/21 he showered and his drsg fell off and they did not have a replacement. She slept with him. A possible secondary transmission. On 3/8-9 she developed a erythema rash on her right arm bicep area with about 6 bumps. Papule no pustule,or vesicle. This was the arm that was next to her husband while sleeping. She was itching it and it bled. On 3/10 rash has lessened, but one of the bumps has a scab on it, not the one that was bleeding.  3/11 a couple of the bump have disappeared.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Hemiparesis, Mydriasis, Paraesthesia, Visual disturbance
Clinical narrative: Given TD on 2/17; 2/19 felt weak, right side of body>left; 2/20 felt weak and foggy, noted increase left pupil size, with decreased ability to focus; 2/21 noted tingling on face with ongoing increase size of left pupil, seen emergently in my office, and then ER with neurology evaluation, no notable weakness on exam, and pupils reactive, L 2mm> R; 2/25 had MRI with MRA, neg, and neuro-opthalmology at Hospital  eval neg; seen in my office 2/26 with pupil improving, and feeling better, less weak, no motor deficits or decreased DTR's, tried on Medrol dose Pak; seen subsequently by oncology with normal lab and Xray, with last follow-up with me 3/12: L pupil still 2mm larger than R, but normally ractive, still slight tingling on face and R forearm, otherwise normal, and energy level almost back to normal/ no other cause than possible TD reaction?
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Parotitis
Clinical narrative: Developed mild left side parotitis days 3 - 6 post primary vaccinia vaccination. Totally resolved without treatment by day 7.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Face oedema, Pain
Clinical narrative: Right side face pain and swelling began on 03/04/03.  Saw MD who is designated as the adverse event physician on 03/06/03.  Prescription given for Famvir 500mg to be taken for 7 days.  Was hospitalized from 03/07/03 through 03/10/03 for IV antibiotic treatment, oral antiviral treatment and pain control.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Colitis
Clinical narrative: Right side face pain and swelling began on 03/04/03.  Saw MD who is designated as the adverse event physician on 03/06/03.  Prescription given for Famvir 500mg to be taken for 7 days.  Was hospitalized from 03/07/03 through 03/10/03 for IV antibiotic treatment, oral antiviral treatment and pain control.
Age: 56.0
Sex: F
Vaccine: SMALL
Symptoms: Balance disorder, Difficulty in walking, Dizziness, Headache, Myalgia
Clinical narrative: On 2/17/03 patient was vaccinated in her left arm with smallpox vaccine.  On 2/26/ she c/o Muscle pain, and on 2/28 she was seen in the ER. Appeared to have some confusion for 2-3mins, unsteady on her feet, lightheaded, dizziness accompanied by a basilar headache. Experienced right sided facial drooping in ER for about 15 mins. Later an infection control nurse observed facial drooping on right side of face, leg weakness, and difficulty walking. Temp was 98.4/ Pulse-109/ Resp-20 BP-146/96. Pt. states that she is better, but continues to have a headache as of 3/13/03. Has not worked since 2/28/03.3/5- Robust take- 1&1/2 cm.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: Pt eval  for 4 day hx of progressively worsening headache, sudden in onset, with assoc. photophobia, fever, chills, night sweats, fatigue, nausea and vomiting.  Mildly elevated temp.(100.7) and tilt positive.  Pt transported to Hospital for further eval at that time.  Pt's condition improved with 1L NS fluid bolus and APAP during the ED stay.  CBC- WBC 8.7, H/H 14.2/41.5, Plat 239.  Pt diagnosed with Viral Syndrome and Acute Cephalgia(resolved), and was discharge back to Command with f/u at BAS.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Photophobia, Pyrexia, Vomiting
Clinical narrative: Pt eval  for 4 day hx of progressively worsening headache, sudden in onset, with assoc. photophobia, fever, chills, night sweats, fatigue, nausea and vomiting.  Mildly elevated temp.(100.7) and tilt positive.  Pt transported to Hospital for further eval at that time.  Pt's condition improved with 1L NS fluid bolus and APAP during the ED stay.  CBC- WBC 8.7, H/H 14.2/41.5, Plat 239.  Pt diagnosed with Viral Syndrome and Acute Cephalgia(resolved), and was discharge back to Command with f/u at BAS.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Fatigue, Malaise, Migraine, Muscular weakness, Oedema
Clinical narrative: Vaccinee has history of chronic urticaria and sciatica post-trauma (1984), both quiescent prior to vaccination.  On day 2 post-smallpox vaccination, vaccinee developed paresthesias of dorsal left hand + minor swelling of hand. Left hand paresthesias have remitted and relapsed subsequently, and continue intermittently through day 18. No report of muscle weakness. Flare of sciatica on days 5-8 (resolved). Otherwise, no similar symptoms at other sites. Symptoms imnproved by NSAIDs (trilisate).  No history of similar symptoms. Migraine-like HA on day 10 post-vaccination; Pruritis. Also fatigue + malaise. Otherwise no systemic symptoms. No fever. No nuchal rigidity. No LE weakness except with sciatica.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pain, Paraesthesia, Pruritus
Clinical narrative: Vaccinee has history of chronic urticaria and sciatica post-trauma (1984), both quiescent prior to vaccination.  On day 2 post-smallpox vaccination, vaccinee developed paresthesias of dorsal left hand + minor swelling of hand. Left hand paresthesias have remitted and relapsed subsequently, and continue intermittently through day 18. No report of muscle weakness. Flare of sciatica on days 5-8 (resolved). Otherwise, no similar symptoms at other sites. Symptoms imnproved by NSAIDs (trilisate).  No history of similar symptoms. Migraine-like HA on day 10 post-vaccination; Pruritis. Also fatigue + malaise. Otherwise no systemic symptoms. No fever. No nuchal rigidity. No LE weakness except with sciatica.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Confusional state, Headache, Injection site ulcer, Migraine, Neuralgia
Clinical narrative: Vaccinee has history of chronic urticaria and sciatica post-trauma (1984), both quiescent prior to vaccination.  On day 2 post-smallpox vaccination, vaccinee developed paresthesias of dorsal left hand + minor swelling of hand. Left hand paresthesias have remitted and relapsed subsequently, and continue intermittently through day 18. No report of muscle weakness. Flare of sciatica on days 5-8 (resolved). Otherwise, no similar symptoms at other sites. Symptoms imnproved by NSAIDs (trilisate).  No history of similar symptoms. Migraine-like HA on day 10 post-vaccination; Pruritis. Also fatigue + malaise. Otherwise no systemic symptoms. No fever. No nuchal rigidity. No LE weakness except with sciatica.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Oedema, Paraesthesia
Clinical narrative: Vaccinee has history of chronic urticaria and sciatica post-trauma (1984), both quiescent prior to vaccination.  On day 2 post-smallpox vaccination, vaccinee developed paresthesias of dorsal left hand + minor swelling of hand. Left hand paresthesias have remitted and relapsed subsequently, and continue intermittently through day 18. No report of muscle weakness. Flare of sciatica on days 5-8 (resolved). Otherwise, no similar symptoms at other sites. Symptoms imnproved by NSAIDs (trilisate).  No history of similar symptoms. Migraine-like HA on day 10 post-vaccination; Pruritis. Also fatigue + malaise. Otherwise no systemic symptoms. No fever. No nuchal rigidity. No LE weakness except with sciatica.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Info has been received from an RN concerning a 25 year old male who on 1/23/02 at approx. 18:00 was vaccinated with a 1st dose of Hep-B, IM in the left arm. The pt did not have any symptoms of illness prior to vaccination. The pt awoke at midnight on 1/24/02 and had a fever of 101F and diarrhea. The pt's diarrhea continued and the pt was referred to a physician. On 1/25/02, the pt recovered. On 1/26/02, the pt felt better and went to work. No additional info is expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Anaphylactic reaction, Asthenia, Asthma, Bradycardia, Hyperhidrosis
Clinical narrative: Info has been received from an MD and a father concerning his 10 wk old son w/a history of a twin birth, gastroesophageal reflex disease (GERD), no known drug allergies, and a family history of asthma and allergies who on 8/9/02 at 12:15 was vax'd IM in the right thigh w/a first dose of Hep B vax recombinant. There was no illness at the time of vax. Concomitant vax on 8/9/02 included a dose of Haemophilus B conjugate vax in the left thigh, a dose of Streptococcus pneumoniae vax in the right thigh, a dose of poliovirus vax in the right thigh, and a dose of Tripedia vax in the left thigh. Concomitant medication prescribed at approx 5 wks of age included ranitidine hydrochloride (Zantac) 1 cc BID for the PT's history of GERD. On 8/9/02 at 12:16, the PT developed swelling at the inject sites, followed 15 mins later by a decrease in his pulse to 110, and 15 mins later an onset of weakness, lethargy, sweating, pallor and wheezing w/the PT passing out from an anaphylactic reaction. The PT was given 3 SC injections of epinephrine, diphenhydramine hydrochloride (Benadryl) liquid PO, albuterol nebulizer treatment, and dexamethasone (MSD) IM in the MD's office. The child was then transported w/oxygen via face mask to the nearest ER and admitted to the hospital for observation for 2 days. While hospitalized the PT received diphenhydramine hydrochloride (Benadryl) 5 mg intravenously every 6 hrs and methylprednisolone sodium succinate (Solu-Medrol) 6 mg intravenously every 12 hrs. On 8/9/02 at 22:00 the PT's temp was 100.2 deg F. On 8/10/02 at 17:20, the PT's oxygen saturation was 100% on room air and labs were drawn including a CBC, IgE, histamine, tryptase, and RAST (see lab section for results). On 8/10/02 at 9:15, the PT's vital signs were reported as a range for his blood pressure 77-98/41-65, pulse 181-186, respirations 40-48, and temp of 97 deg F. On 8/11/02 at 16:45 the child was discharged from the hospital in stable condition w/vital signs reported as heart rate 150, respiration 40, temp 97.5 deg F, and blood pressure 92/48. The PT's family was given an epi pen and instructed on its use and the PT was to follow-up w/his primary care MD "next week". Anaphylactic reaction was considered to be life-threatening by the reporter. Add'l info is expected. Follow up on 03/09/04: "Follow up information was received from the physician indicating that the pt recovered the "next day" on 08/10/02 (also reported as 08/09/02).  The reporter indicated that no further details were available. Anaphylactic reaction was considered to be life-threatening by the reporter. No further information is expected."
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site oedema, Pallor, Pyrexia, Somnolence, Syncope
Clinical narrative: Info has been received from an MD and a father concerning his 10 wk old son w/a history of a twin birth, gastroesophageal reflex disease (GERD), no known drug allergies, and a family history of asthma and allergies who on 8/9/02 at 12:15 was vax'd IM in the right thigh w/a first dose of Hep B vax recombinant. There was no illness at the time of vax. Concomitant vax on 8/9/02 included a dose of Haemophilus B conjugate vax in the left thigh, a dose of Streptococcus pneumoniae vax in the right thigh, a dose of poliovirus vax in the right thigh, and a dose of Tripedia vax in the left thigh. Concomitant medication prescribed at approx 5 wks of age included ranitidine hydrochloride (Zantac) 1 cc BID for the PT's history of GERD. On 8/9/02 at 12:16, the PT developed swelling at the inject sites, followed 15 mins later by a decrease in his pulse to 110, and 15 mins later an onset of weakness, lethargy, sweating, pallor and wheezing w/the PT passing out from an anaphylactic reaction. The PT was given 3 SC injections of epinephrine, diphenhydramine hydrochloride (Benadryl) liquid PO, albuterol nebulizer treatment, and dexamethasone (MSD) IM in the MD's office. The child was then transported w/oxygen via face mask to the nearest ER and admitted to the hospital for observation for 2 days. While hospitalized the PT received diphenhydramine hydrochloride (Benadryl) 5 mg intravenously every 6 hrs and methylprednisolone sodium succinate (Solu-Medrol) 6 mg intravenously every 12 hrs. On 8/9/02 at 22:00 the PT's temp was 100.2 deg F. On 8/10/02 at 17:20, the PT's oxygen saturation was 100% on room air and labs were drawn including a CBC, IgE, histamine, tryptase, and RAST (see lab section for results). On 8/10/02 at 9:15, the PT's vital signs were reported as a range for his blood pressure 77-98/41-65, pulse 181-186, respirations 40-48, and temp of 97 deg F. On 8/11/02 at 16:45 the child was discharged from the hospital in stable condition w/vital signs reported as heart rate 150, respiration 40, temp 97.5 deg F, and blood pressure 92/48. The PT's family was given an epi pen and instructed on its use and the PT was to follow-up w/his primary care MD "next week". Anaphylactic reaction was considered to be life-threatening by the reporter. Add'l info is expected. Follow up on 03/09/04: "Follow up information was received from the physician indicating that the pt recovered the "next day" on 08/10/02 (also reported as 08/09/02).  The reporter indicated that no further details were available. Anaphylactic reaction was considered to be life-threatening by the reporter. No further information is expected."
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Crying
Clinical narrative: Info has been received from the mother of a 2 day old female w/a peanut and rice cereal allergy and an amoxicillin allergy who on 6/8/99 was vax'd w/a first dose of Hep B vax recombinant. There was no concomitant medication. During the evening of 7/9/99, the PT cried more than usual and seemed inconsolable and distraught. The PT's mother contacted the MD who "wanted nothing to do w/the issue". Unspecified medical attention was sought. No further info. is available.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male with no known allergies who, at 8:30 on 10/15/02 was vaccinated IM in the left deltoid with the first dose of hep B vaccine (642741/0153M). There was no concomitant medication. On 10/17/02 the pt developed redness and "itchiness" at the injection site. On 10/18/02 the pt was seen "in the office" with a three inch reddened area with induration, and little bumps and itchiness. The pt was treated with Allegra, one tablet dialy for one week. The nurse reported that the pt will be given Allegra before the administration of the next dose of hep B vaccine, as well as ice after the dose is given. The nurse also reported theat as of 10/21/02, the pt's bumps and itching continued. The outcome of the redness and induration at the injection site was unknown. Conflicting info has been received from the registered nurse. The registered nurse reported that on 10/18/02, at 9:00, the pt develoepd a 3 inch circular induration around the injection site, along with small bumps and ithcing at the injection site. THe pt ws afebriel and otherwise "feeling well." The registered nurse also reported that the pt recovered from the itchiness and injection site induration, the pt's redness was resolving on 10/21/02, but a few small bumps still remained. Further info has been received from the registered nurse. The registered nurse reported that the physician has assessed the pt's injection site as a localized allergic reaction and that no lab tests were performed on the pt. No additional info is expected.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male with no known allergies who, at 8:30 on 10/15/02 was vaccinated IM in the left deltoid with the first dose of hep B vaccine (642741/0153M). There was no concomitant medication. On 10/17/02 the pt developed redness and "itchiness" at the injection site. On 10/18/02 the pt was seen "in the office" with a three inch reddened area with induration, and little bumps and itchiness. The pt was treated with Allegra, one tablet dialy for one week. The nurse reported that the pt will be given Allegra before the administration of the next dose of hep B vaccine, as well as ice after the dose is given. The nurse also reported theat as of 10/21/02, the pt's bumps and itching continued. The outcome of the redness and induration at the injection site was unknown. Conflicting info has been received from the registered nurse. The registered nurse reported that on 10/18/02, at 9:00, the pt develoepd a 3 inch circular induration around the injection site, along with small bumps and ithcing at the injection site. THe pt ws afebriel and otherwise "feeling well." The registered nurse also reported that the pt recovered from the itchiness and injection site induration, the pt's redness was resolving on 10/21/02, but a few small bumps still remained. Further info has been received from the registered nurse. The registered nurse reported that the physician has assessed the pt's injection site as a localized allergic reaction and that no lab tests were performed on the pt. No additional info is expected.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Blood bilirubin increased, Decreased appetite, Fatigue, Globulins increased, Headache
Clinical narrative: Initial and follow-up info has been received from an RN and medical records concerning an 18 year old male, with no known allergies, who on 11/5/02, at 11:00, was vaccinated with the 2nd dose of Hep-B, administered in the left deltoid. There was no illness at the time of vaccination. On the morning of 11/6/02, the child developed sudden onset of "knots" under the bilateral axilla and a temperature of 101.2F, moderate in severity. He was examined by a physician and complained of fatigue and feeling tired. Other symptoms included nausea and a slight headache. At that time, the remainder of his physical assessment was without abnormal findings. The physician's clinical impression was "fever, axillary LAN and malaise secondary to Hep-B shot". The physician questioned a hypersensitivity vs mild reaction. The pt was treated with NSAIDS. On 11/8/02, he was improved, appetite was decreased, and he was "maybe feeling slightly better". The physician documented no LAN except in the axilla. Remainder of physical assessment was without abnormal finding. The physician's impression was Hep-B vaccine reaction. The pt was treated with Naprosyn 500mg, twice a day and encouraged to increase PO intake, "high calorie foods". On 11/12/02, the pt was seen by the physician for follow-up of the rash. He was noted to be feeling much better. At that time the LAN of the axilla was improved. However, he had mildly swollen lymph nodes in the groin area. Papules on the right hip remained, but the rash was documented to be resolving. "? Shingles" was documented, again. The physician noted that the vaccine reaction to Hep-B seemed to be resolving but questioned giving the 3rd dose in the series. Based on the increased total bilirubin, on 11/8/02, the physician suspected possible Gilbert's Syndrome and ordered LFT's to be performed. The pt was seen, by the physician, on 12/3/02 for follow-up for the rash and lab work. Physical assessment findings were within normal limits. The "vaccine reaction" was considered to be resolved and the physician recommended that the pt not receive the 3rd dose in the series. In addition, he documented that he would follow the pt for Gilbert's Syndrome. Decreased appetite was considered to be an incidental finding. No further info is available.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: Initial and follow-up info has been received from an RN and medical records concerning an 18 year old male, with no known allergies, who on 11/5/02, at 11:00, was vaccinated with the 2nd dose of Hep-B, administered in the left deltoid. There was no illness at the time of vaccination. On the morning of 11/6/02, the child developed sudden onset of "knots" under the bilateral axilla and a temperature of 101.2F, moderate in severity. He was examined by a physician and complained of fatigue and feeling tired. Other symptoms included nausea and a slight headache. At that time, the remainder of his physical assessment was without abnormal findings. The physician's clinical impression was "fever, axillary LAN and malaise secondary to Hep-B shot". The physician questioned a hypersensitivity vs mild reaction. The pt was treated with NSAIDS. On 11/8/02, he was improved, appetite was decreased, and he was "maybe feeling slightly better". The physician documented no LAN except in the axilla. Remainder of physical assessment was without abnormal finding. The physician's impression was Hep-B vaccine reaction. The pt was treated with Naprosyn 500mg, twice a day and encouraged to increase PO intake, "high calorie foods". On 11/12/02, the pt was seen by the physician for follow-up of the rash. He was noted to be feeling much better. At that time the LAN of the axilla was improved. However, he had mildly swollen lymph nodes in the groin area. Papules on the right hip remained, but the rash was documented to be resolving. "? Shingles" was documented, again. The physician noted that the vaccine reaction to Hep-B seemed to be resolving but questioned giving the 3rd dose in the series. Based on the increased total bilirubin, on 11/8/02, the physician suspected possible Gilbert's Syndrome and ordered LFT's to be performed. The pt was seen, by the physician, on 12/3/02 for follow-up for the rash and lab work. Physical assessment findings were within normal limits. The "vaccine reaction" was considered to be resolved and the physician recommended that the pt not receive the 3rd dose in the series. In addition, he documented that he would follow the pt for Gilbert's Syndrome. Decreased appetite was considered to be an incidental finding. No further info is available.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Rash maculo-papular
Clinical narrative: Initial and follow-up info has been received from an RN and medical records concerning an 18 year old male, with no known allergies, who on 11/5/02, at 11:00, was vaccinated with the 2nd dose of Hep-B, administered in the left deltoid. There was no illness at the time of vaccination. On the morning of 11/6/02, the child developed sudden onset of "knots" under the bilateral axilla and a temperature of 101.2F, moderate in severity. He was examined by a physician and complained of fatigue and feeling tired. Other symptoms included nausea and a slight headache. At that time, the remainder of his physical assessment was without abnormal findings. The physician's clinical impression was "fever, axillary LAN and malaise secondary to Hep-B shot". The physician questioned a hypersensitivity vs mild reaction. The pt was treated with NSAIDS. On 11/8/02, he was improved, appetite was decreased, and he was "maybe feeling slightly better". The physician documented no LAN except in the axilla. Remainder of physical assessment was without abnormal finding. The physician's impression was Hep-B vaccine reaction. The pt was treated with Naprosyn 500mg, twice a day and encouraged to increase PO intake, "high calorie foods". On 11/12/02, the pt was seen by the physician for follow-up of the rash. He was noted to be feeling much better. At that time the LAN of the axilla was improved. However, he had mildly swollen lymph nodes in the groin area. Papules on the right hip remained, but the rash was documented to be resolving. "? Shingles" was documented, again. The physician noted that the vaccine reaction to Hep-B seemed to be resolving but questioned giving the 3rd dose in the series. Based on the increased total bilirubin, on 11/8/02, the physician suspected possible Gilbert's Syndrome and ordered LFT's to be performed. The pt was seen, by the physician, on 12/3/02 for follow-up for the rash and lab work. Physical assessment findings were within normal limits. The "vaccine reaction" was considered to be resolved and the physician recommended that the pt not receive the 3rd dose in the series. In addition, he documented that he would follow the pt for Gilbert's Syndrome. Decreased appetite was considered to be an incidental finding. No further info is available.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Joint stiffness, Joint swelling, Pain
Clinical narrative: A few weeks after my second Lymerix vaccine I started to get severe pain in both my left and right forearms. The pains then started to travel to different parts of my body, hands, legs, arms (everywhere). Swelling of the hands and finger in this time period I went from no rheumatood factor to a high factor. I am ready to refill my prescription of Lipitor and have a question for you. I am not sure if there is a correlation but for the last two to three months I have had pain in my forearms and or elbow joints. At first I thought this was caused by some physical work that I have done. For the last month I have eliminated that possibility but still have the symptoms. Is there an alternative to Lipitor that I can try to see if I could reduce the stiffness and pain? Requested to evaluated by MD. Delightful fellow who works in IT but is also on search and rescue. During the course of this he was immunized at least three injections of hepatitis vaccine in two of the Lyme vaccine. He developed generalized aches and pains, perhaps some swelling in the small joints of the feet and hands. He is not sure. In the course of the workup he was also placed on Lipitor was discontinued. He was continued with morning stiffness, generalized, moderate in severity but less than one-half hour. Swelling of the joints has dissipated. There are some aches and pains. He has some fatigue but no fever or other constitutional symptoms. He denies skin rashes, sun sensitivity or any known tick bites. He has tried some Celebrex with minimal improvement. No neck or low back pain, painful red eye, bloody diarrhea, pleuritic chest pain or fever. Pain on the bottom of the feet when he walks. Has seen a foot specialist and was told it was "tendons." Follow up labs including quantitative titer of rheumatoid factor and western blot on the lyme antibody, ANA, CPK. Continue Celebrex, 200mg daily. HLA-B27 antigen. Rheumatoid arthritis, serologically positive. Pt has some mild synovitis in a small joints of the hands. Begin Methotrexate 10mgs q week. Begin Sulindac 200 mgs twice a day, in place of Celebrex. RTC three weeks for monitoring of potential toxicities and efficacy. Due to the high concentration of rheumatoid factor, I will probably obtain a chest x-ray when he returns, as well as a baseline set of hand films, to check for joint erosions and space narrowing in the future.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid arthritis, Synovitis
Clinical narrative: A few weeks after my second Lymerix vaccine I started to get severe pain in both my left and right forearms. The pains then started to travel to different parts of my body, hands, legs, arms (everywhere). Swelling of the hands and finger in this time period I went from no rheumatood factor to a high factor. I am ready to refill my prescription of Lipitor and have a question for you. I am not sure if there is a correlation but for the last two to three months I have had pain in my forearms and or elbow joints. At first I thought this was caused by some physical work that I have done. For the last month I have eliminated that possibility but still have the symptoms. Is there an alternative to Lipitor that I can try to see if I could reduce the stiffness and pain? Requested to evaluated by MD. Delightful fellow who works in IT but is also on search and rescue. During the course of this he was immunized at least three injections of hepatitis vaccine in two of the Lyme vaccine. He developed generalized aches and pains, perhaps some swelling in the small joints of the feet and hands. He is not sure. In the course of the workup he was also placed on Lipitor was discontinued. He was continued with morning stiffness, generalized, moderate in severity but less than one-half hour. Swelling of the joints has dissipated. There are some aches and pains. He has some fatigue but no fever or other constitutional symptoms. He denies skin rashes, sun sensitivity or any known tick bites. He has tried some Celebrex with minimal improvement. No neck or low back pain, painful red eye, bloody diarrhea, pleuritic chest pain or fever. Pain on the bottom of the feet when he walks. Has seen a foot specialist and was told it was "tendons." Follow up labs including quantitative titer of rheumatoid factor and western blot on the lyme antibody, ANA, CPK. Continue Celebrex, 200mg daily. HLA-B27 antigen. Rheumatoid arthritis, serologically positive. Pt has some mild synovitis in a small joints of the hands. Begin Methotrexate 10mgs q week. Begin Sulindac 200 mgs twice a day, in place of Celebrex. RTC three weeks for monitoring of potential toxicities and efficacy. Due to the high concentration of rheumatoid factor, I will probably obtain a chest x-ray when he returns, as well as a baseline set of hand films, to check for joint erosions and space narrowing in the future.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site reaction, Vasodilation procedure
Clinical narrative: Left upper arm at inject site w/moderate amount of edema and redness and warm to the touch. Small slit like open area at inject site. No drainage noted. PT returned to clinic 24 hrs post injection for above assessment. Continued on progress note.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Angioneurotic oedema, Dysphagia, Hypersensitivity, Vomiting
Clinical narrative: Received vax 2/18/03. Mom called 2/19/03 stating child was sick (throwing up) all night - choked once, turning blue. Child recovered shortly. Next morning (2/19) child had "whelps" (big, red) all over her body. No trouble breathing on 2/19. Child still throwing. ER vs. PMD said "allergic reaction to one of shots." Child ok on 2/20/03.
Age: 1.5
Sex: M
Vaccine: HBHEPB
Symptoms: Ecchymosis, Erythema, Erythema multiforme
Clinical narrative: MD relayed that post vax child developed circles, red on outside with bruise color in center. Took to another MD at a pediatric center was ? diagnosed. Took to a children's ER on 2/23/03 was Dx'd with erythema multiforme. Child was on antibiotic at time of vax.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Warm, reddened area noted covering left deltoid. Child has no complaints of pain. Parents concerned.
Age: 53.0
Sex: F
Vaccine: HEPA, TD, TYP
Symptoms: Infection, Injection site erythema, Injection site oedema, Injection site pain, Injection site urticaria
Clinical narrative: C/o pain at inject site - redness, swelling, whelps on 2/12 - on 2/13 went to MD on 2/13 at 10 a.m. - states he said "infection" present - given antibiotics - better 2/13/03. (RUE Pain)
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Pruritus, Pyrexia
Clinical narrative: Right UE - localized at inject site. Reddened, itching, hives, small amount of edema. Increased temp.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Right UE - localized at inject site. Reddened, itching, hives, small amount of edema. Increased temp.
Age: 1.6
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Right after giving the DTaP w/in 5-10 mins in the upper right thigh sight got red - size of a quarter. PT was given 1.5 tsp of Benadryl. Gave Polio vax in same leg. M? said she had a past reaction to polio, but no reaction to polio yesterday.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: PT had injections, went home. Napped 5 hrs and woke with inconsolable crying for 1/2 - 3/4 hr.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Vasodilation procedure
Clinical narrative: Site - red, swollen, hot.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Vasodilation procedure
Clinical narrative: Injection site red, swollen, hot.
Age: 18.0
Sex: M
Vaccine: TTOX
Symptoms: Bronchitis, Dyspnoea, Malaise, Pruritus, Urticaria
Clinical narrative: 3/7/03 IM tetanus toxoid given right arm. 3/8/03 PT reported hives all over body and itching. C/o being ill w/bronchitis, w/some S.O.B. via phone. Saw own MD, taking PO Benadryl and steroids PO ordered yet to start.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Urticaria
Clinical narrative: Vax'd on 10/15/02. Also started whole milk for first time on 10/16. On 10/22 PT got a few chicken pox. On the 24th at 3 a.m. she broke out into severe hives. The hives did not affect her breathing. There was no wheezing or fever. She just had horrible locking hives (welts) from head to toe. One was the size of a baseball on her belly. We had to call hospital and gave her 4 ml of Benadryl every 6 hrs. The hives lasted 4 days. They did not go away until PT's mom stopped giving her whole milk. She was on Iscinil since 10 days after birth. Similae (?) at birth made her gassy and fussy. Her pediatrician made up to go to an allergist. On the day of her hives she had a little egg. They thought she may be allergic to milk or egg. These allergies have been ruled out. She now drinks whole milk ? (a copy of specialist's report) is exe?sed. PT's mother thought they should know about this. It is really inconclusive tra? ? caused this. But they could have?
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pruritus, Urticaria
Clinical narrative: Varicella-like rash started evening of 2/28/03 on stomach, then back, then a few lesions on chest over a period of 4-5 days. Inject site clear. Itching. No fever or other Sx's. Lesions scabbed over - cleared.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Sepsis
Clinical narrative: Information has been received from the center (VAERS ID 178149) concerning a 2 month old male who on 12/13/01 was vaccinated IM in the right leg with a first dose of Comvax (640503/0933L). Concomitant vaccine therapy included a first dose SQ in the left leg of poliovirus vaccine (U0344), Tripedia (U03400A) and a first dose of IM in the right leg Prevnar (484145). Other concomitant medication included Zantac and gentian violet. On 12/13/01 the pt was taken to the ER for a febrile illness. He was hospitalized and diagnosed with sepsis. From additional correspondence received at manufacturer on 6/21/02 it was reported: A follow-up call was placed to manufacturer (U2002-00103 originated from manufacturer) to determine if these two cases (U200200103 and U200200151) are duplicates. Manufacturer is unable to confirm if they are duplicates at this time. More info is expected. Follow-up #2 (latest received date 1/14/01): During internal review of this case, it was determined that case U200200103 is a duplicate. Case U200200151 will be referred to as the report of reference. No new info was obtained. The lot number for Tripedia was corrected to U03400A as per the source documentation.  Follow up on 07/07/2003: "From additional information received on 06/24/2003 through a telephone conversation with the reporter from the manufacturer, it was reported that they had not received any new information for this case, nor is any anticipated, therefore this case will be closed."
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Constipation, Dizziness, Headache, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 49 year old Caucasian female MA with a heart murmur who on 11/16/01 at 15:00 was vaccinated with a 1st, 2nd and 3rd dose of Hep-B vaccine recombinant (yeast) (10mcg (IR) GL/MD) and according to the physician was "doing fine". The pt sought unspecified medical attention. The MA reported that on 11/16/01, she had dizziness and fever initially, "only that day". That night, she had pain at the injection site. She also had a headache for 1-2 days after injection and had constipation that lasted for 2 weeks. She stated that none of the adverse events "lasted". No further info is expected.
Sex: U
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from an RN concerning a child who on 1/4/02 was vaccinated with the 3rd dose of Hep-B vaccine recombinant (yeast). It was reported that the child subsequently developed hives. Unspecified medical attention was sought. No further info was provided at the time of this report. Conflicting follow-up from the RN stated that the child did not experience an adverse reaction. No further info is expected.
Age: 1.08
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Info has been received from a consumer concerning her daughter who in 9/01 was vaccinated with a dose of Hep-B. On 11/30/01, the pt was vaccinated with 1 dose each of DPT and IPOL and Hib-Titer. On 12/01, the pt developed hives at the injection site and all over her body. Unspecified medical attention was sought. Follow-up info was received from an RN who indicated that Hep-B vaccine was not the suspected product since the hives were following the other products, not the Hep-B vaccine, which was administered 2 months prior to the event. The outcome of the hives was not reported. No further info is expected.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Info has been received from a health professional concerning a 25 year old female with a history of appendectomy who on 12/17/01 was vaccinated with the 1st dose of Hep-B. There was no concomitant medication. On 12/19/01, the pt experienced red dots on her upper thigh, abdomen, shoulder and cheek. She recovered from the dots. In 1/02, the pt experienced generalized itchy skin. The pt sought medical attention. Additional info has been requested.
Age: 35.0
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Info has been received from a health professional concerning a 35 year old pt who on 5/23/00, 6/28/00 and 1/03/01 was vaccinated with a 1st (1960J), 2nd (0488K) and 3rd dose (0488K) respectively of Hep-B. On 3/1/01, the anti-hepatitis B surface antigen titer was negative. It was noted that the pt failed to respond to the 3 injection series. Additional info has been requested.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy, Nasal congestion, Pyrexia, Rash
Clinical narrative: Info has been received from a pharmacist concerning an 11 year old male with many food allergies and a possible yeast allergy who in 8/01 was vaccinated with a 1st dose and in 2/02 was vaccinated with a 2nd dose of Hep-B. The pharmacist reported that approx. 1 to 2 days after each dose, the pt developed a non-specific rash, swollen glands, a low-grade fever and congestion. All symptoms seemed to resolve approx. 1 week after onset. Additional info has been requested.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Info has been received from a relative of a 13 year old female who was vaccinated with a 4th dose of Hep-B. Subsequently, the pt developed a little bit of swelling around the injection site. The pt had not sought medical attention for her experience. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Conjunctival discolouration
Clinical narrative: Info has been received from a female consumer with no underlying disease who on approx. 2/11/02 was vaccinated with a 3rd dose of Hep-B. On approx. 2/16/02, the pt noticed that her eyes looked yellow. It was noted that she has an appt. with her physician. Unspecified medical attention was sought. Additional info has been requested.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Influenza like illness, Pyrexia
Clinical narrative: Info has been received from a NP concerning a 19 year old female who in approx. 1997, when she was 14 years old, was vaccinated with the 3 dose series of Hep-B vaccine. There was no concomitant medication. Following each administration of the vaccine, the pt experienced flu-like symptoms and developed a high fever. It was reported that the symptoms got worse after each vaccination. The pt was recently checked for titers and the titer was found to be negative. Unspecified medical attention was sought. In follow-up, the NP reported that the pt was lost to follow-up and since the vaccine was not given at her clinic, the nurse could not provide the name of the Hep-B vaccine that the pt received. No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: Info was rec'd from an allergist concerning a pt who was vaccinated with a dose of hepatitis B vaccine recombinant (yeast). The reporter did not know whether it was  hepatitis B vaccine recombinant (yeast) (MSD) or hepatitis B vaccine recombinant (yeast) (Engerix-B). Subsequently the pt developed a large, local site reaction, reported to be enough to be seen at the ER for evaluation. There was no further information, since the pt was not vaccinated by the reporter nor at his facility. It was noted that the child was vaccinated by a pediatrician at another facility. Additional info has been requested.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Info has been rec'd concerning a pt with diabetes mellitus who was vaccinated with her 2nd hepatitis vaccine. (lot #641071/1069L) IM. The pt complained of weakness and was feeling nauseated, dizzy, and queasy within 10 min of receiving the 2nd dose. The pt's vital signs were BP 120/98, P 64 and R 20. The pt was given a finger stick and her glucose was found to be within normal limits. The pt was advised to sit and rest and take ice chips and later "something bland". She was advised to lie down and rest. It was noted that the pt did not have breakfast and was given tea and toast. The pt felt better and went home at 12 Noon and was told to see her own physician if the symptoms persisted. Later, the pt had vomiting and diarrhea. She then called her doctor, who ordered treatment that was unavailable at the local pharmacy, then kaolin (Kaopectate) was ordered. The pt improved and the symptoms subsided. The doctor recommenced that she not receive the 3rd dose. It was reported that the pt recovered on 2/2/02. No further information is expected.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Rash papular, Swelling
Clinical narrative: Information was rec'd concerning a pt with allergies to grass, mold, dust mites, and dairy who on 2/5/02 was vaccinated with the 1st dose of hepatitis B, in the L deltoid/IM. On 2/8/02 the pt experienced swelling of the L arm and red band like papules in clusters on the R arm. The bands measured 6 1/2cm X 1cm and 7cm X 1 1/2cm. The reaction was local and treated with 1% hydrocortisone cream and chlorpheniramine tablets. The pt recovered on 2/13/02. The pt sought medical attention. No further info is expected.