chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Asthenia, Gait disturbance, Pyrexia
Clinical narrative: Developed rheumatoid arthritis after the receipt of anthrax vaccine. Nodule at site of vaccine.
Age: 41.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site mass, Rheumatoid arthritis
Clinical narrative: Developed rheumatoid arthritis after the receipt of anthrax vaccine. Nodule at site of vaccine.
Age: 2.08
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pruritus, Rash
Clinical narrative: Immunizations given at 11:30 Mon. Mother called at 15:00 saying her son had rash on face and feet, pt not having any other symptoms. Mom called at 15:30-rash now all over body, itching, no breathing difficulties. RN called MD-MD wanting to give child 20 mg Benadryl elixir. Call made to Mom from RN at 15:35. Mom to give Benadryl. Mom gave pt 2 doses on evening of 8/14/03. No breathing difficulties. No rash 8/15/03 in AM.
Age: 47.0
Sex: F
Vaccine: SMALL
Symptoms: Myalgia
Clinical narrative: Pt has had muscle pain under vaccine site with movement for several months. She has not seen a physician.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: Generalized red raised rash on trunk now spreading to arms and legs 1 week post smallpox vaccine.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Itchy maculopapular rash 9 days after receiving smallpox vaccine.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Injection site erythema, Injection site oedema, Pyrexia, Screaming
Clinical narrative: Cried-screamed from 2:45-3:15 PM. Then from 4:00-7:00 PM. R Temp 102. Right leg swollen and red at site of injection.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Pyrexia, Rash, Rash vesicular
Clinical narrative: 6 days after MMR, Varivax, Hib and Prevnar had temp of 104.8 and 8 days after these vaccines had a fine red rash on trunk and vesicular rash over body. No Tx needed and everything resolves without any difficulty. Gave only fever reducers. No apparent complications.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Eye movement disorder, Somnolence, Tremor
Clinical narrative: Mom called 10:40 on 8/4/03 stating that on 8/3 while child drinking bottle "not acting himself" looking like falling asleep, eyes rolling back, then shook for a a couple of seconds (per Mom) then fell asleep, whole body shaking for few seconds. 8/5 checked by nurse practitioner-doing well-scheduled for EEG.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Approx 1 month after Anthrax #3, developed muscle and joint pain (myalgia, arthralgia). Approx 6 weeks after Anthrax #3, developed testicular pain. Follow up: chronic myalgias, flu-like symptoms, fever, muscle aches, tiredness.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Testicular disorder
Clinical narrative: Approx 1 month after Anthrax #3, developed muscle and joint pain (myalgia, arthralgia). Approx 6 weeks after Anthrax #3, developed testicular pain. Follow up: chronic myalgias, flu-like symptoms, fever, muscle aches, tiredness.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Skin ulcer
Clinical narrative: Scattered vesicles and dry skin with ulceration. Symptomatic Tx. Chicken pox.
Age: 2.5
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever for 2 days, sleeps a lot and other symptoms (102 F).
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site oedema, Pain
Clinical narrative: 8/8/03 increased pain in left thigh, mild swelling. 8/10/03 much improved.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Swollen, red, raised area right upper arm-much improved on 8/11/03. No fever.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Left arm swelling around deltoid muscle, extending circumference of arm to elbow. No erythema present. No fever. Swelling starting at suppertime, the day of injection and continued to grow overnight.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Mother states left arm (upper) became swollen from shoulder to just above elbow within 24 hours. Now resolved with only a hardened area at injection site of DTPa. Area very hot. Mother used Tylenol for comfort.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Pruritus, Rash
Clinical narrative: 3 hours after IPV developed rash. Flesh colored bumps better the next day, then more the next day, itchy. Mom requested report be filed.
Age: 2.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized redness and swelling of right thigh measuring 21 x 21 cm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Pruritus, Urticaria
Clinical narrative: While pt was still in the building, after receiving vaccines, pt started to develop very pruritic hives all around his head and trunk. Benadryl (1.5 tsp) was given po, observed for 35 minutes. Had slight cough but had clear breath sounds bilaterally. Left stable.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Arm swollen-from shoulder to elbow. Warm to touch. Left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Blister, Injection site erythema
Clinical narrative: Erythema 12 x 10cm overlying injection site. Vesicles (1-2mm) spread over 2 x 2cm in center of erythema left arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Large red, warm, swollen area on right thigh within 24 hours of DTaP injection.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema
Clinical narrative: R deltoid-inflammation, redness appearing 12 hrs post immunization.
Age: 4.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Facial palsy, Hypoaesthesia
Clinical narrative: 8/13/03 family called and child's lip was swollen and numb. Instructed to go to ER. Was seen there and diagnosed with Bell's palsy. 8/14/03 saw ENT doctor, and neurologist doctor.
Age: 4.0
Sex: F
Vaccine: HEPA, IPV, MMR
Symptoms: Ephelides, Pyrexia
Clinical narrative: Fever, "purple freckles" on face developed w/in 2-3 hours post immun. no SOB no stiffneck. Parents informed to give, Tyl or Ibuprofen and watch for fever > 105. Within one hour sx's were resolving. Also told by separate nurse to go to ER.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Coma, Sudden infant death syndrome
Clinical narrative: Child was vaccinated in our office on 8/14/03. Received call from coroner on 8/15/03, that child had expired this morning. Reported was that grandmother heard child cry went into room and found child unresponsive. No further info available at time of completion of report. Autopsy Report received on 11/07/2003 states COD is SIDS.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Convulsion, Otitis media, Pyrexia
Clinical narrative: Seizure at home; immediately taken to the hospital. Seizure lasted after arrival to hospital; unknown duration, temp 102 degrees F. Had low temperature mom stated since immunization. Treated with IV's, KT, Rocephin given at hospital. 60 day follow up on 11/04/2003: "Unknown if vaccine recipient did ever recover from adverse events.  Still having seizures, was seen by neurologist.  He says will out grow. Doing much better." Discharge Summary received on 10/17/2003 states otitis media.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: S/P DTaP at L deltoid 8/13/03. Erythema, warmth, and indurations with tenderness occurred later same day. Seen for f/u 8/15/03 with 7" x 4" area of significant induration. Benadryl recommended. Will Rx with ?
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Rash, Urticaria
Clinical narrative: 7/15/03 at 11:10 rash, hives no fever no other symptoms given Zytec 2.5mg po at 11:15. Pt sent home.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Large patch involving most of L upper arm and shoulder: erythema, warm, raised, irregular borders, sharply demarcated with underlying induration; itches. Given scripts-will report in 2 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Small rash pn L thigh more proximal and lateral to the injection site. 5 days later no Tx.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site oedema
Clinical narrative: Cellulitis; severe local swelling. Tx: Keflex/Prelone/ ?
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Swelling and warmth at site of administration. Swelling 6cm x 10cm.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Influenza like illness, Nasal congestion, Pyrexia
Clinical narrative: Onset 6/5/03 of generalized dizziness and flu-like symptoms with mild congestion and fever. Pt states symptoms persisted x 3 weeks.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Pt came in with an egg size hard, swollen, red lump on deltoid muscle where MMR was given L. No treatment; just Ibu and ice.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Broke out with varicella-like rash 15 days after immuniation #1 over back, chest, neck, scalp.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 8-10cm erythem on L upper arm. Mild erythema warm to tocuh.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Face oedema, Pruritus, Pyrexia
Clinical narrative: Swollen face day after fever of 100 deg for 2 days extreme achyness all over.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Mild case of varicella 8/4/03.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Pt given Pneumovax 0.5cc per started procedure R shoulder. That night developed T 100.7 then swelling and redness at site. Rx A6, 48 h later better.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Rash
Clinical narrative: Pt experienced a large skin eruption at site of DTaP (also received MMR and IPV at other sites). The area was blistered and very red.
Age: 3.5
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Pharyngitis, Rhinitis
Clinical narrative: Cold symptoms x 3 days. Skin with many scatered vesicles with dry areas with ulceration upper in number over 2 h. Symptomatic Tx.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: Pt received DTaP #5, IPV #4 (2 IPV, 1 OPV previously) after one hour developed redness and pruritis to ears, scattered development of hives on face, neck, anticubital and right foot and 1-2 on trunk. No respiratory difficulty. Benadryl 2 tsp-resolution after 20 minutes.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Dyskinesia
Clinical narrative: Parents report to MD on 7/29/03 pt had 6 month immunizations on 7/25/03 (Friday). That evening they noticed episodes of uncontrollable jerking spells and stated he had all weekend on and off. They did call MD on call over weekend. On 07/29/03 they saw MD and he has ordered EEG 8/12/03 and MRI 8/6/03.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Eye oedema, Face oedema
Clinical narrative: Child had preschool PE - was given 5th DTaP and 4th IPV. Left clinic-returned about 1/2 hour later with swelling of lips, eyes and face-no swelling at injection site-to ER.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact
Clinical narrative: Daughter received varicella vaccine 4/5/03. Father came down with disease 4/29/03. Missed 9 days work 4/21-5/7/03.
Age: 3.5
Sex: F
Vaccine: VARCEL
Symptoms: Aspiration, Febrile convulsion, Synovitis
Clinical narrative: Pt admitted to PICU with febrile seizure to toxic synovitis.
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Pyrexia, Screaming
Clinical narrative: Parents brought patient to our clinic today for a physical. State that after her shots last July she developed intractable crying and fever. Was in the ER all night. Father states that the doctor said the fever and crying was related to the shots. No other vaccines given since that time. Family not certain if a VAERS report was filed. This is all the information that I have! Today I gave patient an MMR-the father refused to repeat any of the previous vaccines and insists that we only give one vaccine at a time!
Age: 0.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Herpes zoster, Infection transmission via personal contact, Pain, Viral infection
Clinical narrative: Follow up on 08/19/2003: "Secondary transmission of herpes zoster on 08/06/2002." The ER record states pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site oedema, Rash vesicular
Clinical narrative: pt had a severe local reaction with diffuse swelling of the arm and a vessicular eruption twice the size of a silver dollar at the site of the injection of the DTaP
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Father reported his son received a shot 1 hour ago and he returned to clinic for us to check his son.  Hives on face, trunk, axilla, groin and thighs.  Hives more dense around lips, no SOB, followed father's commands.  Capillary refill WNL.  Benadryl 25mg IM given and ambulance personnel arrived 5 minutes later and transported him to hospital.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Dtap #5MMR #2IPV #4 on 31 July 03 -Child received vaccination in well child check-up MOP noted swelling and local erythema at injection was instructed if increased another 1 ½ this size the child would need to follow up 1 Aug 03- Child told mother leg was uncomfortable MOP examined area and noted "4 inch" erythema and local swelling; no fever, itching, or other problemsMOP took child to ED; child was admitted for "cellulites"; very late at night child was "sleepy" otherwise acting appropriately 2 Aug 03 -Child received IV antibiotics pending lab studies that were taken in the ED; no fever, itching, and acting appropriately 3 Aug 03 - MOP reports decrease swelling and erythema; no fever, itching, and acting appropriately 4 Aug 03 - MOP reports only swelling present; no erythema, fever, itching, and acting appropriately 5 Aug 03 - MOP reports no swelling, erythema, fever, itching, and acting appropriately
Age: 12.0
Sex: M
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Eye swelling, Rash, Urticaria
Clinical narrative: Spoke to mother at 3am, 8/11/03. She stated patienthad rash and hives 8/7/03, eyes swollen - called Dr, no resp. distress - patient improving.
Age: 12.0
Sex: M
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Eyelid oedema, Face oedema, Urticaria
Clinical narrative: Spoke to mother at 3am, 8/11/03. She stated patienthad rash and hives 8/7/03, eyes swollen - called Dr, no resp. distress - patient improving.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin necrosis
Clinical narrative: THIS R.N. SINCE THE TIME OF THE INFLUENZA INJECTION HAS HAD A LARGE DIMPLE IN HER ARM WHICH HAS CONTINUED TO ITCH.
Age: 86.0
Sex: F
Vaccine: DT
Symptoms: Cellulitis
Clinical narrative: PT PRESENTS TO OFFICE TODAY WITH CELLULITIS OF HER RIGHT UPPER ARM
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: My daughter received the Prevnar shot on August 12th at approx. 4pm. At 10:30am on the 13th of August she had a seizure.  Her temp was not taken at the hospital until an hour later which it was 99.8 degrees. She was hospitalized the 13th and 14th and was released after numerous tests did not reveal a cause. The hospital record received on 4/5/04 states macrocephaly.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal, Irritability, Musculoskeletal stiffness, Staring
Clinical narrative: From initial info received on 8/7/03 from a registered nurse regarding an adverse event, it was reported that a five month old male pt received Act-Hib (UA821AA/W1230/2), administered intra-muscularly in the right thigh, IPOL W1002, administered SC in the right thigh, Daptacel C1386AA, administered IM in the left thigh and Prevnar administered IM in the left thigh on 7/28/03. On 7/27/03, one night prior to receiving his vaccinations, the pt had one episode of "arm extension and eye staring." The pt's parent did not notify physician. The infant was seen the next day by the physician and was found to have normal five-month development. Two days after the vaccinations, on 7/30/03, the pt experienced several episodes of body stiffness and eye staring. No fever was noted. The pt's parent brought him to the clinic and he was then sent to the ER for lab work and a CT scan of the head, which were reported as being normal. The pt was then transferred to another hospital, where an MRI and EEG were done. The MRI was reportedly normal, but the EEG was abnormal. The neurologic impression was partial seizure disorder, rule out early infantile spasm. No tonic clonic spells were reported or noted by parent. The pt was treated with phenobarbital and discharged from the hospital after four days. The pt's recovery status was not reported. Follow up on 12/29/03: "Telephone call to reporter on 12/15/03 at 12:30PM.  Reached recording to call back after lunch.  From additional information received on 12/15/03 through a telephone call to the reporter requesting follow-up information, discharge summary, and outcome, it was reported that the child was admitted to a hospital under the care of a neurologist, telephone numbers provided.  The reporter, a nurse, stated that the EEG results were abnormal with a diagnosis of Infant Seizure Disorder.  Reportedly, the pt was discharged on daily Phenobarbital.  The responsible physician saw the child at eight months of age and noted a slight developmental delay.  This physician stated that "this child had an episode of twitching prior to coming in for vaccines that the mother did not recognize or understand."  Reportedly, on the 4th day after receiving the vaccines there was more frequency of symptoms and it was just a coincidence regarding vaccination and some sort of casualty relationship.  The reporter suggested contacting medical records for a copy of the discharge summary, which they did not have on file.  There is no further information available from this contact.  The pt's recovery status was not provided."
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Strabismus
Clinical narrative: From initial info received on 8/7/03 from a registered nurse regarding an adverse event, it was reported that a five month old male pt received Act-Hib (UA821AA/W1230/2), administered intra-muscularly in the right thigh, IPOL W1002, administered SC in the right thigh, Daptacel C1386AA, administered IM in the left thigh and Prevnar administered IM in the left thigh on 7/28/03. On 7/27/03, one night prior to receiving his vaccinations, the pt had one episode of "arm extension and eye staring." The pt's parent did not notify physician. The infant was seen the next day by the physician and was found to have normal five-month development. Two days after the vaccinations, on 7/30/03, the pt experienced several episodes of body stiffness and eye staring. No fever was noted. The pt's parent brought him to the clinic and he was then sent to the ER for lab work and a CT scan of the head, which were reported as being normal. The pt was then transferred to another hospital, where an MRI and EEG were done. The MRI was reportedly normal, but the EEG was abnormal. The neurologic impression was partial seizure disorder, rule out early infantile spasm. No tonic clonic spells were reported or noted by parent. The pt was treated with phenobarbital and discharged from the hospital after four days. The pt's recovery status was not reported. Follow up on 12/29/03: "Telephone call to reporter on 12/15/03 at 12:30PM.  Reached recording to call back after lunch.  From additional information received on 12/15/03 through a telephone call to the reporter requesting follow-up information, discharge summary, and outcome, it was reported that the child was admitted to a hospital under the care of a neurologist, telephone numbers provided.  The reporter, a nurse, stated that the EEG results were abnormal with a diagnosis of Infant Seizure Disorder.  Reportedly, the pt was discharged on daily Phenobarbital.  The responsible physician saw the child at eight months of age and noted a slight developmental delay.  This physician stated that "this child had an episode of twitching prior to coming in for vaccines that the mother did not recognize or understand."  Reportedly, on the 4th day after receiving the vaccines there was more frequency of symptoms and it was just a coincidence regarding vaccination and some sort of casualty relationship.  The reporter suggested contacting medical records for a copy of the discharge summary, which they did not have on file.  There is no further information available from this contact.  The pt's recovery status was not provided."
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal, Musculoskeletal stiffness, Staring
Clinical narrative: From initial info received on 8/7/03 from a registered nurse regarding an adverse event, it was reported that a five month old male pt received Act-Hib (UA821AA/W1230/2), administered intra-muscularly in the right thigh, IPOL W1002, administered SC in the right thigh, Daptacel C1386AA, administered IM in the left thigh and Prevnar administered IM in the left thigh on 7/28/03. On 7/27/03, one night prior to receiving his vaccinations, the pt had one episode of "arm extension and eye staring." The pt's parent did not notify physician. The infant was seen the next day by the physician and was found to have normal five-month development. Two days after the vaccinations, on 7/30/03, the pt experienced several episodes of body stiffness and eye staring. No fever was noted. The pt's parent brought him to the clinic and he was then sent to the ER for lab work and a CT scan of the head, which were reported as being normal. The pt was then transferred to another hospital, where an MRI and EEG were done. The MRI was reportedly normal, but the EEG was abnormal. The neurologic impression was partial seizure disorder, rule out early infantile spasm. No tonic clonic spells were reported or noted by parent. The pt was treated with phenobarbital and discharged from the hospital after four days. The pt's recovery status was not reported. Follow up on 12/29/03: "Telephone call to reporter on 12/15/03 at 12:30PM.  Reached recording to call back after lunch.  From additional information received on 12/15/03 through a telephone call to the reporter requesting follow-up information, discharge summary, and outcome, it was reported that the child was admitted to a hospital under the care of a neurologist, telephone numbers provided.  The reporter, a nurse, stated that the EEG results were abnormal with a diagnosis of Infant Seizure Disorder.  Reportedly, the pt was discharged on daily Phenobarbital.  The responsible physician saw the child at eight months of age and noted a slight developmental delay.  This physician stated that "this child had an episode of twitching prior to coming in for vaccines that the mother did not recognize or understand."  Reportedly, on the 4th day after receiving the vaccines there was more frequency of symptoms and it was just a coincidence regarding vaccination and some sort of casualty relationship.  The reporter suggested contacting medical records for a copy of the discharge summary, which they did not have on file.  There is no further information available from this contact.  The pt's recovery status was not provided."
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Coronary artery disease, Myocardial infarction
Clinical narrative: A 70 year old male received RSV vaccine or Placebo and Influenza vaccine on 11/05/2002 and 251 days later died.  Obituary stated patient died suddenly, no further information at this time.  The investigator assessed the event as unrelated to the study product.  Follow up information received 08/12/2003.  Subject # 00100989.  The investigator spoke with family member regarding patient's death.  Patient was found by his wife sitting in a chair.  Autopsy was performed and cause of death was listed as "massive myocardial infarction".  Investigator assessed the event as unrelated to the study product.  Additional information received 09/03/2003.  Certificate of Death: Date of death: 07/14/2003.  Manner of Death: Natural cause.  Immediate Cause: Arrythmia/MI.  Approximate interval between onset and death is 1 day.  Due to or as a consequence of: End state emphysema.  Approximate interval between onset and death is years.  Did tobacco use contribute to death: Yes.  Preliminary Anatomic Diagnosis: 07/16/2003.  Diagnosis: Coronary Artery Atherosclerosis: Left circumflex 75% narrowed (left dominant circulation).  Cardiomegaly, 500 grams.  Severe Centriacinar Emphysema, bilateral.  Subsidiary Diagnosis: Nodular hypertrophy of prostate.  Simple renal cyst, left.  Small pulmonary embolus.  Meckel's diverticulum.  Colonic diverticula.  Probable cause of death: Cardiac Arrhythmia secondary to coronary artery disease.  Autopsy Limitations: none.  Embalmed: no.  Pending studies: Toxicology-blood, vitreous humor, bile, liver, stomach contents. Medical Records received on 8/27/2003 states arrythmia and coronary artery disease.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Cough, Diarrhoea, Dysphonia, Dyspnoea
Clinical narrative: An 83 year old male received RSV 11 Vaccine or Placebo and Influenza Vaccine on 10/16/2002 and 267 days later died on 07/10/2003. The pt's obituary was seen in the paper. No further info is available at this time but site will contact the family for further details. The Investigator assessed the event as unrelated to the study product. The pt had 3 prior hospitalizations, in 12/31/2002 admitted with a diagnosis of pneumonia (sputum culture pseudomonas), in March for a respiratory illness which did not improve after 2 courses of antibiotics. While in the hospital he had Oxacillin resistant Staph. Aureus and Pneumonia was diagnosed. He was also hospitalized on 04/04/2003 with symptoms of vomiting, diarrhea, abdominal pain, temperature of 103 F. and an oxygen saturation of 82%. A 15-day follow up report received 8/29/2003 adds: Additional info received 8/12/2003. The Investigator spoke with family member regarding pt's death. Pt was admitted to hospice on 07/01/2003 due to increased SOB and respiratory problems. Pt remained in hospice until death on 07/10/2003. Death certificate states Severe COPD as cause of death. Investigator assessed the event as unrelated to the study product. Follow up on 09/17/2003: "Additional information received 09/08/2003.  Copy of Certificate of Death: Cause of Death: Severe Chronic Obstructive Pulmonary Disease.  Other Significant Conditions Contributing to Death But Not Related to Cause: Recurrent Pneumonia." Death Certificate received on 9/12/2003 states COD was COPD.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling cold, Lung disorder, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: An 83 year old male received RSV 11 Vaccine or Placebo and Influenza Vaccine on 10/16/2002 and 267 days later died on 07/10/2003. The pt's obituary was seen in the paper. No further info is available at this time but site will contact the family for further details. The Investigator assessed the event as unrelated to the study product. The pt had 3 prior hospitalizations, in 12/31/2002 admitted with a diagnosis of pneumonia (sputum culture pseudomonas), in March for a respiratory illness which did not improve after 2 courses of antibiotics. While in the hospital he had Oxacillin resistant Staph. Aureus and Pneumonia was diagnosed. He was also hospitalized on 04/04/2003 with symptoms of vomiting, diarrhea, abdominal pain, temperature of 103 F. and an oxygen saturation of 82%. A 15-day follow up report received 8/29/2003 adds: Additional info received 8/12/2003. The Investigator spoke with family member regarding pt's death. Pt was admitted to hospice on 07/01/2003 due to increased SOB and respiratory problems. Pt remained in hospice until death on 07/10/2003. Death certificate states Severe COPD as cause of death. Investigator assessed the event as unrelated to the study product. Follow up on 09/17/2003: "Additional information received 09/08/2003.  Copy of Certificate of Death: Cause of Death: Severe Chronic Obstructive Pulmonary Disease.  Other Significant Conditions Contributing to Death But Not Related to Cause: Recurrent Pneumonia." Death Certificate received on 9/12/2003 states COD was COPD.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia, Productive cough, Pyrexia, Respiratory disorder, Vomiting
Clinical narrative: An 83 year old male received RSV 11 Vaccine or Placebo and Influenza Vaccine on 10/16/2002 and 267 days later died on 07/10/2003. The pt's obituary was seen in the paper. No further info is available at this time but site will contact the family for further details. The Investigator assessed the event as unrelated to the study product. The pt had 3 prior hospitalizations, in 12/31/2002 admitted with a diagnosis of pneumonia (sputum culture pseudomonas), in March for a respiratory illness which did not improve after 2 courses of antibiotics. While in the hospital he had Oxacillin resistant Staph. Aureus and Pneumonia was diagnosed. He was also hospitalized on 04/04/2003 with symptoms of vomiting, diarrhea, abdominal pain, temperature of 103 F. and an oxygen saturation of 82%. A 15-day follow up report received 8/29/2003 adds: Additional info received 8/12/2003. The Investigator spoke with family member regarding pt's death. Pt was admitted to hospice on 07/01/2003 due to increased SOB and respiratory problems. Pt remained in hospice until death on 07/10/2003. Death certificate states Severe COPD as cause of death. Investigator assessed the event as unrelated to the study product. Follow up on 09/17/2003: "Additional information received 09/08/2003.  Copy of Certificate of Death: Cause of Death: Severe Chronic Obstructive Pulmonary Disease.  Other Significant Conditions Contributing to Death But Not Related to Cause: Recurrent Pneumonia." Death Certificate received on 9/12/2003 states COD was COPD.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Difficulty in walking, Dizziness, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: From initial information received on 8/8/03 from the patient regarding an adverse event occurring in the USA, it was reported that the 38 year old female received a TD ADS ADULT vaccination, lot number U0839AA, administered in the right deltoid on 8/2/03 received at an emergency room. Twenty minutes post vaccination the patient had difficulty breathing. Patient now complains of headache, dizziness, malaise, 100 degree F fever, numbness of the arms and legs and difficulty walking. Patient refuses to provide physician information or provide further information. The patient's recovery status was not reported. From additional informaiton received on 14/Aug/2003 through a telephone conversation with the patient's roomate, the patient is being followed by several physicians isnce the adverse event occurred. The complete mailing address of the patient was also provided. No new medically relevant information provided: information got on 14/Aug/2003 not submitted to the Health authorities. 16/Jan/2004: Despite several attempts , no further informaiton was obtainable for this case. No further information is anticipated, this case is considered closed.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Pyrexia
Clinical narrative: From initial information received on 8/8/03 from the patient regarding an adverse event occurring in the USA, it was reported that the 38 year old female received a TD ADS ADULT vaccination, lot number U0839AA, administered in the right deltoid on 8/2/03 received at an emergency room. Twenty minutes post vaccination the patient had difficulty breathing. Patient now complains of headache, dizziness, malaise, 100 degree F fever, numbness of the arms and legs and difficulty walking. Patient refuses to provide physician information or provide further information. The patient's recovery status was not reported. From additional informaiton received on 14/Aug/2003 through a telephone conversation with the patient's roomate, the patient is being followed by several physicians isnce the adverse event occurred. The complete mailing address of the patient was also provided. No new medically relevant information provided: information got on 14/Aug/2003 not submitted to the Health authorities. 16/Jan/2004: Despite several attempts , no further informaiton was obtainable for this case. No further information is anticipated, this case is considered closed.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Tempt to 103.6 (R).
Age: 1.0
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Arthralgia, Dehydration, Joint swelling, Pyrexia, Rash maculo-papular
Clinical narrative: 8 days after vaccination developed maculopapular rash, fever joint swelling (multiple), tachycardia. Symptoms prolonged requiring hospitalization. Final diagnosis systemic onset juvenile rheumatoid arthritis. Still with JRA symptoms. 60 day follow up on 11/05/2003: "Vaccine recipient did not recover from the adverse events.  Still having acute flare of juvenile rheumatoid arthritis (systemic) requiring methotrexate and oral steroids." The discharge summary received on 1/12/04 confirms diagnosis of juvenile rheumatoid arthritis. Also add joint pain, dehydration and weight loss.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid arthritis, Tachycardia, Thrombocythaemia, Weight decreased
Clinical narrative: 8 days after vaccination developed maculopapular rash, fever joint swelling (multiple), tachycardia. Symptoms prolonged requiring hospitalization. Final diagnosis systemic onset juvenile rheumatoid arthritis. Still with JRA symptoms. 60 day follow up on 11/05/2003: "Vaccine recipient did not recover from the adverse events.  Still having acute flare of juvenile rheumatoid arthritis (systemic) requiring methotrexate and oral steroids." The discharge summary received on 1/12/04 confirms diagnosis of juvenile rheumatoid arthritis. Also add joint pain, dehydration and weight loss.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Coma, Convulsion, Eye movement disorder
Clinical narrative: Pt never had any other reaction to vaccine or seizures. After immunizations were administered, child's head leaned forward and then went backward, became stiff resembled a clonic tonic seizure, eyes rolled back and unresponsive. Picked child up and placed on exam table. Incident lasted 1 1/2 minutes. Then responsive, lips pale, able to communicate. HOB up, B/P 182/70, P 68. Instructed aunt, child needs to be evaluated by a MD. She took child to ER per father's request.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Slight redness started on 7/30/03 left leg in AM-by evening redness increased with some tightness to skin. On 7/31/03 in AM redness increased with itching stated by mother.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling of the arm, redness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: 9 x 8cm area erythema/induration after immunizations. Warm to touch right deltoid area. Pt placed on Augmentin 400/5 1 tsp BID for 7 days. Pt to follow up with MD as needed.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site oedema
Clinical narrative: Left arm swollen, no pain or tenderness; recovered OK.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Face oedema, Tongue oedema
Clinical narrative: Lips began to swell and tongue swelled, swallowing felt "funny". No visible swelling of tongue but pt said felt swollen. Slight swelling of upper and lower lips.
Age: 2.9
Sex: M
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Abdominal pain, Lethargy, Loss of consciousness, Somnolence, Stupor
Clinical narrative: About 1/2 hour after receiving vaccine, pt complained of abdominal pain, when mom was getting Tylenol, he became pale and lost consciousness for 2-3 minutes. Was drowsy. Lethargic 20 minutes. Flaccid, hyporesponsive.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Contusion, Injection site erythema, Injection site oedema
Clinical narrative: Severe local reaction DTaP. Developed increased swelling, redness, now bruising (approximate size of tomato).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Localized erythema, edema right anterior thigh. Acute localized cellulitis right anterior thigh status post immunization DTaP #4, IPV #3. Treatment: Augmentin 250mg/5ml 1.5 tsp POB for 7 days. Rulone 15mg/5ml for 7 days. Benadryl liquid 2.5mg/5ml tsp q 80 for 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling of the right thigh anterior only. Treated with Benadryl, Motrin and Keflex.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness/swelling at injection site approx 10 cm across. Recommend ice pack to affected area.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, red, hot band around left arm. Appeared the day after he received the vaccine.
Age: 0.08
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Received MMR on 02/25/2003, 9 days later child has rash and on the next day child has fever of 102 degrees F. Rash lasted about 1 1/2 weeks and fever started after rash. No cough, coryza (runny nose) or conjunctivitis. May be vaccine related.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: 24 hours later developed raised erythematous hot indurated nodule at vaccination site right thigh. No fever. Seen 7/30 and 5cm diameter induration. Parent reports similar reaction to vaccine last year.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever, diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Erythema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Anaphylaxis to MMR vaccine). Injection given at approx 11:55-returned to office at 12:05 from parking lot. Returned with complaint of itching, hives to injection site, thighs. No respiratory distress, per pt felt "like a rock in throat". Diffuse erythema over face, chest, arms, palms/soles. Epi/Benadryl given. Observed and discharged to home at 2:05 PM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site oedema
Clinical narrative: 2 days after immunizations of DTaP and IPV, right arm (upper arm) extremely swollen. Ice compresses (from elbow to shoulder).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red and swollen and hot.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Flushing, Hypoaesthesia, Malaise
Clinical narrative: 1-15 minutes after receiving vaccination, pt complained of left arm numbness and tongue numbness. BP 170/100, HR 100 and felt sick and flushed. Eval by MD.
Sex: M
Vaccine: MMR
Symptoms: Oedema
Clinical narrative: Day after giving MMR, arm swelled up from shoulder to elbow for 3 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Left deltoid with about nickle-sized swelling, surrounded by about 2 inch area of erythema to DTaP site.  Also complained of mild pruritis.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: About 2" x 3" area of erythema with mild swelling and warmth to left deltoid at DTaP site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: About 2" x 3" area of erythema with mild swelling and warmth to left deltoid at DTaP site.
Sex: M
Vaccine: MU
Symptoms: Convulsion, Hypersensitivity
Clinical narrative: Information has been received from a woman at a Pediatric office concerning a male patient with no allergies who in 1970 was vaccinated with a dose of mumps virus vaccine live (lot # not reported). It was reported that the patient had a seizure 2 days after receiving the vaccine and that the patient was allergic to the vaccine. It was reported that it was unknown if the seizure was a febrile seizure. It was unknown if medical attention was sought. Upon internal review, seizure was determined to be an other important medical event (OMIC). The reporter also reported that the patient's son experienced a fever, bilateral otitis media and bilateral bronchitis after being vaccinated with a dose of MMR (second generation) (lot # not reported0. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Oedema
Clinical narrative: Fever x 2 days, 3 x 5 cm tender, swollen duoerect mata left deltoid at site of Td injection.  when seen 08/15/03 at office.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Right arm swollen and red 24 hours post vaccine.
Sex: U
Vaccine: TTOX
Symptoms: Blister, Cellulitis, Erythema, Oedema
Clinical narrative: TD toxoid were injected instead of TB under skin.  A 7in x 4.5 in swollen reddened area with blisters centrally located was developed on my arm.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Hypoaesthesia, Injection site pain, Oedema, Skin burning sensation
Clinical narrative: After the injection my arm started to burn.  I even said to nurse that my arm is burning.  I also have swelling, redness and my arm is tender with numb fingers (pinky and ring finger).
Sex: M
Vaccine: TD
Symptoms: Blister, Erythema, Pain
Clinical narrative: After injection left forearm 1 mm blister surrounded by red area around 1 cm in diameter.  Slightly painful.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Drug administration error, Feeling hot, Rash erythematous
Clinical narrative: I was given a TB test with the wrong medication it was tetanus instead of Tuberculin.  I developed a raised red rash with warmth around the area that is still growing.
Age: 32.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Redness, swelling, tender to touch
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site mass, Injection site oedema, Injection site warmth
Clinical narrative: A large knot with blisters and a large reddened hot area at injection site. Given DT instead of TB.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Lethargy, Pruritus, Pyrexia, Rash
Clinical narrative: Pt became lethargic, developed low-grade fever and itchy rash began on torso. All started 1 hour after receiving immunization. Condition continued with itchy rash spreading to thighs and arms by Sat. Sunday afternoon itch and rash on torso diminished. Pt began to feel better. Fever almost gone. Several rashes appeared on ears. Pt received Tylenol and Benadryl Fri, Sat and Sun.
Age: 27.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema (4cm diameter), slightly raised at injection site. Pt brought copies of his records from the clinic that administered it.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 10x12cm erythema, induration, warmth and tenderness expanding out from R thigh at central injection site-progressing at 48 hrs. Keflex suspension prescribed for possible cellulitis.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vaccination complication
Clinical narrative: Autoinnoculation to left knee (1 cm ulceration)
Age: 36.0
Sex: F
Vaccine: HEP, TD, TD
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: C/O pain in Rt. shoulder area, deltoid that radiates up into right shide of neck & down into inner side upper right arem.  Unable to raise arem above head.  Worst around 2:30pm & during night, called 7/9/03 unable to reach patient
Age: 36.0
Sex: F
Vaccine: HEP, TD, TD
Symptoms: Gait disturbance, Injection site pain, Joint range of motion decreased, Myalgia, Neck pain
Clinical narrative: C/O pain in Rt. shoulder area, deltoid that radiates up into right shide of neck & down into inner side upper right arem.  Unable to raise arem above head.  Worst around 2:30pm & during night, called 7/9/03 unable to reach patient
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Erythema and swelling of rt thigh. 8X15cm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Swelling of right thigh, no tenderness, marked erythema.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Herpes zoster, Infection
Clinical narrative: Developed shingles day after Pneumovax
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: vaccine given on 15 Aug 03, today 19 Aug 03 my upper left arm has a swollen area approximately 2 inches X 1 1/2 inches and firm, hot and sore to the touch and is sore to move.  Was told by PCP this was a moderate reaction, take motrin, use ice packs and if it's still this way in 2 weeks, make a follow-up appointment.  Was also told to keep an eye on any increased redness, this was unusual but not unheard of.
Age: 1.3
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Anorexia, Fatigue, Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: Fatigue and crankiness, as well as little pink spots on chest, 6 days after vaccination.  Loss of appetitite on morning of 7th day.  After his nap on 7th day, woke up at 4:00pm with a fever of 103.3 (taken under arm).  He vomited profusely and I called the doctor.  I went in to the pediatric center at 6:25pm.  I told the nurse his symptoms and that he had had his vaccinations a week before.  The doctor came in, and despite the fact that I mentioned the vaccinations, determined that my son had probably gotten a virus.  Two days later, on Sunday, my son developed little pink spots on his face and torso.  It is now Tuesday and he is still tired and weak.  He wants to be carried around all the time as if he is too tired to get around by himself.  This is a dramatic change.  Before the shots, he was fiercely independent and energetic.  I can't say if this will result in a permanent disability, because I've since read that some of the effects from an MMR shot can take months to develop.