chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Cough, Hyperhidrosis, Injection site oedema, Pain
Clinical narrative: A 60-year-old female reported that she received pneumococcal polyvalent (manufacturer unknown) and influenza virus (manufacturer unknown) vaccines on 10/04/2002.  The following day, she developed an injection site reaction characterized by swelling, redness, and soreness.  The patient also experienced chills, nausea, a headache, coughing, arm cramping, and sore throat.  She was seen in an emergency room where she was treated with an unspecified steroid and instructed to apply ice to the injection site area.  Approximately 1 week later, the patient was seen by her physician who prescribed a "cough medicine".  Results of a chest x-ray "found nothing clinically significant".  As of the date of this report, the reporter states that her "arm is still tender and will cramp occasionally" and that the nausea, sore throat, and cough have not resolved.  This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 vaccine.  See MCN HQ4898728OCT2002.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A 60-year-old female reported that she received pneumococcal polyvalent (manufacturer unknown) and influenza virus (manufacturer unknown) vaccines on 10/04/2002.  The following day, she developed an injection site reaction characterized by swelling, redness, and soreness.  The patient also experienced chills, nausea, a headache, coughing, arm cramping, and sore throat.  She was seen in an emergency room where she was treated with an unspecified steroid and instructed to apply ice to the injection site area.  Approximately 1 week later, the patient was seen by her physician who prescribed a "cough medicine".  Results of a chest x-ray "found nothing clinically significant".  As of the date of this report, the reporter states that her "arm is still tender and will cramp occasionally" and that the nausea, sore throat, and cough have not resolved.  This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 vaccine.  See MCN HQ4898728OCT2002.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: A 63-year-old female reported that she was given a "pneumonia vaccine" (pneumococcal vaccine polyvalent) (manufacturer unknown) on 05/06/2002.  Medical history included respiratory symptoms and allergy to aspirin.  On 05/06/2002 subsequent to immunization, she developed swelling, redness and pain in her right arm.  Treatment medication included Tylenol (acetaminophen) for the pain.  Concomitant therapy included Allegra (fexofenadine hydrochloride(, Prednisone, Requip (ropinirole hydrochloride), Prempro (conjugated estrogens/medroxyprogesterone acetate) and Actonel (risedronate).  The event was reported to be unresolved as of 05/10/2002.  No further information was available at the date of this report.  This report was received from the manufacturer (ID # ROP A0368503A).
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Malaise, Pyrexia, Rash maculo-papular
Clinical narrative: Maculo papular rash, tactile fever and malaise.
Age: 3.9
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Erythema, tenderness, edema R arm 20x22.5cm. Pt given Benadryl and Motrin sx resolved by 6/9.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Booster given (pt did not tell us had reaction in past). 1-2 hrs later arm became red, over next several days hard, warm, painful. 3x2" in size. Only report because we had four other that we reported with same batch within 2 wks.
Age: 6.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: Pt was given four hep B vaccine doses. The follow up states no adverse event occurred on 6/10/03 pt wsa found to have been given four hep B vaccines.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: 6/4-redness, very swollen and hard R thigh.
Age: 1.6
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Erythema, Muscular weakness, Oedema peripheral, Pyrexia
Clinical narrative: Severe erythema, swelling leg with small skin abrasion T 100 degrees. Reported unilateral facial weakness not observed. Resolved.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: DTaP administered no signs or symptoms observed. Cellulitis.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Muscular weakness, Myalgia
Clinical narrative: 04/14/2003: Patient complained of deep muscle pain and weakness in left arm.  Onset 2-3 days past vaccine.  Reported 1 week past vaccine.  04/18/2003: Patient states continued use, symptoms up.  "has to left affected arm in other" To consult private physician.  No redness.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Rash maculo-papular
Clinical narrative: L leg 5" x 6" warm, red raised area. Zyrtec 21 daily.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt got a 103.5 degrees fever 3 days after his vaccines, lasting 4 days, going down to 100 degrees and up to 102 and 103 day x 4 d. Then another fever turned up 7 days after vaccines 101.7 degrees lasting 2 days as well as a rash.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Autism, Coma, Laboratory test abnormal, Malabsorption, Malaise
Clinical narrative: Noticed patient, at the age of 12 months, was sick/ill immediately after his battery of shots on 8/21/00. The shots received on 8/21/00 include the MMR, Comvax, Prevnar and Varivax, comprising 5 signatures or lot assignments on the vaccination records for that specific day.   The decline of overall development became even more obvious after the next round of Prevnar on 10/23/2000 (reduced eye contact, lack of response to name, lack of language,etc.) And continued into December (Prevnar 12/20/2000).
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Overdose, Speech disorder
Clinical narrative: Noticed patient, at the age of 12 months, was sick/ill immediately after his battery of shots on 8/21/00. The shots received on 8/21/00 include the MMR, Comvax, Prevnar and Varivax, comprising 5 signatures or lot assignments on the vaccination records for that specific day.   The decline of overall development became even more obvious after the next round of Prevnar on 10/23/2000 (reduced eye contact, lack of response to name, lack of language,etc.) And continued into December (Prevnar 12/20/2000).
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal discomfort, Chest discomfort, Discomfort, Fatigue, Hypoaesthesia
Clinical narrative: Within 48 hours rash on left side of back approx 4 inches in diameter. Within 2 weeks pain in right elbow, has continued to progressivelly worsen. Swelling of extremities, pain in all joints - fingers, wrists, elbows, shoulders, hips, knees, ankles, toes. Discomfort in neck and spine. Constant nGraumbness and tingling in hands, difficulty writing. Pain ranges from mild discomfort at rest to severe with movement. Loss of range of motion.  Muscle aches/cramping in arms, legs, and feet at rest and with movement. Also chest and abdominal discomfort. Nausea progresses with level of pain. Tired, loss of energy, forgetful.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Joint range of motion decreased, Memory impairment, Myalgia, Nausea, Oedema
Clinical narrative: Within 48 hours rash on left side of back approx 4 inches in diameter. Within 2 weeks pain in right elbow, has continued to progressivelly worsen. Swelling of extremities, pain in all joints - fingers, wrists, elbows, shoulders, hips, knees, ankles, toes. Discomfort in neck and spine. Constant nGraumbness and tingling in hands, difficulty writing. Pain ranges from mild discomfort at rest to severe with movement. Loss of range of motion.  Muscle aches/cramping in arms, legs, and feet at rest and with movement. Also chest and abdominal discomfort. Nausea progresses with level of pain. Tired, loss of energy, forgetful.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Paraesthesia, Rash
Clinical narrative: Within 48 hours rash on left side of back approx 4 inches in diameter. Within 2 weeks pain in right elbow, has continued to progressivelly worsen. Swelling of extremities, pain in all joints - fingers, wrists, elbows, shoulders, hips, knees, ankles, toes. Discomfort in neck and spine. Constant nGraumbness and tingling in hands, difficulty writing. Pain ranges from mild discomfort at rest to severe with movement. Loss of range of motion.  Muscle aches/cramping in arms, legs, and feet at rest and with movement. Also chest and abdominal discomfort. Nausea progresses with level of pain. Tired, loss of energy, forgetful.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Stomach discomfort
Clinical narrative: FATIGUE; NAUS. HEADACHE; PROFUSE SWEATING. ON AND OFF FOR 4 DAYS (UPSET STOMACH RECENTLY STOPING)
Age: 45.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema
Clinical narrative: Erythema and flakey around nose and frhead.  Was not using 1% hydro-cortizone cream.  Started day 7 after vaccination worsening noted day 10 and 11.
Age: 50.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Palpitations
Clinical narrative: 3/17/03 Started having palpitations and chest pain.  Client is taking B/P meds.  Needed echocardiogram on 3/19 the ultrasound during week of the 24th.  4/3 and 4/5 had another episode of palpitations and chest pain.  Stress test done 4/7. Changed meds., wore Holter monitor for 1 week. 5/27 had thyroid storm.
Age: 1.2
Sex: M
Vaccine: DPP, MMR, VARCEL, MMR, VARCEL
Symptoms: Rash pustular
Clinical narrative: 06/10/03 IN OFFICE WITH RASH >50 POX    MOM CALLED ON 06/11/03STATING CHILD HAD SEVERAL POX WITH PUSTULES.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Unintended pregnancy
Clinical narrative: Patient became pregnant within 4 weeks after receiving smallpox vaccination.  Date of vaccination: 3/20/03.  Date of start of last period: 3/17/03.  Pregnancy discovered during week of 4/21/03.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever of 103 x 24h, treated with motrin/tylenol
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Gait disturbance, Oedema, Pyrexia
Clinical narrative: Received vaccines on 6/9/2003.  On following day, he developed low grade temperature (99.9) with later spike to 101.  He also had swelling of extremity with marked redness and induration.  Refused to bear full weight on limb.  On 6/11/2003, had spread of redness beyond demarcation noted on 6/10/2003 with some resolution of redness in old area.  That thigh was swollen 1 inch greater than other thigh.  Pulses and capillary refill were good.  Now running on his own and bearing full weight.  No red streaking seen, and fever was resolved.  No treatment given other than cool compresses.  Also helped by time spent in swimming pool.
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Drug administration error, Headache, Hot flush, Loss of consciousness, Medication error
Clinical narrative: It was reported that a 35 year old male pt received TD ADS ADULT, lot number not reported, administered IV in error, on 5/31/03. Six to seven hours later, the pt experienced uncontrollable vomiting and then went unconscious. The pt was admitted to the hospital. The pt is currently experiencing signs and symptoms of headache and hot flashes, which are persisting. The reporter will obtain the lot number from the hospital records and provide it at a later time. At the time of this report, the pt had not recovered. From additional info received on 12/18/03 from a health care professional, the pt's full name was provided. According to the hospital records received, the pt received the vaccine in the ER on 6/1/03, where he was seen due to an infected injury to his right hand. The injury had occurred three days prior but the pt thought it was minor. On 6/1/03, in the ER, he was treated ith 2 grams of Ancef for the infection and Td 0.5 cc by IV route. The pt had to return six hours later due to nausea, vomiting and fever. Hospital records do not mention the episode of unconsciousness as was on the initial report. The pt also develpoed headaches with tension and migraine as well as photophobia and phonophobia and was referred to the headache clinic. He described his headache as a constant painful sensation extending from his temporal areas bilaterally to the frontal bilateral areas. Pt noted the acute onset of the headache occurred when he was administered Td vaccine IV. Pt has been on multiple medications for treatment including Elavil, Celebrex and hydrocodone, but he was unable to tolerate due to side effects. On 6/18/03, the pt was still complaining of headache. At that time, the pt's review of systems was negative for fever, chills, weight change, vision change, nasal congestion, sore throat, swallowing difficulties, cough, chest pain, shortness of breath, nausea, vomiting, diarrhea, frequence, dysuria, depression, anxiety, head trauma, seizures or loss of consciousness. His physical exam showed his weight to be 193 lb., blood pressure 118/90, pulse 80, respirations 18 and temp of 98.3 deg F. The HEENT exam revealed to pt to be atraumatic and normocephalic. On 7/9/03, the pt presented to the headache clinic for follow-up of his chronic daily headache with features of both tension and migraine. He has been on Vioxx 25mg q.d. in addition to Effexor XR 150mg q.d. x 2 weeks. The pt reported the chronic daily headache has subsided completely at this point. He did have an occasional headache one to two times a week triggered by sound and light. Pt was encouraged to continue his medication therapy and to avoid triggers. On 8/14/03, it was stated that headache continued if pt missed medication Effexor. Follow up on 01/21/04: "No additional information is anticipated. Case is closed."
Age: 35.0
Sex: M
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: It was reported that a 35 year old male pt received TD ADS ADULT, lot number not reported, administered IV in error, on 5/31/03. Six to seven hours later, the pt experienced uncontrollable vomiting and then went unconscious. The pt was admitted to the hospital. The pt is currently experiencing signs and symptoms of headache and hot flashes, which are persisting. The reporter will obtain the lot number from the hospital records and provide it at a later time. At the time of this report, the pt had not recovered. From additional info received on 12/18/03 from a health care professional, the pt's full name was provided. According to the hospital records received, the pt received the vaccine in the ER on 6/1/03, where he was seen due to an infected injury to his right hand. The injury had occurred three days prior but the pt thought it was minor. On 6/1/03, in the ER, he was treated ith 2 grams of Ancef for the infection and Td 0.5 cc by IV route. The pt had to return six hours later due to nausea, vomiting and fever. Hospital records do not mention the episode of unconsciousness as was on the initial report. The pt also develpoed headaches with tension and migraine as well as photophobia and phonophobia and was referred to the headache clinic. He described his headache as a constant painful sensation extending from his temporal areas bilaterally to the frontal bilateral areas. Pt noted the acute onset of the headache occurred when he was administered Td vaccine IV. Pt has been on multiple medications for treatment including Elavil, Celebrex and hydrocodone, but he was unable to tolerate due to side effects. On 6/18/03, the pt was still complaining of headache. At that time, the pt's review of systems was negative for fever, chills, weight change, vision change, nasal congestion, sore throat, swallowing difficulties, cough, chest pain, shortness of breath, nausea, vomiting, diarrhea, frequence, dysuria, depression, anxiety, head trauma, seizures or loss of consciousness. His physical exam showed his weight to be 193 lb., blood pressure 118/90, pulse 80, respirations 18 and temp of 98.3 deg F. The HEENT exam revealed to pt to be atraumatic and normocephalic. On 7/9/03, the pt presented to the headache clinic for follow-up of his chronic daily headache with features of both tension and migraine. He has been on Vioxx 25mg q.d. in addition to Effexor XR 150mg q.d. x 2 weeks. The pt reported the chronic daily headache has subsided completely at this point. He did have an occasional headache one to two times a week triggered by sound and light. Pt was encouraged to continue his medication therapy and to avoid triggers. On 8/14/03, it was stated that headache continued if pt missed medication Effexor. Follow up on 01/21/04: "No additional information is anticipated. Case is closed."
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain, Pyrexia
Clinical narrative: Vaccinated 8am 5/24 with pneumovax. 1 hour later, had quarter sized redness. 5 hours later, systemic symptoms (achiness, malaise), 3 inch redness by that night. Fever next day 104.2 despite Motrin. 48 hours later, WBC count 27K. Subsequently admitted due to progressive site of lesion; raised margins and systemic symptoms. Admitted for 4 days for parenternal antibiotics.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Febrile convulsion, Sinusitis
Clinical narrative: Fever 102 F within 3 hrs of injections and for 36 hrs following. Irritability, anorexia x 1 wk. Recurrence of fever 1 wk after injection with complex seizure (45 minutes and requiring intubation). The discharge note states, "ehtmoid and maxillary sinusitis." The discharge summary received on 3/23/04 states atypical complex febrile seizure.
Age: 0.9
Sex: M
Vaccine: HEP, PNC
Symptoms: Abnormal behaviour, Autism, Cognitive disorder, Injection site erythema, Injection site induration
Clinical narrative: Son born with IUGR and agenasis of corpus collosum. Developed very slowly. He was able to imitate sounds like "gaga," "dada," "mama" and wave bye bye. THen around 14 months he stopped. Lost eye contact. Gave Tylenol. Diagnosed with autism August 2002. Hep B site was red and hard and tender for several days. Pt was more fussy than usual. The 60 day follow up received on 9/5/03 states pt is autistid and has a chromosomal abnormality sp duplication syndrome. Had an extra hep B at 9 months. Too many, too soon.
Age: 0.9
Sex: M
Vaccine: HEP, PNC
Symptoms: Injection site pain, Irritability, Neurodevelopmental disorder
Clinical narrative: Son born with IUGR and agenasis of corpus collosum. Developed very slowly. He was able to imitate sounds like "gaga," "dada," "mama" and wave bye bye. THen around 14 months he stopped. Lost eye contact. Gave Tylenol. Diagnosed with autism August 2002. Hep B site was red and hard and tender for several days. Pt was more fussy than usual. The 60 day follow up received on 9/5/03 states pt is autistid and has a chromosomal abnormality sp duplication syndrome. Had an extra hep B at 9 months. Too many, too soon.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Left arm red, edematous to the size of 9 x .9 cm. Red area measures to the size of "baseball". Warm to touch. Temp 97.4.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Red itchy rash
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: 06/06/03: Tetanus/diphtheria vaccine was administered in right deltoid (0.5 ml/IM). 06/07/03: Pt complains of pain and tenderness of 1 day of duration in area of vaccination. 06/09/03: Pt complains of local edema, warm skin, erythema of 40mm x 40mm and pain of 2 days of duration. No fever, no axillary lymph nodes. Dx: type III reaction (Arthus reaction). Hx: Tylenol, cold compresses, follow up in 72 hours.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Febrile since 5/13/03 (101), received DTaP #3, Hib #3, Prevnar #2 on 5/15/03. Temp to 105.5 5/16 PM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pallor, Urticaria, Wheezing
Clinical narrative: Approx 10 minutes after injection with MMR, IPV, DTaP, pt developed throat clearing, then hives (1st at MMR site, then diffusely), then wheezing and pallor. She was treated with multiple (2) doses of 6mg Benadryl, Xopenex 0.63, dexamerh asone  4mg, epinephrine 0.15 mg and transfer to the ER by EMS where she was improved, no hypoxia and sent home with Benadryl for 5 days.
Age: 3.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Starting at 10 PM, high fever. 2 AM 103.5. 9 AM next morning 103.2
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Local swelling, erythema thigh and knee, warm to touch, onset 6/4, significant improvement 6/5/03.
Age: 50.0
Sex: F
Vaccine: HEPAB
Symptoms: Bronchitis, Upper respiratory tract infection
Clinical narrative: This report describes the occurrence of bronchitis in a 50 year old female who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. This report was received from the subject and has been verified by a physician. The subject reported that she had no relevant medical history or allergies. However, she reported that concurrent medications included fluticasone proprionate+salmeterol xinafoate and triamcinolone acetonide nasal spray. Her physician reported that the concurrent medications were sertraline hydrochloride  and beclomethasone dipropionate nasal spray. The subject received her first injection of Twinrix on 9/17/02; no adverse experiences were reported following this injection. The subject received her second injection of Twinrix on 10/16/02. In November 2002, she developed a severe upper respiratory infection. She was seen by a physician, who made a diagnosis of bronchitis and prescribed two courses of amixicillin clavulanate. The bronchitis resolved. The subject received her third injection of Twinrix on 3/18/03. In April 2003, she again became very ill with bronchitis. As of 4/3/03, she was being treated with levofloxacin. The subject stated that she mentioned this respiratory infection as a possible reaction and he (her primary physician) said it was not likely the cause. I think it was since I reacted after two shots--same symptoms exactly ten days after each shot. The most recent information received was from the treating physician on 6/2/03. The bronchitis resolved. The reporting physician stated, Although I cannot exclude a cause-effect relationship, I am not suspicious of it. The reporting physician considered the two episodes of bronchitis to be serious because they required intervention (the administration of antibiotics) to prevent serious outcome. Therefore, this report has been reclassified as serious.
Age: 9.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red, hot, swollen left arm
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site erythema, Injection site induration, Injection site oedema, Shoulder pain
Clinical narrative: Swelling/redness at site of vaccination in left deltoid. Pt noted pain to shoulder and left claviate/upper chest on 5/24/03. Local erythematous induration at site of vaccination only.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Pt is seen about 36 hours after vaccinated. Left thigh had erythema approx 125 cm x 19 cm (was tender without significant edema. He was given Benadryl 25 mg, Zyrtec 5 mg qd PRN.
Age: 30.0
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Stomach discomfort
Clinical narrative: Pt called and reports 5/28 right arm at injection site redness with swelling. Area the diameteer of a baseball. Also had upset stomach and diarrhea. Called PHN on 5/30 and area still red. Did not come in for PHN to see.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Rash-fine, lacy, itchy - diffuse developed within 24 hours after Hep B #2.
Age: 0.8
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Irritability, Pyrexia
Clinical narrative: Severe induration/erythema of injection site. Fever up to 104.5 with irritability for 4 days. Pt continues to have some indurations, but erythema has resolved.
Age: 1.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Erythema right arm - site increase in temp (most of upper arm involved), ROM WNL, neurovascular exam intact.
Age: 47.0
Sex: F
Vaccine: SMALL
Symptoms: Dermatitis, Dyspnoea, Eye oedema, Pruritus, Rash erythematous
Clinical narrative: Rapid tachycardia - dyspnea & slow resolution. Additional:  Last episode of tachycardia was May 12.  At the time I began having tachycardia I developed a dermatitis-like area extending from lower knuckle of index fingers to thumb. This formed a C shaped area on both hands. On May 16 my hands began to itch. I noted several raised bite like areas. I awoke 3 am the morning of the 17th with severe itching. Both hands were red from the wrists down. We were traveling that weekend.  I alternaed the steroid cream and anti itch spray and took Benadryl which gave very little relief. On the morning of the 18th the itching and rash began over the tops and outside of my ears extending along my jaw line. Since my son had a few itchy areas I was afraid that I had picked up scabies.  By evening my cheekbones resembled my thumb knuckle area. I treated for scabies on the 19th, and continued the Benadryl. By the 22nd my ears and cheeks were like abrasions. They stayed covered in serous type fluid. My eyes were swollen. I was seen by my family physician that prescribed prednisone and to continue on Benadryl. I completed the Benadryl on Wednesday May 28th. The last Benadryl I took was on June 1, My index finger knuckles are rough and red. There are still some areas on my hands and forearms that itch occasionally. My eares peeled and itch occasionally as well.
Age: 47.0
Sex: F
Vaccine: SMALL
Symptoms: Skin exfoliation, Tachycardia
Clinical narrative: Rapid tachycardia - dyspnea & slow resolution. Additional:  Last episode of tachycardia was May 12.  At the time I began having tachycardia I developed a dermatitis-like area extending from lower knuckle of index fingers to thumb. This formed a C shaped area on both hands. On May 16 my hands began to itch. I noted several raised bite like areas. I awoke 3 am the morning of the 17th with severe itching. Both hands were red from the wrists down. We were traveling that weekend.  I alternaed the steroid cream and anti itch spray and took Benadryl which gave very little relief. On the morning of the 18th the itching and rash began over the tops and outside of my ears extending along my jaw line. Since my son had a few itchy areas I was afraid that I had picked up scabies.  By evening my cheekbones resembled my thumb knuckle area. I treated for scabies on the 19th, and continued the Benadryl. By the 22nd my ears and cheeks were like abrasions. They stayed covered in serous type fluid. My eyes were swollen. I was seen by my family physician that prescribed prednisone and to continue on Benadryl. I completed the Benadryl on Wednesday May 28th. The last Benadryl I took was on June 1, My index finger knuckles are rough and red. There are still some areas on my hands and forearms that itch occasionally. My eares peeled and itch occasionally as well.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: mild vesicular rash
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Apnoea, Hypotonia, Laboratory test abnormal, Lethargy, Meningitis
Clinical narrative: Information has been received from a consumer concerning her 4 week old son with no past medical history who on 1/10/03 and on 2/10/03 was vaccinated with a first and second dose (642923/0159M) of hep B virus vaccine rHBsAg IM 5mcg/ml, respectively. There was no concomitant medication. On 2/10/03, the pt developed "bacterial strep meningitis" within hours after receiving the vaccination. The pt was immediately hospitalized and reportedly "had stopped breathing for a period of time." The pt received various treatments for this during a two week hospital stay. On 6/3/03, it was reported that "the pt appears to have recovered completely at this point but is being closely monitored for sequelae." Bacterial strep meningitis and "stopped breathing" were considered to be immediately life-threatening. No further info is available.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Pallor, Sepsis
Clinical narrative: Information has been received from a consumer concerning her 4 week old son with no past medical history who on 1/10/03 and on 2/10/03 was vaccinated with a first and second dose (642923/0159M) of hep B virus vaccine rHBsAg IM 5mcg/ml, respectively. There was no concomitant medication. On 2/10/03, the pt developed "bacterial strep meningitis" within hours after receiving the vaccination. The pt was immediately hospitalized and reportedly "had stopped breathing for a period of time." The pt received various treatments for this during a two week hospital stay. On 6/3/03, it was reported that "the pt appears to have recovered completely at this point but is being closely monitored for sequelae." Bacterial strep meningitis and "stopped breathing" were considered to be immediately life-threatening. No further info is available.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Apnoea, Bacterial infection, Meningitis
Clinical narrative: Information has been received from a consumer concerning her 4 week old son with no past medical history who on 1/10/03 and on 2/10/03 was vaccinated with a first and second dose (642923/0159M) of hep B virus vaccine rHBsAg IM 5mcg/ml, respectively. There was no concomitant medication. On 2/10/03, the pt developed "bacterial strep meningitis" within hours after receiving the vaccination. The pt was immediately hospitalized and reportedly "had stopped breathing for a period of time." The pt received various treatments for this during a two week hospital stay. On 6/3/03, it was reported that "the pt appears to have recovered completely at this point but is being closely monitored for sequelae." Bacterial strep meningitis and "stopped breathing" were considered to be immediately life-threatening. No further info is available.
Sex: F
Vaccine: MEA
Symptoms: Electroencephalogram abnormal, Unintended pregnancy
Clinical narrative: It was reported in a published article that a female patient, who was required to received a measles vaccine for college, was vaccinated on 11/8/90 with a dose of measles virus vaccine live (lot # not reported). It was reported that the patient was 17 days pregnant when she was vaccinated. It was reported that the mother was certain that she was not exposed to alcohol, drugs or other teratogens during her pregnancy. She delivered a boy on 7/2/91 who weighed 6lbs 3ozs and who was noted to have several visible congenital anomalies at birth, namely micrognathia, a cleft palate, hypospadias and cryptorchidism. The baby was rushed to a tertiary hospital where he was found to have an abnormal EEG and where a MRI revealed both cerebral dysgenesis and agensis of the corpus callosum. He developed clinical seizures at the age of 6 months and was discovered to be partially deaf and visually impaired. He was diagnosed with autism before he received his MMR (second generation) vaccine. It was reported that the family's history was negative for autism, and all genetic studies had been negative as well. The mother's second son, a boy born in May 1998 was normal and it was reported this child had not received the MMR (second generation) vaccine. The author stated that in spite of its limitation, this study suggests that an autism/vaccine connection may exist. Upon internal review, clinical seizures, partially deaf, visually impaired and autism were determined to be other important medical events (OMIC). No further information is available. A copy of the published literature article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MEA
Symptoms: Laboratory test abnormal, Vaccination complication
Clinical narrative: It was reported in a published article, that a mother, with a history of being measles susceptible, was revaccinated with a dose of measles virus vaccine live because she was carrying twins. It was noted that this required by the hospital where she was seeking employment. One twin was stillborn at term, and the surviving twin was described by the mother as "vaccine affected, high needs," with many social sensory integration issues." The mother remained susceptible to measles today. The author noted that "vaccination of women around conception may lead to stillbirths, premature delivery and 'vanishing twins' and ' it can also be frequently associated with early onset autism." It was also reported that "in spite of its limitation, this study suggests that an autism/vaccine connection may exist." Upon internal review, social and sensory integration issues were considered to be important medical events (OMIC). It was unknown if medical attention was sought.
Sex: F
Vaccine: RUB
Symptoms: Abortion spontaneous
Clinical narrative: It was reported in a published article that a female patient in 1984 was vaccinated with a post partum dose of rubella virus vaccine live (second generation). Subsequently she had three miscarriages before delivering a boy in September 1987. The author noted that vaccinaton of women around conception may lead to stillbirths, premature delivery, and vanishing twins. It cal also be frequently associated with an early onset of autism. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. It was reported in a published article that this patient delivered her first child, a female in 1984, and received rubella virus vaccine live post partum because she had remained rubella susceptible. After three miscarriages the patient delivered a male in September 1987 and received another post-partum dose of rubella virus vaccine live because she had no detectable rubella immunity. While breast feeding he third child, a female, the patient received her third rubella virus vaccine live booster in four years as she was still rubella susceptible. According to the reporter the patient's son has autism and the patient's daughter has severe dyslexia, serious learning disabilities and ADHD. It was unknown if medical attention was sought.
Age: 41.0
Sex: F
Vaccine: RUB
Symptoms: Abortion spontaneous
Clinical narrative: It was reported in a published article, that a 41 year old female pt, with a strong family history of immune disorders, delivered a normal girl in 1987, was vaccinated with a booster dose of rubella virus vaccine live II in the postpartum period. Subsequently her next pregnancy ended in a miscarriage. The author noted that "vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins." Adverse outcomes associated with postpartum rubella or MMR vaccine. It was unknown if medical attention was sought. It was reported in a published article, title as stated above, that a 41 year old female patient, with a strong family history of immune disorders, delivered a normal girl in 1987, was vaccinated with a booser dose of rubella virus vaccine live (second generation) in the postpartum perious. Subsequently her next pregnancy ended in a miscarriage. The auther noted that "vaccination of women around conception may lead to sillbirths, premature delivery and "vanishing twins." According to the reporter one of the patient's sons had autism (WAES#0305USA00325) and another son had speech difficulties (WAES #0404USA000703). It was unknown if medical attention was sought.
Sex: F
Vaccine: RUB
Symptoms: Neurodevelopmental disorder
Clinical narrative: It was reported in a published article, that a female pt's mother was vaccinated with a dose of rubella virus vaccine live II in 1984. Subsequently the pt, who was born in 1988, and who was breast-fed developed severe dyslexia, learning disabilities and ADHD. It was also reported that "in spite of its limitation, this study suggests that an autism/vaccine connection may exist." Upon internal review, ADHD was considered to be an important medical event (OMIC). It was unknown if medical attention was sought. Follow up: A copy of the published literature article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: RUB
Symptoms: Laboratory test abnormal, Medication error, Premature labour
Clinical narrative: It was reported in a published article, that a female with a history of a premature birth was vaccinated, while hospitalized for cervical banding at 13 weeks gestation with another pregnancy, with a dose of rubella virus vaccine live II due to inadequate titers. Subsequently the pt delivered a baby girl prematurely at 27 weeks gestation. The infant "had a very stormy start to life, and spent 115 days in NICU. Despite her fragility and precarious state, the infant was immunized in the nursery and suffered a severe and near fatal reaction to her second set of immunizations. She was stabilized and discharged home a few days later on oxygen and an apnea monitor. She was promptly noted to be developmentally delayed and was diagnosed with early-onset autism." In conclusion, the author stated that "vaccination of women around conception lead to stillbirths, premature delivery and vanishing twins. It can also be frequently associated with early-onset autism." Upon internal review, premature delivery, severe and near fatal reaction to immunizations, and early-onset autism were determined to be other important medical events (OMIC). No further info is available.
Sex: M
Vaccine: RUB
Symptoms: Hypersensitivity
Clinical narrative: It was reported in a published article, that a male child was born in May 1996 to a mother who was vaccinated on an unspecified date, while she was hospitalized, with a dose of rubella virus vaccine live II. The child was breast fed for 13 months. Subsequently the child experienced severe reactions to most foods, and needed a rotation diet. The child did not receive the "MMR vaccine" because of fear of a reaction. It was reported that the child was developmentally normal and had no signs of autism. The author stated that "In spite of its limitation, this study suggests that an autism/vaccine connection may exist." The author also stated that "Revaccination of women in adulthood should be thoroughly reviewed: It has significant risks for the benefits it provides and often fails to produce immunity." Upon internal review, severe reactions to most foods was determined to be an other important medical event (OMIC). No further info is available.
Sex: M
Vaccine: MMR
Symptoms: Growth retardation, Neurodevelopmental disorder
Clinical narrative: It was reported in a published article, that a male pt's mother was vaccinated with a dose of MMR II shortly before conception. The mother had a son who was developmentally delayed and had Landau-Kleffner Syndrome. Upon internal review, Landau-Kleffner Syndrome was considered to be an important medical event (OMIC). The author noted that "vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins." "It can also be frequently associated with early onset autism." It was also reported that "in spite of its limitations, this study suggests that an autism/vaccine connection may exist." It was unknown if medical attention was sought.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Speech disorder
Clinical narrative: It was reported in a published article that an approximately 36 month old male patient in approximately February 1990 at the age of 29 months, was vaccinated with a dose of MMR (second generation). Subsequently, he had no language by 36 months and a diagnosis of autism was later confirmed. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. Upon internal review, autism was considered to be an important medical event (OMIC). It was unknown if medical attention was sought.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Immune system disorder, Systemic lupus erythematosus
Clinical narrative: It was reported in a published article that a female patient in 1983 was vaccinated with a first dose of MMR (second generation) because of a measles outbreak in college. She tested immune to measles in 1991, 1992, and 1997. During her first pregnancy in 1991, she tested immune to rubella and had a healthy, normal son. At the birth of her second son, in May 1993, she was found to be rubella susceptible and was given a second dose of MMR (second generation) in the postpartum period. The patient now had markers for lupus. Upon internal review, lupus was considered to be an important medical event (OMIC). It was unknown if medical attention was sought. It was reported in a published article, title as stated above, that this patient had developed measles, rubella and mumps despite being vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Because of a diagnosis of "some immune problem", the patient received injections of gamma globulin for awhile. It was reported that the patient received the hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) series in 1998-1999. Upon internal review, lupus was considered to be an important medical event. The reporter indicated that the patient's son had autism (WAES #0306USA00452). It was unknow if medical attention was sought.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Drug withdrawal syndrome, Speech disorder
Clinical narrative: It was reported in a published article that a 12 month old, with a history of always being constipated, who in September 1993 was vaccinated with a dose of MMR (second generation). According to the patient's mother, he lost his acquired speech and eye contact by 12-15 months of age and had now been diagnosed with autism. Concomitant therapy included a dose of measles virus vaccine when the patient was 18 months old. The author noted that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. It cal also be frequently associated with early onset autism. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. Upon internal review, autism was considered to be an important medical event (OMIC). It was unknown if medical attention was sought. Follow-up: A copy of the published literature was attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR
Symptoms: Abortion spontaneous, Drug administration error
Clinical narrative: It was reported in a published article that a female patient, who is HIV positive and who had a miscarriage in 1993, who on 11/11/95 was vaccinated with a dose of MMR (second generation) while nearly three months pregnant. It was reported that the patient was placed on a protocol which mandated MMR (second generation) every 2-3 years. It was noted that the patient had a miscarriage in 1998. The author noted that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. It was unknown if medical attention was sought.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: It was reported in a published article, that a 24 month old HIV negative male, whose mother is HIV positive, was vaccinated per protocol with a first dose of MMR II at 6 months of age. It was reported that as per the protocol, he received a second dose of MMR II at 18 months of age. He regressed into autism around 24 months of age. The author noted that "vaccination can be frequently associated with early onset autism." It was also reported that "in spite of its limitations, this study suggests that an autism/vaccine connection may exist." Upon internal review, autism was considered to be an important medical event (OMIC). It was unknown if medical attention was sought.
Sex: F
Vaccine: MMR
Symptoms: Abortion, Multiple pregnancy
Clinical narrative: It was reported in a published article that a female patient, who is HIV positive and who has a history of three pregnancies and 1 live birth (a son with autism) who in early February 1999, was vaccinated with a dose of MMR (second generation). The patient had become pregnant in January 1999. Two fetal heartbeats were identified earlier in the pregnancy but later, one was lost, and the mother was told that one of the twins had vanished. On 10/2/99 she delivered a boy who was still normal at age 12 weeks. The author noted that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. It was unknown if medical attention was sought.
Age: 0.3
Sex: M
Vaccine: DTAP, MMR
Symptoms: Abnormal behaviour, Agitation, Antisocial behaviour, Cerebral palsy, Gastrooesophageal reflux disease
Clinical narrative: It was reported in a published article that a 16 week old male patient's mother was vaccinated with a dose of MMR (second generation) in the postpartum period. The patient breast-fed well and did not regurgitate. The patient had no problems until the age of 4 months when he reacted violently to a dose of diphtheria toxoid/pertussis vaccine/teta with a high fever and inconsolable screaming. He also developed severe gastroesophageal reflux which later required fundoplication. Because he had athetoid movements the patient was evaluated and diagnosed with cerebral palsy. He is now 13 years old and according to his mother does not respond and cannot be tested; he turns off the world, looks at the ceiling and rocks all day. Though these symptoms are very suggestive, a diagnosis of autism was never considered and he was therefore not included in the affected group. Upon internal review, cerebral palsy was considered to be an important medical event (OMIC).
Age: 0.3
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Screaming
Clinical narrative: It was reported in a published article that a 16 week old male patient's mother was vaccinated with a dose of MMR (second generation) in the postpartum period. The patient breast-fed well and did not regurgitate. The patient had no problems until the age of 4 months when he reacted violently to a dose of diphtheria toxoid/pertussis vaccine/teta with a high fever and inconsolable screaming. He also developed severe gastroesophageal reflux which later required fundoplication. Because he had athetoid movements the patient was evaluated and diagnosed with cerebral palsy. He is now 13 years old and according to his mother does not respond and cannot be tested; he turns off the world, looks at the ceiling and rocks all day. Though these symptoms are very suggestive, a diagnosis of autism was never considered and he was therefore not included in the affected group. Upon internal review, cerebral palsy was considered to be an important medical event (OMIC).
Sex: F
Vaccine: MMR
Symptoms: Dissecting coronary artery aneurysm, Hypokinesia, Kawasaki's disease
Clinical narrative: It was reported in a published article that a female patient (age not reported) was vaccinated on an unspecified date with a dose of MMR (second generation) (lot # not reported). Three weeks after she received the vaccine she developed Kawasaki disease. She was treated vigorously, and received IVIG, but went on to develop a left descending coronary artery aneurysm. The patient was described as having slow motor skills and it was reported that she was in an early intervention program. The author stated that in spite of its limitation, this study suggests that an autism/vaccine connection may exist. Upon internal review, Kawasaki disease, coronary artery aneurysm and slow motor skills were determined to be other important medical event (OMIC). No further information is available.