chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hemiparesis, Influenza like illness, Vomiting
Clinical narrative: Patient complained of severe headache, vomiting, flu-like symptoms, left side body felt weak. Notified nurse 4 days later. Seen by a doctor at hospital.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyskinesia, Tremor
Clinical narrative: Patient had 3 episodes during afternoon and evening after vaccines of quivering/shaking of arms and legs lasting 10-30 seconds. Then we observed similar episode 9/10 or 9/11 and two more on 9/13.
Age: 1.36
Sex: F
Vaccine: DTAPH, HEP, MMR
Symptoms: Erythema, Pyrexia
Clinical narrative: I have asked the parents to take the original of this form for Doctor to complete 7, 12, 11. By history, the child had a temperature of 105 and redness all over the body No treatment was necessary.
Age: 1.01
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Received vaccines 10/04/04. Initially with a small pimple left thigh thigh night. Then 1 night later, larger erythematous, felt warm and hard. Seen by MD on 10/6/4. 2cm erythematous, indurated area left anterior thigh.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Swelling
Clinical narrative: Right arm swelling. Patient complained subjective throat swelling. Treatment: 0.3mg of Epi given, O2 administered. O2 weaned and patient recovered.
Age: 1.02
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever and maculopapular rash on 9/18/04 10 days after vaccination. MMR, Varicella, and PCV vaccines on 9/8/04. Tylenol and Ibuprofen for fever.
Age: 1.02
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever and maculopapular rash on 9/18/04 10 days after vaccination. Received PCV, MMR, and Varicella vaccines on 9/8/04. Tylenol and Ibuprofen for fever.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, localized reaction cutaneous, nausea.
Age: 1.11
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass, Urticaria
Clinical narrative: Right thigh with dime size welt, small bump under injection site.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Impetigo of the pelvic region. Need lengthy treatment of greater than 2 weeks.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test abnormal, Pyrexia
Clinical narrative: Fever up to 101.3 orally starting within receiving Pediarix, Prevnar, and HIB.
Age: 1.23
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Received MMR, and Varivax on 9/27/04. Develops fever on 10/5/04 and chicken pox type rash on 10/7/04.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Patient descirbes significant (r) arm swelling, with greater than 10 cm of induration - occurring 48 hours after 2nd dose anthrax.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Headache, Injection site pain, Pyrexia
Clinical narrative: approx. 20 hours after flu shot my daughter has temperature of 99.3, headache, back ache and arm ache(where shot given)  Given Motrin but still having symptoms
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site mass, Injection site pain
Clinical narrative: Employee states she felt soreness and a knot in her arm at injection site 2 days after vaccine injection.  Then 2 - 3 days later she felt pain starting near injection site, going down her arm.  She states that her right ring and pinky fingers feel like they are going numb.  She states there is no change in skin temperature or color of the fingers.  As of the date of this report, the employee states she has not sought medical care for the problem.  She states she has had carpal tunnel in that same extremity before.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Nausea
Clinical narrative: After receiving the Flu Vaccination, felt nauseous and an odd sensorium occured a few minutes after administration.  Pt. did not fall or lose consciousness.  Pt. also had same symptoms last after receiving the Flu Vaccine, it was attributed to a hot crowded room where vaccine was administered.  Pt also had a Tetanus/ Diphtheria vaccine about month prior without any reaction or symptoms.
Age: 36.0
Sex: M
Vaccine: ANTH, HEP, HEPA, TYP
Symptoms: Arthralgia, Contusion, Cough, Fatigue, Headache
Clinical narrative: Received a red, non-itchy rash ontop of both feet 5 days following vaccinations.  By 6th day, Rash covered all lower extremeties.  On 6th day, I started to feel very tired and only wanted to sleep.  On day 8, I felt exhausted with no energy and noticed rash moved up into hairline and into corner of eyes.  Evening of day 8 I was extremely restless and did not sleep.  Morning of day 9 rash moved onto bridge of nose, cheeks and inside of mouth. Severe bruising was apparent on my arms and I had a bloody discharge from my penis. Had difficulty stopping discharge.  Drove to the ER and was admitted on 9/23/04.  Diagnosis: Severe iodiopathic thrombocytopenic purpura. Admitted with blood platelet count 0 and physical exam findings of wet purpura and diffuse petechiae.  Procedures performed: Bone marrow aspiration performed showed normal cellular marrow with adequate megacaryocytes.  Bone marrow otherwise normal except slightly increased myeloid to erythroid ratio.  Received a single donar platelet phoresis pack, leuki-reduced and irradiated transfusion. Started high dose of Solu-Medrol.  Started intravenous IVIG and he received IVIG four days in a row with good response in platelet count.  I had O Negative blood, so WinRho was not administered.  I received four days of IVIG at a dose of 28 grams a day.  His petechiae improved and he remained free of fever or headaches during his stay.  He was ready for dismissal on 9/27/04.  Post follow up care included Prednisone 10mg six tablets daily while slowly being tapered off each week.  On the sixth week I will finish Prednisone.  In addition, I receive one blood CVC draw weekly until the sixth week.  Medline search for vaccinations he received was conducted.  It's noted my condition was a side-effect of Anthrax. Discharge Summary received on 1/10/2005 states final diagnosis confirmed as idiopathic thrombocytopenic purpura. Add symptoms of pain in hips and elbows, frontal headache, non-productive cough, and generalized achiness.
Age: 36.0
Sex: M
Vaccine: ANTH, HEP, HEPA, TYP
Symptoms: Myalgia, Penis disorder, Petechiae, Rash, Somnolence
Clinical narrative: Received a red, non-itchy rash ontop of both feet 5 days following vaccinations.  By 6th day, Rash covered all lower extremeties.  On 6th day, I started to feel very tired and only wanted to sleep.  On day 8, I felt exhausted with no energy and noticed rash moved up into hairline and into corner of eyes.  Evening of day 8 I was extremely restless and did not sleep.  Morning of day 9 rash moved onto bridge of nose, cheeks and inside of mouth. Severe bruising was apparent on my arms and I had a bloody discharge from my penis. Had difficulty stopping discharge.  Drove to the ER and was admitted on 9/23/04.  Diagnosis: Severe iodiopathic thrombocytopenic purpura. Admitted with blood platelet count 0 and physical exam findings of wet purpura and diffuse petechiae.  Procedures performed: Bone marrow aspiration performed showed normal cellular marrow with adequate megacaryocytes.  Bone marrow otherwise normal except slightly increased myeloid to erythroid ratio.  Received a single donar platelet phoresis pack, leuki-reduced and irradiated transfusion. Started high dose of Solu-Medrol.  Started intravenous IVIG and he received IVIG four days in a row with good response in platelet count.  I had O Negative blood, so WinRho was not administered.  I received four days of IVIG at a dose of 28 grams a day.  His petechiae improved and he remained free of fever or headaches during his stay.  He was ready for dismissal on 9/27/04.  Post follow up care included Prednisone 10mg six tablets daily while slowly being tapered off each week.  On the sixth week I will finish Prednisone.  In addition, I receive one blood CVC draw weekly until the sixth week.  Medline search for vaccinations he received was conducted.  It's noted my condition was a side-effect of Anthrax. Discharge Summary received on 1/10/2005 states final diagnosis confirmed as idiopathic thrombocytopenic purpura. Add symptoms of pain in hips and elbows, frontal headache, non-productive cough, and generalized achiness.
Age: 36.0
Sex: M
Vaccine: ANTH, HEP, HEPA, TYP
Symptoms: Thrombocytopenic purpura
Clinical narrative: Received a red, non-itchy rash ontop of both feet 5 days following vaccinations.  By 6th day, Rash covered all lower extremeties.  On 6th day, I started to feel very tired and only wanted to sleep.  On day 8, I felt exhausted with no energy and noticed rash moved up into hairline and into corner of eyes.  Evening of day 8 I was extremely restless and did not sleep.  Morning of day 9 rash moved onto bridge of nose, cheeks and inside of mouth. Severe bruising was apparent on my arms and I had a bloody discharge from my penis. Had difficulty stopping discharge.  Drove to the ER and was admitted on 9/23/04.  Diagnosis: Severe iodiopathic thrombocytopenic purpura. Admitted with blood platelet count 0 and physical exam findings of wet purpura and diffuse petechiae.  Procedures performed: Bone marrow aspiration performed showed normal cellular marrow with adequate megacaryocytes.  Bone marrow otherwise normal except slightly increased myeloid to erythroid ratio.  Received a single donar platelet phoresis pack, leuki-reduced and irradiated transfusion. Started high dose of Solu-Medrol.  Started intravenous IVIG and he received IVIG four days in a row with good response in platelet count.  I had O Negative blood, so WinRho was not administered.  I received four days of IVIG at a dose of 28 grams a day.  His petechiae improved and he remained free of fever or headaches during his stay.  He was ready for dismissal on 9/27/04.  Post follow up care included Prednisone 10mg six tablets daily while slowly being tapered off each week.  On the sixth week I will finish Prednisone.  In addition, I receive one blood CVC draw weekly until the sixth week.  Medline search for vaccinations he received was conducted.  It's noted my condition was a side-effect of Anthrax. Discharge Summary received on 1/10/2005 states final diagnosis confirmed as idiopathic thrombocytopenic purpura. Add symptoms of pain in hips and elbows, frontal headache, non-productive cough, and generalized achiness.
Age: 54.0
Sex: M
Vaccine: TTOX
Symptoms: Headache
Clinical narrative: A severe headache 18 hours after the shot. Headache extremely severe. Patient said it felt like his brain was on fire and going to explode. Patient had never experienced that kind of headache or pain before, though having numerous headaches before. Headache subsided after 24 hrs. No treatment given
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient received Comvax and Prevnar in Left anterior thigh.  The next day she had some swelling, redness, and warmth to those sites. She had a fever to 101 rectal the night after immunization.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Cough, Dyspnoea, Injection site pain, Productive cough, Rhinorrhoea
Clinical narrative: Patient is a 42-year-old male who was diagnosed with asthma in 1984. He stated that he had good control of his asthma with Theodur, Singulair, and Maxair. He was able to perform his duties as postman walking 6 hrs a day and run 2 miles in 15 min without difficulty or use of inhaler. He reported normal pulmonary function tests in early June and no cough.   Patient received his first anthrax (AVA) on 27 Jun 04. Other than some slight soreness in his arm he reported no problems.   He received AVA #2 on 11 Jul 04. Initially he felt fine then 3-4 days later he developed a runny nose, shortness of breath, wheezing, cough, and slight sputum production. He thought that he was getting a cold, but symptoms progressed. He stated he was able to run on 22 Jul but required his inhaler to do so. He reports that since that time he is requiring the use of his inhaler 3-4 times daily.   Upon return home on 24 Jul 04 he sought medical attention and was told that the ragweed triggered his asthma. He was placed on Claritin, no steroids, and was using his Maxair every 4 hours. He did not notice any improvement and was no longer able to run. He stated that his repeat pulmonary function test in Sep was abnormal. He also stated he was waking up at night with coughing, but since a recent medication change that it has improved.   Patient reports that he has several allergies including cat dander. Since his return he has been around his daughter's cat. He reports that during prior exposure to ragweed he would have nasal congestion but nothing like this. This time he also has the sensation that his ears are blocked.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Wheezing
Clinical narrative: Patient is a 42-year-old male who was diagnosed with asthma in 1984. He stated that he had good control of his asthma with Theodur, Singulair, and Maxair. He was able to perform his duties as postman walking 6 hrs a day and run 2 miles in 15 min without difficulty or use of inhaler. He reported normal pulmonary function tests in early June and no cough.   Patient received his first anthrax (AVA) on 27 Jun 04. Other than some slight soreness in his arm he reported no problems.   He received AVA #2 on 11 Jul 04. Initially he felt fine then 3-4 days later he developed a runny nose, shortness of breath, wheezing, cough, and slight sputum production. He thought that he was getting a cold, but symptoms progressed. He stated he was able to run on 22 Jul but required his inhaler to do so. He reports that since that time he is requiring the use of his inhaler 3-4 times daily.   Upon return home on 24 Jul 04 he sought medical attention and was told that the ragweed triggered his asthma. He was placed on Claritin, no steroids, and was using his Maxair every 4 hours. He did not notice any improvement and was no longer able to run. He stated that his repeat pulmonary function test in Sep was abnormal. He also stated he was waking up at night with coughing, but since a recent medication change that it has improved.   Patient reports that he has several allergies including cat dander. Since his return he has been around his daughter's cat. He reports that during prior exposure to ragweed he would have nasal congestion but nothing like this. This time he also has the sensation that his ears are blocked.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Somnolence
Clinical narrative: ~20 minutes after vaccine was given pt was not fell asleep and would not wake up easily.  Grandmother states that this lasted for ~20 minutes. Upon arrival to office he was sleepy but arousable with normal VS. Within 10 minutes he was normal.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash maculo-papular
Clinical narrative: Received flu vaccine on 10/12/04 at 0830.  On 10/13/04 at 1530 noted maculopapular rash at injection site.  Rash covers area about 60mm by 100mm at injection site on L arm.  It is irregular and does not cover entire site.  States it is not itchy.  Does not have any respiratory symptoms.  Denies egg allergy and eats eggs regularly.  Has had flu shot for the last 6 years.  Had varicella as a child.  Has not changed laundry soap, soaps, lotions, or new medications.  Has not had any new foods.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Erythema, Headache, Hyperventilation
Clinical narrative: I am a very healthy person in good shape and a good size. I have never had an adverse reaction to any vaccines before. I have always thought it was best to get vaccines. I will never feel that way again. Within two minutes of receiving the vaccine I became very nauseous. I had the vaccine administered at about 12:30PM. I am a teacher and worked until 4PM. I went home and continued to feel very nauseous and by 9PM I began having pain in my abdomen that radiated from my stomach and spread upwards and down. I also got a severe headache. It became so severe that I could only breathe very slightly. If I moved at all or laid on my left side the pain was so severe it made me very concerned for my health. My lymph nodes began to swell by 11PM the same day all over my body even in my arms. They hurt and became red. This scared me as it had never happened before! Saturday I had the same difficulty breathing, and my entire abdomen still hurt. I was very weak. My insurance is not in effect or normally I would have went to the ER at that point. I have a high pain tolerance and this was a 10 when I moved or breathed deep on a scale of 0 to 10 with 10 being the worst. Sat. night I was concerned I was getting pneumonia. I laid down in the bed on my left side and terrible pain filled my entire body cavity. I painfully turnmed over on my right side and laid very still. As long as I barely breathed I was ok. I told my husband that if I get better as the night goes on I will not go into the ER but if I get worse at all from this point on or do not get better by the wee hours of the night when one of us usually gets up to use the restroom that I will want him to bring me to the ER. Thankfully about 4AM I awoke and I could lay on my left side the same as I could on the right with no pain as long as I didnt move. With movement I still had severe pain. This continually got better at a very slow rate until 11PM Sunday night when all the pain was gone and my lymph nodes began to go down in sixe and redness. I will never again in my life get the flu vaccine or have my husband or three children get it. I really believed I was going to get pneumonia rapidly and die. I am not a worrier and I did not express this previous thought to my family.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Nausea
Clinical narrative: I am a very healthy person in good shape and a good size. I have never had an adverse reaction to any vaccines before. I have always thought it was best to get vaccines. I will never feel that way again. Within two minutes of receiving the vaccine I became very nauseous. I had the vaccine administered at about 12:30PM. I am a teacher and worked until 4PM. I went home and continued to feel very nauseous and by 9PM I began having pain in my abdomen that radiated from my stomach and spread upwards and down. I also got a severe headache. It became so severe that I could only breathe very slightly. If I moved at all or laid on my left side the pain was so severe it made me very concerned for my health. My lymph nodes began to swell by 11PM the same day all over my body even in my arms. They hurt and became red. This scared me as it had never happened before! Saturday I had the same difficulty breathing, and my entire abdomen still hurt. I was very weak. My insurance is not in effect or normally I would have went to the ER at that point. I have a high pain tolerance and this was a 10 when I moved or breathed deep on a scale of 0 to 10 with 10 being the worst. Sat. night I was concerned I was getting pneumonia. I laid down in the bed on my left side and terrible pain filled my entire body cavity. I painfully turnmed over on my right side and laid very still. As long as I barely breathed I was ok. I told my husband that if I get better as the night goes on I will not go into the ER but if I get worse at all from this point on or do not get better by the wee hours of the night when one of us usually gets up to use the restroom that I will want him to bring me to the ER. Thankfully about 4AM I awoke and I could lay on my left side the same as I could on the right with no pain as long as I didnt move. With movement I still had severe pain. This continually got better at a very slow rate until 11PM Sunday night when all the pain was gone and my lymph nodes began to go down in sixe and redness. I will never again in my life get the flu vaccine or have my husband or three children get it. I really believed I was going to get pneumonia rapidly and die. I am not a worrier and I did not express this previous thought to my family.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Myocardial infarction
Clinical narrative: From initial information received from a health care professional on 10/7/04 regarding an adverse event occurring in the USA, it was reported that an 80 year old male patient with a history of cardiac problems and prostate cancer received a FLUZONE vaccination, lot number U1380AA, administered in the right deltoid on 10/7/04. One hour after receiving the vaccine, the patient died in his car in the hospital parking lot. Per the reporter, the coroner's initial impression was that it may have been a coronary heart attack and he stated that he would check for this. No other information was provided at this time. There was no autopsy done.  Nurse follow up on 10/19/04 states: "No new information."  Follow up on 10/28/04 states: "From additional information received on 10/21/04, it was reported that the pt had no illnesses at the time of vaccination. He received the FLUZONE SV '2004-2005 vaccination IM. He had previously received at least 3 or more influenza vaccines in the past without experiencing any adverse events. His previous medicaitons had included amlodipine, atorvastatin, atenolol, digoxin, furosemide, nitrates, lisinopril and metformin. His current medication list was not available at the time of this report, so it is unknown if the pt was taking any of these medications at the time he received the influenza vaccine on 10/07/04."
Sex: M
Vaccine: OPV
Symptoms: Dyspnoea, Lung neoplasm malignant, Neoplasm malignant
Clinical narrative: Information regarding a polio vaccine was received from an attorney regarding a male patient who received a dose in the early to mid 1960s. The patient has a past history of chemical poisoning. He was reportedly exposed to asbestos and asbestos-containing products. He has a past history of smoking for 20 years. Indication for the polio vaccine was immunization. Product was administered on an unspecified date in the early to mid 1960s. Concomitant medications were not reported. According to the legal complaint, the plaintiff was diagnosed with malignant Mesothelioma in June 2003 and metastasis in July 2003. His symptoms began gradually; however, the plaintiff believes that these symptoms began around October 2002. Reportedly the plaintiff received a polio vaccination in the early to mid 1960s...that was contaminated with SV 40 virus which was a substantial factor, and therefore a cause of the plaintiff's mesothelioma. The legal complaint states that the plaintiff's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. Medical records are on file.
Age: 6.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Headache, Injection site erythema, Injection site reaction, Pyrexia
Clinical narrative: This case was considered medically important (OMIC). Follow up information was received from an investigator providing additional information, correct dates of administration, onset of event dates, additional events, patient outcome and concomitant medications. Information was received from an investigator regarding a 6 year old male who received a dose of Prevnar and Recombivax HB vaccine on 12/5/01. The vaccines were administered as part of clinical trial. The participant developed an injection site erythema, injection site reaction, headache, and fever. The patient's concurrent illness includes HIV infection. Indication for Prevnar was immunization. Product was administered on 12/5/01. Dose regimen was 1 dose (IM). Concomitant therapy included Recombivax HB, Nelfinavir, Epivir, and Retrovir. On 12/6/01, the subject developed a fever of 100 degrees F and a headache. Tylenol was administered, and the events resolved later that day. The patient also developed an injection site erythema greater than quarter size on the right arm, at the Prevnar injection site that was rated Grade 3 (diameter of erythema was greater than or equal to 25mm, but less than 50% of the extremity) and injection site reaction on the same day which also resolved later that evening. The reporter also indicated that on a subsequent follow up phone call on day 7, no signs or symptoms were reported. The investigator(s) considered injection site erythema and injection site reaction definitely related to the study product; while headache and pyrexia were considered possibly related to the study product. The medical monitor(s) assessment for injection site erythema, injection site reaction, headache and pyrexia was unknown.
Age: 6.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Erythema, Hypersensitivity, Injection site induration, Malaise, Myalgia
Clinical narrative: This case was considered medically important (OMIC). Follow up information was received regarding a 6 year old male participant enrolled in a study. The subject received a dose of Prevnar and a dose of Hepatitis B vaccine on 7/24/01 and experienced an allergic reaction, erythema, rash and an injection site induration. The patient's concurrent illness included HIV infection. Indication for Prevnar was immunization. Product was administered on 7/24/01. Dose regiman was 1 dose. Additional suspect vaccine included Hepatitis B vaccine. Concomitant therapy included Norvir, Epivir, and Zerit. On 7/24/04, a 6 year old male patient developed nausea, as did his mother, after dining out. On 7/25/01, he experienced an allergic reaction and rash. The patient's mother noted erythema to hands, trunk, and privates without fever or itching. The patient was evaluated in the clinic. Upon examination, temperature was 36.5 degrees C and erythema was noted on hands, trunk, and privates, along with plantar and palmar erythema. Swelling was noted on his left hand. The patient also had the following toxicities: erythema grade 3, induration grade 3, pain grade 1, rash grade 2, malaise grade 1, myalgia grade 1, allergic reaction grade 2, and injection site induration grade 3. Treatment included Benadryl and Tylenol. The investigator considered hypersensitivity, erythema, rash and injection site induration possibly related to the administration of Prevnar and Hepatitis B vaccines.
Age: 6.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Nausea, Oedema peripheral, Rash
Clinical narrative: This case was considered medically important (OMIC). Follow up information was received regarding a 6 year old male participant enrolled in a study. The subject received a dose of Prevnar and a dose of Hepatitis B vaccine on 7/24/01 and experienced an allergic reaction, erythema, rash and an injection site induration. The patient's concurrent illness included HIV infection. Indication for Prevnar was immunization. Product was administered on 7/24/01. Dose regiman was 1 dose. Additional suspect vaccine included Hepatitis B vaccine. Concomitant therapy included Norvir, Epivir, and Zerit. On 7/24/04, a 6 year old male patient developed nausea, as did his mother, after dining out. On 7/25/01, he experienced an allergic reaction and rash. The patient's mother noted erythema to hands, trunk, and privates without fever or itching. The patient was evaluated in the clinic. Upon examination, temperature was 36.5 degrees C and erythema was noted on hands, trunk, and privates, along with plantar and palmar erythema. Swelling was noted on his left hand. The patient also had the following toxicities: erythema grade 3, induration grade 3, pain grade 1, rash grade 2, malaise grade 1, myalgia grade 1, allergic reaction grade 2, and injection site induration grade 3. Treatment included Benadryl and Tylenol. The investigator considered hypersensitivity, erythema, rash and injection site induration possibly related to the administration of Prevnar and Hepatitis B vaccines.
Age: 1.51
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site induration, Pyrexia
Clinical narrative: Child ran a low grade temp T max 101 degrees the day after given the shot. Baseball sized noticed bump.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 3" x 3" red, warm, swollen area.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Back pain, Chills, Renal pain, Similar reaction on previous exposure to drug
Clinical narrative: Approximately 1 hour after receiving the vaccine: left back pain kidney area, them moved to front; chills fore hip bone 10/6/04 belly is hurting. Frequent BMS; feels much better
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Skin burning sensation
Clinical narrative: Approximately 1 hour after receiving the vaccine: left back pain kidney area, them moved to front; chills fore hip bone 10/6/04 belly is hurting. Frequent BMS; feels much better
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Onset of chills and pain at site. Redness and swelling at injection site. Approximately 4cm x 10cm. Treated with Keflex.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoglycaemia, Injection site pain, Paraesthesia, Syncope
Clinical narrative: Patient received both pneumonia and flu shot. She fainted at stores. Vital signs stable. Patient also said pain at injection site that tingle down back. Patient admitted to not eating much that day and had previous problems with hypoglycemia.  Follow up on 10/18/04 states: "Problem at Pneumovax site."
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Developed hives in extremities 7 days after vaccination, then spread to neck. 3 days later with persistent receiving hives, he also developed shortness of breath, hence brought to ER.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Rash maculo-papular
Clinical narrative: Generalized vaccinia, diffuse maculopapular rash on torso and extremities with vaccine site as exposed for 10 day smallpox vaccine site. Treated by conservative measures. Quarters x 72 , Tylenol, Benadryl, Calamine Lotion, Rest.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Swelling
Clinical narrative: Swelling erythema RUS progressive over 48 hours.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: 3RD after given dT booster, pt's arm began to swell in entire arm of injection site. (left arm. Pt felt fever, nausea with abdominal pain. and about 3 days duration. Now, 11 days later pt has erythema at injection site.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Swelling
Clinical narrative: 3RD after given dT booster, pt's arm began to swell in entire arm of injection site. (left arm. Pt felt fever, nausea with abdominal pain. and about 3 days duration. Now, 11 days later pt has erythema at injection site.
Age: 0.51
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion, Febrile convulsion
Clinical narrative: Tonic clonic seizures. Lasts 10 minutes associated with fever.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Local redness/ increased warmth, no induration/pain. Left upper arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Swelling
Clinical narrative: 6 x 8 cm erythematous induraiton on left arm at shot site. Mild swelling. Full range of motion of extremity.
Age: 1.39
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pyrexia
Clinical narrative: Received Varivax 9/22/04. Developed fever, lesions 10/2/04. Seen at clinic 10/5 with clinical varicella. Received acyclovir secondary underlying chromosomal problem.
Age: 1.19
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria to lower extremities and buttocks, no wheezing, treated with Benadryl 1tsp q 6 hours x 3 and mom told to call if swelling or wheezing and we'll give 4 year boosters 1 at a time, considering allergy referral.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Right upper anterior thigh with warm, red, 11x9 cm itchy area.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: 1. high pitched, shrill crying x 3-4 hours. 2. inconsolable.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Pt states she had a rash all over her body for the first three days after the injection. Then the rash went away and she had itching all over for three days. Patient treated with Benadryl, Zyrtec and Atarax.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site discolouration, Oedema, Swelling
Clinical narrative: Left thigh with circumferential swelling, anterior erythema, blanching. Knee edema, mild tenderness and warmth.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness
Clinical narrative: Left thigh with circumferential swelling, anterior erythema, blanching. Knee edema, mild tenderness and warmth.
Age: 1.71
Sex: F
Vaccine: DTAP, VARCEL, DTAP, MMR
Symptoms: Convulsion, Diarrhoea, Febrile convulsion, Respiratory arrest, Vomiting
Clinical narrative: 34 hours after vaccinations, patient started vomiting and developed severe diarrhea. No fever accompanied this. 72 hours later, patient had seizure, which lasted maybe 1 minute. She stopped breathing and needed CPR. In ER most of day for tests and on IV for dehydration due to vomiting and diarrhea. She was stabilized after 5 min. Doctor at ER determined seizure was febrile , either caused by vaccines or fever, which patient did not have.
Age: 1.71
Sex: F
Vaccine: DTAP, VARCEL, DTAP, MMR
Symptoms: Convulsion
Clinical narrative: 34 hours after vaccinations, patient started vomiting and developed severe diarrhea. No fever accompanied this. 72 hours later, patient had seizure, which lasted maybe 1 minute. She stopped breathing and needed CPR. In ER most of day for tests and on IV for dehydration due to vomiting and diarrhea. She was stabilized after 5 min. Doctor at ER determined seizure was febrile , either caused by vaccines or fever, which patient did not have.
Age: 1.24
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Coma, Gaze palsy, Head discomfort
Clinical narrative: Approximately 1 wk after receiving vaccines listed below mom c/o pt staring off into space and occasionally not responding to her. Pt has been set up for EEG at hospital. On 10/1 mom called our office and reports that pt is rubbing/holding head like uncomfortable 30-40x a day. Pt referred to local ER. To R/O neurological emergency.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ecchymosis, Erythema, Rash papular, Urticaria
Clinical narrative: Rash within 12 hours very urticarial waxed and waved. Also had other rash erythematous papules and some areas on LE of ecchymosis. Resolved after several days with Benadryl and Prednisone. Notes pt was 1st to get a dose from vial of Varivax, 6 others had dose from MMR prior to use.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Anorexia, Fatigue, Pyrexia
Clinical narrative: Fever 103, loss of appetite, tiredness
Age: 0.82
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Developed generalized rash on the night after Hep B #1 was given. No respiratory problem was seen in ER, was given Benadryl and anti-inflammatory med.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Fatigue, Oedema, Pyrexia
Clinical narrative: Received shots 10/5/04 mom called 10/8/04 stating that child's arm was red, swollen, and had fever and fatigue. Came for a visit. Saw PA and was administered an antibiotic for 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema, Tenderness
Clinical narrative: Received vaccination on 10/5/04. Mom called 10/7/04 stating that child's arm contained redness and swelling the size of an apple. His arm was also very tender and hot to touch. He came for a visit, was prescribed a 10 day Tx of antibiotics.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass, Injection site pain, Pruritus
Clinical narrative: Hard area at site measures 50x58mm itching, slight pain. Noticed 24 hrs after vaccine given. Advised cold compresses, Benadryl lotion to site.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Screaming
Clinical narrative: crying inconsolable x 4 hrs, on exam at 4PM consolable, smiling.
Sex: M
Vaccine: DTAP, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site swelling, Oedema
Clinical narrative: 9:15AM 10/8/04 pt seen at Med Center at this time site 10cm long by 11cm wide reddened, warm to touch, site raised: rt leg. On 10/6/04 mother states small lump was noted. 10/7/04 noticed large reddened area swelling. (Just to watch)
Age: 7.0
Sex: F
Vaccine: MMR
Symptoms: Lethargy, Malaise, Rash
Clinical narrative: Pt became ill at school yesterday. Lethargic, no fever reported. Mother noticed bumps on trunk of body after picking child up from school.
Age: 1.51
Sex: F
Vaccine: DTAP, HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 104 and vomiting since 4PM on 10/6/04 (day of vaccination)
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Urticaria, Viral infection
Clinical narrative: Pt received immunizations (DTAP, IPV, Prevnar) on 8/25/04 rash started on 28th/29th Urticaria, had viral illness at time of urticaria. Seen in clinic 9/2 for eval. Tx'd Benadryl. No viral illness at time of shots.
Age: 0.55
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 13 hours after immunizations given
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash maculo-papular
Clinical narrative: Red splotches on Back and Chest since 10/04/04 AM. Fever up to 101.8 from 9/30 and 10/2
Age: 1.12
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash papular, Viral infection
Clinical narrative: Pt developed papulovesicular lesions on face, trunk, arms and legs consistent with varicella 2 wks after receiving varicella vaccine.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Tet injection done on 9/27/04 on 10/1/04 arm was red, hot and hard. She was put on Doxycycline x 7days 100mg.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Muscle spasms, Myalgia
Clinical narrative: Pts right arm, site of infection started aching the day following injection then on 8/2/04 left leg began to cramp and ache (thigh being the worst). General body aches also up to date 8/5/04. Right arm was better completely on 8/2/04.
Age: 1.03
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Viral infection
Clinical narrative: Pt reported febrile seizures, Fever 104
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema, Pruritus
Clinical narrative: itchy at site of DTaP, arm swollen elbow to shoulder, no painful, bright red. Mom left a message.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Very red arm at site of Dtap, mom will call if worse. Morning of 10/12 nickel size red, eve of 10/12 bigger, morn of 10/13 ~4in area of redness, warm, very itchy.
Age: 1.99
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles right lumbar area and right thigh.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Lymphadenopathy, Myalgia, Pain
Clinical narrative: Developed left supraclavicular and left axillary adenopathy, painful, supraclavicular area erythematous. Left ant deltoid warm and partly erythema (not near injection site). Myalgias, afebrile, Keflex 500 7 TID.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Injection site pain, Pyrexia
Clinical narrative: Approx 1 hour after administration developed fever up to 104, felt dizzy and c/o arm soreness.
Age: 7.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Vaccine administered 10/7/04 right deltoid. On the evening of 10/12/04, patient had a 3" red, hot , itchy swollen area at injection site. Mom gave Benadryl with relief of symptoms.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Pain, Paraesthesia, Sensory disturbance, Skin burning sensation
Clinical narrative: Pt called our office on 9/6/04 with complaints of pain and burning sensation at injection site (left deltoid) and pain and burning in both legs, second call 9/9/04: pt continues to have pain, burning and tingling sensation in legs, arms, and hands. 3rd call: 9/15/04: continues to have above symptoms. Was seen by neurologist. Pt informed us that her neurologist diagnosed her with a reaction from the vaccine and has requested we initiate this reports to VAERS.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Erythema, Oedema
Clinical narrative: On evening of vaccination, developed 4 x 9 cm bruising at site with 8 x 11 cm surrounding erythema / slight edema. No fever/ irritability. Benadryl po and compresses.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Generalized rash on face and trunk
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Hypokinesia, Injection site erythema, Injection site mass, Injection site pain, Pain
Clinical narrative: 10-11-04: Pt self report 120mm circular reaction with redness, pain, tenderness 10-12-04:Reports that redness disappeared but a lump remained 30mm circular with tenderness and pain 10-14-04:Pt went to PCM for pain with arm movement and lump remains. Prescribed Tequin for possible infection.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Flushing, Pruritus, Pyrexia, Rash
Clinical narrative: Received flu shot at 0630, 10/12/04.At 1300, felt flushed in face like he had a fever. Felt worse all afternoon. At 1830, chills began and he shook hard and it continued until 0200 10/13/04 when his fever broke. Later the same day he began getting small bumps/raised rash the size of a finger tip on his arms, back and right leg. This morning, 10/14/04, all that remained was a soft ball sized patch of flat red rash on his buttock.  After showering this morning, the rash was gone. All of the rashes itched.
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Chills, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: FEVER 101 VOMITING CHILLS AND SWEATS
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cellulitis, Injection site reaction, Skin striae
Clinical narrative: red streaks extending form HIB vaccination site occuring 10 hrs. after vaccination. Follow up: Cellulitis involved the left leg at the sit of the Hib immunization.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cellulitis, Dehydration, Oral intake reduced, Pyrexia, Vomiting
Clinical narrative: red streaks extending form HIB vaccination site occuring 10 hrs. after vaccination. Follow up: Cellulitis involved the left leg at the sit of the Hib immunization.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Rash maculo-papular, Tinnitus, Urticaria
Clinical narrative: On 10/06/04 received influenza vaccine at 0745.  Five hours later noted tingling in injection arm-superior surface of forearm.  Noted Maculopapular pruritic rash at this site.  At HS noted generalized tingling over entire body.  Noted urticaria around R ankle.  Took cool showers and soda baths for relief.  Buzzing and tingling sensation in ears and general has continued to date.  States is sensitive to meds and has limited Benadryl use.  Denies allergy to eggs.  Has not changed laundry soaps, or sking products.  Has had varicella as child.  Is currently not sick and no children in familly are sick.  No new medications.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pain, Pruritus, Pyrexia
Clinical narrative: The evening and day following the immunization I did have a fever, my arm was warm and sore, which I expected. On Sunday the 10th, I was having itching on my chest at the tops of my breasts and around the anal/vaginal area.  It has gotten worse in the last few days, and has spread from the tops of my ears to my thighs.  I went to see the doctor at the clinic yesterday the 13th- I have no rash, no hives, no visible signs or symptoms.  I am not allergic to eggs, nor have I started any new medications, until now- now I am on prednisone and vistaril.  I have not changed my eating habits and I have not changed any soaps, detergents, etc.  As far as I know I have not been exposed to any other compounds or poisons, have not been in any weeds or anywhere. I do not think they have been spraying for anything.  The only thing I could think of was exposure to a scabies patient about a month or so ago, but I do not have a rash, and the scraping that the doctor took from my skin was negative.  My husband does not have any itching and he did not get a flu shot.  Other than us, we have some house pets, but they are not having any problems either, and they don't hang outside for long.  When they are, they are confined to our back yard and we have not been spraying for anything either.  I have been racking my brain since this all came about and this is the only thing that I can think of that was different about my life and surroundings.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Client received Pneumovax on 10/12/04.  On 10/13/04 the client's husband called and stated the arm was swollen.  I stated that was a normal local reaction.no other symptoms were reported.  I asked the client to use ice packs and Tylenol, if not contraindicated, and was told if no improvement in 48 hrs. to call me. On 10/14/04 the client presented herself to the HD.  Left upper arm from midline to elbow was red,edematous, raised and warm to touch. Client stated it was moving more toward elbow.  The redness wrapped half around arm. The client stated it was painful 10/13/04 but better today. No other symptoms noted or complained. Due to the acute swelling and the client being immuned compromised, I called her walk in clinic she frequents. An appointment was made for today,(10/14/04)