chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC, DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Culture urine negative, Full blood count, Influenza serology negative, Lethargy, Liver function test abnormal
Clinical narrative: High fever, lethargy, uncontrolled crying for short periods of time. See attached hospital records.  5/9/08 Reviewed hospital medical records of 2/28-3/3/2008. FINAL DX: atypical Kawasaki's disease w/o evidence of cardiac lesions Records reveal patient expereinced febrile illness x 7 days w/URI s/s, pale, rash, conjunctivitis, acute OM, emesis, fall, irritability, poor appetite, red lips, swelling of hands/feet w/peeling skin on feet.  Cardiology consult done.  Tx w/IVIG & ASA.  Improved & d/c to home on continued ASA w/cardio f/u & serial echocardiograms.   3/11/08 Reviewed ER medical records of 2/21/08. FINAL DX: possible viral syndrome; r/o Kawasaki disease; & prolonged fever.  Records reveal patient w/fever day s/p vaccines w/fall that day hitting back of head & becoming sleepy.  Returned to ER on 2/22/08 for continued fever, cough, post tussive emesis & irritability.  Temp in ER was 103.1  Sick sibling in home.  TX w/IV antibiotics & antipyretics.  Dx at that time Fever & URI on continued oral antibiotics. No improvement & admitted  2/23-2/28/2008.  Hospital medical records reveal patient experienced cold s/s of low grade fever, cough, runny nose, respiratory congestion, wheezing, intercostal retractions x 2 days.  Seen by PCP & sent to ER.  Temp in ER was 104.  Tx w/breathing treatments & IV antibiotics.  Developed diffuse urticarial rash & inflammed conjunctiva.  Continued to run fever as high as 106.  Transferred to higher level of care. Linked w/307191 Follow-up: Telephone and registered mail attempts to communicate for follow-up have been unsuccessful.
Age: 0.6
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC, DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Pyrexia, Urticaria papular, White blood cell count increased
Clinical narrative: High fever, lethargy, uncontrolled crying for short periods of time. See attached hospital records.  5/9/08 Reviewed hospital medical records of 2/28-3/3/2008. FINAL DX: atypical Kawasaki's disease w/o evidence of cardiac lesions Records reveal patient expereinced febrile illness x 7 days w/URI s/s, pale, rash, conjunctivitis, acute OM, emesis, fall, irritability, poor appetite, red lips, swelling of hands/feet w/peeling skin on feet.  Cardiology consult done.  Tx w/IVIG & ASA.  Improved & d/c to home on continued ASA w/cardio f/u & serial echocardiograms.   3/11/08 Reviewed ER medical records of 2/21/08. FINAL DX: possible viral syndrome; r/o Kawasaki disease; & prolonged fever.  Records reveal patient w/fever day s/p vaccines w/fall that day hitting back of head & becoming sleepy.  Returned to ER on 2/22/08 for continued fever, cough, post tussive emesis & irritability.  Temp in ER was 103.1  Sick sibling in home.  TX w/IV antibiotics & antipyretics.  Dx at that time Fever & URI on continued oral antibiotics. No improvement & admitted  2/23-2/28/2008.  Hospital medical records reveal patient experienced cold s/s of low grade fever, cough, runny nose, respiratory congestion, wheezing, intercostal retractions x 2 days.  Seen by PCP & sent to ER.  Temp in ER was 104.  Tx w/breathing treatments & IV antibiotics.  Developed diffuse urticarial rash & inflammed conjunctiva.  Continued to run fever as high as 106.  Transferred to higher level of care. Linked w/307191 Follow-up: Telephone and registered mail attempts to communicate for follow-up have been unsuccessful.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site bruising, Injection site pain
Clinical narrative: Recieved 3rd Gardasil shot on February 28, 2008. On 3/10/2008 site where shot was administered still sore.  To touch it feels as if the site is bruised.  To rotate arm (i.e. such as crossing arms to pull shirt off) - upper arm where shot was administered in terrible pain.  Sore if sleeping and roll over on it.  The pain has been there around the shot site since the day of the shot and has not lessened.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Swelling face
Clinical narrative: About 4 hours shots were given grandmother noted that patient had left sided facial swelling that had resolved by morning when the patient woke up.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Hypokinesia, Musculoskeletal pain, Myalgia
Clinical narrative: Pt. describes pain in her shoulder and muscles of her Lt. arm.  Has some bruising and finds it hard to move her arm up and down due to soreness.  Denies any swelling at this time. She only takes one ASA 325 mg per day.  No other pain medication. Pain started on Wed. 3/5/08.
Age: 0.38
Sex: M
Vaccine: PPV, RV5
Symptoms: Body temperature, Irritability
Clinical narrative: Temp, extreme fussiness from 27+ hours post immunization (03/07/08) until 03/09/08 8:30 pm.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Blood immunoglobulin E increased, Food allergy
Clinical narrative: Food allergy to milk, which led to soy allergy, sorghum flour allergy  MERCURY IN THE VACCINE!
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Headache, Induration, Injection site vesicles, Palpitations
Clinical narrative: Swelling with 9 cm induration and 4cm x 6 cm area of firm,blistered red lesion at injection site.  Pt reports headache, racing heart beat, severe fatigue for 2 days.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Swelling
Clinical narrative: Swelling with 9 cm induration and 4cm x 6 cm area of firm,blistered red lesion at injection site.  Pt reports headache, racing heart beat, severe fatigue for 2 days.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Heart rate increased, Immunisation reaction, Pain
Clinical narrative: Phone call from parent @ 4:15PM. Stated pt. c/o scalp itching and stinging. Face red, dizziness noted. Mom stated pt. has had no fever, but she gave her Tylenol and called her doctor. Mom reports pts. pulse 114, BP 89/41. Mom reports pt. started her menses today. Asked parent to carry pt. to ER. Phone call from parent again. Stated she talked to their doctor and he said it was from the pertussis-Give Benadryl, was his orders. Onset of symptoms 4PM.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Phone call from parent @ 4:15PM. Stated pt. c/o scalp itching and stinging. Face red, dizziness noted. Mom stated pt. has had no fever, but she gave her Tylenol and called her doctor. Mom reports pts. pulse 114, BP 89/41. Mom reports pt. started her menses today. Asked parent to carry pt. to ER. Phone call from parent again. Stated she talked to their doctor and he said it was from the pertussis-Give Benadryl, was his orders. Onset of symptoms 4PM.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Decreased appetite, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Low grade fever (100.7), persistent cough, slight nasal congestion, increased fussiness, decrease in appetite
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Abnormal behaviour, Aggression, Decreased appetite, Fatigue, Gait disturbance
Clinical narrative: The Hep A vaccine was administered on 3/5/08.  On 3/6/08 my child appeared tired, irritable and was less hungry than usual.  On 3/7/08, he awoke at 6am with a fever of 103 and still had a loss of appetite.  I called the doctor's office as I read the CDC reactions listed on the vaccine sheet given by the doctor, noting that high fever and behavior changes were listed. The nurse said,"It's probably just a virus- if it was a reaction it would probably be a low-grade fever.  Give Tylenol or Motrin if he's uncomfortable and since it is a high fever."  Tylenol was given to lower his temp. and to alleviate his suspected body aches as he said, "My legs aren't working right" when walking up the stairs.  He was given a dose of Ibuprofen at 8pm on 3/7/08.   He had a temp. of 102.7 the next morning on 3/8/08, so Tylenol was given.  He still had a loss of appetite but was more active at times; he had been inactive and more tired the previous days. On 3/8/08 he took a four hour nap when it is usually only about 2 hours long. That night he couldn't fall asleep at his usual 8pm bedtime, he was given a dose of Tylenol as he had a temp. of about 101, and he was awake until 11:30pm. On 3/9/08 he didn't feel feverish, he was more hungry and increasingly more active though he still didn't seem to be back to normal. He was pale (except when the fever was high) and quite irritable at times throughout the course of these symptoms.  His behavior seemed different- though when healthy he is prone to occasional tantrums, his upsets during this time seemed to involve more irrational demands.  It was noticed by others as well that he would occasionally appear "blank", but only for short periods of time. As of the morning of 3/10/08, my child seems to be feeling much better both physically and mentally.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Irritability, Pyrexia, Sleep disorder
Clinical narrative: The Hep A vaccine was administered on 3/5/08.  On 3/6/08 my child appeared tired, irritable and was less hungry than usual.  On 3/7/08, he awoke at 6am with a fever of 103 and still had a loss of appetite.  I called the doctor's office as I read the CDC reactions listed on the vaccine sheet given by the doctor, noting that high fever and behavior changes were listed. The nurse said,"It's probably just a virus- if it was a reaction it would probably be a low-grade fever.  Give Tylenol or Motrin if he's uncomfortable and since it is a high fever."  Tylenol was given to lower his temp. and to alleviate his suspected body aches as he said, "My legs aren't working right" when walking up the stairs.  He was given a dose of Ibuprofen at 8pm on 3/7/08.   He had a temp. of 102.7 the next morning on 3/8/08, so Tylenol was given.  He still had a loss of appetite but was more active at times; he had been inactive and more tired the previous days. On 3/8/08 he took a four hour nap when it is usually only about 2 hours long. That night he couldn't fall asleep at his usual 8pm bedtime, he was given a dose of Tylenol as he had a temp. of about 101, and he was awake until 11:30pm. On 3/9/08 he didn't feel feverish, he was more hungry and increasingly more active though he still didn't seem to be back to normal. He was pale (except when the fever was high) and quite irritable at times throughout the course of these symptoms.  His behavior seemed different- though when healthy he is prone to occasional tantrums, his upsets during this time seemed to involve more irrational demands.  It was noticed by others as well that he would occasionally appear "blank", but only for short periods of time. As of the morning of 3/10/08, my child seems to be feeling much better both physically and mentally.
Age: 0.17
Sex: F
Vaccine: HEPA, PPV
Symptoms: Crying, Irritability, Moaning, Pyrexia, Vomiting
Clinical narrative: With EVERY vaccination, child has received high fever (103), throws up, has to be held for 24 hours, moans, cries, etc. Not sure if this has caused a perm. problem at this point. She seems more touchy and inconsolable after each round of shots.
Age: 70.0
Sex: F
Vaccine: PPV, TD, VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: REdness, swelling started in left arm 3 days after receiving 3 vaccinations, swelling spread, itched, was seen at urgent care, used topical treatment.  Sx resolved.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PNC, RV5
Symptoms: Abdominal pain, Diarrhoea, Influenza like illness, Pyrexia, Respiratory tract congestion
Clinical narrative: My daughter showed flu-like symptoms in the week following a flu shot given on 3/3/2008.  Her symptoms include fever, vomiting, diarrhea, abdominal pain and respiratory congestion.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PNC, RV5
Symptoms: Vomiting
Clinical narrative: My daughter showed flu-like symptoms in the week following a flu shot given on 3/3/2008.  Her symptoms include fever, vomiting, diarrhea, abdominal pain and respiratory congestion.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood culture negative, CSF culture negative, CSF test normal, Culture urine negative, Febrile convulsion
Clinical narrative: Complex febrile seizures 12 hours after vaccine administration. Patient had full septic work up done and treated with antibiotics for 2 days prior to discharge. No focal neurology on discharge. 3/27/08-records received for DOS 3/8-3/10/08-DC DX Complex febrile seizure. Vaccine related febrile illness. Admitted with C/O febrile illness,  new onset seizure times 2 in last 24 hours with frothing from mouth. Fever 104.  No focal neuralgia, no signs of meningitis.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Mother of infant noticed a Varicella-like rash about 2 days after the administration of the Varicella vaccine on abdomen, arms, hands, legs, face, and groin area.  There were no reports of fever or any other type reaction.  Parent was advised to administer age/weight appropriate dose of Tylenol to infant for any pain/fussiness associated with rash.  And parent v/u.  Was told to call MD with any further questions or concerns.
Sex: F
Vaccine: HEP
Symptoms: Headache, Injection site pain, Malaise, Pain, Tenderness
Clinical narrative: Within 6-8 hours, Injection site and upper arm, shoulder, left upper back, neck felt sore and achy.  Headache developed.  Upper arm tender. Generalized malaise.  Lasted about two days.  COmplete resolution after 48 hours.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Confusional state, Depressed mood, Hearing impaired, Somnolence
Clinical narrative: Patient became very despondent and confused she became abnormally affectionate.  She could not take direction she appeared almost unable to hear.  Her speech was limited.   She was extremely sleepy.   This started just two hours after the vaccine was administered.  She has continued to have episodes like this since this day and they last several days that have sudden onset and sudden ending. 5/19/08-records received for DOS 11/8/07-well visit.  5/21/08-ED records received for DOS 12/8/07-DX: Acute behavioral changes. presented with altered behavior. Appears despondent and distant. Began acting out at school and acting odd at home. Slept many hours.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Speech disorder
Clinical narrative: Patient became very despondent and confused she became abnormally affectionate.  She could not take direction she appeared almost unable to hear.  Her speech was limited.   She was extremely sleepy.   This started just two hours after the vaccine was administered.  She has continued to have episodes like this since this day and they last several days that have sudden onset and sudden ending. 5/19/08-records received for DOS 11/8/07-well visit.  5/21/08-ED records received for DOS 12/8/07-DX: Acute behavioral changes. presented with altered behavior. Appears despondent and distant. Began acting out at school and acting odd at home. Slept many hours.
Age: 16.0
Sex: M
Vaccine: YF
Symptoms: Lymphadenopathy, Pharyngolaryngeal pain, Pyrexia, Streptococcal identification test negative, Viral pharyngitis
Clinical narrative: On 2/9/2008, subject developed sore throat and swollen cervical lymph nodes bilaterally, fevers to 99-100 F. MD was seen on 2/11/2008, lymph node to one side was 4 cm, the other side swollen but less than 4 cm.  Strep test was negative. MD diagnosed as viral pharynitis but was placed on/ completed antibiotic course as precaution. No rash or other symptoms reported by father.
Age: 1.13
Sex: F
Vaccine: DTAP
Symptoms: Muscle twitching
Clinical narrative: Twitching after each Dtap - starts approx 2 weeks after vaccination and continues for about 1 month.  Twitches for varying lengths of time usually just as she is going to sleep.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Dizziness, Dysphonia, Erythema, Hypoaesthesia facial
Clinical narrative: Numbing upper lip and end of nostrils extending horizontally to cheeks.  Burning in nostrils; hoarseness; mild hives, facial redness, itching from buttocks to top of head.  Dizziness. After treatment, the numbness moved into the right jaw and R ear. Tingling feeling as numbness began to wear off. No pain or redness at injection site.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Nasal discomfort, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Numbing upper lip and end of nostrils extending horizontally to cheeks.  Burning in nostrils; hoarseness; mild hives, facial redness, itching from buttocks to top of head.  Dizziness. After treatment, the numbness moved into the right jaw and R ear. Tingling feeling as numbness began to wear off. No pain or redness at injection site.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood product transfusion, Full blood count, Petechiae, Platelet count decreased, Rash
Clinical narrative: Pt had immunization on 1/23/08, Synagis on 1/28/08 mother noticed rash on 2/03/08. Admitted to hosp. on 2/06/08. Presented with petechia on abdomen and extremities. With Plt count 26,000 and patient was treated with IVIG 1g/kg x 100.  03/24/2008 MR received for DOS 2/6-7/2008 with DX: ITP. Pt presented for admission from PCP office with platelet count of 26,000 after OV for petechial rash on abdomen, head, palate and extremities. Txd with IVIG
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Enema administration, Intussusception, Irritability, Melaena, Pain
Clinical narrative: Intussusception-melena, pain, crankiness and current jelly stool s/p Air enema x2 which failed and required surgical reduction. 5/6/08-records received for DOS 3/6-3/8/08-DC DX: Intussusception. Presented with projectile vomiting since 3/5/08-bloody stools followed that same evening. Well until evening prior to 6 month check up when he was crying an abnormal amount and fever 102.8 2 nights after vaccines. Oral intake decreased.Surgical laparotomy with reduction of intussusception.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Surgery, X-ray abnormal
Clinical narrative: Intussusception-melena, pain, crankiness and current jelly stool s/p Air enema x2 which failed and required surgical reduction. 5/6/08-records received for DOS 3/6-3/8/08-DC DX: Intussusception. Presented with projectile vomiting since 3/5/08-bloody stools followed that same evening. Well until evening prior to 6 month check up when he was crying an abnormal amount and fever 102.8 2 nights after vaccines. Oral intake decreased.Surgical laparotomy with reduction of intussusception.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Local reaction, Sleep disorder
Clinical narrative: 2-27-08 patient called and complained of "ache" at injection site.  No redness, no swelling - to take Motrin or Tylenol.  3-1-08 patient seen - localized reaction secondary to tetanus shot.  3-10-08 patient called - still in pain - wakes her up at night - states range of motion in arm about 6".  To be seen tonight by doctor.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Prior to 3 vaccines, patient had recovered from low AM blood sugar.  After juice and food consumed blood sugar was 225 (patient tested herself) as reported by patient and she requested 3 vaccines.  She rested 30-40 minutes after immunizations given, then complained of fatigue and "feeling funny".  Paramedics took her blood pressure and vital signs where were within normal limits and escorted her to public transportation.  She ended up being taken by ambulance to local ER where she left without being seen after waiting 3 hours.  No diagnosis oz f.u.  Noted in ER record.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Skin irritation
Clinical narrative: Pt comes into office 2 days after receiving shots. Lt upper arm red, hot, inflamed at site of Dtap and MMR. MOC had been putting ice directly on child's arm so there was some mild irritation from that as well. Telephone call w/mom 2 days later reveals child has completely recovered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 2-25-08 Zostavax vaccine administered SQ arm. 3-3-08 Pt called and said 2 days after vaccine administered, pt report arm started to itch that evening and got hot, raised and reddened about "the length of a hotdog" at injection site. No hives, SOB, etc. Reaction at injection site only. Pt stated someone told her she should report this to the clinic.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Eyelid oedema, Scab, Skin lesion
Clinical narrative: See attached document - "Patient" had reaction that occurred about five days after receiving Zostavax. She noticed some discomfort over her right eye and when she looked in the mirror she had swelling of the eyelid and above the brow. She denied any redness or rash in this area. The swelling, she reports was fairly significant but the eyelid was not completely shut. She placed ice and took Benadryl for this that evening and the following day and saw that is was improving. A couple days later she did break out with one papular lesion that has since crusted over located just adjacent to the nares on the right side. This is presumed to be reaction to the Zostavax vaccine and will be reported.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Activities of daily living impaired, Asthenia, Nasopharyngitis, Pyrexia
Clinical narrative: After I received the vaccine, I started with a cold and high fever. I went to the doctor he prescribed Erythromycin for 7 days. It did not helped. I got worse. I went back to the doctor and he prescribed Azithromycin, didn't helped either. I kept getting worse, I had o strength and I felt like if I was going to have a heart attack. I was taken to the emergency room by rescue. I was admitted in the hospital for 3 days, I was first diagnose with pneumonia and after that with asthmatic bronchitis. I've been in my house for about a week now taking the following medications, Iphatropium Bromide Inhalation, Xopenex Inhalation, Levquin, Singular, and Methylpred Nisulonof. I've been out of my job now for about 10 days. I'm schedule to go back to work this Friday, March 7, 2007. I don't know if I can make it, because I still feel very weak. Thank you for your help. 4/23/08-records received for DOS 2/24/-3/25/08-presented with 1 month hitory of congestion and subjective fever soon after receiving vaccine.  DX Bronchitis.
Age: 0.1
Sex: F
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Child received 1/2 dose of ROTATEQ at 5 week 3 days of age.  No treatment given.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Dyspnoea, Fall, Syncope, Tremor
Clinical narrative: Received HPV at 3:30PM. At 8:30 during volleyball fell on floor, fainted 3-5 Sec. sat up unable to talk, gasping for air for 3min.; improved and fine after5-6 minutes. Shaky was not seen or treated.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pruritus
Clinical narrative: Began 3/5 AM and con't to get worse. Now measures 6 1/4" x 4 1/2". Raised, red and hot. Complained of itching and pain. Recommended Benadryl, Motrin, cool compact and increase fluids.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying greater than a 3 hour period.  Mom called after hours (PNP and reported crying approximately 10 pm.  ? Pertussis reaction.  No treatment given.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Varicella
Clinical narrative: Child developed chickenpox.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Right thigh swelling lateral side; lower half tender
Age: 60.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Generalized itchy rash in entire body the night after MMR injection on 2/25/08.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Swollen, red, warm 5x3cm on patient's left arm deltoid.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Eye swelling, No therapeutic response, Oedema mouth, Sneezing, Urticaria
Clinical narrative: Within 5 minutes after injection sudden onset of sneezing.  Mom left office with child.  Child then with eye/mouth swelling, hives, no responsive distress.  Once back at office, patient given 1 1/2 tsp po Benadryl.  Administered 1 1/2 tsp po Benadryl twice a day for 24 hours then three times a day for 1 day.  Patient discharged to home.  Swelling/hives improved.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: Doctor's office called.  Given out dated vaccine MMR expired 2/25/08, 7 days expired.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Erythema, Pruritus
Clinical narrative: Child received DTaP and Varicella 3-7-08 in right thigh.  Child seen in office 3-10-08 due to 2-3 inch erythema to right thigh.  Bruising and itching noted to site.
Age: 0.48
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Pneumovax 23 instead of Prevnar. Parent denies any adverse events 3-4-08.
Age: 37.0
Sex: F
Vaccine: DTAP, HEPAB
Symptoms: Erythema, Pyrexia, Wrong drug administered
Clinical narrative: Received DTaP and should have received Tdap.  Patient says she had some redness/fever.  Better now.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at injection site.  Treatment included Keflex and Prednisone.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Patient had a diagnosed ear infection without fever on day of visit.  Developed a possible febrile seizure later in the evening.  Seen in the emergency room.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Chicken Pox developed 4 days post vaccination about 15-20 bumps.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 5 x 4 cm raised, warm area to back of (R) arm
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Redness at injection site with warmth reported 1 wk after injection. Now complain of intermittent sharp pain in left upper arm
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Rash pruritic
Clinical narrative: Red, hot, itchy, rash
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Erythema
Clinical narrative: 5 1/2 x 7 in. erythema with 2"x3" unhal discolored bruise
Age: 44.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Computerised tomogram abnormal, Dysphagia, Lymphadenopathy
Clinical narrative: Lymphadenopathy - confirmed via neck CT; Dysphagia
Age: 55.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Abasia, Arthralgia, Body temperature increased, Fluid retention, Lymphadenopathy
Clinical narrative: Stated symptoms started 2/16/08; After 14 days low grade temp.. Rash on stomach in A.M.; later by noon rash on face then later on thighs and arms. Swollen glands of jaw (mumps) 2-21 and 2-22-08 totally down with water retention hands, fingers, legs; Felt all joints painful; Could not walk! Took husbands Glucosamine Tabs (felt better)
Age: 55.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Mumps, Rash
Clinical narrative: Stated symptoms started 2/16/08; After 14 days low grade temp.. Rash on stomach in A.M.; later by noon rash on face then later on thighs and arms. Swollen glands of jaw (mumps) 2-21 and 2-22-08 totally down with water retention hands, fingers, legs; Felt all joints painful; Could not walk! Took husbands Glucosamine Tabs (felt better)
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Diarrhoea, Erythema, Gastroenteritis viral, Headache
Clinical narrative: Left arm edematous, erythematous present; Patient complained of diarrhea, vomiting, headache, neck and back pain. Left arm is tender to move
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Herpangina, Neck pain, Oedema peripheral, Sinusitis, Tenderness
Clinical narrative: Left arm edematous, erythematous present; Patient complained of diarrhea, vomiting, headache, neck and back pain. Left arm is tender to move
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Left arm edematous, erythematous present; Patient complained of diarrhea, vomiting, headache, neck and back pain. Left arm is tender to move
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Local reaction - complained of soreness, redness, site hard to touch
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Left deltoid 4x2cm erythematous reaction.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Swelling, Urticaria
Clinical narrative: Chest pain, hives, dyspnea, swelling. 3/14/08-records received-for DOS 3/2/08-Presented to ER with blood pressure 200/114. Woke up with hives all over and some itching, later noted chest tightness and chest pain on and off. Sharp stabbing pain. Impression chest pain, atypical for caridac angina.  Allergic reaction uncertain etiology.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Nausea, Oedema peripheral, Swollen tongue
Clinical narrative: Temp 101 deg, hands/feet swelling; tongue feels swollen, nausea, headache within 24 hours of Adacel in absence of any other cause
Age: 15.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Tic
Clinical narrative: Initial report received from a health care professional on 21 December 2007. A 15-year-old male patient with a medical history of autism spectrum disorder and a known tic disorder, had received an injection of Fluzone SV 2007-2008 and an injection of Menactra on 05 December 2007. Both vaccines were administered intramuscularly in the deltoid and the lot numbers were not reported. Approximately 48 hours after receiving the vaccines, the patient developed a new vocal tic. At the time of this report, the vocal tic persisted and the patient had not recovered.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site reaction
Clinical narrative: A 17-year-old female patient had received a right deltoid, intramuscular injection of Menactra, lot number U2367AA; and a left deltoid, intramuscular injection of Gardasil, manufacturer Merck, lot number G525U; on 15 August 2007. At an unspecified time post-vaccination, the patient experienced a localized injection site reaction (size not provided) to the right deltoid with a 1 cm. dimple that was oblong in shape. There was no skin breakdown or discomfort. At the time of this report, the patient had not recovered.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Axillary mass
Clinical narrative: A 15-year-old female patient had received a left arm, intramuscular injection of Menactra, lot number U2371AA; a right arm, intramuscular injection of Adacel, lot number C2775AA; and a left arm, intramuscular injection of Human Papilloma Virus Vaccine, manufacturer Merck, lot number 1424F; on 03 January 2008. The next day, the patient developed a 1.5 inch lump at the left axilla without redness or pain. No treatment was provided. At the time of this report, the patient had not recovered.
Age: 53.0
Sex: F
Vaccine: OPV, IPV
Symptoms: Back pain, Body temperature increased, Fatigue, Muscle contractions involuntary, Muscular weakness
Clinical narrative: Permanent teeth loss due to fever; left leg shorter than right leg; post polio syndrome at age 52
Age: 53.0
Sex: F
Vaccine: OPV, IPV
Symptoms: Neck pain, Poliomyelitis, Post polio syndrome, Pyrexia
Clinical narrative: Permanent teeth loss due to fever; left leg shorter than right leg; post polio syndrome at age 52
Age: 53.0
Sex: F
Vaccine: OPV, IPV
Symptoms: Post polio syndrome, Pyrexia, Tooth loss
Clinical narrative: Permanent teeth loss due to fever; left leg shorter than right leg; post polio syndrome at age 52
Sex: U
Vaccine: TYP, TYP
Symptoms: Anger, Fatigue, Pyrexia
Clinical narrative: Took Rx on 2/15. Had fever on 2/16. Pt felt angry, wanted to "shout" at someone.
Sex: U
Vaccine: TYP, TYP
Symptoms: Pyrexia
Clinical narrative: Took Rx on 2/15. Had fever on 2/16. Pt felt angry, wanted to "shout" at someone.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis, Tremor
Clinical narrative: Information has been received from a physician concerning a female patient, who was vaccinated with the third dose of Gardasil.  Subsequently, the patient developed tremors and partial paralysis.  The patient was referred to a hospital.  The patient sought unspecified medical attention.  At the time of the report the outcome was unknown.  No product quality complaint was involved.  Upon internal review, partial paralysis was considered to be an other important medical event.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning her 18 year old daughter, with "possible asthma" and an allergy to sulfamethoxazole (+) trimethoprim (SEPTRA), who on 25-FEB-2008 was vaccinated with the third dose of Gardasil.  There was no concomitant medication reported.  On 26-FEB-2008 the patient experienced a systemic reaction about "24 hours after vaccination with her third dose of Gardasil."  The reaction was not anaphylactic.  Her daughter developed hives, swelling, itching, pain, fever and had difficulty moving her joints.  She was taken to the emergency room and given prednisone and diphenyhydramine hydrochloride (BENADRYL).  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Hives, swelling, itching, pain, fever, and difficulty moving her joints were considered to be other important medical events.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning her 18 year old daughter, with "possible asthma" and an allergy to sulfamethoxazole (+) trimethoprim (SEPTRA), who on 25-FEB-2008 was vaccinated with the third dose of Gardasil.  There was no concomitant medication reported.  On 26-FEB-2008 the patient experienced a systemic reaction about "24 hours after vaccination with her third dose of Gardasil."  The reaction was not anaphylactic.  Her daughter developed hives, swelling, itching, pain, fever and had difficulty moving her joints.  She was taken to the emergency room and given prednisone and diphenyhydramine hydrochloride (BENADRYL).  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Hives, swelling, itching, pain, fever, and difficulty moving her joints were considered to be other important medical events.  Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Autism, Lethargy, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 month old male who was vaccinated with a dose of MMR II. After receiving the vaccine, the patient had a fever and was lethargic for 3 days. The physician now thinks the patient may be showing signs of autism. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Amblyopia, Arthritis, Bedridden, Body temperature increased, Bone densitometry
Clinical narrative: Information has been received from a 48 year old male consumer with arthritis, lazy eye, Hepatitis C, and allergies to methadone, codeine, and anti-depressants, who in July 2004 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot and administration site not reported) and in October 2005 was vaccinated with a dose of PNEUMOVAX 23 (lot and administration site not reported).  Concomitant therapy included influenza virus vaccine (unspecified) one week before the PNEUMOVAX 23 vaccine, and interferon (unspecified) treatments for Hepatitis C.  On an unspecified date in October 2005 the patient was in bed for a month, had an arthritis flare up in all joints, experienced neuro-optic pain, interfered with his interferon treatment, developed incontinence, porus and thinning bones, aggravated his lazy eye, had a local reaction at the injection site, his legs and feet swelled twice the normal size, developed a fever, complete loss of libido, sometimes paralyzed upon waking up, nausea, vomiting, and paresthesia in his legs and fingers.  The patient sought unspecified medical attention.  Laboratory diagnostic tests included a bone density test and blood tests - no results for either were reported.  At the time of reporting the patient had not recovered.  Upon internal review paralysis was determined to be an other important medical event.  Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Bone density decreased, Condition aggravated, Drug interaction, Full blood count, Incontinence
Clinical narrative: Information has been received from a 48 year old male consumer with arthritis, lazy eye, Hepatitis C, and allergies to methadone, codeine, and anti-depressants, who in July 2004 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot and administration site not reported) and in October 2005 was vaccinated with a dose of PNEUMOVAX 23 (lot and administration site not reported).  Concomitant therapy included influenza virus vaccine (unspecified) one week before the PNEUMOVAX 23 vaccine, and interferon (unspecified) treatments for Hepatitis C.  On an unspecified date in October 2005 the patient was in bed for a month, had an arthritis flare up in all joints, experienced neuro-optic pain, interfered with his interferon treatment, developed incontinence, porus and thinning bones, aggravated his lazy eye, had a local reaction at the injection site, his legs and feet swelled twice the normal size, developed a fever, complete loss of libido, sometimes paralyzed upon waking up, nausea, vomiting, and paresthesia in his legs and fingers.  The patient sought unspecified medical attention.  Laboratory diagnostic tests included a bone density test and blood tests - no results for either were reported.  At the time of reporting the patient had not recovered.  Upon internal review paralysis was determined to be an other important medical event.  Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction, Loss of libido, Nausea, Neuralgia
Clinical narrative: Information has been received from a 48 year old male consumer with arthritis, lazy eye, Hepatitis C, and allergies to methadone, codeine, and anti-depressants, who in July 2004 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot and administration site not reported) and in October 2005 was vaccinated with a dose of PNEUMOVAX 23 (lot and administration site not reported).  Concomitant therapy included influenza virus vaccine (unspecified) one week before the PNEUMOVAX 23 vaccine, and interferon (unspecified) treatments for Hepatitis C.  On an unspecified date in October 2005 the patient was in bed for a month, had an arthritis flare up in all joints, experienced neuro-optic pain, interfered with his interferon treatment, developed incontinence, porus and thinning bones, aggravated his lazy eye, had a local reaction at the injection site, his legs and feet swelled twice the normal size, developed a fever, complete loss of libido, sometimes paralyzed upon waking up, nausea, vomiting, and paresthesia in his legs and fingers.  The patient sought unspecified medical attention.  Laboratory diagnostic tests included a bone density test and blood tests - no results for either were reported.  At the time of reporting the patient had not recovered.  Upon internal review paralysis was determined to be an other important medical event.  Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Paraesthesia, Paralysis, Pyrexia, Vomiting
Clinical narrative: Information has been received from a 48 year old male consumer with arthritis, lazy eye, Hepatitis C, and allergies to methadone, codeine, and anti-depressants, who in July 2004 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot and administration site not reported) and in October 2005 was vaccinated with a dose of PNEUMOVAX 23 (lot and administration site not reported).  Concomitant therapy included influenza virus vaccine (unspecified) one week before the PNEUMOVAX 23 vaccine, and interferon (unspecified) treatments for Hepatitis C.  On an unspecified date in October 2005 the patient was in bed for a month, had an arthritis flare up in all joints, experienced neuro-optic pain, interfered with his interferon treatment, developed incontinence, porus and thinning bones, aggravated his lazy eye, had a local reaction at the injection site, his legs and feet swelled twice the normal size, developed a fever, complete loss of libido, sometimes paralyzed upon waking up, nausea, vomiting, and paresthesia in his legs and fingers.  The patient sought unspecified medical attention.  Laboratory diagnostic tests included a bone density test and blood tests - no results for either were reported.  At the time of reporting the patient had not recovered.  Upon internal review paralysis was determined to be an other important medical event.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Haemoglobin decreased, Pancytopenia, Platelet count decreased, White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a 70 year old male with chronic obstructive pulmonary disease, non-small cell lung cancer of the left lung, coronary artery disease and diabetes who in "late January 2008-early February 2008", was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included Metformin, metoprolol, FISH OIL, LASIX and NEUPOGEN. "About 3 weeks ago" the patient developed pancytopenia after the administration of Zostavax (Oka/Merck). The patient's complete blood count in early January was normal. He was hospitalized on 19-FEB-2008 to 23-FEB-2008. On 19-FEB-2008 his complete blood count was the following: white blood cell: 2.3, hemoglobin: 11.1, and platelet count: 41. On 01-MAR-2008 he was admitted to the Intensive Care Unit. On 02-MAR-2008 his complete blood count was the following: white blood cell: 0.7, hemoglobin: 7.2, and platelet count 31,000. On 04-MAR-2008 his platelet count was 7,000. At the time of the report the patient was in the Intensive Care Unit and had not recovered. He was not responding to NEUPOGEN. The physician considered the patient's pancytopenia to be disabling, life threatening, and an other important medical event. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Death
Clinical narrative: On 2/23/08 child received MMR and Varicella vaccinations during routine one year check up. No adverse events reported to physician prior to death on 2/27/08. 6/25/2008 Postmortem examination report received. COD-Acute Febrile Illness. DX based on exam:  Pale doughy lungs. Bite marks on lower lip. Febrile illness by history. Acute inflammatory cells in walls of bronchi in peribronchial alveoli.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Intercostal retraction, Rash, Respiratory distress
Clinical narrative: 1545 - varicella vaccine given.  1630 - rash & redness noted.  1640 - retractions & resp distress noted, O2 given, O2 sat 99-100.  1655 - epinephrine given, decreased resp distress.  1700 - Dr. called.  1700 - 911 called.  1725 - transported to hospital, had albuterol in ambulance, received steroids & IV fluids in hospital.  2/29/08 - 1210 returned to center, stable, no resp distress or rash.  4/11/08 Reviewed ER medical records of 2/28/2008. FINAL DX: Anaphylaxis Records reveal patient developed sudden dyspnea, respiratory distress w/retractions & diffuse erythema 30 min after varicella vaccine.  Tx w/epi & nebs by EMS.  ER exam revealed red urticarial hives all over, coarse wheezing & mottled extremities.  Tx w/IV steroids.  Admitted for observation of rebound & d/c back to institution.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Gallbladder disorder, Gallbladder operation, Pneumonia, Renal failure
Clinical narrative: We received on 28 FEB 2008 from a healthcare professional the following information: A 49-year-old female patient, born on 28 APR 1958, was vaccinated for the first time i.m. with 0.5 ml Fluvirin, batch no. 78479, on 31 OCT 2007.  Within 24 hours, the patient experienced pneumonia, kidney failure and gall bladder failure.  The patient was hospitalised on an unknown date and the gall bladder was removed.  The patient did not have any significant medical history and had never received a flu vaccine in the past.  At the time of reporting, the patient had recovered.  Seriousness criterion: hospitalisation.  Causality: insufficient data (as information from the hospital discharge on important details regarding diagnosis and differential diagnosis is missing).
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Influenza, Pulmonary congestion, Pyrexia
Clinical narrative: 01/30/08 730AM vomiting x1, fever 100.5, headache, chills - No treatment; 1030 AM "feels little better"; 1200AM "vomited x4 and still has headache"; was not feeling well before shot on 1-28. 01/31/08- no nausea and vomiting - still has chills, chest congestion - MD appt. 2/16/08; 2/18/08 received call back from client - evaluated by me on 2/1/08 "flu or view" "not related to shot(Tdap)/ I'm back to full health" RN
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: 01/30/08 730AM vomiting x1, fever 100.5, headache, chills - No treatment; 1030 AM "feels little better"; 1200AM "vomited x4 and still has headache"; was not feeling well before shot on 1-28. 01/31/08- no nausea and vomiting - still has chills, chest congestion - MD appt. 2/16/08; 2/18/08 received call back from client - evaluated by me on 2/1/08 "flu or view" "not related to shot(Tdap)/ I'm back to full health" RN
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Vaccine administered 2/26/08.  Patient presented to clinic on 2/27/08 with area of redness and induration at site of Varicella #2 administration.  (Induration 5/8").  Also complained of itching.  On 2/28/08 size of induration had increased to 15/8" but less itch c/o.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cough, Urticaria
Clinical narrative: Patient developed hives, cough post receiving Varicella, Dtap, IPV, MMR and Influenza (Fluzone) vaccines. Symptoms began at home -> transferred by ambulance to Hosp where he received Rx
Age: 29.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 3/4/08 Ph. call from pt. at 10:55 am. Reports she received immunizations 3/3/08 at approx 12 noon. She reports she noticed pain and swelling at approx 4 pm in left arm at and around injection site. She took ibuprofen 600mg by mouth for pain and swelling at 8pm. She continues to c/o pain today 3/4/08 at 10:55 am. Instructed to F/u with her PCP today if no improvement to left arm.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Petechia and Bruising - idiopathic Thrombocytopenia; 12/13/07 Platelets 5,000; 2/27/08 Platelets 276,000; no medications 3/24/08-records received-Consultation report for 12/14/07-Assessment:ITP platelet count of 4000 with skin bleeding. Bruises for 1 weeks and nose bleeds on and off for past week. Petechia.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event - reporting patient received a 4th dose of Gardasil.  Patient tolerated well, no problems.