chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope, Urine analysis normal, Weight decreased, X-ray abnormal
Clinical narrative: Onset 11-22-09, presented to ER with sensory/ neurologic complaints affecting left thigh & right thigh & general weakness.  Fell.  Syncope.  Febrile - 105.  Rec'd IVIG & antibiotics (for pneumonia).  Resp. failure.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None adverse reaction occured. Client given vaccine that is licensed four years and up, client is three years old.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Decreased appetite, Diarrhoea, Haematochezia, Vomiting projectile
Clinical narrative: PROJECTILE VOMITING, BLOOD AND LOOSE STOOLS, LACK OF APPETITE, CRYING. DR. SENT TO HOSPITAL AND CHILD DX WITH INTUSSUSCEPTION.  12/15/09 Received PCP medical records of 12/8/09.  Patient experienced cough, stiffness, fussiness, decreased appetite x 1 day & diet refusal x 1 day, loose stools x 1 day.  Exam revealed lethargy.  Sent to ER.  12/21/09 Received partial ER medical records of 12/8/09 from PCP.  IS suspected.  Transferred to higher level of care. FINAL DX: Intussusception.  1/11/10 Received additional ER medical records from higher level of care facility.  Exam revealed RUQ mass.  Ileocolic IS confirmed & resolved with enema.  Admitted for observation, progressed well & d/c to home.
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Dizziness, Headache, Nausea, Pallor
Clinical narrative: Severe dizziness, headache, heart racing, pale, weakness, nauseated, Headache and nausea remained through 12/10/2009. All symptoms appear to be gone morning of 12/11/2009.
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Palpitations
Clinical narrative: Severe dizziness, headache, heart racing, pale, weakness, nauseated, Headache and nausea remained through 12/10/2009. All symptoms appear to be gone morning of 12/11/2009.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Injection site swelling, Injection site urticaria, Pain, Pain in extremity
Clinical narrative: Several minutes after injection pain in arm and hand. 8 hours after injection swelling and hives at sight of injection, high fever (103*), headache, body aches. Hives at sight if injection worsened over several days and became severe on entire upper arm. Fever and body aches lasted 5 days. Hives took 7 or 8 days to completely clear. Began taking antihistamine and using topical "cortizone" cream on arm at the onset of hives. Saw doctor on 9/24 and was prescribed antibiotics.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Several minutes after injection pain in arm and hand. 8 hours after injection swelling and hives at sight of injection, high fever (103*), headache, body aches. Hives at sight if injection worsened over several days and became severe on entire upper arm. Fever and body aches lasted 5 days. Hives took 7 or 8 days to completely clear. Began taking antihistamine and using topical "cortizone" cream on arm at the onset of hives. Saw doctor on 9/24 and was prescribed antibiotics.
Age: 1.04
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: 11/21/2009 Dad noticed a red spot on patient Left upper thigh that was getting larger and stating to blister in middle. Patient no seemed to be bothered by it able to put weight on legs.  Dad denied any possible burn. No treatment reassurance and monitor discuss symptoms of skin infection or any problems with standing to call ASAP. 12/10/2009 Mom reported that spot resolved without any problems and patient doing better.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Erythema, Rash erythematous, Sensation of foreign body
Clinical narrative: States left work at 6:45PM and went to mall to return some items.  Was standing in line at one of stores and felt something in the back of her throat that felt like the size of a "golf ball".  Began coughing and wheezing but states no trouble breathing.  Noticed a red rash on her chest when she came home.  No reactions at injection stie.  Some redness from bandaid noted.  Called her FMD at 9:20PM and he advised her to take Benadryl 50 mg. by mouth and if experiences any problems in one hour to go to ER.  States she did look at throat and did not see any swelling of her uvula.  States she fell asleep.  Awoke in AM with hoarse throat and feeling sluggish.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Sluggishness, Wheezing
Clinical narrative: States left work at 6:45PM and went to mall to return some items.  Was standing in line at one of stores and felt something in the back of her throat that felt like the size of a "golf ball".  Began coughing and wheezing but states no trouble breathing.  Noticed a red rash on her chest when she came home.  No reactions at injection stie.  Some redness from bandaid noted.  Called her FMD at 9:20PM and he advised her to take Benadryl 50 mg. by mouth and if experiences any problems in one hour to go to ER.  States she did look at throat and did not see any swelling of her uvula.  States she fell asleep.  Awoke in AM with hoarse throat and feeling sluggish.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Localized reaction at site of injection 2 hours after injection. Pt c/o pain @ site. Found to be swollen and hard. Ice applied. TYLENOL x2 given. Still painful.
Age: 64.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: Pt. recvd H1N1 vaccination on 12/9/09, later that night he began to suffer from runny nose, sneezing.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Asthenia, Blindness unilateral, Confusional state, Delirium, Headache
Clinical narrative: Loss sight in left eye temporarily. Incoherent, severe headache, confused. Delirious, weakness, mild fever- scotoma eye sparkler; Nausea, school nurse would not provide with necessary manufacturer, lot number.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Immunisation reaction, Incoherent, Nausea, Pyrexia, Scotoma
Clinical narrative: Loss sight in left eye temporarily. Incoherent, severe headache, confused. Delirious, weakness, mild fever- scotoma eye sparkler; Nausea, school nurse would not provide with necessary manufacturer, lot number.
Age: 15.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Visual impairment
Clinical narrative: Loss sight in left eye temporarily. Incoherent, severe headache, confused. Delirious, weakness, mild fever- scotoma eye sparkler; Nausea, school nurse would not provide with necessary manufacturer, lot number.
Age: 68.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Full blood count, White blood cell count decreased
Clinical narrative: No reaction, signs or symptoms, pt white blood cell count dropped to a dangerously low level.
Age: 1.43
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: -febrile seizure after administration 24 hours after administered
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Caesarean section, Drug exposure during pregnancy, Labour complication, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse practitioner and a 26 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself who on 19-MAY-2008 was vaccinated intramuscularly in the deltoid with her first dose of GARDASIL (lot# not reported) and became pregnant. There was no concomitant medication. The patient's LMP was 19-MAY-2008 and EDD was 23-FEB-2009. Subsequently the patient experienced no adverse symptoms. The patient sought medical attention with an office visit on an unspecified date. The patient had blood work and a urine pregnancy test to confirm the pregnancy. The patient's outcome was not reported. Follow-up information was received from the consumer who stated that she had a baby boy who is now nine months old; healthy and normal with no problems. She also said her pregnancy was "very good", and she was one week overdue when she went into labor. Additionally she reported an "emergency" cesarean section during labor because the baby "wasn't coming down" and had the umbilical cord wrapped around his arm and after a while" he couldn't take it any more". The reporter stated the baby was fine after he was born and she recovered very well from the surgery. Upon internal review, umbilical cord abnormality was considered an other important medical event. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Muscle twitching
Clinical narrative: Dec 8th 2009 3 hrs after receiving the injectable H1N1 vaccine, pt experienced twitching (muscle movement) on Rt side extending from the outer side of the eye up to the chin- symptoms off and on.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Complained to n school nurse of itching. Nurse said arm injection was given and was red around site, warm to touch. Seen by nurse 12-10-09.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Complained to n school nurse of itching. Nurse said arm injection was given and was red around site, warm to touch. Seen by nurse 12-10-09.
Age: 69.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Got cold and cough on Dec 4, 2009. Home 3 days. Still getting better cough same.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia oral, Swollen tongue, Vaccination complication, Vision blurred
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with asthma and no known drug allergies who on 23-Nov-2009 was vaccinated intramuscularly with her second 0.5ml dose of GARDASIL (lot number 661046/0381X). On 23-NOV-2009, after receiving the vaccine, the patient experienced tongue swelling numbness and blurred vision. Subsequently, the patient recovered from tongue swelling numbness, tongue swelling numbness and blurred vision on the same date. The patient sought medical attention by making a phone call and by contacting the emergency squad. Follow up information was received from a certified medical assistant concerning the 21 year old female. She reported that the patient received GARDASIL vaccination on the following dates: dose # 1 was given on 10-AUG-2009, lot number 661046/0381X and dose # 2 was given on 23-NOV-2009 at 1:45p.m., lot number 661046/0381X (into the left deltoid). The patient did not receive any concomitant vaccinations when the GARDASIL vaccinations were administered. The C.M.A stated that the patient had the reaction to the second dose of GARDASIL when she went back to school. The patient was complaining of tongue swelling, numbness and blurred vision. The patient was a student at the University. The patient called the physician's office and was advised to go to the nearest Emergency Room. An Ambulance was called to take the patient to the Hospital and stabilized the patient. The patient was treated for her reaction to the GARDASIL vaccination (treatment unknown to the reporter). The patient did not go to the Hospital. The patient recovered on 23-NOV-2009. The patient stated that she would not receive the third dose of GARDASIL. The C.M.A. stated that she called the patient to inquire how she was doing and the patient did not return the phone call. The patient did say she received a shot but was not sure. The reporter considered that tongue swelling, numbness and vision blurred required intervention to prevent serious criteria. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Hypoventilation, Nausea
Clinical narrative: 1005 - pt clammy, sweating profusely, dizzy, nausea also. Pale after vaccine administered @ 1000 - juice given, H2O given, placed on CO & P-60 slow shallow breathing, EMS called - arrived 1010 ER at 1012 - evaluated. Pt. declined to go to ER. Pt observed until 1030 escorted to car by staff.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pallor
Clinical narrative: 1005 - pt clammy, sweating profusely, dizzy, nausea also. Pale after vaccine administered @ 1000 - juice given, H2O given, placed on CO & P-60 slow shallow breathing, EMS called - arrived 1010 ER at 1012 - evaluated. Pt. declined to go to ER. Pt observed until 1030 escorted to car by staff.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Bladder cancer, Immune system disorder, Pneumonia
Clinical narrative: Information has been received from a 76 year old female with allergies to egg whites, sulfonamide, codeine and penicillin who over 5 years ago (approximately in 2004) was vaccinated with two doses of PNEUMOVAX 23 (manufacturer unknown). The patient indicated that a couple of years ago (approximately in 2007) she developed pneumonia a couple of times. The patient reported that two years ago she was diagnosed with cancer and had her bladder removed. The patient stated that she was not on any medication at this time; however her immune system was compromised. The patient was hospitalized on an unspecified date. The patient outcome was unknown. This is one of two reports from the same patient. Additional information has been requested.
Sex: M
Vaccine: PPV, RAB
Symptoms: Arthralgia, Decreased appetite, Fatigue, Feeling abnormal, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a male anesthesiologist with a history of shoulder surgery in the past who on 30-NOV-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot# 663936/0508Y) subcutaneously into his tricep. Secondary suspect vaccination on the same day included a dose of RABAVERT intramuscularly in his deltoid in the same arm. On 30-NOV-2009 in the evening the patient experienced myalgia, arthralgia, anorexia and fever of 101F. On 01-DEC-2009, the patient's tricep was painful. The affected area was 5 to 8 inches and had redness and induration. The patient went to the emergency room and was given I.V. antibiotics (unspecified). On 03-DEC-2009, the pain was better but the induration was greater. He went to the emergency room on 03-DEC-2009 in the evening and was given vancomycin for a "possible staph and MRSA infection". On 04-DEC-2009, the swelling had increased but the pain had improved. The physician did not know if the patient had received PNEUMOVAX in the past. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. The physician considered arthralgia, anorexia, fever of 101F, reddened area on tricep was 5 to 8 inches, feeling "wiped out", possible staph and MRSA infection, swelling has increased, tricep had induration, tricep painful and myalgia to be disabling. Additional information has been requested.
Sex: M
Vaccine: PPV, RAB
Symptoms: Injection site induration, Injection site pain, Myalgia, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a male anesthesiologist with a history of shoulder surgery in the past who on 30-NOV-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX (lot# 663936/0508Y) subcutaneously into his tricep. Secondary suspect vaccination on the same day included a dose of RABAVERT intramuscularly in his deltoid in the same arm. On 30-NOV-2009 in the evening the patient experienced myalgia, arthralgia, anorexia and fever of 101F. On 01-DEC-2009, the patient's tricep was painful. The affected area was 5 to 8 inches and had redness and induration. The patient went to the emergency room and was given I.V. antibiotics (unspecified). On 03-DEC-2009, the pain was better but the induration was greater. He went to the emergency room on 03-DEC-2009 in the evening and was given vancomycin for a "possible staph and MRSA infection". On 04-DEC-2009, the swelling had increased but the pain had improved. The physician did not know if the patient had received PNEUMOVAX in the past. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. The physician considered arthralgia, anorexia, fever of 101F, reddened area on tricep was 5 to 8 inches, feeling "wiped out", possible staph and MRSA infection, swelling has increased, tricep had induration, tricep painful and myalgia to be disabling. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Aggression, Anxiety, Bacteraemia, Central auditory processing disorder, Developmental coordination disorder
Clinical narrative: This case was reported in a Litigation report, from a physician concerning a 16 weeks old female patient who on 12-JAN-2005 was vaccinated with a second dose of RECOMBIVAX HB. Concomitant suspect therapy included DTaP, Hib (unspecified carrier) (manufacturer unspecified) and Polio (manufacturer unspecified). On 13-JAN-2005 the patient's parents brought her to the emergency room with a fever and reduced movement of her legs. The admitting diagnosis was occult bacteremia. A hospital summary stated that the principal diagnosis was reaction to diphtheria and tetanus toxoid immunizations. Another physician eventually diagnosed the patient with residual delays and encephalopathy-related adverse reactions to her second set of vaccinations, developmental delays (communication, social, adaptive, fine motor, and self help), possible hyperacusis (over-sensitive hearing) which could be due to abnormal central auditory processing, mild generalized hypotonia and poor body awareness, sensory processing dysfunction, developmental coordination disorder, sleep disturbance, mood swings, mild temper tantrums, social and separation anxiety, and obsessive compulsive traits. Another expert physician said that the patient's developmental delay seemed minimal, with no evidence of a static or progressive encephalopathy. The patient developed a transient fever and her failure to move her legs was a local reaction to the vaccinations and not from damage to her central or peripheral nervous system. Special Master stated that the patient's delay appeared to run in the family, other factors unrelated to vaccination included insufficient nutrition during the ages of five to eleven months and family history of speech delay and immaturity in adaptive and emotional skills. No further information is available.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Developmental delay, Disturbance in attention, Encephalopathy, Hypokinesia, Hypotonia
Clinical narrative: This case was reported in a Litigation report, from a physician concerning a 16 weeks old female patient who on 12-JAN-2005 was vaccinated with a second dose of RECOMBIVAX HB. Concomitant suspect therapy included DTaP, Hib (unspecified carrier) (manufacturer unspecified) and Polio (manufacturer unspecified). On 13-JAN-2005 the patient's parents brought her to the emergency room with a fever and reduced movement of her legs. The admitting diagnosis was occult bacteremia. A hospital summary stated that the principal diagnosis was reaction to diphtheria and tetanus toxoid immunizations. Another physician eventually diagnosed the patient with residual delays and encephalopathy-related adverse reactions to her second set of vaccinations, developmental delays (communication, social, adaptive, fine motor, and self help), possible hyperacusis (over-sensitive hearing) which could be due to abnormal central auditory processing, mild generalized hypotonia and poor body awareness, sensory processing dysfunction, developmental coordination disorder, sleep disturbance, mood swings, mild temper tantrums, social and separation anxiety, and obsessive compulsive traits. Another expert physician said that the patient's developmental delay seemed minimal, with no evidence of a static or progressive encephalopathy. The patient developed a transient fever and her failure to move her legs was a local reaction to the vaccinations and not from damage to her central or peripheral nervous system. Special Master stated that the patient's delay appeared to run in the family, other factors unrelated to vaccination included insufficient nutrition during the ages of five to eleven months and family history of speech delay and immaturity in adaptive and emotional skills. No further information is available.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Local reaction, Mood swings, Obsessive-compulsive disorder, Pyrexia, Sensory integrative dysfunction
Clinical narrative: This case was reported in a Litigation report, from a physician concerning a 16 weeks old female patient who on 12-JAN-2005 was vaccinated with a second dose of RECOMBIVAX HB. Concomitant suspect therapy included DTaP, Hib (unspecified carrier) (manufacturer unspecified) and Polio (manufacturer unspecified). On 13-JAN-2005 the patient's parents brought her to the emergency room with a fever and reduced movement of her legs. The admitting diagnosis was occult bacteremia. A hospital summary stated that the principal diagnosis was reaction to diphtheria and tetanus toxoid immunizations. Another physician eventually diagnosed the patient with residual delays and encephalopathy-related adverse reactions to her second set of vaccinations, developmental delays (communication, social, adaptive, fine motor, and self help), possible hyperacusis (over-sensitive hearing) which could be due to abnormal central auditory processing, mild generalized hypotonia and poor body awareness, sensory processing dysfunction, developmental coordination disorder, sleep disturbance, mood swings, mild temper tantrums, social and separation anxiety, and obsessive compulsive traits. Another expert physician said that the patient's developmental delay seemed minimal, with no evidence of a static or progressive encephalopathy. The patient developed a transient fever and her failure to move her legs was a local reaction to the vaccinations and not from damage to her central or peripheral nervous system. Special Master stated that the patient's delay appeared to run in the family, other factors unrelated to vaccination included insufficient nutrition during the ages of five to eleven months and family history of speech delay and immaturity in adaptive and emotional skills. No further information is available.
Age: 0.33
Sex: F
Vaccine: HEP
Symptoms: Sleep disorder, Social phobia, Vaccination complication
Clinical narrative: This case was reported in a Litigation report, from a physician concerning a 16 weeks old female patient who on 12-JAN-2005 was vaccinated with a second dose of RECOMBIVAX HB. Concomitant suspect therapy included DTaP, Hib (unspecified carrier) (manufacturer unspecified) and Polio (manufacturer unspecified). On 13-JAN-2005 the patient's parents brought her to the emergency room with a fever and reduced movement of her legs. The admitting diagnosis was occult bacteremia. A hospital summary stated that the principal diagnosis was reaction to diphtheria and tetanus toxoid immunizations. Another physician eventually diagnosed the patient with residual delays and encephalopathy-related adverse reactions to her second set of vaccinations, developmental delays (communication, social, adaptive, fine motor, and self help), possible hyperacusis (over-sensitive hearing) which could be due to abnormal central auditory processing, mild generalized hypotonia and poor body awareness, sensory processing dysfunction, developmental coordination disorder, sleep disturbance, mood swings, mild temper tantrums, social and separation anxiety, and obsessive compulsive traits. Another expert physician said that the patient's developmental delay seemed minimal, with no evidence of a static or progressive encephalopathy. The patient developed a transient fever and her failure to move her legs was a local reaction to the vaccinations and not from damage to her central or peripheral nervous system. Special Master stated that the patient's delay appeared to run in the family, other factors unrelated to vaccination included insufficient nutrition during the ages of five to eleven months and family history of speech delay and immaturity in adaptive and emotional skills. No further information is available.
Age: 3.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Mouth ulceration, Pyrexia, Rash
Clinical narrative: Widespread rash and ulceration. H1N1 inj and Seasonal flu injec. given 12/3/09. On 12/4/09, fever=105. 12/5/09, fever 103-105 and widespread rash with mouth ulcerations noted.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Pharyngeal oedema, Swollen tongue
Clinical narrative: itchy eyes, swollen tongue and throat. To ED for IV benedryl and PO prednisone
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Inflamed area about 3 inches long and 1.5 inches wide at injection site. Area is warm to the touch,slightly raised and sore to the touch.  Symptoms still present as of 12/11/2009 at 1:08 PM. No treatment sought to date.
Age: 16.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Student c/o sore throat, headache - BP 108/72 - sent to clinic after 15 min -rested x 20 min, still had headache - called mom - mom gave permission for pt to walk home.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Rash, Torticollis
Clinical narrative: Started as low grade fever and isolated rash to right thigh. The next day rash on abdomen and chest, noted to have torticollis to neck and shoulders. Rash also appeared on neck and buttocks. Treated with hydrocortisone cream, benadryl, ibuprofen.
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Began having hives that would come and go at various times.  On 11/26/2009 went to Emergency room at Hospital as hives were on trunk of body and in lip and mouth.  Put on prednisone for 10 days along with benadryl. After completing prednison hives began to recur.  12/11 doctor suggested claritin bid, and referred to allergist.
Age: 17.0
Sex: M
Vaccine: FLU(H1N1), FLUN3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Migraine, Rash, Skin warm
Clinical narrative: 1.5 in. x 1.25 in. raised, red, hot dorsal left upper arm accompanied by migraine-like headache without aura.  Patient out of school 12/1/09- 12/3/09.  Seen at walk-in clinic 12/3/09, as unable to see PHCP. No treatment given; symptoms resolved on own by 12/3/09.
Age: 0.28
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Lethargy, Retching, Skin discolouration, Vomiting
Clinical narrative: Child vomited in car on way home with in 15 minutes of getting shot.  Vomiting continued until stomach empty.  Then dry heaves every few hours until 4 am on 12/10/2009.  No fever with vomiting.  His color was brown/green/grey.  Late morning of 12/10/2009 stomach was better and he was able to eat. Only was lethargic through out day, no vomiting.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Cough, Dyspnoea, Headache, Nausea
Clinical narrative: Wheezing, coughing, shortness of breath at 7:30 AM.  peakflow dropped from 380 to 330 on 12/11/09 at 4:00 AM.  Asthma exacerbation, nausea, headache, sore arm.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peak expiratory flow rate decreased, Wheezing
Clinical narrative: Wheezing, coughing, shortness of breath at 7:30 AM.  peakflow dropped from 380 to 330 on 12/11/09 at 4:00 AM.  Asthma exacerbation, nausea, headache, sore arm.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Lethargy, Pain, Pyrexia, Sinus headache
Clinical narrative: Fever, headache, bdy ache,lethargic, sinus pressure
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Dysphagia, Ear pain, Facial pain, Facial palsy, Hypoaesthesia oral
Clinical narrative: facial droop, tongue numbness, ear and facial pain, arm weakness, blurred vision and difficulty swallowing and chewing.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test normal, Mastication disorder, Muscular weakness, Vision blurred
Clinical narrative: facial droop, tongue numbness, ear and facial pain, arm weakness, blurred vision and difficulty swallowing and chewing.
Age: 41.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth.
Age: 0.79
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Mother brought child into clinic to receive vaccinations. I explained to mother that child would be receiving the 1st dose of the the seasonal flu. Mother verbalized understanding and gave consent to get vaccination. My provided vaccination card that did not have any documentation of a previous shot. Child record was also viewed and showed not history of previous vaccination. Mother returned to clinic several hours later stating that child had received a flu vaccine on 10/16/2009. Upon further investigation it was found that child had two medical record numbers. On listed the child as a 01 and the other listed the child as a 02. The documentation was found under the 02 prefix. The nurse manager and provider both spoke with the mother and informed her that the child still needed to come back in 4 weeks to have the 2nd dosage of seasonal flu.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Injection site red, warm to touch and painful.  Also swollen.  Redness and swelling about 1 1/2 in size.  Afebrile.  Patient advised to call PCP for further advice.  Recommended tylenol and cool compresses.
Age: 65.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: With rash and itching first noted in injection site then spreading to both arms and trunk.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Fatigue, Pain, Pyrexia, Rash, Streptococcal identification test negative
Clinical narrative: She had (has) a low grade fever, aches, weariness, and was sent home from school today, (12/11/2009). This has persisted now for four days. She also had a rash on her left wrist, presumably unrelated. Facility staff saw her, asked me to report to you.
Age: 17.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Chest discomfort, Dyspnoea, Headache
Clinical narrative: Student received H1N1 vaccine ->came to clinic 30 minutes later c/o headache, and SOB, BP 128/82 -> rested x 20 minutes -> SOB better, c/o some chest pressure -> had juice and crackers, rested -> back to class, symptoms resolved.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Arm where shot given L arm very swollen down to elbow and wrist, went to ER area was itching & hurting, ER doctor thought it was an infection, was given Benadryl & antiboitic Cephalexin; had 1st dose H1N1 on 11/2/09.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: Client report itching on left arm where she had the shot and then spread to her face, head and leg all her left side. She took Benadryl 25mg po every 2 hours total 4 doses. She call her provider office who also recommended to take one Zantac 150mg twice a day until feeling better. Symptoms started around 3:30 pm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Dizziness, Headache, Wheezing
Clinical narrative: Teen noted onset of wheezing, back pain, headache, dizziness within 3 hours of vaccine administration.
Age: 19.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Pt reports rash prior to bed that evening. Pt self treated with BENADRYL 12/10/09 without improvement. 12/11/09-Prescribed ALLEGRA, ATARAX, ZANTAC and prednisone.
Age: 23.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccine 08 Dec 09. Pt noticed redness and swelling later that evening. Pt states she suspected the reaction was normal and decided to wait to be seen since she had to return to hospital 2 days later. Injection site is raised, red and warm to the touch with tenderness to palpation.
Age: 23.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Swelling
Clinical narrative: Pt received vaccine 08 Dec 09. Pt noticed redness and swelling later that evening. Pt states she suspected the reaction was normal and decided to wait to be seen since she had to return to hospital 2 days later. Injection site is raised, red and warm to the touch with tenderness to palpation.
Age: 3.0
Sex: F
Vaccine: DTAP, FLU(H1N1), FLUN3, HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Swelling
Clinical narrative: Pt received vaccine 08Dec09. Pt's mother noticed redness and swelling later that evening. Pt's mother states she suspected the reaction was normal and decided to wait to be seen since she had to return to hospital in 2 days. Site is raised, red and warm to the touch w/some tenderness to palpation.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Eyelid oedema, Urticaria
Clinical narrative: Hive like redness & swelling upper eye lids.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, Blood magnesium, Blood phosphorus, Blood thyroid stimulating hormone
Clinical narrative: pt started noticing her fingers and hands going numb by 11/13/09 pt could not use her arms at all
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Borrelia burgdorferi serology, Brachial plexopathy, C-reactive protein, Culture urine negative, Drug exposure during pregnancy
Clinical narrative: pt started noticing her fingers and hands going numb by 11/13/09 pt could not use her arms at all
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Electromyogram abnormal, Haemoglobin, Hypoaesthesia, Metabolic function test, Muscle contracture
Clinical narrative: pt started noticing her fingers and hands going numb by 11/13/09 pt could not use her arms at all
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Musculoskeletal disorder, Nuclear magnetic resonance imaging normal, Pain, Red blood cell sedimentation rate
Clinical narrative: pt started noticing her fingers and hands going numb by 11/13/09 pt could not use her arms at all
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Fatigue, Malaise
Clinical narrative: Extreme Fatigue/Malaise (Started today) Unknown duration as of yet.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abasia, Hypoaesthesia
Clinical narrative: Unable to ambulate, numbness in legs.
Age: 1.84
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: When child returned to clinic on 12/11/09 for second H1N1 injection, it was noted on the child's vaccination record card that she received nasal mist for the first dose, which is out of age licensure for the vaccine. I was notified of this after the child had left. I was told an interpreter was present and verified with the mother before filling out paperwork that the child did receive mist the first time. CDC Hotline was consulted, which could not give me any information as to whether the child should receive another shot in 28 days to make up for the first dose. The question was forwarded on to CDC Immunization Program for further investigation.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Started vomiting 12/10/09 from 6pm-3am for a total of 16 times. Diarrhea x 1 on 12/11/09 at 10am.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Eyelid oedema, Genital swelling, Pruritus, Pruritus genital, Urticaria
Clinical narrative: 73 yo male presents with a two day hx for hives and swelling of the  eyelids and penis.  This occurs in the context of a recent influenza and  Pneumovax vaccination on 9/29/09.  He first noted itchy legs and groin yesterday with edema of the upper eyelid yesterday afternoon.  The eyelid edema was worse this morning but has since decreased.  He denies eye irritation or eye itchiness.  There has been no ocular discharge or sticking together of the eyelids.  This morning his wife noted multiple hives on his back and on his legs.  Most of them have resolved or subsided without specific therapy.  He denies dyspnea or wheezing.  He has no prior hx for allergies or reactions to vaccinations.  Further, there is no prior hx for seasonal allergy.  He is otherwise on no new meds or topical products and there has been no recent change  in detergents or soap products.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Headache, Nausea, Paraesthesia, Pruritus generalised
Clinical narrative: 12:30 AM 12/04/09 - Chills, headache, nausea, generalized pruritus and tingling. 9 AM 12/04/09 - same as above. Late PM 12/04/09 - symptoms improved with cetirizine, except pruritus/tingling. 12/05/09 - physician advised diphenhydramine.  Symptoms fully resolved by end of day.
Age: 2.0
Sex: F
Vaccine: TYP
Symptoms: Dysphonia, Injection site pain, Pyrexia
Clinical narrative: Hoarseness, low-grade fever, soreness at site of injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hallucination, Pyrexia, Urticaria
Clinical narrative: Hallucinations, fever (TM 102), urticaria (hives).  BENADRYL, ALLEGRA, OVAPRED, MOTRIN given in office.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abnormal faeces, Haematochezia
Clinical narrative: Bloody stool after vaccine. Patient started going to bathroom 12 times, now patient is down to three times a day.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Injection site erythema, Injection site warmth, Wheezing
Clinical narrative: Shortness of air, wheezing, redness & warmth at injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pyrexia
Clinical narrative: Pt began to experience fever 100.2, chills within a 24 hour period after injection.
Age: 61.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given intranasal spray (H1N1 flu) MedImmune lot #500803P exp. 02/21/2010.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Syringe issue
Clinical narrative: Defective syringe. See section 5 of unusual occurence/incident report.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Muscular weakness, Tremor
Clinical narrative: Shot given, 5-10 minutes became dizzy c/o HA, stomach, legs shaky.  When tried to walk, almost fell because legs weak & shaky.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Child had received vaccine. After receiving vaccine, 10 minutes later c/o burning to injection site. Assessment-area red, warm to touch. Ice pack applied. Reassessed 15 min later. Site still red and child c/o burning still. BENADRYL 25 mg PO given. After 15 min, child stated "burning was better", site appeared less red and warm.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, TYP
Symptoms: Erythema, Rash pruritic
Clinical narrative: Woke up this morning with itchy, red rash on arms which has progressed to his legs and trunk.  Took BENADRYL and applied SOLARCAINE.  Denies difficulty breathing.  Referred for medical evaluation today.  Mother participated in phone conversation.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea, Rash erythematous, Rash macular, Vomiting
Clinical narrative: Patient returned to RN about 30 minutes after H1N1 flu vaccination c/o "sick to stomach".  (10:40 AM) Pt had red, splotchy rash on back & arms.  BP 122/80, P 84, R 24.  No itching.  Administered 2 tsp BENADRYL PO at 10:44 AM without notifying parent for verbal consent.  At 10:55 AM, there was no rash on arms & decreased redness on back.  Stated he felt better.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, FLUN(H1N1), HEP, HEPA
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Upper arm where PENTACEL given was swollen, tense, hot, erythema, red line approximately 11 x 11 cm around. Almost cleared by 4 days.
Age: 6.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Erythema nodosum, Nasopharyngitis, Neutrophil percentage increased, Oropharyngeal pain, Pain in extremity
Clinical narrative: Erythema Nodosum. Fever, rash over shins, pain and swelling of leg, start 11/25/09; seen in ER 11/28/09-FLUZONE given 11/11/09; H1N1 vaccine given 11/17/09. Had cold sx, sore throat, rash from 11/12/09.
Age: 6.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Streptococcal identification test positive, Swelling
Clinical narrative: Erythema Nodosum. Fever, rash over shins, pain and swelling of leg, start 11/25/09; seen in ER 11/28/09-FLUZONE given 11/11/09; H1N1 vaccine given 11/17/09. Had cold sx, sore throat, rash from 11/12/09.
Age: 6.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: White blood cell count increased
Clinical narrative: Erythema Nodosum. Fever, rash over shins, pain and swelling of leg, start 11/25/09; seen in ER 11/28/09-FLUZONE given 11/11/09; H1N1 vaccine given 11/17/09. Had cold sx, sore throat, rash from 11/12/09.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: 10 minutes post vaccination - 0945am - child c/o dizziness, nausea, no difficulty walking. Assisted child to lying position. Oriented x 3. Provided juice. Tolerated juice. Vital signs stable: HR 82, BP 106/66, PR 16, Temp 97.2. C/O blurred vision. Cont. to monitor child for 2 hours until parent picked up. Child ate lunch, walked and stated felt better at 11:30am
Age: 16.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Fatigue
Clinical narrative: Student feeling tired, lightheaded after receiving vaccine - rested in observation 10 extra minutes then feeling better - returned to class. Mom notified via voicemail.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Fatigue, Head discomfort
Clinical narrative: After nasal vaccine student felt head get heavy/felt tired; rest 10 minutes extra in observation, ate crackers and drank water. State she felt ok, then back to class. Father notified.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Otitis media
Clinical narrative: Runny nose, sinus congestion 2 days after the H1N1 vaccine, BOM, Rx with ZITHROMAX 250 zpk & RANDEC DM syrup.  Pt stable.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Felt dizzy/lightheaded after receiving IM injection-laid down x 10 min in observation then x 15 min in clinic. Ate crackers and drank water then felt better, return to class, mom notified.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Flushing, Throat irritation
Clinical narrative: Rcvd vaccine 2nd period.  Waited appropriate amt time in observation.  Started feeling flushed, scratchy throat during day.  Came back 6th period.  Sent to clinic for observation.  Mom notified, feeling better.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash erythematous
Clinical narrative: Butter fly shaped bright pink facial rash developed on face
Age: 13.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Syncope
Clinical narrative: Patient has syncope approximately more or less 5 minutes following administration of flu vaccine 1 & H1N1 vaccine.
Age: 1.22
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Grand mal convulsion, Laboratory test, Metabolic function test normal
Clinical narrative: 8 hours after receiving 1st H1N1 vaccine, patient had grand mal tonic clonic seizure, lasting several minutes.  He was brought to ED where metabolic and infectious evaluation was normal.  He was not found to have fever.  He has been neurologically normal before and since.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Myalgia, Productive cough, Sinus operation, Sneezing, Upper respiratory tract congestion
Clinical narrative: Received H1N1 vaccine on Monday 12-17-09.  At time of vaccination, pt congested because he felt was R/T. sinus drainage. Tuesday evening began to experience muscle aches, sneezing, productive cough with clear sputum.
Age: 31.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: Pt was given H1N1 FLUMIST on 11/15/2009 during a mass clinic.  Nurse was not aware of pregnancy.  Pt. instructed to see OB/GYN ASAP.  Pt. approximately 6 wks gestation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), MMR
Symptoms: Immunoglobulins, Injection site pruritus, Injection site rash
Clinical narrative: Pt walked-in with rash on L arm, no fever, no pain, only itchiness. Pt was Rx'ed Prednisolone 15mg/5mL.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Dizziness, Echocardiogram normal, Electroencephalogram normal, Hypertension
Clinical narrative: Initial case report received from a consumer via a local health agency on 30 NOV 2009. A female patient (age unknown), was vaccinated S-OIV-FOCETIRA (batch no. 102046P) on 12 NOV 2009. On the same day, 45 minutes after vaccination, the patient experienced total body paralysis 3 times over 3 hours having consciousness during the paralysis. Since then, the patient had been experiencing chest pains, dizziness, and high blood pressure and had been out of the work for over 2 weeks. The patient performed electroencephalogram (EEG), brain magnetic resonance imaging (MRI), echocardiogram, with all results negatives. At the time of this report, the outcome of the events was unknown. Total body paralysis, high blood pressure, dizziness and chest pain are unexpected after vaccination with S-OIV FOCETRIA. On a case level, this case is considered unlisted. No change in benefit-risk-ratio. No measures necessary. Agency reference no., NA09-008970.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Impaired work ability, Nuclear magnetic resonance imaging brain normal, Paralysis
Clinical narrative: Initial case report received from a consumer via a local health agency on 30 NOV 2009. A female patient (age unknown), was vaccinated S-OIV-FOCETIRA (batch no. 102046P) on 12 NOV 2009. On the same day, 45 minutes after vaccination, the patient experienced total body paralysis 3 times over 3 hours having consciousness during the paralysis. Since then, the patient had been experiencing chest pains, dizziness, and high blood pressure and had been out of the work for over 2 weeks. The patient performed electroencephalogram (EEG), brain magnetic resonance imaging (MRI), echocardiogram, with all results negatives. At the time of this report, the outcome of the events was unknown. Total body paralysis, high blood pressure, dizziness and chest pain are unexpected after vaccination with S-OIV FOCETRIA. On a case level, this case is considered unlisted. No change in benefit-risk-ratio. No measures necessary. Agency reference no., NA09-008970.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Colitis, Diarrhoea, Large intestinal ulcer, Pyrexia
Clinical narrative: We received the following information from a health care professional via agency on 3 DEC 2009: A 39-year-old female patient was vaccinated i.m with FLUVIRIN (batch no. unknown) on an unknown date in 2009 (about 5 weeks before reporting date). She developed abdominal pain, diarrhea and fever (106F) four to five hours after vaccination. Two and a half weeks later the patient suffered from ulcers in the colon and colitis was diagnosed. She had not recovered at reporting date. Agency no.: NA09-009099.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site erythema, Injection site induration, Mobility decreased, Rash
Clinical narrative: Initial case report received from a nurse via agency, on 03 DEC 2009. A patient 48-year-old female was vaccinated with FLUVIRIN (batch no. 1009232P) i.m. on 25 NOV 2009. On 01 DEC 2009, the patient experienced tinnitus, erythema and induration at the injection site, a rash on her chest, and impaired mobility of her arm and shoulder. These events were reported as not recovered. On the same day, the patient experienced vomiting and shortness of breath. The events were reported as recovered. Agency reference no.: NA09-009131.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Vomiting
Clinical narrative: Initial case report received from a nurse via agency, on 03 DEC 2009. A patient 48-year-old female was vaccinated with FLUVIRIN (batch no. 1009232P) i.m. on 25 NOV 2009. On 01 DEC 2009, the patient experienced tinnitus, erythema and induration at the injection site, a rash on her chest, and impaired mobility of her arm and shoulder. These events were reported as not recovered. On the same day, the patient experienced vomiting and shortness of breath. The events were reported as recovered. Agency reference no.: NA09-009131.