chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a licensed practical nurse (LPN), via company representative, concerning a 16 year old female patient with a sulfonamide allergy, who on 26-Mar-2007 was vaccinated with a dose of 0.5ml, IM, of Gardasil (Lot # 656372/0243U). Concomitant therapy included LOESTRIN. The nurse reported that on 26-MAR-2007, "about 15 minutes" after the vaccination, the patient felt dizzy, passed out, "hitting her face and head as she fell." The patient was taken to the ER, and was treated wit intravenous fluids and TYLENOL. A computed tomography (CT) was performed to evaluate for head and neck injury; the CT result was negative. The nurse added that the patient also developed a low grade fever (date not specified). At the time of this report, the nurse indicated that the patient had recovered from the events. Felt dizzy, passed out, hitting her face and head as she fell, and low grade fever were considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Neck injury, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (LPN), via company representative, concerning a 16 year old female patient with a sulfonamide allergy, who on 26-Mar-2007 was vaccinated with a dose of 0.5ml, IM, of Gardasil (Lot # 656372/0243U). Concomitant therapy included LOESTRIN. The nurse reported that on 26-MAR-2007, "about 15 minutes" after the vaccination, the patient felt dizzy, passed out, "hitting her face and head as she fell." The patient was taken to the ER, and was treated wit intravenous fluids and TYLENOL. A computed tomography (CT) was performed to evaluate for head and neck injury; the CT result was negative. The nurse added that the patient also developed a low grade fever (date not specified). At the time of this report, the nurse indicated that the patient had recovered from the events. Felt dizzy, passed out, hitting her face and head as she fell, and low grade fever were considered to be an other important medical event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information had been received from an office manager concerning a 62 year old female with no medical history or known drug allergies who on 03-APR-2007 was vaccinated intramuscularly into the left arm with a second 0.5 ml dose of Pneumovax (Lot # 651320/1008P). Concomitant therapy included CIPRO, ATENOLOL, MICARDIS, SYNTHROID, testosterone gel, CENTRUM, cranberry tablet, ascorbic acid and baby aspirin. On 04-APR-2007 the patient developed swelling and redness along and underneath her left arm towards her elbow after vaccination. The patient visited an urgent care center and was given DECADRON and BENADRYL. It was noted that the patient had previously received a dose of pneumococcal 23v polysaccharide vaccine in 2000 and the patient did not experienced any adverse reaction at that time. At the time of report, the patient was recovering. A lot check was requested by the reporter. Swelling and redness along and underneath her left arm towards her elbow was considered to be disabling. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Abdominal pain, Abnormal behaviour, Barium double contrast, Haematocrit decreased, Haemoglobin normal
Clinical narrative: Information has been received from a physician concerning a 7-month-old male who was vaccinated PO with the second 2.0 ml dose of Rotateq. The physician reported that, 11 days after receiving the second dose, the patient developed intussusception. The patient was taken to the Emergency Room (ER) where the intussusception was reduced by an enema. It was unknown if the patient was hospitalized. At the time of this report, the outcome was unknown. Upon internal review, intussusception was determined to be an other important medical event. Additional information has been requested.   4/13/07 Received MDs report to manufacturer which included all missing information.  VAERS database updated. 4/27/07 Received medical records from hospital of 3/26/07 & clinic of  11/06-3/15/07 which reveal patient experienced on 3/26/07: abdominal pain, lethargy, malaise.  US revealed IS which was reduced.  Observed for 23 hrs & d/c to home. FINAL DX: ileocolic intussusception, successfully reduced by hydrostatic enema.
Age: 0.6
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC
Symptoms: Intussusception, Platelet count normal, Ultrasound abdomen abnormal, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 7-month-old male who was vaccinated PO with the second 2.0 ml dose of Rotateq. The physician reported that, 11 days after receiving the second dose, the patient developed intussusception. The patient was taken to the Emergency Room (ER) where the intussusception was reduced by an enema. It was unknown if the patient was hospitalized. At the time of this report, the outcome was unknown. Upon internal review, intussusception was determined to be an other important medical event. Additional information has been requested.   4/13/07 Received MDs report to manufacturer which included all missing information.  VAERS database updated. 4/27/07 Received medical records from hospital of 3/26/07 & clinic of  11/06-3/15/07 which reveal patient experienced on 3/26/07: abdominal pain, lethargy, malaise.  US revealed IS which was reduced.  Observed for 23 hrs & d/c to home. FINAL DX: ileocolic intussusception, successfully reduced by hydrostatic enema.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diaphragmatic paralysis, Dyspnoea
Clinical narrative: Information has been received from a pharmacist concerning a 50 year old female with chronic obstructive pulmonary disease who on an unknown date was vaccinated with a dose of Zostavax. Concomitant therapy included high dose inhaled corticosteroids (unspecified). The pharmacist reported that within 24 hours of receiving Zostavax the patient complained of trouble breathing. The patient stated that her diaphragm felt as if it was paralyzed. The patient was taken to the emergency room but was not admitted. Subsequently, the patient recovered. Trouble breathing and diaphragm felt as if it was paralyzed were considered to be other important medical events. There was no product quality complaint involved. No further information is available.
Age: 0.34
Sex: F
Vaccine: DTP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Fatigue, Muscle spasms
Clinical narrative: The day after vaccines, child seemed very tired. 10 days later child has muscle spasms which turned into seizures. Medical doctors used Phenobarbital (did not work). Child is now seeing a Natural Health Practitioner.  04/23/2007 MR received for a 6 day hospitalization 02/15-21/2007 for h/o spells which began on 1/18/2007 consisting of leftward eye deviation, flexion and stiffening of arms and legs and redness of the face with a gasp, lasting 5-10 seconds. The infant had them every 20 minutes or so, never during sleep.  She then began having R eyelid twitching, and rhythmic clonic activity of the RUEs and RLEs.  She was brought to the local ED at that time where she had 3 more episodes.  She was txd with phenobarb and admitted. Admitted 02/01-03/2007. Seizures stopped for several days but recurred and been having ~5/day until this admission.  PE shows plagiocephaly and microcephaly.  Left ear posteriorly rotated.  Sacral Hair tuft.  Infant did not make eye contact or track.  Full EOM.  Hair loss sides of head. Otherwise WNL.  Final DX:  Infant-onset partial epilepsy.  Severe developmental delay and growth failure. 04/27/2007 MR received for initial hospitalization (02/2-3/2007) for c/o multiple minor staring episodes where the infant looks off to the left and becomes unresponsive for a few seconds.  They have increased in frequency over the prior 2 weeks.  Infant had 2 grand mal seizures in the ER with eye deviation to the left. PMH: none.  PE: WNL except esotropia noted on the left. Final DX: Infantile seizures.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood pressure normal, Body temperature, Cardiac murmur, Heart rate normal
Clinical narrative: A 17-year-old female who was brought to the emergency room because of progressively worsening right-sided abdominal pain since the day before her admission. She developed some nausea and had emesis in the emergency room. No previous history of abdominal pain. Additionally, she had received an injection of Gardasil three to four days prior to onset of these symptoms. She has no fever and no chills, No chest pain. Nausea and vomiting, as stated. No diarrhea. She did have a normal bowel movement yesterday. Her periods had been regular until she was started on Depo-Provera. No fever. No chills. No significant weight changes. No history of diabetes. Mental health problems as stated earlier. 05/16/07-records received for DOS 3/22-3/30/07;DC DX:Abdominal pain, question etiology. Possible GE reflux disease. Gastritis. post traumatic stress disorder. Question biliary colic. Dilated common bile duct, possibly normal variant. Admitted from ED with worsening right sided abdominal pain. Nausea and emesis.  No fevers,
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Mental disorder, Nausea, Vomiting
Clinical narrative: A 17-year-old female who was brought to the emergency room because of progressively worsening right-sided abdominal pain since the day before her admission. She developed some nausea and had emesis in the emergency room. No previous history of abdominal pain. Additionally, she had received an injection of Gardasil three to four days prior to onset of these symptoms. She has no fever and no chills, No chest pain. Nausea and vomiting, as stated. No diarrhea. She did have a normal bowel movement yesterday. Her periods had been regular until she was started on Depo-Provera. No fever. No chills. No significant weight changes. No history of diabetes. Mental health problems as stated earlier. 05/16/07-records received for DOS 3/22-3/30/07;DC DX:Abdominal pain, question etiology. Possible GE reflux disease. Gastritis. post traumatic stress disorder. Question biliary colic. Dilated common bile duct, possibly normal variant. Admitted from ED with worsening right sided abdominal pain. Nausea and emesis.  No fevers,
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Local redness, warmth, swelling, itching 20 minutes post administration Benadryl PO.
Age: 24.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Inappropriate schedule of drug administration, Medication error, Tuberculin test negative
Clinical narrative: Tdap (Boostrix) .5 cc given to patient. (Given to patient outside approved age range).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Inadvertently gave the 3rd dose 2 days after the 2nd dose (of Gardasil).
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Pruritus
Clinical narrative: Patient had vesicle develop on bilateral legs, thighs, forearms, and stomach. Severe itch. He was given Atarax and used OTC anti-itch lotion.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received IZ's at clinic on 3-28-07. Came back to clinic 3-31-07 to have PPD read. Mom states right deltoid area started swelling and became red and warm to touch on 3-29-07.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Influenza serology negative, Injection site erythema, Injection site nodule
Clinical narrative: Pt states arm was sore on evening of 3/21/07. On 3/22/07 early am-severe arm pain prescribed with Ibuprofen. At 11am on 3/22/07 pt presented with 'Body Aches All Over", T=100.6 and headache. Prescribed with Ibuprofen. Right deltoid had 4 mm diam. erythema with 1 mm central nodule. Rapid flu test-NEG. By evening of 3/22/07 pt was "well" Pt states Hep A shots (8/30/06 + 3/5/07) give him only sore arm.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states arm was sore on evening of 3/21/07. On 3/22/07 early am-severe arm pain prescribed with Ibuprofen. At 11am on 3/22/07 pt presented with 'Body Aches All Over", T=100.6 and headache. Prescribed with Ibuprofen. Right deltoid had 4 mm diam. erythema with 1 mm central nodule. Rapid flu test-NEG. By evening of 3/22/07 pt was "well" Pt states Hep A shots (8/30/06 + 3/5/07) give him only sore arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: DTaP + IPV administered in Left arm. on 3-26-07. Seen today 3-26-07-Large local reaction= 8x8cm in area of DTap. Arm, red, painful and itchy prescribed Zyrtec 10 mg; cold compresses.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Blood culture positive, Febrile convulsion, Full blood count
Clinical narrative: Febrile seizure on 4/4
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Arm swollen from elbow up, noticed this am. redness, soreness with movement
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Moderate Fever, widespread rash/hives
Age: 1.25
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Skin lesion, Vaccination failure, Varicella, Varicella post vaccine
Clinical narrative: Developed approx 20-30 varicella lesions on 4/6/07
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Peripheral coldness
Clinical narrative: Right upper extremity and hand were cold to touch. No change in color. On 2/28/07, pt was vaccinated on 2/28/07 between 415 and 4:30 on 4/28/07. Pt's mother called pediatrician after seen in Er that day given Benadryl at ER. Right extremity on arrival to ER extremity right pink, warm to touch
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4" swollen, red area-tender to touch right deltoid
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: This patient was mistakenly given Dtap (pediatric) instead of Tdap (Adacel). No symptoms were identified at time. Given approx. 4:45 pm 3/27/07.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Injection site rash, Pyrexia
Clinical narrative: MMR given. Patient felt feverish had a headache over weekend and a rash at the injection site 2 inches in diameter
Age: 38.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Erythema, Injection site reaction, Injection site warmth, Paraesthesia, Pyrexia
Clinical narrative: Redness of cheeks, no hives, felt hot and tingling injection sites, fever-had hives the next day
Age: 38.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Urticaria
Clinical narrative: Redness of cheeks, no hives, felt hot and tingling injection sites, fever-had hives the next day
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Injection site pain
Clinical narrative: Prolonged crying for 5 hours - pain to left thigh. Resolved when seen back in office on 4/2/07.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Odynophagia, Pain, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: March 9 shot given. Thereafter, full body aches, constant runny nose, severe sore throat making it painful to swallow, light cough.
Sex: F
Vaccine: TD
Symptoms: Discomfort, Injection site warmth, Oedema peripheral
Clinical narrative: Slightly edematous arm - warm to touch at injection site. Cold packs to arm x 20 minutes, then off. OTC Advil for discomfort - follow up with PMD.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Blister, Pruritus
Clinical narrative: Pads of little fingers left hand began itching, then spread to ring finger (pad only). Next morning spread to middle finger pad and tiny blisters were showing under skin. Has not spread any further by today (4/2/07) but itching continues today.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Cyanosis, Hypoventilation, Irritability, Listless, Pallor
Clinical narrative: Pale, listless, blue lips, irritable, shallow breathing for 3 days after shots.
Age: 1.26
Sex: F
Vaccine: DTAP, IPV, PNC, DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth to both thighs the RT much worse than the left. Started on Keflex susp.
Age: 1.26
Sex: F
Vaccine: DTAP, IPV, PNC, DTAP, IPV, PNC
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Swelling, redness, warmth to both thighs the RT much worse than the left. Started on Keflex susp.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Electroencephalogram, Partial seizures
Clinical narrative: Focal seizure 4/1/07
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash maculo-papular, Rash vesicular, Varicella
Clinical narrative: 8 year old male with history of Varicella immunization (8/22/01). Who developed clinical varicella erythematous maculopapular vesicular eruption, after known exposure to varicella in school. Patient presented for treatment in our office on 3/27/07 with typical varicella rash. Patient was well appearing and advised to bath daily and take Benadryl orally PRN. Patient expected to recover without sequelae.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Diarrhoea, Diarrhoea, Metabolic function test normal, Pyrexia
Clinical narrative: vomiting, fever, diarrhea hospitalized 3/14-3/17.  04/23/2007 MR received from hospital stayof 4 days 03/14-17/2007 for c/o emesis x7 in the previous 24 hours and fever.  Infant had a large, loose, watery stool in the ED.  PE: WNL. Occasional emesis during hospital stay.  IV hydration.  Discharge DX:  Rotavirus (-) acute gastroenteritis vs. post vaccine reaction.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus test negative, Vomiting, X-ray abnormal
Clinical narrative: vomiting, fever, diarrhea hospitalized 3/14-3/17.  04/23/2007 MR received from hospital stayof 4 days 03/14-17/2007 for c/o emesis x7 in the previous 24 hours and fever.  Infant had a large, loose, watery stool in the ED.  PE: WNL. Occasional emesis during hospital stay.  IV hydration.  Discharge DX:  Rotavirus (-) acute gastroenteritis vs. post vaccine reaction.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Body temperature increased, Malaise, Pain in extremity
Clinical narrative: Pt received vaccine in early AM before hemodialysis RX. That evening (? time), pt stated he had an elevated temp, localized soreness on R arm and general malaise. When seen on 3/8 for HD RX only general malaise persisted. F/U dose on 4/5/07 not given.
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: New physician goal to encourage adult immunization with the relatively new product Adacel was adopted by our organization's physicians and the vaccine was stocked in their office locations. Seven adult patient's received Daptacel (diphtheria, tetanus toxoids and acellular pertussis vaccine) instead of the intended Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine) in one of our owned physician practice offices. There are no known adverse outcomes at this time. Patients have been sent letters regarding the need to avoid diphtheria testing before 10 years from the date of this immunization. The error was discovered by a nurse practitioner who routinely holds pediatric immunization clinic. The similarity of names and markings, while different in color, on the boxes contributed to this error. The new adoption of this product, coupled with the unwanted stock of Daptacel remaining in the pharmacy were also contributing factors.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Rash generalised
Clinical narrative: pt came in with rash all over body caregiver stated she introduced pt to egg as well the next day. First time pt had immunizations (pt foster child)
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Patient experienced no symptoms for 48 hours and then noted increased redness, swelling and purple tinge with warmth to the area in the upper right deltoid. At time of exam, pt had warmth to the area, approximately 2 cm x 2 cm. Pt was treated with Prednisone 40 mg daily for five days and Topicort 0.25% topical cream bid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local reaction of vaccination site. Red,swollen,and warm to the touch.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: 7AM, APRIL 11,2007, MOM NOTICED RAISED,RED,HARD,WARM LUMP ON UPPER LEFT ARM. LUMP IS 3" IN DIAMETER. NOT TENDER TO THE TOUCH.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Influenza, Rash
Clinical narrative: Developed Flu symptoms and rash.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness at site. Fever, chills, myalgia, rigors, headache.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Swelling, redness, tenderness at site. Fever, chills, myalgia, rigors, headache.
Age: 26.0
Sex: F
Vaccine: ANTH, HPV4, SMALL
Symptoms: Diarrhoea, Erythema, Insomnia, Lymph node pain, Lymphadenopathy
Clinical narrative: 29 Mar 07 developed rash all over body that lasted approx. 3 days/ took benedryl or claritin for releif.  3Apr 07 lymph nodes became tender and enlarged.  5 Apr 07 lymph nodes hot, red, sore, and itchy accompanied by nausea, vomiting, diarrhea, and fever that desipated on 8 Apr 07.  some lymph nodes are still enlarged and have had a hard time sleeping through the night since I received the vaccinations.
Age: 26.0
Sex: F
Vaccine: ANTH, HPV4, SMALL
Symptoms: Nausea, Pruritus, Pyrexia, Rash generalised, Vomiting
Clinical narrative: 29 Mar 07 developed rash all over body that lasted approx. 3 days/ took benedryl or claritin for releif.  3Apr 07 lymph nodes became tender and enlarged.  5 Apr 07 lymph nodes hot, red, sore, and itchy accompanied by nausea, vomiting, diarrhea, and fever that desipated on 8 Apr 07.  some lymph nodes are still enlarged and have had a hard time sleeping through the night since I received the vaccinations.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: intussusception diagnosed & operated 6 days later.  4/24/07 Received medical records from hospital which reveal patient experienced a 1 day hx of bloody stools & emesis with decreased appetite.  Had been transferred from outlying hospital.  Admitted1/21/07-1/25/07.  Surg consult done & taken to OR for exp lap & ileocecectomy w/primary anastomosis.  During surgery there was diffuse purulent fluid found in peritoneum w/necrotic IS.  Patient progressed well & was d/c to home   FINAL DX: Intussusception, surgically reduced.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Barium double contrast, Barium enema, Decreased appetite, Gastrointestinal necrosis, Haematochezia
Clinical narrative: intussusception diagnosed & operated 6 days later.  4/24/07 Received medical records from hospital which reveal patient experienced a 1 day hx of bloody stools & emesis with decreased appetite.  Had been transferred from outlying hospital.  Admitted1/21/07-1/25/07.  Surg consult done & taken to OR for exp lap & ileocecectomy w/primary anastomosis.  During surgery there was diffuse purulent fluid found in peritoneum w/necrotic IS.  Patient progressed well & was d/c to home   FINAL DX: Intussusception, surgically reduced.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Intestinal anastomosis, Intussusception, Laparotomy, Purulent discharge, Surgery
Clinical narrative: intussusception diagnosed & operated 6 days later.  4/24/07 Received medical records from hospital which reveal patient experienced a 1 day hx of bloody stools & emesis with decreased appetite.  Had been transferred from outlying hospital.  Admitted1/21/07-1/25/07.  Surg consult done & taken to OR for exp lap & ileocecectomy w/primary anastomosis.  During surgery there was diffuse purulent fluid found in peritoneum w/necrotic IS.  Patient progressed well & was d/c to home   FINAL DX: Intussusception, surgically reduced.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray
Clinical narrative: intussusception diagnosed & operated 6 days later.  4/24/07 Received medical records from hospital which reveal patient experienced a 1 day hx of bloody stools & emesis with decreased appetite.  Had been transferred from outlying hospital.  Admitted1/21/07-1/25/07.  Surg consult done & taken to OR for exp lap & ileocecectomy w/primary anastomosis.  During surgery there was diffuse purulent fluid found in peritoneum w/necrotic IS.  Patient progressed well & was d/c to home   FINAL DX: Intussusception, surgically reduced.
Age: 63.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Headache, Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: erythema, tenderness, swelling, hematoma and warmth at injection site; headache and fever; all symptoms x 48h
Age: 63.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: erythema, tenderness, swelling, hematoma and warmth at injection site; headache and fever; all symptoms x 48h
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Vomiting
Clinical narrative: SIDE EFFECT TO ZOSTAVAX -- 12 HOURS, ABDOMINAL CRAMPING AND VOMITING TIMES 1 DAY.  HEADACHES TIME 2 DAYS. NO FEVER AND NO OTHER SYMPTOMS.
Age: 1.03
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, UNK
Symptoms: Body temperature increased, Irritability, Rash, Somnolence
Clinical narrative: Mild rash presented 24 hours after vaccination was administered and was still present after two days. The rash didn't seem to be a bother other than it included a mild temperature, drowsiness, and fussiness. These other symptoms could be related to the other vaccines and may be unrelated to the rash. The only treatment was Childrens Tylenol 1tsp. p.r.n.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Computerised tomogram normal, Concussion, Confusional state, Crying
Clinical narrative: APPROXIMATELY 10 MINUTES AFTER VACCINE ADMINISTRATION CLIENT PASSED OUT FALLING AND HITTING HER HEAD.  CLIENT AROUSED IN A FEW SECONDS. VITAL SIGNS CHECKED. APPROXIMATELY 20 MINUTES LATER CLIENT REPORTED FEELING ANXIOUS AND CONFUSED,  CRYING,  AMBULANCE CALLED
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: APPROXIMATELY 10 MINUTES AFTER VACCINE ADMINISTRATION CLIENT PASSED OUT FALLING AND HITTING HER HEAD.  CLIENT AROUSED IN A FEW SECONDS. VITAL SIGNS CHECKED. APPROXIMATELY 20 MINUTES LATER CLIENT REPORTED FEELING ANXIOUS AND CONFUSED,  CRYING,  AMBULANCE CALLED
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 4/10/07 - 8:00 A.M.  PT REC'D VACCINATIONS.  9 P.M. MOTHER NOTICED THAT THE AREAS OF VACCINATIONS WERE HOT AND "HARDENED".  TYLENOL WAS GIVEN PRIOR TO VACCINATIONS BUT NONE GIVEN AFTER THE VACCINATIONS ON 4/10/07.  THIS MORNING AT 6:45 A.M. AREAS OF VACCINATIONS NOTICIABLE WORSE, LEFT ARM WAS HOT, RED, SWOLLEN FROM SHOULDER TO ELBOW COVERING AT LEAST 1/2 OF WIDTH OF ARM. RIGHT ARM WAS HOT, SWOLLEN 47MM IN CIRCUM. WITH AN INNER CIRCLE 32MM THAT HAD A DARKER COLORATION, WITH MORE TYLENOL WAS GIVEN AT 7:00 A.M. AND ANOTHER DOSE (1 1/2 TSP.) GIVEN AT 12:00 P.M.    MOTHER FELT THAT HER DOCTOR SHOULD SEE THE CHILD AND CHILD WAS SEEN BY DR.  AT 1 P.M. ANTIBIOTIC AND ANTIHISTAMINE PRESCRIPTIONS GIVEN.  MOTHER UNSURE WHAT THE PRESCRIPTIONS
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Oedema peripheral
Clinical narrative: 4/10/07 - 8:00 A.M.  PT REC'D VACCINATIONS.  9 P.M. MOTHER NOTICED THAT THE AREAS OF VACCINATIONS WERE HOT AND "HARDENED".  TYLENOL WAS GIVEN PRIOR TO VACCINATIONS BUT NONE GIVEN AFTER THE VACCINATIONS ON 4/10/07.  THIS MORNING AT 6:45 A.M. AREAS OF VACCINATIONS NOTICIABLE WORSE, LEFT ARM WAS HOT, RED, SWOLLEN FROM SHOULDER TO ELBOW COVERING AT LEAST 1/2 OF WIDTH OF ARM. RIGHT ARM WAS HOT, SWOLLEN 47MM IN CIRCUM. WITH AN INNER CIRCLE 32MM THAT HAD A DARKER COLORATION, WITH MORE TYLENOL WAS GIVEN AT 7:00 A.M. AND ANOTHER DOSE (1 1/2 TSP.) GIVEN AT 12:00 P.M.    MOTHER FELT THAT HER DOCTOR SHOULD SEE THE CHILD AND CHILD WAS SEEN BY DR.  AT 1 P.M. ANTIBIOTIC AND ANTIHISTAMINE PRESCRIPTIONS GIVEN.  MOTHER UNSURE WHAT THE PRESCRIPTIONS
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coxsackie viral infection, Rash, Rash papular, Vaccine positive rechallenge
Clinical narrative: After 2nd set of immunizations, pt developed rash on both legs. (1/24/07)  Rash lasted for several days and eventually cleared.  Pt also developed coxsackie virus about a month later.  After 3rd set of immunizations,(4/4/07) the infant again developed a rash over legs, arms and face.  The rash occurred about 2 days after the immunizations.  Rash is small papules.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: L-ARM RED SWOLLEN 4 X 2 1/2 INCHES , SLIGHT PAIN
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: shingles developed 3/22/2007 on right shoulder and wrist
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Pleuritic pain, Rash macular, Troponin I increased
Clinical narrative: PLEURITIC CHEST PAIN, MACULAR CHEST RASH 45 MIN. TO ONE HOUR AFTER ADM. OF Tdap (ADACEL). TREATED IN ED WITH NEBULIZED LEVALBUTEROL AND DIPHENHYDRAMINE WITH RESOLUTION OF SYMPTOMS; PREDNISONE TABLETS Records received 4/24/07-Admitted with 3 day history of fever and chest pain. Chest pain localized, central and stabbing began shortly after receiving DTaP. 06/05/07-DC summary received from facility for DOS 4/4-4/6/07-DC DX: Idiopathic myocarditis temporally related to TDaP administration. No associated pericardial effusion, cardiac dysfunction or arrhythmia.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Viral test
Clinical narrative: PLEURITIC CHEST PAIN, MACULAR CHEST RASH 45 MIN. TO ONE HOUR AFTER ADM. OF Tdap (ADACEL). TREATED IN ED WITH NEBULIZED LEVALBUTEROL AND DIPHENHYDRAMINE WITH RESOLUTION OF SYMPTOMS; PREDNISONE TABLETS Records received 4/24/07-Admitted with 3 day history of fever and chest pain. Chest pain localized, central and stabbing began shortly after receiving DTaP. 06/05/07-DC summary received from facility for DOS 4/4-4/6/07-DC DX: Idiopathic myocarditis temporally related to TDaP administration. No associated pericardial effusion, cardiac dysfunction or arrhythmia.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, X-ray
Clinical narrative: intussusception   4/13/07 Received vax record which confirms info on report. 5/10/07 Received medical records from hospital which reveal patient experienced bloody stool & bilious emesis. BE successful at reducing IS.  Admitted for observation from 4/7-4/9/07.  Progressed well & was d/c to home.  FINAL DX: Intussusception, s/p BE reduction.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Approx 7 hours after vaccine, patient broke out in red welts on his face, and, to a lesser degree, on his legs, arms, and back, and experienced severe itching. Patient was taken to an emergency walkin clinic. The doctor at the clinic administered a shot to counteract the allergic reaction and a creme to treat the itching. The reaction subsided within three hours. The next day, patient experienced redness and mild itching on face/cheeks, but welts did not appear. Took Benadryl OTC. Redness lasted approx 12 hours, then subsided and did not return.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Patient developed a rash that involved the entire upper arm.  Rash expanded from elbow to top of arm.  Also developed a low grade fever of 101 degrees.  Patient reported not feeling very good.  Onset of event was approximately 24 hours after receiving the vaccine.  Patient was started on an antibiotic and a steroid taper 2 days after the vaccine.  The condition then resolved itself.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Malaise, Pyrexia
Clinical narrative: Patient developed a rash that involved the entire upper arm.  Rash expanded from elbow to top of arm.  Also developed a low grade fever of 101 degrees.  Patient reported not feeling very good.  Onset of event was approximately 24 hours after receiving the vaccine.  Patient was started on an antibiotic and a steroid taper 2 days after the vaccine.  The condition then resolved itself.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, Malaise, Pyrexia, Rash
Clinical narrative: Patient developed a rash that involved the entire upper arm.  Rash expanded from elbow to top of arm.  Also developed a low grade fever of 101 degrees.  Patient reported not feeling very good.  Onset of event was approximately 24 hours after receiving the vaccine.  Patient was started on an antibiotic and a steroid taper 2 days after the vaccine.  The condition then resolved itself.
Age: 4.0
Sex: M
Vaccine: DTAPH, IPV, MMRV
Symptoms: Cough, Erythema, Lethargy, Pruritus generalised
Clinical narrative: adverse reaction started within 5 minutes of injection, mom reports patients fac appeared red, c/o itching "all over", cough, and became lethargic.  Patient was taken to Hospital ER and given Decadron IM and Benadryl PO
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Body temperature increased, Rash pustular
Clinical narrative: Patient with 5mm pustule on right cheek, pustule appeared 5 days after smallpox vaccination given. Pt had temprature of 100.3 at time of outbreak.
Age: 1.03
Sex: M
Vaccine: DTAP, MMR
Symptoms: Allergy test, Bacterial culture, Blood test, Diarrhoea, Stool analysis
Clinical narrative: My son was given the Dpt#5 and MMr at his 12 month checkup. The next day he vomitted a lot and then started chronic diarrhea. The diarrhea was so bad that it would be over ten times a day at times including nights. It was liquid or extremely loose. It went on for 8 months before my pediatricians finally started to listen and made a G.I. appointment, who diagnosed toddlers diarrhea. I found their behavior odd and also the fact that his chart was misplaced on his 18 month checkup. By the way there are two other kids with the same first name with a very similar last name as ours that go there. He is 2 now and I had his vaccine records faxed to me. The 12 month vaccine was missing so it was refaxed. Not only is there absolutely no info or signitures for the MMR and DPT #5 shots given at his 12 month checkup, but on the second form they tried to switch the DPT #5 to 18 mths. and the DPT # 4 to 12mths. I'm very worried about getting his next vaccines because I find it odd that toddlers diarrhea would come on so severe (especially since it was starting to harden like a toddlers should before the vaccine)and I don't know if I really have a good record of vaccines to give to his new doctor. Also, I did not know about the mix up at the time to mention it to the G.I.
Age: 1.03
Sex: M
Vaccine: DTAP, MMR
Symptoms: Vomiting
Clinical narrative: My son was given the Dpt#5 and MMr at his 12 month checkup. The next day he vomitted a lot and then started chronic diarrhea. The diarrhea was so bad that it would be over ten times a day at times including nights. It was liquid or extremely loose. It went on for 8 months before my pediatricians finally started to listen and made a G.I. appointment, who diagnosed toddlers diarrhea. I found their behavior odd and also the fact that his chart was misplaced on his 18 month checkup. By the way there are two other kids with the same first name with a very similar last name as ours that go there. He is 2 now and I had his vaccine records faxed to me. The 12 month vaccine was missing so it was refaxed. Not only is there absolutely no info or signitures for the MMR and DPT #5 shots given at his 12 month checkup, but on the second form they tried to switch the DPT #5 to 18 mths. and the DPT # 4 to 12mths. I'm very worried about getting his next vaccines because I find it odd that toddlers diarrhea would come on so severe (especially since it was starting to harden like a toddlers should before the vaccine)and I don't know if I really have a good record of vaccines to give to his new doctor. Also, I did not know about the mix up at the time to mention it to the G.I.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PT'S LEFT ARM IS SWOLLEN AND RED AROUND THE AREA WHERE VACCINATION WAS ADMIISTERED.
Sex: U
Vaccine: FLU3
Symptoms: Abortion induced, Drug exposure during pregnancy, Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: A report was received from a healthcare professional on 20/Oct/2006 concerning a 34 year old pregnant vaccinee. No details of the vaccinees past medical history or details of any concomitant medications were provided. On 13/Oct/2006 the vaccinee was administered Fluvirin 0.5mls by intramuscular injection. By the following day (19/Oct/2006) she had developed a hugh wheal, about 3 inches in diameter, at the injection site, which was also hot, red and itchy. Further information is requested. A follow-up report was received from a healthcare professional concerning a pregnant 34-year-old female vaccinee. The vaccinee has a history of Hypothyroid since 2003 which is on going. The vaccinee's concomitant medications include Levoxyl, 0.05 mg once a day, orally for Hypothyroid, since 2003 and is on going, Pre-natal vitamins with Doxalymine, 1 tablet once a day, orally for pregnancy since Jun/2006 and is on going, Unisom, 1 tablet once a day, orally for nausea from Sep/2006 to Oct/2006 and Nitrofurantoin, as required, orally for bladder infections in 2004. The vaccinee also received an influenza vaccinee (brand unspecified) in Oct/2005. On 18/Oct/2006, the vaccinee received 0.5ml of Fluvirin, once, intramuscularly into her upper left arm. On 19/Oct/2006, the vaccinee experienced a red wheal at the injection site, which resolved on 23/Oct/2006. On 27/Oct/2006, the vaccine had an elective termination of pregnancy, due to Spina Bifida. The infant was a 12 oz male. The reporter dose not considered the red wheal at the injection site to be serious and is unknown if it is related to Fluvirin. No further information is expected.
Sex: U
Vaccine: FLU3
Symptoms: Injection site warmth, Spina bifida
Clinical narrative: A report was received from a healthcare professional on 20/Oct/2006 concerning a 34 year old pregnant vaccinee. No details of the vaccinees past medical history or details of any concomitant medications were provided. On 13/Oct/2006 the vaccinee was administered Fluvirin 0.5mls by intramuscular injection. By the following day (19/Oct/2006) she had developed a hugh wheal, about 3 inches in diameter, at the injection site, which was also hot, red and itchy. Further information is requested. A follow-up report was received from a healthcare professional concerning a pregnant 34-year-old female vaccinee. The vaccinee has a history of Hypothyroid since 2003 which is on going. The vaccinee's concomitant medications include Levoxyl, 0.05 mg once a day, orally for Hypothyroid, since 2003 and is on going, Pre-natal vitamins with Doxalymine, 1 tablet once a day, orally for pregnancy since Jun/2006 and is on going, Unisom, 1 tablet once a day, orally for nausea from Sep/2006 to Oct/2006 and Nitrofurantoin, as required, orally for bladder infections in 2004. The vaccinee also received an influenza vaccinee (brand unspecified) in Oct/2005. On 18/Oct/2006, the vaccinee received 0.5ml of Fluvirin, once, intramuscularly into her upper left arm. On 19/Oct/2006, the vaccinee experienced a red wheal at the injection site, which resolved on 23/Oct/2006. On 27/Oct/2006, the vaccine had an elective termination of pregnancy, due to Spina Bifida. The infant was a 12 oz male. The reporter dose not considered the red wheal at the injection site to be serious and is unknown if it is related to Fluvirin. No further information is expected.
Age: 34.0
Sex: F
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Arthralgia, Autoimmune disorder, Blood creatinine increased
Clinical narrative: This case was reported by a lawyer and described the occurrence of numbness in a female subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix (unknown). An unspecified time after vaccination with LYMErix, the subject experienced numbness, tingling, fatigue, body pain, autoimmune disease, activities of daily living impaired, facial twitching, memory loss, arthralgia, head vibrating, migraine, myalgia, rash, muscle spasm, poor concentration, stiffness, rheumatological symptoms, neurological impairment, cognitive impairment and decreased activity level. At the time of reporting the outcome of the events were unspecified. The information in this case was receiving via a Statement of Injuries. Follow up information was received on 09 April 2007 via medical records. The subject was a female in her twenties at the time of vaccination with LYMErix. On 06 January 2006 radiologic examination of the brain was performed for an indication of "Lyme" and showed mildly decreased cortical perfusion. It was noted that findings were consistent with "Lyme disease, vasculitis, or medication side effects". On 27 March 2006, testing was positive for Lyme (IgM, Western Blot). The subject was evaluated on 25 October 2006 for Lyme disease. According to the subject's report, she had been in good health, and developed a rash in 1998 or 1999. She was told that she was negative for Lyme disease, and was vaccinated with LYMErix. Following vaccination, she developed a stiff neck and spin, numbness, burning, pins and needles, decreased memory and "word search", and body twitching. She had previously received doxycycline, which helped her symptoms. A history of "neurological Lyme, ? (multiple sclerosis), peripheral neuropathy" was noted. Upon evaluation, the subject endorsed fatigue, memory changes, paraesthesia of the hands and toes, myalgias of the neck and back, and arthralgias. Additional complaints included heart palpitations, poor circulation, insomnia, menstrual cramps, urinary frequency, and nocuturia. On 27 November 2006, assessment included Lyme disease, and treatment with Bicillin was initiated. This case was assessed to be medically significant by manufacturer based upon follow up information. The subject complained of heart palpitations, poor circulation, insomnia, menstrual cramps, urinary frequency, and nocturia. In November 2006 she was diagnosed with a urinary tract infection. These were considered to be incidental findings upon medical record review.
Age: 34.0
Sex: F
Vaccine: LYME
Symptoms: Blood folate, Blood magnesium normal, Blood urea increased, Burning sensation, CD8 lymphocytes
Clinical narrative: This case was reported by a lawyer and described the occurrence of numbness in a female subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix (unknown). An unspecified time after vaccination with LYMErix, the subject experienced numbness, tingling, fatigue, body pain, autoimmune disease, activities of daily living impaired, facial twitching, memory loss, arthralgia, head vibrating, migraine, myalgia, rash, muscle spasm, poor concentration, stiffness, rheumatological symptoms, neurological impairment, cognitive impairment and decreased activity level. At the time of reporting the outcome of the events were unspecified. The information in this case was receiving via a Statement of Injuries. Follow up information was received on 09 April 2007 via medical records. The subject was a female in her twenties at the time of vaccination with LYMErix. On 06 January 2006 radiologic examination of the brain was performed for an indication of "Lyme" and showed mildly decreased cortical perfusion. It was noted that findings were consistent with "Lyme disease, vasculitis, or medication side effects". On 27 March 2006, testing was positive for Lyme (IgM, Western Blot). The subject was evaluated on 25 October 2006 for Lyme disease. According to the subject's report, she had been in good health, and developed a rash in 1998 or 1999. She was told that she was negative for Lyme disease, and was vaccinated with LYMErix. Following vaccination, she developed a stiff neck and spin, numbness, burning, pins and needles, decreased memory and "word search", and body twitching. She had previously received doxycycline, which helped her symptoms. A history of "neurological Lyme, ? (multiple sclerosis), peripheral neuropathy" was noted. Upon evaluation, the subject endorsed fatigue, memory changes, paraesthesia of the hands and toes, myalgias of the neck and back, and arthralgias. Additional complaints included heart palpitations, poor circulation, insomnia, menstrual cramps, urinary frequency, and nocuturia. On 27 November 2006, assessment included Lyme disease, and treatment with Bicillin was initiated. This case was assessed to be medically significant by manufacturer based upon follow up information. The subject complained of heart palpitations, poor circulation, insomnia, menstrual cramps, urinary frequency, and nocturia. In November 2006 she was diagnosed with a urinary tract infection. These were considered to be incidental findings upon medical record review.