chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Visual disturbance
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with seasonal allergies and no history of seizures who on 21-JUN-2007 was vaccinated with the first dose of Gardasil (Lot# 658094/0524U) 0.5 mL IM. Concomitant medication was not reported. On 21-JUN-2007 the patient's mother was checking out of the office when the receptionist saw the patient's eyes roll back in her head and she passed out. The patient hit her head and entire body on the concrete floor. The nurse and physician ran to the patient and it appeared as if she was coming out of a seizure. The patient had lost consciousness and developed visual disturbance, dizziness, headache and vomiting. Medical attention was sought. On 21-JUN-2007 a computed axial tomography (CAT SCAN) was performed and the results were found to be negative for bleeding. The patient was observed in the office for several hours and released home with her mother. At time of reporting the patient had nausea, vomiting, headaches, visual disturbance and was still unsteady on feet. Additional information is not available at the time of reporting. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Hypotension, Malaise, Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning an 18 year old female patient, who on 21-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #655503/0012U). Concomitant therapy included MENACTRA. Five minutes after the vaccination, the patient "developed syncope," while she was in the process of making another appointment. The CMA reported that the patient also experienced weakness, low blood pressure (value not specified), and paleness. Treatment involved administered epinephrine 0.3mg. The patient felt better after 10-15 minutes, and was released with instructions to call the office if she had any further problems. The CMA reported that the patient had not called the office, but indicated the outcome of the events was unknown. The CMA considered one or more of the events to be serious as an other significant medical event, as intervention to prevent serious criteria was required. The CMA indicated episodes of syncope for 2 additional patients following vaccination with Gardasil (0706USA04697, 0706USA04722). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Hypotension, Pallor, Syncope
Clinical narrative: Information has been received from a certified medical assistant (CMA), concerning an 18 year old female patient, who on 21-JUN-2007 was vaccinated IM, with the first dose, 0.5ml, of Gardasil (Lot #655503/0012U). Concomitant therapy included MENACTRA. Five minutes after the vaccination, the patient "developed syncope," while she was in the process of making another appointment. The CMA reported that the patient also experienced weakness, low blood pressure (value not specified), and paleness. Treatment involved administered epinephrine 0.3mg. The patient felt better after 10-15 minutes, and was released with instructions to call the office if she had any further problems. The CMA reported that the patient had not called the office, but indicated the outcome of the events was unknown. The CMA considered one or more of the events to be serious as an other significant medical event, as intervention to prevent serious criteria was required. The CMA indicated episodes of syncope for 2 additional patients following vaccination with Gardasil (0706USA04697, 0706USA04722). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Contusion, Full blood count, Haematology test, Haematoma, Otitis media
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old male who on 21-MAY-2007 was vaccinated with his first dose of Proquad (lot# 657007/0230U). On 06-JUN-2007 the patient experienced immune thrombocytopenia purpura and was hospitalized for three days. He received immunoglobulin. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Petechiae, Platelet count decreased, Reticulocyte count increased, Scan brain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old male who on 21-MAY-2007 was vaccinated with his first dose of Proquad (lot# 657007/0230U). On 06-JUN-2007 the patient experienced immune thrombocytopenia purpura and was hospitalized for three days. He received immunoglobulin. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Immunoglobulins, Thrombocytopenic purpura
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old male who on 21-MAY-2007 was vaccinated with his first dose of Proquad (lot# 657007/0230U). On 06-JUN-2007 the patient experienced immune thrombocytopenia purpura and was hospitalized for three days. He received immunoglobulin. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: YF
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: 7/3/07 Client called today stating she became ill after Yellow Fever vaccination on 10/13/06. Client said she had soreness across abdomen, aching extremities which was all muscular and a fever though did not check actual temperature, which lasted 5 days and then she was well.
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: 35 yo male CONSULT for vaccination reaction.  pt had anthrax (#2) and typhoid one week ago.  pt quickly developed ascending pain from typhoid site on left arm up to neck.  over the next 24 hours, developed neck stiffness and HA.  both symptoms continued to progress over the next 48 hours.  pt reports pain with turning head to either direction, or with any jarring motions.  HA described as generalized, pounding.  little relief with motrin.  denied any photo/phonophobia, numb/tingle.  approx 72 hours after initial injection, developed mild f/c and n/v.  f/c quickly resolved.  n/v persisted over next 72 hours .  HA gradually improved.  pt is physician, and had already self diagnosed with aseptic meningitis; did not seek further medical care.  symptoms only adequately controlled with percocet and phenergan.  +fatigue.  over past 48 hours, overall symptoms have improved considerably.  still with mild HA, neck stiffness.
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Neck pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: 35 yo male CONSULT for vaccination reaction.  pt had anthrax (#2) and typhoid one week ago.  pt quickly developed ascending pain from typhoid site on left arm up to neck.  over the next 24 hours, developed neck stiffness and HA.  both symptoms continued to progress over the next 48 hours.  pt reports pain with turning head to either direction, or with any jarring motions.  HA described as generalized, pounding.  little relief with motrin.  denied any photo/phonophobia, numb/tingle.  approx 72 hours after initial injection, developed mild f/c and n/v.  f/c quickly resolved.  n/v persisted over next 72 hours .  HA gradually improved.  pt is physician, and had already self diagnosed with aseptic meningitis; did not seek further medical care.  symptoms only adequately controlled with percocet and phenergan.  +fatigue.  over past 48 hours, overall symptoms have improved considerably.  still with mild HA, neck stiffness.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Lymphadenopathy, Oedema, Rash
Clinical narrative: LARGE AREA OF EDEMA, CELLULITIS-LIKE RASH AND LYMPHADENOPATHY IN AFFECTED ARM.  THIS WAS HIS THIRD VACCINATION IN THE SERIES.  PT GIVEN BENADRYL AND IBUPROFEN.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Cold compress therapy, Injection site erythema, Pruritus, Urticaria
Clinical narrative: Woke up morning after vaccination with large erythema area at injection site. (+) itch-measure 10 cm x 10 cm erythema with center wheal measure 40mm in diameter Rx Benadryl by mouth every 6 hours x 48 hr for prn; cool compress on site 250/5 4ml by mouth every day x 10 days.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a 2 ml oral dose of Rotateq. Subsequently the patient was diagnosed with intussusception. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia, Salmonellosis
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with an oral first dose of Rotateq. Subsequently the patient developed a salmonella infection. The patient was seen in the emergency room and was admitted to the hospital for observation. The patient was reported to have blood in the stools as a result of the salmonella infection. The patient was due to receive the second dose of Rotateq, but at the time of the report had not yet received it. It was reported that the patient recovered. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Rotateq PO. The nurse reported that the patient had a little bit of blood in their stool after receiving Rotateq. Upon internal review, blood in the stool was determined to be an other important medical event. Additional information is not expected.
Sex: M
Vaccine: RV5
Symptoms: Abdominal distension, Gastrointestinal tube insertion, Respiratory arrest, Respiratory distress
Clinical narrative: Information has been received from a health professional concerning a male infant who was vaccinated with an oral dose of Rotateq (Lot# 654795/1374F). It was reported that the patient was brought into the office a month after he had received Rotateq. The patient's belly was distended and was in respiratory distress and was not breathing. An NG tube was put in to relieve pressure in the patient's stomach so he could breathe. It was reported that the patient recovered. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be immediately life-threatening and other important medical events by the reporter. A lot check has been requested. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow up information has been received through the Merck pregnancy registry, from a 31 year old female healthcare professional, who on 10-MAY-2007 (previously reported as 30-APR-2007), was vaccinated intramuscularly with the second dose of Gardasil (Lot #657736/0389U), and recently found out she was pregnant. The date of the LMP was reported as 26-MAR-2007, with an estimated delivery date on 31-DEC-2007. Unspecified medical attention was sought. It was not known if the patient had been seen by OB/GYN. Follow up information from the healthcare professional, stated that she "had a miscarriage." No further information or details were provided. Upon internal review, "had a miscarriage" was considered to be serious as an other significant medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Eye rolling, Loss of consciousness, Poor quality drug administered
Clinical narrative: Information has been received from a nurse concerning a 14 year old female who was vaccinated with the second dose of the Gardasil (Lot # 658094/0524U) on an unspecified date. It was reported that the patient experienced seizure like activity after receiving the vaccine. Her eyes rolled back in her head and briefly lost consciousness. The patient sought unspecified medical attention. She recovered 40 minutes after injection. The nurse also reported that the refrigerator where the vaccine was stored was "4 degrees colder than it should have been". Upon internal review, seizure-like activity was considered to be an other important medical event. This report is one of two reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Eye rolling, Loss of consciousness, Poor quality drug administered
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who was vaccinated with the third dose of Gardasil on an unspecified date. It was reported that the patient experienced seizure like activity after receiving the vaccine. Her eyes rolled back in her head and briefly lost consciousness. The patient sought unspecified medical attention. She recovered 40 minutes after injection. The nurse also reported that the refrigerator where the vaccine was stored was "4 degrees colder than it should have been". Upon internal review, seizure-like activity was considered to be an other important medical event. This report is one of two reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Grand mal convulsion, Urinary incontinence
Clinical narrative: Information has been received from a healthcare professional concerning a 26 year old female who received a first dose of Gardasil (lot # 657005/0314U) IM into the left deltoid on 06-Jun-2007. Five minutes later she felt lightheaded and experienced a tonic-clonic seizure and urinary incontinence that lasted 1-2 minutes in duration. She was awake, alert and oriented X 3 post event. Upon internal review tonic clonic seizure was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin negative, Dyspnoea, Mobility decreased, Paraesthesia oral, Sensation of heaviness
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history who on 16-APR-2007 was vaccinated with 0.5 ml of the first dose of the Gardasil. On 21-JUN-2007 at 8:45 am, the patient was vaccinated intramuscularly with 0.5 ml of the second dose of Gardasil (Lot # 658100/0525U). There was no concomitant medication. A laboratory pregnancy test was performed and the result was negative. On 21-JUN-2007, at noon, the patient experienced shortness of breath, intermittent tingling of the lips and the feeling of her arm being heavy and difficult to lift. The motion of the patient's arm had gotten worse since 21-JUN-2007 and she found it difficult to do her hair because of the arm. Patient was scheduled to be evaluated at her physician's office on 26-JUN-2007. At the time of the report, the patient's shortness of breath, intermittent tingling of the lips, and feeling of her arm being heavy and difficult to lift persisted. The medical assistant considered the shortness of breath, intermittent tingling of the lips and feeling of her arm being heavy and difficult to lift to be a disabling event. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. However patient was older than 65 year of age. Physician should have given injection rather than RN doing so; per protocol-however MD did not check age.
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Fever of 103.0 with ER visit on 6-29-07. Followed up with Dr Today Dr noticed rash on stomach and back. Red rash, raised. Parents denies any SOB, or anything other than fever of 100 since ER visit on 6-29-07
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Rash, Swelling, Throat tightness
Clinical narrative: Throat tightness, swollen, SOB, rash on arms (Bi), back, did not go the DR (had second shot 1 week before) "I didn't want to miss training"
Age: 24.0
Sex: F
Vaccine: ANTH, HEPA, TYP, UNK
Symptoms: Pain
Clinical narrative: Left arm - (entire) postop vaccines is (+) for pain traveling up to neck, fingers swollen.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper leg bruising and swelling-hot and tender to touch-Friday 6-29-07-seen at ER. much improved on 7/2/07 in office-6" x 15" area slightly red, moderately tender and moderately inflamed. Duricef 500 mg daily x 10 days
Age: 19.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: 4 d after Dtap, (L) deltoid swollen, red, hot and sore also c/o "legs feeling anxious". Tx prednisone 40 mg QD x 3, ICE, Benadryl, Advil
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Developed painful rash over left rib urea one week after receiving vaccine
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: developed painful rash near left axilla and under arm, shingles
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Swelling and itching and pain 5/10
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives - less than 8 hours - Benadryl (2-3 tsp)
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: T-dap on 6/28.following day severe muscle aches, chills, achey joints,fatigue,temp,head ache,nausous.  arm site swollen, hard, hot tender,cant elevate. 3 days down w/continued symptoms.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: T-dap on 6/28.following day severe muscle aches, chills, achey joints,fatigue,temp,head ache,nausous.  arm site swollen, hard, hot tender,cant elevate. 3 days down w/continued symptoms.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea
Clinical narrative: T-dap on 6/28.following day severe muscle aches, chills, achey joints,fatigue,temp,head ache,nausous.  arm site swollen, hard, hot tender,cant elevate. 3 days down w/continued symptoms.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: DAY AFTER VACCINE ADMINISTERED C/O SWELLING, REDNESS, PAIN AT SITE.  2 DAYS AFTER-ALL SX WORSE. 3 DAYS AFTER SWELLING & HARD AREA IN AXILLA.  ALSO C/O NAUSEA & VOMITING.  SENT TO MD AT THAT TIME.  5 DAYS AFTER ADMINISTRATION OF VACCINE REDDENED AREA AT SITE WITH DARK AREA NOTED.  STILL C/O NAUSEA.  SENT BACK TO MD.  PHENERGAN GIVEN.  6TH DAY PAIN & SWELLING SEEM TO BE LESS.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Vomiting
Clinical narrative: DAY AFTER VACCINE ADMINISTERED C/O SWELLING, REDNESS, PAIN AT SITE.  2 DAYS AFTER-ALL SX WORSE. 3 DAYS AFTER SWELLING & HARD AREA IN AXILLA.  ALSO C/O NAUSEA & VOMITING.  SENT TO MD AT THAT TIME.  5 DAYS AFTER ADMINISTRATION OF VACCINE REDDENED AREA AT SITE WITH DARK AREA NOTED.  STILL C/O NAUSEA.  SENT BACK TO MD.  PHENERGAN GIVEN.  6TH DAY PAIN & SWELLING SEEM TO BE LESS.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash generalised
Clinical narrative: MOP brought pt to provider for eval of unusal rash x 10 days after vaccine administration, which covered body. Pt. was given MMRV (proquad)on 21 Jun 07, 0.5ml, right thigh, sc, lot # 0493U (merck)
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Syncope
Clinical narrative: Pain at injection site, syncopal episode several hours after administration
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Fatigue, Nausea, Pain
Clinical narrative: Sore arm and next morning extreme bodyaches and low-grade temperature of 99.7, chills, nausea and extreme fatigue.  No treatment
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Sore arm and next morning extreme bodyaches and low-grade temperature of 99.7, chills, nausea and extreme fatigue.  No treatment
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Within hours of receiving the first HPV Gardasil shot, my daughter experienced irregular menstrual bleeding for 7 days. She had just had her regular menstrual cycle 2 weeks prior to the vaccination.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient had a silver dollar sized bright red rash at site of injection.  It appeared 48 hours after Zostavax administered.  It was also warm to the touch, however was painless.  She called her physician and was instructed to keep an eye on it.  She also contacted the pharmacy so we could report it.
Age: 38.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS, SWELLING AT INJECTION SITE
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: DEVELOPED SHINGLES 4 DAYS AFTER IMMUNIZATION
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Erythema, Eye swelling, Lip swelling, Swelling face, Urticaria
Clinical narrative: 09:50 (L) deltoid with raised welts/extreme redness across top portion of shoulder and upper arm. Diphenhydramine elixir (12.5mg/5ml) 5.5ml administer P.O. 10:00 Childs lips, face and eyes began swelling. Epinephrine (1:1000 1 w/v ampule) 0.10ml given IM left anteriolateral thigh. Another staff member, RN, BSN phoned 911 for an ambulance to transport patient. EMS arrived 10:07 and child taken to ER by ambulance. ER doctor stated he felt it was a reaction to the DTAP given. Spoke with patients mother later on 06/22/2007.  She reports he is doing fine.  Reports he was given a steroid in the ER, however reports no further problems.
Age: 1.17
Sex: M
Vaccine: MMRV, PNC
Symptoms: Convulsion, Muscular weakness, Polymerase chain reaction, Pyrexia, Rash vesicular
Clinical narrative: Approximately 6 days after vaccination, patient developed fever of 107 degrees with seizure and muscle weakness.  He also developed a vesicular rash with approximately 3 dots on his trunk and 2 on his scrotum.  He remians hospitalized in critical condition.  Investigation is onging.
Age: 4.0
Sex: U
Vaccine: IPV, MMRV
Symptoms: Erythema, Pruritus, Skin exfoliation, Skin lesion
Clinical narrative: THE IPV AND MMRV WERE ADMINISTERED ON THE LEFT ANTERIOR THIGH.  SURROUNDING ERYTHEMA DEVELOPED WHICH INITIALLY FORMED A RAISED PLAQUE.  OVER 5 DAYS, THE LESION DECREASED IN SIZE AND WAS NO LONGER RAISED.  THE LESION WAS ITCHY AND HAD ASSOCIATED SCALINESS.  CARETAKERS APPLIED HYDROCORTISONE CREAM WHICH DECREASED THE ITCHINESS AND SIZE OF THE LESION. NO ABSCESS FORMATION. NO INGUINAL LYMPHADENOPATHY.  NO FEVER.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Discomfort, Dizziness, Injection site irritation, Injection site pain, Nausea
Clinical narrative: Intense pain and burning sensation at injection site that occurred 3 hours after vaccination was given. Pain and burning made me dizzy and nauseated. The discomfort lasted about 30 minutes and the injection site remained sore for 4 days.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site irritation, Nausea, Urticaria
Clinical narrative: Intense pain and burning sensation at injection site that occurred 3 hours after vaccination was given. Pain and burning made me dizzy and nauseated. The discomfort lasted about 30 minutes and the injection site remained sore for 4 days.
Age: 0.1
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given too early at 4 weeks of age, five vaccinations, DTaP, IPV, Hep B, Prevnar and Rotateq.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Local site reaction
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Haematochezia, Weight decreased
Clinical narrative: 10 Watery stools with blood over the last 3-4 days. Slight decrease weight, improved today. Feeding well, no fevers.
Sex: F
Vaccine: FLU3, IPV, TDAP
Symptoms: Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: C/O arm pain 1-2 days after vaccines given. C/O generalized muscle soreness, fevers on and off and exhaustion. Unable to pursue activities (walking and swimming) due to fatigue. Arm pain resolved. Other sxs persist.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Cyanosis, Dysphonia, Wheezing
Clinical narrative: Acute wheezing and hoarse cry and cyanotic lips - briefly, restarted spontaneously.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: 9 Days after vaccine noted large lump 2cm on site use warm compresses went down still slight indurated 2 days after measures 1 1/2cm x 1/2cm redden and indurated slight purple /red. Did not have any lump or redness day of vaccine.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Dizziness, Incorrect dose administered, Loss of consciousness
Clinical narrative: This case was reported by a health care professional and described the occurrence of transient loss of consciousness in a 22-year-old female subject who was vaccinated with Engerix B for prophylaxis. The subject is a medical assistant student who has exhibited fear of needles in the past. The subject received three hepatitis B vaccinations as a child without any problems. The subject has no history of allergy to yeast, foods, or medications. On 27 June 2007 at 10:10 the subject received 1st dose of Engerix B at 10 mcg in the left arm. This was considered to be an inappropriate dose of drug administered. The subject should have received an adult dose of Engerix B at 20 mcg. An unspecified amount of time following vaccination with Engerix B, the subject experienced lightheadedness, transient loss of consciousness, nausea, plus audible wheezing and shaking. The subject's blood pressure at the onset of reaction was 136/80. It then dropped to 108/50. Following epinephrine treatment, the subject's pressure increased to 142/62 and then to 166/76. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject as taken to the emergency room via ambulance. The wheezing was bilateral which resolved after epinephrine was given. The subject then regained full consciousness and was able to talk. Her vitals normalized by the time the ambulance arrived which was approximately 10 minutes. Shaking improved. The nurse used ammonia under the subject's nose to wake her up. Ammonia ampules were passed under nose 6 to 7 times. By the time the subject arrived at the hospital, she was generally improved, but had continued nausea and some shaking. Wheezing had ceased and she was stable, alert and oriented. The status of the subject at the time of reporting was not known. The reporting nurse questioned a potential quality issue (product complaint) with the lot of Engerix B used. She stated that the Engerix B product looked as it should have and that there were no perceivable quality issues. The nurse reported that the subject does have a history of a fear of needles that may have contributed to the events.
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, No reaction on previous exposure to drug, Tremor, Wheezing
Clinical narrative: This case was reported by a health care professional and described the occurrence of transient loss of consciousness in a 22-year-old female subject who was vaccinated with Engerix B for prophylaxis. The subject is a medical assistant student who has exhibited fear of needles in the past. The subject received three hepatitis B vaccinations as a child without any problems. The subject has no history of allergy to yeast, foods, or medications. On 27 June 2007 at 10:10 the subject received 1st dose of Engerix B at 10 mcg in the left arm. This was considered to be an inappropriate dose of drug administered. The subject should have received an adult dose of Engerix B at 20 mcg. An unspecified amount of time following vaccination with Engerix B, the subject experienced lightheadedness, transient loss of consciousness, nausea, plus audible wheezing and shaking. The subject's blood pressure at the onset of reaction was 136/80. It then dropped to 108/50. Following epinephrine treatment, the subject's pressure increased to 142/62 and then to 166/76. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject as taken to the emergency room via ambulance. The wheezing was bilateral which resolved after epinephrine was given. The subject then regained full consciousness and was able to talk. Her vitals normalized by the time the ambulance arrived which was approximately 10 minutes. Shaking improved. The nurse used ammonia under the subject's nose to wake her up. Ammonia ampules were passed under nose 6 to 7 times. By the time the subject arrived at the hospital, she was generally improved, but had continued nausea and some shaking. Wheezing had ceased and she was stable, alert and oriented. The status of the subject at the time of reporting was not known. The reporting nurse questioned a potential quality issue (product complaint) with the lot of Engerix B used. She stated that the Engerix B product looked as it should have and that there were no perceivable quality issues. The nurse reported that the subject does have a history of a fear of needles that may have contributed to the events.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Broke out in hives and large patchy spots over her body with sever itching.  She was take to the hospital where they gave her a eppy pin injection and benedryl.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Complement factor C3 decreased, Complement factor C4 decreased, Hordeolum
Clinical narrative: Broke out in hives and large patchy spots over her body with sever itching.  She was take to the hospital where they gave her a eppy pin injection and benedryl.
Age: 13.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Oedema peripheral, Rheumatoid factor decreased, Urticaria
Clinical narrative: Broke out in hives and large patchy spots over her body with sever itching.  She was take to the hospital where they gave her a eppy pin injection and benedryl.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Patient received MMR on 6/22/07. Parents report diffuse macularpapular rash began 6/29/07. Arrived in ER after 6 days of rash and fever >102.1
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Eye irritation, Hypersensitivity, Skin irritation
Clinical narrative: 15 hours after I recieved the injection I took my evening medications. Topamax, mobic, black cohosh, dong quia, frankincense and turmetic. I delveloped a burning sensation all over my body and itched all over including my eyes and bottom of my feet. Nothing including cold water helped this feeling. I called the hospital which told me this was an allergic reaction to something. I have been taking these medications for over a  year. I couldn't go to the hospital because of being the crisis hotline person being on call with my job. I then took two of my morning medications zyrtec and singerlar and soaked in an oatmeal bath which relieved the symtoms. When I woke up this morning my eyes still burned and were feeling itchy as well as my arms. I put bendryl creme on them and took a ativan. I work as a mental health professional I seen a nurse at work this morning who checked me out stated to continue doing what I already am if the feeling continues I need to go back to health department in morning to report it to them and get checked out by the doctor and I should d/c the herbal medications in case it's causing the allegic reaction.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Diarrhoea, Pyrexia
Clinical narrative: The doctor warned me of a fever related to the vaccine that could occur a week after the shot.  On July 2nd, 10 days after the shot, my daycare called me to report a fever of 101.6.  That evening, I found chicken pox like blisters on her arm and leg.  The following day, I found more blisters (smaller) on her chest.  Her fever has since been between 'normal' and 101.3, as of this morning (5am), July 4th.  Temperature was recorded from under her arm 100.3, so I added a degree since it was auxillary.  Her diapers have had looser stools than normal, and she seems to be napping more frequently.  Her appetite seems to be OK, and her fluid intake is good.  She is not lethargic, but her unusual fever and the blisters leads me believe that it is caused by a reaction to the vaccine.  I called the doctor's office twice and they have been helpful.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TD, VARCEL
Symptoms: Dizziness, Feeling cold, Feeling hot, Malaise, Pallor
Clinical narrative: Extreme pallor.  Lips were white. I am a nurse - she looked like she was dying.  She said that she didn't feel good.  She started gagging.  She thought she was going to vomit.  Afterwards she said that she felt hot inside and cold outside.  She almost passed out.  This happened approximately 20-30 minutes after vaccinations. I took her inside clinic - assisting her down hall back to FNP.  They assessed her heart.  Daughter never complained of shob and no localized reaction.  They gave her a pepsi.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TD, VARCEL
Symptoms: Presyncope, Retching
Clinical narrative: Extreme pallor.  Lips were white. I am a nurse - she looked like she was dying.  She said that she didn't feel good.  She started gagging.  She thought she was going to vomit.  Afterwards she said that she felt hot inside and cold outside.  She almost passed out.  This happened approximately 20-30 minutes after vaccinations. I took her inside clinic - assisting her down hall back to FNP.  They assessed her heart.  Daughter never complained of shob and no localized reaction.  They gave her a pepsi.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cyanosis, Grand mal convulsion, Oxygen supplementation, Urinary incontinence
Clinical narrative: Information has been received from a registered nurse via Glaxo Smith Kline concerning a 15 year old female with a history of neurocardiogenic syncope and hives after therapy with sulfamethoxazole (+) trimethoprim (SEPTRA), who on 15-JUN-2007 was vaccinated with Gardasil. Concomitant vaccinations given on 15-JUN-2007 included the first dose of Havrix (lot number AHAVB163B) given in the left arm. The patient had not experienced any adverse events following previous vaccinations. On 15-JUN-2007, less than one day after vaccinations the patient experienced generalized tonic clonic seizures, urinary incontinence and "tonic" cyanosis. The patient experienced the seizure while sitting in the waiting room after her vaccinations were administered. The patient was treated with oxygen and went to the emergency room and was later released. At the time of this report, the patient's vital signs were stable and the events were resolved. The events were felt to be serious for an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Cyanosis, Grand mal convulsion, Urinary incontinence
Clinical narrative: Information has been received from a registered nurse via Glaxo Smith Kline concerning a 15 year old female with a history of neurocardiogenic syncope and hives after therapy with sulfamethoxazole (+) trimethoprim (SEPTRA), who on 15-JUN-2007 was vaccinated with Gardasil. Concomitant vaccinations given on 15-JUN-2007 included the first dose of Havrix (lot number AHAVB163B) given in the left arm. The patient had not experienced any adverse events following previous vaccinations. On 15-JUN-2007, less than one day after vaccinations the patient experienced generalized tonic clonic seizures, urinary incontinence and "tonic" cyanosis. The patient experienced the seizure while sitting in the waiting room after her vaccinations were administered. The patient was treated with oxygen and went to the emergency room and was later released. At the time of this report, the patient's vital signs were stable and the events were resolved. The events were felt to be serious for an other important medical event. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram normal, Culture urine negative, Dyskinesia
Clinical narrative: Had episodes of twitching, characterized by head denoting to Left with twitching of left shoulder and some rolling back of eyes, which occurred numerous times and only seconds in duration each time. Continue to have episodes of head rolling, although decrease in frequency (at 5 days after vaccines). 60 day Follow-up Information 24-OCT-2007: Unsure if symptoms vaccine related. 8/1/07-records received from facility for DOS 6/26-7/6/07-DC summary not available. Presented to ER with abnormal movement of shoulder and head toward left. Temp 100.2.8/15/07-DC summary received for DOS-6/26-6/30/07. DC DX: Viral versus behavioral tick. No evidence of post vaccine seizure at this time. Runny nose for last several days. Temp 100.2 low grade fever in ER.
Age: 0.53
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5
Symptoms: Gaze palsy, Muscle twitching
Clinical narrative: Had episodes of twitching, characterized by head denoting to Left with twitching of left shoulder and some rolling back of eyes, which occurred numerous times and only seconds in duration each time. Continue to have episodes of head rolling, although decrease in frequency (at 5 days after vaccines). 60 day Follow-up Information 24-OCT-2007: Unsure if symptoms vaccine related. 8/1/07-records received from facility for DOS 6/26-7/6/07-DC summary not available. Presented to ER with abnormal movement of shoulder and head toward left. Temp 100.2.8/15/07-DC summary received for DOS-6/26-6/30/07. DC DX: Viral versus behavioral tick. No evidence of post vaccine seizure at this time. Runny nose for last several days. Temp 100.2 low grade fever in ER.
Age: 0.53
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5
Symptoms: Blood culture negative, CSF culture negative, Computerised tomogram normal, Convulsion, Culture urine negative
Clinical narrative: Had episodes of twitching, characterized by head denoting to Left with twitching of left shoulder and some rolling back of eyes, which occurred numerous times and only seconds in duration each time. Continue to have episodes of head rolling, although decrease in frequency (at 5 days after vaccines). 60 day Follow-up Information 24-OCT-2007: Unsure if symptoms vaccine related. 8/1/07-records received from facility for DOS 6/26-7/6/07-DC summary not available. Presented to ER with abnormal movement of shoulder and head toward left. Temp 100.2.8/15/07-DC summary received for DOS-6/26-6/30/07. DC DX: Viral versus behavioral tick. No evidence of post vaccine seizure at this time. Runny nose for last several days. Temp 100.2 low grade fever in ER.
Age: 0.53
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5
Symptoms: Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Gaze palsy, Head titubation
Clinical narrative: Had episodes of twitching, characterized by head denoting to Left with twitching of left shoulder and some rolling back of eyes, which occurred numerous times and only seconds in duration each time. Continue to have episodes of head rolling, although decrease in frequency (at 5 days after vaccines). 60 day Follow-up Information 24-OCT-2007: Unsure if symptoms vaccine related. 8/1/07-records received from facility for DOS 6/26-7/6/07-DC summary not available. Presented to ER with abnormal movement of shoulder and head toward left. Temp 100.2.8/15/07-DC summary received for DOS-6/26-6/30/07. DC DX: Viral versus behavioral tick. No evidence of post vaccine seizure at this time. Runny nose for last several days. Temp 100.2 low grade fever in ER.
Age: 0.53
Sex: F
Vaccine: DTAP, HEP, IPV, PNC, RVX, DTAP, HEP, IPV, PNC, RV5
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Had episodes of twitching, characterized by head denoting to Left with twitching of left shoulder and some rolling back of eyes, which occurred numerous times and only seconds in duration each time. Continue to have episodes of head rolling, although decrease in frequency (at 5 days after vaccines). 60 day Follow-up Information 24-OCT-2007: Unsure if symptoms vaccine related. 8/1/07-records received from facility for DOS 6/26-7/6/07-DC summary not available. Presented to ER with abnormal movement of shoulder and head toward left. Temp 100.2.8/15/07-DC summary received for DOS-6/26-6/30/07. DC DX: Viral versus behavioral tick. No evidence of post vaccine seizure at this time. Runny nose for last several days. Temp 100.2 low grade fever in ER.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Pain
Clinical narrative: Pt is running low grade temp and body aches the day after he received the Adacel and Menactra.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Erythema, Headache, Nausea, Pain
Clinical narrative: Nausea, swelling, redness, pain, headache, vomiting, loose stools
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Vomiting
Clinical narrative: Nausea, swelling, redness, pain, headache, vomiting, loose stools
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Conjunctivitis, Diarrhoea, Kawasaki's disease, Nasal congestion, Pharyngeal erythema
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 25-APR-2007 was vaccinated with an oral 2 ml dose of Rotateq (Lot# 656194/0024U). Concomitant therapy included aspirin, corticosteroids (unspecified), and globulin, immune, IV. On 27-APR-2007, two days after taking Rotateq the patient had a fever and congestion. Then on 02-MAY-2007 the patient still had a fever and also developed a red throat. When the physician saw the patient on 01-JUN-2007, the fever was still there, and the patient had a rash, congestion, diarrhea, and conjunctivitis in the eyes. On 12-JUN-2007 the patient fever still continued and he had thrombocytopenia. Also on 12-JUN-2007 the patient went to the emergency room. While in the emergency room the patient was diagnosed with Kawaski syndrome. The patient had two huge cornea aneurysms. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be life threatening by the reporter. A lot check has been requested. Additional information has been requested. 7/25/07-records received without DC summary. Consulation report 3 month old admitted on 6/13/07 for Kawasaki Disease. Fifteen days prior to admission began with fever max of 102.7 on first day of illness. Daily fevers between 100-101. Fine rash over trunk and dorsum hands. Bilateral conjunctivitis. Over course of illness developed intermittent cracked lips with occasional bleeding followed by pale appearance was reportedly gummy. Cyclic resulting in return of cracked lips and bleeding. Fussy. On day 15 in ED noted to have desquamation of fingertips and toes. RX with IVIG.  12/17/07-DC summary received for DOS 6/13-6/20/07-DC DX Kawasaki Disease
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Pyrexia, Rash, Thrombocytopenia
Clinical narrative: Information has been received from a physician concerning a 9 week old male who on 25-APR-2007 was vaccinated with an oral 2 ml dose of Rotateq (Lot# 656194/0024U). Concomitant therapy included aspirin, corticosteroids (unspecified), and globulin, immune, IV. On 27-APR-2007, two days after taking Rotateq the patient had a fever and congestion. Then on 02-MAY-2007 the patient still had a fever and also developed a red throat. When the physician saw the patient on 01-JUN-2007, the fever was still there, and the patient had a rash, congestion, diarrhea, and conjunctivitis in the eyes. On 12-JUN-2007 the patient fever still continued and he had thrombocytopenia. Also on 12-JUN-2007 the patient went to the emergency room. While in the emergency room the patient was diagnosed with Kawaski syndrome. The patient had two huge cornea aneurysms. No product quality complaint was involved. No other information was provided. The patient's experiences were considered to be life threatening by the reporter. A lot check has been requested. Additional information has been requested. 7/25/07-records received without DC summary. Consulation report 3 month old admitted on 6/13/07 for Kawasaki Disease. Fifteen days prior to admission began with fever max of 102.7 on first day of illness. Daily fevers between 100-101. Fine rash over trunk and dorsum hands. Bilateral conjunctivitis. Over course of illness developed intermittent cracked lips with occasional bleeding followed by pale appearance was reportedly gummy. Cyclic resulting in return of cracked lips and bleeding. Fussy. On day 15 in ED noted to have desquamation of fingertips and toes. RX with IVIG.  12/17/07-DC summary received for DOS 6/13-6/20/07-DC DX Kawasaki Disease
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Full blood count, Haemoglobin, Haemoglobin electrophoresis, Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner, concerning a 10 year old male patient with sickle cell anaemia and a seizure disorder, who on 18-JUN-2007 was vaccinated SQ in the right arm, with a dose, 0.5ml, of Pneumovax 23 (Lot # not provided). Concomitant therapy included folic acid and TRILEPTAL. At the time of injection, the patient experienced pain, redness and swelling at the injection site, and later in the evening of the same day, 18-JUN-2007, he experienced pain, redness, and swelling of his right arm. The child's mother treated him with TYLENOL. On 20-JUN-2007, the child's mother took him to the hospital for evaluation. The child did not have a fever, but was admitted to the hospital to rule out "sepsis, sickle cell crisis, or allergy to (pneumococcal 23v polysaccharide vaccine)." Diagnostic testing was performed, though no results were provided. Treatment included ceftriaxone (manufacturer not specified). On 24-JUN-2007, the child was considered to be "fully recovered," and was released from the hospital. Additional information has been requested. 18-Jun-2007 complete blood cell count, 18-Jun-2007 blood culture, 18-Jun-2007 whole blood hemoglobin electrophoresis test, 18-Jun-2007 upper extremity X-ray, 18-Jun-2007 blood reticulocyte count.