chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.55
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Incorrect dose administered, No adverse reaction
Clinical narrative: Pt was given 0.5 ml of influenza vaccine instead of 0.25 ml. Called CDC was told dose counts and possible positive local reaction. 10-31-07 no reaction per parents.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Fluid retention, Induration, Ultrasound Doppler normal
Clinical narrative: Pt went to ER 10-27-07 c/o left arm redness; ER doctor states;"pt has some erythema surrounding this with a sharply demarcated border consistent with mild cellulitis approximately 10 cm in diameter, no significant lymphadenopathy in area but dose have an indurated area in left axilla.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10-29-07 when she went to bed felt uncomfortable when she layed on her left side. After her bath this morning at 0700 noticed red puffy area below bandaid where received injections. 10/31/07 1150 70mm x 5511 erythema warm to the touch. 10/31/07 0900 totally resolved. No further issues.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Allergy test, Immunology test, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: C/O redness, itchy and swelling around injection site 10/18/07 am. Seen by MD 10/19/07 at 400 pm. "Vaccine rx with hives may also represent Amoxil Rxn but coincident with vaccine". Benadryl and cool compresses.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: C/O redness, itchy and swelling around injection site 10/18/07 am. Seen by MD 10/19/07 at 400 pm. "Vaccine rx with hives may also represent Amoxil Rxn but coincident with vaccine". Benadryl and cool compresses.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: Arm swelling L, and 2 pitting edema, erythema, severe itching and moderate induration at injection site 27 hrs post vaccination. Tx'd with IM Benadryl and Prednisone 20 mg PO X 5d at first visit. Subsequent visits tx with PO Benadryl.
Age: 1.3
Sex: M
Vaccine: DTAPH, HIBV, PNC
Symptoms: Injection site rash, Irritability, Pyrexia
Clinical narrative: Fever to 102 cranky, fever decreased with Tylenol. Rash on R thigh at immunization site.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site swelling, Joint swelling
Clinical narrative: Local redness/swelling, R elbow pain/redness/swelling, R fingers swelling in DIP'S, red rash on hand, axillary adenopathy.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Local redness/swelling, R elbow pain/redness/swelling, R fingers swelling in DIP'S, red rash on hand, axillary adenopathy.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redo IMMS 10/15/07 then 10/16/07 developed large red itchy area on back of R Thigh. Follow up 10/18/07, redness and swelling decreased. 10/22/07 no swelling, no redness, no itching.
Age: 39.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Felt tenderness L upper arm while showering 10/25/07. Then, felt warmth and tenderness and area raised approx size of orange in Left upper arm.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Mother reports tennis ball size area of redness on L arm at site of immunization.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Rash macular, Skin warm, Swelling
Clinical narrative: Temp 99 deg, R arm red, swollen hot "splotchy" 3-4 inches in diameter.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pain
Clinical narrative: After receiving the shot, entire body was extremely sore, large red swelling around shot area, general feeling of illness for about one week.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Localized reaction - redness and swelling at vaccine site.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Scab, Skin lesion, Varicella
Clinical narrative: Varicella vaccine breakthrough. Had varicella vaccine on 9-4-03 and 8-28-07. Diagnosed with varicella on 10-22-07. Had 6 papular-lesions on shoulder and back, some with pustules, one with scab. Afebrile.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Shortly after shot, my arm started to swell and get red and itched a lot -hives (pneumonia shot). Pt. does not have and cannot get the info req.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness and swelling on the right delt.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Burning sensation, Hypokinesia, Musculoskeletal pain, Neck pain
Clinical narrative: Began with onset of heaviness (R) arm with decreased R.O.M. Progressed to pain circling shoulder joint and radiating down to (R) elbow and up to (R) side of neck. Now has soreness, burning sensation from (R) shoulder to elbow. Denies numbness or weakness. Applying ice pack intermittently with relief.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Sensation of heaviness
Clinical narrative: Began with onset of heaviness (R) arm with decreased R.O.M. Progressed to pain circling shoulder joint and radiating down to (R) elbow and up to (R) side of neck. Now has soreness, burning sensation from (R) shoulder to elbow. Denies numbness or weakness. Applying ice pack intermittently with relief.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema, Pain
Clinical narrative: local edema erythema and pain resolved on its on per pt
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Hypersensitivity, Skin warm, Swelling
Clinical narrative: allergic rx, area of infection red warm and swollen w/poss. early cellulitis.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received DTaP instead of Tdap.
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received DTaP instead of Tdap.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Patient received DTaP instead of Tdap. 10-30-07 headache, arm pain. Given Tylenol
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Patient received DTaP instead of Tdap.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Musculoskeletal pain, Pyrexia, Tremor
Clinical narrative: Intense pain in shoulder socket upon movement. Pain 10 out of 10. No redness/swelling reported-Fever/chills present for about 6 hours with shaking. Still complained of joint pain. Had influenza vaccine
Age: 1.0
Sex: M
Vaccine: DT
Symptoms: Disorientation, Fall
Clinical narrative: This case was reported on 14 September 2007 by the patient's mother, who is a health professional. A 12-month-old male patient with no reported medical history received "DT or DTaP", (lot number reported as U1577CA) on 30 May 2006. Vaccine was administered in the morning; by early evening, the patient's mother noted that the child became "very disoriented", and "would walk and then spontaneously fall down at times". The symptoms continued for three days, and subsequently received. No additional information was provided.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Headache, Meningitis viral, Migraine, Nausea, Tenderness
Clinical narrative: Received flu shot on 10/02/07 four hours later became ill very bad pressure headache dizziness vomiting. Three days later was admitted to hospital with temporary vision loss in one eye and other symptoms above. Hospitalized for 10 days. I have viral meningitis as of Oct 29, 07 still have pressure headache that has never gone. I have some hearing loss in one ear.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vertigo
Clinical narrative: Received flu shot on 10/02/07 four hours later became ill very bad pressure headache dizziness vomiting. Three days later was admitted to hospital with temporary vision loss in one eye and other symptoms above. Hospitalized for 10 days. I have viral meningitis as of Oct 29, 07 still have pressure headache that has never gone. I have some hearing loss in one ear.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blindness transient, Deafness unilateral, Dizziness, Headache, Malaise
Clinical narrative: Received flu shot on 10/02/07 four hours later became ill very bad pressure headache dizziness vomiting. Three days later was admitted to hospital with temporary vision loss in one eye and other symptoms above. Hospitalized for 10 days. I have viral meningitis as of Oct 29, 07 still have pressure headache that has never gone. I have some hearing loss in one ear.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Meningitis viral, Vomiting
Clinical narrative: Received flu shot on 10/02/07 four hours later became ill very bad pressure headache dizziness vomiting. Three days later was admitted to hospital with temporary vision loss in one eye and other symptoms above. Hospitalized for 10 days. I have viral meningitis as of Oct 29, 07 still have pressure headache that has never gone. I have some hearing loss in one ear.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Ear discomfort, Headache, Intracranial pressure increased, Meningitis aseptic
Clinical narrative: Received flu shot on 10/02/07 four hours later became ill very bad pressure headache dizziness vomiting. Three days later was admitted to hospital with temporary vision loss in one eye and other symptoms above. Hospitalized for 10 days. I have viral meningitis as of Oct 29, 07 still have pressure headache that has never gone. I have some hearing loss in one ear.
Age: 38.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tinnitus, Vertigo, Vomiting
Clinical narrative: Received flu shot on 10/02/07 four hours later became ill very bad pressure headache dizziness vomiting. Three days later was admitted to hospital with temporary vision loss in one eye and other symptoms above. Hospitalized for 10 days. I have viral meningitis as of Oct 29, 07 still have pressure headache that has never gone. I have some hearing loss in one ear.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Abnormal behaviour, Cardiac arrest, Convulsion, Death, Respiratory failure
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of death in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The subject was an "apparently healthy child." The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received no other vaccinations on 29 October 2007. On the morning of 29 October 2007 the subject received unspecified dose of Havrix (.5 ml or 720 EU, unknown). Following the vaccination, the subject left the office. On 29 October 2007, less than one day after vaccination with Havrix, the mother and child went shopping and the child experienced abnormal behavior, described as acting unusual. The mother returned to the pediatric office with the child and the child "coded" (cardio-respiratory collapse) while in the office. An office physician resuscitated the child and transported the child to the emergency room in her personal car. The emergency room at the hospital was very close to the pediatric office, less than one block. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject received life support during the hospitalization. On either 30 October 2007 or 31 October 2007, the subject was taken off life support and expired. The cause of death was not provided. An autopsy is being performed, however, results were not provided at the time of this initial report. The healthcare professional noted that this office utilized 300 doses of Havrix from an order of 700 doses without any other incidents and considered the events from this subject a product complaint. The physician's office noted to the sales representative that, "there is no way to have known this child would have reacted in this way." The parents of the subject believe the events were vaccine-related. The healthcare professional considered the events were possibly related to vaccination with Havrix.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Abnormal behaviour, Autopsy, Cardiac arrest, Death, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of death in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The subject was an "apparently healthy child." The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received no other vaccinations on 29 October 2007. On the morning of 29 October 2007 the subject received unspecified dose of Havrix (.5 ml or 720 EU, unknown). Following the vaccination, the subject left the office. On 29 October 2007, less than one day after vaccination with Havrix, the mother and child went shopping and the child experienced abnormal behavior, described as acting unusual. The mother returned to the pediatric office with the child and the child "coded" (cardio-respiratory collapse) while in the office. An office physician resuscitated the child and transported the child to the emergency room in her personal car. The emergency room at the hospital was very close to the pediatric office, less than one block. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject received life support during the hospitalization. On either 30 October 2007 or 31 October 2007, the subject was taken off life support and expired. The cause of death was not provided. An autopsy is being performed, however, results were not provided at the time of this initial report. The healthcare professional noted that this office utilized 300 doses of Havrix from an order of 700 doses without any other incidents and considered the events from this subject a product complaint. The physician's office noted to the sales representative that, "there is no way to have known this child would have reacted in this way." The parents of the subject believe the events were vaccine-related. The healthcare professional considered the events were possibly related to vaccination with Havrix.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Resuscitation
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of death in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The subject was an "apparently healthy child." The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received no other vaccinations on 29 October 2007. On the morning of 29 October 2007 the subject received unspecified dose of Havrix (.5 ml or 720 EU, unknown). Following the vaccination, the subject left the office. On 29 October 2007, less than one day after vaccination with Havrix, the mother and child went shopping and the child experienced abnormal behavior, described as acting unusual. The mother returned to the pediatric office with the child and the child "coded" (cardio-respiratory collapse) while in the office. An office physician resuscitated the child and transported the child to the emergency room in her personal car. The emergency room at the hospital was very close to the pediatric office, less than one block. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject received life support during the hospitalization. On either 30 October 2007 or 31 October 2007, the subject was taken off life support and expired. The cause of death was not provided. An autopsy is being performed, however, results were not provided at the time of this initial report. The healthcare professional noted that this office utilized 300 doses of Havrix from an order of 700 doses without any other incidents and considered the events from this subject a product complaint. The physician's office noted to the sales representative that, "there is no way to have known this child would have reacted in this way." The parents of the subject believe the events were vaccine-related. The healthcare professional considered the events were possibly related to vaccination with Havrix.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Brain death, Cardiac arrest, Computerised tomogram abnormal, Convulsion, Death
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of death in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The subject was an "apparently healthy child." The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received no other vaccinations on 29 October 2007. On the morning of 29 October 2007 the subject received unspecified dose of Havrix (.5 ml or 720 EU, unknown). Following the vaccination, the subject left the office. On 29 October 2007, less than one day after vaccination with Havrix, the mother and child went shopping and the child experienced abnormal behavior, described as acting unusual. The mother returned to the pediatric office with the child and the child "coded" (cardio-respiratory collapse) while in the office. An office physician resuscitated the child and transported the child to the emergency room in her personal car. The emergency room at the hospital was very close to the pediatric office, less than one block. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject received life support during the hospitalization. On either 30 October 2007 or 31 October 2007, the subject was taken off life support and expired. The cause of death was not provided. An autopsy is being performed, however, results were not provided at the time of this initial report. The healthcare professional noted that this office utilized 300 doses of Havrix from an order of 700 doses without any other incidents and considered the events from this subject a product complaint. The physician's office noted to the sales representative that, "there is no way to have known this child would have reacted in this way." The parents of the subject believe the events were vaccine-related. The healthcare professional considered the events were possibly related to vaccination with Havrix.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Hypoxia, Intensive care, Intubation, Ischaemia, Mydriasis
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of death in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The subject was an "apparently healthy child." The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received no other vaccinations on 29 October 2007. On the morning of 29 October 2007 the subject received unspecified dose of Havrix (.5 ml or 720 EU, unknown). Following the vaccination, the subject left the office. On 29 October 2007, less than one day after vaccination with Havrix, the mother and child went shopping and the child experienced abnormal behavior, described as acting unusual. The mother returned to the pediatric office with the child and the child "coded" (cardio-respiratory collapse) while in the office. An office physician resuscitated the child and transported the child to the emergency room in her personal car. The emergency room at the hospital was very close to the pediatric office, less than one block. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject received life support during the hospitalization. On either 30 October 2007 or 31 October 2007, the subject was taken off life support and expired. The cause of death was not provided. An autopsy is being performed, however, results were not provided at the time of this initial report. The healthcare professional noted that this office utilized 300 doses of Havrix from an order of 700 doses without any other incidents and considered the events from this subject a product complaint. The physician's office noted to the sales representative that, "there is no way to have known this child would have reacted in this way." The parents of the subject believe the events were vaccine-related. The healthcare professional considered the events were possibly related to vaccination with Havrix.
Age: 3.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Pulse absent, Pupil fixed, Resuscitation, Ventricular fibrillation
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of death in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The subject was an "apparently healthy child." The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject received no other vaccinations on 29 October 2007. On the morning of 29 October 2007 the subject received unspecified dose of Havrix (.5 ml or 720 EU, unknown). Following the vaccination, the subject left the office. On 29 October 2007, less than one day after vaccination with Havrix, the mother and child went shopping and the child experienced abnormal behavior, described as acting unusual. The mother returned to the pediatric office with the child and the child "coded" (cardio-respiratory collapse) while in the office. An office physician resuscitated the child and transported the child to the emergency room in her personal car. The emergency room at the hospital was very close to the pediatric office, less than one block. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject received life support during the hospitalization. On either 30 October 2007 or 31 October 2007, the subject was taken off life support and expired. The cause of death was not provided. An autopsy is being performed, however, results were not provided at the time of this initial report. The healthcare professional noted that this office utilized 300 doses of Havrix from an order of 700 doses without any other incidents and considered the events from this subject a product complaint. The physician's office noted to the sales representative that, "there is no way to have known this child would have reacted in this way." The parents of the subject believe the events were vaccine-related. The healthcare professional considered the events were possibly related to vaccination with Havrix.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a healthcare worker concerning a 66 year old female with no pertinent medical history or drug reactions/allergies who on 20-OCT-2007 was vaccinated with Pneumovax 23 (lot# 655765/0061U) 0.5 mL injection. There was no concomitant medication. On 22-OCT-2007, 2 days after being vaccinated the patient experienced swelling from her shoulder to elbow which extended to her chest area. Medical attention was sought. No further information was provided. At the time of reporting it was unknown if the patient had recovered. The reporter felt that swelling from the shoulder to elbow which extended to the chest area was considered to be disabling. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site mass, Laboratory test, Pyrexia, Syncope
Clinical narrative: Information has been received from a registered nurse, concerning a 45 year old female patient who on 11-SEP-2007 was vaccinated SQ with a dose, 0.5 ml, of Pneumovax 23 (lot #655500/1005F). On 11-SEP-2007, within a few hours of the vaccination, the patient developed a high fever (value not provided), and collapsed at home. She was taken to the emergency room (ER) and was diagnosed with large cellulitis of the arm (treatment not specified). After an unknown duration of time, the patient returned to the ER because "the area was worsening." Treatment included intravenous fluids and an unspecified intravenous antibiotics. On 18-SEP-2007, the patient was seen in the office and was improving. On approximately 23-OCT-2007 (possibly 24-OCT-2007), she still reported a "knot" in her arm at the injection site. The reporting RN considered the events to be immediately life-threatening and an other important medical event. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a registered nurse, concerning a 45 year old female patient who on 11-SEP-2007 was vaccinated SQ with a dose, 0.5 ml, of Pneumovax 23 (lot #655500/1005F). On 11-SEP-2007, within a few hours of the vaccination, the patient developed a high fever (value not provided), and collapsed at home. She was taken to the emergency room (ER) and was diagnosed with large cellulitis of the arm (treatment not specified). After an unknown duration of time, the patient returned to the ER because "the area was worsening." Treatment included intravenous fluids and an unspecified intravenous antibiotics. On 18-SEP-2007, the patient was seen in the office and was improving. On approximately 23-OCT-2007 (possibly 24-OCT-2007), she still reported a "knot" in her arm at the injection site. The reporting RN considered the events to be immediately life-threatening and an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a physician, concerning her relative, a "15 or 16" year old female student with acne, who on an unknown date was vaccinated with the second dose of Gardasil (lot # not provided). Concomitant therapy included doxycycline byclate (DORYX). Following the vaccination, the student experienced arm pain, lightheadedness, generalized body numbness and a shuffling gait. The student also planned to see her family physician. At the time of this report, the student had not recovered from the events. The physician considered the events to be disabling, as the student had missed time in school. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with papilloma viral infection, depression, and no drug allergies, who on 10-SEP-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot# 658556/1060U). There was no concomitant medication. Subsequently, the patient believed that she had become pregnant on the same day as the vaccination. On 08-OCT-2007 a pregnancy test was performed and was positive. The patient's last menstrual period was 27-AUG-2007 and her estimated delivery date was 02-JUN-2008. On 20-OCT-2007 the patient had a miscarriage. No other symptoms were noted. The patient had an office visit. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review miscarriage was considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Electrocardiogram, Pain in extremity, Pain in jaw
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who "one week ago" was vaccinated with a first dose of Gardasil. Concomitant therapy included Menactra. Subsequently, the patient developed arm and jaw pain while she was still in the office. The patient was taken to the emergency room and released on the same day. An electrocardiogram was performed (no results provided). The patient recovered on an unspecified date. No product quality complaint was involved. The physician considered the arm and jaw pain to be other important medical events. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received from a nurse for the Pregnancy Registry for Gardasil concerning a 24 year old female who on 27-NOV-2006 was vaccinated, intramuscularly in the upper quadrant of the left arm, with a 0.5 mL first dose of Gardasil (lot # 653650/0702F). There was no concomitant medication. On 22-JAN-2007 the patient was vaccinated intramuscularly in the upper quadrant of the left arm with a second 0.5 mL dose of Gardasil (lot # 653650/0702F). On 06-MAR-2007 the patient presented to the office stating that on 06-FEB-2007 she had taken a urine pregnancy test in her primary care physician's office which was positive (LMP: 26-DEC-2006; EDD: 02-OCT-2007). Follow-up information indicated that on 19-SEP-2007 the patient delivered the baby via cesarean section. The baby was reported to be healthy. Upon internal review cesarean section was considered to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow-up information has been received through the Merck pregnancy registry from a physician and a nurse concerning a 25 year old female with drug hypersensitivity to aspirin with a history of 3 pregnancies and 1 live birth (2 terminations of pregnancy) who on 18-DEC-2006 was vaccinated with a first 0.5 ml dose of Gardasil (lot reported as "1101F"). There was no concomitant medication. On an unspecified date, the patient took a home pregnancy test and it was positive. On 09-JAN-2007 the patient was seen in the physician's office and blood test was drawn for pregnancy (results not reported). The patient's last menstrual period was 09-DEC-2006 and estimated date of delivery is 15-SEP-2007. The physician reported that he was going to tell the patient to terminate the pregnancy. Follow-up reported that on an unspecified date the patient terminated the pregnancy. Upon internal review, terminated pregnancy was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: PNC
Symptoms: Culture, Empyema
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a pediatrician regarding an 18-month-old patient who experienced empyema, drug effective. The patient received the fourth dose on an unspecified date. The patient experienced empyema, on an unknown on an unknown date in 2007. Unspecified cultures were performed, however the results were not reported. Treatments were not reported and the outcome of empyema was unknown. No further information was available at the time of the report. Culture (results: not reported) was done in Oct-2007.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood count normal, Electrocardiogram normal, Injection site erythema, Loss of consciousness, Pyrexia
Clinical narrative: Vaccinated with influenza and PPV23 on 10/12/07.  Fever on 10/12 through 10/17.  On Sunday, 10/14/07 experienced fever of 102.8 degrees. By 10/14/07, reddened area at injection site - approx 2 cms progressing to reddened oval area from site to elbow of right arm (PPV23 administered in right arm subcutaneously).  "Passed outfor a few minutes" early Sunday, 10/14/07.  Presented on Sunday.  No meds given.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urine analysis normal
Clinical narrative: Vaccinated with influenza and PPV23 on 10/12/07.  Fever on 10/12 through 10/17.  On Sunday, 10/14/07 experienced fever of 102.8 degrees. By 10/14/07, reddened area at injection site - approx 2 cms progressing to reddened oval area from site to elbow of right arm (PPV23 administered in right arm subcutaneously).  "Passed outfor a few minutes" early Sunday, 10/14/07.  Presented on Sunday.  No meds given.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: C-reactive protein normal, Corneal dystrophy, Fatigue, Headache, Musculoskeletal chest pain
Clinical narrative: Patient received flu & pneumo vaccine on 10-30-07. Came to office on 10-31-07 with generalized pain whole body and fatigue which started 10-30-07 in the afternoon after getting flu/pneumo. Slight headache. Started in arms, now whole body. Positive rib pain with movement. No fever or nausea. Has had flu shot previously with no problems.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Patient received flu & pneumo vaccine on 10-30-07. Came to office on 10-31-07 with generalized pain whole body and fatigue which started 10-30-07 in the afternoon after getting flu/pneumo. Slight headache. Started in arms, now whole body. Positive rib pain with movement. No fever or nausea. Has had flu shot previously with no problems.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: 10/29/07-woke up at night (does not know time) left bicep hurt. Left Bicep became red & hot. 10/30/07- Left Bicep became swollen.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Blister, Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: developed varicella disease (fever, vesicles) 11 days after administration of the disease
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain, Skin warm, Tenderness
Clinical narrative: Patient's left arm was erythemic, swollen, and warm.  The patient comlained of slight pain and tenderness in the area.  The affected area covered the top part of her arm.  Patient has taken Tavist and is using Benadryl cream.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt. complained of pain in arm
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Within 18 hours of vaccination I developed high fever (103F), shaking chills, arthralgia, head and neck pain, muscle pain, fatigue.  Symptoms lasted 2 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pyrexia, Tremor
Clinical narrative: Within 18 hours of vaccination I developed high fever (103F), shaking chills, arthralgia, head and neck pain, muscle pain, fatigue.  Symptoms lasted 2 days.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: C-reactive protein increased, Cardiac enzymes increased, Catheterisation cardiac normal, Computerised tomogram normal, Drug screen negative
Clinical narrative: myocardial infarction and possible myositis 2 days after adacel vaccine 11/1/07-records received for DOS 8/19-8/22/07- DC DX:Acute coronary syndrome. Presented to ED with 24 hour history of midsternal chest pain.  Received a tetanus shot one week prior and it is conceivable that this may be an inflammatory myocarditis. Per 60 day follow up: Patient has not returned for follow up after hospitalization.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocardial infarction, Red blood cell sedimentation rate increased
Clinical narrative: myocardial infarction and possible myositis 2 days after adacel vaccine 11/1/07-records received for DOS 8/19-8/22/07- DC DX:Acute coronary syndrome. Presented to ED with 24 hour history of midsternal chest pain.  Received a tetanus shot one week prior and it is conceivable that this may be an inflammatory myocarditis. Per 60 day follow up: Patient has not returned for follow up after hospitalization.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Blister, Blood test, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: My son received the varicella vaccine on 10/17/07 and began to break out with bump/blisters on 10/25/07.  I had to take him to the ER with a fever of 104.3 on 10/27/07 since that day I could not get it to go down below 103.0 with meds.  I also noticed on that day that i had a few bumps breaking out I went to my physician on 10/29/07 with bumps/blisters, who stated that this could be or is chicken pox.  She said she was unsure what to do since I did have the disease as a child.  I have checked around and the vaccine that my son received was dead and therefore he should not of been able to transmit that disease to anyone else.  They are stating that this is a adverse secondary infection and I was thinking that it would be a good idea to report this to the CDC since this should not be something that happens after a child receives a dead vaccine.  The vaccine was given to my son as part of his 12 month vaccination.  He also received that day a few other vaccines that I have also given you the manufacturer and lot number for.  Also he had a very large red raised area around the injection site that is still is their on 11-1-07 but it looks as if it is finally starting to fade the size of the redened area would be about the size of a nickel.  I have also called and asked that his physican note this reaction in his chart.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Secondary transmission, Skin lesion, Varicella
Clinical narrative: My son received the varicella vaccine on 10/17/07 and began to break out with bump/blisters on 10/25/07.  I had to take him to the ER with a fever of 104.3 on 10/27/07 since that day I could not get it to go down below 103.0 with meds.  I also noticed on that day that i had a few bumps breaking out I went to my physician on 10/29/07 with bumps/blisters, who stated that this could be or is chicken pox.  She said she was unsure what to do since I did have the disease as a child.  I have checked around and the vaccine that my son received was dead and therefore he should not of been able to transmit that disease to anyone else.  They are stating that this is a adverse secondary infection and I was thinking that it would be a good idea to report this to the CDC since this should not be something that happens after a child receives a dead vaccine.  The vaccine was given to my son as part of his 12 month vaccination.  He also received that day a few other vaccines that I have also given you the manufacturer and lot number for.  Also he had a very large red raised area around the injection site that is still is their on 11-1-07 but it looks as if it is finally starting to fade the size of the redened area would be about the size of a nickel.  I have also called and asked that his physican note this reaction in his chart.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Muscular weakness, Paraesthesia
Clinical narrative: TEENAGER RECIEVED MENACTRA VACCINE ON 8/8/2007. PER PARENT REPORT IN ABOUT 12 HRS SHE DEVELOPED TINGLING IN FINGERS, HEADACHE AND WEAKNESS IN EXTREMITIES. ADMITTED TO HOSPITAL FOR GUILLAIN-BARRE SYNDROME.  11/16/07 Reviewed hospital medical records which reveal paitent experienced LE paralysis & paresthesias day after vax.  Admitted 8/9-8/12/2007.  Intensivist consult done in ER & dx as probably early GBS. Paralysis resolved on admit. Tx w/IVIG but patient developed high fever & tachycardia & IVIG was d/c'd.  Then developed bradycardia which resolved by next day.  Neuro consults x 2 done & neither agreed w/GBS dx.  FINAL DX: acute paralysis of LE's, resolved; reaction to IVIG, resolved; fever, resolved; bradycardia, resolved.
Age: 52.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Unevaluable event
Clinical narrative: appt reminder call reveals pt had unknown rxn to IZ, to the point that his state dept (National Security) trip to the middle east was cancelled per Dr. recommendation and appt cancelled for further boosters.Unknown if previously reported.Other details unknown.
Age: 7.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Limb discomfort, Skin warm
Clinical narrative: Mother reports extreme left arm discomfort from time of injection for 3 days.   Day after injection had temp of 101.2 for 4 hours.   2 days after injection arm bright red, hot area 3" x 3";  lasted 48 hours.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Local swelling, Pain in extremity, Swelling
Clinical narrative: reorted on 10/29 that she received a flu shot 10/22 @ employee flu clinic. Had soreness and swelling that afternoon. Next day shes said she had swelling @ site; on 10/24 noticed swelling in L neck area. Had some soreness in that area, but not a present. Still has minior swelling in that area. To make appointment with PMD. No fever after flu shot or at present.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Client passed away today.  Cause of death unknown at this time.  An autopsy is to be performed down state.  8/18/09 Autopsy report 11/02/06. Additional information abstracted: Medical complications of omphalocele. History of repair of congenital omphalocele. Severe abdominal adhesions with extensive dilation of loops of small and large intestine. Status post gastrostomy tube placement. Acute proximal and distal convoluted tubular necrosis of kidneys. Extensive intersitial calcification of kidneys.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood pressure decreased, Fall, Feeling hot, Nausea, Pallor
Clinical narrative: After recieving Tdap and HPV4 vaccines, patient stood to leave and became pale and began to fall. She was assisted to a sitting position and aroused with an ammonia capsule.  She stated she felt nauseous and hot. She was assisted to a lying position with feet elevated. B/P was 98/52 Pulse was 66.  Cool compress applied. After 10 minutes B/P was 100/60.  Juice was offered.  After 10 minutes B/P/ 100/64.  Pt assisted to personel vehicle by mother and clinic RN.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood urine present, Computerised tomogram, Herpes zoster, Nuclear magnetic resonance imaging
Clinical narrative: Friday, October 26th, 2007 = Intense stomach pain.  Monday, October 29th, 2007 = Continued pain and prescence of a rash.  Went to emergency room and had tests listed below.  Was shown to have blood in the urine and given Bactrim DS and Vicodin.  Tuesday, October 30th, 2007 went to primary care physician and was diagnosed with shingles.  Given Gabapentin and Famvir as treatment.  As of today's date, Thursday, November 1st, 2007, patient is experiencing less pain and rash is "less blotchy".  Patient says symptoms "come and go" and she just paces herself with day to day activities.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Ultrasound scan
Clinical narrative: Friday, October 26th, 2007 = Intense stomach pain.  Monday, October 29th, 2007 = Continued pain and prescence of a rash.  Went to emergency room and had tests listed below.  Was shown to have blood in the urine and given Bactrim DS and Vicodin.  Tuesday, October 30th, 2007 went to primary care physician and was diagnosed with shingles.  Given Gabapentin and Famvir as treatment.  As of today's date, Thursday, November 1st, 2007, patient is experiencing less pain and rash is "less blotchy".  Patient says symptoms "come and go" and she just paces herself with day to day activities.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: About 5 minutes after recieving sitting in car unable to respond to questions for about 10 minutes. Then back to self.
Age: 23.0
Sex: M
Vaccine: ANTH, FLUN3
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: pain in arm, swelling/itching of R upper arm. cold pack/motrin
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Skin warm
Clinical narrative: vaccination given at 1 pm. Pt began with lightheadedness at 9:30pm. Then patient developed shaking and chills. Skin hot to touch. headache onset 12 midnight. Complaints of " feeling lost"
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: vaccination given at 1 pm. Pt began with lightheadedness at 9:30pm. Then patient developed shaking and chills. Skin hot to touch. headache onset 12 midnight. Complaints of " feeling lost"
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Body temperature increased, Headache, Injection site rash, Injection site vesicles
Clinical narrative: Approximately 18 hours after vaccination, pt experienced T of 102 and approximately 2 cm vesicular rash at site of injection.Pt. also complained of headache.
Age: 69.0
Sex: F
Vaccine: FLUX, HEPAB, IPV, TYP, YF
Symptoms: Asthenia, Brain neoplasm, Fatigue, Hypoaesthesia, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Pt received vaccines for planned trip. After unknown time interval, was fatigued and tired. Progressed to left sided weakness and numbness. Seen in ER and found to have brain tumor via brain MRI. Serum will be sent to CDC for yellow fever testing.  11/2/07 Received vax records.  Yellow fever UE818AA; Hep A/B AHAVB195AB; Typhoid A0394; Polio A0170; Flu 79719.  VAERS database will be updated w/same. Record faxed to CDC.  11/6/07 Reviewed pcp medical records which reveal patient experienced HA x a few days starting w/bright light in left eye & HTN.  at office visit of 10/15/07, no evidence HTN & exam WNL.  10/16 t/c to office after speaking w/travel clinic stated she was not supposed to get YF or polio vaccine due to hx of Sjogren syndrome.  Labs done on 10/16 WNL.  Seen in office 10/22 due to persistent HA.  Returned to travel clinic & referred for MRI of brain which revealed glioma of basal ganglion.  Referred to neurosurgeon. 11/13/07 Reviewed hospital ER medical records which reveal paient seen 10/24/2007 after being sent by travelers clinic for 13 days of vague neuro symptoms including left sided HA, feeling confusion & dopey, inability to perform normal activities, left side paresthesias, blurred vision, anorexia, N/V intermittently & fatigue.  Neuro consult obtained in ER. FINAL DX: Primary brain glioma.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient had total body hives following influenza vaccine administration.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to the touch.  Reaction began 24 hrs after injection.  Swollen hard area remains to 10/31/07.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Hypertension, Rash, Tachycardia
Clinical narrative: RASH, TACHYCARDIA, HYPERTENSION, DIAPHORETIC Per follow-up: Sumitted a report earlier today and I did not notice place to but the treatment that was administered after the reaction. I was treated with an epi-pen Jr, 5o mg of BENADRYL and O2.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: 9:30 am received vaccine - Fluzone; about 8 hrs after became dizzy, nauseous, diaphoretic for 2 hrs; resolved without medications.  no redness, tenderness, or swelling at injection site.  NOTE:  has had flu vaccine in the past - # doses unknown
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise, Pityriasis rosea, Rash macular
Clinical narrative: I am an internal medicine resident at medical center.  2 weeks ago I received the Flumist.  I developed some upper resp. symptoms and malaise. Within a week I developed a macular rash that I self diagnosed as pityriasis rosacea.  Rash was limited to torso in a centripetal pattern. Not itchy.  Rash is now resolving.