chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Broke out around 18:00 with itching and rash. Dark red rash on body. Extremities and face looks like welts.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose fluctuation, Body temperature fluctuation, Hyperhidrosis
Clinical narrative: Blood sugar fluctuates up and down, body temperature fluctuates up and down. Patient sweats a lot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site dryness, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Lady returned saying she had a red area (rash), tender around shot site with a dry skin appearance. Pt said she had had reactions before. Pt had slight fever 100 degrees. Pt said she had blisters (like for 3 weeks).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Reaction to previous exposure to any vaccine
Clinical narrative: Lady returned saying she had a red area (rash), tender around shot site with a dry skin appearance. Pt said she had had reactions before. Pt had slight fever 100 degrees. Pt said she had blisters (like for 3 weeks).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives all over body per ER visit on 8-15-09.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Urticaria and pre orbital rash 4' post MMR vaccine. Per pt's mother pt's Sx completely subsided on 09/29/09.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: About 1 hour after receiving immunization pt. reported experiencing itching @ the site of injection & a hive erupted.  She later developed a "very itchy hive" under her right eye.  The next morning she called her physician who advised her to take a BENADRYL - which she did.  She reported that it helped w/itching.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Pt with post vaccination vesicles c/w VARICELLA.
Age: 0.55
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5
Symptoms: Blood culture negative, Body temperature increased, Urticaria, White blood cell count increased
Clinical narrative: Temperature 101.9 rectal.  Hives.  Rx ROCEPHIN 350 mg IM.
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Mass, Skin warm, Swelling, Tenderness
Clinical narrative: Pt complains of red swollen bump left arm. Warm to touch, very tender.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Emesis, diarrhea occurred the night of immunizations. Lasted approximately 8 hrs. Resolved spontaneously. No fever.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Influenza serology negative, Pyrexia, Streptococcal identification test negative
Clinical narrative: Fever 101.2, weak and fatigued last noc and this AM.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash macular
Clinical narrative: Pink macular rash trunk & extremitary.  Seen in ER 9-16-09.  Treated with DECANDRON and BENADRYL.  Sent home in MEDROL dose pak.
Age: 0.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Aversion, Diet refusal
Clinical narrative: 3 mo old with no prior vaccines. Developed colic @ 2 mo of age. Suspected GERD and started ZANTAC at 2 mo and 1 wk of age. At 3 mo got DTaP and Hib -> 1 day later developed oral aversion and has refused to nurse at 75% of feeding times. This has persisted for 1 mo so far without improvement. Stopped ZANTAC - no improvement.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Fatigue, Somnolence, Throat tightness
Clinical narrative: At 3:30 PM felt "constriction" in throat, by 5:30 PM eyes were swollen shut and felt fatigued. Took BENADRYL and ADVIL and went to sleep. Awoke at 8:30 AM groggy-as BENADRYL wore off-symptoms returned, took more BENADRYL and ADVIL after speaking with physician.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Nausea
Clinical narrative: Pt states became dizzy and nauseous after flu shot - states her face was hot and "weird".
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharospasm, Eye disorder, Full blood count, Malaise, Pruritus generalised
Clinical narrative: Started with itching - generalized, no rash c/o not feeling well. 7 days later - c/o twitching to eyes - Referred to ER/Primary  on 10/16 - with twitching/unable to close Lt eye.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Bronchitis, Cough, Muscle contracture
Clinical narrative: Coughing began 1 week after 2nd VARIVAX administration. Coughing worse with swimming, temp 101-102, intercostal muscle retractions, pulse 150, resp 50. Seen at ER. See sheets. Dx bronchitis. Tx with oral steroids and ALBUTEROL nebulizer.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Bronchiolitis, Chest X-ray abnormal, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: Tachypnea, lung rales and dx'd with bronchiolitis and treated with oral prednisone and albuterol neb q 4 hrs. Child had fever, cough and sore throat beginning 1 wk after VARIVAX vaccination. Sibling had similar C/O's 1 wk after VARIVAX given @ same time as sister.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rales, Tachypnoea
Clinical narrative: Tachypnea, lung rales and dx'd with bronchiolitis and treated with oral prednisone and albuterol neb q 4 hrs. Child had fever, cough and sore throat beginning 1 wk after VARIVAX vaccination. Sibling had similar C/O's 1 wk after VARIVAX given @ same time as sister.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Cold compress, TYLENOL for pain.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Arthritis, Crying, Erythema, Pyrexia
Clinical narrative: Imms given mid - day 10/5. Returned to clinic late aft. with left thigh red and hot to knee and crying inconsolably. TYLENOL was given at home. MOTRIN given in office with instruction for BENADRYL and cold compresses. Still crying on departure from RR 10/6 without further s/s. No additional meds were required. Slept well.
Age: 0.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: This non serious case was received on 02 February 2009 from a health care professional. A three month old female patient received the following vaccinations on the morning of 31 January 2009: an initial dose injection of ActHib lot number UF594AA (Sanofi Pasteur SA lot number D0070-1) intramuscularly in the right leg an initial dose of Tripedia (lot number U2398B) intramuscularly in the left leg. On the morning of 02 February 2009 the patient presented to the doctor's office with hives described as flat on both wrists and trunk. The patient did not have any other complaints. Follow up information was resolved on February 2009 from a health care professional. The patient's parents were instructed to contact an allergist if the patient's hives continued. The patient recovered from the event. No treatment was necessary. Follow-up information received on 11 March 2009 from a nurse. Per the reporter, they have no additional information at this time. No further information is expected.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site rash
Clinical narrative: This non serious case was received on 09 February 2009 from a health care professional. A 24 month old male patient with history of atopic eczema and dermatitis (February 2008) received a fourth dose of Tripedia (lot number U2471A) and a second dose of HAVRIX (manufacturer GSK, lot number AHAVB235) both intramuscularly in the left thigh on 29 January 2009. On 30 January 2009 the patient developed a red plaque like rash at the injection site extending to the left hip and left lower abdomen. No itching was noted. The patient had a doctor's visit on 06 February 2009. The recovery status was unknown. Follow-up information was received from the health care professional considered the event to be recovered.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash generalised
Clinical narrative: Initial report was received 13 July 2009 from a health care professional.  A 15-month-old (also reported as a 16 month old) female patient with a history of AMOXIL allergy had received an injection of ACTHIB (route and site not reported), lot number UF595AA (Sanofi Pasteur, SA lot number D0069-1) and an injection of TRIPEDIA, lot number U2471BA on 09 July 2009 and on the evening of vaccination, she developed a generalized rash.  The patient had no concurrent illness and no pre-existing medical conditions.  She had not experienced any adverse events following prior vaccinations.  At the time of the report, the patient's recovery status was unknown.  Follow-up information was received from the health care professional on 17 August 2009.  The patient received ACTHIB in the right thigh, and TRIPEDIA in the left thigh.  The generalized rash persisted three to four days, resolving on 12 July 2009.  The patient was seen by her physician, and treated with BENADRYL (1 tsp PO, Q6h X 2-3 days).  No etiology or diagnosis had been determined.  Documents held by sender: None.
Sex: U
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site inflammation, Injection site pain
Clinical narrative: This case was received from a pharmacist on 23 July 2009. It involves a cluster of three unidentified patients. Three patients received intramuscular injections of Tripedia (lot number U2471BA). Following vaccination, all three were seen in the emergency department with symptoms of Cellulitis, inflammation, and soreness at the injection site. No additional information was provided, and outcome was unknown. Follow-up information received 31 July 2009 from a health care professional. According to the reporter, there were total of six adults who experienced the events (previously reported as three). Per the reporter, the patients had been large adults who had received Tripedia instead of Adacel. The needle length used to administer the vaccine had been 5/8 in length; and they developed cellulitis. Recovery status was unknown at the time of the report.
Age: 0.3
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX, GlaxoSmithKline. Previous and/or concurrent vaccination included unspecified vaccine; manufacturer unspecified; unknown given on an unspecified date. On an unspecified date, the subject received unspecified dose of ROTARIX (intramuscular, unknown thigh). At an unspecified time after vaccination with ROTARIX, the subject experienced injection site redness and inappropriate route of vaccination. The healthcare professional inquired for more information on ROTARIX being administered via intramuscularly instead of orally. She did not know when this maladministration occurred. She states that another vaccine was administer on the same day but did not know which vaccine. No additional information is known at this time. At the time of reporting the outcome of the events were unspecified.
Age: 26.0
Sex: F
Vaccine: RV1
Symptoms: Accidental exposure, Chemical eye injury, Eye pruritus
Clinical narrative: This case was reported by a sale representative and described the occurrence of eyes splashed with vaccine in a 26-year-old female subject who was administered ROTARIX (GlaxoSmithKline) to her child. A physician or other health care professional has not verified this report. On 21 September 2009 the subject was attempting to administer a dose of ROTARIX to her child and the vial did not puncture properly resulting in the vaccine getting in her eye. The subject experienced itching of the eye. The outcome of the event was not reported. It was the reporter's opinion that this event was probably related to ROTARIX.
Sex: U
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of threw up in a child  subject of unspecified gender who was vaccinated with ROTARIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of ROTARIX (unknown).  At an unspecified time after vaccination with ROTARIX, the subject experienced threw up. The reporter's child threw up after receiving ROTARIX. She was questioning if he should receive another does. No other information was provided. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of vomiting in a male subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (unknown). Five minutes after vaccination with ROTARIX, the subject experienced vomiting. The mother of the subject stated her son vomited five minutes after the vaccine and they did not repeat it. She inquired about "how long does the virus shed? What precautions does a parent need to take? Does it need to be repeated? Will he be covered for the rotavirus?" At the time of reporting the outcome of the event was unspecified.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia
Clinical narrative: Initial case received from a physician, via another manufacturer (WAES 0909USA01973), on 28 September 2009. The following is verbatim from that report: "Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009, and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown)." Follow-up information has been received from an office manager in the physician's office indicating that the patient received her first dose of GARDASIL (Lot number 663451/0216Y) on 11-AUG-2009 in her right arm. Suspect therapy included MENACTRA (Lot number U2926) in the left arm." "The PPD testing result was negative. It was reported that the patient had incoherent speech on 11-AUG-2009." "On 14-AUG-2009, the patient went to the ER (Hospital name not reported) for right arm numbness, lethargy, insomnia, and amnesia. On 14-AUG-2009, EEG results were normal". "On 27-AUG-2009, the patient was admitted to hospital. The patient was admitted to the Psychiatric Unit". "On 30-AUG-2009, the patient was transferred out of the Psychiatric Unit on to a regular hospital floor". "On 31-AUG-2009, the patient's MRI of the brain was normal. The patient was not treated with any medications and was referred to a Neurologist (name unknown to reporter) and an Infection Disease Specialist (name unknown to reporter). The patient was discharged from the hospital on 31-AUG-2009. The patient had recovered." "On 10-SEP-2009, the patient was seen by the physician and the physician documented "impression anxiety". "Additional information has been requested".
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia, Laboratory test, Tuberculin test
Clinical narrative: Initial case received from a physician, via another manufacturer (WAES 0909USA01973), on 28 September 2009. The following is verbatim from that report: "Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009, and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown)." Follow-up information has been received from an office manager in the physician's office indicating that the patient received her first dose of GARDASIL (Lot number 663451/0216Y) on 11-AUG-2009 in her right arm. Suspect therapy included MENACTRA (Lot number U2926) in the left arm." "The PPD testing result was negative. It was reported that the patient had incoherent speech on 11-AUG-2009." "On 14-AUG-2009, the patient went to the ER (Hospital name not reported) for right arm numbness, lethargy, insomnia, and amnesia. On 14-AUG-2009, EEG results were normal". "On 27-AUG-2009, the patient was admitted to hospital. The patient was admitted to the Psychiatric Unit". "On 30-AUG-2009, the patient was transferred out of the Psychiatric Unit on to a regular hospital floor". "On 31-AUG-2009, the patient's MRI of the brain was normal. The patient was not treated with any medications and was referred to a Neurologist (name unknown to reporter) and an Infection Disease Specialist (name unknown to reporter). The patient was discharged from the hospital on 31-AUG-2009. The patient had recovered." "On 10-SEP-2009, the patient was seen by the physician and the physician documented "impression anxiety". "Additional information has been requested".
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Amnesia, Anxiety, Condition aggravated, Dizziness, Heart rate increased
Clinical narrative: Initial case received from a physician, via another manufacturer (WAES 0909USA01973), on 28 September 2009. The following is verbatim from that report: "Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009, and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown)." Follow-up information has been received from an office manager in the physician's office indicating that the patient received her first dose of GARDASIL (Lot number 663451/0216Y) on 11-AUG-2009 in her right arm. Suspect therapy included MENACTRA (Lot number U2926) in the left arm." "The PPD testing result was negative. It was reported that the patient had incoherent speech on 11-AUG-2009." "On 14-AUG-2009, the patient went to the ER (Hospital name not reported) for right arm numbness, lethargy, insomnia, and amnesia. On 14-AUG-2009, EEG results were normal". "On 27-AUG-2009, the patient was admitted to hospital. The patient was admitted to the Psychiatric Unit". "On 30-AUG-2009, the patient was transferred out of the Psychiatric Unit on to a regular hospital floor". "On 31-AUG-2009, the patient's MRI of the brain was normal. The patient was not treated with any medications and was referred to a Neurologist (name unknown to reporter) and an Infection Disease Specialist (name unknown to reporter). The patient was discharged from the hospital on 31-AUG-2009. The patient had recovered." "On 10-SEP-2009, the patient was seen by the physician and the physician documented "impression anxiety". "Additional information has been requested".
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Hypoaesthesia, Incoherent, Insomnia, Lethargy, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Initial case received from a physician, via another manufacturer (WAES 0909USA01973), on 28 September 2009. The following is verbatim from that report: "Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009, and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown)." Follow-up information has been received from an office manager in the physician's office indicating that the patient received her first dose of GARDASIL (Lot number 663451/0216Y) on 11-AUG-2009 in her right arm. Suspect therapy included MENACTRA (Lot number U2926) in the left arm." "The PPD testing result was negative. It was reported that the patient had incoherent speech on 11-AUG-2009." "On 14-AUG-2009, the patient went to the ER (Hospital name not reported) for right arm numbness, lethargy, insomnia, and amnesia. On 14-AUG-2009, EEG results were normal". "On 27-AUG-2009, the patient was admitted to hospital. The patient was admitted to the Psychiatric Unit". "On 30-AUG-2009, the patient was transferred out of the Psychiatric Unit on to a regular hospital floor". "On 31-AUG-2009, the patient's MRI of the brain was normal. The patient was not treated with any medications and was referred to a Neurologist (name unknown to reporter) and an Infection Disease Specialist (name unknown to reporter). The patient was discharged from the hospital on 31-AUG-2009. The patient had recovered." "On 10-SEP-2009, the patient was seen by the physician and the physician documented "impression anxiety". "Additional information has been requested".
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Tuberculin test negative
Clinical narrative: Initial case received from a physician, via another manufacturer (WAES 0909USA01973), on 28 September 2009. The following is verbatim from that report: "Information has been received from a physician concerning a 15 year old female with a diagnosis of anxiety on 10-JUN-2009, no drug allergies and no other medical history, who on 11-AUG-2009 was vaccinated with her first dose of GARDASIL (IM, lot # unspecified). Suspect therapy included MENACTRA. There was no other concomitant medication. Two hours after the vaccination, the patient developed numbness to her arms and hands, lightheadedness and increased heart rate. Several hours after the symptoms began the patient was taken to the emergency room (name of hospital was not specified) by squad. The patient was released home from the emergency room. A few days later the symptoms continued and the patient was hospitalized for 48 hours (diagnosis not specified). The patient had been in the physician's office for follow up appointments on 12-AUG-2009, 20-AUG-2009, and on 10-SEP-2009. Labs and diagnostic tests included PPD skin test on 11-AUG-2009. Tests were completed (types of tests and results were not specified). At the time of the report, the patient had recovered (date unknown)." Follow-up information has been received from an office manager in the physician's office indicating that the patient received her first dose of GARDASIL (Lot number 663451/0216Y) on 11-AUG-2009 in her right arm. Suspect therapy included MENACTRA (Lot number U2926) in the left arm." "The PPD testing result was negative. It was reported that the patient had incoherent speech on 11-AUG-2009." "On 14-AUG-2009, the patient went to the ER (Hospital name not reported) for right arm numbness, lethargy, insomnia, and amnesia. On 14-AUG-2009, EEG results were normal". "On 27-AUG-2009, the patient was admitted to hospital. The patient was admitted to the Psychiatric Unit". "On 30-AUG-2009, the patient was transferred out of the Psychiatric Unit on to a regular hospital floor". "On 31-AUG-2009, the patient's MRI of the brain was normal. The patient was not treated with any medications and was referred to a Neurologist (name unknown to reporter) and an Infection Disease Specialist (name unknown to reporter). The patient was discharged from the hospital on 31-AUG-2009. The patient had recovered." "On 10-SEP-2009, the patient was seen by the physician and the physician documented "impression anxiety". "Additional information has been requested".
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug exposure during pregnancy
Clinical narrative: Initial report received on 24 September 2009 from a health care professional. This case pertains to one of a cluster of three patients involving misuse. The same reporter provided information regarding three patients who had been exposed to an investigational product involving a clinical trial sponsored by Sanofi Pasteur, but who were not enrolled in the study. All three patients had received investigational product instead of a marketed influenza vaccine. Information regarding the other two patients is reported in cases 2009-04113 and 2009-04157. A healthy 19-year-old pregnant female, had received a first intramuscular right buttock injection of investigational product, INFLUENZA VIRUS VACC USP TRIVAL A&B HIGH DOSE, SUBVIRION-U (lot number UD12307) on 23 September 2009 at 15:30 hours. The right buttock is not a recommended site of administration for this product. Obstetrical history included three prior pregnancies that resulted in one live birth with no congenital anomalies, one elective termination of pregnancy and one spontaneous abortion. The patient's expected date of delivery is 31 December 2009. Prenatal tests included serologies performed on 01 July 2009, and ultrasound on 27 August 2009 that were normal. The patient has not experienced any adverse events. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Drug administered at inappropriate site, Drug exposure during pregnancy, Serology normal, Ultrasound scan normal, Wrong drug administered
Clinical narrative: Initial report received on 24 September 2009 from a health care professional. This case pertains to one of a cluster of three patients involving misuse. The same reporter provided information regarding three patients who had been exposed to an investigational product involving a clinical trial sponsored by Sanofi Pasteur, but who were not enrolled in the study. All three patients had received investigational product instead of a marketed influenza vaccine. Information regarding the other two patients is reported in cases 2009-04113 and 2009-04157. A healthy 19-year-old pregnant female, had received a first intramuscular right buttock injection of investigational product, INFLUENZA VIRUS VACC USP TRIVAL A&B HIGH DOSE, SUBVIRION-U (lot number UD12307) on 23 September 2009 at 15:30 hours. The right buttock is not a recommended site of administration for this product. Obstetrical history included three prior pregnancies that resulted in one live birth with no congenital anomalies, one elective termination of pregnancy and one spontaneous abortion. The patient's expected date of delivery is 31 December 2009. Prenatal tests included serologies performed on 01 July 2009, and ultrasound on 27 August 2009 that were normal. The patient has not experienced any adverse events. Documents held by sender: None.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Asthenia, Body temperature increased, Cough, Flushing
Clinical narrative: Patient reports headache, T- 100 degrees, pain at ankles and knees, swelling at Right side of neck, vague weakness, symptoms, starting at 009/23/2009 AM. Also pain at injection site.  After injection nurse commented on flushing- patient states she was like that before.  09/25/2009 spoke with client who saw Dr. yesterday.  Client states Dr. said she had infection that started prior to vaccine that she was unaware of.  Started on antibiotics and feels slightly better today.   She is also coughing up yellow phlegm.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Increased upper airway secretion, Injection site pain, Local swelling
Clinical narrative: Patient reports headache, T- 100 degrees, pain at ankles and knees, swelling at Right side of neck, vague weakness, symptoms, starting at 009/23/2009 AM. Also pain at injection site.  After injection nurse commented on flushing- patient states she was like that before.  09/25/2009 spoke with client who saw Dr. yesterday.  Client states Dr. said she had infection that started prior to vaccine that she was unaware of.  Started on antibiotics and feels slightly better today.   She is also coughing up yellow phlegm.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Asthenia, Body temperature normal, Cough, Flushing
Clinical narrative: Patient reports headache, T- 100 degrees, pain at ankles and knees, swelling at Right side of neck, vague weakness, symptoms, starting at 009/23/2009 AM. Also pain at injection site.  After injection nurse commented on flushing- patient states she was like that before.  09/25/2009 spoke with client who saw Dr. yesterday.  Client states Dr. said she had infection that started prior to vaccine that she was unaware of.  Started on antibiotics and feels slightly better today.   She is also coughing up yellow phlegm.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Increased upper airway secretion, Infection, Injection site pain, Local swelling
Clinical narrative: Patient reports headache, T- 100 degrees, pain at ankles and knees, swelling at Right side of neck, vague weakness, symptoms, starting at 009/23/2009 AM. Also pain at injection site.  After injection nurse commented on flushing- patient states she was like that before.  09/25/2009 spoke with client who saw Dr. yesterday.  Client states Dr. said she had infection that started prior to vaccine that she was unaware of.  Started on antibiotics and feels slightly better today.   She is also coughing up yellow phlegm.
Age: 75.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Abasia, Lumbar puncture
Clinical narrative: GUILLAIN-BARRE Syndrome. Ascending paralysis. 9-26-09 onset, to present (10-7-09). IVIG - treatment.  10/19/09 Physician fax received for date of service 10/12/09.  Dx:  Death secondary to Guillain-Barre Syndrome. Assessment:  Intubated due to GBS.  EMG showed denervation distally.  Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient.
Age: 75.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Blood product transfusion, Computerised tomogram head, Electromyogram, Guillain-Barre syndrome, Helicobacter pylori identification test negative
Clinical narrative: GUILLAIN-BARRE Syndrome. Ascending paralysis. 9-26-09 onset, to present (10-7-09). IVIG - treatment.  10/19/09 Physician fax received for date of service 10/12/09.  Dx:  Death secondary to Guillain-Barre Syndrome. Assessment:  Intubated due to GBS.  EMG showed denervation distally.  Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient.
Age: 75.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Hepatitis viral test, Neurological examination, Viral test negative
Clinical narrative: GUILLAIN-BARRE Syndrome. Ascending paralysis. 9-26-09 onset, to present (10-7-09). IVIG - treatment.  10/19/09 Physician fax received for date of service 10/12/09.  Dx:  Death secondary to Guillain-Barre Syndrome. Assessment:  Intubated due to GBS.  EMG showed denervation distally.  Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Guillain-Barre syndrome, Hypertension, Muscular weakness, Paralysis
Clinical narrative: Began to develop muscle weakness in his extremeties ~24 hrs after the vaccination. Was taken to the ER, where they found a markedly elevated BP. This was the focus of the treatment. He was hospitalized for 3 days. During this time, the muscle weakness progressed to the point where ambulation was difficult. After discharge, a neurologist diagnosed Guillian Barre Syndrome. The pt was told recovery would take months and he may not regain all his strength.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Chest X-ray normal, Computerised tomogram head, Echocardiogram, Face and mouth X-ray normal
Clinical narrative: Began to develop muscle weakness in his extremeties ~24 hrs after the vaccination. Was taken to the ER, where they found a markedly elevated BP. This was the focus of the treatment. He was hospitalized for 3 days. During this time, the muscle weakness progressed to the point where ambulation was difficult. After discharge, a neurologist diagnosed Guillian Barre Syndrome. The pt was told recovery would take months and he may not regain all his strength.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Muscular weakness, Scan brain, Ultrasound Doppler
Clinical narrative: Began to develop muscle weakness in his extremeties ~24 hrs after the vaccination. Was taken to the ER, where they found a markedly elevated BP. This was the focus of the treatment. He was hospitalized for 3 days. During this time, the muscle weakness progressed to the point where ambulation was difficult. After discharge, a neurologist diagnosed Guillian Barre Syndrome. The pt was told recovery would take months and he may not regain all his strength.
Age: 64.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ultrasound Doppler normal
Clinical narrative: Began to develop muscle weakness in his extremeties ~24 hrs after the vaccination. Was taken to the ER, where they found a markedly elevated BP. This was the focus of the treatment. He was hospitalized for 3 days. During this time, the muscle weakness progressed to the point where ambulation was difficult. After discharge, a neurologist diagnosed Guillian Barre Syndrome. The pt was told recovery would take months and he may not regain all his strength.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Abortion spontaneous, Back pain, Blood human chorionic gonadotropin positive, Dehydration, Drug exposure during pregnancy
Clinical narrative: A serious clinical trial report of a Grade 3 miscarriage was received from an investigator concerning a 26 year-old female, who is enrolled in a study. The subject's medical history included: dysmenorrhea (1994), tension headaches (2000), anemia (11/2008), and menorrhagia (10/2008 to 12/2008). Concomitant medications included acetaminophen: Rho (d) Immune Globulin (Human) Injection, naproxen sodium, and extra strength acetaminophen. Method of contraception used during the study by the subject was condoms and spermacide. The subject's last menstrual period was 11-July-2009. On 21-August-2009, the subject received on 0.2ml dose of MEDI8662-BFS. This was the subject's first and only dose as per the study protocol. On 18-Sep-2009, the subject went to the emergency room for abnormal vaginal bleeding. A serum pregnancy test was done and had a positive result. A sonogram of the uterus showed: size 10.8 X 6.6 X 5.9 cm. The uterus not be confirmed, probably due to technical reasons rather than physiologic reasons. The left ovary could not be seen either transabdominally or tranvaginally; and the adnexel regions were within limits; there was no pelvic free fluid. The age determination showed a gestational sac of 1.85 cm or six weeks two days, a crown-rump length is 1.27 cm or seven weeks three days. Fetal heart rate was confirmed at 152 beats per minute with M-node scanning. Intravenous saline was administered for dehydration prophylaxis and acetaminophen 650 mg was given for low back pain secondary to abnormal vaginal bleeding. Rho (D) Immune Globulin (Human) injection 50 mcg was also administered prophylactically to prevent fetal death. The subject was released from the emergency room and reported on 22-Sep-2009 that everything was fine. On 23-Sep-2009, the subject was again seen in the emergency room and had miscarriage. She was instructed to follow up with her gynecologist. Treatment for the event of miscarriage was not reported. The event of Grade 3 miscarrage resolved on 23-Sep-2009. Rechallenge is not applicable as in this clinical trial only one dose of study drug is given. The investigator assessed the relationship of the event miscarriage as possible. Analysis of similar events: a search of the safety database for the preferred term of miscarriage was performed on 28-Sep-2009 and noted only this case of miscarriage after the administration. Clinical trial case - patient was found not to be on FLUMIST when unblinded. 19-Feb-2010.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Foetal heart rate abnormal, Ultrasound scan normal, Vaginal haemorrhage
Clinical narrative: A serious clinical trial report of a Grade 3 miscarriage was received from an investigator concerning a 26 year-old female, who is enrolled in a study. The subject's medical history included: dysmenorrhea (1994), tension headaches (2000), anemia (11/2008), and menorrhagia (10/2008 to 12/2008). Concomitant medications included acetaminophen: Rho (d) Immune Globulin (Human) Injection, naproxen sodium, and extra strength acetaminophen. Method of contraception used during the study by the subject was condoms and spermacide. The subject's last menstrual period was 11-July-2009. On 21-August-2009, the subject received on 0.2ml dose of MEDI8662-BFS. This was the subject's first and only dose as per the study protocol. On 18-Sep-2009, the subject went to the emergency room for abnormal vaginal bleeding. A serum pregnancy test was done and had a positive result. A sonogram of the uterus showed: size 10.8 X 6.6 X 5.9 cm. The uterus not be confirmed, probably due to technical reasons rather than physiologic reasons. The left ovary could not be seen either transabdominally or tranvaginally; and the adnexel regions were within limits; there was no pelvic free fluid. The age determination showed a gestational sac of 1.85 cm or six weeks two days, a crown-rump length is 1.27 cm or seven weeks three days. Fetal heart rate was confirmed at 152 beats per minute with M-node scanning. Intravenous saline was administered for dehydration prophylaxis and acetaminophen 650 mg was given for low back pain secondary to abnormal vaginal bleeding. Rho (D) Immune Globulin (Human) injection 50 mcg was also administered prophylactically to prevent fetal death. The subject was released from the emergency room and reported on 22-Sep-2009 that everything was fine. On 23-Sep-2009, the subject was again seen in the emergency room and had miscarriage. She was instructed to follow up with her gynecologist. Treatment for the event of miscarriage was not reported. The event of Grade 3 miscarrage resolved on 23-Sep-2009. Rechallenge is not applicable as in this clinical trial only one dose of study drug is given. The investigator assessed the relationship of the event miscarriage as possible. Analysis of similar events: a search of the safety database for the preferred term of miscarriage was performed on 28-Sep-2009 and noted only this case of miscarriage after the administration. Clinical trial case - patient was found not to be on FLUMIST when unblinded. 19-Feb-2010.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Myalgia, Pyrexia
Clinical narrative: Severe fever, muscle aches, itchy eyes Fever 101.2 at 6 AM, took 500 mg Tylenol
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, No reaction on previous exposure to drug, Pruritus, Throat irritation
Clinical narrative: Note: pt received vaccine 9/11 but did not report any adverse event to me until she returned from a trip 9/30 and emailed me.  According to her email, she had "red itchy hives all over my body, my throat was itchy and I felt generally weird all over.  Benadryl took care of it eventually."  She said the hives occurred within two hours of the vaccine, and resolved completely within 4 hours of taking diphenhydramine.  she has received previous flu vaccines without incident.  all of the equipment we used is latex free.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Note: pt received vaccine 9/11 but did not report any adverse event to me until she returned from a trip 9/30 and emailed me.  According to her email, she had "red itchy hives all over my body, my throat was itchy and I felt generally weird all over.  Benadryl took care of it eventually."  She said the hives occurred within two hours of the vaccine, and resolved completely within 4 hours of taking diphenhydramine.  she has received previous flu vaccines without incident.  all of the equipment we used is latex free.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Pt returned to our pharmacy stating that she got the flu shot on 9/18/09 and she was concerned about a bruise on her arm and soreness/tenderness where the injection was given. She denied any signs of difficulty breathing, N/V, fever, dizziness, hives, hoarseness or wheezing. Pt did mention that bruises appeared to get smaller in size compared to day 1. Advise if she experiences any of the above mentioned symptoms to consult her physician ofc. Instructed pt to take ibuprofen with food to alleviate any pain and inflammation at the injection site.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: large area of redness and itching at injection site. Treated with Benadryl and Cortisone cream.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient complained of fast heart rate, dizziness, numbness and tingling in hands and feet. 10/12/09 Medical records received from dates of service 10/2/09 to 10/8/09 10/2/09 OV for c/o ball in throat feeling, acne, hair loss and to begin gardasil vaccination series. DX: questionable reflux, acne, hair loss. 10/8/09 OV c/o HA, dizziness, moody, heart racing, jerking arms, tingle in fingers occurring after getting gardasil vaccination. DX: HA, dizziness, tachycardia.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Computerised tomogram, Electrocardiogram, Eye irritation
Clinical narrative: APPROX 4.5 HOURS AFTER ADMINISTRATION OF VACC. I DEVELOPED SUDDEN ONSET OF CHEST PAIN,WITHIN 30MIN-LUNG PAIN/PRESSURE/BURNING,WITHIN 30MIN TIGHTENING/BURNING OF THROAT AND THICKENING OF THE TONGUE/TINGLING LIPS AND BRIGHT RED BURNING OF EYES
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Ocular hyperaemia, Paraesthesia oral, Throat irritation, Throat tightness
Clinical narrative: APPROX 4.5 HOURS AFTER ADMINISTRATION OF VACC. I DEVELOPED SUDDEN ONSET OF CHEST PAIN,WITHIN 30MIN-LUNG PAIN/PRESSURE/BURNING,WITHIN 30MIN TIGHTENING/BURNING OF THROAT AND THICKENING OF THE TONGUE/TINGLING LIPS AND BRIGHT RED BURNING OF EYES
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue disorder
Clinical narrative: APPROX 4.5 HOURS AFTER ADMINISTRATION OF VACC. I DEVELOPED SUDDEN ONSET OF CHEST PAIN,WITHIN 30MIN-LUNG PAIN/PRESSURE/BURNING,WITHIN 30MIN TIGHTENING/BURNING OF THROAT AND THICKENING OF THE TONGUE/TINGLING LIPS AND BRIGHT RED BURNING OF EYES
Age: 12.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Hives on face and neck for 5 days; treated with Benadryl
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Chest pain. Went to ER. Diagnosed with a heart attack.  10/13/09 ICD-Codes received: 788.50 Unspecified chest pain, 107.1 Subendocardial infarction, 414.01 Cornary atherosclerosis, 275.2 Disorder of magnesium metabolism, 276.8 Hypopotassemia, 281.9 Unspecified deficiency anemia, 272.4 Unspecified hyperlipemia, 564.1 Irritable bowel syndrome, 356.9 Peripheral neuropathy, 715.90 Osteoarthrosis, 305.1 Tobacco use disorder, V58.65 Long term use of steroids, V58.66 Long term use of aspirin, V45.82 Percutaneous transluminal coronary angioplasty status, V43.64 Hip joint replacement status.11/30/2009 MR and DC summary for 10/4-10/6/2009,  DC Dx Chest pain    patient admitted with chest pain, patient had cardaic cath after abnormal nuclear stress test.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Crying, Decreased appetite, Diarrhoea, Fatigue, Influenza serology negative
Clinical narrative: Irritability followed by low-grade fever initially. Progressed to extreme irritability/crying, fever that ranged daily from low-grade in the morning to high (103+) at night , loss of appetite, diarrhea, fatigue/listlessness. Today (~6 days after symptom onset) fever has been gone <24 hrs but irritability, fatigue, loose stools, and loss of appetite persist, and a slight rash (primarily on back and chest) is observed.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Irritability, Listless, Pyrexia, Rash
Clinical narrative: Irritability followed by low-grade fever initially. Progressed to extreme irritability/crying, fever that ranged daily from low-grade in the morning to high (103+) at night , loss of appetite, diarrhea, fatigue/listlessness. Today (~6 days after symptom onset) fever has been gone <24 hrs but irritability, fatigue, loose stools, and loss of appetite persist, and a slight rash (primarily on back and chest) is observed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: redness and warmth of (left) deltoid region. Warm compress applied.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Ocular hyperaemia, Upper respiratory tract congestion, Wheezing
Clinical narrative: WHEEZING, CHEST TIGHTNESS, SEVERE CONGESION, BLOODSHOT EYES
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood test, Chest X-ray, Chills, Culture urine
Clinical narrative: Weak, high fever (103.7 on its way down, don't how high it had gotten to), head ache, body aches, chills, nausia, dizziness, fast heart rate (122 at the hospital ER), hard to breath, pale.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate increased, Nausea
Clinical narrative: Weak, high fever (103.7 on its way down, don't how high it had gotten to), head ache, body aches, chills, nausia, dizziness, fast heart rate (122 at the hospital ER), hard to breath, pale.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pallor, Pyrexia
Clinical narrative: Weak, high fever (103.7 on its way down, don't how high it had gotten to), head ache, body aches, chills, nausia, dizziness, fast heart rate (122 at the hospital ER), hard to breath, pale.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 3"x4" hard red warm swollen area