chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Streptococcal identification test negative, Throat tightness, Urine analysis normal, X-ray abnormal
Clinical narrative: June 15,2009 received MENACTRA vaccine to protect against meningitis-sore arm, fever, aches. June 16, 2009 feeling sick, extreme nausea, fever, skin very pale, aches, sore arm, headache. June 17, 2009 sore arm, pale, headache, feeling a little better. June 18, 2009 seems a little better. June 22, 2009 sharp abdominal pain (localized in 2 places), back pain (localized in 2 places). June 23, 2009 on and off abdominal and back pain. June 24, 2009 abdominal pain. June 25 through June 29, 2009 abdominal pain continues, chest pain, sensation of throat closing, fearful of not being able to breathe, crying, upset. June 30, 2009 doctor visit inconclusive. July 2, 2009 pain and fear continues, called doctor: discontinue swimming. July 6, 2009 still in great pain during day, subsides in evening, hurting at night (9 PM). July 7, 2009 Dr. visit: nonspecific chest/abdomen/back pain, possible gastritis, x-rays showed constipation, NEXIUM 20 mg daily x 30 days, try MIRALAX as needed for constipation. July 23 abdominal and chest pain con't through weekend. July 27 doctor visit and lab work. August still complaining of abdominal, back and chest pain. Sept. 2 Abdominal fullness, pelvic pressure, unable to participate in enjoyable activities due to discomfort. Sept. 3 called doctor, keep on MIRALAX and bulk up fiber and water intake. Sept. 8 pain and discomfort continues. Sept. 12-13 some pain and discomfort but not lasting. Sept. 15 looks pale in afternoon, falls asleep early evening about 1 hour, woke for supper. Sept. 16 severe discomfort (3 bms during day but con't to feel urge and unable). Sept. 21-23 severe sore throat, very pale, fatigued. Sept. 22 doctor visit, strep test neg., later (evening) runny nose, congestion, headache. Sept. 28 complains of urge to urinate-after having urinated still has urge, has been going on for about 1 week or longer. Sept. 29 doctor visit, urinalysis normal. Sept.-Oct. no appreciable improvement. 10/15/2009 received PCP records for multiple ov's from 6/2009 to 10/2009. Patient has multiple c/o's: fever, sore arm, pale, abdominal pain, nausea, chest pain, pelvic pain, sore throat, fever, urine frequency, sensation of throat closing. Tx : Nexium, Miralax, Bentyl with no resolutin of sx. Referred for GI consult date 10/29/2009.  1/7/2010 received Urgent care clinic records for 7/7/2009 patient with c/o's chest/abdominal/back pain
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Injected limb mobility decreased, Pain in extremity
Clinical narrative: 24 hr flu symptoms, as well as pain in arm that has not gone away. Nurse hit a nerve when she administered the shot.  Pain lifting arm since.
Age: 28.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Pain in extremity
Clinical narrative: on 10/8 - I gave pt these immunizations:  influenza in L arm, and pneumonia in R arm.  Adverse effect was noted in R arm. 10/09/09 pm:  I evaluated his arm - no erythema or edema noted at this time, but advised pt to f/u if s/sx of cellulitis appeared.  He did c/o limited mobility and pain in R arm.  10/10/09 am:  Pt went to PMD due to s/sx of cellulitis.  Given ABX (Keflex)
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema, Pain in extremity, Skin warm
Clinical narrative: Gave pt influenza in L arm and pneumonia in R arm on 9/29/09.  Pt came back to clinic on 10/2 with c/o pain in R arm.  Also had redness, warmth and edema - but not at immunization site.  He was immunized on lateral aspect of R arm, adverse effect appeared on medial aspect of R arm.
Age: 11.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Confusional state, Dizziness, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 100, dizziness, sore throat, confusion, headache.
Age: 32.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Abdominal pain lower, Feeling abnormal
Clinical narrative: Pt states she came to facility and received 2 shots on 10/05/2009. Records show MMR and Tdap was administered. She states immediately developed pain right lower quadrant and lower abdomen. Denies nausea, vomiting, rash. Symptoms lasted 2 days. States on 10/11/2009 "body became light". Non specific in complaint or description. States on Tues 10/13/2009 prior to returning to facility "feel funny in my body" Non descriptive in definition. Has not been seen by HCP.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Chills
Clinical narrative: Severe chills (shivering) which lasted about 25 minutes. Bouts came in waves which each succeeding bout shorter than the previous. This was followed by a moderate temperature which lasted (+/-) 4 hours. I feel fine today, 10/13/2009. Has never happened before.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Diarrhoea, Headache, Pyrexia, Respiratory tract congestion
Clinical narrative: A non serious spontaneous report of runny nose, congestion, headache, chills, fever, vomiting and diarrhea has been received from a consumer/ mother concerning her four-year-old son, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included birth at 37 weeks, tonsillectomy and adenoidectomy at 22 months and a urinary tract infection in April-2009. On 28-Aug-2009, prior FluMist vaccination, the patient had mild nasal congestion. He was not taking any concomitant medications and did not receive any other vaccines on the day FluMist was administered. The patient's brother experienced high fever and lethargy after receiving his first dose of DTAP at two-months-old and did not  experience any reactions after subsequent doses of Diphtheria and Tetanus Toxoid, pediatrics (DT) only. The patient received his first dose of FluMist on 28-Aug-2009 at 2:00.pm. On 30-Aug-2009, the patient awoke with nasal congestion and a runny nose. As the day went on he developed a headache, chills and fever. His mother treated him with Children's Acetaminophen. On 31-Aug-2009, his mother reported that he seemed better. She called her pediatrician's office and spoke to the "head nurse" about the events. During that call, the nurse informed her that the events were most likely related to the FluMist vaccination. On the evening of 31-Aug-2009, her son developed a fever, diarrhea and vomiting. His temperature was 101.3 degrees Fahrenheit. She treated him with Children's Ibuprofen. On 01-Sep-2009, his mother again called the pediatrician's office and spoke with the same nurses regarding the fever, diarrhea and vomiting he experienced on 31-Aug-2009. During the call on 01-Sep-2009, the nurse informed the patient's mother reported that her other children received FluMist the same day and did not experience any "reactions" and have not been sick. She added that she, her husband, his siblings and visiting grandparents who were around the patient did not get sick. The mother indicated she did not think she would have FluMist administered again. The events resolved.  Additional information was received on 14-Oct-2009 from the physician's office and incorportated into the narratives included confirmation that no other vaccinations were provided on the day FLUMIST was administered or within four weeks prior and that the patient was not taking any concomitant medications.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Rhinorrhoea, Urinary tract infection, Vomiting
Clinical narrative: A non serious spontaneous report of runny nose, congestion, headache, chills, fever, vomiting and diarrhea has been received from a consumer/ mother concerning her four-year-old son, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included birth at 37 weeks, tonsillectomy and adenoidectomy at 22 months and a urinary tract infection in April-2009. On 28-Aug-2009, prior FluMist vaccination, the patient had mild nasal congestion. He was not taking any concomitant medications and did not receive any other vaccines on the day FluMist was administered. The patient's brother experienced high fever and lethargy after receiving his first dose of DTAP at two-months-old and did not  experience any reactions after subsequent doses of Diphtheria and Tetanus Toxoid, pediatrics (DT) only. The patient received his first dose of FluMist on 28-Aug-2009 at 2:00.pm. On 30-Aug-2009, the patient awoke with nasal congestion and a runny nose. As the day went on he developed a headache, chills and fever. His mother treated him with Children's Acetaminophen. On 31-Aug-2009, his mother reported that he seemed better. She called her pediatrician's office and spoke to the "head nurse" about the events. During that call, the nurse informed her that the events were most likely related to the FluMist vaccination. On the evening of 31-Aug-2009, her son developed a fever, diarrhea and vomiting. His temperature was 101.3 degrees Fahrenheit. She treated him with Children's Ibuprofen. On 01-Sep-2009, his mother again called the pediatrician's office and spoke with the same nurses regarding the fever, diarrhea and vomiting he experienced on 31-Aug-2009. During the call on 01-Sep-2009, the nurse informed the patient's mother reported that her other children received FluMist the same day and did not experience any "reactions" and have not been sick. She added that she, her husband, his siblings and visiting grandparents who were around the patient did not get sick. The mother indicated she did not think she would have FluMist administered again. The events resolved.  Additional information was received on 14-Oct-2009 from the physician's office and incorportated into the narratives included confirmation that no other vaccinations were provided on the day FLUMIST was administered or within four weeks prior and that the patient was not taking any concomitant medications.
Age: 4.0
Sex: M
Vaccine: DTP, FLUN3, IPV, TTOX
Symptoms: Arthralgia, Burning sensation, Ear discomfort, Myalgia, Pyrexia
Clinical narrative: A non-serious, spontaneous report of joint pain, muscle aches, left ear burning and fever has been received from a patient's father concerning his four year old son subsequent to Flumist. This case is submitted in accordance with manufacturer post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patients medical history was not reported. The patient received Flumist on 02-Sep-2009 as well as his four year old shots such as DTP, tetanus, MMR, polio, and chicken pox vaccines. On the night of 02-Sep-2009, the patient complained of joint and muscle pain.  Around 3 am on 03-Sep-2009, the patient ran a fever of 102.9 degrees. and in the morning of the same day his left ear was burning. The outcome of the events was not reported. All follow-up attempts have been made per company SOPs. No further information available. Per MI convetions, non - MI mfr not captured - queries 1-6.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Lethargy, Oropharyngeal pain, Pyrexia
Clinical narrative: Stomach ache (Abdominal pain upper). Fever (Pyrexia). Sore throat (Oropharyngeal pain). Lethargic (Lethargy). A non-serious spontaneous report of lethargic, stomach ache, high fever, and sore throat has been received from a nurse concerning a 4-year-old female, subsequent to FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FluMist on 02-Sep-2009. The patient received a single dose before onset of the events. On 03-Sep-2009, the patient developed lethargy, stomach ache, high fever, and sore throat. The outcome and causality were not reported.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Inappropriate schedule of vaccine administered (Inappropriate schedule of drug administration). A non-serious spontaneous report of administration of FLUMIST 12 days apart was received from a patient parent concerning a 36-month-old male subsequent to the administration of FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST 12 days apart, first on 27-Aug-2009 and then inadvertently on 08-Sept-2009. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved.   All follow-up attempts have been made per company SOPs.  No further information is available. 08 Mar 2010.
Sex: U
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous report of FluMist administration to a child on aspirin has been received from a physician concerning a child subsequent to FluMist. On unknown date, FluMist was given to a child on chronic aspirin therapy. The patient's medical history was not reported. On 21-Sep-2009, the reporter confirmed there were no adverse events after FluMist administration. There was not adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with the post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.   All follow-up attempts have been made per company SOPs.  No additional information available.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, Unevaluable event
Clinical narrative: A non-serious, report of administration of TIV and 1 week later FLUMIST in a 24-month-old female patient was received from a nurse. On 04-Sep-2009 the patient received a "flu shot" and on 11-Sep-2009, received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMISTS.
Age: 53.0
Sex: M
Vaccine: FLUN3
Symptoms: Back pain, Chest pain
Clinical narrative: A spontaneous, non-serious report of back and chest pain has been received from a other involving a patient (demographics unknown) subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 10-Sep-2009, the patient received FLUMIST. Hours later, he was experienced back and chest pain. No further information was available. The outcome of the events, back and chest pain, was unknown. All follow-up attempts have been made per company SOPs. No further information is availbale.
Age: 3.3
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Insomnia, Pyrexia, Retching
Clinical narrative: A non-serious spontaneous report of not being able to sleep, fever, gagging and cough has been received from a consumer concerning a three-year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's pos-marketing commitment on accelerated reporting for the newly indicated population of 2years to 59 months of age for FLUMIST. The only medical history reported identifies the child as being "pre-asthmatic". The patient received FLUMIST on 08 Sep 2009. The day after receiving FLUMIST the child experienced not being able to sleep, fever, gagging and cough. The primary care physician recommended she continue breathing treatment at home. After three days the symptoms have not resolved. All follow up attempts have been made per company SOPs.  No further information is available. 08 Mar 2010.
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Body temperature increased, Myalgia, Pyrexia
Clinical narrative: A non-serious spontaneous report of muscle pain, fever, and stomach pain has been received from a consumer, patient's parent, concerning a female child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received one dose of FLUMIST on 09-Sept-2009. The patient experienced muscle pain, fever, and stomach pain on 12-Sept-2009. The patient was taking acetaminophen, and her body temperature was 102.5. The outcomes of the events were not provided. 1-3 All follow-up attempts have been made per our SOPs.  Information is not available.  19-Feb-2010.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: A non-serious spontaneous report of generalized urticaria has been received from a physician concerning a four-year-old female, subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 15-Sep-2009. On 16-Sep-2009, about 24 hours after administration of FLUMIST the patient developed generalized urticaria. Outcome and causality were not reported. All follow-up attempts have been complete per company SOP.  No further information available. 10-Mar-2010.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza serology positive, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: A non-serious spontaneous report of influenza type B was received from a consumer concerning a four year old female, subsequent to FluMist. The patient's past medical history and concomitant medications were not reported. The patient received FluMist on 14-Sep-2009. On 16-Sep-2009 the patient developed a running fever of 101.9 with some sneezing and a runny nose. The patient was tested at the physician's office and was positive for influenza type B. The outcome and causality of the event were not reported.  All follow-up attempts have been made per company SOPs.  No further information is available. 19-Feb-2010.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: A non serious spontaneous report of influenza type B was received from a consumer concerning a 34 month old female, subsequent to Flumist. The patient's past medical history and concomitant medications were not reported. The patient received Flumist on 14-Sep-2009. ON 16-Sep-2009 the patient developed a running fever of 101.7 degrees Fahrenheit with some sneezing and a runny nose. The patient was tested at the physician's office and was positive for influenza type B. The outcome of the event was not reported.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pneumonia, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of pneumonia has been received form a consumer/father concerning his 25-month-old daughter, subsequent to FLUMIST. The patient's medical history and concomitant medication were not reported. The patient received FLUMIST on 16-Sep-2009. After receiving FLUMIST, the patient experienced a fever of 102 degrees Fahrenheit, runny nose and cough on an unspecified date. On 18-Sep-2009, she was experiencing a fever of 104 degrees Fahrenheit and was taken to her doctor for evaluation. Per the patient's father, his daughter was diagnosed with pneumonia. She was at home at the time of the report. The pneumonia and fever were ongoing. The outcome of runny nose and cough were not reported. All follow-up have been completed per company SOPs.  No further information is available.  10 Mar 2010.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: A non-serious, spontaneous report of rash, fever, and very irritable has been received from a physician concerning his 24-mouth-old son subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history and concomitant medications were not reported. The patient received FluMist on 04-Sep-2009. Not long after receiving FluMist, the patient contracted rash, fever and was irritable. As of 18-Sep-2009, only the symptoms of irritability exist at time in the child. The rash and fever resolved. All follow-ups have been completed per company SOP.  No further information available.
Sex: M
Vaccine: FLUN3
Symptoms: Rash, Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of runny nose has been received from a registered nurse concerning a male child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medication were not provided. The patient received a total of one dose of FLUMIST on 07-Sep-2009. The patient's mother reported that he has had a runny nose since he was administered FLUMIST on 07-Sep-2009. The patient's was rubbing his nose so much that he was getting a rash under the nostril area. As of 21-Sep-2009, the event was ongoing. All follow-up attempts have been made per company SOP.  No further information is available.  19-Feb-2010.
Age: 0.8
Sex: U
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous case of FluMist administered to a nine-month-old was received from a registered nurse concerning a nine-month-old infant. There was no adverse event associated with vaccination error therefore, treatment and causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing committment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia, Vomiting
Clinical narrative: A non-serious spontaneous report of fever and vomiting has been received from a registered nurse concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history nor concomitant medications were provided. The patient received FLUMIST on 17-Sep-2009. On 21-Sep-2009, the patient experienced a fever of 101.4 and vomiting.  No outcome was provided.  The events resolved on 22-Sep-2009.  Additional information was received on 14-Oct-2009 and incorporated into the narrative: outcome and patient's date of birth.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye pruritus, Throat irritation
Clinical narrative: itchy eyes and throat with non productive cough  1st time receiving flu vaccine
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder and arm soreness, could not lift arm above waist.  Took some tynenol and put icy hot on my arm and shoulder.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Cough, Diarrhoea, Dysphonia, Nasal congestion
Clinical narrative: 10/09/09 4:00PM H1N1 Vaccine (Live, Attenuated) nasal spray administered.  10/10/09 Upon waking at 7:00AM noted coughing and sore throat. Temp. 99 range  10/11/09 Continued coughing and sore throat with hoarseness and diarrhea. Temp. 99 range.  10/12/09  Coughing, sore throat, hoarseness, diarrhea, with nasal congestion and runny nose. Temp.99 range  10/13/09  Cough has worsened and slightly productive, nasal congestion has worsened.  Temp. 99 range.  The following symptoms have subsided: sore throat and hoarseness.  A visit to her doctor today as a precautionary.  Continue to monitor symptoms.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Oropharyngeal pain, Productive cough, Rhinorrhoea
Clinical narrative: 10/09/09 4:00PM H1N1 Vaccine (Live, Attenuated) nasal spray administered.  10/10/09 Upon waking at 7:00AM noted coughing and sore throat. Temp. 99 range  10/11/09 Continued coughing and sore throat with hoarseness and diarrhea. Temp. 99 range.  10/12/09  Coughing, sore throat, hoarseness, diarrhea, with nasal congestion and runny nose. Temp.99 range  10/13/09  Cough has worsened and slightly productive, nasal congestion has worsened.  Temp. 99 range.  The following symptoms have subsided: sore throat and hoarseness.  A visit to her doctor today as a precautionary.  Continue to monitor symptoms.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Hypersensitivity, Laboratory test, Rash pruritic
Clinical narrative: Client flew home Thurs evening.  Client states rash/itching to feet started 10/08/09 in the evening, then radiating rash upwards towards legs, change in voice. Was seen in ER, treated for allergic reaction, possibly to Thimerisol.  Started on Prednisone and antihistamines.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Swelling face
Clinical narrative: A non-serious spontaneous report of rash and swelling around nose and face has been received from a nurse practitioner concerning a 24-month-old female patient subsequent to receiving FluMist. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Medical history and concomitant medications were not reported. On 24-Sep-2009, the patient received FluMist. A few hours after receiving FluMist, the patient developed a rash and swelling around the nose and face. No further information was provided. The outcome of the events, rash and swelling around nose and face was unknown. All follow-up attempts have been completed per company SOP.  No futher information available.  10 Mar 2010.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: dizziness, severe headache, nausea, vomiting 10/16/09 Medical records received for dates 10/12/09 to 10/15/09. Symptoms: Pt received vaccine 10/12/09 parent called MD office to state approx. ½ hour after vaccine pt. c/o dizziness, diarrhea, HA, vomiting 2-3x, syncope. F/u appt. 10/15/09 c/o stomach issues, HA, nausea. Decreased appetite continued. Assessment: Mild TTP LLQ, referred to GI specialist. Pt has HA if overeacts then vomits, stress worsens problem. DX: Possible reaction to vaccine. Chronic abdominal pain, chronic HA.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye irritation, Injection site pain, Limb discomfort
Clinical narrative: Starting at 6 am 5 days after receiving the flu vaccine, employee experienced sor throat, low grade fever, chest congestion, coughing, chills, and burning eyes. The same day vaccine was administered she developed soreness in the right upper arm where her injection was given. These symptoms had improved but not resolved as of 10/12/2009.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Movement disorder, Musculoskeletal disorder, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Starting at 6 am 5 days after receiving the flu vaccine, employee experienced sor throat, low grade fever, chest congestion, coughing, chills, and burning eyes. The same day vaccine was administered she developed soreness in the right upper arm where her injection was given. These symptoms had improved but not resolved as of 10/12/2009.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Hypersensitivity, Nervousness, Pain, Peripheral coldness
Clinical narrative: Wednesday evening -- about  6 hours after I received the flu vaccine, I started feeling &#8220;itchy&#8221;.  I went to bed and the next morning I was covered in hives  and had felt  &#8220;shaky&#8221;.  I had hives on my neck,  both arms, trunk, and both legs .  Nothing near the injection site. I took Benadryl.   From work that day, I contacted the administrator of the vaccine and talked to a nurse who told me to continue taking Benadryl and if my throat would start to close or I had shortness of breath, to go to the emergency room.   I continued to take the Benadryl.  The next morning  (Friday) my hives were worse. There were more of them and they were bigger.  Especially on both wrists.  They were extra thick on the inside of both wrists&#8212;about 4 inches long and &frac12; in wide.   The hives were more itchy and I feel more &#8220;shaky&#8221; and nervous.  The hives on my wrists were very thick, and swollen.  They were very painful.  The swelling seemed to cut off circulation to my hands and my hands were cold.  The hives  were warm to the touch.   I went to work, continuing to take the Benadryl.  The Benadryl did not seem to help.  The symptoms were continually getting worse.  I left work  at 10:30 to see a doctor.  By 11 am I was at the doctors office and I explained that I was having an allergic reaction to a flu vaccine.  This was about   45 hours after the vaccine.  With severe symptoms of an allergic reaction, I was given an injection of  DepoMedrol  80 mg IM.    I was also given a prescription of Loratadine 10 mg.    Within an hour of the DepoMedrol  shot,  the worst  hives  (on my wrists)  started to become less painful .  The &#8220;shakiness&#8221; that I was having went away.   Over  the next several hours,  and into the evening, the hives got lighter in appearance.   The next day,  Saturday ,  there was more improvement .   The next day , today (Sunday)  still more improvement.   You can still tell where the hives were &#8211;the areas look like light colored bruises.  There is some slight itchiness in hands and feet each day since but Benadryl  helps.    I am not allergic to eggs.     This was my first flu vaccine.    Needless  to say, I will not get a vaccine next year.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Skin warm, Swelling, Tremor, Urticaria
Clinical narrative: Wednesday evening -- about  6 hours after I received the flu vaccine, I started feeling &#8220;itchy&#8221;.  I went to bed and the next morning I was covered in hives  and had felt  &#8220;shaky&#8221;.  I had hives on my neck,  both arms, trunk, and both legs .  Nothing near the injection site. I took Benadryl.   From work that day, I contacted the administrator of the vaccine and talked to a nurse who told me to continue taking Benadryl and if my throat would start to close or I had shortness of breath, to go to the emergency room.   I continued to take the Benadryl.  The next morning  (Friday) my hives were worse. There were more of them and they were bigger.  Especially on both wrists.  They were extra thick on the inside of both wrists&#8212;about 4 inches long and &frac12; in wide.   The hives were more itchy and I feel more &#8220;shaky&#8221; and nervous.  The hives on my wrists were very thick, and swollen.  They were very painful.  The swelling seemed to cut off circulation to my hands and my hands were cold.  The hives  were warm to the touch.   I went to work, continuing to take the Benadryl.  The Benadryl did not seem to help.  The symptoms were continually getting worse.  I left work  at 10:30 to see a doctor.  By 11 am I was at the doctors office and I explained that I was having an allergic reaction to a flu vaccine.  This was about   45 hours after the vaccine.  With severe symptoms of an allergic reaction, I was given an injection of  DepoMedrol  80 mg IM.    I was also given a prescription of Loratadine 10 mg.    Within an hour of the DepoMedrol  shot,  the worst  hives  (on my wrists)  started to become less painful .  The &#8220;shakiness&#8221; that I was having went away.   Over  the next several hours,  and into the evening, the hives got lighter in appearance.   The next day,  Saturday ,  there was more improvement .   The next day , today (Sunday)  still more improvement.   You can still tell where the hives were &#8211;the areas look like light colored bruises.  There is some slight itchiness in hands and feet each day since but Benadryl  helps.    I am not allergic to eggs.     This was my first flu vaccine.    Needless  to say, I will not get a vaccine next year.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ataxia, Blood culture negative, Blood electrolytes normal, CSF cell count normal, Culture urine negative
Clinical narrative: ataxia, falling repeatedly 10/20/2009 hospital records from 10/11-10/13/2009. Patient with c/o's fever and ataxic gait. Tx: dx studies and labs, IV ABX.  DC DX Acute Cerebellar Ataxia. F/up with PCP and Neurologist.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Differential white blood cell count normal, Enterovirus serology test, Epstein-Barr virus test negative, Fall, Full blood count normal
Clinical narrative: ataxia, falling repeatedly 10/20/2009 hospital records from 10/11-10/13/2009. Patient with c/o's fever and ataxic gait. Tx: dx studies and labs, IV ABX.  DC DX Acute Cerebellar Ataxia. F/up with PCP and Neurologist.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes simplex serology negative, Polymerase chain reaction
Clinical narrative: ataxia, falling repeatedly 10/20/2009 hospital records from 10/11-10/13/2009. Patient with c/o's fever and ataxic gait. Tx: dx studies and labs, IV ABX.  DC DX Acute Cerebellar Ataxia. F/up with PCP and Neurologist.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Sore arm, chills, slight fever, aches, stiff neck, diarrhea x 3 days.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Sore arm, chills, slight fever, aches, stiff neck, diarrhea x 3 days.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: developed hives of the upper extremities and groin five hours after the injection.  Treated with topical and oral steroids.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site swollen, red, hot to touch, approx size of silver dollar, no knot per rn
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Wrong technique in drug usage process
Clinical narrative: ACT HIB VACCINE MIXED INCORRECTLY WITH STERILE DILUENT FROM MERCK. VERIFIED WITH MEDICAL DIRECTOR AT SANOFI THAT THIS DOSE WAS NOT INVALID AND THAT STERILE DILUENT CAN BE USED IN PLACE OF ACT HIB DILUENT.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza serology positive, Pyrexia, Rhinorrhoea
Clinical narrative: A non-serious report of Influenza has been received from a pharmacist concerning a four-year old female subsequent to FLUMIST. This case is subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reported for the newly indicated population of 2 years to 59 months of age of FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received a total of one dose of FLUMIST on 23-Sep-2009. The patient experienced the event of Influenza, fever, runny nose, and positive flu test, on 25-Sep-2009. She was treated with oseltamivir phosphate. Outcome of the event is unknown. All follow-up attempts per company SOPs have been completed.  No further information is available.  19-Feb-2010.
Age: 1.92
Sex: M
Vaccine: FLUN3
Symptoms: Vaccination error
Clinical narrative: A non-serious spontaneous report of "administration of FLUMIST to 23-month-old" was received from a nurse practitioner, In the USA, involving a 23-month-old male. ON 25-Sep-2009, the patient received FLUMIST. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 2.0
Sex: U
Vaccine: FLUN3, HEPA
Symptoms: Pyrexia, Vomiting projectile
Clinical narrative: A non-serious spontaneous report of severe projectile vomiting and fever has been received from a registered nurse concerning a 24-month-old patient of unknown sex subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST along with Hepatitis A vaccine an unknown date. The patient received a total of one dose of FLUMIST before the onset of the event. The patient experienced severe projectile vomiting and fever five hour after FLUMIST and Hepatitis A vaccine administration. The symptoms of severe projectile vomiting lasted approximately four hours. The events of severe projectile vomiting and fever were resolved. Reporter assessed the events of severe projectile vomiting and fever as related to FLUMIST and Hepatitis A vaccine. All follow up attempts have been completed per company SOP's.  No further information is available. 19-Feb-2010.
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: A spontaneous, non-serious report of administration of FluMist six days apart was received from a registered nurse concerning a male child (age unknown). Medical history and concomitant medications were not reported. On 23-Sep-2009, the patient received FluMist at a physician office. Six days later, on 29-Sep-2009, the patient received another dose of FluMist at school. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. All follow-up attempts have been completed per company SOP's.  No further information is available. 19-Feb-2010.
Age: 1.93
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccination error (Vaccination error). A non-serious spontaneous report of FluMist administration to 23-month old was received from a non health-care professional in the United States concerning a 23-month-old male.  The patient was administered FluMist. There was no adverse event associated with this inappropriate age administration: therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Hypersomnia, Immobile, Lethargy
Clinical narrative: Headaches, tired, requiring excessive sleep of over 10 hours, normal sleep ranges from 6 to 7. Reported to clinic by wednesday, by Saturday was dealing with muscle weakness, at times between sleep and alertness, almost felt like I was paralyzed. Could not lift arms, make fist, and could only roll over to adjust discomfort, then the tiredness part set it, over 12 hours of sleeping, tiredness and lathargy.  Was fine for about five days, then symptons reappeared yesterday.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Muscular weakness
Clinical narrative: Headaches, tired, requiring excessive sleep of over 10 hours, normal sleep ranges from 6 to 7. Reported to clinic by wednesday, by Saturday was dealing with muscle weakness, at times between sleep and alertness, almost felt like I was paralyzed. Could not lift arms, make fist, and could only roll over to adjust discomfort, then the tiredness part set it, over 12 hours of sleeping, tiredness and lathargy.  Was fine for about five days, then symptons reappeared yesterday.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Increased upper airway secretion, Vomiting
Clinical narrative: A non-serious spontaneous report of "threw up" has been received from a consumer, patient's mother, concerning a four-year-old female subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medication were not reported. The patient received a total of one dose of FLUMIST before the onset of the event on 29-Sep-2009. The patient "threw up" mostly phlegm, about two-three minutes after FLUMIST administration of 29-Sep-2009. The outcome of the event was unknown. All follow-up attempts have been completed per company SOPs.  No further information is available. 19-Feb-2010.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, General physical health deterioration, Headache, Injection site erythema
Clinical narrative: Redness at site of injection. Prolonged (one week) soreness in upper arm, shoulder and elbow.  Mild headache. Fatigue.  Decreased stamina.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Redness at site of injection. Prolonged (one week) soreness in upper arm, shoulder and elbow.  Mild headache. Fatigue.  Decreased stamina.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: A non-serious spontaneous report of fever, aches, weakness, a runny and congested nose, and cough has been received from a nurse concerning a 4-year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient.  On 24-Sep-2009, the patient received FLUMIST. The patient received a single dose before onset of the events. Two days after receiving FLUMIST, the patient developed fever, aches, weakness, a runny and congested and, more recently a cough. Outcome and causality were not reported.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Rhinorrhoea
Clinical narrative: A non-serious spontaneous report of fever, aches, weakness, a runny and congested nose, and cough has been received from a nurse concerning a 4-year-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient.  On 24-Sep-2009, the patient received FLUMIST. The patient received a single dose before onset of the events. Two days after receiving FLUMIST, the patient developed fever, aches, weakness, a runny and congested and, more recently a cough. Outcome and causality were not reported.
Sex: U
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious, spontaneous report of administered full dose in one nostril in child patient was received from a medical assistant. There was no adverse event associated with this mediation error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing concomitant on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.   All follow-up attempts have been completed per SOP.  No further informaiton is available.  10-Mar-2010.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Influenza, Influenza serology positive, Pyrexia
Clinical narrative: A spontaneous, non-serious report of type B influenza has been received from a certified medical assistant concerning a four-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On or about 27-Sep-2009, the patient received FLUMIST. On 30-Sep-2009, the patient presented to the doctor's office with a fever of 101 degrees Fahrenheit. She tested positive for type B influenza. No further information was available.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: fever, fatigue, weakness
Age: 0.56
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Convulsion
Clinical narrative: Seizures, Multiple.  Sent to hospital, diastat administered, hospitalized x 3 days. 11/13/09 Medical records received for date 4/23/05 to 4/25/05. DX: Prolonged afebrile seizure. Complex partial seizures. Presented to ER with parents c/o starring to right. Parent states pt had URI, low fever, irritable. Pt. starring to rt. upon arrival. Later in ER RUE, RLE began jerking, head toward rt. approx 5min. Assessment: fever(+), vomit(+), loose stool(+), otherwise WNL.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Aura, Migraine
Clinical narrative: Migraine with auras
Age: 2.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Pyrexia
Clinical narrative: Increased tiredness and low grade fever that over next 24 hours worsened.  Fever peaked at 105.8 F on 10/5/2009 at 6:00pm.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pruritus, Pyrexia
Clinical narrative: Severe itching, mostly the legs. High fever 102 degrees, Aches and shivering lasting 2 days
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Herpes zoster, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Hives and itching to arms and chest. Benadryl 50mg po given with improvement of symptoms until the following day when she blistered on arms and face. Went to physician who diagnosed shingles secondary to allergic reaction to seasonal flu vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Complaint of bruising, redness and swelling injection site.  Seen at local hospital and given anti-inflammatory injection per patient
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Rapid onset of fever 103.7 orally, headache, dry heaves, took two extra strenght Tylenol 1000 mg. 3L fluids over three hours, water and tea, bed rest. Fever broke @ 2300 excessive sweating fever did not return, temp @ 1430 98.9. No appetite, dry heaves during fever, after fever broke tired and went to bed
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Retching
Clinical narrative: Rapid onset of fever 103.7 orally, headache, dry heaves, took two extra strenght Tylenol 1000 mg. 3L fluids over three hours, water and tea, bed rest. Fever broke @ 2300 excessive sweating fever did not return, temp @ 1430 98.9. No appetite, dry heaves during fever, after fever broke tired and went to bed
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm at first. Then, began feeling achy in arms, shoulders, neck, head, and back. By about 10:30, achiness spread to entire body and bad enough to take Tylenol.  By 1:00 a.m., aches were severe throughout my entire body.  I am a healthy, active person, but that night I was absolutely miserable. Felt like I had been "hit by a train."  As achy as I've ever felt throughout entire body. Called in sick to work at 6:00 a.m.  Took ibuprofen, which helped a little.  No other symptoms except severe aches from head to toe.  By late afternoon, symptoms began to subside.  Very mild by about 10:00 p.m.  Next morning I felt perfectly normal. This was my first ever flu shot.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Insomnia
Clinical narrative: Burning and stinging at injection site which turned to soreness. Unable to sleep on her left arm. Note 1cm by 1cm palpable mass at injection site.