chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Respiratory tract congestion, Sinus congestion, Tenderness, Vomiting, Wheezing
Clinical narrative: Patient received influenza and pneumovax vaccinations on 10/1/08 in the clinic. Patient reported that on 10/2/08, he had new onset of head congestion, nasal congestion, headache with facial tenderness, feeling hot, generalized body aches, chest congestion with frequent cough of yellow secretions. Patient was seen to rule out pneumonia and dehydration due to fever and nausea and vomiting. Patient was treated with antibiotics, promethazine, acetaminophen and recovered. Symptoms: Fever, Wheeze, dehydration, nausea, vomiting.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Immunisation reaction, Nausea, Oedema peripheral
Clinical narrative: Pt developed very large raised, hot, red reaction over (R) deltoid area following administration of 2008 Flu vaccine and Pneumovax at adjacent sites. Also had severe headache with nausea and vomiting.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Vomiting
Clinical narrative: Pt developed very large raised, hot, red reaction over (R) deltoid area following administration of 2008 Flu vaccine and Pneumovax at adjacent sites. Also had severe headache with nausea and vomiting.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUN3
Symptoms: Erythema, Headache, Influenza like illness, Injection site erythema, Injection site oedema
Clinical narrative: SM woke up with redness and swelling at site where he received his anthrax injection. SM also notes that he developed a HA after receiving his anthrax and FLUMIST shot that day. HA resolved the next day. Symptoms: Edema @ injection site 50-120mm, erythema, tenderness, headache, general, flu-like symptoms< 96 hours.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUN3
Symptoms: Injection site swelling, Tenderness
Clinical narrative: SM woke up with redness and swelling at site where he received his anthrax injection. SM also notes that he developed a HA after receiving his anthrax and FLUMIST shot that day. HA resolved the next day. Symptoms: Edema @ injection site 50-120mm, erythema, tenderness, headache, general, flu-like symptoms< 96 hours.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dysphonia, Dyspnoea, Nausea
Clinical narrative: Given 10/20/08 @ 11:15 AM, 1:15 PM developed hoarseness, tightness in throat, felt SOB, coughing 3:00 PM. Came to nurse T 97.5, BP 103/70, P 72 Peak flow 350. Given BENADRYL 50 mg P.O. 7:00 PM - chills, fever, nausea - took ADVIL 400mg next morning - all symptoms resolved.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Peak expiratory flow rate, Pyrexia, Throat tightness
Clinical narrative: Given 10/20/08 @ 11:15 AM, 1:15 PM developed hoarseness, tightness in throat, felt SOB, coughing 3:00 PM. Came to nurse T 97.5, BP 103/70, P 72 Peak flow 350. Given BENADRYL 50 mg P.O. 7:00 PM - chills, fever, nausea - took ADVIL 400mg next morning - all symptoms resolved.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Headache, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Vomiting, Headache, Generalized weakness, fever swelling @ site of injection.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient given ADACEL in place of DTaP. No reaction.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reactions. Given to Foster child to catch up Imm. No adverse reaction.
Age: 7.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: No adverse event
Clinical narrative: No adverse reactions. Given to Foster child to catch up Imm.
Age: 14.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event. Flu vaccine labeled for adult use only administered in error to a 14 year old.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Eye pruritus, Eye swelling, Hypersensitivity, Joint range of motion decreased
Clinical narrative: C/O nausea evening after vaccine. (8/21/08) am awakened with stiff joints, fingers tingling, SOB, itchy eyes. Called HD -referred immediately to private physician. Doctor reported obvious allergic reaction to unknown component. Joints poor ROM, eyes puffy, red. Treated with BENADRYL - symptoms improved. Advised no repeat of any of these vaccines.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Joint stiffness, Nausea, Ocular hyperaemia, Paraesthesia
Clinical narrative: C/O nausea evening after vaccine. (8/21/08) am awakened with stiff joints, fingers tingling, SOB, itchy eyes. Called HD -referred immediately to private physician. Doctor reported obvious allergic reaction to unknown component. Joints poor ROM, eyes puffy, red. Treated with BENADRYL - symptoms improved. Advised no repeat of any of these vaccines.
Age: 3.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Accidental exposure
Clinical narrative: While administering 2nd half of FLUMIST dose to left nare pt jumped back while plunger was being pushed. Some of the FLUMIST went into patients right eye. Eye was flushed with water and no c/o blurring vision or pain. No adverse rx noted.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event. Flu vaccine labeled for adult use only administered in error to a 12 year old.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Cough, Eye swelling, Throat tightness
Clinical narrative: During a break from basketball she looked in mirror and noted swelling around her eyes.  At the same time she developed some cough and a "full" feeling in her throat. These symptoms subsided within 30-40 minutes but eyes still swollen in am 10/31/08. (Also had contact with a dog before basketball)
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient got tingling sensation on her palm - and felt numbness on index and thumb of Lt hand, lasted for about an hour before diminishing.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Unresponsive to stimuli, Vision blurred
Clinical narrative: 30 seconds after GARDASIL vaccine was administered she complained of feeling weird. While in seated position she slumped forward was unresponsive for less than 3 seconds. Then stated she had blurred vision. Felt faint, was reclined to lying position with lower extremities elevated. Became aware and responsive, she was monitored for 15 min. Left office without complications.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 9.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red hot deltoid 180 degrees around.  Not circumferential;  Tender to palp.  Started 24 hrs after shot given Tdap.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Activities of daily living impaired, Anorexia, Asthenia
Clinical narrative: My daughter became ill on April 9th, 2008, 4 months after her second vaccine of GARDICIL vaccine, with a rash all over her body. The following week, she began vomiting multiple times per day for over four weeks. From April 9th through June 28, 2008 she experiences severe migraines, bloody noses, complete lack of energy, loss of appetite, nausea, acid reflux, weak and ache legs, constant stomach pain, trouble with vision. She has has chest x-ray, abdominal ultrasound, CT of abdomen with contract, MRI of brain with contrast, upper GI, endoscope, BRAVO, EEG and colonoscopy. She was in the ER department due to nausea and unable to eat and drink. She was sent home after numerous tests that showed nothing. She was unable to attend school from April 21, 2008 through June 20, 2008 due to her is and was home schooled. She is currently under the care of a pediatric neurologist, pediatric gastrointestinal physician and an immunologist who are truing to elevate her symptoms with various medications. All medical tests have come back normal except for her having a small hiatal hernia. As quickly as her symptoms came on, they stopped on June 28th. She received her third GARDASIL vaccine on July 29th, 2008. A week later on August 6, 2008, her symptoms returned again, severe pain in the abdomen, nausea, loss of appetite, difficulty with vision and concentration. I will begin the paperwork again this week with her doctor to have her home schooled as she hasn't been able to attend school for the past two weeks. I have also included copies of her physician reports for your review. Medicine she has taken or is currently taking: REGLAN, CARAFATE, TOPAMAX, PREVACID.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood culture, Colonoscopy, Computerised tomogram, Culture urine, Disturbance in attention
Clinical narrative: My daughter became ill on April 9th, 2008, 4 months after her second vaccine of GARDICIL vaccine, with a rash all over her body. The following week, she began vomiting multiple times per day for over four weeks. From April 9th through June 28, 2008 she experiences severe migraines, bloody noses, complete lack of energy, loss of appetite, nausea, acid reflux, weak and ache legs, constant stomach pain, trouble with vision. She has has chest x-ray, abdominal ultrasound, CT of abdomen with contract, MRI of brain with contrast, upper GI, endoscope, BRAVO, EEG and colonoscopy. She was in the ER department due to nausea and unable to eat and drink. She was sent home after numerous tests that showed nothing. She was unable to attend school from April 21, 2008 through June 20, 2008 due to her is and was home schooled. She is currently under the care of a pediatric neurologist, pediatric gastrointestinal physician and an immunologist who are truing to elevate her symptoms with various medications. All medical tests have come back normal except for her having a small hiatal hernia. As quickly as her symptoms came on, they stopped on June 28th. She received her third GARDASIL vaccine on July 29th, 2008. A week later on August 6, 2008, her symptoms returned again, severe pain in the abdomen, nausea, loss of appetite, difficulty with vision and concentration. I will begin the paperwork again this week with her doctor to have her home schooled as she hasn't been able to attend school for the past two weeks. I have also included copies of her physician reports for your review. Medicine she has taken or is currently taking: REGLAN, CARAFATE, TOPAMAX, PREVACID.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram, Endoscopy, Epistaxis, Gastrooesophageal reflux disease, Hiatus hernia
Clinical narrative: My daughter became ill on April 9th, 2008, 4 months after her second vaccine of GARDICIL vaccine, with a rash all over her body. The following week, she began vomiting multiple times per day for over four weeks. From April 9th through June 28, 2008 she experiences severe migraines, bloody noses, complete lack of energy, loss of appetite, nausea, acid reflux, weak and ache legs, constant stomach pain, trouble with vision. She has has chest x-ray, abdominal ultrasound, CT of abdomen with contract, MRI of brain with contrast, upper GI, endoscope, BRAVO, EEG and colonoscopy. She was in the ER department due to nausea and unable to eat and drink. She was sent home after numerous tests that showed nothing. She was unable to attend school from April 21, 2008 through June 20, 2008 due to her is and was home schooled. She is currently under the care of a pediatric neurologist, pediatric gastrointestinal physician and an immunologist who are truing to elevate her symptoms with various medications. All medical tests have come back normal except for her having a small hiatal hernia. As quickly as her symptoms came on, they stopped on June 28th. She received her third GARDASIL vaccine on July 29th, 2008. A week later on August 6, 2008, her symptoms returned again, severe pain in the abdomen, nausea, loss of appetite, difficulty with vision and concentration. I will begin the paperwork again this week with her doctor to have her home schooled as she hasn't been able to attend school for the past two weeks. I have also included copies of her physician reports for your review. Medicine she has taken or is currently taking: REGLAN, CARAFATE, TOPAMAX, PREVACID.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Migraine, Nausea, Nuclear magnetic resonance imaging, Oesophageal pH
Clinical narrative: My daughter became ill on April 9th, 2008, 4 months after her second vaccine of GARDICIL vaccine, with a rash all over her body. The following week, she began vomiting multiple times per day for over four weeks. From April 9th through June 28, 2008 she experiences severe migraines, bloody noses, complete lack of energy, loss of appetite, nausea, acid reflux, weak and ache legs, constant stomach pain, trouble with vision. She has has chest x-ray, abdominal ultrasound, CT of abdomen with contract, MRI of brain with contrast, upper GI, endoscope, BRAVO, EEG and colonoscopy. She was in the ER department due to nausea and unable to eat and drink. She was sent home after numerous tests that showed nothing. She was unable to attend school from April 21, 2008 through June 20, 2008 due to her is and was home schooled. She is currently under the care of a pediatric neurologist, pediatric gastrointestinal physician and an immunologist who are truing to elevate her symptoms with various medications. All medical tests have come back normal except for her having a small hiatal hernia. As quickly as her symptoms came on, they stopped on June 28th. She received her third GARDASIL vaccine on July 29th, 2008. A week later on August 6, 2008, her symptoms returned again, severe pain in the abdomen, nausea, loss of appetite, difficulty with vision and concentration. I will begin the paperwork again this week with her doctor to have her home schooled as she hasn't been able to attend school for the past two weeks. I have also included copies of her physician reports for your review. Medicine she has taken or is currently taking: REGLAN, CARAFATE, TOPAMAX, PREVACID.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Rash generalised, Thirst decreased, Vaccine positive rechallenge, Visual impairment
Clinical narrative: My daughter became ill on April 9th, 2008, 4 months after her second vaccine of GARDICIL vaccine, with a rash all over her body. The following week, she began vomiting multiple times per day for over four weeks. From April 9th through June 28, 2008 she experiences severe migraines, bloody noses, complete lack of energy, loss of appetite, nausea, acid reflux, weak and ache legs, constant stomach pain, trouble with vision. She has has chest x-ray, abdominal ultrasound, CT of abdomen with contract, MRI of brain with contrast, upper GI, endoscope, BRAVO, EEG and colonoscopy. She was in the ER department due to nausea and unable to eat and drink. She was sent home after numerous tests that showed nothing. She was unable to attend school from April 21, 2008 through June 20, 2008 due to her is and was home schooled. She is currently under the care of a pediatric neurologist, pediatric gastrointestinal physician and an immunologist who are truing to elevate her symptoms with various medications. All medical tests have come back normal except for her having a small hiatal hernia. As quickly as her symptoms came on, they stopped on June 28th. She received her third GARDASIL vaccine on July 29th, 2008. A week later on August 6, 2008, her symptoms returned again, severe pain in the abdomen, nausea, loss of appetite, difficulty with vision and concentration. I will begin the paperwork again this week with her doctor to have her home schooled as she hasn't been able to attend school for the past two weeks. I have also included copies of her physician reports for your review. Medicine she has taken or is currently taking: REGLAN, CARAFATE, TOPAMAX, PREVACID.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, X-ray, X-ray with contrast upper gastrointestinal tract
Clinical narrative: My daughter became ill on April 9th, 2008, 4 months after her second vaccine of GARDICIL vaccine, with a rash all over her body. The following week, she began vomiting multiple times per day for over four weeks. From April 9th through June 28, 2008 she experiences severe migraines, bloody noses, complete lack of energy, loss of appetite, nausea, acid reflux, weak and ache legs, constant stomach pain, trouble with vision. She has has chest x-ray, abdominal ultrasound, CT of abdomen with contract, MRI of brain with contrast, upper GI, endoscope, BRAVO, EEG and colonoscopy. She was in the ER department due to nausea and unable to eat and drink. She was sent home after numerous tests that showed nothing. She was unable to attend school from April 21, 2008 through June 20, 2008 due to her is and was home schooled. She is currently under the care of a pediatric neurologist, pediatric gastrointestinal physician and an immunologist who are truing to elevate her symptoms with various medications. All medical tests have come back normal except for her having a small hiatal hernia. As quickly as her symptoms came on, they stopped on June 28th. She received her third GARDASIL vaccine on July 29th, 2008. A week later on August 6, 2008, her symptoms returned again, severe pain in the abdomen, nausea, loss of appetite, difficulty with vision and concentration. I will begin the paperwork again this week with her doctor to have her home schooled as she hasn't been able to attend school for the past two weeks. I have also included copies of her physician reports for your review. Medicine she has taken or is currently taking: REGLAN, CARAFATE, TOPAMAX, PREVACID.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: pain in entire body.  Eyes are red.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: AFLURIA vaccine given on L deltoid, within next 3 hours an indurated area formed approximately 3" in diameter.  Redness then developed on entire deltoid area extending into the axilla and onto L anterior chest wall.  Area warm to touch.  By 10/28/2008 pm- redness receding, warmth remains, decreased induration @ injection site small amt soreness.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Full blood count, Mobility decreased, Neuralgia, Pain in extremity
Clinical narrative: R arm pain, decreased mobility, neuralgia to (R) forearm within 8-12 hours of PNEUMOVAX.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Feeling abnormal, Immediate post-injection reaction, Syncope vasovagal
Clinical narrative: Pt had syncope/vagal response after GARDISIL #3 and ADACEL. I was in the room with pt. as she was in mid sentence saying "she felt funny". Pt sitting on exam table and laid down about 20-30 sec returned to NL. Alert and oriented x 2. BP WNL. Pt without breakfast. Pt waited 20 minutes and was with nl exam- left office d/t finished. Pt states she passes out with shots.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Chills, Decreased appetite, Lethargy, Myalgia
Clinical narrative: Symptoms started @ 10PM 10/17/08.  Pt c/o chills fever, achey muscles, lethargy.  Pain in back, decrease appetite- 1 wk duration.  Wife has same signs + symptoms but had no flu shot.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Symptoms started @ 10PM 10/17/08.  Pt c/o chills fever, achey muscles, lethargy.  Pain in back, decrease appetite- 1 wk duration.  Wife has same signs + symptoms but had no flu shot.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchy, redness x 1 week after injection @ injection site.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe L arm pain continuing 2 weeks post injection, causing decrease in mobility and causing shoulder pain when trying to raise L arm above head.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site induration, Vomiting
Clinical narrative: About 15 min after shots, pt had to pull her car over to the shoulder to vomit. She was sweating severely she states with chills, she contemplated using her epipen. Today 45 mm erythema with induration of varicella site, (10-23-08).
Age: 64.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Asthenia, Dizziness, Eye pain, Hypoaesthesia, Throat tightness
Clinical narrative: 2 hr. after getting TDAP she started to experience slight dizziness & weakness when walking - sl. tightness in her throat, numbness in her face, sore eyes - blurred vision in both eyes that comes & goes.
Age: 64.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Vision blurred
Clinical narrative: 2 hr. after getting TDAP she started to experience slight dizziness & weakness when walking - sl. tightness in her throat, numbness in her face, sore eyes - blurred vision in both eyes that comes & goes.
Age: 64.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Asthenia, Chills, Diarrhoea, Discomfort, Dyspnoea
Clinical narrative: 2 hr. after getting TDAP she started to experience slight dizziness & weakness when walking - sl. tightness in her throat, numbness in her face, sore eyes - blurred vision in both eyes that comes & goes.
Age: 64.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Eye pain, Eye swelling, Fatigue, Headache, Hypoaesthesia facial
Clinical narrative: 2 hr. after getting TDAP she started to experience slight dizziness & weakness when walking - sl. tightness in her throat, numbness in her face, sore eyes - blurred vision in both eyes that comes & goes.
Age: 64.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy, Nausea, Odynophagia
Clinical narrative: 2 hr. after getting TDAP she started to experience slight dizziness & weakness when walking - sl. tightness in her throat, numbness in her face, sore eyes - blurred vision in both eyes that comes & goes.
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis, Erythema, Oedema peripheral
Clinical narrative: Pt presented to pharmacy sunday 10/26/08 with dermatitis in L deltoid area.  Area approximately 3"x2" raised, red area.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye discharge, Injection site pain, Myalgia
Clinical narrative: 10-22 shot L deltoid 11:45 AM.  45 minutes later , sore site, began to cough, then wheezing, mild, then eyes bloodshot & oozing thick exudate.  Went home 3:30.  Chills + muscle aches off + on x 5 hours 1:00 pm.  Perfect health following day 10-23-08.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Wheezing
Clinical narrative: 10-22 shot L deltoid 11:45 AM.  45 minutes later , sore site, began to cough, then wheezing, mild, then eyes bloodshot & oozing thick exudate.  Went home 3:30.  Chills + muscle aches off + on x 5 hours 1:00 pm.  Perfect health following day 10-23-08.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Pt states "Right after I was given the PNEUMOVAX, the whole muscle begin to hurt".  Later in the afternoon the inj site was "swollen, painful & hot" No redness, later in day the back of upper arm became painful & hot.  By the evening, pt's whole arm from elbow to shoulder was very painful.  She was unable to lift her arm or really use it due to the pain.  No fever, N,V.  Pt called on 10-22-08.  We had her come in to be seen.  The pain at injection site was less but the pain on the tricep area still was very painful.  It was hot to the touch + very painful even with a light touch.  There was a lump in that area also.  Pt was seen by Dr + sent home with dx of 'adverse reaction to drugs.  NOS.'  Pt was told to take BENADRYL 1-2 tabs every 6 hrs + a recheck visit was made for the next day.  Pt seen again on 10-23-08.  The site of the injection was less painful out continued to be more painful then inj.  site, Pt was able to use her arm + lift.  At the tricep area, it was still warm with the lump.  The lump at the inj. site was gone.  Dr said for pt to continue with BENADRYL and call if it got worse or not better.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Myalgia
Clinical narrative: Pt states "Right after I was given the PNEUMOVAX, the whole muscle begin to hurt".  Later in the afternoon the inj site was "swollen, painful & hot" No redness, later in day the back of upper arm became painful & hot.  By the evening, pt's whole arm from elbow to shoulder was very painful.  She was unable to lift her arm or really use it due to the pain.  No fever, N,V.  Pt called on 10-22-08.  We had her come in to be seen.  The pain at injection site was less but the pain on the tricep area still was very painful.  It was hot to the touch + very painful even with a light touch.  There was a lump in that area also.  Pt was seen by Dr + sent home with dx of 'adverse reaction to drugs.  NOS.'  Pt was told to take BENADRYL 1-2 tabs every 6 hrs + a recheck visit was made for the next day.  Pt seen again on 10-23-08.  The site of the injection was less painful out continued to be more painful then inj.  site, Pt was able to use her arm + lift.  At the tricep area, it was still warm with the lump.  The lump at the inj. site was gone.  Dr said for pt to continue with BENADRYL and call if it got worse or not better.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Erythema, Hypoaesthesia oral
Clinical narrative: Face red/raw.  Tightness to chest.  Numbness to mouth
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Disorientation, Dizziness, Full blood count normal, Headache
Clinical narrative: Patient given flu shot 10/27/08.  C/o headache, disorientation, generalized weakness, lightheadedness.
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test normal, Red blood cell sedimentation rate decreased
Clinical narrative: Patient given flu shot 10/27/08.  C/o headache, disorientation, generalized weakness, lightheadedness.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth, Pain
Clinical narrative: Site of injection on day of injection pea size nodule, then by 2 days increasing size Red area, then by day 5 continued, warm, tender 12.5 x 10 cm Red area. Pt reported body aches also for 48 hrs and tingling into (L) leg - Resolved 4 days after vaccination.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Site of injection on day of injection pea size nodule, then by 2 days increasing size Red area, then by day 5 continued, warm, tender 12.5 x 10 cm Red area. Pt reported body aches also for 48 hrs and tingling into (L) leg - Resolved 4 days after vaccination.
Age: 1.4
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Fall
Clinical narrative: Seemingly dizzy and off balance.  Falling to his left side.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Asthma, Chills, Palpitations, Pyrexia
Clinical narrative: After 2 hrs Pt has stomach cramps, later asthma sx increased, had a few palputation.  Took IBUPROFEN.  In evening had fever + chills.  Next day (10/22) feels better.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anorexia, Asthenia, Body temperature increased, Erythema, Nausea
Clinical narrative: C/o sore arm, redness since Wednesday.  Stated felt nauseated, weak & no appetite, & temp of 100 degrees on Thursday.  States feels better today.  Instructed to notify MD if symptom worsen, ice for arm & over the counter pain reliever.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: C/o sore arm, redness since Wednesday.  Stated felt nauseated, weak & no appetite, & temp of 100 degrees on Thursday.  States feels better today.  Instructed to notify MD if symptom worsen, ice for arm & over the counter pain reliever.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Rc'd shot and had no problems until AM of 4th day. Red and hard area (10 mm) over injection site. Tenderness and rapidly spreading swelling down arm towards elbow (about 1" from elbow) came to HD 9/3/08 and arm still red and swollen.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Feeling hot, Hypophagia, Retching
Clinical narrative: After waiting our required 20 minutes after vaccine 5:05 pm we left. Upon arriving home she complained of her tummy hurting and didn't eat dinner at 5:30 pm. Laid on bed holding tummy. She felt warm but not hot. At approx 6:30-6:45 pm she vomited and had diarrhea not making it to bathroom, everything. Vomiting continued every 1/2 hour to 45 min. until midnight then again at 2 am on 10-15-08. She couldn't drink water. Dry heaves again at 3 am. She was able to sleep off and on until 6:30 am on 10-15-08. She missed school that day. (10-15-08).
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: After waiting our required 20 minutes after vaccine 5:05 pm we left. Upon arriving home she complained of her tummy hurting and didn't eat dinner at 5:30 pm. Laid on bed holding tummy. She felt warm but not hot. At approx 6:30-6:45 pm she vomited and had diarrhea not making it to bathroom, everything. Vomiting continued every 1/2 hour to 45 min. until midnight then again at 2 am on 10-15-08. She couldn't drink water. Dry heaves again at 3 am. She was able to sleep off and on until 6:30 am on 10-15-08. She missed school that day. (10-15-08).
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed generalized urticaria rash on body on the evening after flu shot.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Nausea, Vomiting
Clinical narrative: While drinking hot cocoa, she got lightheaded, warm feeling and nauseated.  30 minutes after onset, she vomited.  She felt better a few hours after injection.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Irritability, Nausea, Vertigo
Clinical narrative: 35 minutes after injection.  Dizziness, nausea, irritable, vertigo, flushed.  Felt better after several hours.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Influenza like illness, Injection site pain, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: Arm very sore at vaccination site.  The evening immediately after vaccination throat became red & sore.  For 2 weeks following was fatigued and had flul like/cold symptoms.  Treated with rest & fluid juices. No vomiting or dia.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Erythema, Irritability, Swelling
Clinical narrative: 4 hours after immunizations, developed marked redness and swelling on left leg and fussy while in clinic. Mom stated redness and swelling has improved quite a bit over past few hours. Plan: start low dose of Benadryl x 1-2 days (dose given in clinic). Occasional Tylenol for discomfort. Border of skin outlined with pen. Follow erythema for worsening / expansion. F'U if worsens.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Fluid retention, Full blood count normal, Local swelling, Parotitis, Swelling face
Clinical narrative: Face & neck started swelling at 11:00 P.M. on 10/23/2008.  No improvement by 10/26/2008.  Physician evaluated her and said she had parotitis with retained fluid.  Instructed her to take BENADRYL + IBUPROFEN.  Some improvement by 10/27/2008.  Nurse pract.  ordered CBC (WNC).  Continued improvement 10/28/08.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Swelling
Clinical narrative: Arm with localized pain.  Swelling & bruising- treated with TRAMADOL.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed redness and swelling at ANTHRAX injection site approximately 3-4 days post injection.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient noted redness, swelling, warmth, pain approx 24 hrs post vaccination with anthrax. Within 48 hours the redness and swelling went from his shoulder to below his elbow. Was treated with amoxy for 10 days and this helped.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Dr. ordered PREVNAR (dose #1) to be given and it was out of age limit. She is 6 yrs old.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Mother did not have up to date record with infant so PEDIARIX was given 3 1/2 wks from the previous dose (2nd PEDIARIX given 6/17/08 and 3rd 7/9/08 at her Dr's office).
Age: 1.1
Sex: M
Vaccine: PPV
Symptoms: Blood immunoglobulin G increased, No adverse event
Clinical narrative: No adverse event occurred. This patients IgG was low & so was post pn levels.
Age: 0.8
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Incorrect drug dosage form administered
Clinical narrative: No adverse symptoms. HIB mixed with MMR diluent, vaccine will be readministered correctly.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Severe pain (L) deltoid area.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness with swelling @ injection site extending to elbow. Heat to the area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Amyotrophic lateral sclerosis, Arthralgia, Gene mutation, Muscular weakness, Paraesthesia
Clinical narrative: Concerned about new diagnosis of ALS in 2/2008 with receipt past AVA vaccine in 2000. SM had preexisting muscle weakness, joint pain paresthesia since 1988 when dx with sciatica, HNP, tendonitis, et el. AVA vaccinations began in Feb 1999 (10 years later). He continued with s/s for HNP over next several years with symptoms on ALS beginning in 2006 with diagnosis of ALS in Feb 2008. SM with strong family hx ALS: father, brother, paternal grandfather.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Tendonitis
Clinical narrative: Concerned about new diagnosis of ALS in 2/2008 with receipt past AVA vaccine in 2000. SM had preexisting muscle weakness, joint pain paresthesia since 1988 when dx with sciatica, HNP, tendonitis, et el. AVA vaccinations began in Feb 1999 (10 years later). He continued with s/s for HNP over next several years with symptoms on ALS beginning in 2006 with diagnosis of ALS in Feb 2008. SM with strong family hx ALS: father, brother, paternal grandfather.
Sex: U
Vaccine: FLU3
Symptoms: Burning sensation, Eye swelling, Pruritus generalised, Rash generalised, Urticaria
Clinical narrative: 10/8/08 patient received flu vaccine.  10/13/08 patient states she was itchy all over with a rash, and had burning sensation.  10/15/08 patient has hives and woke up with eyes swollen shut.  10/16/08 patient had hives in morning, but clearing up as day progressed.
Sex: F
Vaccine: DT
Symptoms: Unevaluable event
Clinical narrative: PT. Followed up by PCP. Please contact Dr.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Eye swelling, Pruritus, Swelling face
Clinical narrative: Pt's cheeks got very puffy and swollen 15 days after his MMR vaccine. His face was swollen around his eyes and between his eyes at the top of his nose, his skin on his face was red and itchy, then later got rough and had raised bumps on it.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Chest pain, Movement disorder
Clinical narrative: After receiving the shot I started have chest pains and couldn't hardly move. The pain started moving towards my back side and got worse.
Sex: M
Vaccine: ANTH, SMALL, TTOX
Symptoms: Headache, Mouth ulceration, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Body ache, headache, fever, swollen arm pits, swollen tongue, sores on tongue & mouth.
Sex: M
Vaccine: ANTH, SMALL, TTOX
Symptoms: Swollen tongue, Tenderness
Clinical narrative: Body ache, headache, fever, swollen arm pits, swollen tongue, sores on tongue & mouth.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Pruritus, Swelling
Clinical narrative: 6 x6 area of redness, swelling, pain and itching. Onset several hours post injection. Local reaction only. No anaphylaxis.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching & swelling at injection location pretty intense reaction - but no breathing problems.
Age: 22.0
Sex: M
Vaccine: JEV, SMALL
Symptoms: C-reactive protein increased, Full blood count, Metabolic function test, Oedema peripheral, Red blood cell sedimentation rate increased
Clinical narrative: Had dessemination of vaccinia vaccination associated with Pedal Edeme following 2nd JAP B vaccine.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Dizziness
Clinical narrative: Mother called stated child started running T last night about 100 degrees (o). Today child called mother & said she felt like she was going to pass out when she tried to stand up. Still running T 100 degrees (o). Advised mother to call MD.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Client "broke out" into widespread rash on upper torso one hour after receiving FLUZONE.  Client took CLARITIN - applied topical cream and arrived at hospital ER at 4:45 PM-  She was stable- given prescription for PREDNISONE 20 mg BID x 3 days every 6 hours.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Feeling abnormal, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Patient received Flu and Pneumonia vaccine.  Pt says she took a nap when she got home.  Later that afternoon she woke up with her arm sore swollen and she felt really bad.  Pt called RCHD 10/10/05, states she feels very tired and sick and arm still hurts.  Ask pt. if she has any fever and if she contacted her doctor.  States no she hasn't.  Encouraged to call doctor for appointment.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, Cough, Dyspnoea, Full blood count, Hypersensitivity
Clinical narrative: Flu vaccine given at 11:46 am on 10/14/08. Pt. started coughing at 10:30 pm- To ER for difficulty breathing. Given IV SOLUMEDROL, BENADRYL and ATIVAN. Adm to hosp with cough and allergic Rx. D/C on 10/14.  11/11/08 Reviewed hospital medical records of 10/14-10/15/2008. FINAL DX: cough, allergic reaction  Records reveal patient experienced severe intractable cough & hoarseness which could not be controlled in ER w/bronchodilators & steroids.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test, Prothrombin time
Clinical narrative: Flu vaccine given at 11:46 am on 10/14/08. Pt. started coughing at 10:30 pm- To ER for difficulty breathing. Given IV SOLUMEDROL, BENADRYL and ATIVAN. Adm to hosp with cough and allergic Rx. D/C on 10/14.  11/11/08 Reviewed hospital medical records of 10/14-10/15/2008. FINAL DX: cough, allergic reaction  Records reveal patient experienced severe intractable cough & hoarseness which could not be controlled in ER w/bronchodilators & steroids.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Dyspnoea, Hypersensitivity, Stridor
Clinical narrative: Presented to ER at 20:20 with c/o difficulty breathing. Treated in ER with IV SOLUMEDROL and BENADRYL. Admitted to hosp. with allergic reaction and stridor. D/C home 10/15/08 at 3:00 pm on MEDROL DOSE PK.   11/11/08 Reviewed hospital medical records of 10/14-10/15/2008. FINAL DX: allergic reaction to flu vaccine w/acute respiratory distress Records reveal patient experienced hoarseness, SOB & stridor.  Tx w/IV steroids & antihistamine.  Improved & d/c to home on continued oral meds & tapering steroids.
Age: 18.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient pregnant when given MMR. No event noted.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Burning sensation, Injected limb mobility decreased, Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a 61 year old female patient. The patient had allergies and "borderline pneumonia" in December 2005, born with organs reversed and monitored for cardiac problems. The patient could not take pain medications due to severe stomach distress after codeine. On 24-OCT-2006 the patient was vaccinated with PNEUMOVAX 23 (lot # 651374/0485F; dose and route not reported). In "late October 2006", the patient developed a severe injection site reaction shortly after receiving PNEUMOVAX 23. She developed a lump that was red, warm, painful, and very swollen. The arm "burned" to the point where putting ice only helped the "top layer of skin" but nothing more. On an unspecified date, an ultrasound of the arm was performed. The patient reported that "it looked like an elephant pacifier". The lump was drained and came right back so the physician recommended surgery and performed a surgery in the office in December 2007 to remove the lump. He did not cut into muscle but said it might take up to 1 year for the nerve endings to heal. It continues to swell up and throb from that time on to the present. She can't use this left arm to lift anything and is restricted in her movements. She can't use her personal trainer. The patient considered her experience to be disabling. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Surgery, Ultrasound scan abnormal
Clinical narrative: Information has been received from a 61 year old female patient. The patient had allergies and "borderline pneumonia" in December 2005, born with organs reversed and monitored for cardiac problems. The patient could not take pain medications due to severe stomach distress after codeine. On 24-OCT-2006 the patient was vaccinated with PNEUMOVAX 23 (lot # 651374/0485F; dose and route not reported). In "late October 2006", the patient developed a severe injection site reaction shortly after receiving PNEUMOVAX 23. She developed a lump that was red, warm, painful, and very swollen. The arm "burned" to the point where putting ice only helped the "top layer of skin" but nothing more. On an unspecified date, an ultrasound of the arm was performed. The patient reported that "it looked like an elephant pacifier". The lump was drained and came right back so the physician recommended surgery and performed a surgery in the office in December 2007 to remove the lump. He did not cut into muscle but said it might take up to 1 year for the nerve endings to heal. It continues to swell up and throb from that time on to the present. She can't use this left arm to lift anything and is restricted in her movements. She can't use her personal trainer. The patient considered her experience to be disabling. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Wound drainage
Clinical narrative: Information has been received from a 61 year old female patient. The patient had allergies and "borderline pneumonia" in December 2005, born with organs reversed and monitored for cardiac problems. The patient could not take pain medications due to severe stomach distress after codeine. On 24-OCT-2006 the patient was vaccinated with PNEUMOVAX 23 (lot # 651374/0485F; dose and route not reported). In "late October 2006", the patient developed a severe injection site reaction shortly after receiving PNEUMOVAX 23. She developed a lump that was red, warm, painful, and very swollen. The arm "burned" to the point where putting ice only helped the "top layer of skin" but nothing more. On an unspecified date, an ultrasound of the arm was performed. The patient reported that "it looked like an elephant pacifier". The lump was drained and came right back so the physician recommended surgery and performed a surgery in the office in December 2007 to remove the lump. He did not cut into muscle but said it might take up to 1 year for the nerve endings to heal. It continues to swell up and throb from that time on to the present. She can't use this left arm to lift anything and is restricted in her movements. She can't use her personal trainer. The patient considered her experience to be disabling. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal tenderness, Barium enema normal, Crying, Diarrhoea haemorrhagic, Gastroenteritis
Clinical narrative: Information has been received from a physician concerning a 4 month old male who on 14-OCT-2008 at 09:00, was vaccinated with his second dose of 2 ml oral ROTATEQ.  Concomitant therapy included poliovirus vaccine, PREVNAR, and hepatitis B virus vaccine (unspecified).  Around 4 that day, the patients mother reported that that patient had diarrhea with blood and the child was irritable and had been crying.  They were sent to the ER and a barium enema was performed and ruled out intussusception.  It was determined to be severe gastroenteritis.  The event of severe gastroenteritis improved after stopping therapy.  The patient was considered to be recovering.  The patient sought unspecified medical attention.  There was no product quality complaint.  Additional information was received from the physician who reported that on 13-OCT-2008 at 10:00 (previously reported as 14-OCT-2008 at 09:00), the patient was vaccinated with the second dose of oral ROTATEQ (Lot # 660877/0305X), the second dose of IM IPOL (SANOFI PASTEUR, Lot # A0490-2) (site left), the second dose of IM PREVNAR (WYETH, Lot # C86141) (site right), the second dose of IM ACTHIB (SANOFI PASTEUR, Lot # UF259AA) (site right) and  the second dose of DAPTACEL (SANOFI PASTEUR, Lot # C2935AA) (site left).  On 13-OCT-2008 at 16:00, the patient's mother called and stated that the patient started with diarrhea 1-2 hours prior and now cries a lot and has bloody stool.  The patient was seen immediately.  The patient was fussy and had a tender abdomen and documented blood in stool.  There was visual blood in the stool as well as occult blood in the stool.  The patient was seen at the emergency room.  A barium enema was negative.  The patient was considered to be recovered on 15-OCT-2008.  Severe gastroenteritis and bloody stool were considered to be immediately life-threatening, and other important medical events.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Haematochezia, Irritability, Laboratory test abnormal, Occult blood positive
Clinical narrative: Information has been received from a physician concerning a 4 month old male who on 14-OCT-2008 at 09:00, was vaccinated with his second dose of 2 ml oral ROTATEQ.  Concomitant therapy included poliovirus vaccine, PREVNAR, and hepatitis B virus vaccine (unspecified).  Around 4 that day, the patients mother reported that that patient had diarrhea with blood and the child was irritable and had been crying.  They were sent to the ER and a barium enema was performed and ruled out intussusception.  It was determined to be severe gastroenteritis.  The event of severe gastroenteritis improved after stopping therapy.  The patient was considered to be recovering.  The patient sought unspecified medical attention.  There was no product quality complaint.  Additional information was received from the physician who reported that on 13-OCT-2008 at 10:00 (previously reported as 14-OCT-2008 at 09:00), the patient was vaccinated with the second dose of oral ROTATEQ (Lot # 660877/0305X), the second dose of IM IPOL (SANOFI PASTEUR, Lot # A0490-2) (site left), the second dose of IM PREVNAR (WYETH, Lot # C86141) (site right), the second dose of IM ACTHIB (SANOFI PASTEUR, Lot # UF259AA) (site right) and  the second dose of DAPTACEL (SANOFI PASTEUR, Lot # C2935AA) (site left).  On 13-OCT-2008 at 16:00, the patient's mother called and stated that the patient started with diarrhea 1-2 hours prior and now cries a lot and has bloody stool.  The patient was seen immediately.  The patient was fussy and had a tender abdomen and documented blood in stool.  There was visual blood in the stool as well as occult blood in the stool.  The patient was seen at the emergency room.  A barium enema was negative.  The patient was considered to be recovered on 15-OCT-2008.  Severe gastroenteritis and bloody stool were considered to be immediately life-threatening, and other important medical events.  Additional information has been requested.