chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Shoulder pain
Clinical narrative: Patient's husband reports that she received the flu shot on 10/25/06. On 10/31/06 went to the ER with severe pain in neck and shoulders with some limited movement to upper extemities.  Pain was the major presenting SX.  Patient's husband reports that patient was given a DX of "pinched nerve" or something like that.  Patient was given Vicodin and Ibuprofen and sent home.  Within 1 to 2 hours after arriving home, patient had complete paralysis.  Patient was able to talk and had no breathing difficulties, but could not move her upper or lower extemities.  Patient was transported to ER via 911 where she remains at the time of this report.  Some improvement has been reported at the time of this writing.  Pt is able to move her L arm and leg. Pt is able to wiggle toes and fingers on the right side.  Pt has no bowel or bladder function. Dx is Transverse Myelitis.  1/2/07 Received medical records from REHAB hosital which reveal patient admitted 11/8/06-11/29/06 with a 3 day history of progressive numbness & weakness of extremities.  Treated w/steroids, PT/OT & antibiotics.  Consults by ID, neuro & PMR PMH: hypothyroidism FINAL DX: cervical cord transverse myelitis; tetroplegia w/Brown Sequard syndrome; hypothyroidism; neurogenic bowel & bladder, resolved; low grade fever; c diff colitis; & strep & yeast UTI, resolved. 2/1/07 Received medical records from first hospital which reveal patient admitted 11/1-11/8/06 after experiencing bilateral arm & leg weakness to the point that she could not walk.  Two days prior to admit, had been helping to move furniture when felt pain in neck spreading to shoulder & weakness into her right arm.  Seen at urgent care center & received pai meds.  When leaving center, legs became weak to the point could not walk.  Ambulance called & taken to ER.   Admit exam revealed right arm strength of 0, left arm movement only from elbow down.  Right leg strength 0 & left leg can flex from knee down.  Having urine & bowel problems requiring enemas & Foley cath. Neuro & neurosurg consults done.  Tx w/5 days of high dose steroids which provided improvement but patient was still unable to walk.  PT/OT started. Transferred to rehab hospital, to f/u w/neuro & neurosurg & to repeat MRI of c spine in 6-8 weeks. FINAL DX: Transverse myelitis with right sided paralysis & left sided weakness; DJD in cervical spine; & history of hypothyroidism.
Age: 0.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Insomnia, Pain, Tendonitis
Clinical narrative: Patient received vaccine afternoon and woke the next morning with decreased mobility and pain.  Unable to sleep due to pain.  Went to personal physicain who DX patient with tendonitis due to the flu shot.  Taking Aleve with good results.  Mobility improving and pain diminishing.
Age: 15.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Posturing
Clinical narrative: Tonic posturing 1-2 seconds following administration of Tdap vaccine, 1 minute following Influenza vaccine.  Tonic upper extremity posturing lasted approximately 20 seconds, with full resolution of symptoms.
Age: 36.0
Sex: F
Vaccine: FLUN3
Symptoms: Angioneurotic oedema, Pruritus, Swelling face, Urticaria, Vaccination complication
Clinical narrative: TWO DAYS AFTER ADMINISTRATION OF LIVE NASAL FLU VACCINE, DEVELOPED ITCHING, SUBSEQUENT EXTENSIVE URTICARIAL REACTION LASTING SEVERAL WEEKS INCLUDING ANGIOEDEMA OF FACE AND LIPS. MR received. Patient received Flumist on 10/10/2006.  On 10/12/2006 began experiencing hives which continued several weeks.  First sought treatment on 11/01/2006 for urticaria which was treated with Zyrtec, a Methylprednisolone dose-pak and Cimetidine.  On 11/07/2006 she sought treatment for facial swelling and continued hives. Swelling of lips and cheeks were noted, no stridor. Assessment:  Urticaria with angioedema. Prednisone taper. F/U on 11/09/2006 with hives decreasing, but still having itching. Assessment: Urticaria/angioedema likely 2' to live flu vaccine, improving.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: swollen, red, itchy injection site, swelling, pain in arm, chest tightness, head ache, slight swelling of tongue.  Give Benadryl and albuterol
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Tongue oedema
Clinical narrative: swollen, red, itchy injection site, swelling, pain in arm, chest tightness, head ache, slight swelling of tongue.  Give Benadryl and albuterol
Age: 0.8
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Crying, Diarrhoea, Epilepsy, Eye movement disorder
Clinical narrative: Patient received the DTaP vaccine...within a couple she began uncontrollable crying non-stop. She also began a fever. About 1 1/2 days later she collapse and had a hypotonic hypo-responsive episode and a seizure. She was rushed to the hospital where it was confirmed of her seizure episode. I followed up with her pediatrician and the county health dept. and they both agreed it was due to an allergic reaction from the Pertussis from the DTaP vaccine. Since the incident she had 3 more febrile seizures in a 6 month period. Then on October 31, 2006 she had 6 seizures (non-febrile) and was taken to the hospital and had multiple test done. She is 17 months old now and has been diagnosed with epilepsy. There is no history on either side of her family of any seizures (febrile or non-febrile). Note on 6/29/05-diarrhea times 8 days. 3/29/06-fever on day of shot at health dept 102. On amoxillin now for OM for 5 days. Seizures 2 days after vaccine, eyes rolled, fell on her side, facial grimace lasted 2-3 minutes. Seizure in ER. Assessment: history of seizures related to dTap.  6/22/06-rash, fever 1 month ago. No family HX of seizures. Assessment: seizure disorder. DDST.  Referred to neurologist. 6/29/06-has not seen neurologist. Recommend that child not have dTap.  11/15/06-Dr. did not see patient records received from hospital for DOS 3/24/06 DC DX: Febrile Convulsions Otitis Media NOS Fever Febrile seizure 1-2 minutes 30 minutes prior to ER visit. Became limp, "strange eye movment" Temp in ER 101.9 PE Right TM erythematous. remainder WNL. ER visit 5/11/06-DX: Febrile convuslions after DTAP vaccine.  3/31/2010 Follow up: Still has seizures mostly at night, was given medication to present the seizures and had an adverse reaction to it, doctor had us stop medication.
Age: 0.8
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Fall, Febrile convulsion, Gaze palsy, Grimacing, Hypotonia
Clinical narrative: Patient received the DTaP vaccine...within a couple she began uncontrollable crying non-stop. She also began a fever. About 1 1/2 days later she collapse and had a hypotonic hypo-responsive episode and a seizure. She was rushed to the hospital where it was confirmed of her seizure episode. I followed up with her pediatrician and the county health dept. and they both agreed it was due to an allergic reaction from the Pertussis from the DTaP vaccine. Since the incident she had 3 more febrile seizures in a 6 month period. Then on October 31, 2006 she had 6 seizures (non-febrile) and was taken to the hospital and had multiple test done. She is 17 months old now and has been diagnosed with epilepsy. There is no history on either side of her family of any seizures (febrile or non-febrile). Note on 6/29/05-diarrhea times 8 days. 3/29/06-fever on day of shot at health dept 102. On amoxillin now for OM for 5 days. Seizures 2 days after vaccine, eyes rolled, fell on her side, facial grimace lasted 2-3 minutes. Seizure in ER. Assessment: history of seizures related to dTap.  6/22/06-rash, fever 1 month ago. No family HX of seizures. Assessment: seizure disorder. DDST.  Referred to neurologist. 6/29/06-has not seen neurologist. Recommend that child not have dTap.  11/15/06-Dr. did not see patient records received from hospital for DOS 3/24/06 DC DX: Febrile Convulsions Otitis Media NOS Fever Febrile seizure 1-2 minutes 30 minutes prior to ER visit. Became limp, "strange eye movment" Temp in ER 101.9 PE Right TM erythematous. remainder WNL. ER visit 5/11/06-DX: Febrile convuslions after DTAP vaccine.  3/31/2010 Follow up: Still has seizures mostly at night, was given medication to present the seizures and had an adverse reaction to it, doctor had us stop medication.
Age: 0.8
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Hypotonic-hyporesponsive episode, Laboratory test, Otitis media, Pyrexia, Rash
Clinical narrative: Patient received the DTaP vaccine...within a couple she began uncontrollable crying non-stop. She also began a fever. About 1 1/2 days later she collapse and had a hypotonic hypo-responsive episode and a seizure. She was rushed to the hospital where it was confirmed of her seizure episode. I followed up with her pediatrician and the county health dept. and they both agreed it was due to an allergic reaction from the Pertussis from the DTaP vaccine. Since the incident she had 3 more febrile seizures in a 6 month period. Then on October 31, 2006 she had 6 seizures (non-febrile) and was taken to the hospital and had multiple test done. She is 17 months old now and has been diagnosed with epilepsy. There is no history on either side of her family of any seizures (febrile or non-febrile). Note on 6/29/05-diarrhea times 8 days. 3/29/06-fever on day of shot at health dept 102. On amoxillin now for OM for 5 days. Seizures 2 days after vaccine, eyes rolled, fell on her side, facial grimace lasted 2-3 minutes. Seizure in ER. Assessment: history of seizures related to dTap.  6/22/06-rash, fever 1 month ago. No family HX of seizures. Assessment: seizure disorder. DDST.  Referred to neurologist. 6/29/06-has not seen neurologist. Recommend that child not have dTap.  11/15/06-Dr. did not see patient records received from hospital for DOS 3/24/06 DC DX: Febrile Convulsions Otitis Media NOS Fever Febrile seizure 1-2 minutes 30 minutes prior to ER visit. Became limp, "strange eye movment" Temp in ER 101.9 PE Right TM erythematous. remainder WNL. ER visit 5/11/06-DX: Febrile convuslions after DTAP vaccine.  3/31/2010 Follow up: Still has seizures mostly at night, was given medication to present the seizures and had an adverse reaction to it, doctor had us stop medication.
Age: 0.8
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Syncope, Tympanic membrane hyperaemia
Clinical narrative: Patient received the DTaP vaccine...within a couple she began uncontrollable crying non-stop. She also began a fever. About 1 1/2 days later she collapse and had a hypotonic hypo-responsive episode and a seizure. She was rushed to the hospital where it was confirmed of her seizure episode. I followed up with her pediatrician and the county health dept. and they both agreed it was due to an allergic reaction from the Pertussis from the DTaP vaccine. Since the incident she had 3 more febrile seizures in a 6 month period. Then on October 31, 2006 she had 6 seizures (non-febrile) and was taken to the hospital and had multiple test done. She is 17 months old now and has been diagnosed with epilepsy. There is no history on either side of her family of any seizures (febrile or non-febrile). Note on 6/29/05-diarrhea times 8 days. 3/29/06-fever on day of shot at health dept 102. On amoxillin now for OM for 5 days. Seizures 2 days after vaccine, eyes rolled, fell on her side, facial grimace lasted 2-3 minutes. Seizure in ER. Assessment: history of seizures related to dTap.  6/22/06-rash, fever 1 month ago. No family HX of seizures. Assessment: seizure disorder. DDST.  Referred to neurologist. 6/29/06-has not seen neurologist. Recommend that child not have dTap.  11/15/06-Dr. did not see patient records received from hospital for DOS 3/24/06 DC DX: Febrile Convulsions Otitis Media NOS Fever Febrile seizure 1-2 minutes 30 minutes prior to ER visit. Became limp, "strange eye movment" Temp in ER 101.9 PE Right TM erythematous. remainder WNL. ER visit 5/11/06-DX: Febrile convuslions after DTAP vaccine.  3/31/2010 Follow up: Still has seizures mostly at night, was given medication to present the seizures and had an adverse reaction to it, doctor had us stop medication.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Anaphylactic reaction, Dysphagia, Hypertrophy, Mucous membrane disorder, Paraesthesia
Clinical narrative: Patient recieved FluMist at approximately 11:30am with no complaints. While at lunch the patient comlained of something in his throat and began to gag himself, Mom thought something could be caught in his throat but after drinking fluids the sensation began to get worse.  She returned to the office for him to be examined.  On exam he was noted to be in no acute distress.  He did have pallor, have slight tonsilar hypertrophy, swollen mucous membranes with clear rhinorrhea. Chest exam was clear. Paient reported tingling sensation in tongue and throat, with throat feeling funny. He was noted to be swallowing with mild difficulty.  He was given a dose of epi IM and po Atarax.  Symptoms improved in 30 minutes.  MR received/, revealing a well child exam of 10/03/2006. Only c/o is "seeing spots" for which he was given a referral. Child returned 11/08/2006 for c/o intermittant diarrhea x 2 weeks. FluMist given.  One hour later child returned with c/o throat closing and trying to gag himself by putting fingers in throat. Exam:  pale "panic" appearance, turbinates swollen with clear d/c, lungs clear. Txd with Atarax and epinephrine IM. Symptoms resolved in 30". Impression: "Anaphylactic reaction to FluMist".
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Retching, Rhinorrhoea
Clinical narrative: Patient recieved FluMist at approximately 11:30am with no complaints. While at lunch the patient comlained of something in his throat and began to gag himself, Mom thought something could be caught in his throat but after drinking fluids the sensation began to get worse.  She returned to the office for him to be examined.  On exam he was noted to be in no acute distress.  He did have pallor, have slight tonsilar hypertrophy, swollen mucous membranes with clear rhinorrhea. Chest exam was clear. Paient reported tingling sensation in tongue and throat, with throat feeling funny. He was noted to be swallowing with mild difficulty.  He was given a dose of epi IM and po Atarax.  Symptoms improved in 30 minutes.  MR received/, revealing a well child exam of 10/03/2006. Only c/o is "seeing spots" for which he was given a referral. Child returned 11/08/2006 for c/o intermittant diarrhea x 2 weeks. FluMist given.  One hour later child returned with c/o throat closing and trying to gag himself by putting fingers in throat. Exam:  pale "panic" appearance, turbinates swollen with clear d/c, lungs clear. Txd with Atarax and epinephrine IM. Symptoms resolved in 30". Impression: "Anaphylactic reaction to FluMist".
Age: 36.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Medication error
Clinical narrative: NONE
Age: 56.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: NONE
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Hypokinesia, Injection site erythema, Injection site inflammation, Muscular weakness
Clinical narrative: Information has been received from a 60 year old female nurse who on 10/12/06 was vaccinated with 1 dose of Pneumococcal 23v polysaccharide vaccine. On 10/12/2006 the nurse experienced severe pain and developed erythema in injection site arm (right arm). The nurse explained that she received this dose of Pneumococcal 23v polysaccharide vaccine at a pharmacy and that a spring loaded needle was used. The nurse felt that the injection was given too high on her deltoid muscle, and that the needle may have injured a bone. The nurse also started that she experienced difficulty raised her right arm due to extreme pain and weakness. She was treated with Vicodin and an unspecified steroid. The nurse received physical therapy. At the time of this report, the pt was recovering. The nurse felt the severe pain, erythema, weakness, difficulty in raising arm, bone injury and inappropriate site administration were considered to be disabling and other medical events (OMIC).
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Shoulder pain, Tremor, X-ray
Clinical narrative: Information has been received from a 60 year old female nurse who on 10/12/06 was vaccinated with 1 dose of Pneumococcal 23v polysaccharide vaccine. On 10/12/2006 the nurse experienced severe pain and developed erythema in injection site arm (right arm). The nurse explained that she received this dose of Pneumococcal 23v polysaccharide vaccine at a pharmacy and that a spring loaded needle was used. The nurse felt that the injection was given too high on her deltoid muscle, and that the needle may have injured a bone. The nurse also started that she experienced difficulty raised her right arm due to extreme pain and weakness. She was treated with Vicodin and an unspecified steroid. The nurse received physical therapy. At the time of this report, the pt was recovering. The nurse felt the severe pain, erythema, weakness, difficulty in raising arm, bone injury and inappropriate site administration were considered to be disabling and other medical events (OMIC).
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Bone disorder, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 60 year old female nurse who on 10/12/06 was vaccinated with 1 dose of Pneumococcal 23v polysaccharide vaccine. On 10/12/2006 the nurse experienced severe pain and developed erythema in injection site arm (right arm). The nurse explained that she received this dose of Pneumococcal 23v polysaccharide vaccine at a pharmacy and that a spring loaded needle was used. The nurse felt that the injection was given too high on her deltoid muscle, and that the needle may have injured a bone. The nurse also started that she experienced difficulty raised her right arm due to extreme pain and weakness. She was treated with Vicodin and an unspecified steroid. The nurse received physical therapy. At the time of this report, the pt was recovering. The nurse felt the severe pain, erythema, weakness, difficulty in raising arm, bone injury and inappropriate site administration were considered to be disabling and other medical events (OMIC).
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injury, Medication error
Clinical narrative: Information has been received from a 60 year old female nurse who on 10/12/06 was vaccinated with 1 dose of Pneumococcal 23v polysaccharide vaccine. On 10/12/2006 the nurse experienced severe pain and developed erythema in injection site arm (right arm). The nurse explained that she received this dose of Pneumococcal 23v polysaccharide vaccine at a pharmacy and that a spring loaded needle was used. The nurse felt that the injection was given too high on her deltoid muscle, and that the needle may have injured a bone. The nurse also started that she experienced difficulty raised her right arm due to extreme pain and weakness. She was treated with Vicodin and an unspecified steroid. The nurse received physical therapy. At the time of this report, the pt was recovering. The nurse felt the severe pain, erythema, weakness, difficulty in raising arm, bone injury and inappropriate site administration were considered to be disabling and other medical events (OMIC).
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Respiratory disorder, Respiratory tract infection
Clinical narrative: A 60 year old male pt had received a first dose, left deltoid injection on Fluzone SV 2006-2007, lot number U2240AA, on 10/05/2006. On the same day, the pt felt ill and went to an ER. He was hospitalized for respiratory problems/infection and died on an unk number of days shortly afterwards. Past medical history was not reported. It was not known whether the pt had any illnesses at the time of vaccination. The exact date of death was not reported.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Infection, Malaise, Respiratory disorder
Clinical narrative: A 60 year old male pt had received a first dose, left deltoid injection on Fluzone SV 2006-2007, lot number U2240AA, on 10/05/2006. On the same day, the pt felt ill and went to an ER. He was hospitalized for respiratory problems/infection and died on an unk number of days shortly afterwards. Past medical history was not reported. It was not known whether the pt had any illnesses at the time of vaccination. The exact date of death was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: I got a flu shot on Tuesday afternoon and it hurt worse than normal, it was an intense stinging sensation rather than the mild burning sensation I've gotten from previous flu shots. Within 3 hours I was very sore & achy, which I expected, and I took some ibuprofen. Within 3 more hours I was in more pain than I could believe. It was like I had electricity running through my entire body and a hangover at the same time and then got hit by a truck on top of it. Every single joint and musle was painful -- beyond "sore" and "achy" to excruciating pain! At one point I told DH that even my teeth and hair hurt. I slept fitfully & feverishly all Tuesday night and then all day Wednesday! I'm feeling better Thursday but I still have a couple of areas that still feel like they have a "charge" to them. I have never had any reaction to any vaccine or any medication before.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Hypoaesthesia, Hypokinesia, Malaise, Pain
Clinical narrative: 24 hours after injection administered in upper left arm, patient experience swelling in, deep pain in, and inability to move left arm; numbness in extremities; shortness of breath; severe lethargy and malaise.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Swelling
Clinical narrative: 24 hours after injection administered in upper left arm, patient experience swelling in, deep pain in, and inability to move left arm; numbness in extremities; shortness of breath; severe lethargy and malaise.
Age: 24.0
Sex: M
Vaccine: FLUX, HEP, HEPA, TYP, YF
Symptoms: Encephalitis, Headache, Meningitis, Mydriasis, Vision blurred
Clinical narrative: Seriousness criteria other Medically significant (OMIC). A 24 year old male pt with a history of asthma and allergy of Vicodin received doses of YF Vax, influenza vaccine (Manufacturer unk), Hepatitis A vaccine (manufacturer unk), Hepatitis B vaccine (manufacturer unk), and Typhoid vaccine (manuf unk), in mid October 2006. The lot numbers were reported as unk. The routes and dates of administration were not reported. As per the reporter, all of the vaccines except for the YF Vax were administered at another facility. Approx two days after receiving the vaccines, the pt complained of a general headache, right pupil enlargement and blurred eyesight in his right eye. The pt used a scopolamine patch approx six to seven hours after the pupil changes were noted. He was evaluated at an emergency room, where he was diagnosed with possible meningitis ore questionable mild encephalitis. An MRI and CBC chemistry were all neg. The condition resolved and the pt recovered from the events.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Confusional state, Dysarthria, Hypokinesia, Hypoxia
Clinical narrative: A report was received from a health care professional concerning a 65 year old male vaccinee. The vaccinee has a past medical history of gastric banding, and a current history of coronary artery disease,d congestive cardiac failure, Type II Diabetes mellitus and kidney stones. Concomitant medications included Altace, Coreg, Elavil, Keflex, Lasix and Potassium. The vaccinee had received Influenza vaccine in the past with on adverse effects. On 10/17/06 the vaccine received influenza vaccine (Brand unspecified) in his right shoulder and pneumococcal 23 v polysaccharide vaccine in his left shoulder. Within 3 hours the vaccinee developed localised pain in his left arm and shivering. An hour later he had sluggish speech and was confused. He was taken to the ER with a systolic blood pressure of 129 and saturated oxygen at 100%. He was confused, had slurred speech and severe shivering and was treated with oxygen and a warm blanket. The vaccinee had severe left shoulder pain, especially with movement, with a heavy sensation in the arm. The physician indicated that blood test including cardiac enzymes were performed, and that the events did not appear to be cardiac related. The vaccinee was not able to raise his arm but was able to move his fingers, there was severe pain with passive movement of the arm. Additional vital signs included systolic blood pressure 109, pulse 55, temp 97.1. Hospital transfer for further evaluation, treatment and possible hospital admission were being considered at the time of the report. The reporter considered the events to be serious, immediately life threatening and in important medical event (OMIC).
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Sensation of heaviness, Shoulder pain
Clinical narrative: A report was received from a health care professional concerning a 65 year old male vaccinee. The vaccinee has a past medical history of gastric banding, and a current history of coronary artery disease,d congestive cardiac failure, Type II Diabetes mellitus and kidney stones. Concomitant medications included Altace, Coreg, Elavil, Keflex, Lasix and Potassium. The vaccinee had received Influenza vaccine in the past with on adverse effects. On 10/17/06 the vaccine received influenza vaccine (Brand unspecified) in his right shoulder and pneumococcal 23 v polysaccharide vaccine in his left shoulder. Within 3 hours the vaccinee developed localised pain in his left arm and shivering. An hour later he had sluggish speech and was confused. He was taken to the ER with a systolic blood pressure of 129 and saturated oxygen at 100%. He was confused, had slurred speech and severe shivering and was treated with oxygen and a warm blanket. The vaccinee had severe left shoulder pain, especially with movement, with a heavy sensation in the arm. The physician indicated that blood test including cardiac enzymes were performed, and that the events did not appear to be cardiac related. The vaccinee was not able to raise his arm but was able to move his fingers, there was severe pain with passive movement of the arm. Additional vital signs included systolic blood pressure 109, pulse 55, temp 97.1. Hospital transfer for further evaluation, treatment and possible hospital admission were being considered at the time of the report. The reporter considered the events to be serious, immediately life threatening and in important medical event (OMIC).
Age: 1.13
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Eye movement disorder, Tremor
Clinical narrative: Child had suspected seizure x 2 episodes, 1 wk after the MMR was given. Pt was playing around 7pm when her head fell back, eyes rolled back, and shaking of arms/legs x about 2 minutes 911 was called and Pt was taken to ER and admitted to Pediatrics.  1/2/07 Received medical records from hospital which reveal patient had 3 admissions: #1 -- 10/23/06-10/25/06 Final Dx: seizure like episodes.  No further seizure like episodes were observed while hospitalized.  Family witnessed patient suddenly falling backwards while playing & extremities shook for approx 2 min.  Not responsive during this episode & foamed at the mouth.  Decreased responsiveness for approx 30 min afterwards.  Other symptoms were runny nose, decreased sleep & increased clinginess for approx 1 week prior to admit. #2 -- 11/5/06 was ER visit for seizures x 2 lasting approx 6 min & left eye stye.  During seizure, eyes open, unresponsive, stiff arms & legs lasting approx 2 min.  .  Additional antiseizure meds rxd. #3 -- 11/17/06 admitted overnight for seizures witnessed by EMS staff as grand mal seizure which did not respond to diastat, did resolve with valium IV.  Other symtoms were sinus congestion & cough for 3 days prior to admit.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Crying, Electroencephalogram abnormal, Lymphocyte count decreased, Monocyte count normal
Clinical narrative: 25 minutes seizure generalized within 12 hours of vaccination.  12/4/06 Received medical records from hospital which reveal patient went to bed on day of vax as normal but 2 hours later awoke crying.  Parent then witnessed a gen tonic clonic seizure which lasted approx 25 min.  Emesis x 2.  First trial of rice cereal on day of vax also.  Had recently changed formula as well.  No further seizure activity was noted & patient d/c to home next day for outpatient follow up. Family hx: neg for seizures & no prior hx of seizures in patient. Final DX: seizures, new onset. Per information received from annual follow up, child still suffers from seizures occasionally. Per 60 day follow up: Pt had seizures night of vaccines 11-6-06 pt has had subsequent vaccines and have gone well. MRI was normal. Has had no seizures since per doctor.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Neutrophil count normal, Nuclear magnetic resonance imaging brain abnormal, Vomiting, White blood cell count increased
Clinical narrative: 25 minutes seizure generalized within 12 hours of vaccination.  12/4/06 Received medical records from hospital which reveal patient went to bed on day of vax as normal but 2 hours later awoke crying.  Parent then witnessed a gen tonic clonic seizure which lasted approx 25 min.  Emesis x 2.  First trial of rice cereal on day of vax also.  Had recently changed formula as well.  No further seizure activity was noted & patient d/c to home next day for outpatient follow up. Family hx: neg for seizures & no prior hx of seizures in patient. Final DX: seizures, new onset. Per information received from annual follow up, child still suffers from seizures occasionally. Per 60 day follow up: Pt had seizures night of vaccines 11-6-06 pt has had subsequent vaccines and have gone well. MRI was normal. Has had no seizures since per doctor.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Hypokinesia, Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial and swelling followed by persistent pain at injection site. Pain with movement beyond typical 24-72 hours. Has not returned to work. Immunized due to worker's compensation injury/exposure to raw sewage.
Age: 1.58
Sex: F
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient received vaccines and left the office. Her Father brought her back in about 10 minutes with hives on face, arms and trunk.  This was approximately 20-30 minutes after receiving her vaccines.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Severe pain and redness/heat at site, fever, nausea, headache, body aches.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Severe pain and redness/heat at site, fever, nausea, headache, body aches.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Syncope
Clinical narrative: Chill, muscle aches, fever, increased fatigue, syncopal episode.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Syncope
Clinical narrative: Around 4:45 pm - Difficulty breathing, I couldn't seem to take a deep breath, and also little faint - lasted about 15 minutes - no treatment, because I was driving home from work during the time.  It was scary to the point of me almost pulling over to the side and pressing my ONSTAR button for assistance, but I let my windows down and kept on driving.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site erythema, Injection site mass, Injection site swelling, Pain
Clinical narrative: 11/8/2006 EVENING, FIRST NOTICED RED, SWOLLEN, LUMP AT INJECTION SITE. SLIGHTLY WARM. HURTS TO LIFT ARM. REDDENED AREA IS 2"X1".  DOESN'T ITCH.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nausea, Pain, Retching
Clinical narrative: Acute pain all the way down the R arm (ulnar nerve) in which the vaccine was administered. Pain was followed by numbness for approximately 12 hours. Also, acute nausea and gagging, sick to stomach for over 24 hours.
Age: 44.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Patient's arm at site of injection became very red, about the size of her hand and a hard knot developed under the skin that was 3 inches x 1 1/2 inches. This area is still hot to touch and very tender, four days later.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: On 7/6/06, a 4 year old female patient received a 0.5ml IM DTaP immunization in the left thigh and experienced red lesions on the left medial thigh at the injection site the next day (7/7/06). By 7/9, the area had become tender to the touch, and a 4-5 cm halo with blisters at the lower edge of the halo had appeared. The patient also received a 0.5ml IM Hepatitis A vaccination at another site on the left thigh; however, no lesions were noted in that area. She was started on Orapred® 30mg daily x 5 days on 7/10. The mother subsequently reported that the blisters resolved; she was told to return to the clinic if there are any further concerns. It is unknown how many previous doses of vaccine the patient has received, or what the other 2 vaccinations (1 in right arm, 1 in left arm) were; the notes did not reveal what vaccination was given in these areas.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Eyelid oedema, Face oedema
Clinical narrative: Employee alleges bilateral blepharedema, along with swelling of lips. C/O slight chest tightness but no frank shortness of air. Employee did not seek medical treatment as of this date. Employee also alleges similar symptoms last year, following the flu shot, but "did not put it together until it happened again this year".
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: PATIENT EXPERIENCED CELLULITIS TYPE REACTION AT SITE OF PNEUMONIA VACCINATION AND VISITED HIS PHYSICIAN, PHYSICIAN ASKED FOR REACTION TO BE REPORTED BUT NO TREATMENT WAS GIVEN.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Disorientation, Dizziness, Dyspnoea, Nausea, Syncope
Clinical narrative: Patient fainted in waiting area less than five minutes after receiving Gardasil injection. Patient disoriented and c/o difficulty breathing when roused. C/O nausea, dizziness. Sent to ER & diagnosed as vasovagal syncope. Patient c/o sores in genital area 3 days post vaccination. Upon visit to doctor, diagnosed with Condyloma.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Patient fainted in waiting area less than five minutes after receiving Gardasil injection. Patient disoriented and c/o difficulty breathing when roused. C/O nausea, dizziness. Sent to ER & diagnosed as vasovagal syncope. Patient c/o sores in genital area 3 days post vaccination. Upon visit to doctor, diagnosed with Condyloma.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Malaise, Presyncope, Syncope
Clinical narrative: Patient fainted in waiting area less than five minutes after receiving Gardasil injection. Patient disoriented and c/o difficulty breathing when roused. C/O nausea, dizziness. Sent to ER & diagnosed as vasovagal syncope. Patient c/o sores in genital area 3 days post vaccination. Upon visit to doctor, diagnosed with Condyloma.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted in waiting area less than five minutes after receiving Gardasil injection. Patient disoriented and c/o difficulty breathing when roused. C/O nausea, dizziness. Sent to ER & diagnosed as vasovagal syncope. Patient c/o sores in genital area 3 days post vaccination. Upon visit to doctor, diagnosed with Condyloma.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Condition aggravated, Dyspnoea
Clinical narrative: Was injected on 08/15/2006.  Began to have shortness of breath by 8/21/2006.  Was seen on 08/22/2006.  Was found to have an asthma exacerbation that required at least a week of oral steroids to calm down.
Age: 30.0
Sex: F
Vaccine: FLU3, MMR, TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus, Rash
Clinical narrative: 11:20AM-Pt was given 3 vaccines. 1st)Influenza-L Deltiod. 2nd)MMR-L upper arm,SQ 3rd) Adacel (Tdap)-R Deltoid. Within 3 minutes after Adacel injection, pt c/o extreme itching to R upper arm. On inspection, the area around the Adacel injection site was reddened and swollen, from approx 1 1/2 inches below the site up and over her shoulder.  Pt took a Benadryl, then stated this isn't going to work. The rash was spreading quickly to her neck and face.  I drew up a dose of Epinephrine (0.5cc) and injected it into the pt's L upper arm.  About 90 seconds later, the pt stated "It isn't working." I drew up a 2nd dose of Epinephrine, (0.5cc), and gave it to her in her R upper arm. Then, immediately after, a co-worker began to transport pt to the Emergency Dept.  The total time spent from initial injection to leaving for the ED was less than 5 minutes.  The pt cored on the way to the ED, approx 3 minutes after leaving the office.  The pt was taken directly to the ICU, where she was intubated.  1/19/07 Received medical records from hospital which reveal patient admitted 11/10-11/13/06 for anaphylaxis & SOB s/p vax. Required intubation due to unstable airway.  Treated with high dose steroids & Benadryl.  Extubated following day but had bronchoscopy & was re intubated due to labored breathing & edematous soft tissue above the vocal cords.  Successfully extubated on 11/12 & remained stable for 24 hours prior to d/c home.  Patient was to obtain a PCP & get appointment ASAP. FINAL DX: Anaphylaxis, secondary to vax; vocal cord dysfunction; history of depression. Followup 3/30/2010. We are almost certain it was the Tdap (adacel) vaccine that caused the reaction.
Age: 1.66
Sex: M
Vaccine: FLU3
Symptoms: CSF test abnormal, Guillain-Barre syndrome, Insomnia, Irritability, Nervous system disorder
Clinical narrative: ~16 days after immunization pt. developed bilateral [[name]] pain and refusal to weight bear, extreme irritability and fussiness.  Waking from sleep at night.  ~25 days after vaccine continued irritability and ED visit with pain with neck flexion as well as hip flexion.  No fevers.  Given Tylenol/Motrin throughout course.  Admitted to hospital, underwent LP with high protein, no other abnormalities.  Had EMG which demonstrated conduction velocities of acquired peripheral nerve disease and diagnosed with Guillan [[name]] Syndrome. 12/21/06 Received medical records from hospital which reveal patient admitted 11/4/06-11/13/06 after having severe cervical & back rigidity & pain with significant irritability for approx 9 days.  Patient had been seen at multiple outpatient facilities prior to admit & dx w/viral syndrome.  Admitted with meningismus & irritability.  Tx w/IVIG.  Responded slowly but was able to again walk at time of d/c.  Was to f/u w/neuro & have PT/OT at home. Final Dx: Guillain [[name]] Syndrome with additional dx of sensory neuropathy, encephalopathy and plexopathy changes.
Age: 1.66
Sex: M
Vaccine: FLU3
Symptoms: Pain, Proctalgia
Clinical narrative: ~16 days after immunization pt. developed bilateral [[name]] pain and refusal to weight bear, extreme irritability and fussiness.  Waking from sleep at night.  ~25 days after vaccine continued irritability and ED visit with pain with neck flexion as well as hip flexion.  No fevers.  Given Tylenol/Motrin throughout course.  Admitted to hospital, underwent LP with high protein, no other abnormalities.  Had EMG which demonstrated conduction velocities of acquired peripheral nerve disease and diagnosed with Guillan [[name]] Syndrome. 12/21/06 Received medical records from hospital which reveal patient admitted 11/4/06-11/13/06 after having severe cervical & back rigidity & pain with significant irritability for approx 9 days.  Patient had been seen at multiple outpatient facilities prior to admit & dx w/viral syndrome.  Admitted with meningismus & irritability.  Tx w/IVIG.  Responded slowly but was able to again walk at time of d/c.  Was to f/u w/neuro & have PT/OT at home. Final Dx: Guillain [[name]] Syndrome with additional dx of sensory neuropathy, encephalopathy and plexopathy changes.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Nausea, Pain, Swelling, Urticaria
Clinical narrative: On November 2 about 30 minutes after the injection I became dizzy. On November 3 I still felt light headed and nausea with pain around a 5 in right arm all day. The night of November 3 I noticed large welts on right arm.  On November 4 the welts continued into my armpit and into the right side of my chest along with significant pain and swelling in right arm, under arm and chest.  I took Benadryl the afternoon and night of November 4 because I was traveling.  November 5 I took more Benadryl and the swelling began to dissipate.  Through out Noveber 5 the swelling,pain and welts continued to improve with the help of Benadryl.  By November 7 all swelling, pain and welts had resolved.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: Adverse Reaction Timeline:  09:30 am: I received a flu vaccination (FLUARIX). 10:30 am: I began to experience the onset of a headache. 10:45 am: I began to experience pain and soreness in my right arm. 11:00 am: My headache had become more painful. 11:30 am: I ate lunch and took extra strength Tylenol hoping to alleviate the pain I was experiencing. 12:30 pm: My headache is now throbbing and I am feeling a slight fever/sweat. 12:45 pm: I depart outside to get some fresh air; it was cool and raining outside.  1: 30 pm:  I took another extra strength Tylenol to try to alleviate the pain of my severe headache, and the pain/sore/stiffness in my right arm. 2:00 pm:   I drank a lot of cold water, but my headache is still throbbing and is more painful as I move my head. 3:00 pm:   I began to experience a slight relief from my headache, but my arm is still sore and painful. 4:00 pm:   The pain of my headache is still there, but is no longer throbbing and as intense. My arm is still painful to move. 5:00 pm:   I took another extra strength Tylenol with dinner and now the pain of my headache is starting to lessen. My arm is still painful when moving or touching. 6:00 pm:   I lied down to take a nap and awoke at 7:00 pm still feeling the pain of my headache and arm. 9:00 pm:   The pain of my headache is lessening, but my arm is still painful. 10:00 pm:  I went to bed still feeling slight pain of my headache, and my arm continues to be painful. 11-08-2006 05:00 am:  I get up still feeling a light headache, but the pain in my arm has now lessened. 06:00 am thru 4:30 pm:  I continued to have a slight headache throughout the day, the pain had lessened in my arm and head, but I experienced extreme and frequent urination all day long. I had to urinate constantly throughout the day, which I thought was very unusual. I had to urinate approximately every 20-30 minutes through out the day, and forced myself to drink water to prevent dehydration. 4:30pm thru 10:00pm: The pain in my arm is very slight, but I continued to have a slight headache. 11-09-2006 I had experienced a light headache throughout the day with some light dizziness and a muffled feeling in my left ear.  11-10-2006 I continue to have slight headaches off and on and experience slight dizziness at times throughout the day. I decided to complete the VAERS-1 form, and called the clinic for information to complete the form. They were very uncooperative and would not give out the full name of the person who administered the vaccine, or the name of the Doctor. They also tried to convince me that the PROBLEMS I was experiencing were not related to the flu vaccine. They did not ask how I was doing, or what measures I should take to alleviate my symptoms. I had to ask them many times for the information required to complete the Form VAERS-1(FDA). They were very uncooperative and extremely unprofessional!! As of 11-10-2006 at 5:31pm I still have a slight headache/dizziness, and if the pain continues I will go to urgent care tomorrow to find out why I am still having these PROBLEMS from the FLU VACCINATION.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Paraesthesia, Thermal burn
Clinical narrative: Minutes after getting the shot, I started to feel paresthesias in different parts of my body, the first one being some burning sensation & very slight pain in a buttock which I self-injured about a year ago (when I injected myself with Toradol & Norflex and since then have had pain & some numbness). Every tingling and/or prickling sensation I felt lasted only very few seconds, it was on different parts of my body (specially arms & calfs), and the whole episode lasted only a few minutes.  Could this have been possible, or was this a product of my imagination?  I wasn't "looking" for any adverse reaction, I just started to feel this, and suddently it came to my mind that this could be an effect from the vaccine. It lasted for only very few minutes, and I just thought you might want to know about this.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Malaise, Platelet count decreased
Clinical narrative: Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06.  11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome.  Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit.  Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics.  ID & resp consults done.  No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion.  WBC 12.2, plts 40.  Rapid influenza test was neg.  Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Renal failure, Respiratory failure, White blood cell count increased
Clinical narrative: Healthy 82 yo male well at physical exam 10/31/06. Received flu vaccine mass immunization 11/04*06, Ill on Mon-Tues 11/6-7, Admitted to hospital 11/07/06. Steven Johnson Syndrome, Renal and respiratory failure and death on 11/9/06.  11/20/06 Received medical records from hospital which reveal patient admitted 11/7/06-11/9/06 for hypoxia then quickly developed a macular, then petechial associated with circumoral desquamation, very concerning for Stevens Johnson syndrome.  Patient had fever (103-104)/chills, myalgias, DOE w/dry cough, 5# weight loss over 1 week & weakness for approx 1 week prior to admit.  Also had tooth abscess approx 5 days prior to admit for which he did not receive antibiotics.  ID & resp consults done.  No death certificate included. PMH: hyperlipidemia & pre diabetes. LABS: CXR revealed bilat infiltrates w/effusion.  WBC 12.2, plts 40.  Rapid influenza test was neg.  Blood, urine & sputum cultures neg. Final DX: respiratory failure; sepsis, pneumonia, hypotension, renal failure, liver failure. 11/27/06 Received death certificate from funeral home which states COD as sepsis & pneumonia with acute renal failure as contributing factor.