chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dyspnoea, Hypersensitivity, Laryngeal oedema
Clinical narrative: 1:46pm at first dizziness, had client sit with nurse took BP, relax techniques. 2:00 came back throat closing tight. given Benadryl 1.25 fast melt no results. Getting worse Epi 1/1000 0.3cc SQ at 2:05pm then again 2.15pm called 911 DIT worse, SOB, throat closing now chest pain. 911 to Hospital. 12/21/06-records received. DX: Allergic reaction. received epinephrine injection in ER, CT showed some laryngeal and pharyngeal edema without obvious tongue, lip or papular edema. Allergic to penicillin and sulfa.  Impression: angioedema of oral pharynx  Some thrombophlebitis of left arm from IV therapy.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Thrombophlebitis
Clinical narrative: 1:46pm at first dizziness, had client sit with nurse took BP, relax techniques. 2:00 came back throat closing tight. given Benadryl 1.25 fast melt no results. Getting worse Epi 1/1000 0.3cc SQ at 2:05pm then again 2.15pm called 911 DIT worse, SOB, throat closing now chest pain. 911 to Hospital. 12/21/06-records received. DX: Allergic reaction. received epinephrine injection in ER, CT showed some laryngeal and pharyngeal edema without obvious tongue, lip or papular edema. Allergic to penicillin and sulfa.  Impression: angioedema of oral pharynx  Some thrombophlebitis of left arm from IV therapy.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Irritability
Clinical narrative: Immediate confluent erythema on lower extremities and irritability. Lasted approximately 15-20 minutes.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Rash under skin, non red 10pm 11-28-06 on stomach/back/shoulders. Turned red (bumps) and extended down arms to hands and 12-4-06 extending to legs.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cystitis, Pharyngolaryngeal pain, Pollakiuria, Pyrexia
Clinical narrative: Fever, treatment Rocephin 500 mg 10/23/06. Frequent urination on 11/5/06. Sore throat and fever on 12/1/06. Fever on 12/3/06 and 12/4/06.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: No reaction patient inadvertently given Adacel at age 7.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: No reaction. Patient inadvertently given Adacel at age 5.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Swelling of upper two-thirds of R arm. Outer arm beneath vaccine site 2 days after vaccine.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Neck pain, Paraesthesia
Clinical narrative: 11-28-06 3:00pm vaccine administered in right deltoid. Advised Tylenol every 4 hours times 24 hour to combat any muscle soreness , aches. 11-29-06 08:00 complained of "feeling like have flu"-weak, achy, Temp 98.8. At 11:00 same day tem 99.9, complained of "weak", neck pain, "feet feel numb/tingling. Sent home to go to Dr.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Muscular weakness, Pain
Clinical narrative: Patient states 1 week after injection right arm became painful; top of shoulder to hand. Loss of motion and weakness. Went to ER. R arm improving now.
Age: 1.02
Sex: M
Vaccine: FLU3, HEP, MMR, VARCEL
Symptoms: Erythema, Injection site nodule, Lymphadenopathy, Pyrexia, Rash vesicular
Clinical narrative: 11-21-06 onset with fever (102-103), red spot on Left thigh, seen in ER. 11-25-06 office visit Left thigh with nontender, 1cm nodular erythematous patch, ?? early superficial veseculation. Bilateral inguinal adenopathy 1cm 3-4 each side. Treatment: warm soaks, treat fever, close observation.
Age: 1.04
Sex: F
Vaccine: FLU3, HEP, MMR, VARCEL
Symptoms: Erythema, Lymphadenopathy, Skin nodule
Clinical narrative: 11-20-06 nodule Left groin area. Right groin with 4 3/4 cm shotty mobile nodes, not matted. Left groin with 3 shotty nodes, recheck 10 days or sooner. 11-24-06 axillary adenopathy, inguinal nodes bilateral shotty 3/4 cm. Re check next week-sooner 5-6 on Right femoral, 2-3 on Left not matted. 11-27-06 no real change in nodes. Left thigh with 1cm erythema slight induration. Recheck in a week.
Age: 1.14
Sex: M
Vaccine: FLU3, HIBV, VARCEL
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Multiple (>50) diffuse pox lesion-concentrated in genital and perianal region. Onset 8 days post immunization.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain, Rash, Rash macular
Clinical narrative: Developed pain lateral aspect of Right thigh then waist then lateral aspect torso. Then on 12/3/06 he developed a rash on right thigh. Clusters of small gray macules scattered in dermatone L3+4.
Age: 5.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: 5.5cmx4cm red and hot to touch.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Fever at 103-104 the night of the shot for about 3-4 hours and much crying. Fever next day 101-102.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site inflammation, Lymphadenitis
Clinical narrative: Caused brusitis and lymphadenitis. Second inflammation from influenza vaccine.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Viral infection, Vomiting
Clinical narrative: 3 days after vaccines administered presented to emergency room with fever, vomiting and diarrhea, positive for Rotavirus.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Gangrene, Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: 3 days after vaccines administered presented to emergency room with fever, vomiting and diarrhea, positive for Rotavirus.
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site oedema
Clinical narrative: Swollen arm, shoulder to elbow.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Disturbance in attention, Erythema, Eye disorder, Eyelid oedema
Clinical narrative: Disorientation eyes couldn't focus swelling of eyes and all around eyes, eyes turned very red blood shot, crusty sand like substance all around eyes. Flu like symptoms very strong. Unable to concentrate, sun tan look all around eyes on face was red.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Ocular hyperaemia, Staring
Clinical narrative: Disorientation eyes couldn't focus swelling of eyes and all around eyes, eyes turned very red blood shot, crusty sand like substance all around eyes. Flu like symptoms very strong. Unable to concentrate, sun tan look all around eyes on face was red.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: High Fever, left arm very red, swollen, hot above elbow and very painful. Seen by urgent care doctor who ordered blood test and diagnosed cellulitis, prescribed antibiotic Omnicef. Follow up by family doctor, currently under doctors care. Nurse who administered vaccines was distracted by the small daughter of another worker. Child picked up vials of vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: High Fever, left arm very red, swollen, hot above elbow and very painful. Seen by urgent care doctor who ordered blood test and diagnosed cellulitis, prescribed antibiotic Omnicef. Follow up by family doctor, currently under doctors care. Nurse who administered vaccines was distracted by the small daughter of another worker. Child picked up vials of vaccine.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Anorexia, Asthenia, Feeling cold, Hot flush, Malaise
Clinical narrative: Freezing cold, than hot, no appetite, all over sick feeling, no energy. It is 3 weeks from the day of the vaccination, and I am still feeling weak etc. Talked to other people about this, and many had the same problems.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: Flu shot rt arm, chills and fever 8 hours after shot. Lasted several hours. Pneumococcal left arm, within 8 hours upper arm extremely sore, soreness lasted 5 days.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Pain, swelling, heat, redness at injection site, symptomatic right deltoid . Treatment.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Fever, joint pain, chills, muscle aches took 2 Aleve went to bed, sweat it out. Symptoms lasted about 18 hours.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Paraesthesia, Shoulder pain, Skin discolouration
Clinical narrative: 1/2 hr after inj felt a terrible deep pain travel down left arm. With days after pain radiated across shoulder, had pins and needles in both hands shot was given very high up on tip of shoulder. Left hand discoloration. Felt weak, Went to employee health. Said I got a tendonitis.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: 1/2 hr after inj felt a terrible deep pain travel down left arm. With days after pain radiated across shoulder, had pins and needles in both hands shot was given very high up on tip of shoulder. Left hand discoloration. Felt weak, Went to employee health. Said I got a tendonitis.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Nausea, Vomiting
Clinical narrative: C/O left arm swelling and nausea, vomiting.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Mother reports right arm became red, painful, nodule noted 3 days after vaccine given. Seen by local MD and health dept. No TX given per mom.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Headache, Nausea, Petechiae
Clinical narrative: 10 min after given flushing, nausea, headache, petechia back, came to RN office, redness decrease to chest with hives. Benadryl 50mg IM given, V/S prior 11am 143/76m 78 16 after 11:15 144/82 74, 11:30 pt fine. Returned to class room.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 10 min after given flushing, nausea, headache, petechia back, came to RN office, redness decrease to chest with hives. Benadryl 50mg IM given, V/S prior 11am 143/76m 78 16 after 11:15 144/82 74, 11:30 pt fine. Returned to class room.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, weakness, general body aches, injection site pain starting evening of injection and continuing still today. Fever running 103-104 F and is reduced to 99-100 with NSAID and Tylenol use.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Patient developed 2 days pain, erythema, and tenderness of left arm, spreading into forearm.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Gingival bleeding, Myalgia, Ocular hyperaemia
Clinical narrative: Received first flu shot on 12/2. Approximately six hours later developed muscle aches, extreme fatigue, bleeding gums, swelling of tissue under the tongue, barking cough and redness in eyes. Symptoms resolved after 24 hours.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Tongue oedema
Clinical narrative: Received first flu shot on 12/2. Approximately six hours later developed muscle aches, extreme fatigue, bleeding gums, swelling of tissue under the tongue, barking cough and redness in eyes. Symptoms resolved after 24 hours.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dry throat, Dysphagia, Respiratory distress
Clinical narrative: Within 2 hrs of vaccination developed scratchy throat, difficulty swallowing and some respiratory distress. No action taken subsided 1 hr later.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: 3 days after Imm developed large local reddened lump on right arm (SubQ) gradually subsided site of ProQuad.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Medication error, Pain
Clinical narrative: Pneumovax administered at flu clinic at 11am. Returned at 1:25pm with c/o pain, inability to move arm. Nr redness, swelling noted. Referred to ER for eval. ER Dr gave vistarel and advised injection may have been given too high in deltoid (rotator cuff area). Saw PCP on 11/7. Has Hx of bad rotator cuff. Pt had prior Pneumovax on 4/13/06 this was unknown to vaccine administrator at the clinic. Pt called on 11/13/06 reports he is back to normal for him. He has chronic pain in that arm and takes pain med regularly.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria onset about 4 hours after vaccine. RX Benadryl, than oral Allegra and Ranitadine, No oral
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Myalgia
Clinical narrative: symptoms occurred about 1.5 week after vaccination from the flu shot. - sensitivity to touch on lower front thigh, wasn't able to wear  clothes on the left leg - muscle pain in hip both pains still exist, and slowly fading. the vaccine given was: vaccin antigrippal VAXIGRIP (DIN 02223929) INFLUVAC (DIN 02269562) not sure which one was given since it was not checked off last year, the same happened, but no muscle pain, only sensitive to touch.  2 years ago, I had the same problem but extrememly worse. sensitivity to touch was unbearable on both legs, muscle pain was excruciating, behind the calves and complete lower waist, these symptoms lasted 1.5 months.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Pain
Clinical narrative: Patient received vaccine on 11/20/06 and experienced mild pain on 11/20-11/21 which went away.  On 11/28/06 patient started having severe pain at injection site.  The pain was severe enough to wake her up at night.  Also a nodule was noted at the injection site.  She reported this to her Safety Officer at the company where she works. (The flu shots had been administered at the company through the health department)  The Safety Officer contacted a health center who recommended heat and exercise.  At the time of interview with the patient on 12/11/06 she reports sx have significantly improved to where she only has a slight ache when moving in certain positions.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Client states that friday eve he started with slightly raised red patchy like area on his mid abdomen, buttocks & thighs. Today it is also on his mid and lower arms. He takes prilosec & ibuprofen. He has also ate cookies on friday 11-30-2006 & poss before that were sent to him by his mother from which contain powdered milk which he states he allergic to. States he has been taking benadryl for the itching & hives but no real relief. States no difficulty breathing or swallowing.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Approximately five minutes after administration of Td, employee verbalized feeling a hot flash, then cold sweat.  Then approximately 10 minutes later while escorting to Emergency Dept via wheelchair, she reported some shortness of breath and headache.
Age: 18.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rash
Clinical narrative: Tel call on 12/7/06 Pt reported fever,rash-face,neck,chest,back and arms, and itching. Symptoms began 4 hours after immunizations were given. Home visit 12/11/06  Pt took benedryl and tylenol. Itching resolved, Temp-98F, Some red raised pimple-like rash is evident on face, back, chest and reddened areas on neck and arm.   Pt. reports soreness from a blister like formation on left floor of mouth under tongue. Nurse observed grayish flap of skin approximately 3/16" square. Pt used  listerine and salt water to rinse area X1 with no relief. Nurse recommende pt. go to doctor for evaluation. Pt.'s response "I don't like doctors." Nurse recommended continued rinsing of mouth with saltwater and listerine for one week and see doctor if soreness continues and flap is not gone.
Age: 46.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea, Laryngospasm, Stridor, Wheezing
Clinical narrative: 5 hours after FluMist administered, patient experienced shortness of breath, wheezing. 12/27/06-records of ER visit received and reviewed. Chief complaint: throat closing. Progress note: most likely possibility seems laryngospasm, unclear etiology. Possible allergy although seemed to have cleared rapidly for this. Doubt mucous as no cough. Seems unlikely that steroids will help.  DC DX: acute stridor, resolved. No treatment provided.
Age: 34.0
Sex: M
Vaccine: HEPAB, JEV
Symptoms: Hypoaesthesia, Pain, Rash, Swelling
Clinical narrative: Rash under left eye, mild numbness and swelling in both hands, Slight pain in Right wrist, Soreness in legs and Left achilles tendon pain starting approximately week of November 13,  and worse week of December 11 after 3 JE vaccine did not correlate events with vaccine until after 3rd dose of JE. Rash under left eye gettim.  1/8/07 Received medical records from PCP which reveal: Patient seen 12/13/06 with c/o rash on left side of face s/p 2nd JE vax.  Also shortly after 3rd JE vax, had joint aches/pains.  Patient was planning to travel to India 12/06.  Exam revealed small patch of tiny slightly reddened vesicular lesions on left side of face just lateral of the lateral canthus of the eye.  All joints had full ROM.  NSAIDs were only treatment recommended. Dx: probable reaction to innoculations resulting in phenomena similar to a fixed drug reaction & serum sickness, with both resolving.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: On day of shot, area below shot on arm and continuing to elbow became red and itchy with some large lumps.  Thereafter, to date (one week after shot administration) have developed small numbers of hives each day on various parts of the body, but primarily on face, ears and scalp.  Have taken benadryl and other diphenhydramine products to reduce itching.  Am surprised the reaction has continued this long and has not yet stopped.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Eye irritation, Pruritus, Throat tightness
Clinical narrative: Over 3-1/2 hour time period after receiving vaccine, developed cough, burning sensation in eyes, throat tightness, facial itching, dizziness.  Reported to Employee Health Center where she was given diphenhydramine 25 mg.   Temperature 98.7, pulse 64, BP 130/70.  Referred to walk-in clinic for medical evaluation and  treatment.
Age: 1.0
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Discomfort, Pyrexia, Rash
Clinical narrative: beginning 12/10/06, patient bagan getting diffuse spotty bumps over torso and spreading to neck. Prior to rash, Mom states patient ran fever up to 101.5 for 4-5days. Rash was observed and advised to use aveeno bath and/or acetaminophin for discomfort and fever.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Salivary hypersecretion, Urticaria
Clinical narrative: Client stated that at approximately 9:00 PM he began to salivate so uncontrollably that he was unable to control the amount of saliva by simply swallowing.  Under his tongue was tingling.  Mosquito bite size hives covered his neck, his wrists, thighs and ankles and a "V" shaped pattern of hives extended from his shoulders to his sternum.  The client, who happens to be a nurse, took Benedryl and the symptoms subsided.  The client fully recovered.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Fatigue, Pain, Pharyngolaryngeal pain, Pruritus
Clinical narrative: symptoms include aching, tiredness, fever, and sore throat; Ann itchy red splotchy blister-like rashes on head(in hair), forehead, side and front of abdomen, and legs. Treatment analgesic + antihistamines.
Age: 43.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: symptoms include aching, tiredness, fever, and sore throat; Ann itchy red splotchy blister-like rashes on head(in hair), forehead, side and front of abdomen, and legs. Treatment analgesic + antihistamines.
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Cognitive disorder, Fatigue, Headache
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing loss in a male subject of unspecified age who was vaccinated with Lyme disease vaccine (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject was vaccinated with Lymerix. According to a statement of injuries, at an unspecified time after vaccination with Lymerix, the subject experienced joint pain and swelling, flu like symptoms, hearing loss, tingling in extremities, headache, fatigue, possible memory loss and decreased activities of daily life. The statement further alleged that the subject suffered from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune medicated, or other mechanism, all caused by vaccination with Lymerix, including but not limited to those set forth above. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Hearing impaired, Influenza like illness, Nervous system disorder, Oedema, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing loss in a male subject of unspecified age who was vaccinated with Lyme disease vaccine (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject was vaccinated with Lymerix. According to a statement of injuries, at an unspecified time after vaccination with Lymerix, the subject experienced joint pain and swelling, flu like symptoms, hearing loss, tingling in extremities, headache, fatigue, possible memory loss and decreased activities of daily life. The statement further alleged that the subject suffered from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune medicated, or other mechanism, all caused by vaccination with Lymerix, including but not limited to those set forth above. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid factor
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing loss in a male subject of unspecified age who was vaccinated with Lyme disease vaccine (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject was vaccinated with Lymerix. According to a statement of injuries, at an unspecified time after vaccination with Lymerix, the subject experienced joint pain and swelling, flu like symptoms, hearing loss, tingling in extremities, headache, fatigue, possible memory loss and decreased activities of daily life. The statement further alleged that the subject suffered from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune medicated, or other mechanism, all caused by vaccination with Lymerix, including but not limited to those set forth above. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypokinesia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of loss of left function in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis.  The subject's medical history included multiple sclerosis.  On an unspecified date before 07 December 2006, the subject received unspecified dose of Fluarix at an unspecified site of injection. At an unspecified time after vaccination with Fluarix, on an unspecified date before 07 December 2006, the subject experienced loss of leg function and leg numbness. The events resolved on an unspecified date on or before 07 December 2006.  Comment: Loss of leg function was assessed as medically serious. (OMIC)
Age: 1.34
Sex: F
Vaccine: DTAP, HEP, MMRV, PNC
Symptoms: Supraventricular tachycardia
Clinical narrative: Episode of SVT admitted to hospital.  MR received which revealed a 16 month old without significant medical history other than myringotomy tubes, who presented to the ER tachycardic > 200 BPM after several days of lethargy, decreased appetite, poor sleep and irritibility following multiple vax.    HPI:  Child presented to local ER 4 days s/p vax. with several day history of poor sleep, poor appetite, unwillingness to lie down, decreased UOP and irrititability.  Heart was noted to be racing.  Found in ER to be in SVT at 280BPM, but well perfused, warm, good BP, and no respiratory distress. Flown to another hospital.  Arrived in decompensated SVT with BP of 56/44.  Tx'd with Adenosine with no effect. Cardioversion under sedation performed with return to NSR @ 138 and BP up to 116/77. Had 2nd occurance with HR @330 requiring 2nd cardioversion. Assessment:  SVT related to Atrial Fibrillation. D/C summary received, as above. Child was treated with propranolol and observed x4 doses q8h. No episodes of tachycardia during that time. D/Cd home on propranalol. D/C DX: Tachyarrythmia, most likely supraventricular tachycardia. Status post cardioversion.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cardiac failure congestive, Cerebrovascular accident, Coronary artery disease, Dysarthria
Clinical narrative: Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hyperlipidaemia, Hypertension, Myocardial infarction, Orthopnoea
Clinical narrative: Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Transient ischaemic attack, Wheezing
Clinical narrative: Within 4 hours after receiving the vaccine she started having pain and weakness throughout her body. She had a stroke several years ago and 5 by pass heart surgery in 2000. Since her husband has the same symptoms, we thought it was from the flu shot and would soon end, but about 8, 11/09/06 she was taken to hospital by rescue squad. 12/19/06-records received and reviewed. DC Summary: Acute non-ST elevation myocardial infarction. Congestive Heart Failure due to Ischemic left ventricular dysfunction Coronary artery disease with previous coronary artery bypass graft surgery Transient ischemic attack with right arm weakness. Hypertension Hyperlipidemia Status post bilateral carotid endarterectomy and cholescyctectomy. Presented to ER with dyspnea and wheezing, flu vaccine 2 weeks ago and had prolonged viral syndrome that she did not seek treatment for. On day of admission developed 2 episodes of right arm weakness and right facial and tongue weakness with slurred speech and she developed sudden dyspnea, orthopnea and wheezing. 12/1/08-copy of death certificate received-COS multisystemic organ failure. Date of death 4/15/08. Information received on annual follow up: Adverse event unrelated to vaccination. Patient has multiple on going health problems. Date of vaccination was 10/27/06 not 11/3/06 as originally reported.
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: Arm sore and hurts to raise above her head. This was her first flu shot.
Age: 0.69
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Pyrexia
Clinical narrative: Mother states 30 minutes to 1 hour after shot the baby was fussy, so she fed him and the baby took a nap. At 1130, temp was 99, at 1230 PM, temp was 102. The baby was given Tylenol and a cool bath. At 130PM, temp 104 and baby was crying so the mother gave him Motrin and a cool bath. At 230 PM, temp 100. The baby was seen by a doctor. The doctor told the mother it was a reaction to the flu shot. She was instructed to give Motrin and Tylenol alternating every 2hours as needed for temp. The mother states she did this all night, keeping the temp at 100. It remains at 100 today at 1000 AM.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Myalgia
Clinical narrative: Muscle pain with shot resulted in progressed with shooting pain progressing down arm within 2 hours. 3 days of discomfort when moving arm behind body 1 hour. Advil 500 mg started yesterday mild pain still present.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site induration
Clinical narrative: 24 Hours after injection on left upper arm, mom noticed area of redness and child scratching. Are is 4 X 81/2 cm with a small amount induration. Mildly tender on palpation.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: No adverse reactions per patient's mother. Note: patient had received prior dose of vaccine in October accidentally given second dose.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Following Pneumovax immunization in left deltoid, raised area 2 1/2 X 3 over left bicep developed, red, warm to touch. Patient self-treated with Benadryl PO presented on 11-17-06 for observation. Referred to PCP who diagnosed cellulitis and treated with IM Rocephin and oral Ceftin.
Age: 9.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Right arm redness and swelling.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Headache, Influenza like illness, Muscular weakness, Nausea, Pain
Clinical narrative: Onset at 10 am 12/07/06: muscle weakness, aching later in the evening, fever of 102 F with nausea and flu like symptoms, no vomiting or diarrhea, next am 12/8 awakened with headache all other symptoms resolved.
Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Onset at 10 am 12/07/06: muscle weakness, aching later in the evening, fever of 102 F with nausea and flu like symptoms, no vomiting or diarrhea, next am 12/8 awakened with headache all other symptoms resolved.
Age: 21.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Nausea
Clinical narrative: Donor received tetanus shot at 1639 and reports having lightheadness and nausea starting at 1900 and lasting on 12/04/06. Donor states she was going from a sitting to standing position. After 15 minutes symptoms didn't reoccur.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Hives within secondary of vaccine. No SOB. Hives resolved with Benadryl PO-prn.
Age: 1.1
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Erythema, Injection site induration
Clinical narrative: Right upper arm with 2.1 cm X 2.2 cm are of induration with slightly smaller area of erythema. ? tender to touch.
Age: 7.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Varicella vaccine breakthrough diagnosed with Varicella on 12/06/2006 20 pox. Afebrile.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Nasal congestion, Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: Within 30 minutes of vaccines, sneezing, stuffy and running nose, 3 hives on neck and face. .
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Patient red 4 year immunizations at WIC office 11/29/06. Rash began left arm where mom states DTaP was given.
Age: 8.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Rash
Clinical narrative: 12/06/2006 Seen by us 12/5/06 after rash for 2 days. No fever. Few chicken pox lesions on trunk and rest of body. (20). No fever. Child treated with Atarax.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection transmission via personal contact
Clinical narrative: Exposed to someone with Varicella. Now has a few bumps on the forehead, arm.
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: 104 degrees temperature, bones ache all over reaction to flu vaccine.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Infection transmission via personal contact
Clinical narrative: Exposed to someone with Varicella. Now 2 days of typical Varicella.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC
Symptoms: Crying, Erythema, Pain, Swelling
Clinical narrative: HIB vaccine (ACTHib) administered right leg, causing swelling from knee top groin, erythema, pain and crying.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Injection site induration, Tenderness
Clinical narrative: Left lateral upper arm with 11.5x9.5cm area of erythema, tenderness and warmth. Mild induration centrally. No postule, crusting or drainage.
Age: 1.03
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Per parent shingles eruption.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient experienced pain swelling and redness after injection. Seen in office 5 days later. Tylenol, warm compresses and follow up given.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: 11/13/06 Patient seen rash on body since 11-10-06, nauseated raised bumps on back , head, stomach, axillary region, right side of face. Itchy. Temp 98.0, Pulse 80 rate 14. Diagnosed chicken pox post varicella vaccine admin. Prescribed Acyclovin 800 mg 4 times a day for 5 days. Chickenpox precautions. 10/28/06-Varicella zoster IGM/IGG negative
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Mild temp 101F at 6pm.
Age: 0.24
Sex: F
Vaccine: HIBV, PNC
Symptoms: Crying, Respiratory disorder, Swelling
Clinical narrative: Crying at least for 3 hours after receiving HIB, Prevnar. Her left thigh was swollen and she stopped breathing for at least 30 seconds. Parent brought her to hospital. Dr. the pediatrician who saw her said vital signs are stable and no need to admit her.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pyrexia, Urticaria
Clinical narrative: Severe muscle pain and stiffness with fever in area surrounding injection site within 12 hours. Raised welts, itching in area surrounding injection within 24 hours. Pain in underarm to breast of left arm. Symptoms treated with over the counter pain relievers and over the counter allergy medicine. Symptoms resolved by 4 days.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Eye irritation, Faecal incontinence, Fatigue, Lacrimation increased
Clinical narrative: Could not hold bowel for 2 weeks. Fatigue, eyes felt like sand and very sore then eyes stinging. Eyes water for about 4 hours.
Age: 22.0
Sex: F
Vaccine: HEP, HEPA, IPV, TD
Symptoms: Skin nodule
Clinical narrative: Patient received vaccines on 12/5/06 in preparation for travel. The next evening she felt a swollen node, approx pea sized, just above her collarbone on the left. Denies fever or any other symptoms.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Muscle spasms, Pruritus, Weight decreased
Clinical narrative: Headaches, cramps in the feet, itching on trunk and arms, and loss of weight
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Acidosis, Dehydration, Diarrhoea
Clinical narrative: Initial report received on 11/29/2006 from another manufacturer, report number WAES0611USA05055. The initial reporter to this manufacturer has been a health care professional. A fourth month old female health pt had received an injection of Daptacel, lot number unk, an injection of poliovirus vaccine inactivated, manufacturer unk, lot number unk, an oral administration of Rotateq, unk, on 11/9/06. Route and sites of administration of the injections were unk. Two days post vaccination, the pt experienced 20 episodes of severe diarrhea. She was examined in an ER, found to be acidotic secondary to dehydration, and admitted to the hospital. The physician noted that the pt did look happy and content even though she had awful diarrhea. Stool test for rotavirus was neg. As of 11/18/06, the pt was still hospitalized as her diarrhea and dehydration persisted. Per the report, the physician was unsure if the pts events were related to rotavirus vaccine. The physician considered diarrhea and severe dehydration to be important medical events (OMIC). At the time of this report, the pt had not recovered.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: A report was received from a healthcare professional concerning a 55-year-old female vaccinee.  No details concerning the vaccinee's past medical history were provided. On 07/Nov/2006 the vaccinee was administered influenza vaccine (brand unspecified) and Pneumovax 23, 0.5 ml subcutaneously in separate sites (not specified).  In November 2006, the patient was hospitalized for treatment with IV antibiotics because she developed a cellulitis shortly after vaccination.  The cellulitis was unresponsive to oral antibiotics, the vaccinee was discharged from the hospital on 16/Nov/2006.  The event outcome was not provided.  The reporter considered the events to be serious due to hospitalization and also medically significant. (OMIC)
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein normal, CSF glucose abnormal, CSF oligoclonal band absent, CSF protein abnormal, CSF white blood cell count positive
Clinical narrative: Numbness to tongue, fingers and toes. The pts wife contacted me on Dec 8 2006 to obtain information about the flu vaccine manufacturer. I provided her with the information and she told me her husband was hospitalized for 10 days. she said the doctor diagnosed her husband with Gillian Barre related to flu vaccine.Seen in ER for C/O numbness in both hands (fingertips) and both feet with c/o abd pain ongoing times 5 days. ER DX: Left maxillary sinusitis, bilaterally upper and lower extremity numbness, abdominal pain, unspecified.  Labs: WNL.  01/30/07-records received and reviewed from University Hospital of Arkansas for DOS 11/28-12/02/06- DC DX: Resolving mild Guillain-Barre Syndrome HX of Present Illness:complained of bilateral lower extremity weakness with tingling and numbness over tips of toes and fingers started one week ago and has been getting progressively worse. Denies difficulty swallowing for bladders incontinence.  CT of head prior to admission: sinusitis. No treatment.  Information received from the annual follow up indicates patient has not recovered. Patient has been informed by doctor that he has chronic re-occuring symptoms: legs hurt, shortness of breath on exertion, fatigue, swelling on right side of body.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram abnormal, Dyspnoea exertional, Fatigue, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Numbness to tongue, fingers and toes. The pts wife contacted me on Dec 8 2006 to obtain information about the flu vaccine manufacturer. I provided her with the information and she told me her husband was hospitalized for 10 days. she said the doctor diagnosed her husband with Gillian Barre related to flu vaccine.Seen in ER for C/O numbness in both hands (fingertips) and both feet with c/o abd pain ongoing times 5 days. ER DX: Left maxillary sinusitis, bilaterally upper and lower extremity numbness, abdominal pain, unspecified.  Labs: WNL.  01/30/07-records received and reviewed from University Hospital of Arkansas for DOS 11/28-12/02/06- DC DX: Resolving mild Guillain-Barre Syndrome HX of Present Illness:complained of bilateral lower extremity weakness with tingling and numbness over tips of toes and fingers started one week ago and has been getting progressively worse. Denies difficulty swallowing for bladders incontinence.  CT of head prior to admission: sinusitis. No treatment.  Information received from the annual follow up indicates patient has not recovered. Patient has been informed by doctor that he has chronic re-occuring symptoms: legs hurt, shortness of breath on exertion, fatigue, swelling on right side of body.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Muscular weakness, Neck pain, Pain in extremity, Swelling
Clinical narrative: Numbness to tongue, fingers and toes. The pts wife contacted me on Dec 8 2006 to obtain information about the flu vaccine manufacturer. I provided her with the information and she told me her husband was hospitalized for 10 days. she said the doctor diagnosed her husband with Gillian Barre related to flu vaccine.Seen in ER for C/O numbness in both hands (fingertips) and both feet with c/o abd pain ongoing times 5 days. ER DX: Left maxillary sinusitis, bilaterally upper and lower extremity numbness, abdominal pain, unspecified.  Labs: WNL.  01/30/07-records received and reviewed from University Hospital of Arkansas for DOS 11/28-12/02/06- DC DX: Resolving mild Guillain-Barre Syndrome HX of Present Illness:complained of bilateral lower extremity weakness with tingling and numbness over tips of toes and fingers started one week ago and has been getting progressively worse. Denies difficulty swallowing for bladders incontinence.  CT of head prior to admission: sinusitis. No treatment.  Information received from the annual follow up indicates patient has not recovered. Patient has been informed by doctor that he has chronic re-occuring symptoms: legs hurt, shortness of breath on exertion, fatigue, swelling on right side of body.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: White blood cell count
Clinical narrative: Numbness to tongue, fingers and toes. The pts wife contacted me on Dec 8 2006 to obtain information about the flu vaccine manufacturer. I provided her with the information and she told me her husband was hospitalized for 10 days. she said the doctor diagnosed her husband with Gillian Barre related to flu vaccine.Seen in ER for C/O numbness in both hands (fingertips) and both feet with c/o abd pain ongoing times 5 days. ER DX: Left maxillary sinusitis, bilaterally upper and lower extremity numbness, abdominal pain, unspecified.  Labs: WNL.  01/30/07-records received and reviewed from University Hospital of Arkansas for DOS 11/28-12/02/06- DC DX: Resolving mild Guillain-Barre Syndrome HX of Present Illness:complained of bilateral lower extremity weakness with tingling and numbness over tips of toes and fingers started one week ago and has been getting progressively worse. Denies difficulty swallowing for bladders incontinence.  CT of head prior to admission: sinusitis. No treatment.  Information received from the annual follow up indicates patient has not recovered. Patient has been informed by doctor that he has chronic re-occuring symptoms: legs hurt, shortness of breath on exertion, fatigue, swelling on right side of body.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Rash, Tenderness
Clinical narrative: Red, tender rash just above buttocks. Also spreading to inner thigh. Patient states no complaints of pain. Treatment given of Valtrex 500mg 3 times a day for 7 days.  The report we just received following a patient's adverse event to a vaccine is parly incorrect.  Our patient received ZOSTAVAX "shingles" vaccine on 10/31/06 and reported an adverse event 11/18/06.  She developed shingles about 2 1/2 weeks after receiving the ZOSTAVAX vaccine.  This was confirmed by her internist physician on 11/28/06.  The only other vaccine the patient received with ZOSTAVAX was Influenza vaccine, each vaccine was given in separate deltoid.  There was no complaint of an adverse event following the Influenza vaccine by the patient.  In conclusion the patient had an adverse advent following administration of ZOSTAVAX "shingles" vaccine.  She was treated and has recovered since.  Please see below for information on the ZOSTAVAX vaccine given to patient on 10/31/06:
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Blood pressure increased, Dyspnoea, Erythema
Clinical narrative: Seriousness criteria other medially significant (OMIC). A 59 year old female pt, with no concurrent illnesses, and a past medical history of asthma, diabetes, and allergy to Daypro, Septra, and Rocephin, had received a right deltoid IM injection of Fluzone SV lot number U2283AA, on 11/30/06. Six to eight minutes post immunization, the pt became tomato red, had shortness of breath, blood pressure increased to 210/110, and anaphylaxis. She was treated with two doses of epinephrine for fifteen minutes, IM Benadryl, IM Dexamethasone and oxygen. She was transported to the emergency room where she was observed, and then sent home. Diagnostic tests performed were not reported. The subject had not received any other vaccinations with four weeks of vaccination on 11/30/2006. At the time of this report, the pt had recovered.
Sex: U
Vaccine: FLU3
Symptoms: Chest pain, Hypertension
Clinical narrative: Initial report received on 01 December 2006 from a health care professional. A patient (demographics not reported), who had no concurrent illnesses, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2259AA, on an unknown date. Within 24 to 48 hours post-immunization, the patient experienced chest pain and had "hypertension". At an unspecified amount of time later, the patient was admitted to the hospital and underwent a cardiac catherization. Reportedly, the cardiac catherization was normal. The reporter for this case is the same as for case 2006-03337.