chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain
Clinical narrative: Swollen arm down into hand.  Throbbing/pain in arm and hand.  MD stated reaction needed to be reported. Pt had had influenza vaccine every year for the past several years.  Pt had a liver transplant approx 5 years ago.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Pt reports that she took a flu shots and twelve hours later developed hives and a rash over her body.  Pt taking Benadryl with no relief.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: On October 27, 2008 flu vaccine administered to deltoid region of left arm at around 3:30pm. Mom called on October 28th to report redness and induration at the site. She come in at 3:15 on the 28th to be seen by Dr. The area was noted by Dr. to have a reddened area about 3 1/2 to 4 inches around the injection site and a moderately sized hive near the site. The doctor ordered benedryl 25mg 3-4 times/day and ice to the site. PHN spoke with Dad on 10/31. Dad reports arm is completely cleared.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient received vaccine on 10/28/08 and called this morning reporting redness and swelling by injection site and a rash. Flat rash not raised on arms, torso, legs.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Arthralgias in arms and legs within 24 hours of administration
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Oedema mouth, Pharyngeal oedema
Clinical narrative: Edema of the face and mouth and throat.
Age: 48.0
Sex: M
Vaccine: DT
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: DECAVAC TETANUS AND DIPHTHERIA WAS ADMINISTERED ON 29 OCT 08.  PT NOTED INJECTION SITE PAIN ON 30 OCT PRIOR TO CONDUCTING PHYSICAL EXERCISE, BUT NOTED THE PAIN DID NOT PREVENT PUSHUPS.  PT PRESENTED ON 31 OCT WITH INJECTION SITE PAIN.  INJECTION SITE AREA NOTED ERYTHEMA WITH TENDERNESS AND WARMTH.  PT ALSO C/O GENERALIZED MAILASE FEELING.  HE HAS SELF ADMINISTERED TYLENOL AND WARM COMPRESSES WITH LITTLE RELIEF.  TX WILL CONSIST OF IBUPROFEN AND ICE MASSAGES WITH DIRECTION TO EMERGENCY ROOM IF N/V OCCUR OR SIGNS OF CELLULITIS PRESENT.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Rash erythematous, Rash macular
Clinical narrative: One episode of dizziness approx 36 hours after influenza vaccine injection followed by slow onset of red fine macular rash over trunk. Presented to clinic 2 days afer vaccination, given loratadine, rash resolved on 10-30-08.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Heart rate increased, Hypertension, Loss of consciousness, Vomiting
Clinical narrative: passed out, vomited, increased heart rate, headache, high blood pressure
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Dysphonia, Dyspnoea
Clinical narrative: Difficulty breathing, hoarseness/wheezing, coughing, fever, chills,weakness, fast heart beat, general aches.  This came on slowly about 3 hours after the shot, and gradually built up.  In a matter of 7 hours, it was over, and I felt fine.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Pain, Pyrexia, Wheezing
Clinical narrative: Difficulty breathing, hoarseness/wheezing, coughing, fever, chills,weakness, fast heart beat, general aches.  This came on slowly about 3 hours after the shot, and gradually built up.  In a matter of 7 hours, it was over, and I felt fine.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Seven days after he recieved the Flu vaccine, he had 100% of his body covered in hives. He went to the hospital and they gave him Decadron.  He still has the hives and they come and go. They will flair up instantly and go away within 2 hours and then come back.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dizziness, Dyspnoea, Nausea, Palpitations
Clinical narrative: returned to work past injection in evening started itching all over and SOB states was dizzy, felt heart pounding called and reported this on 10/27/08 states she then took a benadryl and went to sleep. states woke up again next morning felt better but remained nauseated and SOB but felt this was related to her hx of asthma. Has a Doctor appt on 10/29/08.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pleurisy, Pruritus generalised
Clinical narrative: returned to work past injection in evening started itching all over and SOB states was dizzy, felt heart pounding called and reported this on 10/27/08 states she then took a benadryl and went to sleep. states woke up again next morning felt better but remained nauseated and SOB but felt this was related to her hx of asthma. Has a Doctor appt on 10/29/08.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody negative, Arthralgia, Myalgia, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: 48 hours after adacel vaccination pt began experiencing significant myalgias and arthralgias. Diagnosed with serum sickness on 7/24/08. Treated with prednisone.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Serum sickness
Clinical narrative: 48 hours after adacel vaccination pt began experiencing significant myalgias and arthralgias. Diagnosed with serum sickness on 7/24/08. Treated with prednisone.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Headache, Induration, Injection site discolouration
Clinical narrative: Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever , malaise and severe headache. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt also describes a sore knot developed across her rt shoulder blade approximately quarter size which lasted about a week.  Pt in bed 1 week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation.  Called MD because she thought she had the flu and was not seen by MD but prescribed erythomycin on Oct 22. Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 2 inches by one inch in size no pain. Pt questions whether the vaccine was kept adequately frozen well since they had heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they were told that the vaccine was being prepared till the actual receipt of the injection. Clinic Staff were contacted for lot number and clarified that vaccine was stored transported from another pharmacy off site in a cooler with ice packs. Clinic staff also mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever , malaise and severe headache. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt also describes a sore knot developed across her rt shoulder blade approximately quarter size which lasted about a week.  Pt in bed 1 week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation.  Called MD because she thought she had the flu and was not seen by MD but prescribed erythomycin on Oct 22. Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 2 inches by one inch in size no pain. Pt questions whether the vaccine was kept adequately frozen well since they had heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they were told that the vaccine was being prepared till the actual receipt of the injection. Clinic Staff were contacted for lot number and clarified that vaccine was stored transported from another pharmacy off site in a cooler with ice packs. Clinic staff also mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal pain, Pyrexia
Clinical narrative: Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever , malaise and severe headache. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt also describes a sore knot developed across her rt shoulder blade approximately quarter size which lasted about a week.  Pt in bed 1 week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation.  Called MD because she thought she had the flu and was not seen by MD but prescribed erythomycin on Oct 22. Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 2 inches by one inch in size no pain. Pt questions whether the vaccine was kept adequately frozen well since they had heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they were told that the vaccine was being prepared till the actual receipt of the injection. Clinic Staff were contacted for lot number and clarified that vaccine was stored transported from another pharmacy off site in a cooler with ice packs. Clinic staff also mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Induration, Inflammation, Injection site discolouration
Clinical narrative: Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the right side of the chest, along with systemic symptoms including fever and malaise. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt had fever of 100, malaise with the injection site, arm and chest inflammation for about 1 week.  Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 1 inches by one inch in size no pain.  Clinic staff mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the right side of the chest, along with systemic symptoms including fever and malaise. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt had fever of 100, malaise with the injection site, arm and chest inflammation for about 1 week.  Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 1 inches by one inch in size no pain.  Clinic staff mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Husband and wife both recieved zostavax on Oct 7.  Separate reports have been submitted for each vaccinee. Pt received vaccine under the rt arm 1 finger away from the arm pit. The pt experienced a large injection site reaction consisting of warmth, induration, pain, extending from the elbow to the right side of the chest, along with systemic symptoms including fever and malaise. The vaccine had been administered at a clinic, from a single vial. Pt experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest.  No rash but involved area was very swollen, red, warm to touch, painful and was also described "hard as a rock".  The area on the arm and chest then "broke up" after about a week into smaller knots. Pt had fever of 100, malaise with the injection site, arm and chest inflammation for about 1 week.  Better by Oct 25.  MD office then called pt to have bloodwork taken on October 30 pt not sure why or what type of blood work was being collected will be contacted by Dr next week. Currently injection site is red, pinkish blue 1 inches by one inch in size no pain.  Clinic staff mentioned that Merck had done a lot check on the vaccine lot and found no problems in their data.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Mental impairment
Clinical narrative: Violent and continuous vomitting, diarhea, headaches, dizziness, exhaustion, loss of mental ability for 4-5 days.  Occurred afternoon of vaccination date.  Treatment included plenty of hydration and restriction of solid food.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Vomiting
Clinical narrative: Violent and continuous vomitting, diarhea, headaches, dizziness, exhaustion, loss of mental ability for 4-5 days.  Occurred afternoon of vaccination date.  Treatment included plenty of hydration and restriction of solid food.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Flu shot was given above the proper muscle, given in the burses(sp?)  It has left me with painful use of my arm and my current Dr. feels I need therpy to get the use back in my arm.
Age: 21.0
Sex: U
Vaccine: HEPA, TYP
Symptoms: Erythema, Local reaction, Pain, Pruritus, Pyrexia
Clinical narrative: Received several travel immunizations on 10/23/08 had low grade fever on that HS.  On Wednesday and Thursday 10/29/08 and 10/30 /08 had 40 mm wheal with slight pain and very itchy.  Today w/ 40 mm erythema.  No SOB, no nausea no vomiting no systemic problems just local reaction
Age: 21.0
Sex: U
Vaccine: HEPA, TYP
Symptoms: Urticaria
Clinical narrative: Received several travel immunizations on 10/23/08 had low grade fever on that HS.  On Wednesday and Thursday 10/29/08 and 10/30 /08 had 40 mm wheal with slight pain and very itchy.  Today w/ 40 mm erythema.  No SOB, no nausea no vomiting no systemic problems just local reaction
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Oedema peripheral, Pyrexia
Clinical narrative: On 10/04/08 P. called to report arm was hot, swollen, and red.  Advised to use tylenol and ice. On 10/06/08 pt. saw MD for same complaints and fever. Pt. took keflex for 7 days but got bad stomach upset and stopped. 10/27/08 pt. called to say still has swollen lymph nodes with pain.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Stomach discomfort
Clinical narrative: On 10/04/08 P. called to report arm was hot, swollen, and red.  Advised to use tylenol and ice. On 10/06/08 pt. saw MD for same complaints and fever. Pt. took keflex for 7 days but got bad stomach upset and stopped. 10/27/08 pt. called to say still has swollen lymph nodes with pain.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Client developed itching of the left arm approx 5 hours after receiving vaccine in left deltoid. By the next morning the left arm was sore, swollen from the shoulder to about 2 " above the elbow and about about halfway around the arm from the back of the arm to the mid part of the arm. Also reports redness and warmth in entire area with hardness in the tissue in the upper part of the arm with a blothchy red rash like appearance. Client was advised by staff to see her physician. She reports she wnet to work at 2:15 PM the day after recieving the vaccine and was advised by a nurse at work to go home and take Benadryl which she did. Reports that symptoms are subsiding. Has not seen physician.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Rash macular, Skin warm
Clinical narrative: Client developed itching of the left arm approx 5 hours after receiving vaccine in left deltoid. By the next morning the left arm was sore, swollen from the shoulder to about 2 " above the elbow and about about halfway around the arm from the back of the arm to the mid part of the arm. Also reports redness and warmth in entire area with hardness in the tissue in the upper part of the arm with a blothchy red rash like appearance. Client was advised by staff to see her physician. She reports she wnet to work at 2:15 PM the day after recieving the vaccine and was advised by a nurse at work to go home and take Benadryl which she did. Reports that symptoms are subsiding. Has not seen physician.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Feeling hot, Hypersensitivity
Clinical narrative: Pt reported Influenza injection at 9:00am on 10/30/08. This was her first flu shot.  Nose started running aprox. 9:15am with sneezing and watery eyes following.  Started uncontrollably coughing and chilling.  Felt hot to touch but no temperature was taken.  Felt Short of Breath and begin wheezing when went to Emergency Room aprox. 4:30pm.  Was treated in Emergency room at 1725 with Benadryl, prednisone and pepcid. Was diagnosed in ER with Allergic reaction to Flu shot.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Rhinorrhoea, Sneezing, Wheezing
Clinical narrative: Pt reported Influenza injection at 9:00am on 10/30/08. This was her first flu shot.  Nose started running aprox. 9:15am with sneezing and watery eyes following.  Started uncontrollably coughing and chilling.  Felt hot to touch but no temperature was taken.  Felt Short of Breath and begin wheezing when went to Emergency Room aprox. 4:30pm.  Was treated in Emergency room at 1725 with Benadryl, prednisone and pepcid. Was diagnosed in ER with Allergic reaction to Flu shot.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Eye swelling, Hypersensitivity, Urticaria
Clinical narrative: Swollen eyes, hives over trunk of body, legs, back, arms, neck
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: RED 3 INCH CIRCULAR RASH AT INJECTION SITE THAT APPEARED THE NEXT MORNING AFTER GETTING SHOT. CONTACTING HER DR. OFFICE AND THE NP/PA PRESCRIBED HER A MEDROL DP, AND USE COLD COMPRESSES. I ADVISED PT TO CALL ME TOMM. TO CHECK ON HER AND CALL IMMEDIATELY TO GET HELP IF IT WORSENS.  11/3/08 Per patient-no permanant disability. Pt recovered from rash. No f/u required
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Skin discolouration, Skin warm, Tenderness
Clinical narrative: On 10/06/08, an employee received an IM influenza, in left arm.  After several days, per the employee, her left arm was warm to touch, swollen and discolored.  By 10/14 area of discoloration spread down to elbow.  During this time the employee was out of work because of another medical problem.  On 10/20/08, when the employee reported the above incident to the Employee Health Nurse, there was no swelling but discoloration approximately one (1) inch below the injection site to elbow.  Discolored area measured approximately 29 inches  wide and 15 inches long.  The area covered the outer aspects of the left arm to the elbow.  The discoloration was a deep purplish color.  Employee stated area was  not painful or warm to touch, but some tenderness. As of today (10/28/08), the employee left arm has improved considerably. Area now measures approximately five inches wide and 12 inches long.  The area is mostly on the inner aspects of the arm above elbow.  The discoloration varies from a slight purplish to yellow.  Employee states the discolored area is a little sore but no tenderness at the sight of the influenza vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Culture urine negative, Full blood count normal, Lumbar puncture normal, Unevaluable event
Clinical narrative: 10/14/08-2mo set given (pediarix{DTaP/IPV/HepB}, Rotateq,PCV,Hib)
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Urine analysis normal
Clinical narrative: 10/14/08-2mo set given (pediarix{DTaP/IPV/HepB}, Rotateq,PCV,Hib)
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Muscle twitching
Clinical narrative: NECK TWITCHING
Age: 15.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event.  Pt received Afluria -Influenza vaccine- vaccine to be given to age 18 and above.  this individual is 15 yrs old
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Urticaria
Clinical narrative: Patient had urticaria that presented as a diffuse rash over the course of 3 days and successfully treated with benedryl.  2/2/09 Received D/C summary for 10/29-10/31/2008. FINAL DX: urticarial rash. Records reveal rash had markedly improved w/tx by antihistamine by d/c to home.   1/27/09 Received hospital medical records of 10/29-10/31/2008. FINAL DX: no d/c summary available.  Allergy consult states likely infectious vs delayed reaction to vaccine. Records reveal patient experienced erythematous maculopapular rash all over x 1 day, irritability, reduced oral intake x 2 days & loose green stool.  Exam revealed erythematous swelling of all extremities thought to be coaslescing welts & temp 38.3..  Tx w/antibiotics & antihistamins.  LP done.  Allergy consult done & referred for additional allergy testing prior to further vaccines.  1/12/09 Received PCP medical records & vaccine records which included RO given 10/24/08. FINAL DX: H&P states allergic type rash Records reveal patient experienced congestion as reported by parent on 10/24 but MD exam was WNL.  RTC w/erythematous rash & extremity edema x 1 day on 10/29.  Sent to hospital for eval.  D/C from hospital 10/31 where dx w/urticaria.  Seen by Allergist 11/18, initial allergy tests were neg.  RTC for additional allergy testing 12/30 & had URI at that time w/nasal congestion & no fever.  Allergy tesing neg.  Not tested for RO & asked to hold until tested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Ocular hyperaemia, Throat irritation, Throat tightness
Clinical narrative: Pt report she got Influenza injection aprox. 10:30am on 10/30/08.  at aprox 3:45pm she noticed throat closing up, eyes got red and swollen and throat felt "burning hot"  Went to ER at 4:00pm was seen at 1618 in Emergency Room and was treated with Benadryl, prednisone, and pepcid.  Pt also reports she has been on Penicillian for 2 weeks and took a dose at aprox 3:00pm
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother called today and states that noticed yesterday red raised walnut area on left upper arm, where the MMR was given and was still red a raised this morning. Instructed to come into center to have area looked at, as this is closer to there home, states she will if not better when she picks him up at 3:30 today.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT COMPLAINED OF A VERY SORE ARM FROM A FLU SHOT 3 WEEKS AGO.  SHE HAS HAD THE SORE ARM SINCE VACCINATION AND STILL HAS TROUBLE LIFTING IT UP.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Eye discharge, Eye swelling, Headache
Clinical narrative: coughing, swollen tongue, area under the tongue swollen, fever 100, chills, swollen eyes, discharge from eyes, headache
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: coughing, swollen tongue, area under the tongue swollen, fever 100, chills, swollen eyes, discharge from eyes, headache
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Patient received Influenza vaccine 10/17/08. At 4:00 pm on 10/19/08 mother noticed patient's right arm was red, swollen and hot at 8:45 pm mother took patient to ER. Patient was seen by Dr. Mother was told patient had developed cellulitis and was started on Clindomicin-75 mg, 4x daily for 7 days. Patient followed up with MD on 10/20/08. Dr. diagnosed patient with an allergy to something in the vaccine. Lab work was drawn but results are not back as of yet.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Antinuclear antibody, Arthralgia, Blood creatine phosphokinase normal, Metabolic function test normal, Myalgia
Clinical narrative: Muscle and joint pain about 2 to 4 weeks after Twinrix injection #2.  Sx started September 2008 and persist.  Sx have improved slightly.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Myoglobin blood, Red blood cell sedimentation rate increased
Clinical narrative: Muscle and joint pain about 2 to 4 weeks after Twinrix injection #2.  Sx started September 2008 and persist.  Sx have improved slightly.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Loss of consciousness, Urinary incontinence
Clinical narrative: Patient received influenza vaccine on 10/30/08. Approximately 30 seconds after receiving vaccine patient patient exhibit very short seizure like activity and loss consciousness, she was incontinent of bladder. Pattient was lowered to the floor by public health nurses and oxygen was applied. An ambulance was called but mother refused transport. Mother was strongly encouraged to have patient seen in the ER and to follow up with patient's physician. Mother stated she would do this.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Rash
Clinical narrative: patient received vaccine on 10/28/08 and this morning found a flat rash on his legs and reddness around site of injection.  He stated today for the 1st time that he recently had a sinus infection and was taking Bactrim as an antibiotic.  He took his last Bactrim this morning.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever 101-103 degrees for over 24 hours at time of filing form. An increase in asthma symptoms. sore throat. at time of filing symptoms are not resolved. Will be returning to physician in the morning, urgent care clinic visit due to it will be a saturday.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt developed redness, swelling, at injection site on left deltoid
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 21 October 2008 the subject received a dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion.  It was suggested that the subject was seen in the emergency room.  Limited information was available.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.  The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office.  The medical doctor's office contacted the second distributor with the limited information.  It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room.  Linked case numbers include A0754338A and A0754339A.
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008 the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion. It was suggested that the subject was seen in the emergency room. Limited information was available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office. The medical doctor's office contacted the second distributor with the limited information. It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room. Linked case numbers include A0754328A and A0754339A.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose decreased, Convulsion
Clinical narrative: This case was reported by a physician via an injectables and vaccines distributor and described the occurrence of convulsion in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline).  On 21 October 2008 the subject received a dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject experienced convulsion, a drop in her blood sugar down to 46 and weakness.  She was taken to the emergency room.  Limited information was available.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.  The person reporting this event was a distributor who sold the product to another distributor who then sold it to a medical doctor's office.  The medical doctor's office contacted the second distributor with the limited information.  It was reported that three subjects experienced convulsions and a female subject experienced a drop in her blood sugar and weakness and was taken to the emergency room.  Linked case numbers include A0754328A and A0754338A.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Albumin CSF increased, Allen's test, Anion gap increased, Asthenia, Basophil count normal
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium increased, Blood chloride, Blood phosphorus
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium, Blood sodium, Carbon dioxide decreased, Carbon dioxide normal, Eosinophil count
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Haematocrit, Haemoglobin increased, Heart rate increased
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Laboratory test, Lymphocyte count decreased
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell haemoglobin concentration, Mean cell haemoglobin normal, Mean cell volume increased, Mean platelet volume decreased, Monocyte count normal
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Mydriasis, Mydriasis, Nausea, Oxygen saturation, PCO2 decreased
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Platelet count normal, Protein total increased, Red blood cell count increased, Red blood cell sedimentation rate increased
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count
Clinical narrative: Localized redness; swelling at site of injection. Area was approx. 3-4" in diameter, hot to touch. 10 am. Ice applied to site. 50 mg of PO BENADRYL given. Patient was c/o nausea, heart palpitations, weakness, pupils dilated, face was flushed. BP 118/70 P 102. EMS called at 1022. Pt transported by ambulance to medical center.  11/11/08 Reviewed hospital medical records of 10/31-11/5/2008 FINAL DX: no d/c summary available.  H&P states allergic reaction to vaccine Records reveal patient experienced immediate injection site pain, swelling & redness, palpitations, passed out, rash, paresthesia of extremities & face, & HA.  No reaction to previous flu shots.  Seen in ER, treated w/antihistamines & steroids.  Improved & d/c to home.  Developed difficulty swallowing & returned to ER.  Again tx w/steroids.  Neuro, allergy & ID consults done.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, C-reactive protein increased, Chest X-ray normal, Chest pain
Clinical narrative: 21 y/o male presented to ER on 8/25/2008 with 2 day history of sharp mid-sternal chest pain, radiating to neck and shoulders; worsened by positional changes, and deep breathing; SM reported 4-5 day prodrome of fever, malaise, and bifrontal headache. He had received primary SPV 8 days prior; SPV site progressed normally - no increase in pain or induration; no hx of cough, SOB, Immobility, leg pain or swelling, or trauma; no sick contacts or foreign travel. On 8/25/2008 SM was transferred from ER to hospital for cardiac care with diagnosis of suspected myocarditis; he was stable throughout his hospitalization without systemic symptoms (cvs, pulm, GI, neuro); he was discharged 8/27/2008.   12/12/2008 Reviewed medical records of 8/29-10/21/2008 & hospital admission 8/25-8/27/2008. FINAL DX: acute myopericarditis Records reveal patient experienced sub-sternal chest pain x 2 days.   Tx w/antiinflammatores.  Improved & d/c to outpatient cardiac f/u.  Continued to have chest tightness w/exercise but asymtomatic at rest.  Chest tightness gradually resolved completely.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Fibrin D dimer increased, Full blood count normal, Headache
Clinical narrative: 21 y/o male presented to ER on 8/25/2008 with 2 day history of sharp mid-sternal chest pain, radiating to neck and shoulders; worsened by positional changes, and deep breathing; SM reported 4-5 day prodrome of fever, malaise, and bifrontal headache. He had received primary SPV 8 days prior; SPV site progressed normally - no increase in pain or induration; no hx of cough, SOB, Immobility, leg pain or swelling, or trauma; no sick contacts or foreign travel. On 8/25/2008 SM was transferred from ER to hospital for cardiac care with diagnosis of suspected myocarditis; he was stable throughout his hospitalization without systemic symptoms (cvs, pulm, GI, neuro); he was discharged 8/27/2008.   12/12/2008 Reviewed medical records of 8/29-10/21/2008 & hospital admission 8/25-8/27/2008. FINAL DX: acute myopericarditis Records reveal patient experienced sub-sternal chest pain x 2 days.   Tx w/antiinflammatores.  Improved & d/c to outpatient cardiac f/u.  Continued to have chest tightness w/exercise but asymtomatic at rest.  Chest tightness gradually resolved completely.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Malaise, Metabolic function test, Musculoskeletal pain, Myoglobin blood, Neck pain
Clinical narrative: 21 y/o male presented to ER on 8/25/2008 with 2 day history of sharp mid-sternal chest pain, radiating to neck and shoulders; worsened by positional changes, and deep breathing; SM reported 4-5 day prodrome of fever, malaise, and bifrontal headache. He had received primary SPV 8 days prior; SPV site progressed normally - no increase in pain or induration; no hx of cough, SOB, Immobility, leg pain or swelling, or trauma; no sick contacts or foreign travel. On 8/25/2008 SM was transferred from ER to hospital for cardiac care with diagnosis of suspected myocarditis; he was stable throughout his hospitalization without systemic symptoms (cvs, pulm, GI, neuro); he was discharged 8/27/2008.   12/12/2008 Reviewed medical records of 8/29-10/21/2008 & hospital admission 8/25-8/27/2008. FINAL DX: acute myopericarditis Records reveal patient experienced sub-sternal chest pain x 2 days.   Tx w/antiinflammatores.  Improved & d/c to outpatient cardiac f/u.  Continued to have chest tightness w/exercise but asymtomatic at rest.  Chest tightness gradually resolved completely.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Troponin I increased, Ultrasound scan normal
Clinical narrative: 21 y/o male presented to ER on 8/25/2008 with 2 day history of sharp mid-sternal chest pain, radiating to neck and shoulders; worsened by positional changes, and deep breathing; SM reported 4-5 day prodrome of fever, malaise, and bifrontal headache. He had received primary SPV 8 days prior; SPV site progressed normally - no increase in pain or induration; no hx of cough, SOB, Immobility, leg pain or swelling, or trauma; no sick contacts or foreign travel. On 8/25/2008 SM was transferred from ER to hospital for cardiac care with diagnosis of suspected myocarditis; he was stable throughout his hospitalization without systemic symptoms (cvs, pulm, GI, neuro); he was discharged 8/27/2008.   12/12/2008 Reviewed medical records of 8/29-10/21/2008 & hospital admission 8/25-8/27/2008. FINAL DX: acute myopericarditis Records reveal patient experienced sub-sternal chest pain x 2 days.   Tx w/antiinflammatores.  Improved & d/c to outpatient cardiac f/u.  Continued to have chest tightness w/exercise but asymtomatic at rest.  Chest tightness gradually resolved completely.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Debridement, Injected limb mobility decreased, Joint effusion, Joint irrigation, Joint swelling
Clinical narrative: Rt shoulder pain, swollen, swelling into fingers, cannot close fist or lift arm, redness over deltoid. Ultrasound showed huge glenohumeral joint effusion, tapped it = WBC 86K, 90% poly. No organism seen. Surgery - Irrigation & debridement of shoulder - 20mL purulent material.  11/21/2008  MR received for DOS 10/8-10/2008 with DX: Right septic shoulder. Pt presented after several ER and PMD visits with c/o severe R shoulder pain.  Pt had pain immediately after injection with worsening pain, swelling into the fingers, and inability to lift arm and close fist. PE (+) for R deltoid swelling and erythema, decreased ROM.  Shoulder was tapped following presence of joint effusion on US and placed on abx. Dramatic improvement by POD#1.