chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Disturbance in attention, Fatigue, Headache, Pyrexia
Clinical narrative: FATIGUE, HEADACHE, COUGH, FEVER, CONGESTION, NOT ABLE TO CONCENTRATE. WENT TO URGENT CARE ON WED, 11/11/09. DR. PRESCRIBED TAMI-FLU.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract congestion
Clinical narrative: FATIGUE, HEADACHE, COUGH, FEVER, CONGESTION, NOT ABLE TO CONCENTRATE. WENT TO URGENT CARE ON WED, 11/11/09. DR. PRESCRIBED TAMI-FLU.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain, Oedema peripheral, Pain
Clinical narrative: Patient describe severe pain in arm where received injection.  She could lift her arm but not above shoulder and is very painful.  She went to the doctor, her arm was swollen and the pain radiated up to the neck.  She was prescribed hydrocodone for the pain.
Age: 16.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Body temperature increased, Gastrooesophageal reflux disease, Skin warm
Clinical narrative: Patient complained of acid reflux. I noticed he felt warm.  Took temp. and at this time it is 99.7.
Age: 6.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain upper, Diarrhoea, Pyrexia
Clinical narrative: Stomach ache; diarrhea; low fever.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Fluvirin with Thimerosal given to OB pt.  LMP: 6/3/09.  EDC: 03/09/2010.  Pt does not have an ob/gyn.  Pt notified on 11/06/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine. 11/24/2009 MD records, vaccine given to pregnant patient, no side effects reported at this time.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever, Chills, joint and muscle ache, nausea and headache.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, joint and muscle ache, nausea and headache.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Fluvirin with Thimerosal given to OB pt.  LMP: 04/06/2009.  EDC: 01/10/2010.  Pt does not have an ob/gyn.  Pt notified on 11/6/09.  Denies any adverse effects.  Pt NOT hospitalized after receiving H1N1 vaccine. 11/25/09 OB records received. Normal OB visit pt. 30wks pregnant. Received H1N1 vax. FHT (+)142.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Fluvirin with thimerosal given to OB pt.  LMP: 04/03/2009. EDC: 01/08/2010.  Pt does not have an OB/GYN.  Pt notified on 11/06/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine. 11/19/09 Medical records received. OB records. Pt pregnant received H1N1 IM vax on 10/29/09 pt. was 30wks pregnant. No adverse event noted, normal IUP.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Fluvirin with thimerosal given to OB pt.  LMP: unsure.  EDC: 01/10/2010.  Pt does not have an OB/GYN.  Pt notified on 11/12/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine.  11/19/09:  OB records received for dates of service 6/8/09 to 11/6/09.  Assessment:  Gravida 2 Para 1 at 30+5 weeks gestation (EDC 1/10/10), received H1N1 vaccine on 11/6/09.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Fluvirin with thimerosal given to OB pt.  LMP: 07/24/2009.  EDC: 04/30/2009.  Pt does not have an OB/GYN.  Pt notified on 11/06/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine. 11/19/2009 OB visit 10/26/2009, patient pregnant EDC 4/30/2009, no sx at this time
Age: 1.03
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Pt began with petechiae over lower extremities and buttocks that spread upward to trunk.   11/18/09:  Outpatient Hospital record received for dates of service 11/10/09 to 11/14/09.  Dx:  Idiopathic thrombocytopenic purpra.    Assessment:  Presented with 4  day history of bruising and petechiae.  Platelet count 2000.  ITP Dx'd.  Treated with WinRho IV. Slight chills after infusion.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Glossodynia, Urticaria
Clinical narrative: Child complained that tongue hurt, and shortly after, parents noticed hives on hand and ankle.  Tongue pain went away, and hydrocortisone applied to the hives helped.  Next day, more hives on hands and tops of both feet up to ankles, gave Benadryl, called pediatrician who advised 1 tsp. Benadryl 3x/day for 5 days, and would like to see patient.  Patient still under supervision.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Fluvirin with thimerosal given to OB pt.  LMP: 02/20/2009.  EDC: 11/27/2009.  Pt does not have an OB/GYN.  Pt notified on 11/6/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine. 11/18/09 Medical records received.  OB records.  . OB patient given vaccine on 10/30/09.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blister, Erythema, Injection site rash
Clinical narrative: Has developed rashes on the site of the arm where vaccine was injected. The area has become reddish with blisters turned to white/yellow. Visted a family Dr. He has prescribed the following prescriptions: 1. MUPIROCIN 2% OINTMENT 22GM APPLY 3 times a day for 5 days 2. SULFAMETH-TRIMETH SUSP(grape) 1 tsp by mouth twice daily for 10 days.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Drug exposure during pregnancy, No adverse event
Clinical narrative: Fluvirin with thimerosal given to OB pt.  LMP: 02/02/2009.  EDC: 11/29/2009.  Pt does not have an OB/GYN.  Pt notified on 11/06/2009.  Denies any adverse effects.  Pt not hospitalized after receiving H1N1 vaccine. 11/19/09 Medical records received for 11/13/09. OB records. DX: IUP 38wks, normal OB ck. (+)FM.
Age: 22.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Arthralgia, Bone pain, Chills, Dysuria, Fatigue
Clinical narrative: Started with a sore throat on first day.  Next three days had a mucus producing cough and runny nose.  The following three days included borderline fever switching from feeling extremely hot and sweaty to cold and shivering.  I also can't seem to stay hydrated, drinking constantly but staying thirsty and barely urinating.  I've felt very fatigued with aching spine and joints.
Age: 22.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Feeling of body temperature change, Hyperhidrosis, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: Started with a sore throat on first day.  Next three days had a mucus producing cough and runny nose.  The following three days included borderline fever switching from feeling extremely hot and sweaty to cold and shivering.  I also can't seem to stay hydrated, drinking constantly but staying thirsty and barely urinating.  I've felt very fatigued with aching spine and joints.
Age: 22.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rhinorrhoea, Thirst
Clinical narrative: Started with a sore throat on first day.  Next three days had a mucus producing cough and runny nose.  The following three days included borderline fever switching from feeling extremely hot and sweaty to cold and shivering.  I also can't seem to stay hydrated, drinking constantly but staying thirsty and barely urinating.  I've felt very fatigued with aching spine and joints.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chest pain, Ear pain, Fatigue, Migraine, Musculoskeletal stiffness
Clinical narrative: Began with headache, turned into a migraine, body aches, stick neck, sore throat, pain in chest and ears, very tired, lasted 4+ days.
Age: 32.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: Began with headache, turned into a migraine, body aches, stick neck, sore throat, pain in chest and ears, very tired, lasted 4+ days.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Eye swelling, Hypersensitivity, Oedema peripheral, Rash, Urticaria
Clinical narrative: Hives rash swollen legs a allergic reaction. Treatment is some type of steroids.
Age: 42.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Flushing, Pruritus, Urticaria
Clinical narrative: Persistent flushed and itchy face that lasted close to week.  Some hives.  I used Benadryl cream and elixir, round the clock.  Still have slight redness and reduced itchiness.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Decreased appetite, Dysphonia, Flushing, Pyrexia, Respiratory tract congestion
Clinical narrative: Patient was administered a full dose of the H1N1 nasal mist vaccine on November 5, 2009.  Patient woke up with a very high fever on 11/13/2009 that wouldn't break with Tylenol (finally it lowered with a cold bath).  He has had a fever over 100 since then (today is 11/16/2009.  He can't stop coughing, is hoarse, extremely congested, has little appetite, and his cheeks are flushed.
Age: 23.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Asthenia, Cough, Malaise, Respiratory tract congestion
Clinical narrative: My daughter became ill within a day or so of taking the H1N1 Flu mist.  She has overall body weakness, a cough and congestion.
Age: 31.0
Sex: F
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Ageusia, Facial palsy
Clinical narrative: I developed Bell's palsy on the morning of 11/10/09.  It began with loss of taste and right sided facial paralysis.  Treatment included: oral prednisone (60 mg QD x 2 days, 40 mg QD x 2 days, 20 mg QD x 2 days) and Valtrex 1 g TID x 7 days.  Symptoms are ongoing at the time of this submission. 11/19/2009 Spoke with MD/reporter who self diagnosed and treated.  Did not seek other medical attention.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Hypokinesia, Movement disorder
Clinical narrative: She lost head control and her head would only turn to the right. She wouldn't move her head left anymore it was stiff right.
Age: 2.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Full blood count normal, Laboratory test normal, Lymphadenitis, Lymphadenopathy
Clinical narrative: Traumatically swollen lymph node under right ear/jaw.  Taken to pediatrician's office to be diagnosed with cervical adenitis.  Prescribed 4ML of Augmentin twice daily for 10 days.  Just dispensed dose number 9 -- absolutely no reduction in swelling, but no increased swelling either.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Facial palsy, Muscle twitching, Paralysis
Clinical narrative: initial symptoms of Bell's Palsy noted---eye twitching, start of mouth paralysis. 12/28/2009 OB records state on 10/21/2009 patient with c/o's lt sided facial numbness and decreased eyelid movement. Dx'd with Lt Bells Palsy.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anaphylactic reaction, Lip swelling, Rash, Throat tightness
Clinical narrative: Swelling of lips, rash on neck, sensation of throat "closing off" Likely anaphylaxis. Treated with epinephrine, Solumedrol, Benadryl. 11/18/09:  ED reocrds and Discharge Summary received for dates of service 11/16/09 to 11/17/09.  Dx:  Angioedema, Anaphylaxis.   11/23/09 DC summary received for date 11/16/09. Same info as prev. records received. Assessment: (+)angioedema of lips, uvula. Pt was admitted and tx overnight. pt. stable at dc.  Assessment:  Presents with swelling of the lips, upper more than lower, also involvement of the uvula,  feeling of throat "closing off" and puritic rash on the neck.  No difficulty breathing or swallowing.  Oxygen saturation 100% on room air.  Given epinepherine and IV Solumedrol.  Admitted for a short stay in stable condition.    ICD 9 Codes:  995.0, 995.1.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Condition aggravated, Fatigue, Hyperhidrosis, Tremor, Vomiting
Clinical narrative: After being well all day long, at about 6:30pm my daughter started to feel extremely tired. At 7:00pm she vomited. At 8:00pm she vomited again and her whole body was shaking and she was sweating. At 10pm she vomited again. She then slept till 1pm after which she started vomiting again and did so every hour until the morning. We counted ten episodes of vomiting. We were advised to take her to ER the next morning to treat for dehydration. During this day she did not vomit again, but the following morning she vomited again. She has had no fever or other pain or symptoms other than extreme fatigue. We think she is recovering now but will have a better sense in the next few days.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Burning sensation, Facial pain, Hypoaesthesia, Hypoaesthesia facial, Neck pain
Clinical narrative: 36 hours after dose administered - Pt experienced numbness and pain in the left face and neck. Burning and paresthesias of the left hand.  11/18/09:  Primary care records received for date of service 11/13/09:  Dx:  H1N1 Vaccination reaction, trigeminal neuralgia and brachial neuritis.  Assessment:  Presents with c/o numbness and pain in left face and left anterior neck as well as burning and paresthesias in the left hand.  Sx. have decreased over the last couple of days, but have not resolved.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia
Clinical narrative: 36 hours after dose administered - Pt experienced numbness and pain in the left face and neck. Burning and paresthesias of the left hand.  11/18/09:  Primary care records received for date of service 11/13/09:  Dx:  H1N1 Vaccination reaction, trigeminal neuralgia and brachial neuritis.  Assessment:  Presents with c/o numbness and pain in left face and left anterior neck as well as burning and paresthesias in the left hand.  Sx. have decreased over the last couple of days, but have not resolved.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Activities of daily living impaired, Diarrhoea, Fatigue, Feeling of body temperature change, Injection site swelling
Clinical narrative: Fingertip sized swelling left deltoid, site of seasonal flu shot. 3 episodes of diarrhea morning after injections. Felt hot/cold, fatigue. Missed work 11/5 and 11/6/09.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Influenza
Clinical narrative: Reported symptoms consistent with H1N1 by mom who is a physician.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Rash, pain, erythema following injection of flu (H1N1) vaccine 24 hours later.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Noticed slight induration (redness/mild swelling) at injection site after 24 hours of administration. Induration disappeared within 3-4 days without any type of treatment.
Age: 21.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Immediate post-injection reaction, Injection site nodule, Injection site pain, Swollen tongue
Clinical narrative: Telephone call from clients mother, email from client reporting tenderness at injection site and a small bump there immediately after administration but swelling of her tongue and difficulty breathing 10 1/12 hours after administration. Took 2 BENADRYL, Went to ER.  11/23/09 Medical records received for DOS 11/12/2009. Final DX:  Allergic reaction. S/P vaccine tongue swelling, throat tightness. Resolved w/Benadryl tab, steroid tx.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia facial, Hypoaesthesia oral, Muscular weakness
Clinical narrative: Numbness/weakness on left side of face, lips, arm, leg. 12/8/09 Medical records received for date 11/17/09. DX: none given. Presenting c/o numbness over left side body affecting face, arm, and leg. Pt states received H1N1 vax and within 15 min experienced these sx. Pt states weakness in limbs as well. Assessment: decrease to light touch left side face, decreased on left arm/leg.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: Received vaccine at 8:45am. Developed itching 20 post vaccine. Generalized. Progressively worse over next 24 hours - 2pm. 11/12/2009 pt reported to clinic with generalized macular papular rash - erythenia generalized uticaria - given BENADRYL 0.5, ZANTAC 150 mg, Prednisone 10mg tapering dose
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Eye swelling, Hearing impaired
Clinical narrative: Swelling of eyes, redness of face, difficulty hearing.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: IPV and DTAP given in L arm. Pt developed pain at site of injection Friday 11/13/09. Arm swollen, red, hot and itchy from shoulder to elbow on 11/14/09-Advised to give BENADRYL. By 11/16/09-swelling remained over upper half of upper arm. No pain, redness.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain at site of shot and weakness in (R) arm after shot. Pt seen 1 week later and symptoms are slowly improving.
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain began at time of immunization and worsened. Arm soreness, only able to lift arm approx 4" then intense pain begins. Rate pain at 8/10. Hes taken Advil.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Full blood count abnormal, Henoch-Schonlein purpura, Pyrexia, Rash, Urine analysis
Clinical narrative: Pt presented on 11/10/09 with a rash diagnosed as Henoch-Schonlein purpura . Was apparently febrile to 103F after vaccination.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: C/O pains.......... at injection site (RT Del) few hours afterwards. Developed redness and swelling from............. to elbow by evening same day. Swelling and redness still present at 10/30 visit.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Erythematous papules over arms, legs, and upper chest. Some areas of urticaria over elbows. Gave BENADRYL 12.5 mg BID and ranitidine 150mg bid.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Hypersensitivity, Influenza like illness
Clinical narrative: Patient c/o flu like symptoms joint pain, fatigue and hypersensitivity in hand and feet 3 days after anthrax vaccination; lasted 5 days skin on fingers, toes, heels peeled off.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Dysgeusia, Feeling abnormal, Heart rate increased, Palpitations
Clinical narrative: 9/25/09 6:19 PM After administering vaccine, about 1 minute after, pt began c/o metallic taste in mouth and feeling like heart was racing. Pt concerned b/c she is a cardiac patient, had adverse reaction to multidose flu-vaccine in past, localized to arm of injection. Also noted felt like something was in throat. No sob, no diaphoresis. No cp. Pt talking clearly, immediately phoned cardiologist office and remained on phone with for duration of time in clinic. Vitals were as followed every 2 minutes: 1. BP - 154/88 HR - 147 O2 sat - 99% 2. BP - 150/84 HR-127 O2 sat 97% 3. BP - 110/80 HR - 120 O2 sat - 95% 911 was called b/c patient still felt "funny", felt weak, felt like heart was racing. Ambulance arrived in 2 minutes, patient transported to hospital.  11/17/09 Hospital records received for date 9/25/09. DX: Transient dyspnea with palpitations. Reaction to flu vax. Chief c/o received vax and within 1 minute c/o metallic taste in mouth, visual changes, palpitations, lightheadedness. Assessment: WNL. Pt sx resolved and dc home stable.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Sensation of foreign body
Clinical narrative: 9/25/09 6:19 PM After administering vaccine, about 1 minute after, pt began c/o metallic taste in mouth and feeling like heart was racing. Pt concerned b/c she is a cardiac patient, had adverse reaction to multidose flu-vaccine in past, localized to arm of injection. Also noted felt like something was in throat. No sob, no diaphoresis. No cp. Pt talking clearly, immediately phoned cardiologist office and remained on phone with for duration of time in clinic. Vitals were as followed every 2 minutes: 1. BP - 154/88 HR - 147 O2 sat - 99% 2. BP - 150/84 HR-127 O2 sat 97% 3. BP - 110/80 HR - 120 O2 sat - 95% 911 was called b/c patient still felt "funny", felt weak, felt like heart was racing. Ambulance arrived in 2 minutes, patient transported to hospital.  11/17/09 Hospital records received for date 9/25/09. DX: Transient dyspnea with palpitations. Reaction to flu vax. Chief c/o received vax and within 1 minute c/o metallic taste in mouth, visual changes, palpitations, lightheadedness. Assessment: WNL. Pt sx resolved and dc home stable.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Blood pressure increased, Cardiac function test, Dysgeusia, Heart rate increased, Immediate post-injection reaction
Clinical narrative: 9/25/09 6:19 PM After administering vaccine, about 1 minute after, pt began c/o metallic taste in mouth and feeling like heart was racing. Pt concerned b/c she is a cardiac patient, had adverse reaction to multidose flu-vaccine in past, localized to arm of injection. Also noted felt like something was in throat. No sob, no diaphoresis. No cp. Pt talking clearly, immediately phoned cardiologist office and remained on phone with for duration of time in clinic. Vitals were as followed every 2 minutes: 1. BP - 154/88 HR - 147 O2 sat - 99% 2. BP - 150/84 HR-127 O2 sat 97% 3. BP - 110/80 HR - 120 O2 sat - 95% 911 was called b/c patient still felt "funny", felt weak, felt like heart was racing. Ambulance arrived in 2 minutes, patient transported to hospital.  11/17/09 Hospital records received for date 9/25/09. DX: Transient dyspnea with palpitations. Reaction to flu vax. Chief c/o received vax and within 1 minute c/o metallic taste in mouth, visual changes, palpitations, lightheadedness. Assessment: WNL. Pt sx resolved and dc home stable.
Age: 63.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Laboratory test, Muscular weakness, Paraesthesia, Visual impairment
Clinical narrative: 9/25/09 6:19 PM After administering vaccine, about 1 minute after, pt began c/o metallic taste in mouth and feeling like heart was racing. Pt concerned b/c she is a cardiac patient, had adverse reaction to multidose flu-vaccine in past, localized to arm of injection. Also noted felt like something was in throat. No sob, no diaphoresis. No cp. Pt talking clearly, immediately phoned cardiologist office and remained on phone with for duration of time in clinic. Vitals were as followed every 2 minutes: 1. BP - 154/88 HR - 147 O2 sat - 99% 2. BP - 150/84 HR-127 O2 sat 97% 3. BP - 110/80 HR - 120 O2 sat - 95% 911 was called b/c patient still felt "funny", felt weak, felt like heart was racing. Ambulance arrived in 2 minutes, patient transported to hospital.  11/17/09 Hospital records received for date 9/25/09. DX: Transient dyspnea with palpitations. Reaction to flu vax. Chief c/o received vax and within 1 minute c/o metallic taste in mouth, visual changes, palpitations, lightheadedness. Assessment: WNL. Pt sx resolved and dc home stable.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Acute sinusitis, Aphasia, Barium swallow abnormal, CSF test abnormal, Ear pain
Clinical narrative: Guillain-Barre Syndrome.  11/18/09 ED, hospital records received, service dates 11/7/09 to 11/13/09. Assessment: Guillain-Barre suspected. Patient began to c/o tingling in upper/lower extremities 10-12 days prior to admission. Seen at two prior facilities where dx of viral illness was provided and patient discharged. Became weak, tired, slurred speech, walking unsteady, drooling. Pediatrician suspected Guillain-Barre and referred to ED. Body aches, Patient weak but not areflexic. Ataxic, deep tendon reflexes weak. Grip strength weak. Numbness.  11/19/09 DC summary received for service dates 11/7/09 to 11/13/09. Assessment: Cerebellitis. Admitted for sudden onset of tingling of upper and lower extremities, weakness, ataxia, and dysarthria. Deep tendon reflexes diminished, IVIG. Speech remained slurred, aspiration. NG tube placed. Discharged. Neurology and infectious disease consultations scheduled.   12/23/09  Clinic record received for DOS 11/16/09. DX: Acute sinusitis, Acute otitis media with effusion (R), Serous otitis media (L), sore throat -due to NG tube, Guillain-Barre syndrome.   Patient presents with c/o left earache, fever and sore throat. Patient tearful and tired-appearing. Muscles painful to palpation and patient using a walker. Has paresthesias of both hands and both feet. Feeling around lips and tongue improved. Patient prescribed amoxicillin and acetaminophen/codeine.  12/23/09 Clinic record and diagnostic test reports received for DOS 11/18/09-11/25/09  DX: Guillain-Barre syndrome, dysphasia. Muscle tenderness improved. Hypesthesia. Plan Swallow Study.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Myalgia, Oropharyngeal pain, Otitis media, Otitis media acute
Clinical narrative: Guillain-Barre Syndrome.  11/18/09 ED, hospital records received, service dates 11/7/09 to 11/13/09. Assessment: Guillain-Barre suspected. Patient began to c/o tingling in upper/lower extremities 10-12 days prior to admission. Seen at two prior facilities where dx of viral illness was provided and patient discharged. Became weak, tired, slurred speech, walking unsteady, drooling. Pediatrician suspected Guillain-Barre and referred to ED. Body aches, Patient weak but not areflexic. Ataxic, deep tendon reflexes weak. Grip strength weak. Numbness.  11/19/09 DC summary received for service dates 11/7/09 to 11/13/09. Assessment: Cerebellitis. Admitted for sudden onset of tingling of upper and lower extremities, weakness, ataxia, and dysarthria. Deep tendon reflexes diminished, IVIG. Speech remained slurred, aspiration. NG tube placed. Discharged. Neurology and infectious disease consultations scheduled.   12/23/09  Clinic record received for DOS 11/16/09. DX: Acute sinusitis, Acute otitis media with effusion (R), Serous otitis media (L), sore throat -due to NG tube, Guillain-Barre syndrome.   Patient presents with c/o left earache, fever and sore throat. Patient tearful and tired-appearing. Muscles painful to palpation and patient using a walker. Has paresthesias of both hands and both feet. Feeling around lips and tongue improved. Patient prescribed amoxicillin and acetaminophen/codeine.  12/23/09 Clinic record and diagnostic test reports received for DOS 11/18/09-11/25/09  DX: Guillain-Barre syndrome, dysphasia. Muscle tenderness improved. Hypesthesia. Plan Swallow Study.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tearfulness
Clinical narrative: Guillain-Barre Syndrome.  11/18/09 ED, hospital records received, service dates 11/7/09 to 11/13/09. Assessment: Guillain-Barre suspected. Patient began to c/o tingling in upper/lower extremities 10-12 days prior to admission. Seen at two prior facilities where dx of viral illness was provided and patient discharged. Became weak, tired, slurred speech, walking unsteady, drooling. Pediatrician suspected Guillain-Barre and referred to ED. Body aches, Patient weak but not areflexic. Ataxic, deep tendon reflexes weak. Grip strength weak. Numbness.  11/19/09 DC summary received for service dates 11/7/09 to 11/13/09. Assessment: Cerebellitis. Admitted for sudden onset of tingling of upper and lower extremities, weakness, ataxia, and dysarthria. Deep tendon reflexes diminished, IVIG. Speech remained slurred, aspiration. NG tube placed. Discharged. Neurology and infectious disease consultations scheduled.   12/23/09  Clinic record received for DOS 11/16/09. DX: Acute sinusitis, Acute otitis media with effusion (R), Serous otitis media (L), sore throat -due to NG tube, Guillain-Barre syndrome.   Patient presents with c/o left earache, fever and sore throat. Patient tearful and tired-appearing. Muscles painful to palpation and patient using a walker. Has paresthesias of both hands and both feet. Feeling around lips and tongue improved. Patient prescribed amoxicillin and acetaminophen/codeine.  12/23/09 Clinic record and diagnostic test reports received for DOS 11/18/09-11/25/09  DX: Guillain-Barre syndrome, dysphasia. Muscle tenderness improved. Hypesthesia. Plan Swallow Study.
Age: 56.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood bicarbonate decreased, Blood pH normal, Chest X-ray, Chest discomfort, Cold sweat
Clinical narrative: Approx 1 1/2 hrs post injection pt. became hot and flushed. Hands became clammy. At approx 0630 pt. having difficulty breathing and itching. Pt. seen in ER and treated with IV Solumedrol, BENADRYL, Epi. Pt dc'd home and returned back to ER with chest tightness. Treated with Solumedrol, BENADRYL, Epi and Vistaril. Pt. admitted for observation then transferred to ICU.  12/09/09 MR received for DOS 11/14/09.  DX: Allergic reaction.  Pt presented with wheezing, stridor, chest tightness, rash, pruritus. tx: EpiSQ, vistaril, Solu-medrol, Methylprednisolone. Pt discharged home in stable condition.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Feeling hot, Flushing, Intensive care, PCO2 decreased
Clinical narrative: Approx 1 1/2 hrs post injection pt. became hot and flushed. Hands became clammy. At approx 0630 pt. having difficulty breathing and itching. Pt. seen in ER and treated with IV Solumedrol, BENADRYL, Epi. Pt dc'd home and returned back to ER with chest tightness. Treated with Solumedrol, BENADRYL, Epi and Vistaril. Pt. admitted for observation then transferred to ICU.  12/09/09 MR received for DOS 11/14/09.  DX: Allergic reaction.  Pt presented with wheezing, stridor, chest tightness, rash, pruritus. tx: EpiSQ, vistaril, Solu-medrol, Methylprednisolone. Pt discharged home in stable condition.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: PO2 increased, Pruritus, X-ray
Clinical narrative: Approx 1 1/2 hrs post injection pt. became hot and flushed. Hands became clammy. At approx 0630 pt. having difficulty breathing and itching. Pt. seen in ER and treated with IV Solumedrol, BENADRYL, Epi. Pt dc'd home and returned back to ER with chest tightness. Treated with Solumedrol, BENADRYL, Epi and Vistaril. Pt. admitted for observation then transferred to ICU.  12/09/09 MR received for DOS 11/14/09.  DX: Allergic reaction.  Pt presented with wheezing, stridor, chest tightness, rash, pruritus. tx: EpiSQ, vistaril, Solu-medrol, Methylprednisolone. Pt discharged home in stable condition.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Muscular weakness
Clinical narrative: Flu shot given in left deltoid. Pain began on 10/21/09, the day after the injection and pain progressively worse to left deltoid with mild swelling. Rates pain 8-10.5 out of 10 weakness to left shoulder began around 11/11/09, worsen unable to lift arm. No prior injury.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain
Clinical narrative: Patient reported onset of headache same day vaccine (Gardasil) #1 was given. Pain lasted for one week, was relieved by taking OTC acetaminophen.
Age: 39.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Musculoskeletal chest pain, Pain in extremity, Paraesthesia, Vaccination complication
Clinical narrative: R arm became painful from fingertips through shoulder and into R chest wall. Tingling in fingertips and arm off and on. Saw physician 11-12-09 we thought it was a reaction to the vaccine and gave her Mobic and Darvocet. 11-16-09 still has symptoms - same -maybe a little better will be seeing a Neurologist soon.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Lt deltoid cellulitis - area red, warm, and painful to touch. Treated with AUGMENTIN 875-125 BID x 5 days. No fever or rash.
Age: 1.06
Sex: M
Vaccine: FLUX, HEP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right lower extremity. Nickel size erythematous patch around injection site of varicella.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Influenza serology negative, Loss of control of legs, Paraesthesia oral, Pyrexia
Clinical narrative: On 11-5-09 pt c/o fever. Got up in AM before school and legs "collapsed". Went to school. Came home had a fever at 4:15pm 100 degrees headache. Did eat well. 4:40pm c/o eyes blurry tingling of lips. Instructed to go to ER. Went to ER.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vision blurred
Clinical narrative: On 11-5-09 pt c/o fever. Got up in AM before school and legs "collapsed". Went to school. Came home had a fever at 4:15pm 100 degrees headache. Did eat well. 4:40pm c/o eyes blurry tingling of lips. Instructed to go to ER. Went to ER.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Left arm, shot red area.
Age: 11.0
Sex: M
Vaccine: MNQ, PNC, PPV
Symptoms: Lumbar puncture, Meningitis pneumococcal, Wrong drug administered
Clinical narrative: Pt. had received PREVNAR inadvertently on 11-8-05. Pt. received MENACTRA on 7-24-07 - Pt. was diagnosed with pneumococcal meningitis on 10-6-09. 11/17/09 Medical records received for dates 10/6/09 to 10/26/09 DX: bacterial meningitis. Pt. presented w/ fever. Pt was prev. thought to have vax. But was given wrong vax. Pt. admitted, tx IV abx.  F/u on 10/26 infection resolved.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of Right deltoid. Rx - Prednisone x 4 d. Will see her again in 3 days pro.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient phoned pharmacy 11/11/09. Arm pained and patient has difficulty raising arm and rotating.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Rash
Clinical narrative: dizziness 11/13/09 2 hours after injection 1 hr resolved. Rash-widespread 11/14/09 - itchiness resolved with BENADRYL on 11/15/09.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, HEPA, MMR
Symptoms: Injection site induration
Clinical narrative: Indurated rt deltoid. Able to move. The pt shoulder well. No obvious swelling.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Diarrhoea, Migraine, Rhinorrhoea
Clinical narrative: Severe joint pain, chills, diarrhea, migraine headache, runny nose. Symptoms lasted approx. 48 hrs, with residual joint pain (less painful) for 5 days.
Sex: U
Vaccine: HEP
Symptoms: Burning sensation
Clinical narrative: Gave 32 Hepatitis B vaccine to group of patients #9. Almost all complained of vaccine burning when administered. Was given in deltoid with 1" 13 gauge needle. These same individuals that received #1 month earlier and did not complain. However, #1 was manu by Merck Lot #1446X
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Aneurysm, Hypertension, Mental status changes, Thrombocytopenia, Troponin increased
Clinical narrative: Patient given 2 vaccines in our clinic on 11/4/09. Later that same day patient was hospitalized. See attached hospital admit form.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder sore. Pain in forearm and hand. Applied ice packs. Took Ibuprofen.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Grand mal convulsion
Clinical narrative: Child had grand mal seizure 11/13/2009 per parent. 11/19/09 DC summary and hospital records received for dates 11/9/09 to 11/10/09.  DX: partial complex generalized seizure disorder. Pt. presented per parent w/ unprovoked seizures. Pt parent states first on 11/8 pt. began twitching, unresponsive, pt taken to ER DX: status epilepticus.  Pt had additional seizure in ER. Assessment: several seizure episodes seen in ED prior, script given, not filled. Seizure occurrence again, parent brought to ER, pt admitted.
Age: 4.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Feeling abnormal, Immediate post-injection reaction, Pallor
Clinical narrative: A serious spontaneous report of "anaphylactic reaction within minutes," and non-serious spontaneous report of fever, and colds has been received from a registered nurse concerning a four-year-old male, subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included egg allergy when he was two years old but has since been cleared by his allergist. The patient has since eaten eggs with no problem. He has peanut allergy. Concomitant medication was not reported. The patient received FluMist for the first time on 14-Oct-2009. Within minutes of vaccination, the patient experienced anaphylactic reaction. He was noted to be pale around the mouth which then turned bluish including the lips, experienced ringing in ears, and swollen eyes. The patient also complained of "funny feeling around mouth and ears." He also started crying and rubbing his eyes. There was no periorbital edema. The patient was warm to touch but temperature was not recorded. The mother who was with the patient gave him oral diphenhydramine hydrochloride. While in the clinic, the patient was administered one dose each of IM epinephrine and diphenhydramine  hydrochloride and oral prednisolone to control symptoms. The patient responded favorably and is now being followed up with no signs of long term symptoms. On 17-Oct-2009, the patient was noted to have fever and colds. The temperature was not recorded. As of 19-Oct-2009, the patient continues to have fever and colds and was not able to go to school. The mother will continue to monitor the patient's temperature. The outcome of anaphylactic reaction was recovered while the events of fever and colds are ongoing.
Age: 4.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Activities of daily living impaired, Anaphylactic reaction, Crying, Cyanosis, Eye swelling
Clinical narrative: A serious spontaneous report of "anaphylactic reaction within minutes," and non-serious spontaneous report of fever, and colds has been received from a registered nurse concerning a four-year-old male, subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included egg allergy when he was two years old but has since been cleared by his allergist. The patient has since eaten eggs with no problem. He has peanut allergy. Concomitant medication was not reported. The patient received FluMist for the first time on 14-Oct-2009. Within minutes of vaccination, the patient experienced anaphylactic reaction. He was noted to be pale around the mouth which then turned bluish including the lips, experienced ringing in ears, and swollen eyes. The patient also complained of "funny feeling around mouth and ears." He also started crying and rubbing his eyes. There was no periorbital edema. The patient was warm to touch but temperature was not recorded. The mother who was with the patient gave him oral diphenhydramine hydrochloride. While in the clinic, the patient was administered one dose each of IM epinephrine and diphenhydramine  hydrochloride and oral prednisolone to control symptoms. The patient responded favorably and is now being followed up with no signs of long term symptoms. On 17-Oct-2009, the patient was noted to have fever and colds. The temperature was not recorded. As of 19-Oct-2009, the patient continues to have fever and colds and was not able to go to school. The mother will continue to monitor the patient's temperature. The outcome of anaphylactic reaction was recovered while the events of fever and colds are ongoing.
Age: 4.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Feeling abnormal, Feeling hot, Nasopharyngitis, Pallor, Pyrexia
Clinical narrative: A serious spontaneous report of "anaphylactic reaction within minutes," and non-serious spontaneous report of fever, and colds has been received from a registered nurse concerning a four-year-old male, subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included egg allergy when he was two years old but has since been cleared by his allergist. The patient has since eaten eggs with no problem. He has peanut allergy. Concomitant medication was not reported. The patient received FluMist for the first time on 14-Oct-2009. Within minutes of vaccination, the patient experienced anaphylactic reaction. He was noted to be pale around the mouth which then turned bluish including the lips, experienced ringing in ears, and swollen eyes. The patient also complained of "funny feeling around mouth and ears." He also started crying and rubbing his eyes. There was no periorbital edema. The patient was warm to touch but temperature was not recorded. The mother who was with the patient gave him oral diphenhydramine hydrochloride. While in the clinic, the patient was administered one dose each of IM epinephrine and diphenhydramine  hydrochloride and oral prednisolone to control symptoms. The patient responded favorably and is now being followed up with no signs of long term symptoms. On 17-Oct-2009, the patient was noted to have fever and colds. The temperature was not recorded. As of 19-Oct-2009, the patient continues to have fever and colds and was not able to go to school. The mother will continue to monitor the patient's temperature. The outcome of anaphylactic reaction was recovered while the events of fever and colds are ongoing.
Age: 4.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Skin warm, Tinnitus
Clinical narrative: A serious spontaneous report of "anaphylactic reaction within minutes," and non-serious spontaneous report of fever, and colds has been received from a registered nurse concerning a four-year-old male, subsequent to FluMist. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history included egg allergy when he was two years old but has since been cleared by his allergist. The patient has since eaten eggs with no problem. He has peanut allergy. Concomitant medication was not reported. The patient received FluMist for the first time on 14-Oct-2009. Within minutes of vaccination, the patient experienced anaphylactic reaction. He was noted to be pale around the mouth which then turned bluish including the lips, experienced ringing in ears, and swollen eyes. The patient also complained of "funny feeling around mouth and ears." He also started crying and rubbing his eyes. There was no periorbital edema. The patient was warm to touch but temperature was not recorded. The mother who was with the patient gave him oral diphenhydramine hydrochloride. While in the clinic, the patient was administered one dose each of IM epinephrine and diphenhydramine  hydrochloride and oral prednisolone to control symptoms. The patient responded favorably and is now being followed up with no signs of long term symptoms. On 17-Oct-2009, the patient was noted to have fever and colds. The temperature was not recorded. As of 19-Oct-2009, the patient continues to have fever and colds and was not able to go to school. The mother will continue to monitor the patient's temperature. The outcome of anaphylactic reaction was recovered while the events of fever and colds are ongoing.
Age: 0.55
Sex: U
Vaccine: FLUN3, FLUN3
Clinical narrative: A non-serious spontaneous report of a six-month old child received FLUMIST was received from a pharmacist. Relevant medical history and concomitant medications were not reported. On 27 Oct 2009, the patient received FLUMIST. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to resolved. This case is submitted in accordance with the manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 0.51
Sex: U
Vaccine: FLUN3, FLUN3
Clinical narrative: A non-serious spontaneous report of a six-month-old received FLUMIST was received from a pharmacist. Relevant medical history and concomitant medications were not reported. On 27-Oct-2009, the patient received FLUMIST.  There was no adverse event associated with this medication error, Therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. This case is submitted in accordance with manufacturer post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Ear pain, Neck pain, Swelling face
Clinical narrative: Mother reported child's face was swollen on left side. Child stated her ear was itchy and her neck hurt.  Mother reported nose, cheek, and eye were swollen and red.  Mother denied child having any other symptoms including trouble breathing, nausea/vomiting, rash, or wheezing.  Mother reported she called their doctor who advised giving Benadryl.  The Benadryl helped the swelling but the swelling returned when the Benadryl wore off.  They were instructed to give Claritin as well by their physician.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Erythema, Eye swelling, Neck pain, Ocular hyperaemia, Pruritus
Clinical narrative: Mother reported child's face was swollen on left side. Child stated her ear was itchy and her neck hurt.  Mother reported nose, cheek, and eye were swollen and red.  Mother denied child having any other symptoms including trouble breathing, nausea/vomiting, rash, or wheezing.  Mother reported she called their doctor who advised giving Benadryl.  The Benadryl helped the swelling but the swelling returned when the Benadryl wore off.  They were instructed to give Claritin as well by their physician.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Swelling face
Clinical narrative: Mother reported child's face was swollen on left side. Child stated her ear was itchy and her neck hurt.  Mother reported nose, cheek, and eye were swollen and red.  Mother denied child having any other symptoms including trouble breathing, nausea/vomiting, rash, or wheezing.  Mother reported she called their doctor who advised giving Benadryl.  The Benadryl helped the swelling but the swelling returned when the Benadryl wore off.  They were instructed to give Claritin as well by their physician.
Age: 52.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pleural effusion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pleural effusion in a 52-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 16 October 2009 at 10:19 the subject received a "standard" dose of FLULAVAL (unknown, right arm). On 16 October 2009, 8 hours after vaccination with FLULAVAL, the subject experienced pleural effusion. This case was assessed as medically serious by GSK. At the time of reporting the pleural effusion was improved. 11/20/09 Medical records received for date 10/22/09. DX: pleural effusion. Presenting SX: c/o pain in posterior back, worse w/ deep breath and cough. was seen recently in past few days in ER w/ dx of pleurisy. Assessment: WNL