chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Muscular weakness, Myalgia, Posture abnormal
Clinical narrative: Bladder infection -> BACTRIM 10/17/10 5 days txt 1 BID. Within 24 hrs. - aching, headache = sick. Went out of town & got very sick. 10-25-10. Blinding headaches in back of head = flame in back of head. Lift head with both hands to lift head. Crippled in legs 10/22 = very sick. 10/23 - really sick. 10/27 called dr. Nov 5th - Dr. - ophthalmologist. 80mg prednisone daily for eyes. Fall on toilet. To put slacks on - had to lift legs with hands. Joints - really bad - after Prednisone by PM - joints improved. Giant cell arimatica = txt. Poly myalgia = txt. Went to office - 10-29 appt. Went to - eye dr. - arteritis (blinding) - 80mg Prednisone ASAP. Biopsy on temporal artery - negative. Within 7% error rate. 75mg/day Prednisone. Rheumatologist - going to see now Dr. continues to treat.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: Itching at injection site - inflamed - c/o itching nose.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itchy in a 5 x 10 cm oral area at site of vaccination.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pruritus, Pruritus generalised, Rash macular, Urticaria
Clinical narrative: Two hours after flu shot was given pt had hives, red blotches, soreness, itchy skin on legs and arms. He itched all over body. Took him to ER. Was given BENADRYL & steroids, sent home. Cont w/ med for 2 days. Cleared.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: 3 inch diameter - red, raised, warm circular area noted after injection. Arm very sore. All lasted 5 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Anxiety, Blood glucose normal, Dyspnoea, Nausea
Clinical narrative: About 10 minutes after vaccination, patient began to complain of abdominal fullness, nausea, shortness of breath, anxiety. No dizziness or chest pain. BP & glucose monitored until EMTs arrived.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye movement disorder, Gaze palsy, Grand mal convulsion, Musculoskeletal stiffness, Presyncope
Clinical narrative: Pt. received Flu shot and then had blood pressure and cholesterol checked after finger stick pt. proceeded to have tonic/clonic seizure eyes rolled back and deviated to the right extremities stiffened (+) tremors approximately 20 sec 2nd seizure approximately 10 sec.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Pt. received Flu shot and then had blood pressure and cholesterol checked after finger stick pt. proceeded to have tonic/clonic seizure eyes rolled back and deviated to the right extremities stiffened (+) tremors approximately 20 sec 2nd seizure approximately 10 sec.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hepatic enzyme increased, Hypoaesthesia facial
Clinical narrative: Numbness of the right side of face, headache on the right side. Right side of face still numb.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Tetanus shot on 11-15-10. Came in today red, round 2 x 2 in diameter spot on right deltoid, warm to touch. Take TYLENOL, compresses, & come back on Monday if still there.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Pt had large area on (R) bicep of induration like hives, vaccine was given in proper place (R) deltoid. Also (L) arm had 4cm area induration at vaccine site.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Eye swelling, Feeling abnormal, Lip swelling, Oedema peripheral, Rash
Clinical narrative: Fine rash on face, back of neck, both hands, inside both arms, swelling of face entirely, eyes, lips, even arms. My body felt swollen. This lasted for two weeks. I administered BENADRYL & felt better.
Age: 64.0
Sex: U
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Fine rash on face, back of neck, both hands, inside both arms, swelling of face entirely, eyes, lips, even arms. My body felt swollen. This lasted for two weeks. I administered BENADRYL & felt better.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Local reaction, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Local reaction - itching following injection, following day progressed to full body hives, 3rd day swelling on hands and eyelids.
Sex: U
Vaccine: FLU3
Symptoms: Haemorrhage, Swelling
Clinical narrative: Swelling, bleeding arm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore upper arm beginning a couple days after vaccination and continuing to present time.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Polyuria
Clinical narrative: Patient experienced chills, shivering, and polyuria starting 6 hours after vaccine was administered. The chills and shivering lasted for one hour.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Induration, Skin warm
Clinical narrative: Pt reports 7 inch x 8 inch red induration hot to touch with red streaking . Temp 101 degrees x 2 days self care of Ibuprofen - TYLENOL then rested without being seen.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Diplopia, Liver function test abnormal, Nuclear magnetic resonance imaging brain normal, Strabismus, VIth nerve paralysis
Clinical narrative: Developed 6th nerve palsy soon after receiving Flu injection. Sudden onset of binocular horizontal double vision. Exotropia Rt eye.
Age: 1.03
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Pt noted to have febrile sz x 2 min < 24 hr after vaccine admin.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Apnoea, Death
Clinical narrative: Pt was a 31 week preemie with hx of NEC D/C from NICU 3 weeks prior to event. He was on O2 NC; ostomy bag; NG feeds on AB monitor 24 hours after vaccination Pt became apneic at home and was pronounced dead at local ER.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Eye swelling, Throat tightness
Clinical narrative: Same day of administration of flu shot went to Urgent Care due to swollen yes, feeling like "throat was closing up" - given steroid injection.
Age: 10.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, swelling, redness.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Impaired work ability, Laryngitis, Lethargy
Clinical narrative: No pain with flu vaccine injection or local reaction. Had flu vaccine last yr (seasonal flu vaccine) without probs on 9/16/09. States has felt chills fatigue, lethargy, laryngitis since seasonal flu vaccine this yr. States trouble staying awake since given. Placed off duty and referred to PCP for further eval and tx.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: No pain with flu vaccine injection or local reaction. Had flu vaccine last yr (seasonal flu vaccine) without probs on 9/16/09. States has felt chills fatigue, lethargy, laryngitis since seasonal flu vaccine this yr. States trouble staying awake since given. Placed off duty and referred to PCP for further eval and tx.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Received DTAP vaccine on 11/17/10 on (L) deltoid. Presents with 13cm x 14cm erythematous area surrounding injection site (L) upper arm with mild induration.
Age: 23.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Pt presented to clinic 11/3/10. Rt deltoid erythematous, inflamed, pt reports pruritis at injection site. Denies any SOB, CP, and or generalized sx's. See pt's chart.
Age: 1.89
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient received 2nd pediatric flu (blended) for the season, during waiting period in clinic patient started developing a rash on chest and abdomen also behind ears & on neck BENADRYL Liq given 5 ml orally.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Nausea, Oedema peripheral, Pain
Clinical narrative: Client noted some mild soreness 11-08-10 evening in area of injection (back of (R) arm). By 8am on 11-09-10 she had an area approx. 3 inches in diameter on back (R) arm that was red, warm, swollen & tender to touch. No soreness or swelling noted in (R) deltoid where Flu vaccine given. Client cannot receive injections in (L) arm. The area increased in size over 11-09-10 and by 11-10-10 arm was (she had husband measure it) 4 inches by 5 inches. Tuesday evening 11-09-10 she did have a temp as high as 101.4 degrees F and did take acetaminophen 3-4 x over next 24 hours to reduce the fever. She also had a headache and ringing in her ears on 11-09-10. On 11-11-10 she felt nauseated but did not vomit and that stopped 11-11-10 evening. She called her MD on 11-10-10, the same morning she called us at the Health Dept. She was not advised to do more than comfort measures (ie ice to area or warm compresses if ice didn't help) or OTC fever reducers. By evening of 11-11-10 reddened, sore, swollen area was decreasing in size. By Sat 11-13-10 the red area was about the size of a quarter but area approx 4 inches or so was still slightly swollen and tender to touch. Did not have fever, nausea, headache or ringing in ears.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm, Tenderness, Tinnitus
Clinical narrative: Client noted some mild soreness 11-08-10 evening in area of injection (back of (R) arm). By 8am on 11-09-10 she had an area approx. 3 inches in diameter on back (R) arm that was red, warm, swollen & tender to touch. No soreness or swelling noted in (R) deltoid where Flu vaccine given. Client cannot receive injections in (L) arm. The area increased in size over 11-09-10 and by 11-10-10 arm was (she had husband measure it) 4 inches by 5 inches. Tuesday evening 11-09-10 she did have a temp as high as 101.4 degrees F and did take acetaminophen 3-4 x over next 24 hours to reduce the fever. She also had a headache and ringing in her ears on 11-09-10. On 11-11-10 she felt nauseated but did not vomit and that stopped 11-11-10 evening. She called her MD on 11-10-10, the same morning she called us at the Health Dept. She was not advised to do more than comfort measures (ie ice to area or warm compresses if ice didn't help) or OTC fever reducers. By evening of 11-11-10 reddened, sore, swollen area was decreasing in size. By Sat 11-13-10 the red area was about the size of a quarter but area approx 4 inches or so was still slightly swollen and tender to touch. Did not have fever, nausea, headache or ringing in ears.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Within 2 hours of PNEUOMVAX injection in right upper arm client couldn't raise her arm due to pain. Within 4 hours she was experiencing chills (took temp - 97 degrees). Went to primary care MD within 7 hours injection & was told that reaction was more severe (by MD per client) as she'd had them close together (1st PNEMUOVAX vac was 10 1/2 yrs ago). MD prescribed a 5 day course of Prednisone medication. Also ice to area. As of 11/22/10 5pm still has arm pain but can move arm in full range of motion. PHN advised another follow-up visit to MD if continues to have (R) arm pain.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain
Clinical narrative: Left shoulder pain - was seen by physician in physical rehab department. Recommended TYLENOL dosing and MRI. Dx probable bursitis due to injection. Elected to delay MRI, hoping symptoms would improve.
Age: 14.0
Sex: M
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Erythema, Limb discomfort, Oedema peripheral
Clinical narrative: 11/19/10 After receiving MENACTRA on (R) arm next day developed arm redness & swelling with discomfort. Came into office 11/22 and was 108 X 60 light red. Seen by Dr who felt no treatment necessary.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Achy, chills, no fever arm sore.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Rash papular
Clinical narrative: Local swelling within 24-30 hour time frame, swollen to size of about 4 inches wide but barely raised, red. Went to ER - given cephalexin, prednisone 60mg qd x 5 d, & SOLU-MEDROL; returned 10/27 & red diffuse papules & given prednisone again.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Cardiac failure congestive, Fatigue, Feeling cold, Headache
Clinical narrative: Day of vaccine pt told family felt cold/tired/h/a. Next day swollen/gray/ "not breathing" hosp with CHF - then went into A-fib.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Peripheral coldness, Respiratory arrest, Skin discolouration
Clinical narrative: Day of vaccine pt told family felt cold/tired/h/a. Next day swollen/gray/ "not breathing" hosp with CHF - then went into A-fib.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Nerve injury, Pain in extremity
Clinical narrative: Received flu shot Sunday, November 7th. Says it is very painful & she cannot move her arm. Claims she has nerve damage. Has not seen a doctor yet. Has no insurance.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: REDNESS AND SWELLING AT INJECTION SITE AND SURROUNDING AROUND ARM, UP TO SHOULDER (RIGHT ARM), PAINFUL
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Muscle disorder, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Complained of pain & discomfort to left deltoid muscle greater than 1 month post Tdap vaccination. 10/13/2010: Was seen in Employee Health by Dr. 10/14/2010: MRI was done. Referred to Orthopedic Center for consult and treatment. 10/22/2010: Dr. diagnosed employee: rotator cuff tendinits of left shoulder, probably underlying exacerbated by the injection with subsequent shoulder pain and limited function. 11/01/2010: Employee was treated with Depo-Medrol injections. Recommended Physical therapy. Still ongoing treatment.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Rotator cuff syndrome
Clinical narrative: Complained of pain & discomfort to left deltoid muscle greater than 1 month post Tdap vaccination. 10/13/2010: Was seen in Employee Health by Dr. 10/14/2010: MRI was done. Referred to Orthopedic Center for consult and treatment. 10/22/2010: Dr. diagnosed employee: rotator cuff tendinits of left shoulder, probably underlying exacerbated by the injection with subsequent shoulder pain and limited function. 11/01/2010: Employee was treated with Depo-Medrol injections. Recommended Physical therapy. Still ongoing treatment.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pallor, Pyrexia, Vomiting
Clinical narrative: Fever of 102 degrees, severe vomiting, chills, paleness, body aching until 5:00 AM
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Convulsion
Clinical narrative: It was reported to us that the day after she got her routine vaccination that she had a seizure and went to the emergency room. No fever @ the time of/or after seizure. On 11/18 she had 2 more seizures and was hospitalized for them and is now on medication for the seizures.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Convulsion, Headache, Lumbar puncture normal, Neck pain
Clinical narrative: FLU VACC + BENADRYL 50 MG --> SEVERE NECK PAIN & HEADACHE, FREQUENT SEIZURES X 2.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: FLU VACC + BENADRYL 50 MG --> SEVERE NECK PAIN & HEADACHE, FREQUENT SEIZURES X 2.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Ultrasound scan normal
Clinical narrative: Patient claimed she received the pneumovax vaccine at approx. 9 AM and an hour later she began to have swelling, erythema, and pain (9/10) in upper right arm where the vaccine was given.  Patient was treated with percocet (5/325 mg) for the pain until ultrasounds came back negative for cellulitis.  She was discharged home with instructions for using ice and elevation.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Disease recurrence, Pruritus, Pyrexia, Rash pustular, Varicella
Clinical narrative: He received the Varicella vaccine in 2002 and contracted full Chicken Pox in 2008 and again on 11/22/10 (milder case than first case)...Fever, pustules, and itching present in both cases.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pain, Rash
Clinical narrative: Pain and rash. Pt parent adviced by doctor to give acetaminophen.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Multiple pruritic, erythematous patches lasting ~24 hours.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Injection site inflammed, red, warm and painful.  Size: 70mm x 50mm.  Delayed reaction, patient only noticed on the morning of report.  Hydrocortisone cream applied to area.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash erythematous, Skin warm
Clinical narrative: 50 cent size red spot the first day then baseball size redness the next day still warm to touch
Age: 12.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Swelling, Urticaria
Clinical narrative: HIVES WITH SWELLING
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Severe pain and swelling in arm for a 1 week period
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Diplopia, Headache, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: 11/03/10 Headache, 11/07/10 nausea, vomiting, diarrhea. 11/08/10 numbness of left side of face, left hand, stiff neck. 11/20/10 seeing double. 11/23/10 papillo edema diagnosed per optometrist. Seen by PCP, referred to ER. Transferred to Hospital for neuro consult.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Nausea, Papilloedema, Vomiting
Clinical narrative: 11/03/10 Headache, 11/07/10 nausea, vomiting, diarrhea. 11/08/10 numbness of left side of face, left hand, stiff neck. 11/20/10 seeing double. 11/23/10 papillo edema diagnosed per optometrist. Seen by PCP, referred to ER. Transferred to Hospital for neuro consult.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Mass, Pain
Clinical narrative: Painful lump was noted by patient. When seen by provider on 11/23/2010 she had a quarter sized area of induration and slight erythema at the site of injection
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: The day after the injection, patient noticed red area on arm. About 3/4 inch in diameter, it looked like a scab had been scratched off. I saw the area today, it is smaller (about 1/2 inch) and red around edge. It does not look infected and no drainage. Patient has been applying neosporin and will continue to do so.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Feeling abnormal
Clinical narrative: Approx. 15 min after receiving flu vaccine c/o feeling funny, shortness of breath and cough. Went to ER @ 7PM. Received oxygen and was given RX for home nebulizer.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt began vomiting 8 hrs after shots and had fever (not taken). Vomited 15 times. Had headache. Was seen by MD on 11/12. No stiff neck. Temp 99.2. Zofran was given for nausea.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Disease prodromal stage
Clinical narrative: Pt developed vesicles approx 6 days following vaccination with varicella, along with viral prodrome. Symptomatic care.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Child developed hives all over body appox 3 minutes post vaccine. Epi 0.3 given IM at 10:45 AM 911 called 10:46 AM Pt transported to hospital. No resp distress present.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Mononucleosis heterophile test, Pain
Clinical narrative: Body aches, chills, some trouble breathing early on.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at site of injection
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Fall, Pallor
Clinical narrative: Vaccine admininstered at 8:50 AM at school based flu clinic; At 9:10 AM patient was in computer class and fell off off her chair onto her stomach and involuntary movements for less than a minute.  She immediately sat up on her knees and was oriented but very pale.  Pulse was regular and 72, mother was called.  Pulse checked several times and no change. No injuries noted. No complaints of pain. Color returned. Mother arrived and took patient to doctor's office.  Nurse called mother at 3:15 PM and found child feeling well.  Nurse had left the room at 9:35 AM after child denied dizziness or any problems.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Muscle spasms, Ultrasound scan normal, Vaginal haemorrhage
Clinical narrative: Just a few hours after getting the shot, I started bleeding vaginally, NOT spotting. An ultrasound on Wednesday, Nov. 17, showed a strong heartbeat. Bleeding became more severe. Cramping began on Nov. 19, 2010. I miscarried at 3:15 on Friday, Nov. 19.   I had had no spotting or other signs of a miscarriage before getting the shot
Age: 18.0
Sex: M
Vaccine: FLUN3, HEP, HPV4, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: When patient got home from clinic notice red bumps. Returned to clinic with hives to lips, face, chest, back, and legs. Patient monitored and given Benadryl.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Chills, Cough, Headache, Pyrexia, Sinus congestion
Clinical narrative: Strong uncontrollable cough, chills, headache, sneezing, sinus congestion and low fever
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Sneezing
Clinical narrative: Strong uncontrollable cough, chills, headache, sneezing, sinus congestion and low fever
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Dysphonia, Oropharyngeal pain
Clinical narrative: Hoarseness, sore throat, hacking cough, difficulty swallowing.
Age: 52.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe chill, headache, fever, body ache and tiredness.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The guest reported the incident to me on Saturday, November 20, 2010 in the afternooon. Per the guest the itchy and redness on her right arm started Tuesday evening of the next day. I requested her to come into the pharmacy and advised her to take some Benadryl. When she came into the pharmacy Saturday afternoon, I observed the injection site to be red and the size of 1.5mm in diameter. The immediate area was clear but the two areas where the adhesive of the band-aid was applied were very red and slightly raised. The red areas made an outline of the two adhesive areas of the band-aid. She complined of it being itchy since Tuesday night but waited to Saturday to call but she did apply some old steroid cream on it. She mentioned that this was the first time in receiving a flu shot where she had this type of reaction. The denied having received the H1N1 last year. The vaccine administered contained the H1N1 with the Flu vaccine. I gave her some Benadryl topical gel and hydrocortisone cream since her old cream had expired over 3 years ago.
Age: 59.0
Sex: F
Vaccine: HEPA, MEN, TDAP, YF
Symptoms: Pruritus, Rash macular, Skin discolouration
Clinical narrative: 10/19 8pm Red blotches appeared over entire body - very itchy, skin turned purple till 10/24.  I took oral BENADRYL 25 mg every 2 hours. 10/21 11AM MD administered CALDRONE shot. 10/26 rash gone mostly. 11/15 still some rash.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram, Electrocardiogram, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Numbness feet with progression - intubated - Guillain-Barre - unable to manage secretions.  11/23/10 patient currently admitted to ICU.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Incontinence, Intensive care, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Numbness feet with progression - intubated - Guillain-Barre - unable to manage secretions.  11/23/10 patient currently admitted to ICU.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, PNC13
Symptoms: Blood glucose normal, Febrile convulsion, Full blood count normal, Urine analysis normal
Clinical narrative: Had febrile seizure approximately 12 hrs after vaccines. Temp 104. Seizure lasted 15 mins. Went to ER - normal labs. Seen 11/23/10 normal exam.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Fall, Gait disturbance, Injection site haemorrhage, Skin laceration, Tooth injury
Clinical narrative: Pt was standing in waiting room a few min after vaccine was administered. She took gauze off the injection site. Cried out "Oh blood!" - staggered across waiting room and fell into window ledge. Cutting forehead & knocked out tooth.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Muscular weakness, Speech disorder
Clinical narrative: After vaccine, pt had mental confusion, felt unsafe to drive, had difficulty speaking x 6 hours. Leg weakness x 4 hours.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, FLU3, MMR, PNC13
Symptoms: Conjunctivitis, Measles, Pyrexia, Rash morbilliform
Clinical narrative: Flaccid Morbilliform rash, conjunctivitis, fever, consistent with measles - onset 12 d after MMR.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Local rxn 9 1/2-11 1/2 cm erythema surrounding injection site (L) upper arm slight warmth to touch.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site papule, Rash
Clinical narrative: 1 day after IZ (MMR, Varicella, Hep A, PREVNAR) localized reaction - red, papular on both thighs; nl colored, fine rash face, abdomen, back 9 days after IZ: fine rash changed to dark red, papular 10 d after IZ.
Age: 66.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Activities of daily living impaired, Arthralgia, Discomfort, Injection site pain, Injection site swelling
Clinical narrative: Sore arm at injection site with 4 x 6 inch swollen a day after TDAP injection, one week later both knee joint sore & discomfort then left hand with same symptoms. Not able to do daily exercise: still has discomfort now.
Age: 66.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Pain in extremity
Clinical narrative: Sore arm at injection site with 4 x 6 inch swollen a day after TDAP injection, one week later both knee joint sore & discomfort then left hand with same symptoms. Not able to do daily exercise: still has discomfort now.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Patient developed fever with temperature to 102.5 24 hours after injection persisting another 24 hours. Localized swelling/redness 8 x 10 cm.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blister, Injection site vesicles
Clinical narrative: Patient seen on 11/10/10 noted for 1 day of clear fluid filled vesicles bilaterally on posterior arms and few scattered on upper thighs. Lesions not pruritic. Patient with no history of fever = normal activity. No ill contacts.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody, Arthralgia, Full blood count, Injection site pain, Pain in extremity
Clinical narrative: Pain to (L) shoulder, arm, wrist pain to (L) hip, thigh.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Pain to (L) shoulder, arm, wrist pain to (L) hip, thigh.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Pyrexia, Rash macular
Clinical narrative: Fever to 104 degrees shrill cry macular rash body.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Local reaction
Clinical narrative: Patient had a local reaction after her flu shot. The area where she got the shot became red and warm to the touch. She wasn't sure if she had a fever. She said she had a bump where she got the shot. This bump became smaller over time. She felt better after 3 days.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Chills, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: 11/20 -> Patient woke up feeling like legs were very weak & stiff. He could not walk and had chills throughout the day. 11/21 -> Patient contemplated on visiting the ER. If he stood up he felt like he needed to keep moving.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse result from FLUMIST administered 10/14/2010 & 10/22/10.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness, heat, swelling from upper arm to elbow. CIRPO, BENADRYL; Loratadine.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Headache, Swelling face, Urticaria
Clinical narrative: Headache, chest pain = tightness, facial swelling. Hives (head and knees only).
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia
Clinical narrative: The evening after receiving vaccine mom states pt. would not nap or sleep through the night for four days. The most she would sleep was 30 min. at a time, had insomnia. Otherwise well, no symptoms.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Left arm shoulder pain.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: "Pain in left arm/shoulder since receiving flu shot in left upper arm. Pain increases with some activities such as putting on bra or t-shirts, and hanging up clothes".
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: "I got the flu shot and after my arm is in pain".
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthrogram normal, Drug administered at inappropriate site, Musculoskeletal pain, Nuclear magnetic resonance imaging normal
Clinical narrative: "Nurse gave flu shot very upper arm at the shoulder joint".
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: "I received the flu shot in my upper right arm on Oct 6th and I'm still have muscle pain around injection site more than a month later."
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: "Getting flu vaccine".
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Dysphonia, Dyspnoea, Nasal congestion, Oedema mouth
Clinical narrative: "At approx 3:00 PM noted increased shortness of breath, hoarse voice, nasal congestion, swelling of the soft palate, itching/burning sensation on the lips, mouth & throat. HX of angioedema with unknown cause".
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Oral discomfort, Oral pruritus, Throat irritation
Clinical narrative: "At approx 3:00 PM noted increased shortness of breath, hoarse voice, nasal congestion, swelling of the soft palate, itching/burning sensation on the lips, mouth & throat. HX of angioedema with unknown cause".
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: "Shot given, while going in burned and pain at site, has continued to have pain and hurts to raise arm".
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Weak, pain in the neck pain and numbness in the arm following the shot.
Age: 0.85
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Skin lesion, Streptococcus test, Streptococcus test positive, Urticaria
Clinical narrative: Several hours after flu vaccine was given, developed multiple pruritic urticarial lesions - generalized - face - extremities trunk.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vaccine positive rechallenge
Clinical narrative: Felt dizzy and nauseated 10-15 minutes after receiving the influenza vaccine. Had the same sensation 10 yrs ago upon receiving influenza vaccination. Received H1N1 vaccination 2009 without adverse reaction. Brought to ER and discharged home.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Sensation of heaviness
Clinical narrative: "Went to get flu injection, given in LD, did not have any discomfort or pain the day of the injection. The morning after the injection my arm started to have a heavy feeling (which did not both me) by the evening my left shoulder joint was painful... It is with certain articulation of the joint that prompts the pain".
Age: 1.15
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Mom called advice nurse on 11/5/10 to report child had hives on both thighs and back following her flu shot on 11/2/10. On call doctor called, advised to give child 1 tsp of BENADRYL. Mother brought child in for well check appt. with Dr. on 11/19/10 and showed him pictures on her cell phone.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: "I received my flu shot this morning, went home & went to sleep. As expected when I woke my arm was very stiff and hurt to move it. After 3 days of it hurting I started to think it was not just the non-movement of my arm after the shot. The pain was starting in my upper arm & shooting down my bicep to my elbow & causing problems in my wrist.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient's upper arm still hurting 7 1/2 weeks after injection.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Right shoulder pain - received flu shot.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Allergy test, Urticaria
Clinical narrative: Pt. was given DTAP & Influenza, woke up with hives all over. No difficulty breathing, Skin - extensive hives all over. No significant local reaction at vaccine sites.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Throbbing pain in upper arm, from site of injection to elbow area for approx 4 hours.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain, Rash, Skin warm
Clinical narrative: Rash on arm and reaching back - warm patch - pain & difficulty moving arm.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pt noted - "A lot of pressure during administration of flu shot in upper L arm - followed by immediate pain that worsened. Unable to lift (L) arm on 11-14-10, MD vs on 11-15-10. Unable to do ROM - grinding clicking sound upon movement. Ibuprofen, VICODIN.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Tendonitis
Clinical narrative: Pt noted - "A lot of pressure during administration of flu shot in upper L arm - followed by immediate pain that worsened. Unable to lift (L) arm on 11-14-10, MD vs on 11-15-10. Unable to do ROM - grinding clicking sound upon movement. Ibuprofen, VICODIN.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Persistent pain at site and persisting over (4 wks) time. Sharp pain worsened by movement. No redness. No fever. No chills.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Complains of very sore arm for 4 days after shot. States that she has had a constant headache since. Notes also been dizzy sporadically off and on since then.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Amnesia, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: Pt. came in for 3rd injection & stated that her last injection she felt dizzy, "not herself", she could not remember that day. She felt confused, SOB? all day - did not call MD or go to ER. No treatment was given.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Back pain, Body temperature increased
Clinical narrative: Back pain, temp in 101.4.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture negative, CSF test normal, Chest X-ray normal, Culture urine negative, Full blood count normal
Clinical narrative: Patient had mild URI symptoms, no fever, at time of immunizations at 3:15 pm on 11/19/10. That evening he developed high fever up to 105.6 - documented by parents, Went to ER. At 1 AM on 11/20/10 temp = 103. 1. Septic work-up done, including blood tests, urine, CSF exam, C X-ray all neg. Within 24h fever resolved. Pt back to normal except URI. No meds except for fever med (TYLENOL).
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Influenza virus test negative, Pyrexia
Clinical narrative: Patient had mild URI symptoms, no fever, at time of immunizations at 3:15 pm on 11/19/10. That evening he developed high fever up to 105.6 - documented by parents, Went to ER. At 1 AM on 11/20/10 temp = 103. 1. Septic work-up done, including blood tests, urine, CSF exam, C X-ray all neg. Within 24h fever resolved. Pt back to normal except URI. No meds except for fever med (TYLENOL).
Age: 0.36
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt. was given a TDAP injection instead of DTAP.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, VARCEL
Symptoms: Bacterial infection, Blister, Erythema, Rash
Clinical narrative: Received varicella vaccine 11/8 3d had fever 1-2 wks later eruption of vesicle sl patch of redness poss shingles. She previously has had other vaccines without side effects/similar occurrence.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: MENACTRA given in right deltoid. Arm was red & hot. It covered from 1" below elbow up to neck (At the time public health nurse saw it). Mother said it had been slightly worse but couldn't describe how. Saw PA at Drs office & put on steroid for 6 days. Had also been taking BENADRYL.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, swelling, pain at vaccine site, fever 101-103.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chills, Decreased appetite, Flatulence, Musculoskeletal discomfort
Clinical narrative: Vaccination rec. 11/13/2010 at 3:30 PM pt experienced muscle & joint discomfort, itchy & painful skin all over. Gastrointestinal complaints gas etc. Had chills unknown if there was fever, did not feel like eating until 11/14/10 in evening.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain of skin, Pruritus
Clinical narrative: Vaccination rec. 11/13/2010 at 3:30 PM pt experienced muscle & joint discomfort, itchy & painful skin all over. Gastrointestinal complaints gas etc. Had chills unknown if there was fever, did not feel like eating until 11/14/10 in evening.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: Sore (L) arm w/redness (site of injection) and inability to move same arm in all directions per pt. Patient not seen that day by me because I was out.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Condition aggravated, Macular degeneration, Vision blurred
Clinical narrative: About 18 hours after his PNEUMOVAX he had blurry vision. He has macular eye disease at baseline but it got acutely worse.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Hallucinations, mixed
Clinical narrative: On July 16th, 2010 my daughter (11 yrs old) received a booster shot of some kind named: ADACEL that I never gave my consent or never signed anything to my child to get this shot. This was a shot 7th grade students were supposed to get. My child is a 6th grader! My 11 yr old would have hallucinations, seeing & talking to spirits, anxiety attacks, went to 2  hospitals since school started. The first incident was Sep. 8-Sep. 13 she was admitted in a hospital. The second was Oct. 8th-Oct.15 2010.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Intensive care, Loss of consciousness
Clinical narrative: After my daughter got the shot she started having seizures, passing out and was finally hospitalized and put in the intensive care unit. She had over fifty seizures in four days. She is still having a lot of problems.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient got PNEUMOVAX 11/16/2010 & came to the office 11/18/10 with cellulitis well below site.
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Local swelling, Oedema peripheral, Pruritus, Throat irritation
Clinical narrative: Initial report received from a nurse on 18 Dec 2009: This patient received FLUVIRIN on 16 Dec 2009. The patient experienced itching and swelling on both arms and trunk and later had face and throat itching on 16 Dec 2009. The patient was treated in emergency room but not admitted. The outcome of the event was reported as recovered.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Initial report received from a health care professional on 23 Dec 2009: This patient was vaccinated with FLUVIRIN on an unknown date. On an unspecified date post vaccination the patient experienced acute disseminating encephalomyelitis. The patient outcome was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Allergy to vaccine, Heart rate increased, Hypoaesthesia
Clinical narrative: Case previously recorded as MA2009-3022. We received the following information via our legal contractor on 15 OCT 2009: A male patient was vaccinated in a pharmacy with influenza vaccine (manufacturer or batch no. unknown) on an unspecified date. The patient had an allergic reaction to the flu shot. He experienced numbness in his left arm and an increased heart rate. The pharmacist on duty administered an epipen shot. The paramedics were called and the patient was transported to the hospital. Interval between vaccination and onset of the symptoms or outcome is unknown. Addendum: Despite requests on 04 OCT 2009 and 21 OCT 2009 we did not receive any further information. No change in assessment.
Age: 90.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Gait disturbance, Rash generalised
Clinical narrative: Case previously recorded as MA2009-4452.  Initial case report received from a consumer source via MedCom on 19 NOV 2009.  A 90 year old male was vaccinated i.m. for the first time with SOIV FLUVIRIN (H1N1 influenza virus vaccine, batch no. Not provided) on 14-NOV-2009.  On 18 NOV 2009, he saw a physician who prescribed Benadryl to treat a rash all over his body.  On the morning of 19 NOV 2009, the patient experienced difficulty walking and weakness.  At the time of this report, the patient was being transported by ambulance to his local hospital.  The outcome was reported as ongoing.  On a case level, the case is considered expected.  No change in risk benefit ratio.  MedCom reference no : NA09-008534.
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blister, Injection site pain, Injection site vesicles, Neuralgia, Pain
Clinical narrative: Case previously recorded as MA2009-4529.  Initial case report received from a rheumatologist via MedCom US, on 19 Nov 2009.  A 69 year old male was vaccinated i.m. for the first time with S-OIV FLUVARIN (H1N1 influenza virus vaccine, batch no 1073696P) on 09 NOV 2009.  On 12 NOV 2009, the injection site became painful and the pain worsened as time passed.  On 16 NOV 2009, herpetic like painful blisters appeared near the injection site and spread on his arm.  The patient later experienced neuritic like pain in the same arm, and the pain continued on 19 NOV 2009.  The patient sought medical attention but no information was provided.  These events were reported as neuralgia, injection site reaction and injection site vesicles.  The patient's outcome was not recovered.  MedCom US reference no.: NA09-008573
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Case previously recorded as MA2009-4844. Initial case report received from a pharmacist via Novartis on 24 NOV 2009. A 58-year-old male patient was vaccinated with FLUVIRIN (batch no. 101716P1A) i.m. on 21 NOV 2009. The patient experienced dizziness following the shot flu and blood pressure slightly increased. The patient had recovered on 21 NOV 2009. MedCom reference no.: NA09-008751.
Age: 69.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Borrelia test negative, Hypoaesthesia facial, Nuclear magnetic resonance imaging brain normal, VIIth nerve paralysis
Clinical narrative: Initial report received from a physician on 05 Jan 2010: On 13 Nov 2009, the patient was vaccinated with Influenza A H1N1 (batch # 102045P1). Four days later, on 17 Nov 2009, the patient experienced right facial nerve palsy (Bell's palsy). On 18 Nov 2009, the patient met his primary care physician, and he was started on VALTREX and CEFTIN (details unspecified). However, the patient had no Zoster lesions and no other signs or symptoms of Lyme disease (the patient lives in an area where Lyme disease is relatively common). Blood tests for Lyme disease were negative. On an unspecified date, the patient was referred to a neurologist. On an unreported date the patient underwent a brain MR and was found to be negative. The outcome of the event was reported as no significant improvement in the condition. The causality of the event was not reported. Follow up received from physician on 02 Mar 2010: This polymedicated patient had medical history of diabetes mellitus, increased cholesterol and seasonal rhinitis, received influenza virus vaccine on 13 Nov 2009. On 17 Nov 2009, the patient experienced facial numbness and contacted the reporting physician with Bell's palsy on 18 Nov 2009. The outcome of the event was reported as dense Facial palsy present.
Age: 87.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Convulsion, Electroencephalogram normal, Intensive care, Mechanical ventilation, Mental status changes
Clinical narrative: Initial report received from a healthcare professional on 15 Jan 2010: This polymedicated patient had a medical history of type II diabetes, hypertension (HTN), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), gastro-esophageal reflux disease (GERD), hyperlipidemia, anemia, Parkinson's disease, gout, renal insufficiency and psoriasis. The patient had received influenza vaccine in past season without any adverse event. The patient vaccinated with FLUVIRIN  (lot number: 102132P1) on 13 Jan 2010. Following FLUVIRIN administration, the patient experienced a seizure, with a latency of 4 hours and hospitalized. The patient had no history of seizure or epilepsy. An electro-encephalogram (EEG)  after the seizure showed no epileptic activity. The patient was on a ventilator in the intensive care unit and was treated with antiepileptic medications and antibiotics because of possible aspiration during the seizure. The patient was sedated and did not return to baseline mental status since the seizure. Outcome of the events was reported as condition unchanged. Follow up report received on 23 Apr 2010: Two requests for follow-up information were sent on 09 Feb 2010 and 29 Mar 2010 respectively, but no reply had been received. Hence the case was closed due to the lack of response.