chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: (R) deltoid with induration.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Biopsy muscle abnormal, Blood creatine phosphokinase increased, Central nervous system lesion, Disturbance in social behaviour, Eye movement disorder
Clinical narrative: Decrease in developmental milestones, hypotonic w/ no head support, not smiling, not tracking w/ eyes, more sleepy and irritable.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Irritability, Myofascitis, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Decrease in developmental milestones, hypotonic w/ no head support, not smiling, not tracking w/ eyes, more sleepy and irritable.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Childhood disintegrative disorder, Emotional disorder, Hypotonia, Irritability, Posture abnormal
Clinical narrative: Decrease in developmental milestones, hypotonic w/ no head support, not smiling, not tracking w/ eyes, more sleepy and irritable.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Somnolence, Visual impairment
Clinical narrative: Decrease in developmental milestones, hypotonic w/ no head support, not smiling, not tracking w/ eyes, more sleepy and irritable.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: Shortness of breath and then chest pain in the center of the chest.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Induration, Oedema peripheral, Pruritus, Rash
Clinical narrative: Arm is swollen; there's a 6"x4" rash on arm.  Area is swollen, hard to the touch and itches incessantly.  Calamine or Aveeno lotion does not abate the itching.  Showed area to local pharmacist who advised to take Benadryl since reaction was internal. Rash, swelling, itch and hardness still very apparent today, 07/21/2010.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Rash papular
Clinical narrative: Pt developed erythematous papules on soles of feet & palms of hands within minutes of receiving PREVNAR vaccine - resolved with IM BENADRYL.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Dry mouth, Dysphagia, Erythema, Local reaction, Swelling
Clinical narrative: Local reaction of left shoulder. 2 inches red and swelling in 24 hours. Dry mouth with swallow problem next day. Pt went to ER and given Prednisone/BENADRYL and PEPCID.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Grandmother noticed redness and swelling of (L) arm several hours after injection. Pt was given TYLENOL and ice on site for discomfort. Pt con't to c/o pain in (L) arm. Encouraged MD evaluation.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Irritability, Pain in extremity, Pyrexia, Rash, Rash papular
Clinical narrative: Fever began day after the vaccine and lasted for 4 days, maximum temp 102.8.  Rash started 4 days after vaccine and still persists.  Irritability, sore legs, but no obvious arthritis.  Mild facial puffiness 6 days after vaccine but no other allergy signs.  Rash is fine pink papules on the trunk and upper legs, not urticaria or petichiae. Rash does not include palm and soles.  No daycare exposure and family members all well presently.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Swelling face
Clinical narrative: Fever began day after the vaccine and lasted for 4 days, maximum temp 102.8.  Rash started 4 days after vaccine and still persists.  Irritability, sore legs, but no obvious arthritis.  Mild facial puffiness 6 days after vaccine but no other allergy signs.  Rash is fine pink papules on the trunk and upper legs, not urticaria or petichiae. Rash does not include palm and soles.  No daycare exposure and family members all well presently.
Age: 1.39
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: DTAP given x2 within 1 week. 4-28-10 5-7-10.
Age: 0.77
Sex: F
Vaccine: DTAP
Symptoms: Nystagmus
Clinical narrative: Vertical nystagmus for approx. 5-10 seconds.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Irritability, Vomiting
Clinical narrative: IRRITABLE, VOMITING, LOW GRADE TEMP, WENT TO ER AND NEEDED IV FLUIDS
Age: 3.0
Sex: M
Vaccine: MMR, PPV
Symptoms: Fatigue, Listless, Pyrexia
Clinical narrative: High fever (102.2 F underarm temp), listlessness/fatigue, administered fever reducing pain killer.
Age: 12.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Redness sl swelling at injection site 4-5cm; local rxn only.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dyskinesia, Fall, Head injury, Syncope
Clinical narrative: Initial report received from a nurse on 15 Jul 2010: This patient was vaccinated with MENVEO (batch number: unknown) on an unspecified date. The patient concomitantly received HEPATITIS A vaccine (manufacturer unknown; therefore conservatively considered as HAVPUR INN). The patient experienced syncope associated with "seizure like movements". The patient fell and head struck. The patient was admitted to hospital on an unknown date. The outcome of the events was not reported.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Wound
Clinical narrative: "11 x 10 cm indurated erythematous swelling of Rt. upper arm. Small puncture wound visible-no fluctuance or oozing" (Per provider note).
Age: 1.05
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Elevated temp of 105 on 07/16/10, 07/17/10, 07/18/10, 07/19/10 and 07/20/10.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient complained of itching, redness, swelling around the injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain, Pruritus generalised
Clinical narrative: Severe overall itching and front and back torso pain. It was painful when she put covers on in bed. Patient took po Benadryl 25mg at noon and at 6PM on 07/18/2010. Pain gone on 7/19/2010 and itching relieved 80%. As of 7/20/2010, itching was totally gone.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: I am unsure of the exact time of onset. Husband received vaccine to prevent shingles, wife immediately thereafter developed shingles.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Left arm below injection site became swollen, red, warm to touch, tender.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Blood gases, Computerised tomogram, Echocardiogram, Electrocardiogram, Full blood count
Clinical narrative: 32 y/o patient approximately 1 Mar 10. Myopericarditis. Airlifted out of the country. Tx 18 days at medical center.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Myopericarditis, Nuclear magnetic resonance imaging
Clinical narrative: 32 y/o patient approximately 1 Mar 10. Myopericarditis. Airlifted out of the country. Tx 18 days at medical center.
Age: 62.0
Sex: U
Vaccine: FLUX
Symptoms: Burning sensation, Pain, Pruritus, Rash papular, Urticaria
Clinical narrative: Flu shot given at work Oct. 2009. Started itching one week later, saw doctor Nov 14, 2009. Lots of different medicine. Broke out with hives, still under doctors care. Nothing is working, I am devastated. I am writing because I broke out with hives: one week after taking a free regular flu vaccine at work. I have never had hives before in my life. No one in my family have never had hives. I had the shot in October of 2009. I don't remember the exact date, but I think it was between October 22nd thru October 27th. One week later I started to itch really bad. I went to the pharmacy to get something for the itching. I told him what had happen. He said I could have a reaction from that flu shot. I kept itching, the second week the red bumps came everywhere on my body. Face, legs, arms, stomach, neck. I am still getting them nothing is working. I went to see my primary doctor after three weeks because I was trying to take what the pharmacist suggested to take. Around November 14, 2009, I went to see my doctor. I told - him what happened. He said I got an allergy from something, he said it was hives. He told me to take BENADRYL, but it didn't help. November 18, 2009 I went to the Emergency Room, they said something got in my system and gave me hives, I got prescription for it, BENADRYL. I have been to the emergency room on 3 different times, I have seen 2 different allergists, I am now having acupuncture for it. I am tired of suffering from this hives. It won't go away. It only came on me a week after I took that flu shot in October 2009 at work. I am still under the doctors care. This is a list of medicines doctors have me taking but nothing works. Please send me the correct form to fill out for a claim if this one I am sending is not the correct one. See list of medicines given to me by different doctors for this hives, on next page.  This break out from hives is very painful, burning and itching. It is strange that I got this break out and hives after I took the flu vaccine. ALLEGRA, CLARINEX, CLARITIN, ZYRTEC, BENADRYL, prednisone, fluocinonide cream, PEPCID AC, hydroxyzine HCL, cortisone creams, herbal medicine - from acupuncture. I am still under doctors care. You can contact me. Please leave a message if I am at work. This is my home telephone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 10 x 13cm area of redness and warmth but no signs of infections.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Dizziness, Pallor, Trendelenburg position
Clinical narrative: After client complained feeling lightheaded approx 3 min after receiving vaccines. Client became pale - did not lose consciousness. Client placed in Trendlenberg position and ice pack applied to forehead. Client offered apple juice and consumed by client. Client monitored 15 minutes and discharged from clinic ambulatory to home with mother.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Dizziness, Pallor, Trendelenburg position
Clinical narrative: Client complained of feeling lightheaded approx. 3 min after receiving vaccines.  Client became pale - did not lose consciousness.  Client placed in Trendlenberg position and ice pack applied to forehead.  Client offered apple juice and consumed by client.  Client monitored 15 min and discharged from clinic ambulatory to home with mother.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Pallor, Trendelenburg position
Clinical narrative: Approximately 3 minutes after receiving vaccine, client complained of feeling light headed and was pale. He was assisted into Trendelenberg position. Ice pack placed on forehead, apple juice offered and consumed by client. Did not lose consciousness. Monitored thirty minutes and discharged home-ambulatory.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash
Clinical narrative: Approximately 3 minutes after receiving vaccine, client complained of feeling light headed and was pale. He was assisted into Trendelenberg position. Ice pack placed on forehead, apple juice offered and consumed by client. Did not lose consciousness. Monitored thirty minutes and discharged home-ambulatory.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Injection site rash, Pallor, Trendelenburg position
Clinical narrative: Approximately 3 minutes after receiving vaccine, client complained of feeling light headed and was pale. He was assisted into Trendelenberg position. Ice pack placed on forehead, apple juice offered and consumed by client. Did not lose consciousness. Monitored thirty minutes and discharged home-ambulatory.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Pallor, Trendelenburg position
Clinical narrative: Mom called at around 4:00 pm 7/16/10. States she picked her son up from sitter and he has 3" long by 2" wide rash about 1" below where MCV4-P was given 7/15/10. No other complaint states rash has been there several hours.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash
Clinical narrative: Mom called at around 4:00 pm 7/16/10. States she picked her son up from sitter and he has 3" long by 2" wide rash about 1" below where MCV4-P was given 7/15/10. No other complaint states rash has been there several hours.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Injection site rash, Pallor, Trendelenburg position
Clinical narrative: Mom called at around 4:00 pm 7/16/10. States she picked her son up from sitter and he has 3" long by 2" wide rash about 1" below where MCV4-P was given 7/15/10. No other complaint states rash has been there several hours.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Pallor, Trendelenburg position
Clinical narrative: Approximately 3 min after receiving vaccines, client complained of feeling light headed and was pale.  He was assisted into Trendelenberg position.  Ice pack placed on forehead, apple juice offered and consumed by client.  Did not lose consciousness.  Monitored 30 min and discharged home - ambulatory.  Mom called at about 4:00 PM 7/16/10.  States she picked her son up from sitter and he has a 3" long by 2" wide rash about 1" below where MCV4 was given 7/15.  No other complaints.  States rash has been there several hours.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash
Clinical narrative: Approximately 3 min after receiving vaccines, client complained of feeling light headed and was pale.  He was assisted into Trendelenberg position.  Ice pack placed on forehead, apple juice offered and consumed by client.  Did not lose consciousness.  Monitored 30 min and discharged home - ambulatory.  Mom called at about 4:00 PM 7/16/10.  States she picked her son up from sitter and he has a 3" long by 2" wide rash about 1" below where MCV4 was given 7/15.  No other complaints.  States rash has been there several hours.
Age: 10.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Dizziness, Injection site rash, Pallor, Trendelenburg position
Clinical narrative: Approximately 3 min after receiving vaccines, client complained of feeling light headed and was pale.  He was assisted into Trendelenberg position.  Ice pack placed on forehead, apple juice offered and consumed by client.  Did not lose consciousness.  Monitored 30 min and discharged home - ambulatory.  Mom called at about 4:00 PM 7/16/10.  States she picked her son up from sitter and he has a 3" long by 2" wide rash about 1" below where MCV4 was given 7/15.  No other complaints.  States rash has been there several hours.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site erythema, Injection site joint movement impairment, Injection site pain, Injection site swelling
Clinical narrative: On morning of Sept 30, 2006 patient had extreme soreness, redness, swelling and a feeling of warmth in area of left shoulder where shot was given. Patient had hardly any strength in left hand or arm & was unable to move left arm much at all patient felt sick & had chill which lessen in time patient has some movement in arm but not normal capacity now.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Malaise, Muscular weakness
Clinical narrative: On morning of Sept 30, 2006 patient had extreme soreness, redness, swelling and a feeling of warmth in area of left shoulder where shot was given. Patient had hardly any strength in left hand or arm & was unable to move left arm much at all patient felt sick & had chill which lessen in time patient has some movement in arm but not normal capacity now.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site swelling, Oedema peripheral
Clinical narrative: Mother called reported redness and swelling (L) arm back of (L) arm from armpit to elbow large amt of swelling and redness with hard nodule at varicella injection site to (L) posterior arm.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: On 07/09/10 mom calls states child injection site red and swollen, child complains of headache and body aches, no fever.  Advised cool compressors to site and Ibuprofen.  If s/s worsen or do not improve go to ER.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Erythema multiforme
Clinical narrative: Erythema multiforme acute arthralgias onset 2 days after.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 4 x 4cm reddened, slightly swollen, warm area.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Visual impairment
Clinical narrative: About 7 min. after vaccine was given child states seeing black spots in vision and feeling lightheaded.  We had child lay down and rest w/feet up.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dysphonia, Dyspnoea, Oropharyngeal pain, Pain
Clinical narrative: Body aches, hoarseness, mild sob, coughing, sore throat.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eyelid oedema
Clinical narrative: Bilateral eye puffiness within 5 hrs after receiving 4 y.o booster vaccines (MMR, KINRIX, VARIVAX).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 4 x 5cm, erythematous, raised induration on (L) thigh, irregular borders with central clearing, no color, NTTP, no pruritis.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site rash, Injection site urticaria
Clinical narrative: Immediately after administration of MMR-patient developed rash and hive at and surrounding injection site. Topical cortisone and oral BENADRYL.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Pt received DMM around 1230p.  Pt's grandmother called our office at 230 stating pt was scream since 1 PM.  Advised to return with pt.  Grandmother called at 240 stating pt stopped screaming.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4 to 5 cm area of erythema and increased heat at injection site after PREVNAR 13 given preceding day. No streaking/infection. No fever.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Mother reported that after a day "on the golf course" she fainted and had "seizure like activity" - was not hospitalized, but advised by MD to report to VAERS - (High temperatures & humidity locally).
Age: 4.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness 13 cm X 10 cm.  Warm to touch.  Tender to touch.  Swelling.  BACTRIM DS 200 mg - 40 mg/ 5 ml 10 ml po BID X 10 days - for possible cellulitis.  Pt. to F/U prn.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever/rash started 7/6.
Age: 1.42
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left lower (outer) aspect of upper arm swollen, red and painful when pressure applied. Sx. started 1 day after injection. No Tx reported.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness, Joint swelling, Rhinorrhoea
Clinical narrative: Client states extreme swelling of both knees 13 d after vaccine. Very runny nose on day 12, lasting approximately 24 hr. Day 13, both wrists and ankles very stiff, "wouldn't bend". Above problems lasted -  approximately 48 hours. By day 16, problems had mostly resolved except for residual stiffness of joints which still continues.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Moderate swelling, warmth, redness at (L) deltoid.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cardiac monitoring, Feeling abnormal, Loss of consciousness, Paraesthesia
Clinical narrative: Patient felt weird, left arm and left side of body became tingly, did pass out.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arrhythmia, Cardiac monitoring, Chest pain
Clinical narrative: Patient felt weird, left arm and left side of body became tingly, did pass out.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Fall, Fatigue, Feeling abnormal, Feeling of body temperature change, Full blood count normal
Clinical narrative: Patient felt weird, left arm and left side of body became tingly, did pass out.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Gaze palsy, Head injury, Hot flush, Loss of consciousness, Moaning
Clinical narrative: Patient felt weird, left arm and left side of body became tingly, did pass out.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pain, Palpitations, Paraesthesia, Peripheral coldness, Visual impairment
Clinical narrative: Patient felt weird, left arm and left side of body became tingly, did pass out.
Age: 19.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash all over body, took Benadryl 50mg and the itching stopped, seen by Nurse Practitioner and given Loratadine 10mg to take daily.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Cellulitis, Chest X-ray normal, Diarrhoea, Full blood count
Clinical narrative: Diarrhea/loose stools/high fevers within hours of vaccination. Progressive large local inflammation/induration at injection site. Up to 9 x 9 cm. Fever persisted x 1 week. Treated with clindamycin for presumed cellulitis.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site inflammation, Pyrexia, Stool analysis normal, White blood cell count increased
Clinical narrative: Diarrhea/loose stools/high fevers within hours of vaccination. Progressive large local inflammation/induration at injection site. Up to 9 x 9 cm. Fever persisted x 1 week. Treated with clindamycin for presumed cellulitis.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blister, Chills, Dysgeusia, Headache, Injection site erythema
Clinical narrative: 30 yo AD SSGT received his primary smallpox vaccine (VV04-003A, ACAMBISH/BAH) along with ANTHRAX vaccine #1 (MIP/FAV230) and TYPHOID Vi (PCM/B1026-2) on 01 July 2010. He denied any recent or past illness, exposures to illness (has 3 young children at home), or problems pre vaccination. He reported SPV site became red, tender with pustular formation (Robust take) reporting a small red lesion to posterior edge SPV Tegaderm dressing about day 5-6 that had similar characteristics to existing SPV site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He has kept this site covered and protected similar to SPV site. Day 11 (7/12/2010) while enroute for transport, this SM plane landed. SM advised he felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to edges of his tongue. He c/o a bad taste in mouth. He also noted onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, n/v/d, or shortness of breath. 7/13/2010. He afebrile (97.0-98.0 F) with no current complaints of headache, fever, chills or hand paresthesia/tingling...symptoms resolved <24 hours from onset. However he still had diffuse scattered single macules/papules to upper chest, back, neck and abdominal regions and a sore throat. Dx: non-viral pustulosis, pharyngitis.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site pain, Injection site pustule, Oropharyngeal pain, Paraesthesia, Paraesthesia oral
Clinical narrative: 30 yo AD SSGT received his primary smallpox vaccine (VV04-003A, ACAMBISH/BAH) along with ANTHRAX vaccine #1 (MIP/FAV230) and TYPHOID Vi (PCM/B1026-2) on 01 July 2010. He denied any recent or past illness, exposures to illness (has 3 young children at home), or problems pre vaccination. He reported SPV site became red, tender with pustular formation (Robust take) reporting a small red lesion to posterior edge SPV Tegaderm dressing about day 5-6 that had similar characteristics to existing SPV site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He has kept this site covered and protected similar to SPV site. Day 11 (7/12/2010) while enroute for transport, this SM plane landed. SM advised he felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to edges of his tongue. He c/o a bad taste in mouth. He also noted onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, n/v/d, or shortness of breath. 7/13/2010. He afebrile (97.0-98.0 F) with no current complaints of headache, fever, chills or hand paresthesia/tingling...symptoms resolved <24 hours from onset. However he still had diffuse scattered single macules/papules to upper chest, back, neck and abdominal regions and a sore throat. Dx: non-viral pustulosis, pharyngitis.
Age: 30.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pharyngitis, Pyrexia, Rash maculo-papular, Rash pustular, Skin lesion
Clinical narrative: 30 yo AD SSGT received his primary smallpox vaccine (VV04-003A, ACAMBISH/BAH) along with ANTHRAX vaccine #1 (MIP/FAV230) and TYPHOID Vi (PCM/B1026-2) on 01 July 2010. He denied any recent or past illness, exposures to illness (has 3 young children at home), or problems pre vaccination. He reported SPV site became red, tender with pustular formation (Robust take) reporting a small red lesion to posterior edge SPV Tegaderm dressing about day 5-6 that had similar characteristics to existing SPV site. This "blister" broke when the dressing was removed (tape pulled "blister" off). He has kept this site covered and protected similar to SPV site. Day 11 (7/12/2010) while enroute for transport, this SM plane landed. SM advised he felt feverish, had chills, a sore throat, frontal headache, and tingling to both hands (no radiation) and to edges of his tongue. He c/o a bad taste in mouth. He also noted onset of singular red macules then papules scattered about upper chest and neck region. This rash was not to face, lower torso, extremities, or palms/soles. He denied any chest pain, n/v/d, or shortness of breath. 7/13/2010. He afebrile (97.0-98.0 F) with no current complaints of headache, fever, chills or hand paresthesia/tingling...symptoms resolved <24 hours from onset. However he still had diffuse scattered single macules/papules to upper chest, back, neck and abdominal regions and a sore throat. Dx: non-viral pustulosis, pharyngitis.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Child's grandmother called - said child broke out in hives day after receiving vaccines and 1 hour after eating broccoli for first time.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: NEURONTIN 300mg AM 600mg pm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion missed, Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Full blood count normal, Haemorrhage
Clinical narrative: Information has been received from a physician for a of GARDASIL a pregnancy registry product, concerning a 17 year old female with convulsion who in approximately July 2009, was vaccinated with the second dose of GARDASIL (Lot # unknown). Concomitant therapy included DEPAKOTE. The physician reported that the patient had received the second dose of GARDASIL. In late May 2010, the patient became pregnant and subsequently, at 8 weeks gestation, experienced bleeding and missed abortion, at which time she visited the emergency room. The physician stated it was unclear if the patient was still on DEPAKOTE during the pregnancy. The reporting physician considered the events bleeding and missed abortion to be other important medical events. Additional information has been requested.
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Abasia, Asthenia, Cyanosis, Pallor
Clinical narrative: This case was considered medically important for the event of too weak to walk. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 30-month-old female patient who turned very pale, was too weak to walk, and lips turned blue. The patient received the first dose on an unspecified date along with a dose of Hepatitis A vaccine (manufacturer unknown). Additional suspect medication included Hepatitis A vaccine. On 13-Jul-2010, the patient turned very pale, her lips turned blue and she was too weak to walk. The symptoms lasted about 10 minutes and the patient recovered. Treatment was not reported. The mother was instructed to contact the physician if symptoms returned. No additional information was available at the time of this report.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Antibody test abnormal, Cough, Pertussis, Stridor
Clinical narrative: Initial report received from a health care professional on 13 July 2010. A 10-year-old female patient, with a medical history of asthma, received the following vaccinations: TRIPEDIA (lot number U1350BA) dose 4 on 01 September 2005, TRIPEDIA (lot number U0543BA) dose 3 on 20 November 2002, TRIPEDIA (lot number U0311BA) dose 2 on 12 July 2001, TRIPEDIA (lot number U0341BA) dose 1 on 02 January 2001 and one DTAP (lot number and manufacturer unknown) prior to 02 January 2001. The patient was hospitalized (date not reported) with a diagnosis of pertussis via a direct fluorescent antibody (DFA) test. No details on the patient's testing were available. The patient's family reported on 07 July 2010 that the patient was discharged from the hospital (date of discharge not provided) and still had a cough and stridor. The outcome for the event was reported as not recovered. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Cough, Immunology test, Pertussis, Stridor
Clinical narrative: Initial report received from a health care professional on 13 July 2010. A 10-year-old female patient, with a medical history of asthma, received the following vaccinations: TRIPEDIA (lot number U1350BA) dose 4 on 01 September 2005, TRIPEDIA (lot number U0543BA) dose 3 on 20 November 2002, TRIPEDIA (lot number U0311BA) dose 2 on 12 July 2001, TRIPEDIA (lot number U0341BA) dose 1 on 02 January 2001 and one DTAP (lot number and manufacturer unknown) prior to 02 January 2001. The patient was hospitalized (date not reported) with a diagnosis of pertussis via a direct fluorescent antibody (DFA) test. No details on the patient's testing were available. The patient's family reported on 07 July 2010 that the patient was discharged from the hospital (date of discharge not provided) and still had a cough and stridor. The outcome for the event was reported as not recovered. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling cold, Feeling hot, Injected limb mobility decreased, Injection site pain
Clinical narrative: No swelling - very painful in R shoulder - difficult to raise arm. Feels hot and cold. Using Tylenol PRN and a cold pack during the night.
Age: 4.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness the size of mom's palm at injection site
Age: 96.0
Sex: M
Vaccine: PPV
Symptoms: Chest pain
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with chest pain. Vaccination took place on 09.22.2008. According to the physician the relationship is None. We would be happy to fax you the Study SAE report.
Age: 95.0
Sex: M
Vaccine: PNC
Symptoms: Cellulitis
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with Cellulitis of leg. Vaccination took place 11.07.2007. According to the physician the relationship is Unlikely. We would be happy to fax you the Studys SAE report.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient experienced "hot poker" feeling on top of her head, on her leg, and 1 or 2 other places.  Lasted about 2 hours.  Developed red spot over place on leg where had this sensation.  Injection site became fiery red, itchy and swollen the next day.  Also had flu like symptoms.  Took antihistamine and applied hydocortisone cream with relief.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient experienced "hot poker" feeling on top of her head, on her leg, and 1 or 2 other places.  Lasted about 2 hours.  Developed red spot over place on leg where had this sensation.  Injection site became fiery red, itchy and swollen the next day.  Also had flu like symptoms.  Took antihistamine and applied hydocortisone cream with relief.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: SWELLING, HARD KNOT, ITCHING AT ADMINISTRATION SITE, REDNESS 2-3" DIAMETER; X3D; TOPICAL CORTISONE APPLIED, BENADRYL, ADVIL PO
Age: 2.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling around injection site - left anterior thigh, size 14 x 15 cm.  Not raised. Site tender to touch.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Aphasia, Aspiration, Computerised tomogram, Convulsion, Electroencephalogram
Clinical narrative: 6/24/10 had a partial seizure.  Went to ER and was sent home that day. 6/28/10 Fever and rash. 6/30/10 Fussy and rash. 7/4/10 Running fever, 45 minute long seizure that ended in respiratory failure.  He was intubated, which caused him to aspirate and that led to pneumonia.  He was in PICU/PEDS for 14 days and had 7 more seizures.  When he was extubated we noticed that he had lost all of his motor skills and speech.  Now that he is out of the hospital he has PT/OT and speech several times a week.  Patient is also having follow up care with his pediatrician and the neurologist that saw him in the hospital.  He is also scheduled to see a physical rehab doctor.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Endotracheal intubation, Extubation, Intensive care, Irritability, Laboratory test
Clinical narrative: 6/24/10 had a partial seizure.  Went to ER and was sent home that day. 6/28/10 Fever and rash. 6/30/10 Fussy and rash. 7/4/10 Running fever, 45 minute long seizure that ended in respiratory failure.  He was intubated, which caused him to aspirate and that led to pneumonia.  He was in PICU/PEDS for 14 days and had 7 more seizures.  When he was extubated we noticed that he had lost all of his motor skills and speech.  Now that he is out of the hospital he has PT/OT and speech several times a week.  Patient is also having follow up care with his pediatrician and the neurologist that saw him in the hospital.  He is also scheduled to see a physical rehab doctor.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Nuclear magnetic resonance imaging, Partial seizures, Pneumonia, Pneumonia aspiration, Psychomotor skills impaired
Clinical narrative: 6/24/10 had a partial seizure.  Went to ER and was sent home that day. 6/28/10 Fever and rash. 6/30/10 Fussy and rash. 7/4/10 Running fever, 45 minute long seizure that ended in respiratory failure.  He was intubated, which caused him to aspirate and that led to pneumonia.  He was in PICU/PEDS for 14 days and had 7 more seizures.  When he was extubated we noticed that he had lost all of his motor skills and speech.  Now that he is out of the hospital he has PT/OT and speech several times a week.  Patient is also having follow up care with his pediatrician and the neurologist that saw him in the hospital.  He is also scheduled to see a physical rehab doctor.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Pyrexia, Rash, Respiratory failure, X-ray
Clinical narrative: 6/24/10 had a partial seizure.  Went to ER and was sent home that day. 6/28/10 Fever and rash. 6/30/10 Fussy and rash. 7/4/10 Running fever, 45 minute long seizure that ended in respiratory failure.  He was intubated, which caused him to aspirate and that led to pneumonia.  He was in PICU/PEDS for 14 days and had 7 more seizures.  When he was extubated we noticed that he had lost all of his motor skills and speech.  Now that he is out of the hospital he has PT/OT and speech several times a week.  Patient is also having follow up care with his pediatrician and the neurologist that saw him in the hospital.  He is also scheduled to see a physical rehab doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pain
Clinical narrative: First felt a sting and then noticed the red area which had the shingle sore on the front right shoulder.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Varicella
Clinical narrative: First felt a sting and then noticed the red area which had the shingle sore on the front right shoulder.
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Dyspnoea, Injection site erythema, Injection site swelling, Muscle rigidity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). In July 2010 the subject received 1st dose of BOOSTRIX (details unknown). In July 2010, "soon" after vaccination with BOOSTRIX, the subject experienced swelling injection site, injection site redness, body temperature increased, muscular rigidity, shortness of breath and panic attack. The healthcare professional considered the events were disabling. Relevant test results included the subject's body temperature increased from normal to 100 degrees Fahrenheit to 102. 4 degrees Fahrenheit. At the time of reporting the events were improved. The healthcare professional reported that the subject was vaccinated with BOOSTRIX in the last few days prior to reporting. Injection site swelling and redness started soon after the vaccination shot with the subject's temperature going from normal to 100F to 102.4F and complaint of muscle rigidity, shortness of breath and a panic attack lasting about 3 to 4 hours. The healthcare professional reported the onset date of the events as being in the last few days prior to reporting, and that the events lasted 3 to 4 hours. Due to HIPAA laws, the healthcare professional did not provide any further information.
Sex: F
Vaccine: TDAP
Symptoms: Panic attack
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). In July 2010 the subject received 1st dose of BOOSTRIX (details unknown). In July 2010, "soon" after vaccination with BOOSTRIX, the subject experienced swelling injection site, injection site redness, body temperature increased, muscular rigidity, shortness of breath and panic attack. The healthcare professional considered the events were disabling. Relevant test results included the subject's body temperature increased from normal to 100 degrees Fahrenheit to 102. 4 degrees Fahrenheit. At the time of reporting the events were improved. The healthcare professional reported that the subject was vaccinated with BOOSTRIX in the last few days prior to reporting. Injection site swelling and redness started soon after the vaccination shot with the subject's temperature going from normal to 100F to 102.4F and complaint of muscle rigidity, shortness of breath and a panic attack lasting about 3 to 4 hours. The healthcare professional reported the onset date of the events as being in the last few days prior to reporting, and that the events lasted 3 to 4 hours. Due to HIPAA laws, the healthcare professional did not provide any further information.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Computerised tomogram, Dysphagia, Electromyogram, Immunoglobulin therapy
Clinical narrative: (1) weakness, difficult swallow. (2) IDIG treatment.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: (1) weakness, difficult swallow. (2) IDIG treatment.
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 1 day after vaccine administration, leg was sore 2 days after vaccine a erythematous area surrounded site of administration. It measured 9cm x 7.5 cm.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, swelling, pain and itching (7 x 10 cm erythema).
Sex: F
Vaccine: HEP, RUB
Symptoms: Confusional state, Dyspnoea, Nervousness, Pruritus, Throat irritation
Clinical narrative: Itching, confusion, SOB, clearing throat, nervous.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Unevaluable event
Clinical narrative: No signs of infection when pt was being treated.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC, VARCEL
Symptoms: Injection site swelling
Clinical narrative: LAT mild swelling.
Age: 51.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Headache, Pain in extremity
Clinical narrative: Pt c/o sore arm. Pt woke up between 1-3 am on 7-14-10 with a headache. Pt took MOTRIN with no relief at 7am took MOTRIN again. Pt c/o shivering which started at 915am. Pt states office temp 68 degrees. Pt took ASA at 12N. 1215pm pt states shivering starting to resolved. Pt also c/o feeling lightheadedness since 8am or 9am  and still has it. Pt eats very light. Pt never took temp.
Age: 54.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TDAP, TYP, YF
Symptoms: Blood test abnormal, Cough, Inflammation, Night sweats, Oedema peripheral
Clinical narrative: Recurring fevers, cough, feet and hands swell, tender skin, night sweats; all recurring to present time.
Age: 54.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TDAP, TYP, YF
Symptoms: Pain of skin, Pyrexia
Clinical narrative: Recurring fevers, cough, feet and hands swell, tender skin, night sweats; all recurring to present time.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: 7/15/10 went to ER for upper arm swelling. 7/16/10 went to ER for worsening extending to whole arm. Hospitalize till 7/19/10. Got IV antibiotics.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Flushing, Pallor
Clinical narrative: On 7/21/10 Pt was given Tdap shot in RA deltoid. After shot pt felt warm, face got flush then turned pale BP  at that time was 130/74. Shot given at 1:15 pm. Pt never lost awareness of surrounds and was able to respond. Fanned pt and she began to gain color. After 10 mins escorted to bathroom and tolerated walk well. Then rechecked BP at 1:45pm 110/70. Pt report feeling well. After leaving office felt rush again and then referred to minor med.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Swelling at site both arms with (L) being worse-fever. headache, chills, nausea.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Injection site joint movement impairment, Injection site pain, Pain
Clinical narrative: Pt received her first dose of ENGERIX-B, Hep B vaccine left deltoid on 6/8/10. She c/o pain in (L) deltoid at injection site approximately 4 days later that began to radiate to (L) shoulder, reported difficulty lifting (L) arm, pain progressed x approximately 3 wks and now wk of 7/16/10 states it is resolving but still has pain (mild) when raises (L) arm at injection site in (L) deltoid.
Age: 22.0
Sex: M
Vaccine: FLUX, SMALL, TYP, FLUX, SMALL, TYP
Symptoms: Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the trial on 05 March 2010. A 22-year-old male received the following vaccines on 04 March 2009: ACAM2000 (lot number not reported); TYPHIM Vi (lot number not reported); and influenza split virus vaccine (manufacturer and lot number not reported). Eleven days post-vaccination, the subject was diagnosed with acute pericarditis. An electrocardiogram, performed on Day 11, was reported as abnormal. A Troponin I, performed on Day 12, was 6.14 ng/mL (abnormal). The subject's medical history includes chest pain and headaches. The outcome was not reported. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 33.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This report was received from the investigator in the trial on 12 April 2010. A 33 year-old male subject received the following vaccines on 8 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported) Twelve days after vaccination, the subject was diagnosed with non-specific myocarditis. The subject was also diagnosed with unspecified disease of the pericardium 14 days after vaccination. The subject had a history of dizziness/fainting spells. On Day 13 (21 March 2010), the following tests were performed: Troponin I, 12.3 (abnormal); electrocardiogram, normal; and echocardiogram, normal. The outcome was not reported. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 37.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator in the above mentioned trial on 13 April 2010.  A 37 year-old male subject received ACAM2000, (lot number not reported) on 12 March 2009.  The subject previously received TYPHIM VI, (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported) on 21 February 2009.  On 24 March 2009 (twelve days after vaccination with smallpox vaccine, the subject was diagnosed with non-specific myocarditis.  On 23 March 2009, the subject had an electrocardiogram which was abnormal.  On 24 March 2010), the subject had a Troponin I which was 1.79 (abnormal) and an echocardiogram which was also abnormal.  The subject had no significant medical history.  The outcome was not reported.  Note:  There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.  List of documents held by sender:  None
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Encephalitis, Lumbar puncture abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: This report was received from the investigator in a trial on 12 April 2010. A 20 year-old male subject received ACAM2000 (lot number not reported) on 05 January 2009. Twenty days after vaccination, on 25 January 2009, the subject was diagnosed with encephalitis following immunization procedures. The subject has a history of abnormal electrocardiogram (date not provided). An MRI performed on 21 January 2009 was reported as normal. An echocardiogram performed on 22 January 2009 was normal. A lumbar puncture performed on 29 January 2009 was reported as abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.