chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Bradycardia, Chest X-ray, Endotracheal intubation, Extubation, Haematocrit decreased
Clinical narrative: Coded. Former 28 wk gest infant was on peds floor prior to discharge. He had been fed 45 min before event. Monitor alarm for bradycardia HR 78. RN responded, infant apneic, PPV initiated --> code after chest compressions, intubation, to NICU on ventilator. Extubated approx 48 hours; NPO while on vent. 10/22/2009 hospital records from 7/8-9/13/2009. Baby boy 28 wks per C-section , condition stable was out of NICU and preparing for discharge presented with sx of apnea, bradycardia, possible aspiration pneumonia post vaccinations 9/2009. TX: transferred back to NICU, vented and IV ABX. DC DX's: 28 wk premie, RDS, suspected aspiration pneumonia vs imunnization effect. ICD-9 codes: v30.01, 774.2, 775.4, 779.3, 765.14, 765.24, 770.89, 458.9, 770.81, 770.7, 773.2, 762.0, 362.22, v05.3, v06.3, 772.6, 761.7, 762.5, 348.0, 779.81
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Infantile apnoeic attack, Resuscitation
Clinical narrative: Coded. Former 28 wk gest infant was on peds floor prior to discharge. He had been fed 45 min before event. Monitor alarm for bradycardia HR 78. RN responded, infant apneic, PPV initiated --> code after chest compressions, intubation, to NICU on ventilator. Extubated approx 48 hours; NPO while on vent. 10/22/2009 hospital records from 7/8-9/13/2009. Baby boy 28 wks per C-section , condition stable was out of NICU and preparing for discharge presented with sx of apnea, bradycardia, possible aspiration pneumonia post vaccinations 9/2009. TX: transferred back to NICU, vented and IV ABX. DC DX's: 28 wk premie, RDS, suspected aspiration pneumonia vs imunnization effect. ICD-9 codes: v30.01, 774.2, 775.4, 779.3, 765.14, 765.24, 770.89, 458.9, 770.81, 770.7, 773.2, 762.0, 362.22, v05.3, v06.3, 772.6, 761.7, 762.5, 348.0, 779.81
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Dizziness, Hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Feeling disoriented and dizzy within about 2 hours. Severe swelling at vaccination site within 12 hours, with skin very hot to touch for about one week. High fever (over 102 in patient with normal temp of less than 98.6) within about 4 hours lasting about 30 hours. Patient took Benadryl and ibuprofen after contacting physician's office the next morning.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Feeling disoriented and dizzy within about 2 hours. Severe swelling at vaccination site within 12 hours, with skin very hot to touch for about one week. High fever (over 102 in patient with normal temp of less than 98.6) within about 4 hours lasting about 30 hours. Patient took Benadryl and ibuprofen after contacting physician's office the next morning.
Age: 60.0
Sex: F
Vaccine: PNC
Symptoms: Gastroenteritis viral
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for Gastroenteritis, viral. Vaccination took place 1/16/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  9/22/09 Pneumo Study SAE report hospitalization DOS 8/24/09 to 8/27/09. Assessment: Acute enterocolitis, dehydration. Patient presented with nausea, vomiting, abdominal cramping. Unable to tolerate even liquids. Loose green stools. Harsh breath sounds. Admitted for treatment of dehydration associated with presumed viral gastroenteritis.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Cough, Dysphonia, Headache
Clinical narrative: Severe sore throat, extreme red eyes, body aches, temp of 101.1, headache, chills, dry cough, hoarseness. Took holistic cold?flu medication and went to bed
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Severe sore throat, extreme red eyes, body aches, temp of 101.1, headache, chills, dry cough, hoarseness. Took holistic cold?flu medication and went to bed
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Gait disturbance, Joint swelling, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: Zoster vaccine was  given after strong encouragement from MD. The next day my finger, hand and knees bilaterally were swollen, stiff. and uncomfortable making it difficult for me to walk. I saw MD 1 week later when symptoms persisted. I was told to give it time and that it would go away on it's own.  The symptoms persisted for 6 weeks before finally going away. Of note is the fact that stress seemed to exacerbate the symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Zoster vaccine was  given after strong encouragement from MD. The next day my finger, hand and knees bilaterally were swollen, stiff. and uncomfortable making it difficult for me to walk. I saw MD 1 week later when symptoms persisted. I was told to give it time and that it would go away on it's own.  The symptoms persisted for 6 weeks before finally going away. Of note is the fact that stress seemed to exacerbate the symptoms.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PT. EXPERIENCED PAIN,REDNESS AND SWELLING AT INJECTION SITE AND ITCHING.REDNESS MEASURES APPROX. 6 CENTIMETERS. WARM TO TOUCH. PT. COMPLAINS OF INCREASED WEAKNESS.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: PT. EXPERIENCED PAIN,REDNESS AND SWELLING AT INJECTION SITE AND ITCHING.REDNESS MEASURES APPROX. 6 CENTIMETERS. WARM TO TOUCH. PT. COMPLAINS OF INCREASED WEAKNESS.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Dysphonia, Flushing, Lip swelling, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: At 5:30 pm, patient came in with a red raised patchy and papular rash of axilla bilat. and wrists bilat. Very itchy. Also throat felt swollen and hoarse, lips felt swollen and tingly. VS 98.5, 126/81, 99, 20. LS clear ENT WNL. Face flushed. No HX of any kind of allergies. Had taken 50mg of liq. Benadryl just prior to visit at clinic. Itching and facial flush resolved while here. Advised to continue the Benadryl and return to clinic if worse not better.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: At 5:30 pm, patient came in with a red raised patchy and papular rash of axilla bilat. and wrists bilat. Very itchy. Also throat felt swollen and hoarse, lips felt swollen and tingly. VS 98.5, 126/81, 99, 20. LS clear ENT WNL. Face flushed. No HX of any kind of allergies. Had taken 50mg of liq. Benadryl just prior to visit at clinic. Itching and facial flush resolved while here. Advised to continue the Benadryl and return to clinic if worse not better.
Age: 37.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Dizziness, Loss of consciousness, Road traffic accident
Clinical narrative: Patient reports feeling "fine" after injections.  Around 11 AM she became dizzy and lightheaded while driving. She hit a light pole as a result of momentarily "blacking out" while driving.
Age: 29.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling, and warmth at site, site is painful to palpation
Age: 1.64
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Body temperature increased, Eye swelling, Hypersomnia, Ocular hyperaemia
Clinical narrative: MOTHER STATES CHILD "NOT ACTING THE SAME" AS USUAL, WHEN ASKED TO CLARIFY, MOM STATED SHE IS "NOT ACTING RIGHT." cHILD SLEPT AFTER IMMUNIZATIONS UNTIL 9:OO P.M., AND CHILD'S TEMPERTATURE WAS 101 DEGREES. CHILD IS RECEIVING TYLENOL EVERY 4 HRS. PER MOTHER, STARTED TYLENOL AFTER RECEIVING SHOTS. MOTHER ALSO COMPLAINED CHILD HAD "KNOTS" UNDER BOTH EYES, WHEN ASKED TO CLARIFY, DESCRIBED AREAS AS SWOLLEN, NO DRAINAGE NOTED. AREAS WERE DESCRIBED AS "A LITTLE RED."
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Large red swollen area on right arm.  Red area is hard and warm to the touch.  First seen by mother on Thursday 9/10/2009.  Went to urgent care evening of 9/10/2009 dx. with cellulitis right bicep tx with omnicef.  Red area increased in size by am of 9/11/2009 went to Pediatrician dx with allergical local reaction tx continue omnicef, benadryl (oral) q 6hrs.  Per mother after leaving peds office child complained of scratchey throat peds office notified advised mother to take to ER.  Sparrow ER dx as local reaction continue tx from above adding benadryl cream, pepcid and steroid.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Injection site warmth, Throat irritation
Clinical narrative: Large red swollen area on right arm.  Red area is hard and warm to the touch.  First seen by mother on Thursday 9/10/2009.  Went to urgent care evening of 9/10/2009 dx. with cellulitis right bicep tx with omnicef.  Red area increased in size by am of 9/11/2009 went to Pediatrician dx with allergical local reaction tx continue omnicef, benadryl (oral) q 6hrs.  Per mother after leaving peds office child complained of scratchey throat peds office notified advised mother to take to ER.  Sparrow ER dx as local reaction continue tx from above adding benadryl cream, pepcid and steroid.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Paraesthesia
Clinical narrative: Onset of weakness and tingling in Left arm 24 hous after receiving flu vaccine.  The vaccine was administered in the Left arm.  The weakness occurred in the forearm and hand.  Described as feeling like "pins" and "poor circulation".  No swelling, no redness. Good capillary refill, color pink. Given Ibuprofen 600 Mg. 1 po q 8 hrs prn.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Arthropathy, Fatigue, Head discomfort, Immediate post-injection reaction, Musculoskeletal discomfort
Clinical narrative: Immediately after receiving  the Td vaccine I began to feel the vaccine course through my body, affecting my joints/muscles. Feeling stiffness, pain and fatigue While affecting my head as well, feeling the full affect after 20 min. It began in the arm in which the (Td) vaccine (left side)was administered. It coursed through the entire left side of my body first, then affected the right side. I was given "Thuja" remedy for symptoms (Purchased at the office at the time of vaccination).  It helped  my symptoms after 2 doses, * However I still continue to feel symptoms. They said Since I was feeling improvement, I didn't need to be seen again ( spoke via phone today 9/11/09 @ approx. 2:00PM with receptionist).
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Immediately after receiving  the Td vaccine I began to feel the vaccine course through my body, affecting my joints/muscles. Feeling stiffness, pain and fatigue While affecting my head as well, feeling the full affect after 20 min. It began in the arm in which the (Td) vaccine (left side)was administered. It coursed through the entire left side of my body first, then affected the right side. I was given "Thuja" remedy for symptoms (Purchased at the office at the time of vaccination).  It helped  my symptoms after 2 doses, * However I still continue to feel symptoms. They said Since I was feeling improvement, I didn't need to be seen again ( spoke via phone today 9/11/09 @ approx. 2:00PM with receptionist).
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dysphagia, Immediate post-injection reaction, Nausea
Clinical narrative: Reports feeling dizzy right after administration but it passed. Next day (during the night or within 12 hours of administration) felt chills,  sore throat described as hard to swallow; nausea in the night but it passed; no vomiting. Symptoms had passed by start of next work day.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain
Clinical narrative: Reports feeling dizzy right after administration but it passed. Next day (during the night or within 12 hours of administration) felt chills,  sore throat described as hard to swallow; nausea in the night but it passed; no vomiting. Symptoms had passed by start of next work day.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Nausea, Vision blurred
Clinical narrative: At the time of administrtion, patient stated," My god, this hurts a real lot" She states she made that statment as the vaccine was being administered.  At approximatel 6pm or 5 hours after vaccine administered, patient experienced vision problems...problem seeing, "blurry", thought I must be getting an infection in my eye, felt nauseous and even when I put on my glasses it did not help. Blurry vision started out of the blue on that evening and continued for several days until Saturday when it got better. Nausea started at the same time, was able to eat lightly; lasted until Saturday. No vomiting. Just wanted to sleep; ended up leaving work early approximately 24 hours after vaccine administered...so tired; too exhausted to work on Friday; felt better by Sunday.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: patient experience swelling/warmness on the injection arm NOT at the injection site, swelling and redness occurred lower on the arm than where the vaccinations were received
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Induration, Pruritus, Tenderness
Clinical narrative: Pt noted pruritis in the area 9/10/09, redness and tenderness noted soon afterwards.  No history of other injury to the area.  Exam reveals 70mm X 80mm area of erythema and slight insuration.  No central lesion/bump
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Hyperhidrosis
Clinical narrative: Coughing.  Troubles breathing.  Sweating.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Patient not feeling well after receiving vaccine. Patient advised to sit down and RPH tended to patient. 911 was called. EMS came and monitored patient. Patient taken to the hospital.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: Rashes on face and legs and generalized itching, patient took BENADRYL 25mg Tablets - 1 tab q 4-6 hr. prn : Recovered in two days.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: C/o rash forming a ring approximately 4 inches below site of injection on left arm.  No fever, no difficulty breathing.  L arm is swollen & itches.  Recommended BENADRYL & ice pack to the patient.  (after 24 H, pt still had a rash in the same spot not itchy.)
Age: 55.0
Sex: U
Vaccine: FLU3
Symptoms: Blood pressure increased
Clinical narrative: Patient claims her blood pressure has elevated since the flu shot and she first reported this to me 7 days after the shot.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Vaccine on 8/13/09 rash on lower torso 8/20/09 - Pain. Saw Dr. on 8/21/09 received Acyclovir and PERCOCET. Missed vacation - Better now 9-10-09.
Age: 1.17
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Local redness, warmth & tenderness at injection site approximately 1 1/2 cm diam by 2 days after injection.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Vaccination complication
Clinical narrative: Fussy, sleeplessness, maculor papulor rash entire body has a localized reaction also R lower thigh red-slightly raised 1 x 1/2cm with satellite lighter pink/red area measured 1.4 x 1cm (Varivax).
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Varicella
Clinical narrative: Rt thigh redness and swelling developed within 2 days of vaccine (3x5 cm in diameter). Went away and 10 days later recurred with vesicles suggestive of chicken pox in center of redness.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash
Clinical narrative: Rash following immunization, not uticarial.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient received FLUVIRIN flu shot on 9-8-09 and had no adverse reaction. He became swelling on next day 9-9-09. He went to ER & was given PREDNISONE. ER MD suspected may be due to flu shot.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, No reaction on previous exposure to drug, Pain in extremity, Rash
Clinical narrative: Painful injection site followed with achy arm, rash on trunk, legs and neck. Patient says he has never had a reaction to a flu shot.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, erythema, pruritus (L) deltoid - BENADRYL and CEPHALEXIN X 1week
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Asthenia, Feeling cold, Syncope, Vaccine positive rechallenge
Clinical narrative: Fainting, feeling of coldness and weakness. Same reaction on 02/12/2009 but vaccine was given with other four.
Age: 67.0
Sex: M
Vaccine: YF, YF
Symptoms: Rash erythematous
Clinical narrative: Vaccine administered 09/01/09;  On 09/07/09 pt. noticed red patches on hands + thighs which felt itchy + "tight", pt seen 09/10/09.
Age: 67.0
Sex: M
Vaccine: YF, YF
Symptoms: Dry skin, Pruritus, Rash erythematous, Skin tightness
Clinical narrative: Vaccine administered 09/01/09;  On 09/07/09 pt. noticed red patches on hands + thighs which felt itchy + "tight", pt seen 09/10/09.
Age: 13.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Urticaria on face, legs, torso - improved w/ BENADRYL in 24hrs.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Hot flush, Loss of consciousness, Nausea, Skin warm
Clinical narrative: Patient had hotflush, passed out and became unconscious, when patient came to, felt nauseated, was clammy to touch and hot. Pt was given water and ice pack and put head between legs. After 20 minutes she felt better and left.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema, Rash
Clinical narrative: Pt got a flu shot in the pharmacy at 6:45 PM on 09/10/09 and had no symptoms of allergy. When pt got home and took Lisinopril at 10AM on the same day then had a reaction swelling throat, difficulty of breathing, rash. Pt went to emergency room and was administered steroid, BENADRYL and was discharged the same night - pt reported he was on Lisinopril for 3 years.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: -Redness & swelling injection arm in elbow region & forearm -bruising in injection site.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Immunization on 9/9/09. Mom noted quarter-sized erythema and warmth on 9/10/09. On 9/11/09, 9cm x 10cm area of warmth and erythema on R thigh in area of immunization administration.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt said he got some itchy hives developed 2 hours later, and it got worse overnight. He took BENADRYL for 2 days then he went to his primary care MD. MD gave him a steroid injection & pt continued taking BENADRYL. Rash has gone or gradually decreased.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Miscarriage Pt was not aware she was pregnant at time of vaccine Pt was 5-6 wks pregnant at time of vaccine. H/o prior miscarriage about 1 yr ago.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever, swelling in L upper arm.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Erythema, Feeling abnormal, Induration, Pain
Clinical narrative: Reaction to pneumonia vaccine -arm red - hot - hard - scabbed - client ran fever - achy - felt poorly - started within 24 hours of receiving vaccine - missed work due to fever & symptoms - arm still hard & scabbed.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Scab, Skin warm
Clinical narrative: Reaction to pneumonia vaccine -arm red - hot - hard - scabbed - client ran fever - achy - felt poorly - started within 24 hours of receiving vaccine - missed work due to fever & symptoms - arm still hard & scabbed.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Pt. rec'd VARIVAX injection subcutaneously in left arm. When she returned to office area 3cm x 3 1/2cm red, blistering, hot to touch.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Hyperhidrosis, Nausea, Tinnitus, Vision blurred
Clinical narrative: 10 mins after vaccine admin. pt c/o dizzy --> sat down c/o ears ringing, blurred vision & seeing spots, nauseous & diaphoretic --> lasted approx 10 mins. BP 96/60.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Visual impairment
Clinical narrative: 10 mins after vaccine admin. pt c/o dizzy --> sat down c/o ears ringing, blurred vision & seeing spots, nauseous & diaphoretic --> lasted approx 10 mins. BP 96/60.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Hallucination, Hyperhidrosis, Vomiting
Clinical narrative: Per mother pt. experienced hallucinations, diaphoresis and vomiting late afternoon on date of receiving Tdap immunization.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Posture abnormal, Syncope
Clinical narrative: Patient very apprehensive re flu vaccine. Told to wait 15 min since it was 1st time to get shot. LPN noticed pt. starting to slump in chair. RN came to aid - put head of pt between knees. Fainted 8 seconds or less then was to verbalize & oriented - diaphoretic AP 84. 911 called pt transported to hospital.
Age: 2.0
Sex: M
Vaccine: RUB
Symptoms: Erythema, Sneezing
Clinical narrative: Pt sneezing, face red, no breathing difficulty.  Mom gave a dose of BENADRYL + advised to observe.
Age: 34.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Asthenia, Hypotonia, Injected limb mobility decreased, Paraesthesia
Clinical narrative: States that about 30 minutes after she received a TDAP has been unable to move arm well. Good movement to fingers. Arm and fingers has tingling sensation - no pain to shoulder used warm and cold compresses with no relief. States took MOTRIN with no relief. No redness or swelling noted. Temp. 97.8 denies any other symptoms - states has no strength to raise arm - appears limp
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Injection site pain
Clinical narrative: Chills, tired all over, tenderness + pain at the injection site- lasted for 2 hours.  Now still c/o redness, swelling + pain.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Decreased appetite, Differential white blood cell count, Full blood count normal, Influenza serology negative, Pyrexia
Clinical narrative: Fever 105.9, no appetite.
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Streptococcal identification test negative
Clinical narrative: Fever 105.9, no appetite.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever 101- injection site red and swollen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness, to left upper arm, measures -approx, - 50x22 cms. Symptoms appeared 9/5/09. Redness - measured approx - 50x42cms (remained active - playful).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Local reaction, Oedema peripheral, Skin warm
Clinical narrative: Reported to Dr's office on 9-4 arm was inflamed, swollen + warm.  Dr stated localized topical reaction.  Tx w/ BENADRYL - O.T.C  Follow up on 9-8 reaction resolved.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness, warmth, soreness at swelling site about 2-3 inches across.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Back pain, Borrelia burgdorferi serology negative, CSF cell count normal, CSF glucose normal, CSF protein normal
Clinical narrative: Significant irritability, back pain, muscle aches, difficult to console - started morning after vaccine administration, required office visit, ER visit, hospitalization. Resolved within 24 hours with IV ketorolac, morphine, hydration. Also redness and induration (3cm) L thigh at site of MMR and Varicella.  9/17/09 ER record received for DOS 9/11/09 with D/C DX: Excessive crying.  R/O encephalitis.  R/O Immunization reaction.  Backache. The mornng after vax pt c/o leg and back pain, difficulty bearing weight, screaming, feeling hot and cold, chills, tiredness and fever.  PE (+) for refusal to walk, spasm of the paraspinal areas of thoracolumbar spine, mild local reaction at MMR and Varicella vax sites. Observed o/n and d/c.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: CSF white blood cell count negative, Chest X-ray normal, Culture, Emotional distress, Gram stain negative
Clinical narrative: Significant irritability, back pain, muscle aches, difficult to console - started morning after vaccine administration, required office visit, ER visit, hospitalization. Resolved within 24 hours with IV ketorolac, morphine, hydration. Also redness and induration (3cm) L thigh at site of MMR and Varicella.  9/17/09 ER record received for DOS 9/11/09 with D/C DX: Excessive crying.  R/O encephalitis.  R/O Immunization reaction.  Backache. The mornng after vax pt c/o leg and back pain, difficulty bearing weight, screaming, feeling hot and cold, chills, tiredness and fever.  PE (+) for refusal to walk, spasm of the paraspinal areas of thoracolumbar spine, mild local reaction at MMR and Varicella vax sites. Observed o/n and d/c.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Irritability, Metabolic function test, Myalgia
Clinical narrative: Significant irritability, back pain, muscle aches, difficult to console - started morning after vaccine administration, required office visit, ER visit, hospitalization. Resolved within 24 hours with IV ketorolac, morphine, hydration. Also redness and induration (3cm) L thigh at site of MMR and Varicella.  9/17/09 ER record received for DOS 9/11/09 with D/C DX: Excessive crying.  R/O encephalitis.  R/O Immunization reaction.  Backache. The mornng after vax pt c/o leg and back pain, difficulty bearing weight, screaming, feeling hot and cold, chills, tiredness and fever.  PE (+) for refusal to walk, spasm of the paraspinal areas of thoracolumbar spine, mild local reaction at MMR and Varicella vax sites. Observed o/n and d/c.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Neutrophil percentage increased, Urine analysis normal, Virus culture, White blood cell count normal
Clinical narrative: Significant irritability, back pain, muscle aches, difficult to console - started morning after vaccine administration, required office visit, ER visit, hospitalization. Resolved within 24 hours with IV ketorolac, morphine, hydration. Also redness and induration (3cm) L thigh at site of MMR and Varicella.  9/17/09 ER record received for DOS 9/11/09 with D/C DX: Excessive crying.  R/O encephalitis.  R/O Immunization reaction.  Backache. The mornng after vax pt c/o leg and back pain, difficulty bearing weight, screaming, feeling hot and cold, chills, tiredness and fever.  PE (+) for refusal to walk, spasm of the paraspinal areas of thoracolumbar spine, mild local reaction at MMR and Varicella vax sites. Observed o/n and d/c.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Shot given under the arm, odd spot to begin with...the arwa surrounding the injection site has grown to a welt the size of 3" by 2" and is red, itchy and stinging. The shot was given on 9/10/2009 late afternoon and reaction began within 3 hours after. Two days later, it's just as bad and no over the counter anti-itch cream or antibiotic cream have eased the symptoms.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site anaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in arm where injection given, dizziness, lightheadedness.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous
Clinical narrative: Red bumps on upper left chest and back.  Few other similar bumps located on lower arms and right shoulder.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Chest pain, Nausea, Oedema peripheral, Swollen tongue
Clinical narrative: Patient was given vaccination at about 1:55PM with no problem. Husband told me following morning around 5:00am she experienced nausea, feet swelling, tongue swelling, pain in sternum and BP of 90/60. Patient went to the ER and received Prednisone 20mg - 2 tabs twice daily for four days.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site anaesthesia
Clinical narrative: pt described numbness in arm where he received vaccine from shoulder to elbow about 20 minutes after receiving vaccine
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm red, swollen, and hot from top of shoulder to elbow extending halfway around the arm.  Pt is also complaining of a slight wheeze approximately 24 hours after the injection.  Diphenhydramine oral was ordered and given.  Oxygen was placed intranasally.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Wheezing
Clinical narrative: Left arm red, swollen, and hot from top of shoulder to elbow extending halfway around the arm.  Pt is also complaining of a slight wheeze approximately 24 hours after the injection.  Diphenhydramine oral was ordered and given.  Oxygen was placed intranasally.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthma, Body temperature increased, Colitis, Computerised tomogram abnormal
Clinical narrative: Had dizziness after first shot on 5/11/2009. My daughter had mild dizziness and headaches on and off after shot but the first week of July she had severe dizziness and nausea. Taken to emergency room for treatment. Treated with antibiotic and antivert. 10 days after this visit, taken back to emergency room with 103 degree temp, severe abdominal pain, dizziness, nausea and vomiting. Also had asthma attack that required rescue inhaler. Had not had asthma attack for over 10 years. Treated at ER  with IV fluids, IV antibiotics, IV pain medications and IV antiemetics. CT of abdomen showed infection of the colon. Sent home on Flagyl, Cipro, Lortab and Phenergan. Had some blood in stool and rectal pain for 3 weeks after this visit. Continues to have dizziness, nausea and left upper quadrant abdominal pain. Has bleeding between periods and fatigue. Prior to the Gardisil shot, my daughter was healthy and had not been in emergency room for over 5 years. She was scheduled for her second shot on 7/13/2009 and we did not get it. 11/3/2009 records from ED visits 7/2 and 7/11/2009.Dc Dx Vertigo, abdominal pain, Colitis Patient presented on 7/2/2009 with c/o's vertigo and dizziness. Tx'd with antivert, medrol dose pak. On 7/11/2009 patient presented with c/o's nausea, vomiting, fever and LUQ abd pain. Tx: IVF, IV ABX, IV Zofran and Dilaudid.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Haematochezia, Headache, Menstruation irregular
Clinical narrative: Had dizziness after first shot on 5/11/2009. My daughter had mild dizziness and headaches on and off after shot but the first week of July she had severe dizziness and nausea. Taken to emergency room for treatment. Treated with antibiotic and antivert. 10 days after this visit, taken back to emergency room with 103 degree temp, severe abdominal pain, dizziness, nausea and vomiting. Also had asthma attack that required rescue inhaler. Had not had asthma attack for over 10 years. Treated at ER  with IV fluids, IV antibiotics, IV pain medications and IV antiemetics. CT of abdomen showed infection of the colon. Sent home on Flagyl, Cipro, Lortab and Phenergan. Had some blood in stool and rectal pain for 3 weeks after this visit. Continues to have dizziness, nausea and left upper quadrant abdominal pain. Has bleeding between periods and fatigue. Prior to the Gardisil shot, my daughter was healthy and had not been in emergency room for over 5 years. She was scheduled for her second shot on 7/13/2009 and we did not get it. 11/3/2009 records from ED visits 7/2 and 7/11/2009.Dc Dx Vertigo, abdominal pain, Colitis Patient presented on 7/2/2009 with c/o's vertigo and dizziness. Tx'd with antivert, medrol dose pak. On 7/11/2009 patient presented with c/o's nausea, vomiting, fever and LUQ abd pain. Tx: IVF, IV ABX, IV Zofran and Dilaudid.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Proctalgia, Vomiting
Clinical narrative: Had dizziness after first shot on 5/11/2009. My daughter had mild dizziness and headaches on and off after shot but the first week of July she had severe dizziness and nausea. Taken to emergency room for treatment. Treated with antibiotic and antivert. 10 days after this visit, taken back to emergency room with 103 degree temp, severe abdominal pain, dizziness, nausea and vomiting. Also had asthma attack that required rescue inhaler. Had not had asthma attack for over 10 years. Treated at ER  with IV fluids, IV antibiotics, IV pain medications and IV antiemetics. CT of abdomen showed infection of the colon. Sent home on Flagyl, Cipro, Lortab and Phenergan. Had some blood in stool and rectal pain for 3 weeks after this visit. Continues to have dizziness, nausea and left upper quadrant abdominal pain. Has bleeding between periods and fatigue. Prior to the Gardisil shot, my daughter was healthy and had not been in emergency room for over 5 years. She was scheduled for her second shot on 7/13/2009 and we did not get it. 11/3/2009 records from ED visits 7/2 and 7/11/2009.Dc Dx Vertigo, abdominal pain, Colitis Patient presented on 7/2/2009 with c/o's vertigo and dizziness. Tx'd with antivert, medrol dose pak. On 7/11/2009 patient presented with c/o's nausea, vomiting, fever and LUQ abd pain. Tx: IVF, IV ABX, IV Zofran and Dilaudid.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Immediate post-injection reaction, Pyrexia, Rhinorrhoea
Clinical narrative: MY Daughter received the "MIST" in the nose for seasonal influenza. Live, Intranasal Influenza Vaccine immediate clear runny nose, fever of 102 within 24 hours, dry cough within 24 hours.  fever lasted for less than 48 hours. runny nose continued with a cough for about one week.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Burning sensation, Dizziness, Dysphagia, Flushing
Clinical narrative: Got shot at 1:00 pm on thursday sept 10th 2009 at pharmacy by pharmacist. 30 minutes after shot started profuse sweating and feeling like my stomach and skin were on fire then had some trouble swallowing. 3 pm became red rashy and hived on face neck and upper chest and at 4pm begin urinating every 5 to 10 minutes and until 10 pm that evening. Started taking Benadryl at 4 pm called family physician. No response til next day from them. Called pharmacy also next day which recommended Benadryl and call doctor. Doctor advised Benadryl.  Doctor gave prescription of Atarax Sat Sept 12th due to still having flushing/hiving but has become less harsh and coming and going away. I am somewhat better today Sept 13th but still have mild symtoms but a little lightheaded feeling. Family doctor said to avoid any future flu vaccines despite being in the risk category of needing one and for your information I also regularly get flu vaccines yearly though last year (2008) it hurt from my shot location to my hand and up through my neck but cleared up within two days and I did not report that did not know it was a potential problem. This 2008 shot was also at the same pharmacy.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Hyperhidrosis, Injection site pain, Pollakiuria, Rash erythematous, Urticaria
Clinical narrative: Got shot at 1:00 pm on thursday sept 10th 2009 at pharmacy by pharmacist. 30 minutes after shot started profuse sweating and feeling like my stomach and skin were on fire then had some trouble swallowing. 3 pm became red rashy and hived on face neck and upper chest and at 4pm begin urinating every 5 to 10 minutes and until 10 pm that evening. Started taking Benadryl at 4 pm called family physician. No response til next day from them. Called pharmacy also next day which recommended Benadryl and call doctor. Doctor advised Benadryl.  Doctor gave prescription of Atarax Sat Sept 12th due to still having flushing/hiving but has become less harsh and coming and going away. I am somewhat better today Sept 13th but still have mild symtoms but a little lightheaded feeling. Family doctor said to avoid any future flu vaccines despite being in the risk category of needing one and for your information I also regularly get flu vaccines yearly though last year (2008) it hurt from my shot location to my hand and up through my neck but cleared up within two days and I did not report that did not know it was a potential problem. This 2008 shot was also at the same pharmacy.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Fatigue, Myalgia
Clinical narrative: Muscle and joint pain all over, fatigue and general weakness.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Malaise
Clinical narrative: Began to feel dizzy and light headed.  Went to bathroom and for almost 10 minutes my body went into a full sweat.  I was soaking wet feeling either like I was going to faint or get sick.  I did neither.  After 10 minutes I was able to get up and dry myself off.  I then got a bottle of water and lied down for an hour.  I felt better after that.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia facial, Immunisation reaction, Paraesthesia, Photosensitivity reaction, Skin lesion
Clinical narrative: 8/21 Zoster vaccine administered; 8/27 a pock sore on L forehead; 8/28 L forehead & cheek tingling & slightly numb; 8/29 tingling/numbness spread to chin on L; symptoms lessened by late afternoon; 8/30 symptoms very mild; 8/31 same; 9/1 tingling/numbness on L forehead, around eye, around L mouth and in evening L side of tongue swollen; went to health dept. to get info to file VAERS form and nurse visited with me; 9/2 all symptoms continue; health dept. nurse called to see how I was and encouraged me to call doctor which I did; doctor checked for other neurological problems and potential for stroke - everything was clear; he conceded it must be a reaction from the vaccine - strange as it was;  the health dept. nurse also said it was a reaction they had not see or heard about prior to my case; doctor gave me an anti-viral prescription to fill out if I developed a rash or the tingling/numbness went into my neck/throat; 9/3 symptoms present but lessened towards evening; 9/4 symptoms seemed nearly gone early in the morning but kicked in again later; later in the day symptoms subsided considerably; 9/5 symptoms very slight; 9/6 symptoms very slight; out in sun briefly and L cheek bone area became very agitated by the sun - iced it to get it calmed down and stayed out of sun; 8/7 symptoms very slight; with hat on in sun got just the slightest reaction on L cheek bone area;9/8 symptoms gone. Did not have the anti viral prescription filled.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: 8/21 Zoster vaccine administered; 8/27 a pock sore on L forehead; 8/28 L forehead & cheek tingling & slightly numb; 8/29 tingling/numbness spread to chin on L; symptoms lessened by late afternoon; 8/30 symptoms very mild; 8/31 same; 9/1 tingling/numbness on L forehead, around eye, around L mouth and in evening L side of tongue swollen; went to health dept. to get info to file VAERS form and nurse visited with me; 9/2 all symptoms continue; health dept. nurse called to see how I was and encouraged me to call doctor which I did; doctor checked for other neurological problems and potential for stroke - everything was clear; he conceded it must be a reaction from the vaccine - strange as it was;  the health dept. nurse also said it was a reaction they had not see or heard about prior to my case; doctor gave me an anti-viral prescription to fill out if I developed a rash or the tingling/numbness went into my neck/throat; 9/3 symptoms present but lessened towards evening; 9/4 symptoms seemed nearly gone early in the morning but kicked in again later; later in the day symptoms subsided considerably; 9/5 symptoms very slight; 9/6 symptoms very slight; out in sun briefly and L cheek bone area became very agitated by the sun - iced it to get it calmed down and stayed out of sun; 8/7 symptoms very slight; with hat on in sun got just the slightest reaction on L cheek bone area;9/8 symptoms gone. Did not have the anti viral prescription filled.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure normal, Hyperhidrosis, Paraesthesia, Tachycardia
Clinical narrative: Patient reported diaphoresis, tachycardia, and tingling bilaterally in arms about 5 minutes after vaccine administration.  We monitored B.P. and within 30 minutes the patient stabilized and felt fine.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Heart rate increased, Immediate post-injection reaction, Oedema peripheral
Clinical narrative: 9/13/09 - 3PM - Patient received inactivated a 0.5 ml FLUZONE in L arm right after that Pt c/o of swelling and redness. Pt complaint of arm being heavy. Vital signs Temp 98.8, Pulse 110, Rt - 20, B/P O2 Sat - 92% neuro exam(-). Pt discharged after with father as NAD.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen saturation decreased, Sensation of heaviness
Clinical narrative: 9/13/09 - 3PM - Patient received inactivated a 0.5 ml FLUZONE in L arm right after that Pt c/o of swelling and redness. Pt complaint of arm being heavy. Vital signs Temp 98.8, Pulse 110, Rt - 20, B/P O2 Sat - 92% neuro exam(-). Pt discharged after with father as NAD.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Culture, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Day following immunization, patient's sister reported pain, mass, and erythema at site of injection.  That evening symptoms spreading and pt went to E.R.  Given PREDNISONE and  culture taken.  Confirmed with patient 9-13-09.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site lymphadenopathy, Injection site pain, Pyrexia
Clinical narrative: Patient received PNEUMOVAX on 9/11/09 developed swollen lymphnodes on her right arm (injection site), arm severely hurt, fever of 100.7 degrees F, and chills.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood potassium decreased, Chest pain, Convulsion, Dizziness, Dyspnoea
Clinical narrative: SOB - tachycardia, muscles drawing, dizziness, blurred vision. Kept in hosp 1 day - another episode same s/sx on Monday 8-31-09.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Facial palsy, Headache, Liver function test normal, Musculoskeletal stiffness
Clinical narrative: SOB - tachycardia, muscles drawing, dizziness, blurred vision. Kept in hosp 1 day - another episode same s/sx on Monday 8-31-09.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Nausea, Oxygen saturation normal, Pain in extremity, Palpitations
Clinical narrative: SOB - tachycardia, muscles drawing, dizziness, blurred vision. Kept in hosp 1 day - another episode same s/sx on Monday 8-31-09.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Renal function test normal, Speech disorder, Vision blurred
Clinical narrative: SOB - tachycardia, muscles drawing, dizziness, blurred vision. Kept in hosp 1 day - another episode same s/sx on Monday 8-31-09.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood potassium increased, Dizziness, Dyspnoea, Electrocardiogram normal, Metabolic function test
Clinical narrative: SOB - tachycardia, muscles drawing, dizziness, blurred vision. Kept in hosp 1 day - another episode same s/sx on Monday 8-31-09.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle tightness, Oxygen saturation normal, Tachycardia, Vision blurred
Clinical narrative: SOB - tachycardia, muscles drawing, dizziness, blurred vision. Kept in hosp 1 day - another episode same s/sx on Monday 8-31-09.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Decreased appetite, Discomfort, Dry mouth, Headache, Oedema peripheral
Clinical narrative: (R) deltoid sore, (R) arm mild-moderate edema. Fever at 100-101 deg. F, inappetence, HA, dry mouth, generalized discomfort. Breathing not affected. No tachycardia.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: (R) deltoid sore, (R) arm mild-moderate edema. Fever at 100-101 deg. F, inappetence, HA, dry mouth, generalized discomfort. Breathing not affected. No tachycardia.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Colitis ulcerative, Condition aggravated, Diarrhoea haemorrhagic
Clinical narrative: We received the following information from the literature article on 02 SEP 2009: A female adult patient had suffered from exacerbation of ulcerative colitis following an influenza vaccination (manufacturer, batch no. or vaccination date not reported). The woman had been managed with 6-MP, sulfasalazine, and intermittent steroids and she had been in remission without steroids for 9 months when she was vaccinated with another influenza vaccine. The night after that vaccination she developed abdominal pain and bloody diarrhea (please refer to case MA2009-2379). (Requests were sent on 03 SEP 2009, 09 SEP 2009 and 17 NOV 2009, no follow-up information received.)
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Colectomy total, Condition aggravated, Cushingoid, Diarrhoea haemorrhagic
Clinical narrative: We received the following information from a literature article on 02 SEP 2009: A female adult patient with ulcerative colitis had been managed with 6-MP, sulfasalazine, and intermittent steroids and she had been in remission without steroids for 9 months. After 9 months on 6-MP and while in remission, she received a subcutaneous injection of influenza vaccine (manufacturer and batch no. unknown) and that night she developed abdominal pain and bloody diarrhea. On examination she had very active ulcerative colitis with friability, ulceration, and exudate. She also had recurrence of bilateral uveitis. She was hospitalised and treated with intravenous adrenocorticotropin hormone (ACTH) followed by tapering doses of prednisone. Again she improved, but incompletely. The 6-MP was increased to 150 mg/day and she required larger doses of steroids, becoming very cushingoid. One year after the diagnosis of ulcerative colitis was established the chronicity of her illness and the complications of steroids warranted surgical intervention. She underwent total colectomy with establishment of an ileoanal pouch anastomosis. Pathology confirmed the presence of a universal ulcerative colitis and there was no involvement of the terminal ileum. After 1 year with intermittent pouchitis, the pouch and the ileum looked normal. The patient suffered from earlier exacerbation of ulcerative colitis after a previous influenza vaccination (please refer to case MA2009-2378). (Requests were sent on 03 SEP 2009, 09 SEP 2009 and 17 NOV 2009, no follow-up information received.)