chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Non-cardiac chest pain
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for chest pain-non cardiac on 02/06/2009. Vaccination took place on 1/08/2007. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 3/11/09-records received for DOS 2/6-2/7/09 DC DX:Chest pain non-cardiac. Presumabley chest wall pain. Over past 3 months has had intermittent chest discomfort.  Admitted to observation.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hip fracture
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 8/13/2008 for right hip fracture. Vaccination took place on 11/07/2007. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  4/7/09 Received SAE reports which reveal patient experienced trip & fall while under hospice care for severe COPD.  Sustained right hip fracture, right periorbital ecchymosis & swelling on 8/13/08.  Had received Prevnar on 11/7/2007.  Admitted to hospital 8/13-8/19/2008.  Cardio & Ortho consults done.  Surgery for nail fixation 8/14.  D/C to nursing home for PT & continued hospice.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Gait disturbance, Hypoaesthesia, Muscular weakness
Clinical narrative: Patient was vaccinated for meningitis, Gardasil, and tetanus on 2/18/2009.  On 2/19/2009 she could hardly walk her legs were numb and very weak and she could barely move.  I took her back to the Dr on 2/20/2009 and they said she had Guillain Barre Syndrome. 3/9/09-records received-office visit 2/18/09-seen for routine visit. Office visit 2/20/09-C/O legs numb possible reaction to immunizatons. C/O numbness and weakness of both legs from knees down. Fatigues. PE:normal. DX: Paresthesia. 4/21/09-records received-office visit 3/17/09-C/O could not walk after shots last ime states had guillain barre syndrome. Day after vaccine could not walk, could walk with knees locked. Remained this way for over 3 weeks then in past 5 days progessively improved and now back to normal. No weakness of ankle movements and not unstable, describes a numb feeling without anesthesia from knee down. Sprained writs 9 months ago and has knee pain with activiites that require knee bending. PE:retropatellar tenderness bilaterally. Moves all extremities 5/5, sensation intact. 2+ DTRS. DX: muscle weakness generalized. sprain/strain wrist. patellofemoral syndrome. DX is not GBS as merely weakness of knee joint. Office visit 4/14/09-C/O left wrist pain and knees hurt. Fell down stairs yesterday.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Femoral artery occlusion, Reocclusion
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 11/06/2008 for left fem artery reocclusion. Vaccination took place on 1/09/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 3/11/09-records received for DSO 9/25-9/26/08-DC DX:Bilateral fem-pop artery in-stent restenosis with disabling claudication. Bilateral lower extremity claudication andovascular intervention.
Age: 81.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Femoral arterial stenosis
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 11/06/2008 for left fem artery reocclusion. Vaccination took place on 1/09/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 3/11/09-records received for DSO 9/25-9/26/08-DC DX:Bilateral fem-pop artery in-stent restenosis with disabling claudication. Bilateral lower extremity claudication andovascular intervention.
Age: 81.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Femoral artery occlusion, Reocclusion
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 9/25/2008 with bilat femoral popliteal artery restenosis. Vaccination took place on 1/09/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 81.0
Sex: U
Vaccine: PPV, PPV
Symptoms: Femoral arterial stenosis
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 9/25/2008 with bilat femoral popliteal artery restenosis. Vaccination took place on 1/09/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.
Age: 66.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Dysphonia, Increased upper airway secretion, Lacrimation increased, Musculoskeletal pain, Oropharyngeal pain
Clinical narrative: Sore throat-WATERY EYES-RUNNY NOSE-worn ousore right shoulder(shot was in left bicep)-Phlegm-hoarseness-
Age: 66.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Sore throat-WATERY EYES-RUNNY NOSE-worn ousore right shoulder(shot was in left bicep)-Phlegm-hoarseness-
Age: 1.67
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Erythema and edema localized at injection site. slightly raised irregular borders approx. 2-3 in in diameter. Symptoms appeared 24 hours after immunization was given. Pt reported to medical 24 hours after symptoms appeared. Pt was given benadryl and cold compresses and instructed to f/u in 24 hours
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Amnesia, Electroencephalogram, Fall, Grunting, Immediate post-injection reaction
Clinical narrative: She recived Gardisil in left arm then Menigitis vaccine in right arm.  Within a mintue of reciveing the second shot she passed out, her body became rigid with her eyes open in a fixed stare, jaw clinched, arms tightened towarsd body, shoulders rolled in towards body, lightly urinated on self, making a low grunting/gurgling sound.  This went on for sveral minutes.  She does not remember anything after the second shot until she woke up on the floor with a fleet of doctors around her. 3/09/09-records received for DOS 3/4/09-After receiving vaccines had a vagal reaction fell to floor lost consciousness and hit forehead. Had some jerking movements of extremities. Now C/O shoulder pain.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injury, Loss of consciousness, Muscle rigidity, Muscle tightness, Staring
Clinical narrative: She recived Gardisil in left arm then Menigitis vaccine in right arm.  Within a mintue of reciveing the second shot she passed out, her body became rigid with her eyes open in a fixed stare, jaw clinched, arms tightened towarsd body, shoulders rolled in towards body, lightly urinated on self, making a low grunting/gurgling sound.  This went on for sveral minutes.  She does not remember anything after the second shot until she woke up on the floor with a fleet of doctors around her. 3/09/09-records received for DOS 3/4/09-After receiving vaccines had a vagal reaction fell to floor lost consciousness and hit forehead. Had some jerking movements of extremities. Now C/O shoulder pain.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Urinary incontinence
Clinical narrative: She recived Gardisil in left arm then Menigitis vaccine in right arm.  Within a mintue of reciveing the second shot she passed out, her body became rigid with her eyes open in a fixed stare, jaw clinched, arms tightened towarsd body, shoulders rolled in towards body, lightly urinated on self, making a low grunting/gurgling sound.  This went on for sveral minutes.  She does not remember anything after the second shot until she woke up on the floor with a fleet of doctors around her. 3/09/09-records received for DOS 3/4/09-After receiving vaccines had a vagal reaction fell to floor lost consciousness and hit forehead. Had some jerking movements of extremities. Now C/O shoulder pain.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Electroencephalogram, Fall, Head injury, Immediate post-injection reaction
Clinical narrative: She recived Gardisil in left arm then Menigitis vaccine in right arm.  Within a mintue of reciveing the second shot she passed out, her body became rigid with her eyes open in a fixed stare, jaw clinched, arms tightened towarsd body, shoulders rolled in towards body, lightly urinated on self, making a low grunting/gurgling sound.  This went on for sveral minutes.  She does not remember anything after the second shot until she woke up on the floor with a fleet of doctors around her. 3/09/09-records received for DOS 3/4/09-After receiving vaccines had a vagal reaction fell to floor lost consciousness and hit forehead. Had some jerking movements of extremities. Now C/O shoulder pain.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: She recived Gardisil in left arm then Menigitis vaccine in right arm.  Within a mintue of reciveing the second shot she passed out, her body became rigid with her eyes open in a fixed stare, jaw clinched, arms tightened towarsd body, shoulders rolled in towards body, lightly urinated on self, making a low grunting/gurgling sound.  This went on for sveral minutes.  She does not remember anything after the second shot until she woke up on the floor with a fleet of doctors around her. 3/09/09-records received for DOS 3/4/09-After receiving vaccines had a vagal reaction fell to floor lost consciousness and hit forehead. Had some jerking movements of extremities. Now C/O shoulder pain.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: Patient called and states she has had arm pain since receiving infuenza shot 10/16/2008.  Has seen MD X2.  Was put on NSAIDS TID X 1 week w/ no relief. Is now on steroids.  States pain comes and goes and is a burning feeling.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: arm soreness                                                                                     Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: no adverse reaction        Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying
Clinical narrative: Pt. received 2 month vaccines in office, returned home with mother and then cried continuously for >4 hours, with mother unable to soothe baby
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: no adverse event       Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Oropharyngeal pain
Clinical narrative: sore throat for 24 hours.     Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: no adverse events.   Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: no adverse reaction.     Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Optic neuritis
Clinical narrative: Approximately 2 weeks after receiving the meningococcal vaccination and tetanus vaccinations, patient developed optic neuritis.4/15/09-records received for DOS 1/9-1/14/09-DC DX:Bilateral optic neuritis. Presented with 1 week history of headache and 4 day history of increasing blurred vision. Began with right-sided frontal headaches. Mild right facial swelling. Initially diagnosed with sinusitis. Noted to have papilledema with normal pressures.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Patient self reported sore arm for 3 weeks.  Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: no adverse reaction.  Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: no adverse reaction.  Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Cyanosis, Dizziness, Immediate post-injection reaction, Migraine, Nausea
Clinical narrative: Immediately following vaccination go light headed turned blue and fainted out for approximately 60 seconds immediately followed by a migrain headache and nausea that lead us to the emergencey room 5 days later.3/6/09-records received for DOS 2/21/09-presented to ED with C/O ongoing headache, suddenly felt lightheaded and drowsy and slowly consciousness after recieving Gardasil vaccine 5 days prior. After regaining consciousness C/O severe frontal headache which waxes and wanes, worsened with bright lights and loud noises. Nauseated, emesis. Diagnosis-Headache.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Immediately following vaccination go light headed turned blue and fainted out for approximately 60 seconds immediately followed by a migrain headache and nausea that lead us to the emergencey room 5 days later.3/6/09-records received for DOS 2/21/09-presented to ED with C/O ongoing headache, suddenly felt lightheaded and drowsy and slowly consciousness after recieving Gardasil vaccine 5 days prior. After regaining consciousness C/O severe frontal headache which waxes and wanes, worsened with bright lights and loud noises. Nauseated, emesis. Diagnosis-Headache.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Condition aggravated, Migraine, Nausea, Syncope, Vomiting
Clinical narrative: Immediately following vaccination go light headed turned blue and fainted out for approximately 60 seconds immediately followed by a migrain headache and nausea that lead us to the emergencey room 5 days later.3/6/09-records received for DOS 2/21/09-presented to ED with C/O ongoing headache, suddenly felt lightheaded and drowsy and slowly consciousness after recieving Gardasil vaccine 5 days prior. After regaining consciousness C/O severe frontal headache which waxes and wanes, worsened with bright lights and loud noises. Nauseated, emesis. Diagnosis-Headache.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Headache, Migraine, Syncope, Urine human chorionic gonadotropin negative
Clinical narrative: Immediately following vaccination go light headed turned blue and fainted out for approximately 60 seconds immediately followed by a migrain headache and nausea that lead us to the emergencey room 5 days later.3/6/09-records received for DOS 2/21/09-presented to ED with C/O ongoing headache, suddenly felt lightheaded and drowsy and slowly consciousness after recieving Gardasil vaccine 5 days prior. After regaining consciousness C/O severe frontal headache which waxes and wanes, worsened with bright lights and loud noises. Nauseated, emesis. Diagnosis-Headache.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Abdominal pain, Erythema, Hypoaesthesia oral, Measles antibody positive, Mumps antibody test
Clinical narrative: Complained of itchy throat, "patient stated throat closing and feeling very itch all body", abdominal pain, mouth numbness,facial erythema, positive rash around neck, vital signs: BP 100/80, P 90, RR 14.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pruritus generalised, Rash, Rubella antibody positive, Throat irritation, Throat tightness
Clinical narrative: Complained of itchy throat, "patient stated throat closing and feeling very itch all body", abdominal pain, mouth numbness,facial erythema, positive rash around neck, vital signs: BP 100/80, P 90, RR 14.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Chills, Erythema, Heart rate, Hypoaesthesia oral, Rash
Clinical narrative: Complained of itchy throat, "patient stated throat closing and feeling very itch all body", abdominal pain, mouth numbness,facial erythema, positive rash around neck, vital signs: BP 100/80, P 90, RR 14.
Age: 34.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Respiratory rate, Throat tightness
Clinical narrative: Complained of itchy throat, "patient stated throat closing and feeling very itch all body", abdominal pain, mouth numbness,facial erythema, positive rash around neck, vital signs: BP 100/80, P 90, RR 14.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: SITE OF INJECTION WITH REDNESS,SWELLING,WARM TO TOUCH.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Arthropathy, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Exagerate local reaction. Painful with patient asking to be carried. Swelling of left quadricep with loss of knee landmarks, erythema and warmth at injection site measuring 12X7 cm. Still able to walk. Supportive care, ibuprofen. If spreading will give keflex for presumed cellulitis.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Gamma-glutamyltransferase increased, Hepatitis viral test, Liver function test normal
Clinical narrative: This case was reported by a physician and described the occurrence of elevated gamma glutamyl transferase in a 44-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included Aspirin. On 12 December 2008 the subject received 1st dose of TWINRIX (unknown). On 21 January 2009, 40 days after vaccination with TWINRIX, the subject experienced elevated gamma glutamyl transferase (120). A repeat test was done on 12 February 2009 and gamma glutamyl transferase was found to be elevated to 268. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. It was not known if the event was related to vaccination with TWINRIX. It was noted that the subject was vaccinated with monovalent hepatitis B vaccine, which by lot number appeared to be ENGERIX B, on 12 February 2009. The increased GGT was from a blood draw prior to administration with hepatitis B vaccine.
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a child (4 to 6 years of age) male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX at 0.5 ml. At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis and swelling arm. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The physician considered the events were probably related to vaccination with KINRIX.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Culture stool, Haematochezia, Intussusception, Vomiting
Clinical narrative: Pt experienced vomiting and 1 bloody stool. He was taken to ED where they found he had intussusception. He was treated w/air enema. He was observed for 8 hrs w/o any reoccurance and then released. 3/11/09-records received for DOS 1/6/09-follow up after ER visit for C/O vomiting times 2 days on 1/2/09- 3/17/09-records received for DOS 1/2-1/3/09-DC DX: Intussusception. Presented with 1 day history of vomitng and one bloody stool, abdominal pain, fussy, irritability. Successful reduction via air enema.
Age: 1.1
Sex: M
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Rash papular, Scab
Clinical narrative: Right thigh began to get red and swell with 2 papules appearing in central lesion that had fluid but dried up. I saw today about 2 weeks post vaccines and has 3 - 4 cm2 induration with central area 2 cm erythema and 2 papules with scabbed top.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased, Injection site erythema, Injection site pain, Pain
Clinical narrative: Initially redness, soreness at injection site - approx 8 hrs later increase HR with some PVC'S, severe HA and backache, low grade fever 99.6 lt headed, body aches - (L) arm redness extending injection site to elbow -10/15/08 - Dx = Severe systemic Rxn to flu vaccine per ID physician told never have another flu vaccine.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Ventricular extrasystoles
Clinical narrative: Initially redness, soreness at injection site - approx 8 hrs later increase HR with some PVC'S, severe HA and backache, low grade fever 99.6 lt headed, body aches - (L) arm redness extending injection site to elbow -10/15/08 - Dx = Severe systemic Rxn to flu vaccine per ID physician told never have another flu vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Vomiting
Clinical narrative: Swelling of Right thigh and vomiting. Went to emergency room on 2/26/09 follow up. In our office on 3/3/09 thigh looked normal child is fine.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Injection site erythema, Injection site rash, Injection site warmth, Rash
Clinical narrative: 1.3.5 inches X 3 inches round, red, warm to touch region left deltoid.  Were HEP A given.  Slight red rash around injection site and back.  18 hours post injection given.  Dx: allergic reaction localized.  Tx BENADRYL apply cold compress, monitor if is worsen take to E.R.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt developed fever 101.7. 15 cm area of redness, tenderness, and swelling. Localized just to vaccine location. Treated with oral MOTRIN and BENADRYL, ice
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Back pain, Injection site pain, Pyrexia
Clinical narrative: T-101.3, achy at site of injection, tenderness and achy in back. Ibuprofen given - 2 hrs later: Pt felt better, decrease fever, back tenderness gone. Fever & pain @ 4AM with aches - resolved.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: Swelling in tongue - Labored breathing - BENADRYL
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5 yr injections given - mom calling stating childs (L) leg was swollen from knee to groin and red.  - No temp - n pain.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Full blood count normal, Headache, Mononucleosis heterophile test negative, Pyrexia
Clinical narrative: Severe headache-fever-dizziness. Doctor visit, bedrest, Toradol injection for headache-Hydrozodone for headache
Age: 13.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Mother called 2 days after immunizations listed were given. States child has Hx of eczema rash-mild, but noted some hive-like raised areas on skin over body. No breathing problems. Does itch. No new product use per parent. Mom gave BENADRYL on day 1 + day 2 and stated better when called on Day 2 after shots. Instructed to go to ER if breathing problems.
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Fever after receiving  Tdap at 03/02/2009 . Temperature= 101 (Ty) control by Tylenol.
Age: 3.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Chest X-ray, Culture urine, Decreased activity, Injection site cellulitis
Clinical narrative: Cellulitis at injection site dx by CHOP. Admitted x 48 hours for IV antibiotics, nml, us, neg, cxs. Full recovery of mobility. Had HIB + pneumococcal saccharide immunizations. 9:30 that night decreased activity, would not sit up or roll. Winces with mvmnt to LE.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Injection site discomfort, Injection site haematoma, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Pt received flu shot at clinic on 11/3/08. States she started with discomfort to left upper arm from flu shot area to her elbow and states "it feels bruised" - the pain from (L) shoulder to (L) elbow is exactly in line where shot was given. Saw MD on 12/29 and Xray done; 1/6/09 MRI (L) arm and neck; 2/2 saw MD; 2/13/09 has procedure to deaden nerve; next MD appt 3/16/09.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray limb
Clinical narrative: Pt received flu shot at clinic on 11/3/08. States she started with discomfort to left upper arm from flu shot area to her elbow and states "it feels bruised" - the pain from (L) shoulder to (L) elbow is exactly in line where shot was given. Saw MD on 12/29 and Xray done; 1/6/09 MRI (L) arm and neck; 2/2 saw MD; 2/13/09 has procedure to deaden nerve; next MD appt 3/16/09.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX vaccine administered 2/24/09 Right upper arm. Two days afterward the patient called the office questioning if site reaction was normal. Patient was seen by Dr. The site was red , swollen and warm. Patient reports this resolved over the next 24 hours.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Within 1/2 of immunization, patient returned to the doctors office to report injection site was itchy. Site was seen by Dr. Site was also red, slight swollen and warm. Within 24 hrs itching was gone. Site is slight swollen and pink per patient.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Within 1/2 of immunization, patient returned to the doctors office to report injection site was itchy. Site was seen by Dr. Site was also red, slight swollen and warm. Within 24 hrs itching was gone. Site is slight swollen and pink per patient.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration
Clinical narrative: (L) thigh has 2.5 X 2.5 cm indurated erythematous area @ VARIVAX site.
Age: 0.5
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Abnormal behaviour, Hypotonic-hyporesponsive episode, Weight bearing difficulty
Clinical narrative: Child became limp, unable to hold head up, Refused to bear weight on Lower extremities. Awake and alert but "out of it" according to father. This lasted 10 days, but did not call to inform Pediatrician.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Bruxism, Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness, Pallor
Clinical narrative: Child rcvd ADACEL, MENACTRA, FLUZONE, Hep A, VARIVAX, and GARDASIL - just after receiving GARDASIL she stiffened up and eyes rolled back, turned pale, teeth clenched according to mom; BP - 119/79 - HR -~70/min- area no urticaria, lungs CTA, No angioedema- episode lasted approx 5 mins - received O2 via IVC (2 liters).
Age: 0.7
Sex: F
Vaccine: DTAP
Symptoms: Crying, Pyrexia
Clinical narrative: Per Mom and Dad; reporting to us today at well check visit that on 10/21/08 approx 1900 pt had fever of 104, responded to treatment of TYLENOL, in am fever again of 102 and then that evening of 10/22/08 patient cried for 5 hours (9pm to 2pm) went to Hospital ER at 12 midnight (will provide copy).
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Chest discomfort, Fatigue, Myalgia, Pyrexia, Rash
Clinical narrative: 22 hours later had fever of 102.5 degrees, 103 degrees on the next day, controlled by TYLENOL/MOTRIN every 4 hours. Called doctor the first day but was told it was probably viral. Fever lasted 3-6days. Went in to see doctor on 2nd day sent home no treatment was given. On 2/28/09 rash appeared on chest/back/neck, towards head, also complained of pressure on chest, muscle aches fever. Doctor advised parent to take child to ER; was there for 7 hours and then released. Today still feel tired, weak, rash has gone away.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Abdominal pain, Bowel movement irregularity, Explorative laparotomy, Haematochezia, Occult blood positive
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with live attenuated ROTARIX, GlaxoSmithKline.  On an unspecified date the subject received 1st dose of ROTARIX (unknown).  One month after vaccination with ROTARIX, the subject experienced intussusception.  The subject required surgery and the adverse event resolved.  The physician considered the event was clinically significant (or requiring intervention).  The physician considered the event was possibly related to vaccination with ROTARIX.  3/13/09 Received hospital medical records of 1/13-1/17/2009. FINAL DX: Intussusception, recurrent, surgically reduced; Meckel's diverticulum resected; & appendectomy Records reveal patient experienced bloody, mucuous stool.  IS initially 1/11/09 & was reduced by contrast enema & admitted overnight for observation.  Similar s/s of irritability & diet refusal recurred 1/13, sent for air contrast enema which diagnosed & was successful at reducing.  Admitted for observation & IS recurred.  Taken to OR on 1/15 where IS successfully reduced.  Progressed well postoperatively & d/c to home.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Screaming, Surgery, Ultrasound scan abnormal
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with live attenuated ROTARIX, GlaxoSmithKline.  On an unspecified date the subject received 1st dose of ROTARIX (unknown).  One month after vaccination with ROTARIX, the subject experienced intussusception.  The subject required surgery and the adverse event resolved.  The physician considered the event was clinically significant (or requiring intervention).  The physician considered the event was possibly related to vaccination with ROTARIX.  3/13/09 Received hospital medical records of 1/13-1/17/2009. FINAL DX: Intussusception, recurrent, surgically reduced; Meckel's diverticulum resected; & appendectomy Records reveal patient experienced bloody, mucuous stool.  IS initially 1/11/09 & was reduced by contrast enema & admitted overnight for observation.  Similar s/s of irritability & diet refusal recurred 1/13, sent for air contrast enema which diagnosed & was successful at reducing.  Admitted for observation & IS recurred.  Taken to OR on 1/15 where IS successfully reduced.  Progressed well postoperatively & d/c to home.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Intussusception, Surgery
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of intussusception in a 4-month-old subject of unspecified gender who was vaccinated with live attenuated ROTARIX, GlaxoSmithKline.  On an unspecified date the subject received 1st dose of ROTARIX (unknown).  One month after vaccination with ROTARIX, the subject experienced intussusception.  The subject required surgery and the adverse event resolved.  The physician considered the event was clinically significant (or requiring intervention).  The physician considered the event was possibly related to vaccination with ROTARIX.  3/13/09 Received hospital medical records of 1/13-1/17/2009. FINAL DX: Intussusception, recurrent, surgically reduced; Meckel's diverticulum resected; & appendectomy Records reveal patient experienced bloody, mucuous stool.  IS initially 1/11/09 & was reduced by contrast enema & admitted overnight for observation.  Similar s/s of irritability & diet refusal recurred 1/13, sent for air contrast enema which diagnosed & was successful at reducing.  Admitted for observation & IS recurred.  Taken to OR on 1/15 where IS successfully reduced.  Progressed well postoperatively & d/c to home.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning an 85 year old female with a history of "lung cancer surgery" who on 08-FEB-2008 was vaccinated with ZOSTAVAX (Merck) SQ (lot#659326/1824U). Concomitant therapy included NORITATE, LIPITOR and MSD. On 07-FEB-2009 the patient developed a case of the shingles. The physician reported that the patient was prescribed VALTREX for treatment. Unspecified medical attention was sought. Follow-up information from a registered nurse indicated that the Patient with no allergy and a history of chickenpox when 8 years old received her first dose of ZOSTAVAX vaccine live (Merck) SQ, 0.5ml (lot#659326/1824U) into the left upper arm. The patient had no recent exposure to chickenpox or herpes zoster. On 02-FEB-2009 (also reported by the same nurse as 09-FEB-2009), the patient developed zoster vesicular eruption with 8-10 lesions on right trunk for 3 weeks. No rash occurred at the site of injection or elsewhere within 42 days of the vaccination. Other systemic symptoms included 3/10 pain. There was no direct fluorescent antibody done and no specimen was collected. The patient was treated with oral VALTREX 1gm TID for one week. Subsequently, the patient recovered. The reporter considered shingles to be an other important medical event. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 85 year old female with a history of "lung cancer surgery" who on 08-FEB-2008 was vaccinated with ZOSTAVAX (Merck) SQ (lot#659326/1824U). Concomitant therapy included NORITATE, LIPITOR and MSD. On 07-FEB-2009 the patient developed a case of the shingles. The physician reported that the patient was prescribed VALTREX for treatment. Unspecified medical attention was sought. Follow-up information from a registered nurse indicated that the Patient with no allergy and a history of chickenpox when 8 years old received her first dose of ZOSTAVAX vaccine live (Merck) SQ, 0.5ml (lot#659326/1824U) into the left upper arm. The patient had no recent exposure to chickenpox or herpes zoster. On 02-FEB-2009 (also reported by the same nurse as 09-FEB-2009), the patient developed zoster vesicular eruption with 8-10 lesions on right trunk for 3 weeks. No rash occurred at the site of injection or elsewhere within 42 days of the vaccination. Other systemic symptoms included 3/10 pain. There was no direct fluorescent antibody done and no specimen was collected. The patient was treated with oral VALTREX 1gm TID for one week. Subsequently, the patient recovered. The reporter considered shingles to be an other important medical event. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Abasia, Hypoaesthesia, Incorrect dose administered
Clinical narrative: Information has been received from the patient's sister concerning her sister with no pertinent medical history or drug reactions or allergies who on unspecified dates was vaccinated with three doses of GARDASIL. There was no concomitant medication. After the third dose of GARDASIL, the patient experienced numbness in both legs. The consumer reported that the patient could not walk so she was admitted to a hospital for one week. When the patient was in the hospital they did many tests (also reported as no lab tests were performed) but could not find anything wrong and the patient was told it was psychological. The consumer also reported that in 2009, "recently", the patient was just administered a fourth dose of GARDASIL, but no adverse event was involved. At the time of this report, the outcome was unknown. No further information is available.  4/23/09 MR received from PCP with vax rec. Multiple vax received 9/10/07. Admitted to hospital 11/11-14/2007 with D/C DX:  Convulsion Disorder (no mention of convusions in MR-conversion d/o dx by psych).  Anxiety, convulsion reaction and asthma. Pt presented with increasing weakness and numbness of arms and legs. Recent viral gastritis. Psych consult to deal with family related anxiety.  Able to walk with crutches at d/c. HPV#2 given 11/15/07. No mention of hospitalization in record.  MD unaware of admission.  Viral syndrome 3/27/08.  HPV#3 5/13/08. OV 6/24/08 to r/o UTI 2' to urinary incontinence x 10 with dysuria. Tx abx. Reporting leg pain and dizziness 10/24/08.  Diarrhea reported 12/27/08. Stomach pain and diarrhea reported 2/3/09.  Recieved 4th dose Gardasil 2/26/09   4/27/09 MR received for DOS 11/11-14/07 with DX as above.  Conversion Disorder (not convulsion disorder mentioned by neuro consult). Admitted to r/o TM or GBS. Pt reports cannot feel legs, arms are weak, with neck pain 7/10. Pt reports recent virus. (+) Waddell's sign.  Medical w/u has been (-), so physch consult requested.. Pt has had multiple stressors recently. (+) insomnia. DX:  Conversion Disorder.  Anxiety Disorder./
Age: 0.5
Sex: U
Vaccine: RV1
Symptoms: Infantile spitting up
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of spitting up in a 6-month-old subject of unspecified gender who was vaccinated with ROTARIX. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced spitting up. The nurse reported that the subject received ROTARIX and then spit up out the door. She questioned whether to repeat the dose. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: RV1
Symptoms: Abnormal faeces, Faeces discoloured
Clinical narrative: This case was reported by a physician via another manufacturer and described the occurrence of pellet-like stools in an infant subject of unspecified gender who was vaccinated with ROTARIX. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject produced 4 to 5 tiny pellets in stools. At the time of reporting the outcome of the event was unspecified. No further information was available. Follow-up information received on 27 February 2009 indicated that the subject was a 6 week old male. The infant received ROTARIX orally on 09 January 2009 and one day later, on 10 January 2009, experienced a stool change. There were pellets in his stool and it was chalky in color. Not every stool, but some here and there until resolution 7 days later on 16 January 2009. In the reporter's opinion, the events were possibly related to treatment with ROTARIX.
Age: 0.2
Sex: F
Vaccine: DTAP, RV1
Symptoms: Enema administration, Intussusception
Clinical narrative: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old female subject who was vaccinated with ROTARIX. The subject had no concomitant medications, relevant medical history or adverse events following previous vaccinations. Previous and/or concurrent vaccination included DAPTACEL; Sanofi given on an 20 January 2009. On 20 January 2009 the subject received 1st dose of ROTARIX (1ml, oral). On 24 January 2009, 4 days after vaccination with ROTARIX, the subject experienced intussusception. It was attempted to resolve the intussusception with enemas twice and then the subject did have to undergo bowel surgery. The subject was in the hospital for four to five days and has since been released. The physician saw the subject on 02 February 2009 and stated that the subject was "recovering nicely". The physician did not think he will use ROTARIX again. The physician considered the event was disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the event was improved. The physician considered the event was probably related to vaccination with ROTARIX.  4/13/09 MR received for DOS 1/25-28/2009 with d/C DX:  Intussusception of intestine. Pt presented with 2 day hx of emesis, bloody stool and lethargy with intermittent fussiness. PE (+) for abd distention.  IS dx by US.  Attempted reduction by BE only partially successful. Unable to fully reduce so pt to OR for Ex lap with reduction of IS and incidental appy. Improved on d/c.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with combined KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where the KINRIX was given). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age range of 4 to 6 years received KINRIX within the last week developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770472A, A0770473A, A0770474A and A0770475A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with combined KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where the KINRIX was given). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age range of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770473A, A0770474A, A0770475A and A0770476A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm ( the arm where KINRIX was given). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age range of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include. A0770472A, A0770473A, A0770474A and A0770476A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where the KINRIX was given). At the time of reporting the outcome of the event was unspecified. Th healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770472A, A0770473A, A0770475A and A0770476A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where KINRIX was given). At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that  5 subjects in the age range of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770472A, A0770474A, A0770475A and A0770476A.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: I had the 1st GARDASIL vaccination in Oct 2008 and ever since then I have been having high fevers, between to 102-103.0.