chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Upper respiratory tract infection, Viral infection
Clinical narrative: 11/21/06 seen for URI, 11/27/06 fever unknown illness, 11/29/06 to ER for listlessness, 11/30/06 admitted for viral meningitis, 12/05/06 transferred to NICU for truncal ataxia. 12/07/06 d/c home, normal CT, no growth on CSF x2, Abnl MRI. 01/08/07-records received and reviewed.  DOS 12/1-12/5/06 DC DX: from Methodist Hospital. Began with FUO, progressed to listlessness and not responsive, not looking at people. CSF: WBC 100 with glucose and protein studies consistent with meningitis. IV Rocephin, vancomycin and acyclovir. CSF cultures negative, PCR HSV negative, CXR mild bronchitis. Allergic to vancomycin. IV treatments discontinued. However, clinical picture did not rapidly improve. CT essentially negative. Suspected possibility of partially treated bacterial meningitis and repeated LP showed 0 WBC, slightly decreased glucose and protein in range of 60s. Restarted on acyclovir and Rocephin. Afebrile throughout stay. PE: nucal rigidity, truncal ataxia and drooling. Transferred to Sutter Hospital. records requested.  01/16/07-records received and reviewed from Sutter Memorial . DC Summary for DOS 12/5-12/7/06 DC DX: Viral meningeal encephalitis MRI no mass or hydrocephaly. Abnormal signal bi-thalamic and bilaterally in basal ganglia. This can be due to ischemic hypoxemic, infectious , inflammatory demyelinating causes. The absence of definite diffusion abnormality suggests that acute ischemia is not the explanation. Differential diagnosis is ischemia, infection, demyelination. Admitted with truncal ataxia and no feeding and fevers.  RX with acyclovir, ceftriaxone and vancomycin. Developed red man syndrome with vancomycin
Age: 0.26
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: No adverse reaction, vaccine (Flu) given to a 3 month old.
Age: 1.61
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Patient experienced fevers of 101.3-101.4 with rash 4 days following administration of Hep A and flu vaccine. Parents gave Tylenol and Motrin for fever.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 101F day after vaccines
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pallor
Clinical narrative: Patient turned pale after 2-3 minutes of receiving all 3 vaccinations and recovered slowly next few without intubation.
Age: 0.19
Sex: M
Vaccine: UNK
Symptoms: Pallor
Clinical narrative: Child turned pale but acting normal for 2 hours a day after IZ were given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: Sore arm, she could barely move it. She took Tylenol. She then developed swelling and rash below the site by 8/10/05.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Malaise, Pain, Rash maculo-papular, Rash pruritic, Skin ulcer
Clinical narrative: 12/11/06 reported onset of 25 disseminated pruritic Maculo papular lesions associated with malaise, achiness.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Eye infection, Varicella
Clinical narrative: 12/11/06 reported onset of 25 disseminated pruritic Maculo papular lesions associated with malaise, achiness.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Warm to touch with slight elevation at injection site to LT deltoid.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dysarthria, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Friday, Nov 14, 2006 had flu shot. Friday night child complained of sore arm and shoulder. Monday there was a local rash around the injection site, some redness to the arm down to the elbow, and generalized pain between shoulder and elbow. Tuesday rash was spreading down arm and unto chest and child was reporting many aching joints. Child taken to physician on Tuesday scripts for Zyrtec and Oraped new. Child does have asthma and normally has Proventil syrup. He was wheezing on Tuesday. By Thursday evening child was brought to ER and admitted because rash was getting worse, joints down to knee painful and swollen. Slurred speech, neck swollen. Child will not eat plain eggs, but can eat cake and other things made with eggs.
Sex: M
Vaccine: FLU3
Symptoms: Joint swelling, Oedema, Rash, Shoulder pain, Wheezing
Clinical narrative: Friday, Nov 14, 2006 had flu shot. Friday night child complained of sore arm and shoulder. Monday there was a local rash around the injection site, some redness to the arm down to the elbow, and generalized pain between shoulder and elbow. Tuesday rash was spreading down arm and unto chest and child was reporting many aching joints. Child taken to physician on Tuesday scripts for Zyrtec and Oraped new. Child does have asthma and normally has Proventil syrup. He was wheezing on Tuesday. By Thursday evening child was brought to ER and admitted because rash was getting worse, joints down to knee painful and swollen. Slurred speech, neck swollen. Child will not eat plain eggs, but can eat cake and other things made with eggs.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 65 year old female with no allergies or medical history who on 19-Dec-2006 was vaccinated with a 0.5 ml dose of varicella-zoster virus vaccine live. Concomitant therapy included cetirizine hydrochloride (ZYRTEC). On 19-Dec-2006, the patient experienced a headache after vaccination and was hospitalized. The patient recovered on 20-Dec-2006. No diagnostic laboratory test were performed. A product quality complaint was not involved. No further information is available.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Pain
Clinical narrative: Stomach, extreme fatigue, headache, body aches, chills.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Antinuclear antibody negative, Asthenia, Blood creatine phosphokinase normal, Full blood count normal, Gait disturbance
Clinical narrative: BL leg pain, aching some weakness.  Follow-up received states - I don't know lot numbers, or any other vaccine info. Flu vaccine was given at Health Dept. - First shot was in batch that was frozen- went to have another in case 1st one wasn't any good. Stiff, trouble walking, pain in neck shoulders, arms, and hands, hands and wrist swelling, alot of pain.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Joint swelling, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Oedema peripheral
Clinical narrative: BL leg pain, aching some weakness.  Follow-up received states - I don't know lot numbers, or any other vaccine info. Flu vaccine was given at Health Dept. - First shot was in batch that was frozen- went to have another in case 1st one wasn't any good. Stiff, trouble walking, pain in neck shoulders, arms, and hands, hands and wrist swelling, alot of pain.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: BL leg pain, aching some weakness.  Follow-up received states - I don't know lot numbers, or any other vaccine info. Flu vaccine was given at Health Dept. - First shot was in batch that was frozen- went to have another in case 1st one wasn't any good. Stiff, trouble walking, pain in neck shoulders, arms, and hands, hands and wrist swelling, alot of pain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Soreness right arm onset day of injection progressively got worse each day. No redness, no fever, entire arm hurts since injection, pain seems to radiate from site of injection. Worse today than yesterday. No HX arthritis or difficulty moving arm prior to injection.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Syncope
Clinical narrative: 10 minutes after receiving Gardasil #1-patient became dizzy,hot, blacked out. Patient recovered completely after 20 minutes.
Age: 49.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL, TYP
Symptoms: Blood cholesterol increased, Dermatitis, Ear pain, Hypertension, Myalgia
Clinical narrative: Muscle pain, skin rash, high blood pressure, ear pain, itching
Age: 49.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL, TYP
Symptoms: Pruritus, Rash, Tendonitis
Clinical narrative: Muscle pain, skin rash, high blood pressure, ear pain, itching
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea post Rotateq. Well hydrated.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site induration, Myalgia, Pain
Clinical narrative: On 12/4 10:30pm left deltoid a little red, tender. By 12am 12/5 left deltoid hot, swollen, hard to touch 3.5" diameter area. Patient experienced achiness all over. In morning of 12/5 sore throat, muscle aches. By afternoon temp 101 by mouth; site itchy. Arm normal by 12/7. Saw primary care physician on 12/11 prescribed Albuterol and Amoxicillin. No chest x-ray done.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Pruritus, Swelling, Tenderness
Clinical narrative: On 12/4 10:30pm left deltoid a little red, tender. By 12am 12/5 left deltoid hot, swollen, hard to touch 3.5" diameter area. Patient experienced achiness all over. In morning of 12/5 sore throat, muscle aches. By afternoon temp 101 by mouth; site itchy. Arm normal by 12/7. Saw primary care physician on 12/11 prescribed Albuterol and Amoxicillin. No chest x-ray done.
Age: 10.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Nausea, Pyrexia, Rash
Clinical narrative: Vaccine administered at patient's home 1/1/07 in evening. On 1/3/07 mom noticed Right upper arm redness, warmth, then 1/4/07 worse with nausea, low grade fever, rash
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Rash appeared on child's face 2 hours after immunizations as stated by child's mother.
Age: 1.11
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Rash started this AM (papulovesicular)
Age: 0.59
Sex: M
Vaccine: TD
Symptoms: Wrong drug administered
Clinical narrative: 7 month infant given Decavac (Td) 0.5ml instead of ordered Fluzone pf 0.25ml. Had received Pediarix doses 11/30/06, 10/2/06 and 7/28/06. No known affects-reporting due to close proximity of Pediarix doses and adversed dosing.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Vomiting
Clinical narrative: Vomiting x1, then broke out in spots over next 2 days. No fever.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient now has chicken pox.
Age: 1.21
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Abasia, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Approximately 12 hours after receiving immunizations patient developed diffuse urticaria and fever.  Subsequently his feet became swollen and he was unable to walk.  See in ED and treated with Zyrtec and Hydeoxyzine.  All symtoms resolved within 96 hours.  2/22/07 Received medical records from hospital which reveal patient experienced pruritic rash for approx 2 days w/fever, crankiness & difficulty walking.  Derm consult done in ER.  Had already been treated by PCP w/Benadryl & Zyrtec.  Exam revealed diffuse, erythematous confluent rash & scattered targetoid lesions sparing palms & soles FINAL DX: Urticarial hypersensitivity reaction, probably viral, less likely vaccinations.
Age: 1.0
Sex: F
Vaccine: HEP, MMRV, VARCEL
Symptoms: Herpes simplex
Clinical narrative: Shingles Diagnosed 1/4/2007
Age: 17.0
Sex: F
Vaccine: FLU3, HEP, MNQ
Symptoms: Chest discomfort, Cold sweat, Dizziness, Dyspnoea, Nausea
Clinical narrative: Client rec'd the 3 vaccines listed below @ 0935. Client went back out in the lobbly after vac. adm.-Reported that she was lightheaded-staff assisted her back to the clinic room and was placed in Trendellenburg position @ 0945 client pale & clammy, reporting nausea and seeing spots BP 110/60, P 90, R 20--0950 BP 122/70, P 90, R 20, cool cloth to forehead, still c/o symptoms persisting--1000 BP 120/70,P 100, R 24 Ammonia inhalant used--1008 BP 122/70, P 96, R 22 c/o symptoms of seeing spots, nausea & dizziness but sl. improving--1015 client offered apple juice-drank about 2 oz & stated it made her inc. nausea, client began to c/o min. shaking-covered with coat c/o SOB/chest tightness after asked by staff stated chest was "tight" from lower left abd to mid abd to epigastric area to mid chest- No respitory distress observed, color has much improved, no diaphoresis or clamminess assessed--1025 O2 mask 2L applied--Immediately after placing O2 she voiced that her breathing was better, but that other symptoms persist- Dr. called & notified--order to have 911 called and have client taken to ER via ambulance-client able to get onto amb. stretcher with min. assist- no ortho static changes--1035 client left via ambulance--IVF started by EMS-- ER reports client was d/c'd home after CXR and ECG completed, caretaker reported at 1400 that client was totally asymptomatic
Age: 17.0
Sex: F
Vaccine: FLU3, HEP, MNQ
Symptoms: Pallor, Tremor, Visual disturbance
Clinical narrative: Client rec'd the 3 vaccines listed below @ 0935. Client went back out in the lobbly after vac. adm.-Reported that she was lightheaded-staff assisted her back to the clinic room and was placed in Trendellenburg position @ 0945 client pale & clammy, reporting nausea and seeing spots BP 110/60, P 90, R 20--0950 BP 122/70, P 90, R 20, cool cloth to forehead, still c/o symptoms persisting--1000 BP 120/70,P 100, R 24 Ammonia inhalant used--1008 BP 122/70, P 96, R 22 c/o symptoms of seeing spots, nausea & dizziness but sl. improving--1015 client offered apple juice-drank about 2 oz & stated it made her inc. nausea, client began to c/o min. shaking-covered with coat c/o SOB/chest tightness after asked by staff stated chest was "tight" from lower left abd to mid abd to epigastric area to mid chest- No respitory distress observed, color has much improved, no diaphoresis or clamminess assessed--1025 O2 mask 2L applied--Immediately after placing O2 she voiced that her breathing was better, but that other symptoms persist- Dr. called & notified--order to have 911 called and have client taken to ER via ambulance-client able to get onto amb. stretcher with min. assist- no ortho static changes--1035 client left via ambulance--IVF started by EMS-- ER reports client was d/c'd home after CXR and ECG completed, caretaker reported at 1400 that client was totally asymptomatic
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Facial palsy, Hypoaesthesia
Clinical narrative: Diagnosed with Bells Palsy. Developed symptoms on 27 DEC 06.  Immunization was on 06 DEC 06.  Initial symptoms included loss of taste.  Numbness began 29 DEC 06. 1/26/07 Received medical records from hospital which reveal patient seen in ER on 12/31/06 with left facial weakness with forehead involvement & left eye tearing.  Seventh cranial nerve palsy on left c/w Bells phenomenon. Tx w/steroids, eye ointment & d/c to home to f/u with PCP.  FINAL DX: Left facial Bells Palsy.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypokinesia, Injection site erythema, Injection site swelling
Clinical narrative: Awakened on 11/11/2006 from nights sleep and felt numbness in the arm she had injection in and was unable to use arm or hand. She took 200 mg of Ibuprofen a day and Benadryl 25 mg a day since. She has swelling about the size of a half dollar and redness at injection site.Is regaining some use of that hand and arm. Has son in another state who had this exact reaction.  She has taken the Flu shot many times and has never had this reaction. Does not plan to seek care of MD at this time. But will let him know at her next visit. Has someone from the family staying with her right now and is not alone. Denies any other signs or symptoms. This reported on 11/11/06.  On 11/20/06 client reported she is totally recovered with no lingering numbness in hand or arm. Can use hand and arm without problem.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Erythema, Oedema peripheral, Pyrexia, Rash macular
Clinical narrative: 2 days after vaccination, patient presented with acute onset of swelling and redness of bilateral hands and feet.  In addition, patient had a macular red rash on his chest.   The day after vaccination, patient had a fever of 100.9 degrees.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Flu and Pneumonia vaccine administered on 10/31/06,both in left deltoid. On 11/03/06 client came into clinic with husband complaining of swelling and tenderness of left arm at injection site. Symptoms began on 11/01/06 and has increased in severety. Has been putting ice packs on it but no other treatment.Reports no fever except at injection site. Feeling O.K. just fatigued and tired. Advised client to begin taking Ibuprofen 200 mg and follow directions on pkg. Advised to take Benedryl 50 mg according to pkg directions. Continue with cold compresses. On 11/06/2006 client reported swelling is smaller area but still has some fever in arm with tenderness. On 12/22/06 client reported she is fine and did not have to seek care of MD.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: CAME TO CLINIC CONCERNED ABOUT RED LUMP ON CHILDS LEFT LEG AFTER IMMUNIZATIONS RECEIVED AT WIC. RED, WARM TO THE TOUCH, 4.5 CM IN DIAMETER. SEEN BY A DR FOR LOCALIZED REACTION.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Red, warm area developed at injection site of DTaP the day following injection.  Seen in office - consistent with sterile abscess.  No evidence for lymphangitis.  Instructed to use warm compresses and shown signs/symptoms of cellulitis.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye oedema, Oedema peripheral, Pain, Pruritus, Rash
Clinical narrative: Pt given vaccine on 12/26.  Began to experience generalized pruritis and mild rash on 12/17. By 12/28 had severe urticarial rash requiring oral steroids. Rash did not improved with steroids and antihistamines, and pt developed edema of hands, feet and eyes and some respiratory symptoms on 12/31. Given IV decadron with relief by an outside provider. Symptoms improving but persistent mild rash at time of my recent re-evaluation on 1/2/07. Her hands remain sore.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: White blood cell count increased
Clinical narrative: Pt given vaccine on 12/26.  Began to experience generalized pruritis and mild rash on 12/17. By 12/28 had severe urticarial rash requiring oral steroids. Rash did not improved with steroids and antihistamines, and pt developed edema of hands, feet and eyes and some respiratory symptoms on 12/31. Given IV decadron with relief by an outside provider. Symptoms improving but persistent mild rash at time of my recent re-evaluation on 1/2/07. Her hands remain sore.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye oedema, Neutrophil count normal, Oedema peripheral, Platelet count increased, Rash
Clinical narrative: Pt given vaccine on 12/26.  Began to experience generalized pruritis and mild rash on 12/17. By 12/28 had severe urticarial rash requiring oral steroids. Rash did not improved with steroids and antihistamines, and pt developed edema of hands, feet and eyes and some respiratory symptoms on 12/31. Given IV decadron with relief by an outside provider. Symptoms improving but persistent mild rash at time of my recent re-evaluation on 1/2/07. Her hands remain sore.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Respiratory disorder, Urticaria, White blood cell count increased
Clinical narrative: Pt given vaccine on 12/26.  Began to experience generalized pruritis and mild rash on 12/17. By 12/28 had severe urticarial rash requiring oral steroids. Rash did not improved with steroids and antihistamines, and pt developed edema of hands, feet and eyes and some respiratory symptoms on 12/31. Given IV decadron with relief by an outside provider. Symptoms improving but persistent mild rash at time of my recent re-evaluation on 1/2/07. Her hands remain sore.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea 10x/day reduce PO intake pt was admitted though ER at hospital with IV hydration. 01/16/07 Received medical records from hospital which reveal patient admitted 12/9/06-12/10/06 with diarrhea & poor feeding since receiving vax.  Dehydrated on exam & by labs.  Rehydrated overnight then given oral challenge which was tolerated.  No further diarrhea & d/c home to be seen by PCP in 1-2 days.  FINAL DX: Gastroenteritis.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Blood amylase increased, Lipase increased, Pancreatitis
Clinical narrative: Pancreatitis, Lipase 6686, amylase 1175, 81F, IV hydration, improved in 24 hours, lipase to 1008, amylase to 628.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Vaccination failure
Clinical narrative: NONE
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia, Vomiting
Clinical narrative: Diarrhea, vomiting, blood in still 2x's 12-18-06.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pain in arm from elbow to upper arm and shoulder.
Age: 0.48
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Seizures. Went to ER for treatment.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Blood pressure increased, Dizziness, Hypoacusis, Nausea, Pallor
Clinical narrative: 3-5 min following vaccine complained of dizziness, hearing loss right ear; became desiphoretic, complained of nausea, pale. Remained conscious. Elevated blood pressure 100/60; cool cloth to head; head lowered between knees. Began to feel better after 15 min. Dr in attendance. Hearing returned to right ear.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chills, Malaise, Pyrexia, Urticaria
Clinical narrative: 12/15- Patient went to her doctor 12/15/06 after developing hives, fever, malaise. 1st shot MMR 10/24/06, 2nd shot 12/1/06. 12/19/06-developed joint pain. 12/31/06 developed fever, chills, hives. - referred to infectious disease specialist. Patient treated with IV fluids, steroids (Prednisone), Hydronyzone HCl.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Injection site discolouration, Rash, Rash papular
Clinical narrative: Patient developed rash after receiving Hep B #2. Rash blanching red papules to chest Right arm and face. No hives noted.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, low grade fever
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Eczema, Injection site erythema, Injection site vesicles
Clinical narrative: Crusted smallpox scar with satellite vesicles on erythemous base trunk (20).  Recrudescence Smallpox vaccination with eczema herpeticem.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Catatonia, Coma, Depressed level of consciousness, Hypotonia, Hypoventilation
Clinical narrative: Parent called in evening after immunizations were given, reporting that child could not be roused,was "unresponsive", "catatonic", "floppy" and "breathing shallowly".  Instucted by Dr to go to ER. Told in ER that child suffered from reaction to immunizations.
Age: 1.01
Sex: F
Vaccine: DTAP, HEP, HIBV, MMRV, PNC
Symptoms: Irritability, Metabolic function test, Pyrexia, Rash
Clinical narrative: 12/20 fever to 105. 12/20-12/28 continued fever, increased irritability. 12/28&29 To Dr. 12/30 Fever to 105, rash on trunk, hospitalized. 12/31 rash is covering entire body and eyes. 1/3 rash is fading, but can still be felt.  01/08/2007 Verified with reporter that vaccination and AE occured in December of 2006 (not 2005).  Child would have been approximately one year of age at the time. 01/16/2007 MR received from vaccine provider which included vax. record, photos of rash, and labs from hospital visit. 02/16/2007 MR received for ER visit of 12/24/06 for c/o fever, cough, runny nose. Clinical Impression: Fever, Pharyngitis.  02/21/2007 MR received for one night admission of 12/30/2006 for c/o dehydration and fever.  Child also had a diffuse papillary rash over the torso and extending to the extremities.  Mom states rash is similar to one he had in response to Zithromax.  D/C 12/31/2006. Assessment:  Dehydration.  Fever- most likely viral.  The rash can be explained by one of 3 things. 1) reaction to antibiotics-highly probable. 2) reaction to MMR or Varicella vaccine.  3) Viral exanthem. Seen again in ER 12/31/2006 for rash. Clinical Impression:  1) Fever  2) Diffuse rash, Drug reaction. Follow up: Verification requested per Dr. at FDA.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: The annual Influenza shot caused me severe pain in my right arm - from the base of my skull to the index finger on my right side (side of injection) Last year 2006 I had a reaction from the base of my skull.
Age: 5.0
Sex: M
Vaccine: HBHEPB, MMRV
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a physician and a person from a pediatrician's office concerning a 5 year old male with an allergy to Proquad, who on 26 Oct 2006 was vaccinated subcutaneously in the left lower arm with a first 0.5 ml dose of Proquad (lot # 654471/0812F). Concomitant vaccination included a third dose of Comvax (lot # 653974/0198F) given intramuscularly in the left upper arm.  There was no illness at the time of vaccination. On 26 Oct 2006 following vaccination, the patient developed a fever of 100.6 degrees Fahrenheit, a sore left arm. The patient still complained the next day and the mother noticed that his arm was red and swollen. The site grew worse over the next two days. The patient was seen by a physician on 29 Oct 2006 and the child had a straight line red streak from the injection site above the elbow down to the elbow. No laboratory and diagnostic tests were performed. The patient was treated with ice and Tylenol. Five days later the redness was decreased, still very sore and his temperature had decreased. The outcome was reported as recovered. No product quality complaint was involved. It was reported that four years prior the patient was vaccinated with a dose of Proquad and a dose of varicella virus vaccine; no reaction occurred. It was also noted that at 3 years of age following the fourth dose of Dtap the patient experienced "swollen, red". Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Feeding disorder neonatal, Haematochezia, Intussusception, Listless, Pallor
Clinical narrative: Initial report received on 27 December 2006 from another manufacturer, report number WAES0612USA00490 who ha received the information from agency. An 11-week-old female patient with anemia was vaccinated in the morning of 14 November 2006 with the first intra-muscular dose  in the left leg of IPOL (lot#41031), the first intra-muscular dose, into the left leg of Daptacel (lot#C2650AA), the first oral dose of Rotateq (lot#655174/0848F), the first intra-muscular dose in the right leg Comvax (lot#654147/06793) and the first intra-muscular dose in the right leg of PREVNAR (lot#B08689D). In the morning 29 November 2006, 15 days post vaccination, the patient was noted to be listless, poorly fed and had three bloody mucousy stools. The patient was seen in a physician's office and was described as being pale and listless. The patient was referred to the Pediatric Emergency Room (ER). An air-contrast Barium enema was diagnostic and therapeutic for the patient's intussusception. The patient was subsequently hospitalized for one night. At the time of this report, the patient was considered to be recovered and was doing well. The reporter considered the intussusception to be life-threatening. The records of testing prior to release of the lots (of Rotateq) in question have been rechecked, found to be satisfactory, met requirements of the Center for Biologics Evaluation and Research (CBER) and were released by the regulatory agency.
Sex: F
Vaccine: UNK
Symptoms: Blood pressure increased, Dysphagia, Dyspnoea, Fatigue, Hypersensitivity
Clinical narrative: Immediate rash same day of vaccine looked very much like a sunburn. Spike in blood pressure from 110/80 148/?. Difficulty breathing in next days, difficulty swallowing, general tiredness worsened every day nausea and vomiting.
Sex: F
Vaccine: UNK
Symptoms: Nausea, Rash, Vomiting
Clinical narrative: Immediate rash same day of vaccine looked very much like a sunburn. Spike in blood pressure from 110/80 148/?. Difficulty breathing in next days, difficulty swallowing, general tiredness worsened every day nausea and vomiting.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood creatinine increased, Coordination abnormal, Encephalitis, Feeling abnormal, Headache
Clinical narrative: Information has been received from a registered nurse concerning a 32-year-old male with sleep apnea, drug hypersensitivity (morphine) and allergic reaction to antibiotics (mycin eye drops) and a history of avascular necrosis of the right hip and two unspecified replacement surgeries who on 18-Dec-2006 was vaccinated with a 0.5 ml dose of varicella virus live (Lot#653973/0798F) subcutaneously in the right upper arm. Concomitant therapy clonazepam (KLONOPIN) and lamotrigine (LAMICTAL). Twenty four hours after the vaccination the patient experienced a "weird feeling". On 20-Dec-2006 the patient experienced twitching, fasciculation's of fascia muscles, ataxia, vertigo, severe headache with photophobia and was seen in the emergency room. An infectious disease physician noted three lesions on the patient's chest. A neurologist was consulted for the possibility of encephalitis of Guillain-Barre and the patient was transferred to an intercity hospital where he remained admitted at the time of this report. At the time of this report, the patient is being treated for chicken pox reaction related to post-vaccination. Acyclovir was given but was discontinued due to an increase of creatinine levels in the kidneys. The following tests were performed on 20-Dec-2006: cerebrospinal fluid white cell count (no growth after one day), WBC count (8.9), blood glucose (61), cerebrospinal fluid total protein test (179), hemoglobin (14), hepatic function tests (normal), platelet count (260), potassium (4.1), sodium (236), computed axial tomography of the head (normal), and magnetic resonance imaging (no acute finding). On 03-Jan-2006, a registered nurse reported that she had heard the patient was "getting better" but remained hospitalized. No additional information to report. There was not product quality complaint involved. Feeling weird, twitching, fasciculation's of fascia muscles, ataxia, vertigo, severe headache with photophobia, lesion of chest, and chicken pox reaction requiring intervention (acyclovir) were considered other important medical events (OMIC). Additional information has been requested. ER 12/20/06 with C/O diarrhea, muscle fasciculations, ataxia, vertigo 2 days after varicella vaccine, gradual onset but significantly worse morning of admission.  PMH:Bipolar disorder, right hip avascular necrosis, obstructive sleep apnea. Allergies to mycins and morhpine sulfate. Transferred to Main Methodist Hospital. 03/09/07-reocrds received for DOS 12/1-12/29/06. DC DX: Chickenpox. Peripheral neuropathy. Mild encephalitis secondary to chicken pox. Obstructive sleep apnea. Bipolar disorder.   HX:Injured at work on 12/18/07, received DT and zoster vaccines. On day before admission developed severe posterior headache, photophobia, trouble walking and on day of admission itchy vesicular rash.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Muscle contractions involuntary, Muscle twitching, Photophobia, Skin ulcer, Vertigo
Clinical narrative: Information has been received from a registered nurse concerning a 32-year-old male with sleep apnea, drug hypersensitivity (morphine) and allergic reaction to antibiotics (mycin eye drops) and a history of avascular necrosis of the right hip and two unspecified replacement surgeries who on 18-Dec-2006 was vaccinated with a 0.5 ml dose of varicella virus live (Lot#653973/0798F) subcutaneously in the right upper arm. Concomitant therapy clonazepam (KLONOPIN) and lamotrigine (LAMICTAL). Twenty four hours after the vaccination the patient experienced a "weird feeling". On 20-Dec-2006 the patient experienced twitching, fasciculation's of fascia muscles, ataxia, vertigo, severe headache with photophobia and was seen in the emergency room. An infectious disease physician noted three lesions on the patient's chest. A neurologist was consulted for the possibility of encephalitis of Guillain-Barre and the patient was transferred to an intercity hospital where he remained admitted at the time of this report. At the time of this report, the patient is being treated for chicken pox reaction related to post-vaccination. Acyclovir was given but was discontinued due to an increase of creatinine levels in the kidneys. The following tests were performed on 20-Dec-2006: cerebrospinal fluid white cell count (no growth after one day), WBC count (8.9), blood glucose (61), cerebrospinal fluid total protein test (179), hemoglobin (14), hepatic function tests (normal), platelet count (260), potassium (4.1), sodium (236), computed axial tomography of the head (normal), and magnetic resonance imaging (no acute finding). On 03-Jan-2006, a registered nurse reported that she had heard the patient was "getting better" but remained hospitalized. No additional information to report. There was not product quality complaint involved. Feeling weird, twitching, fasciculation's of fascia muscles, ataxia, vertigo, severe headache with photophobia, lesion of chest, and chicken pox reaction requiring intervention (acyclovir) were considered other important medical events (OMIC). Additional information has been requested. ER 12/20/06 with C/O diarrhea, muscle fasciculations, ataxia, vertigo 2 days after varicella vaccine, gradual onset but significantly worse morning of admission.  PMH:Bipolar disorder, right hip avascular necrosis, obstructive sleep apnea. Allergies to mycins and morhpine sulfate. Transferred to Main Methodist Hospital. 03/09/07-reocrds received for DOS 12/1-12/29/06. DC DX: Chickenpox. Peripheral neuropathy. Mild encephalitis secondary to chicken pox. Obstructive sleep apnea. Bipolar disorder.   HX:Injured at work on 12/18/07, received DT and zoster vaccines. On day before admission developed severe posterior headache, photophobia, trouble walking and on day of admission itchy vesicular rash.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 32-year-old male with sleep apnea, drug hypersensitivity (morphine) and allergic reaction to antibiotics (mycin eye drops) and a history of avascular necrosis of the right hip and two unspecified replacement surgeries who on 18-Dec-2006 was vaccinated with a 0.5 ml dose of varicella virus live (Lot#653973/0798F) subcutaneously in the right upper arm. Concomitant therapy clonazepam (KLONOPIN) and lamotrigine (LAMICTAL). Twenty four hours after the vaccination the patient experienced a "weird feeling". On 20-Dec-2006 the patient experienced twitching, fasciculation's of fascia muscles, ataxia, vertigo, severe headache with photophobia and was seen in the emergency room. An infectious disease physician noted three lesions on the patient's chest. A neurologist was consulted for the possibility of encephalitis of Guillain-Barre and the patient was transferred to an intercity hospital where he remained admitted at the time of this report. At the time of this report, the patient is being treated for chicken pox reaction related to post-vaccination. Acyclovir was given but was discontinued due to an increase of creatinine levels in the kidneys. The following tests were performed on 20-Dec-2006: cerebrospinal fluid white cell count (no growth after one day), WBC count (8.9), blood glucose (61), cerebrospinal fluid total protein test (179), hemoglobin (14), hepatic function tests (normal), platelet count (260), potassium (4.1), sodium (236), computed axial tomography of the head (normal), and magnetic resonance imaging (no acute finding). On 03-Jan-2006, a registered nurse reported that she had heard the patient was "getting better" but remained hospitalized. No additional information to report. There was not product quality complaint involved. Feeling weird, twitching, fasciculation's of fascia muscles, ataxia, vertigo, severe headache with photophobia, lesion of chest, and chicken pox reaction requiring intervention (acyclovir) were considered other important medical events (OMIC). Additional information has been requested. ER 12/20/06 with C/O diarrhea, muscle fasciculations, ataxia, vertigo 2 days after varicella vaccine, gradual onset but significantly worse morning of admission.  PMH:Bipolar disorder, right hip avascular necrosis, obstructive sleep apnea. Allergies to mycins and morhpine sulfate. Transferred to Main Methodist Hospital. 03/09/07-reocrds received for DOS 12/1-12/29/06. DC DX: Chickenpox. Peripheral neuropathy. Mild encephalitis secondary to chicken pox. Obstructive sleep apnea. Bipolar disorder.   HX:Injured at work on 12/18/07, received DT and zoster vaccines. On day before admission developed severe posterior headache, photophobia, trouble walking and on day of admission itchy vesicular rash.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site inflammation, Somnolence
Clinical narrative: Patient received routine WBC, EPS, DT with immunizations on 01/03/2007. Dad called01/05/2007 stated patient was sleeping more and not taking formula well. Patient seen in our office and gained 5 oz and well hydrated inflammation at site of Prevnar injection.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Dyskinesia, Laboratory test abnormal, Myoclonus, Sleep disorder, Tremor
Clinical narrative: Information has been received from an investigator concerning a 30 day old female with no concurrent conditions and a history of hyperbilirubinemia who entered a study. On 21-NOV-2006 and 19-DEC-2006, the patient was vaccinated IM with a first and second 0.5 mL dose of blinded therapy, respectively. On 25-DEC-2006, the patient was admitted to the hospital with a witnessed episode of arm and shoulder rhythmic jerking. The episode lasted approximately 30 seconds. The father stated that the patient was asleep at the time he noted the shaking. The father attempted to awaken the patient and stop the movements but was unsuccessful. Previously witnessed episodes occurred on 21-DEC-2006 and 24-DEC-2006. There were no recent anoxic, infectious, traumatic, or hemorrhagic injuries. There was no history of fever and no other signs of illness. The patient had a complete physical at the time of admission to the hospital on 25-DEC-2006 and no abnormal findings were noted at that time. Multiple tests were ordered and some results remain pending. A basic metabolic profile was within normal limits. Total bilirubin was 5.9, AST/ALT 75/64, blood cultures revealed WBC 7.2, hemoglobin 13.1, urinalysis was within normal limits, cerebrospinal fluid glucose 48, protein 85, WBCs 9, gram stain with a few segs, few leukocytes, no organisms seen, HSV PCR was negative and urine and blood cultures were pending at the time of discharge. The patient was found stable for discharge on 26-DEC-2006 with a discharge diagnosis of "sleep myoclonic activity." The patient was discharged home recovered, in good condition, and free of any symptoms. The reporting investigator felt that myoclonic sleep activity was possibly related to study therapy. The record for this patient was unblinded on 03-JAN-2007. The patient was treated with modified process vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Hypoxia, Wheezing
Clinical narrative: Seriousness Criteria: Other - Medically Significant (OMIC). Initial report received on 28 December 2006 from a consumer, who is also the patient. A 56 year old female patient, received on 19 October 2006, (approximately) 0.25 ml (half dose) of Fluzone vaccine and 15 minutes post vaccination began coughing, wheezing and experienced difficulty breathing. The patient was treated with levalbuterol hydrochloride (Xopenex) and oxygen. The wheezing and difficulty breathing lasted for 2 hours. The coughing lasted for 2 days. The patient had recovered. The patient's medical history included: asthma and allergy to sulfa and IVP dye (anaphylaxis). The patient's concomitant medications included: "Macadis", calcium and ASA.
Age: 21.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Tremor, Vomiting
Clinical narrative: Uncontrolled shaking, passed out, shortness of breath, dizziness, vomiting.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out/fainted within 5 minutes of HPV Gardasil injection. She came to with smelling salts then fainted again. Ambulance called, transported patient to local hospital.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Hyperhidrosis
Clinical narrative: Client received Fluzone '06-07' influenza vaccine at 2:20 pm. At 2:40 pm employee health notified he was cold, clammy, diaphoretic. He was transported to the Emergency  Care Center per wheel chair. Placed on chart, vitals were stable. No other treatment. Discharge from hospital 20 minutes after arrival.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Significant diarrhea without blood up to 8-10 stool a day for 6 days.
Age: 1.24
Sex: F
Vaccine: FLU3, MMRV
Symptoms: Diarrhoea, Rash papular, Upper respiratory tract infection
Clinical narrative: Fine pink papular rash forehead, chest, back, diarrhea 2 days prior to this and recent mild URI symptoms.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: Initial report received from a health care professional in the USA on 12 December 2006. A 18 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 24 November 2006, the patient called to reports red spots on hands. The patient did not have any illness at the time of the vaccination. She was treated with Benadryl. She was not seen at the doctor's office and has moved. It was reported that she recovered.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Hypersensitivity, Pruritus, Skin burning sensation
Clinical narrative: Initial report received from a health care professional in the USA on 12 December 2006. A 18 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 24 November 2006, the patient called to reports red spots on hands. The patient did not have any illness at the time of the vaccination. She was treated with Benadryl. She was not seen at the doctor's office and has moved. It was reported that she recovered.
Age: 20.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, FLUX, HPV4, MNQ, FLU3, HPV4, MNQ
Symptoms: Erythema, Flushing, Pruritus, Rash macular
Clinical narrative: Initial report received from a health care professional in the USA on 12 December 2006. A 18 year old, female patient (with a medical history of no known allergies) developed a flushed, red and itchy face, 2 days after she received Fluzone (lot number U2240AA) intramuscularly in the left deltoid, Menactra (lot number U2159AA) intramuscularly in the right deltoid and Gardasil (lot number unknown) on 20 November 2006. On 24 November 2006, the patient called to reports red spots on hands. The patient did not have any illness at the time of the vaccination. She was treated with Benadryl. She was not seen at the doctor's office and has moved. It was reported that she recovered.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dyspnoea, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Red raised hot area 5 inches x 5 inches on right upper arm nausea/vomiting within 10 minutes of administration shortness of breath for 24 hours after administration chills and fever 102.4. Given Benadryl: Tylenol, Albuterol, Moist heat area.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Grand mal convulsion, Nervous system disorder
Clinical narrative: Had Grand Mal seizure about 1 hour after receiving Pneumovax. The seizure reportedly lasted about 5 minutes. He suffered a laceration over his right eyebrow and was admitted to the hospital.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Fine rash to neck, chest, and arms accompanied by pruritus took Benadryl 25 mg every 4-6 hours as needed for itching. Saw FP provider 10/30/06 prescribed triamcinolone ointment.
Age: 1.02
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin ulcer
Clinical narrative: Areas of red raised pre-vesicular lesions trunk and groin.
Age: 17.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Unevaluable event
Clinical narrative: advised mother to call client's pediatrician for further evalutation.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: I received the flu vaccine and the shingles vaccine at the same time.  The shingles vaccine is named Zostavax (I believe).  I have redness, some swelling, itching, and soreness and the site of the shingles injection.  No treatment at present time.
Age: 50.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Tinnitus
Clinical narrative: Tinnitus showed up a few days after vaccination and has gotten worse. Constant ringing in ears and chirping sounds.
Age: 7.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: THE PATIENT COMPLAINED OF SORENESS AT THE INJECTION SITE AND LATER IN THE EVENING, HER ARM SWELLED. THE NEXT DAY, THE SWELLING AND REDNESS WAS MORE PRONOUNCED AND SHE SPIKED A FEVER OF 101 DEGREES FAHRENHEIT. ON EXAMINATION, HER LEFT DELTOID HAD A 9 CM X 9 CM X 3 CM SWELLING AND INDURATION, IT WAS ALSO TENDER AND WARM.