chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Diarrhoea, Eye pain, Fatigue, Migraine, Multiple myeloma
Clinical narrative: Multiple Myeloma, Asthma, Joint Pain, Erectile Dysfunction, Pneumonia, Optic Nerve Pain. Per follow up report received 05/06/2005:  Patient had not recovered. Medical records reviewed stated patient experienced thrombocytopenia, proteinuria, anemia and compression fractures of the spine.
Age: 45.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Nasal congestion, Optic neuritis, Penis disorder, Pneumonia, Pyrexia
Clinical narrative: Multiple Myeloma, Asthma, Joint Pain, Erectile Dysfunction, Pneumonia, Optic Nerve Pain. Per follow up report received 05/06/2005:  Patient had not recovered. Medical records reviewed stated patient experienced thrombocytopenia, proteinuria, anemia and compression fractures of the spine.
Age: 45.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Vomiting, Wheezing
Clinical narrative: Multiple Myeloma, Asthma, Joint Pain, Erectile Dysfunction, Pneumonia, Optic Nerve Pain. Per follow up report received 05/06/2005:  Patient had not recovered. Medical records reviewed stated patient experienced thrombocytopenia, proteinuria, anemia and compression fractures of the spine.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pruritus, Rash macular, Rash pustular
Clinical narrative: Pt developed sporadic flat erythematous macular lesions on chest with itching.  I diagnosed as non viral pustulosis and treating with oral antihistamine and topical steroid to chest rash.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Decreased appetite, Fontanelle bulging, Pyrexia, Somnolence
Clinical narrative: Mother called on 1/27/05 stating that she took pt(and twin sibling- also reported on) to E.D. on 1/26/05 which was one day after patient received vaccines due to the following symptoms:  "bulging soft spot", increased sleep, decreased appetite, low grade fever up to 100.7 (rectal), and mild cough. E.D. diagnosed pt (per mother's report) as "possible reaction to DTaP".  Pt was sent home from the E.D.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site rash, Rash, Rash macular
Clinical narrative: WHILE STILL IN CLINIC, CHILD DEVELOPED BLOTCHY RED RASH ON FACE FIRST, THEN ON CHEST AND STOMACH AREAS, AND AT INJECTION SITES. BENEDRYL 1 TSP PO WAS GIVEN AT 9:43 A.M.  RASH HAD ALREADY STARTED TO FADE ON FACE, AND RASH WAS TOTALLY GONE FROM BODY WITHIN 20 MINUTES.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Decreased appetite, Fontanelle bulging, Pyrexia, Somnolence
Clinical narrative: Pt received 6 mo vaccines on 1/25/05. Parent called 1/27/05 reporting that she took pt and twin sib (already reported on) to E.D. 1/26/05 due to the following sx's which began 11pm on 1/25/05:  "bulging soft spot", increased sleepiness, decreased appetite, low grade fever up to 100.7, and mild cough. E.D. diagnosis per mom was "possible reaction to DTaP". No bloodwork was done at E.D.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Infection, Pyrexia
Clinical narrative: Approximately 16 hrs after shots patient had a seizure, and was taken to the emergency room. Emergency room Dr. diagnosed patient with double ear infection along with fever. Patient was released from E.R. at around 2:30 p.m. on 02/24/2005.
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Contusion, Pruritus, Urticaria
Clinical narrative: Received Twinrix on February 8th, 2005. States that on February 11 or 12th she started with some itching and by the 23rd of February she now has hives covering from her neck to her knees. States that on the 15th of February she also noted a blue streak, appeared like a bruise, that was approximately 2 inches long that started at the injection site of her left arm. This site is slowly fading.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypersensitivity, Rash
Clinical narrative: This 2 month old female presents today with chief complaint of skin eruption. Patient seen after office hours at 10:20 PM at the clinic. Child received Pediarix, Hib and Prevnar at 6 PM today. Allergic reaction.
Age: 0.41
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Abnormal behaviour, Antisocial behaviour, Speech disorder
Clinical narrative: The baby stopped babbling immediately.  Did not make a sound for a month, did not babble again until 4 months later, but not as well as before vaccination.  Also started within 24 hours, odd behaviors like repetative hand flapping.  Slowly developed eating issues.  Eye contact slowly decreased.  Did not respond when called name.  Did not progress much relationally and socially after shot.  Developed 50 words by 16 months, lost all words by 18 months.  Requires speech therapy, occupational therapy, feeding therapy, intensive behavioral therapy, and Relationship Development Intervention.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Cough, Dysphonia
Clinical narrative: Cough , hoarseness
Age: 28.0
Sex: F
Vaccine: HEP, TYP
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: This 27 year old female took the first capsule of Vivotif (typhoid vaccine live oral Ty21a) on 03/12/2004, 8:30AM. Five hours later on 03/12/2004, 13:30PM she developed extreme stomach cramping, frequent diarrhea, chills, slight nausea and fatigue. Symptoms resolved within 24 hours except for a sore stomach lasting longer.
Age: 60.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Blister, Neck pain, Swelling
Clinical narrative: This 59 year old female took the fourth capsule of Vivotif on 05/05/2004.  12 days later, on 05/17/2004 she developed blisters on tongue, neck pain and swelling.  Outcome was not reported. She concommitantly received vaccinations with Hepattis A, Havrix and Polio vaccine. Follow up information received on 06/17/2004:  The reporter stated that there was no swelling, but sleepiness with sudden onset.  The symptoms completely resolved.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: This 34 year old female was vaccinated with Vivotif on 06/25/2004.  One day later on 06/26/2004 the patient developed nausea,  vomiting, abdominal pain, dizziness and fever.  The symptoms completely resolved.  From the patient's history abdominal bypass surgery 3 years ago is known.
Age: 58.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: This 57 year old male took the first Vivotif capsule (Typhoid Vaccine Live oral Ty21a, batch no. 3000416) on 09/03/2004 before dinner on empty stomach. Then two hours after the dinner he developed abdominal cramps. The second capsule he took on 09/05/2004 without any problems. On 09/05/2004 one hour before dinner he took the third capsule and again developed abdominal cramps one hour after dinner, additionally he experienced vomiting and nausea. The symptoms lasted throughout the night. The patient did not take the fourth capsule. Pharmacovigilance Comments: This case is considered non-serious and expected. Causality is assessed as possible.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: This 40 year old male took the first capsule of Vivotif on 10/04/2004.  About 6 hours later he noted an itchy rash on trunk and thighs.  He had no other new exposure that day.  He was examined on 10/05/2004 and found to have a diffuse erythermatous papulo-vesicular rash.  Under topical treatment with beclomathasone and peroral treatment with loratadine the rash resolved within 24 hours.
Age: 0.33
Sex: F
Vaccine: DTP, HIBV, IPV, PNC
Symptoms: Abscess, Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information received from a physician concerning a 17 week old female with no relevant medical history who on 10/13/2004 was vaccinated in the left thigh with a dose of HiB conjugate vaccine (OMPC) (lot 648204/0015P). On 10/13/2004, the patient was concomitantly vaccinated with a dose of polio virus vaccine in the left thigh below the HiB conj. vaccine (OMPC) administration site, a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid in the right thigh and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (CRM197) (Prevnar) in the right thigh. On 10/14/2004, the patient was seen with a slight fever of 100 degrees Fahrenheit and red streaks 2 inches long in the lateral aspect of the left thigh.  There was also a streak from the polio virus vaccien 3cm downward. The physician noted that the patient received  diptheria toxoid (+)pertussis vaccine (unspecified) (+) tetanus toxoid in the right thigh and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (CRM197) (Prevnar) in the right thigh with no reactions noted. The physician reported that the patient was treated with amoxicillin/clavulanic acid (Augmentin ES) - The physician reported that the patient received both vaccines in the same thigh in the past with no reactions. The patient was seen in the office later in the day on 10/14/2004 and the area on the thigh was worse. The patient was sent to the ER for blood cultures and possible admission. The patient was subsequently hospitalized on 10/14/2004. The physician requested a lot check for lot 648204/0015P. On 10/18/2004, the physician indicated the baby's injection site was very indurated with a sterile abscess. The patient's fever and injection site erythema, induration, and sterile abscess were considered other medical events.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be statisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additonal information has been requested. (OMIC)
Age: 0.33
Sex: F
Vaccine: DTP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Information received from a physician concerning a 17 week old female with no relevant medical history who on 10/13/2004 was vaccinated in the left thigh with a dose of HiB conjugate vaccine (OMPC) (lot 648204/0015P). On 10/13/2004, the patient was concomitantly vaccinated with a dose of polio virus vaccine in the left thigh below the HiB conj. vaccine (OMPC) administration site, a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid in the right thigh and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (CRM197) (Prevnar) in the right thigh. On 10/14/2004, the patient was seen with a slight fever of 100 degrees Fahrenheit and red streaks 2 inches long in the lateral aspect of the left thigh.  There was also a streak from the polio virus vaccien 3cm downward. The physician noted that the patient received  diptheria toxoid (+)pertussis vaccine (unspecified) (+) tetanus toxoid in the right thigh and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (CRM197) (Prevnar) in the right thigh with no reactions noted. The physician reported that the patient was treated with amoxicillin/clavulanic acid (Augmentin ES) - The physician reported that the patient received both vaccines in the same thigh in the past with no reactions. The patient was seen in the office later in the day on 10/14/2004 and the area on the thigh was worse. The patient was sent to the ER for blood cultures and possible admission. The patient was subsequently hospitalized on 10/14/2004. The physician requested a lot check for lot 648204/0015P. On 10/18/2004, the physician indicated the baby's injection site was very indurated with a sterile abscess. The patient's fever and injection site erythema, induration, and sterile abscess were considered other medical events.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be statisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additonal information has been requested. (OMIC)
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 week old Caucasian female with panhypopituitarism who on 6/23/04 at10:30 AM was vaccinated with a second dose of HIB conjugate vaccine (lot # 648205/0034P), IM in the left thigh. Concomitant therapy that day at 10:35 AM included a second dose of diphtheria toxoid (+) hepatitis B virus vaccine (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (lot # 21919B9), IM in the right thigh. On 6/23/04 in the AM (previously reported as 6/24/04) the patient developed a high fever and had a seizure that lasted 10 minutes. The patient was taken to the emergency room for treatment. Unspecified medical attention was sought. No product quality complaint involved. Upon review, seizure was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 1.99
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pruritus, Rash erythematous
Clinical narrative: Started Sunday 02/20/2005 scattered red raised bumps on arms, upper torso, upper part of legs. Itch , hurt.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Ear pain, Hypoaesthesia, Neck pain
Clinical narrative: Neck pain right side.  Ear pain right side.  Numbness on half of tongue.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: CSF test abnormal, Gait disturbance, Guillain-Barre syndrome, Headache, Hyperkalaemia
Clinical narrative: Pt presented with SIADH and muscle weakness and was coincidentally diagnosed with Guillain Barre. She was treated with PO demeclocycline and IVIG and physical therapy.  04/20/05 Involved case final diagnosis of GBS, with URI Hx prior to flu vax, with onset of S/S 10 days' post flu vax. Pt presented w inability to stand, walk, myalgia and some worsening of low back pain. On exam strength noted to be 5/5 in all extremities but w absent DTR's in lower extremities. Pt's labs were consistent w SIADH and initial intervention focused on correcting the electrolytes. The following day, the chemistries became increasingly altered and mental status changes of hallucinations and disorganized speech. Work-up at that point included CT's of chest and head (which had unsure clinical significance or negative), LP with Protein level 159 and EMG which showed slowing of nerve conduction in lower extremities and changes in both motor and sensory nerves of upper extremities.  Pt in MICU due to Hyponatremia  & MRI of head at this time showed tiny scattered areas of deep white matter with a high C2 signal(of doubtful significance).  Questional Dx of viral meningitis and lupus cerebritis was ROed and after being transfered back to floor, pt given 4 rounds of IVIG, pt's mental status cleared dramatically, her sodium level trended upward with increased dose of Demeclocycline. She did have increase in BP, controlled w metoprolol; With these changes, pt transfered to rehab.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Hyponatraemia, Inappropriate antidiuretic hormone secretion, Ketosis, Laboratory test abnormal
Clinical narrative: Pt presented with SIADH and muscle weakness and was coincidentally diagnosed with Guillain Barre. She was treated with PO demeclocycline and IVIG and physical therapy.  04/20/05 Involved case final diagnosis of GBS, with URI Hx prior to flu vax, with onset of S/S 10 days' post flu vax. Pt presented w inability to stand, walk, myalgia and some worsening of low back pain. On exam strength noted to be 5/5 in all extremities but w absent DTR's in lower extremities. Pt's labs were consistent w SIADH and initial intervention focused on correcting the electrolytes. The following day, the chemistries became increasingly altered and mental status changes of hallucinations and disorganized speech. Work-up at that point included CT's of chest and head (which had unsure clinical significance or negative), LP with Protein level 159 and EMG which showed slowing of nerve conduction in lower extremities and changes in both motor and sensory nerves of upper extremities.  Pt in MICU due to Hyponatremia  & MRI of head at this time showed tiny scattered areas of deep white matter with a high C2 signal(of doubtful significance).  Questional Dx of viral meningitis and lupus cerebritis was ROed and after being transfered back to floor, pt given 4 rounds of IVIG, pt's mental status cleared dramatically, her sodium level trended upward with increased dose of Demeclocycline. She did have increase in BP, controlled w metoprolol; With these changes, pt transfered to rehab.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Leukocytosis, Muscular weakness, Myalgia, Pain, Thinking abnormal
Clinical narrative: Pt presented with SIADH and muscle weakness and was coincidentally diagnosed with Guillain Barre. She was treated with PO demeclocycline and IVIG and physical therapy.  04/20/05 Involved case final diagnosis of GBS, with URI Hx prior to flu vax, with onset of S/S 10 days' post flu vax. Pt presented w inability to stand, walk, myalgia and some worsening of low back pain. On exam strength noted to be 5/5 in all extremities but w absent DTR's in lower extremities. Pt's labs were consistent w SIADH and initial intervention focused on correcting the electrolytes. The following day, the chemistries became increasingly altered and mental status changes of hallucinations and disorganized speech. Work-up at that point included CT's of chest and head (which had unsure clinical significance or negative), LP with Protein level 159 and EMG which showed slowing of nerve conduction in lower extremities and changes in both motor and sensory nerves of upper extremities.  Pt in MICU due to Hyponatremia  & MRI of head at this time showed tiny scattered areas of deep white matter with a high C2 signal(of doubtful significance).  Questional Dx of viral meningitis and lupus cerebritis was ROed and after being transfered back to floor, pt given 4 rounds of IVIG, pt's mental status cleared dramatically, her sodium level trended upward with increased dose of Demeclocycline. She did have increase in BP, controlled w metoprolol; With these changes, pt transfered to rehab.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Dermatitis, Eczema, Eosinophilia, Rash, Rash maculo-papular
Clinical narrative: 2/24/05 note: Information taken from the scientific literature article. Subject is a 24 year old female with  no prior history of skin problems, rhinitis or asthma and no family history of allergic diseases. The dose, date, and lot # of the Anthrax vaccine are unk. Concomitant medications at the time of the event, other vaccine history, concomitant illness at the time of the vaccination, and previous reactions to vaccines are unk. In 1998, after the initial series of three Anthrax vaccinations, the pt complained of eczema. The rash appeared as an eczematous dermatitis of her arms, thighs and trunk. Two days after the 4th vaccine, new macules and papules developed on her trunk and extremities. Eruption on her trunk and extremities worsened after the 5th vaccination. After the first three Anthrax vaccinations, topical steroids were used to treat the rash which improved over a few months. After the 5th Anthrax vaccination, oral steroids improved the rash after several days. A skin biopsy performed revealed spongiotic dermatitis with eosinophils. A skin prick test to Anthrax vaccine and tests of complement and immune complexes were negative. No hematologic, hepatic or renal abnormalities, nor evidence of inflammation or autoantibodies were detected per laboratory evaluation. At the time of this report, it is unk if the pt recovered from these events.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Pruritus, Throat tightness
Clinical narrative: Fluzone administered 11:40 AM 02/23/2005.  From 2:00 to 6:30PM same day, complained of subjective throat tightness, dyspnea and itching.  Objective findings minimal.  No apparent distress, no stridor, lungs clear to ascultation with wheeze.  Developed 2-3 macular, itchy erythematous patches.  Treated with Benadryl  and observed for 2 hours.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Symptoms:  4cm of erythema, 1cm of induration.  Treatment:  None; recovery 4 days.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Skin burning sensation
Clinical narrative: 4 x 2 1/2 inch area of erythema left upper extremity, burning, itch.  Weakness of grip due to pain.  Treatment:  Prednisone burst, Motrin as needed; recovery 2 days after start of prednisone.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Injection site discolouration, Pyrexia
Clinical narrative: 4 x 5 inch red firm warm area on right outer thigh with centrally blanched area around injection site.  Temp 99.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: 02/14/2005 - 5 year old male child given 3 vaccines - DTAP right deltoid intramuscular, IVP - left arm subcutaneous, MMR - right arm subcutaneous.   02/17/2005 child presented with redness, swollen area 1x1.5 inches with warmth, complained of itching "but not so bad today" said child.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Post vaccination autoinoculation, Pruritus, Skin ulcer, Swelling
Clinical narrative: 27 year old male reports "redness and swelling with bumps on my eyes since Sunday".  Referred to vaccine healthcare center for probable autoinoculation following smallpox vaccine.  Also, noted new lesions on his trunk and legs last pm. Received primary smallpox vaccine (3 jabs, left arm) on 01/26/2005.  His smallpox vaccine site has followed typical progression, with reported pruritis of site.  Vaccine site assessed as "major reaction" on 02/02/2005.  Systemic tender, swollen gland in his left axilla on 02/04, which seems to be resolving.  On Sunday, 02/06/2005, patient noted some "bumps", redness, and swelling on his eyelids.  When he awoke on 02/07/2005, the eyelids were worse, and he sought evaluation at site where he received the vaccine .  he was evaluated by the FNP who consulted with the physician.  Patient was referred to Opthamology and was seen that morning, 02/09/2005.  He was also seen by the Dermatologist for evaluation of non-pruritic, acne-like lesions on his trunk and upper legs, which he first noted last night, 02/08/2005. patient denies eye pain, visual photosensitivity, blurred vision, or decreased visual acuity.  He does not wear contacts or glasses.  He denies any recent use of eye drops. Patient had received a general briefing on smallpox vaccine shortly after arriving with a separate specific briefing on small vaccine site care on the day of vaccine receipt.  He received trifold pamphlet on smallpox vaccine.  He denies illness or symptoms on the day of vaccine receipt.  Patient reports practicing frequent hand washing, specifically after touching vaccine site or bandages.  He has been keeping vaccine site covered with a 2x2 band-aid with adhesive on all sides or a standard band-aid.  He has been wearing a short sleeve t-shirt to bed with a standard band-aid over the vaccine site.  He thinks the most likely explanation of mechanism of autoinoculation would be that he scratched the site (under the band-aid) and then rubbed his eyes during his sleep.  His current living arrangements are with 3 other roommates (all recently vaccinated with SPV) in a barracks setting.  He has a tentative deployment date of 02/22.
Age: 1.16
Sex: M
Vaccine: HIBV, IPV, TD, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever, Febrile seizure.  Tylenol and Motrin used to treat.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Autoantibody positive
Clinical narrative: Autonoculation of smallpox from left deltoid to left cheek.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Movement disorder, Pain
Clinical narrative: Local left upper arm reaction red, raised indurated 8cm x 8cm.  Patient having trouble moving arm.  Left arm painful with movement.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: Raised red area after injection, hive adjacent to MMR site with center induration. Doctor prescribed Benadryl 12.5/5ml. On 02/23/05 call placed to dad at 2 pm, he states area is going away after taking benadryl. Called dad 4 pm, child sleeping no respiratory distress noted.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Feeling hot, Gait disturbance, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Information has been received from a nurse and the mother of a 37 month old male with a milk allergy that causes constipation and mild GERD and a history of upper respiratory infections for which he received levalbuterol hydrochloride (XOPENEX) aerosol treatments who on 02Feb04 was vaccinated IM in the right thigh with a dose of Hib conj vaccine. On 02Feb04 the pt was also vaccinated in the right thigh with a dose of poliovirus vaccine inactivated (unspecified) (Lot U0612), a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot A600A2) and a dose given SC of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live  (RA 27/3) (lot 644845/0138N). The pt's mother noted that one of the vaccines was given in his right thigh and one in his arm. The nurse reported that the sites of administration and manufacturers were not documented. Other concomitant medication included motelukast sodium. There was no illness at the time of vaccination. On 03Feb04 the pt's mother called the office with complaints of a reaction in the pt's leg. She noticed that he was twice as big as the other one, and it was red and hot to the touch. The doc suggested a multivitamin, and acetaminophen (Tylenol), diphenhadramine (Benadryl) and ibuprofen (Motrin) as needed. The mother reported that later that day the swelling had worsened, and he was unable to stand up. She brought him to the ER, and he was given cetirizine hydrochloride (Zyrtec), acetaminophen (Tylenol) and diphenhydramine (Benadryl) and prednisolone sodium phosphate (Orapred) 5mg (2 tsp). The ER diagnosis was an acute large local reaction of the right thigh. The pt was not admitted to the hospital. On 04Feb04 the mother reported that her son's leg was still swollen and hard, but the redness was gone and it was no longer hot to the touch. He was able to stand but he had difficulty walking. On 05Feb04 the pt was seen for follow up in the doctor's office, and according to the nurse, was considered recovered. The nurse believed this adverse event to be non serious. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse and the mother of a 37 month old male with a milk allergy that causes constipation and mild GERD and a history of upper respiratory infections for which he received levalbuterol hydrochloride (XOPENEX) aerosol treatments who on 02Feb04 was vaccinated IM in the right thigh with a dose of Hib conj vaccine. On 02Feb04 the pt was also vaccinated in the right thigh with a dose of poliovirus vaccine inactivated (unspecified) (Lot U0612), a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot A600A2) and a dose given SC of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live  (RA 27/3) (lot 644845/0138N). The pt's mother noted that one of the vaccines was given in his right thigh and one in his arm. The nurse reported that the sites of administration and manufacturers were not documented. Other concomitant medication included motelukast sodium. There was no illness at the time of vaccination. On 03Feb04 the pt's mother called the office with complaints of a reaction in the pt's leg. She noticed that he was twice as big as the other one, and it was red and hot to the touch. The doc suggested a multivitamin, and acetaminophen (Tylenol), diphenhadramine (Benadryl) and ibuprofen (Motrin) as needed. The mother reported that later that day the swelling had worsened, and he was unable to stand up. She brought him to the ER, and he was given cetirizine hydrochloride (Zyrtec), acetaminophen (Tylenol) and diphenhydramine (Benadryl) and prednisolone sodium phosphate (Orapred) 5mg (2 tsp). The ER diagnosis was an acute large local reaction of the right thigh. The pt was not admitted to the hospital. On 04Feb04 the mother reported that her son's leg was still swollen and hard, but the redness was gone and it was no longer hot to the touch. He was able to stand but he had difficulty walking. On 05Feb04 the pt was seen for follow up in the doctor's office, and according to the nurse, was considered recovered. The nurse believed this adverse event to be non serious. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Joint range of motion decreased, Multiple epiphyseal dysplasia, Sleep apnoea syndrome, Torticollis
Clinical narrative: Information has been received from a physician concerning a 9 week old female with a medical history of sleep apnea without heart deceleration. Vertex presentation with no perinatal problems and no family history of musculoskeletal problems or dyplasia of the hip who on 04/23/2003 was vaccinated with a dose of Hib conj vaccine (OMPC) (manufacturer unk.). Concomitant therapy on 04/23/2003 included diphtheria toxoid(+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. The patient was seen by an orthopecidic speciallist on 05/01/2003 with regard to her neck. On approximately 04/23/2003, "in the last few weeks" , it was noted that she tended to keep her left ear towards her left shoulder and her chin to the right. "Over the last week or two", she had been positioned and stretched by her mother and she seemed to be improving. The patient was diagnosed with positional torticollis. On exam, the child was healthy and well proportioned. The physicain did not see signifigant posturing towards the left ; however the  patients' mother mentioned that she did not keep her ear to the left shoulder and her chin to the right. There was no nodule in the sternomastoid muscles. There was full range of motion of the cervical spine. Her hips had 85 to 90 degrees of abduction. There was a negative Barlow's and a negative Ortolani's test. Internal rotation was 40 degrees and external rotation was 50 degrees. Her kneess had full extension. There was no significant metatarsus adductus. The physician recommended that the child sleep with her chin to the left and that she should be stretched with her right ear to the right shoulder and she should be made to look up to the left as much as possible. A follow up visit was recommeded in the two months. The physician also noted that he expected this would resolve "without a lot of treatment". A follow up visit with the orthopedic specialist on 07/24/2003 revealed persistant mild torticollis which was improving. It was noted that the child had changed in her positions and was monitored in how she slept. Her mother stated that she still saw a tendency for the child to positon to the left, however, the physician "could not see any evidence of that". She had active and passive motion in both directions which were equal. There were no nodules in the neck and passive range of motion was full. Hip abduction was 85 degrees bi laterally. The diagnosis was positional torticollis, resolved. The physician reassured the mother that as long as she made sure the child did not sleep in one position, this would  continue to improve and by 9-12 months, she shouldn't notice any differences. The reporter also mentioned the patients' mother (WAES#0208USA01862) who experienced an exposure during pregnancy with varicella virus vaccine live (MSD). No further information is expected.
Age: 0.08
Sex: M
Vaccine: HIBV, PNC
Symptoms: Medication error, Vomiting
Clinical narrative: Information has been received from a physicain concerning a 30 day old male with no medical history and no allergies who 0n 04/05/2004 was vaccinated with a dose of Hib conjugate vaccine(OMPC)(lot #647881/1250N). Concomitant vaccine therapy included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine(CRM197)(PREVNAR)t was reported that the pt. inadvertently received the Hib conj vazvvine(OMPC) at 4 weeks old. The pt dreveloped vomiting that same afternoon which subsequently subsided. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. Additonal information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Medication error
Clinical narrative: This report was received from manufacturer for Pediarix and was assigned manufacturer control number A0505621A.This report concerns a 9 week old female patient with no allergies and no known past medical history who on 03/16/2004 was vaccinated with a first dose of Hib conj vaccine (OMPC) (manufacturer unk). Concomitant vaccination on 03/16/2004 included a first 0.5ml dose of diphtheria toxoid(+)hepatitis B virus vaccine rHBsAg (yeast)(+)pertussis acellular 3-component vaccine (+) poliovirus inactivated (Vero)(+) tetanus toxoid (Pediarix)(lot#21883B2) amd a first dose of pneumococcal 4 6B 9V 18C 19F 23F conj vaccine (crm197)(Prevnar). There was no illness at the time of vaccination. It was noted this was the patient's first set of vaccinations and she was the first baby born to a young couple. The reporter stated the patient inadvertently received first 0.5ml dose of diphtheria toxoid(+) hepatitis B virus vaccine rHBsAg(yeast)(+)pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero)(+)tetanus toxoid (Pediarix)(lot#21883B2) that was past the labeled expiration date of 03/11/2004. Subsequently on 03/16/2004, the patient developed irritability. The parents thought the patient was more irritable than she should have been. Medical attention was not sought, laboratory tests were not performed and no treatment was given. The irritability lasted only the evening of the vaccinations. On 03/16/2004, the irritability resolved with no other problems. This was originally reported by a registered nurse. Additional information is not expected.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor, Tremor neonatal
Clinical narrative: Information has been received from GlaxoSmithKline (manufacturer control no A0528466A) from the mother of a 21 week old male who on 09/13/2004 was vaccinated with a dose of Hib conj vaccine(OMPC), a second dose of diphtheria toxoid(+) Hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (Pediarix) and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine(CRM197)(Prevnar). Concomitant therapy included acetaminophen(Tylenol). The patients mother reported that she felt, " what appeared to be the baby experiencing tremors twice during the pregnancy" The patients concurrent conditions were not reported. Approximately 11 days after the administration of the vaccines, on 09/24/2004, the patient experienced "shaking and tremors while nursing" The event lasted "about 10 seconds" On 09/27/2004, the patient experienced a tremor described as "head shaking" The head shaking "lasted a shorter period of time than the tremors on 09/24/2004. On 10/02/2004, the patient experienced a tremor " in both his legs" the patient was seen at a physicians office. The event was ongoing at the time of the report. No further infomation is available.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor
Clinical narrative: Information has been received from GlaxoSmithKline (manufacturer control no A0528466A) from the mother of a 21 week old male who on 09/13/2004 was vaccinated with a dose of Hib conj vaccine(OMPC), a second dose of diphtheria toxoid(+) Hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (Pediarix) and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine(CRM197)(Prevnar). Concomitant therapy included acetaminophen(Tylenol). The patients mother reported that she felt, " what appeared to be the baby experiencing tremors twice during the pregnancy" The patients concurrent conditions were not reported. Approximately 11 days after the administration of the vaccines, on 09/24/2004, the patient experienced "shaking and tremors while nursing" The event lasted "about 10 seconds" On 09/27/2004, the patient experienced a tremor described as "head shaking" The head shaking "lasted a shorter period of time than the tremors on 09/24/2004. On 10/02/2004, the patient experienced a tremor " in both his legs" the patient was seen at a physicians office. The event was ongoing at the time of the report. No further infomation is available.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Nausea, Rash, Vomiting
Clinical narrative: This 19 year old female started to take the 4 dose regimen Vivtotif (oral typhoid vaccine) on  01/16/2004. After ingesting the second dose on 01/18/2004 she experienced nausea and vomitting, abdominal cramps and rash. She subsequently discontinued to take further capsules. The patient recovered without sequelae. Pharmacovigilance Comments: Nausea, vomiting, abdominal cramps and rash are known to occur after intake of the oral typhoid vaccine. These ADR's are labeled and therefore expected. The causality is assessed as possible.
Age: 29.0
Sex: F
Vaccine: DT, HEPA, TYP
Symptoms: Rash, Urticaria
Clinical narrative: This 29 year old female was vaccinated with Vivotif (oral typhoid vaccine type Ty21a)(batch no: 3000231). She took the first capsule on 01/10/2004 and the last capsule on 01/18/2004. Four days after the intake of the last capsule, on 01/23/2004 she developed a rash and hives which required an emergency room visit. She was treated with diphenhydramine and prednisone. She left for Nicaragua on 01/26/2004 from where she forwarded by fax that the hives worsened again.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: This 23 year old male was vaccinated with Vivotif (Ty21a oral typhoid vaccine: batch no. 3000297) on 05/08/2004 at 9:30 A.M.. One day later, on 05/09/2004 at 3:00 he woke up with chills, shaking, and maybe. At 7:00 A.M. he experienced headache, nausea, and sweats. He took ibuprofen and felt better by 12:00 A.M.. By 05/10/2004 the symptoms had completely resolved. One day before the vaccination with Vivotif he received Hepatitis A immunization with Havrix, Hepatitis B immunization with Engerix and Yellow Fever vaccine. From the patients history an allergy to pollen and animal dander are known but the patient does'nt remember if the doctor examined these allergies. Pharmacovigilance Comments: This case is considered non-serious and the reactions except for hyperhydrosis as expected.  Causality is assessed as possible.
Age: 10.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: This 10 year old male received the first dose of the oral typhoid vaccine on 06/05/2004 before noon, after 10:00 pm he experienced fever and nausea/ vomiting for one day. He completely recovered.
Age: 26.0
Sex: M
Vaccine: HEPAB, IPV, TYP
Symptoms: Balanitis, Erythema, Hypersensitivity, Oral mucosal blistering, Periorbital oedema
Clinical narrative: This 26 year old male took the first capsule of Vivotif (Ty21a oral typhoid vaccine, batch no. 3000341) on  07/19/2004 and concomitantly he was vaccinated with Twinrix i.m. and polio s.c.. One day later, on 07/20/2004 he developed redness, puffiness amd itching to the shaft of the penis, on 07/21/2004 he developed further blisters around the mouth. In spite of the symptoms he took the second Vivotif capsule on 07/21/2004. The symptoms continued  and additionally he developed oedema of the medial part of the eyes, nose, and mouth. He continued the vaccination and took the 3rd capsule on 07/23/2004 and the last capsule on 07/25/2004. The same day after the last  dose he noticed a rash on knuckles. At the time of reporting the outcome was not known and the patient did not yet contact his primary care physician. Pharmacovigilance Comments: The patient was concomitantly vaccinated against polio, hepatitis A/ B, and typhus: the symptoms can not be specifically assigned to one of the administered vaccines. However, the close time relationship , the continuation and the increasing intensity of the symptoms over time is a strong argument for a possible causality for Vivotif. Hypersensitivity reactions are known to occur following oral typhus immunization and hypersensitivity reactions are therefore  labeled for Vivotif. The case is assessed as expected, non-serious and causality possible. Further information on the outcome and possibly performed allergy test had been requested.
Age: 26.0
Sex: M
Vaccine: HEPAB, IPV, TYP
Symptoms: Pruritus, Rash
Clinical narrative: This 26 year old male took the first capsule of Vivotif (Ty21a oral typhoid vaccine, batch no. 3000341) on  07/19/2004 and concomitantly he was vaccinated with Twinrix i.m. and polio s.c.. One day later, on 07/20/2004 he developed redness, puffiness amd itching to the shaft of the penis, on 07/21/2004 he developed further blisters around the mouth. In spite of the symptoms he took the second Vivotif capsule on 07/21/2004. The symptoms continued  and additionally he developed oedema of the medial part of the eyes, nose, and mouth. He continued the vaccination and took the 3rd capsule on 07/23/2004 and the last capsule on 07/25/2004. The same day after the last  dose he noticed a rash on knuckles. At the time of reporting the outcome was not known and the patient did not yet contact his primary care physician. Pharmacovigilance Comments: The patient was concomitantly vaccinated against polio, hepatitis A/ B, and typhus: the symptoms can not be specifically assigned to one of the administered vaccines. However, the close time relationship , the continuation and the increasing intensity of the symptoms over time is a strong argument for a possible causality for Vivotif. Hypersensitivity reactions are known to occur following oral typhus immunization and hypersensitivity reactions are therefore  labeled for Vivotif. The case is assessed as expected, non-serious and causality possible. Further information on the outcome and possibly performed allergy test had been requested.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Blister, Depression, Depression suicidal, Dyspnoea, Fibromyalgia
Clinical narrative: This is a non-serious spontaneous case from a consumer in  the USA involving difficulty breathing, the reporter causality is possibly related to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A 48 year old female received FluMist on 10/19/2004. Approximately 4 hours later, the patient developed blisters in and around nose area and ear congestion, more on the right than the left. One to 2 weeks later, she experienced difficulty breathing which required two doctor visits where she received aerosol treatments. The patient also claimed she experienced depression at the time as well as had suicidal thoughts because she felt that she wasn't getting better. She had a history of Chronic Fatigue Syndrome, fibromyalgia, herpes simplex, and depression. The patient stated she has recovered from these reactions  except for the constant ear congestion.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Herpes simplex, Nasal congestion, Sleep disorder
Clinical narrative: This is a non-serious spontaneous case from a consumer in  the USA involving difficulty breathing, the reporter causality is possibly related to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A 48 year old female received FluMist on 10/19/2004. Approximately 4 hours later, the patient developed blisters in and around nose area and ear congestion, more on the right than the left. One to 2 weeks later, she experienced difficulty breathing which required two doctor visits where she received aerosol treatments. The patient also claimed she experienced depression at the time as well as had suicidal thoughts because she felt that she wasn't getting better. She had a history of Chronic Fatigue Syndrome, fibromyalgia, herpes simplex, and depression. The patient stated she has recovered from these reactions  except for the constant ear congestion.
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site vesicles
Clinical narrative: 15 cc serosanguinous fluid exuded from site on 8th day post vaccination.  Continued on 9th day with about 1/2 the amount of fluid of the previous day.  Today, fluid continues (enough in past 12 hours to soak center of 4 2X2 gauze).
Age: 0.39
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Crying, Hypertonia, Hypokinesia, Infection
Clinical narrative: Child started having minor tensing of the legs and arms in the begging of October whitch we thought were just baby quirks, it is now believed to have been minor seizures. They continued to get worse until in mid November she was constantly crying and tensing every few hours. She received another set of shots on 12/01/04. On 12/3/04 I was at my doctor's office when she had a spell, my doctor seen it and said it was seizures, by this time they were so bad that she was either asleep or having a seizure. My doctor sent us over to her doctor who put her on Femabarbitol.By 12/20/04 they were still present and we were sent to a hospital. A follow up appointment was made for 1/3/05 at this visit she was put on Lamictal wih some seizures still present. On 1/06/05 she was hospitalized to start Dilantin because of out of control seizure frequency. On 1/14/05 she was started on Ativan because frequency of seizures was still high. She is currently on Lamictal and Dilantin. Her 2 month well check on 2/28/04 shows we had rolls over one way,communicates by cooing, grasps small objects, watches objects moved across in front of face, and brings hands together. She no longer have rolls over and she is just now trying to do the other things again. Her 4 month well check on 12/1/04 shows she holds head steady when upright,laughs out loud,no head lag, raises chest while on stomach using arms for support,lifts head to 90 degree angle while on stomach, bears weight on legs when held in standing position,follows ob jects moved side to side, along with her acheivements showed on her 2 month well check. She is currently in Physical and occupational therapy to try to restablish these things she no longer does. She has very bad head lag and doesn't crawl and holds her hands in fists along with the lists of things above from her 2 well checks that she no longer does. I have medical records to support these details. Medical records received on 3/11/2005 states infection. Delayed development, on seizure meds.