chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngeal oedema, Swelling face
Clinical narrative: Employee received vaccine at approximately 7:15 Am on 1/5/07. Employee went home after shift.  As she stated, around 11AM her throat started swelling up, she had difficulty swallowing, and lips started to swell.  She called rescue, and was taken to local ER
Age: 1.29
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Day after DTaP  vaccines given patient presented to clinic with a cellulitis medial to the injection site
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Difficulty in walking, Feeling hot, Swelling
Clinical narrative: Left leg swollen, hot to tough, difficult for child to waok on it. Lasted about a day. Treatment was Benadryl and ice packs.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: right thigh erythema and induration measuring 11.6 x 8.4 cm
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Convulsion, Gastrooesophageal reflux disease, Unevaluable event
Clinical narrative: none. TC to reporter who states the AE is seizures which progressed to hypotonia, laryngomalacia, GERD, and laryngeal reflux.  01/29/2007 MR received documenting a 40 day hospital stay (8/23-10/02/2006) for new onset, intractable seizures beginning ~3 weeks following Pediarix vax. Infant began having seizures 8/16/2006 and was managed outside hospital prior to admission, but had been having increasingly frequent and more intense seizures which led to admission for video EEG monitoring on 08/23/2006.   Following admission, infant continued having daily seizures and infantile spasms.  Was treated with phenobarbital, Topamax, ACTH, and Keppra. Consults for Genetics, GI, Pediatric Pulmonary, and Otolaryngology. Additional DXs of Laryngomalacia and reflux. Infant was finally discharged on 10/02/2006 in order to seek a 2nd opinion from an epilepsy specialist.  Discharge DX: Intractable seizures. 02/26/2007 MR received from seizure specialist for several consultations beginning 10/02/2006 through 01/22/2007, including several Epilepsy Monitoring Unit stays for evaluation.  Multiple seizure types noted: Partial seizures within clusters of spasms manifest as tonic posturing of right or left thumb with mouth movements and eye deviation.  Infantile spasms occuring daily.  Axial Tonic seizures. Impressions:  Medically refracory epilepsy manifest by complex partial seizures and infantile spasms.  Laryngomalacia.  Feeding difficulties 2' to Laryngomalacia.Hypotonia.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cardiac failure congestive, Condition aggravated, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Patient received a flu and pneumonia shot on 12/19/06. The patient has lupus. The patient developed left hand and right leg numbness immediately after the injections were given. 02/23/07-records received and reviewed for DOS 12/18-12/26/06 DC DX: meningitis, staphylococcus coagulase negative lupus induced monoeuritis multiplex congestive heart failure exacerbation; two dimensional echo showed global hypokinesia with concentric left ventricular hypertrophy pulmonary hypertension chronic anemia and B12 deficiency diabetes mellitus hypertension SLE Presented with shortness of breath and bilateral lower extremity swelling for three days.  PE: CNS:generalized decrease in strength 4/5 all extremities. Sensation decreased in left lower extremity. Plantars are downgoing.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Meningitis, Mononeuritis, Mononeuropathy multiplex, Sensory loss
Clinical narrative: Patient received a flu and pneumonia shot on 12/19/06. The patient has lupus. The patient developed left hand and right leg numbness immediately after the injections were given. 02/23/07-records received and reviewed for DOS 12/18-12/26/06 DC DX: meningitis, staphylococcus coagulase negative lupus induced monoeuritis multiplex congestive heart failure exacerbation; two dimensional echo showed global hypokinesia with concentric left ventricular hypertrophy pulmonary hypertension chronic anemia and B12 deficiency diabetes mellitus hypertension SLE Presented with shortness of breath and bilateral lower extremity swelling for three days.  PE: CNS:generalized decrease in strength 4/5 all extremities. Sensation decreased in left lower extremity. Plantars are downgoing.
Age: 1.21
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Patient developed cellulitis in left leg medial to injection sites day after vaccine given
Age: 1.61
Sex: M
Vaccine: DTP, FLUX
Symptoms: Cough, Pyrexia
Clinical narrative: High Fever and coughing 02/09/07-records received and reviewed for DOS 01/01-01/05/07 DC DX: acute bronchiolitis/RAD viral syndrome possible reaction to DTAP and flu shot.  Rhinosinusitis Seen in ER for hyperpyrexia. Temp in ER 106 with cough and wheezing. Started one week prior to admission. Cold without fever. Received vaccines 4 days prior admission. One and one half days later developed fever to 103-104. Seen in ER on 12/31/06, treated with Motrin, Tylenol and cough medication and sent home. Temperature spiked to 105 prior to admission. No seizure. No meningeal signs. PE: Temp on admission 98.3. WNL except for Throat injected, tonsils enlarged, nose clear mucus.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Headache, Injection site reaction, Pain
Clinical narrative: On 1-3-07 pneumovax and influenza vaccine administered. On 1-4-07 patient started with fever and headache. Soreness and reddness in arm began 1-6-07. Reddness and swelling extended from left shoulder to elbow.  Patient seen on 1-8-07 by Dr. Patient diagnosed with pneumovax reaction with secondary cellulitis. Keflex 500 tid given. Seen by Dr. on 1-12-07 - patient has decreased redness and cellulitis. Patient under care of Dr.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: On 1-3-07 pneumovax and influenza vaccine administered. On 1-4-07 patient started with fever and headache. Soreness and reddness in arm began 1-6-07. Reddness and swelling extended from left shoulder to elbow.  Patient seen on 1-8-07 by Dr. Patient diagnosed with pneumovax reaction with secondary cellulitis. Keflex 500 tid given. Seen by Dr. on 1-12-07 - patient has decreased redness and cellulitis. Patient under care of Dr.
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC, DTAP, FLU3, HEPA, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: at thigh with 4cm x 7.5 cm erythema and induration 7.2cm x 4 cm at Hep A site.
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC, DTAP, FLU3, HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: at thigh with 4cm x 7.5 cm erythema and induration 7.2cm x 4 cm at Hep A site.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC, FLU3, HEPA, MMRV, PNC
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash vesicular
Clinical narrative: fever to 101 x 2 days, decreased appetite-loose stool, 3 vesicular lesions-back trunk-1 hard
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC, FLU3, HEPA, MMRV, PNC
Symptoms: Anorexia, Body temperature, Diarrhoea, Pyrexia, Rash vesicular
Clinical narrative: fever to 101 x 2 days, decreased appetite-loose stool, 3 vesicular lesions-back trunk-1 hard
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC, FLU3, HEPA, MMRV, PNC
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: fever to 101 x 2 days, decreased appetite-loose stool, 3 vesicular lesions-back trunk-1 hard
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pyrexia
Clinical narrative: His arm became swollen, red and warm.  Mother brought child to the doctor with a fever (we have attempted to contact the mother weekly for further information and have been unsuccessful.
Age: 7.0
Sex: F
Vaccine: HEP, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Presented to our office with 1 day history of rash on scalp and back diagnosed with chicken pox
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Donor called from home and reported a fever of , chills and body aches.  Donor reported calling Dr's office and nurse gave instructions to take Tylenol every 4 hours for fever and to only come in if fever was 104 F. Instructed donor to not over dose and take Tylenol and Ibuprofen alternating every 2 hours for a short time. If fever hasn't gone down to report to PMD.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Injection site warmth
Clinical narrative: Redness, induration and warmth at site of injection with suspected abscess
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Pyrexia, Wheezing
Clinical narrative: Pt developed fever, chills, wheezing 2 hours after typhoid injection on 1/10/07. Sought medical attention on 1/11/07 with PCP. Received IV fluids, prednisone and Zyrtec.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Had pneumonia vaccine in left deltoid. Seen 1/8 Deltoid red swollen rx fever and chills.
Age: 1.23
Sex: F
Vaccine: DTAP, FLUN3, HBHEPB, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: Pt given FluMist as ordered in clinic order form. Child had no adverse affects. Parents vomited 1/2 hr.
Age: 27.0
Sex: F
Vaccine: IPV, PPV
Symptoms: Feeling hot, Pain, Urticaria
Clinical narrative: Patient received Pneumococcal vacc in the R deltoid on 1/8/07.  In the evening of 1/9/07, the patient noted increased pain in the upper R arm/localized hives/area hot to touch.  No systemic signs.  On 1/10/07 am patient reported back to clinic.  Had been taking otc ibuprofen.  Advised to continue and take otc ibuprofen as directed and to take otc loratadine 10 mg q day.  Also advised to use ice packs locally to affected area as needed.  On 1/11/07 hives improved and pain decreased.  On 1/12/07, patient noted continued improvement.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Vomiting
Clinical narrative: Pt recieved the ful vaccine in the left deltoid on Wednesday at 12:40 p.m.  On Saturday the patients spouse called and stated his wife was unable to get out of the bed, she has vertigo and vomiting.  He denies any local reaction to the vaccine.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Retching, Vomiting
Clinical narrative: vomiting, dry heaving on and off for 24 hours starting two hours after receiving Rotateq oral rota virus vaccine.  Diarrhea starting 48 hours after vaccine lasting 3 days
Age: 0.76
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Eczema, Erythema, Screaming, Vomiting
Clinical narrative: Inconsolable screaming for several hours, red splotches on legs for several hours, refused to eat for 2 weeks, vomited for several days, eczema developed all over body which is still there 6 years later
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Dysphagia, Eye swelling, Pharyngeal oedema, Pruritus
Clinical narrative: Swelling, especially in face: eyes swollen shut, throat - very difficult to swallow, Itching all over body, especially in feet and hands. Vommiting and diarrhea.
Age: 49.0
Sex: M
Vaccine: TYP
Symptoms: Swelling face, Vomiting
Clinical narrative: Swelling, especially in face: eyes swollen shut, throat - very difficult to swallow, Itching all over body, especially in feet and hands. Vommiting and diarrhea.
Age: 0.21
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Rash, Viral infection
Clinical narrative: Child developed a viral like rash on entire body 24 hours post vaccinations. This remained for 96 hours.  No nausea, no diarhea.  Did have loss of appetite and irritability. No treatment. Talked with parent about reactions to vaccines
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Pt complained of nausea and vomiting on the day following the immunization.  No other symptoms.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Feeling hot, Haematoma
Clinical narrative: Hematoma, firmness, warmth Motrin, warm compresses
Age: 9.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Feeling hot, Haematoma
Clinical narrative: Hematoma, firmness, warmth Warm compresses, Motrin
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Angiogram pulmonary abnormal, Atrial tachycardia, Blood culture negative, Blood sodium decreased, Chest X-ray abnormal
Clinical narrative: We have a patient who swears that she is now in Hospital (january 2007) for "Bilateral Lobal Pneumonia" due to her recieving Fluzone from us on 10/25/2006.  She has always gotten her yearly flu shot with no complications, but felt tired and/or lethargic weeks after this years vaccination.  Her daughter relayed all this info to me.  1/26/07 Received medical records from hospital which reveal patient experienced respiratory distress & was admitted 1/8-1/11/07.  Treated w/antibiotics, bronchodilators & steroids.  Improved significantly & was d/c on tapering prednisone & close f/u. FINAL DX: Multilobar pneumonia in a smoker; possible bronchogenic neoplasm which will be worked up as outpatient; hyponatremia; COPD; multifocal atrial tachycardia, short duration; tobacco abuse; & hyperlipidemia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Chronic obstructive pulmonary disease, Electrocardiogram abnormal, Fatigue, Hyponatraemia, Lethargy
Clinical narrative: We have a patient who swears that she is now in Hospital (january 2007) for "Bilateral Lobal Pneumonia" due to her recieving Fluzone from us on 10/25/2006.  She has always gotten her yearly flu shot with no complications, but felt tired and/or lethargic weeks after this years vaccination.  Her daughter relayed all this info to me.  1/26/07 Received medical records from hospital which reveal patient experienced respiratory distress & was admitted 1/8-1/11/07.  Treated w/antibiotics, bronchodilators & steroids.  Improved significantly & was d/c on tapering prednisone & close f/u. FINAL DX: Multilobar pneumonia in a smoker; possible bronchogenic neoplasm which will be worked up as outpatient; hyponatremia; COPD; multifocal atrial tachycardia, short duration; tobacco abuse; & hyperlipidemia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: No reaction on previous exposure to drug, Pneumonia, Supraventricular tachycardia, Tobacco user, White blood cell count increased
Clinical narrative: We have a patient who swears that she is now in Hospital (january 2007) for "Bilateral Lobal Pneumonia" due to her recieving Fluzone from us on 10/25/2006.  She has always gotten her yearly flu shot with no complications, but felt tired and/or lethargic weeks after this years vaccination.  Her daughter relayed all this info to me.  1/26/07 Received medical records from hospital which reveal patient experienced respiratory distress & was admitted 1/8-1/11/07.  Treated w/antibiotics, bronchodilators & steroids.  Improved significantly & was d/c on tapering prednisone & close f/u. FINAL DX: Multilobar pneumonia in a smoker; possible bronchogenic neoplasm which will be worked up as outpatient; hyponatremia; COPD; multifocal atrial tachycardia, short duration; tobacco abuse; & hyperlipidemia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Chest X-ray abnormal, Cough, Ear pain
Clinical narrative: We have a patient who swears that she is now in Hospital (january 2007) for "Bilateral Lobal Pneumonia" due to her recieving Fluzone from us on 10/25/2006.  She has always gotten her yearly flu shot with no complications, but felt tired and/or lethargic weeks after this years vaccination.  Her daughter relayed all this info to me.  1/26/07 Received medical records from hospital which reveal patient experienced respiratory distress & was admitted 1/8-1/11/07.  Treated w/antibiotics, bronchodilators & steroids.  Improved significantly & was d/c on tapering prednisone & close f/u. FINAL DX: Multilobar pneumonia in a smoker; possible bronchogenic neoplasm which will be worked up as outpatient; hyponatremia; COPD; multifocal atrial tachycardia, short duration; tobacco abuse; & hyperlipidemia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Failure to thrive, Headache, Hypersomnia, Pneumonia
Clinical narrative: We have a patient who swears that she is now in Hospital (january 2007) for "Bilateral Lobal Pneumonia" due to her recieving Fluzone from us on 10/25/2006.  She has always gotten her yearly flu shot with no complications, but felt tired and/or lethargic weeks after this years vaccination.  Her daughter relayed all this info to me.  1/26/07 Received medical records from hospital which reveal patient experienced respiratory distress & was admitted 1/8-1/11/07.  Treated w/antibiotics, bronchodilators & steroids.  Improved significantly & was d/c on tapering prednisone & close f/u. FINAL DX: Multilobar pneumonia in a smoker; possible bronchogenic neoplasm which will be worked up as outpatient; hyponatremia; COPD; multifocal atrial tachycardia, short duration; tobacco abuse; & hyperlipidemia.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Aphasia, Confusional state, Convulsion, Encephalitis, Encephalopathy
Clinical narrative: Received Tdap on 11 December. On 16-17 December she felt unwell, complaining of nausea, then vomiting, and headache. Presented to ER on Monday 18 December and was sent home with work excuse for 3 days, but re-presented 19 December. She was brought by her husband with mental status changes, confusion with expressive aphasia and husband reported she had headache, neck pain and stiffness. LP revealed findings c/w encephalitis vs viral meningitis and she was admitted, treated with acyclovir, dexamethasone and antibiotics. Her mental status waxed and waned on the first two days. She had a seizure on 20 December, treated with dilantin, and was very encephalopathic requiring 1 on 1 nursing observation and support for confusion. On 21 December her symptoms improved and she was discharged on 22 December with no apparent confusion, although her memory is poor for all events from 16 - 23 December. She did not return to work for another several days.  1/23/07 Received medical records from hospital which reveal patient admitted 12/19-12/22/06 for acute mental status changes of confusion, naming difficulties, expressive aphasia, HA, stiff neck, photophobia & 2 days of nausea. Received flu vax 12/1, TDaP on 12/11 & PPD on 12/11.  LP done. Neuro, ID consults done. Treated with antibiotics & antivirals, steroids.  Mental status waxed & waned & then she had a seizure & remained confused & nonverbal for several hours afterward.  Treated w/Dilantin.  Stabilized, mental status cleared & was d/c to home to f/u w/PCP, ID & Neuro. FINAL DX: Meningitis/encephalitis w/seizrues.  ID consult felt dx due to vax & timing favored DTap over flu.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Laboratory test abnormal, Malaise, Memory impairment, Meningitis
Clinical narrative: Received Tdap on 11 December. On 16-17 December she felt unwell, complaining of nausea, then vomiting, and headache. Presented to ER on Monday 18 December and was sent home with work excuse for 3 days, but re-presented 19 December. She was brought by her husband with mental status changes, confusion with expressive aphasia and husband reported she had headache, neck pain and stiffness. LP revealed findings c/w encephalitis vs viral meningitis and she was admitted, treated with acyclovir, dexamethasone and antibiotics. Her mental status waxed and waned on the first two days. She had a seizure on 20 December, treated with dilantin, and was very encephalopathic requiring 1 on 1 nursing observation and support for confusion. On 21 December her symptoms improved and she was discharged on 22 December with no apparent confusion, although her memory is poor for all events from 16 - 23 December. She did not return to work for another several days.  1/23/07 Received medical records from hospital which reveal patient admitted 12/19-12/22/06 for acute mental status changes of confusion, naming difficulties, expressive aphasia, HA, stiff neck, photophobia & 2 days of nausea. Received flu vax 12/1, TDaP on 12/11 & PPD on 12/11.  LP done. Neuro, ID consults done. Treated with antibiotics & antivirals, steroids.  Mental status waxed & waned & then she had a seizure & remained confused & nonverbal for several hours afterward.  Treated w/Dilantin.  Stabilized, mental status cleared & was d/c to home to f/u w/PCP, ID & Neuro. FINAL DX: Meningitis/encephalitis w/seizrues.  ID consult felt dx due to vax & timing favored DTap over flu.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Vomiting
Clinical narrative: Received Tdap on 11 December. On 16-17 December she felt unwell, complaining of nausea, then vomiting, and headache. Presented to ER on Monday 18 December and was sent home with work excuse for 3 days, but re-presented 19 December. She was brought by her husband with mental status changes, confusion with expressive aphasia and husband reported she had headache, neck pain and stiffness. LP revealed findings c/w encephalitis vs viral meningitis and she was admitted, treated with acyclovir, dexamethasone and antibiotics. Her mental status waxed and waned on the first two days. She had a seizure on 20 December, treated with dilantin, and was very encephalopathic requiring 1 on 1 nursing observation and support for confusion. On 21 December her symptoms improved and she was discharged on 22 December with no apparent confusion, although her memory is poor for all events from 16 - 23 December. She did not return to work for another several days.  1/23/07 Received medical records from hospital which reveal patient admitted 12/19-12/22/06 for acute mental status changes of confusion, naming difficulties, expressive aphasia, HA, stiff neck, photophobia & 2 days of nausea. Received flu vax 12/1, TDaP on 12/11 & PPD on 12/11.  LP done. Neuro, ID consults done. Treated with antibiotics & antivirals, steroids.  Mental status waxed & waned & then she had a seizure & remained confused & nonverbal for several hours afterward.  Treated w/Dilantin.  Stabilized, mental status cleared & was d/c to home to f/u w/PCP, ID & Neuro. FINAL DX: Meningitis/encephalitis w/seizrues.  ID consult felt dx due to vax & timing favored DTap over flu.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Apnoea, Convulsion
Clinical narrative: This case was reported by a consumer and described the occurrence of seizures in a 4 month old male subject who was vaccinated with Pediarix for prophylaxis. The reporter is the mother of the subject and a sales representative. A physician or other health care professional has not verified this report. The subjects medical history included premature birth. There were no concurrent medications. The subject no adverse events following receipt of prior immunizations. On 11 July 2006 the subject received 2nd dose of Pediarix. On 11 July 2006, the subject received an unspecified dose of Prevnar. On 12 July 2006, 1 day after vaccination with Pediarix, the subject experienced three seizures and stopped breathing four times. The subject was transported by ambulance to an emergency room. During transport to the emergency room, the subject required resuscitation. The reporter considered the events to be life threatening and to require clinically significant intervention (OMIC). The events resolved on 12 July 2006.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Cognitive disorder, Facial palsy, Fatigue, Headache
Clinical narrative: This case was reported by a lawyer via a statement of injuries and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, mental fog, headaches, Bell's palsy, numbness, and tingling. He reportedly also suffered from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all caused by vaccination with Lymerix. Additionally, he experienced decreased of daily life and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were unspecified.
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Immune system disorder, Mental impairment, Nervous system disorder, Paraesthesia
Clinical narrative: This case was reported by a lawyer via a statement of injuries and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, mental fog, headaches, Bell's palsy, numbness, and tingling. He reportedly also suffered from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all caused by vaccination with Lymerix. Additionally, he experienced decreased of daily life and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were unspecified.
Sex: M
Vaccine: LYME
Symptoms: Rheumatoid factor
Clinical narrative: This case was reported by a lawyer via a statement of injuries and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, mental fog, headaches, Bell's palsy, numbness, and tingling. He reportedly also suffered from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all caused by vaccination with Lymerix. Additionally, he experienced decreased of daily life and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events were unspecified.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Application site warmth, Erythema, Pain, Pruritus, Skin discolouration
Clinical narrative: SQ injection RA-swelling-painful to the touch and hot. On 1-7-07, patient still c/o pain on 1-12-07. Arm red, warm to the touch and itching and purplish discoloration, larger than golf ball.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Swelling
Clinical narrative: SQ injection RA-swelling-painful to the touch and hot. On 1-7-07, patient still c/o pain on 1-12-07. Arm red, warm to the touch and itching and purplish discoloration, larger than golf ball.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Received flu vaccine on 11/2/06. She presented to our clinic on 12/7/06 complained of persistent pain to injection site. Denies swelling, redness to injection site. She presented to primary care physician on 1/10/07 because of persistent arm pain, difficulty combing hair and putting bra on. She returned to our clinic on 1/11/07 to report continued Left arm pain.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Croup infectious, Crying, Diarrhoea, Pyrexia, Viral infection
Clinical narrative: Unconsolable crying for more than 24 hours-onset at the time shots were given. Recommended treatment at 6 1/2 hours after onset-Motrin 1/2 tsp, warm bath, massage warm compresses at injection site. Instructed to see medical doctor if not better soon. 15 1/2 hours after onset-Parent's brought the infant to hospital at 1:35AM 12/21/06. RSV and flu test done. Recommended Pedialyte and Tylenol. 25 1/2 hours after onset-Parents brought infant 12/22/06 at 11:41AM with chief complaint crying for 8 hours straight, fever 102, diarrhea x2, shortness of breath, coughing (croup), CBC, EPA and lateral of chest done. Released to home condition unchanged. Diagnosis viral syndrome.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Injection site pain, Meningism, Neuropathy, Pyrexia
Clinical narrative: 12 hours after vaccine-intense pain at site with fever as high as 101.7. 24 hour post vaccine lue-lle neuropathy and meningeal irritation with arthralgia.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Crying, Dyspnoea, Pharyngolaryngeal pain, Wheezing
Clinical narrative: 5minutes after pt received vaccines he complained that his throat hurt and had difficulty breathing. Pt began crying stating "I can't breathe". Pt found to be wheezing. Epinephrine 0.2 ml given along with Albuterol nebulizer treatment. EMS called. Pt's condition improved.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot
Clinical narrative: Right thigh-red with heat. Treatment-Benadryl
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Gastrointestinal disorder, Screaming
Clinical narrative: Initial report received on 05 January 2007 from an other manufacturer, report number WAES0611USA02666, who received the original report from a physician. This report was a follow up report to previously submitted reports on 16 November 2006, and 22 November 2006 by the other manufacturer. Information has been received from a physician concerning a 19 week old male with congenital hypospadias and no allergies who on 22 August 2006 and 24 October 2006, at 1200pm, was vaccinated by mouth with the first and second 2.0 mL doses, respectively, of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (lot number 655175/0849F). Concomitant vaccinations administered on 24 October 2006 included the second IM dose in the left thigh of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (lot number C2649AA), the second SC dose in the right thigh of poliovirus vaccine inactivated (lot number Y1030-2), the second IM dose in the left thigh of hepatitis B virus vaccine (+) Hib conj vaccine (lot number 65442/0268F) and the second IM dose in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (lot number B08688C). There was no illness or other concomitant drug therapy at the time of vaccination. There were also no other vaccinations administered within four weeks prior to 24 October 2006. The physician reported that on 04 November 2006, at 1600 pm, the patient experienced uncontrolled screaming for hours. The patient was taken to the emergency room (ER) where an acetaminophen (TYLENOL) suppository was given which helped quiet him. A physical examination was negative and no testing was performed. The patient was discharged to home and seemed fine. Within 15 minutes (also reported as approximately a half hour) of the ER visit, the patient began uncontrollable screaming and was taken to a pediatric ER. On 05 November 2006, the patient was admitted to a hospital for evaluation and to rule-out intussusception. An abdominal X-ray and ultrasound ruled out intussusception. It was noted the patient was administered IV fluids. No surgery was required. On 06 November 2006, the patient was discharged from the hospital as he was considered to be recovered. The patient was scheduled to be seen in the physician's office on 08 November 2006. No product quality complaint was involved. Follow up information from the physician confirmed that intussusception was ruled-out via abdominal X-ray and ultrasound and that no formal diagnosis was made. The abdominal X-ray and ultrasound also revealed air in the patient's GI tract. The patient was reported to be fine and it was noted that a third dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live would be administered. The physician also considered the uncontrollable screaming to be an other important medical event (OMIC). Additional information is not expected by the other manufacturer.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been received concerning an 18 week old patient who on 06 NOV 2006 was vaccinated with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (lot # 654489/0941F). It was reported that on 06-NOV-2006, the patient developed intussusception. Unspecified medical attention was sought and treatment included an air enema. At the time of this report, the outcome was unknown. Upon internal review, intussusception was determined to be an other important medical event (OMIC). The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received through the CDC concerning a 22 week old female with gastroesophageal reflux disease (GERD) and a chromosome abnormality (SC trait: SGA) who on 18-SEP-2006 was vaccinated PO with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (lot # 653661/0146F). Concomitant vaccinations administered on that same day included the second IM dose of Hib conj vaccine, the second IM dose of diphtheria toxoid (+) hepatitis B virus vaccine (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (lot # AC21B059DA) and the second IM dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (lot # B08657K). Other concomitant drug therapy included ranitidine HCl (ZANTAC). It was reported that on 05-NOV-2006, the patient developed intussusception. Unspecified medical attention was sought and was hospitalized for four days. On 09-NOV-2006, the intussusception was reduced with Barium enema. The patient was considered to be recovered. Intussusception was also considered to be life-threatening. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Information has been received concerning an 18 week old female with no medical history who on 02-OCT-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live. Concomitant vaccinations administered on that same day included the first IM dose in the left thigh of diphtheria toxoid (+) hepatitis B virus vaccine (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (lot # AC2B033BA), the first IM dose in the left thigh of Hib conj vaccine (lot # 652867/0084F) and the first IM dose in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (lot # B08639A). There was no illness or other concomitant drug therapy at the time of vaccination. It was reported that on 04-DEC-2006, the patient developed symptoms of bloody stool. Unspecified medical attention was sought. On that same day, the patient was hospitalized for surgical reduction of intussusception. At the time of this report, the outcome was unknown. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements and was released by the regulatory agency. Intussusception was also considered to be life-threatening. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Hypoaesthesia, Miller Fisher syndrome, Paraesthesia
Clinical narrative: Tingling and numbness in hands, legs, face. Double vision. Imbalance. (Please see discharge summary attached). Discharge diagnosis: Miller-Fisher syndrome. History: Patient is a 52 year old lady who had a flu shot on Friday and started to have lower extremity weakness started the next day of the flu shot and she fell in the bathroom withou losing her consciousness. She has noticed increasing weakness in her legs over two days, and she also reported numbness in the lower extremities that started distally and gradually spread upward. The patient went to an outside hospital where a CT scan of the head was done and reported as normal, and the patient was discharged from the ER there. Then the patient noticed that the numbness was increasing, and she noted that her hands became weak and she was dropping things from her hands. The patient also started to have a change in her voice. Her voice became of a nasal tone althought she has an unclear voice to start with, but she said that her voice on presentation was much different then it used to be. The patient also gave a history of double vision.
Age: 26.0
Sex: F
Vaccine: MMR, TTOX, VARCEL
Symptoms: Abdominal pain, Medication error
Clinical narrative: Patient was administered MMR, Varicella and T-D vaccine while 5 wks pregnant.
Age: 42.0
Sex: F
Vaccine: YF
Symptoms: Pruritus
Clinical narrative: Patient complained of itching which started and remained mainly in face, then progressed to limbs. Symptoms started within 1 - 2 hours after receiving the vaccine.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Bacterial infection, Bronchitis
Clinical narrative: On 12 Oct 2006, two days after receiving FluMist therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving Flumist therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on Ketek and Medrol dose pak  therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FluMist therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FluMist therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with Dilaudid, hydration therapy and clear liquids. The patient indicated that she received no antibiotic therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to Ketek therapy. No reporter causality as it related to FluMist therapy was provided.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Colitis, Cough, Diarrhoea, Diarrhoea haemorrhagic, Laboratory test abnormal
Clinical narrative: On 12 Oct 2006, two days after receiving FluMist therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving Flumist therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on Ketek and Medrol dose pak  therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FluMist therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FluMist therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with Dilaudid, hydration therapy and clear liquids. The patient indicated that she received no antibiotic therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to Ketek therapy. No reporter causality as it related to FluMist therapy was provided.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Malaise, Nasal congestion, Oral pain, Pyrexia
Clinical narrative: On 12 Oct 2006, two days after receiving FluMist therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving Flumist therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on Ketek and Medrol dose pak  therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FluMist therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FluMist therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with Dilaudid, hydration therapy and clear liquids. The patient indicated that she received no antibiotic therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to Ketek therapy. No reporter causality as it related to FluMist therapy was provided.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Medication error, Unintended pregnancy
Clinical narrative: Information has been received through the manufacturer pregnancy registry and from a medical assistant concerning a 37 year old female who on 09-OCT-2006 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (lot # 653736/0868F). It was reported that on 22-OCT-2006 "the patient discovered she was 7 weeks pregnant) method of confirmation of pregnancy was reported to be a pap smear. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information was received from a medical assistant who reported that on 15-DEC-2006 the patient experienced vaginal spotting. That same day the patient was seen by her obstetrician who performed an abdominal ultrasound. The ultrasound confirmed that there was no fetal heartbeat. On an unspecified date a total serum human chorionic gonadotropin test was performed, results not provided. On 18-DEC-2006, the patient underwent an uncomplicated uterine dilation and curettage as an outpatient. On 02-JAN-2007 the patient was seen by her obstetrician for a post-operative exam which revealed that the patient had a full recovery without complications. The patient was advised to return to full regular activity. Upon internal review, the spontaneous abortion was considered to be an other medical event (OMIC). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Medication error, Unintended pregnancy
Clinical narrative: Information has been received from a registered nurse for the pregnancy registry for Gardasil concerning an 18 year old white female with seasonal allergies and no medical history, who on 16-NOV-2006 was vaccinated IM with a 0.5 ml dose of Gardasil (lot# 654540/0800F). Concomitant therapy included Depo-Provera and Nasonex. On 16-NOV-2006, the patient's pregnancy test was negative. On 05-DEC-2006, the patient's pregnancy test was positive. It was noted that the patient may have an abortion but that was not related to the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information indicated that the patient's LMP was on 28-OCT-2006 (estimated delivery date is 04-AUG-2007). On 03-JAN-2007 (reported as 03-JAN-2006), the patient had an elective termination. Upon internal review, elective termination was considered to be an other important medical event (OMIC). No further information was available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Convulsion, Crying, Loss of consciousness
Clinical narrative: Information has been received from the mother of a 17 year old female patient with acne and pertinent medical history and drug reactions/allergies reported as none who on 19-DEC-2006 was vaccinated with an initial dose of Gardasil, injection in the left upper arm. Concomitant therapy included sulfamethoxazole/trimethoprim. On 19-DEC-2006, the patient experienced two seizures after receiving the Gardasil vaccine. The patient's mother reported that the patient "blacked out" about one to two minutes after receiving the injection and was unconscious for about a minute before she experienced the first seizure. The patient had felt nauseous when she had regained consciousness. The patient's mother then reported that the patient "blacked out again" and had the second seizure which was more "severe". When the patient came out of it she started crying. The patient's mother reported that the physician kept them at the office for about three hours to watch her and she was given water. The patient was instructed to see a neurologist. Subsequently at the time of this report, the patient recovered from seizures. Seizures was considered to be an other important medical event (OMIC). Additional information has been requested.