chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactoid reaction, Dizziness, Dyspnoea, Fall, Hypersensitivity
Clinical narrative: Allergic (anaphylactoid) reaction resulting in acute shortness of breath with wheezing occuring within 5 to 10 minutes post injection, light-headedness resulting in loss of balance and falling. Treated with methylprednisolone IV, famotidine IV, Anzemet IV, diphenhydramine IV and albuterol/ipratropium inhalation treatments x4.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Allergic (anaphylactoid) reaction resulting in acute shortness of breath with wheezing occuring within 5 to 10 minutes post injection, light-headedness resulting in loss of balance and falling. Treated with methylprednisolone IV, famotidine IV, Anzemet IV, diphenhydramine IV and albuterol/ipratropium inhalation treatments x4.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Injection site warmth, Swelling
Clinical narrative: Swelling of deltoid area on same day that vaccine administered, swelling warmth abd pain continued til 11/24/2006, has not progressed ansd is a little better.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Anorexia, Chills, Cough, Injection site warmth, Pain
Clinical narrative: Noon time arm was painful and felt hot;by 3:30 pm high gever chills (no temp taken), no appetite & arm swollen around from elbow to below axilla.  By 3:00 am the next day (11/18/06) felt better, swelling down but bruised on entire upper (from elbow to shoulder)appetite returned, and some coughing from cold. Client believes he had contracted a slight cold around the time of the immunization and at the time of the immunization adamant at denying previous PPV-23 vaccine.  (Noted later on investigation with local provider that one was given 5/27/05).
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Noon time arm was painful and felt hot;by 3:30 pm high gever chills (no temp taken), no appetite & arm swollen around from elbow to below axilla.  By 3:00 am the next day (11/18/06) felt better, swelling down but bruised on entire upper (from elbow to shoulder)appetite returned, and some coughing from cold. Client believes he had contracted a slight cold around the time of the immunization and at the time of the immunization adamant at denying previous PPV-23 vaccine.  (Noted later on investigation with local provider that one was given 5/27/05).
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Sleep disorder, Somnolence, Swelling
Clinical narrative: My arm turned red and became very swollen & painful. I could not stand to touch the arm from shoulder level to elbow. The pain interfered with sleep the night of 11-22. I was very weak and tired the evening of the 22nd and all day on the 23rd, so tired that I slept 3x during the day & had to go to bed at 6:30 p.m. Now, it's 3 days later & some swelling persists. I did not seek medical help.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood pressure increased, Headache, Injection site erythema, Pyrexia, Urticaria
Clinical narrative: Redness with about 2-3 inches diameter welts on arm around injection site day after injection; redness with welts covered about 6 inches diameter second day after injection.  Second day after injection fever of 102.0, severe headache in top and back of head, and blood pressure of 168/88.  Fever lasted for approximately 36 hours, began about 48 hours after injection.
Age: 1.41
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Nasal congestion, Pyrexia
Clinical narrative: Congestion, high fever up tp 103.9 and cough.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Injection site induration, Injection site vesicles
Clinical narrative: 2 small pustules around vaccination site; 2 pustules with surrounding erythema by axilla; 4cm induration on left chest above left nipple, with overlying erythema. Treated with pulse-dose prednisone, keflex, motrin.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Pt reported pain throughout arm where Pneumovax was administered.  She also reported swelling throughout same arm and underarm, along with fever and chills.  Vaccine was administed at 1pm, signs/symptoms started around 6:30 pm, and lasted approximately two days according to patient.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Dysphonia, Dyspnoea, Rhinorrhoea, Upper respiratory tract congestion
Clinical narrative: Within 36 to 48 hours of nasal FluMist vaccine, my son started complaining of stomach pain and runny nose.  This progressed to Upper Respiratory Congestion, Hoarseness, Loss of Voice, and some difficulty breathing within 48 more hours.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning an approximately 2-month-old patient who was vaccinated PO with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Concomitant vaccinations administered on that same day included "routine immunizations." The nurse reported that the patient subsequently died. The nurse didn't think the patient's death had anything to do with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) and believed the patient may have had meningitis. No further information was provided. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse concerning an approximately 2-month-old patient who was vaccinated PO with the first 2.0 ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). Concomitant vaccinations administered on that same day included "routine immunizations." The nurse reported that the patient subsequently died. The nurse didn't think the patient's death had anything to do with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) and believed the patient may have had meningitis. No further information was provided. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a pharmacy intern concerning an 81 year old female with sulfa allergy who of 05-Oct-2006 (initially reported as 04-Oct-2006) at 10:49 AM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot#651399/0486F), intramuscularly in the left arm.  Concomitant therapy that day and time included a first dose of influenza virus split virion 3v vaccine inactivated (Fluarix), intramuscularly in the right arm.  There was no illness at the time of vaccination. Subsequently, the patient "awoke that night" on 05-Oct-2006 with a rash on abdomen, neck and under her breasts and on neck with itching.  The patient used diphenhydramine HCL (BENADRYL) orally and cream topically for symptoms.  The pharmacist advised patient to call her physician.  It was reported that the patient was prescribed methylprednisolone sodium succinate (SOLUMDROL).  It was also reported that the patient has received pneumococcal 23v polysaccharide vaccine more than 5 years ago. "a long time ago," and had no adverse reaction.  The reporter considered the patient's experience to be an other medical event.  Additional information has been requested. (OMIC)
Age: 81.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacy intern concerning an 81 year old female with sulfa allergy who of 05-Oct-2006 (initially reported as 04-Oct-2006) at 10:49 AM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot#651399/0486F), intramuscularly in the left arm.  Concomitant therapy that day and time included a first dose of influenza virus split virion 3v vaccine inactivated (Fluarix), intramuscularly in the right arm.  There was no illness at the time of vaccination. Subsequently, the patient "awoke that night" on 05-Oct-2006 with a rash on abdomen, neck and under her breasts and on neck with itching.  The patient used diphenhydramine HCL (BENADRYL) orally and cream topically for symptoms.  The pharmacist advised patient to call her physician.  It was reported that the patient was prescribed methylprednisolone sodium succinate (SOLUMDROL).  It was also reported that the patient has received pneumococcal 23v polysaccharide vaccine more than 5 years ago. "a long time ago," and had no adverse reaction.  The reporter considered the patient's experience to be an other medical event.  Additional information has been requested. (OMIC)
Age: 61.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Corneal reflex decreased, Facial palsy, Hearing impaired, Hemiparesis, Lacrimation increased
Clinical narrative: After flu shot, he developed left Bell's palsy and left hearing difficulty, left facial ???? sensation.
Age: 61.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Neuritis, Speech disorder, Swelling, Tenderness
Clinical narrative: After flu shot, he developed left Bell's palsy and left hearing difficulty, left facial ???? sensation.
Age: 61.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Facial palsy, Hearing impaired
Clinical narrative: After flu shot, he developed left Bell's palsy and left hearing difficulty, left facial ???? sensation.
Age: 34.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Aphasia, Coma, Encephalitis, Hemiparesis, Paralysis
Clinical narrative: A 34 year old female pt received a second dose of Imovax rabies vaccine, lot number E0401-1 on 11/8/06 as part of a pre exposure series for her job as a veterinary technician. The pt also received a dose of influenza vaccine (trade name, manufacturer and lot number unk) on an unspecified date within four weeks of receiving the rabies vaccine. On 11/10/06, two days after receiving the second dose of rabies vaccine, the pt complained of left sided weakness and a headache that progressed to muteness. She also developed hemiparesis and rapid neurological decline. On 11/11/06, she was admitted to the hospital and and is currently in the intensive care unit. An MRI showed marked white matter disease consistent with demyelination encephalitis and it was reported that her brain is rapidly deterioration. The pt is currently a quadriplegic, is non responsive and can only open her eyelids slightly. The working diagnosis was acute encephalomyelitis and transverse myelitis. She was not recovered from the events. The pt has no significant past medical history other than unspecified food allergies. She denied any use of concomitant medications and had no illnesses at the time of vaccination on 11/8/06. She had previously received a first dose of Imovax Rabies vaccine, lot number Z0401-1, on 11/01/06 as part of pre exposure series for her work as a veterinary technician. As per the reporter, the department of health is trying to obtain additional information at present. In particular, they are trying to determine whether this pt could have had any exposure to contaminated saliva or sick animals prior to her pre exposure series. The case has been reported to VAERS, however , no VAERS number was provided.  Additional information was received on 11/18/2006 and 11/20/2006 and incorporated into this initial version. It was reported that the pts serum was positive, CSF neg for rabies antibody. A real time PCR of the vaccine vials was neg for rabies antibodies. Per the reporter, there is no data to support a rabies diagnosis in the pt, or evidence of rabies virus in the vials, as expected. The pt ad died (exact date of death not reported). An autopsy will be performed.
Age: 34.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Quadriplegia
Clinical narrative: A 34 year old female pt received a second dose of Imovax rabies vaccine, lot number E0401-1 on 11/8/06 as part of a pre exposure series for her job as a veterinary technician. The pt also received a dose of influenza vaccine (trade name, manufacturer and lot number unk) on an unspecified date within four weeks of receiving the rabies vaccine. On 11/10/06, two days after receiving the second dose of rabies vaccine, the pt complained of left sided weakness and a headache that progressed to muteness. She also developed hemiparesis and rapid neurological decline. On 11/11/06, she was admitted to the hospital and and is currently in the intensive care unit. An MRI showed marked white matter disease consistent with demyelination encephalitis and it was reported that her brain is rapidly deterioration. The pt is currently a quadriplegic, is non responsive and can only open her eyelids slightly. The working diagnosis was acute encephalomyelitis and transverse myelitis. She was not recovered from the events. The pt has no significant past medical history other than unspecified food allergies. She denied any use of concomitant medications and had no illnesses at the time of vaccination on 11/8/06. She had previously received a first dose of Imovax Rabies vaccine, lot number Z0401-1, on 11/01/06 as part of pre exposure series for her work as a veterinary technician. As per the reporter, the department of health is trying to obtain additional information at present. In particular, they are trying to determine whether this pt could have had any exposure to contaminated saliva or sick animals prior to her pre exposure series. The case has been reported to VAERS, however , no VAERS number was provided.  Additional information was received on 11/18/2006 and 11/20/2006 and incorporated into this initial version. It was reported that the pts serum was positive, CSF neg for rabies antibody. A real time PCR of the vaccine vials was neg for rabies antibodies. Per the reporter, there is no data to support a rabies diagnosis in the pt, or evidence of rabies virus in the vials, as expected. The pt ad died (exact date of death not reported). An autopsy will be performed.
Age: 34.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Aphasia, Depressed level of consciousness, Hypersensitivity, Hypoxia, Immune system disorder
Clinical narrative: A 34 year old female pt received a second dose of Imovax rabies vaccine, lot number E0401-1 on 11/8/06 as part of a pre exposure series for her job as a veterinary technician. The pt also received a dose of influenza vaccine (trade name, manufacturer and lot number unk) on an unspecified date within four weeks of receiving the rabies vaccine. On 11/10/06, two days after receiving the second dose of rabies vaccine, the pt complained of left sided weakness and a headache that progressed to muteness. She also developed hemiparesis and rapid neurological decline. On 11/11/06, she was admitted to the hospital and and is currently in the intensive care unit. An MRI showed marked white matter disease consistent with demyelination encephalitis and it was reported that her brain is rapidly deterioration. The pt is currently a quadriplegic, is non responsive and can only open her eyelids slightly. The working diagnosis was acute encephalomyelitis and transverse myelitis. She was not recovered from the events. The pt has no significant past medical history other than unspecified food allergies. She denied any use of concomitant medications and had no illnesses at the time of vaccination on 11/8/06. She had previously received a first dose of Imovax Rabies vaccine, lot number Z0401-1, on 11/01/06 as part of pre exposure series for her work as a veterinary technician. As per the reporter, the department of health is trying to obtain additional information at present. In particular, they are trying to determine whether this pt could have had any exposure to contaminated saliva or sick animals prior to her pre exposure series. The case has been reported to VAERS, however , no VAERS number was provided.  Additional information was received on 11/18/2006 and 11/20/2006 and incorporated into this initial version. It was reported that the pts serum was positive, CSF neg for rabies antibody. A real time PCR of the vaccine vials was neg for rabies antibodies. Per the reporter, there is no data to support a rabies diagnosis in the pt, or evidence of rabies virus in the vials, as expected. The pt ad died (exact date of death not reported). An autopsy will be performed.
Age: 34.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Nervous system disorder, Respiratory disorder, Sensation of heaviness
Clinical narrative: A 34 year old female pt received a second dose of Imovax rabies vaccine, lot number E0401-1 on 11/8/06 as part of a pre exposure series for her job as a veterinary technician. The pt also received a dose of influenza vaccine (trade name, manufacturer and lot number unk) on an unspecified date within four weeks of receiving the rabies vaccine. On 11/10/06, two days after receiving the second dose of rabies vaccine, the pt complained of left sided weakness and a headache that progressed to muteness. She also developed hemiparesis and rapid neurological decline. On 11/11/06, she was admitted to the hospital and and is currently in the intensive care unit. An MRI showed marked white matter disease consistent with demyelination encephalitis and it was reported that her brain is rapidly deterioration. The pt is currently a quadriplegic, is non responsive and can only open her eyelids slightly. The working diagnosis was acute encephalomyelitis and transverse myelitis. She was not recovered from the events. The pt has no significant past medical history other than unspecified food allergies. She denied any use of concomitant medications and had no illnesses at the time of vaccination on 11/8/06. She had previously received a first dose of Imovax Rabies vaccine, lot number Z0401-1, on 11/01/06 as part of pre exposure series for her work as a veterinary technician. As per the reporter, the department of health is trying to obtain additional information at present. In particular, they are trying to determine whether this pt could have had any exposure to contaminated saliva or sick animals prior to her pre exposure series. The case has been reported to VAERS, however , no VAERS number was provided.  Additional information was received on 11/18/2006 and 11/20/2006 and incorporated into this initial version. It was reported that the pts serum was positive, CSF neg for rabies antibody. A real time PCR of the vaccine vials was neg for rabies antibodies. Per the reporter, there is no data to support a rabies diagnosis in the pt, or evidence of rabies virus in the vials, as expected. The pt ad died (exact date of death not reported). An autopsy will be performed.
Age: 34.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Aphasia, Coma, Demyelination, Encephalitis, Headache
Clinical narrative: A 34 year old female pt received a second dose of Imovax rabies vaccine, lot number E0401-1 on 11/8/06 as part of a pre exposure series for her job as a veterinary technician. The pt also received a dose of influenza vaccine (trade name, manufacturer and lot number unk) on an unspecified date within four weeks of receiving the rabies vaccine. On 11/10/06, two days after receiving the second dose of rabies vaccine, the pt complained of left sided weakness and a headache that progressed to muteness. She also developed hemiparesis and rapid neurological decline. On 11/11/06, she was admitted to the hospital and and is currently in the intensive care unit. An MRI showed marked white matter disease consistent with demyelination encephalitis and it was reported that her brain is rapidly deterioration. The pt is currently a quadriplegic, is non responsive and can only open her eyelids slightly. The working diagnosis was acute encephalomyelitis and transverse myelitis. She was not recovered from the events. The pt has no significant past medical history other than unspecified food allergies. She denied any use of concomitant medications and had no illnesses at the time of vaccination on 11/8/06. She had previously received a first dose of Imovax Rabies vaccine, lot number Z0401-1, on 11/01/06 as part of pre exposure series for her work as a veterinary technician. As per the reporter, the department of health is trying to obtain additional information at present. In particular, they are trying to determine whether this pt could have had any exposure to contaminated saliva or sick animals prior to her pre exposure series. The case has been reported to VAERS, however , no VAERS number was provided.  Additional information was received on 11/18/2006 and 11/20/2006 and incorporated into this initial version. It was reported that the pts serum was positive, CSF neg for rabies antibody. A real time PCR of the vaccine vials was neg for rabies antibodies. Per the reporter, there is no data to support a rabies diagnosis in the pt, or evidence of rabies virus in the vials, as expected. The pt ad died (exact date of death not reported). An autopsy will be performed.
Age: 34.0
Sex: F
Vaccine: RAB, RAB, RAB
Symptoms: Hemiparesis, Laboratory test abnormal, Myelitis transverse, Nervous system disorder, Quadriplegia
Clinical narrative: A 34 year old female pt received a second dose of Imovax rabies vaccine, lot number E0401-1 on 11/8/06 as part of a pre exposure series for her job as a veterinary technician. The pt also received a dose of influenza vaccine (trade name, manufacturer and lot number unk) on an unspecified date within four weeks of receiving the rabies vaccine. On 11/10/06, two days after receiving the second dose of rabies vaccine, the pt complained of left sided weakness and a headache that progressed to muteness. She also developed hemiparesis and rapid neurological decline. On 11/11/06, she was admitted to the hospital and and is currently in the intensive care unit. An MRI showed marked white matter disease consistent with demyelination encephalitis and it was reported that her brain is rapidly deterioration. The pt is currently a quadriplegic, is non responsive and can only open her eyelids slightly. The working diagnosis was acute encephalomyelitis and transverse myelitis. She was not recovered from the events. The pt has no significant past medical history other than unspecified food allergies. She denied any use of concomitant medications and had no illnesses at the time of vaccination on 11/8/06. She had previously received a first dose of Imovax Rabies vaccine, lot number Z0401-1, on 11/01/06 as part of pre exposure series for her work as a veterinary technician. As per the reporter, the department of health is trying to obtain additional information at present. In particular, they are trying to determine whether this pt could have had any exposure to contaminated saliva or sick animals prior to her pre exposure series. The case has been reported to VAERS, however , no VAERS number was provided.  Additional information was received on 11/18/2006 and 11/20/2006 and incorporated into this initial version. It was reported that the pts serum was positive, CSF neg for rabies antibody. A real time PCR of the vaccine vials was neg for rabies antibodies. Per the reporter, there is no data to support a rabies diagnosis in the pt, or evidence of rabies virus in the vials, as expected. The pt ad died (exact date of death not reported). An autopsy will be performed.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Face oedema
Clinical narrative: 11/14/2006 Started with Hives per mom to feet, legs, arms, hands, face as well as fatigue, dizziness, decrease appetite. Provider found few erythematous lesions on trunk, arms, legs in clinic 11/15/06.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Fatigue, Hypersensitivity, Pallor, Pruritus, Pyrexia
Clinical narrative: 11/14/2006 Started with Hives per mom to feet, legs, arms, hands, face as well as fatigue, dizziness, decrease appetite. Provider found few erythematous lesions on trunk, arms, legs in clinic 11/15/06.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Urticaria
Clinical narrative: 11/14/2006 Started with Hives per mom to feet, legs, arms, hands, face as well as fatigue, dizziness, decrease appetite. Provider found few erythematous lesions on trunk, arms, legs in clinic 11/15/06.
Age: 7.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Decreased appetite, Dizziness, Erythema, Fatigue, Skin ulcer
Clinical narrative: 11/14/2006 Started with Hives per mom to feet, legs, arms, hands, face as well as fatigue, dizziness, decrease appetite. Provider found few erythematous lesions on trunk, arms, legs in clinic 11/15/06.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash erythematous, Skin atrophy
Clinical narrative: Vaccine given 11/10/06, 6:30 am. Raised rash under arm pit occurred 48 hrs later, noticed indentation of armpit 96 hrs later, and experienced deltoid muscle atrophy 1 W/L later.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle atrophy, Rash, Rash maculo-papular
Clinical narrative: Vaccine given 11/10/06, 6:30 am. Raised rash under arm pit occurred 48 hrs later, noticed indentation of armpit 96 hrs later, and experienced deltoid muscle atrophy 1 W/L later.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Injection site erythema, Injection site hypersensitivity, Injection site pain, Nasal congestion
Clinical narrative: 7cm x 4.5cm erythematous patch at site of injection on left upper arm.  Left earache, nasal congestion, pain and pruritus at injection site.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: 7cm x 4.5cm erythematous patch at site of injection on left upper arm.  Left earache, nasal congestion, pain and pruritus at injection site.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever 101.8 several hours after vaccination.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: Cellulitis at the vaccine site with fever of 99.7 on 11/24/06 after Pneumovax given 11/20/06.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site inflammation, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: T101, inflamed at site and warm to touch, 11/15 usual shot pain, 11/16 slight pain still, 11/17 inflamed an temp went to patient first DX with cellulitis antibiotics given 10 d supply.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Bacterial infection, Chills, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: Pt began this am with flu like symptoms, chills, muscle ache and swollen gland, severe headache, syncope and neck stiffness. 11/22/06 conversation with ARNP, pt was diagnosed with Strep throat at the ER on 11/17/06.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Myalgia, Syncope
Clinical narrative: Pt began this am with flu like symptoms, chills, muscle ache and swollen gland, severe headache, syncope and neck stiffness. 11/22/06 conversation with ARNP, pt was diagnosed with Strep throat at the ER on 11/17/06.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Erythema, Joint stiffness, Pain, Swelling
Clinical narrative: Patient complained of left upper arm/shoulder pain and stiffness last night after shot was administered.  Redness, swelling to the left upper arm above elbow.  TYLENOL taken with relief of pain.  Patient in our clinic today for assessment.  Seen by doctor mentioned.  Diagnose: Cellulitis, KEFLEX treated.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a physician concerning a 55 year old male with cardiac failure, hyperlipidaemia, obesity, apnoea, arthritis, a penicillin allergy and drug hypersensitivites to diphenhydramine hydrochloride (BENADRYL), Lisinopril and atenolol.  On 17-Oct-2006, the patient was vaccinated intramuscularly with 0.5 ml of pneumococcal 23v polysaccharide vaccine (Lot#654593/0358F).  Concomitant therapy included 22 unspecified therapies.  On 17-Oct-2006, later in the evening, the patient developed an injection site reaction which was painful, red and tender.  At that time, the patient did not have a fever noted.  Later the next day, the patient developed a temperature of 102.5 F and went to the emergency room (ER).  On 18-Oct-2006, the patient had developed a warm, red shoulder with 5-6 cm erythema.  The patient was admitted to the hospital from 19-Oct-2006 to 22-Oct-2006.  It was reported that the patient had a biopsy conducted but the results were unknown by the physician.  At the time of this report, the patient had recovered from the events (date unknown).  The reporter considered the events to be serious as immediately life-threatening and disabling.  A lot check of concern has been requested.  Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated with an oral first dose of Rotavirus Vaccine. Subsequently the pt experienced a blood stool and abdominal pain and had to be taken to the hospital. The duration of the hospital was not known. At the time of the report the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Dehydration, Gastrointestinal disorder, Viral infection
Clinical narrative: Information has been received from a physician concerning a child who a while ago, was vaccinated with an oral first dose of Rotavirus vaccine. One month later, the pt was admitted to the hospital with Rotavirus and dehydration. It was reported that the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated with a dose of Rotavirus vaccine (lot 654970/0777F). Concomitant vaccines on the same day included his other 2 month vaccines. On 11/10/06 the pt experienced diarrhea with a little blood in the stool. It was noted that bloodwork wad done. No other information was provided. Upon internal review, blood in stool was considered to be other important medical event (OMIC). Additional information has been requested.
Age: 0.21
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that the patient subsequently developed blood in their stool.  Unspecified medical attention was sought. At the time of this report, the outcome was unknown.  Upon internal review. blood in stool was determined to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion, Fall, Injury, Syncope
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of a prior seizure (on an unk date about a year ago during a hair cut) who on 11/6/06 was vaccinated IM in the deltoid with the second dose of HPV vaccine (lot not provided). It was reported that the pt had no difficulties when the first dose of the vaccine was administered on an unspecified date. On 11/6/06 the medical assistant administered the vaccine, then turned to discard the needle. The pt fainted, fell from the exam table, hit her head on the floor and had a seizure. Paramedics were called, a cervical collar was placed on the pt and she was transported to the ER. The pt was evaluated in the ER, a CT scan was performed which was reported as normal. The pt was discharged to home from the ER and instructed to follow up with neurology. The medical assistant stated that the physician felt that the pt had a vasovagal response after receiving the vaccine and that the seizure was a result of the head trauma which the pt suffered from the fall off the exam table. It was reported that the physician felt that the seizure was related to the head trauma and not related to the vaccine. The medical assistant also reported that the physician felt the pt had recovered from the event. Upon internal medical review the seizure was felt to be an important medical event (OMIC). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 14 year old female with a history of a prior seizure (on an unk date about a year ago during a hair cut) who on 11/6/06 was vaccinated IM in the deltoid with the second dose of HPV vaccine (lot not provided). It was reported that the pt had no difficulties when the first dose of the vaccine was administered on an unspecified date. On 11/6/06 the medical assistant administered the vaccine, then turned to discard the needle. The pt fainted, fell from the exam table, hit her head on the floor and had a seizure. Paramedics were called, a cervical collar was placed on the pt and she was transported to the ER. The pt was evaluated in the ER, a CT scan was performed which was reported as normal. The pt was discharged to home from the ER and instructed to follow up with neurology. The medical assistant stated that the physician felt that the pt had a vasovagal response after receiving the vaccine and that the seizure was a result of the head trauma which the pt suffered from the fall off the exam table. It was reported that the physician felt that the seizure was related to the head trauma and not related to the vaccine. The medical assistant also reported that the physician felt the pt had recovered from the event. Upon internal medical review the seizure was felt to be an important medical event (OMIC). Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV, TD, VARCEL
Symptoms: Central nervous system lesion, Encephalitis
Clinical narrative: Information has been received from an office manager concerning a 79 year old female who on 10/30/06 was vaccinated SC in the right arm with a 0.5ml dose of varicella virus vaccine live (lot 654693/1052F). Concomitant therapy that day included a dose of Pneumococcal 23v polysaccharide vaccine and a dose of Diphtheria toxoid/tetanus toxoid. The vaccinations occurred during an immigration physical exam. On approx 11/14/06 the pt developed encephalitis and brain lesions and was hospitalized. The pts encephalitis and brain lesion persisted. There was no product quality complaint. The reporter considered the events to be other important medical events and life threatening. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Herpes zoster, Rash vesicular, Skin burning sensation, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 or 12 year old male with a history of an enlarged spleen and splenectomy (age 6 or 9 years) and numerous vaccine (names unk) who was vaccainted with a dose of Pneumococcal 23v polysaccharide vaccine (dose and date not reported). Subsequently about 2 years ago, the pt experienced vesicular and burning dermatones that was diagnosed as shingles. The nurse practitioner thought the pt was going to come back to the office for a recheck the following week but does not remember seeing this pt again. The nurse practitioner dose not remember a lot of details from this case because it was from about two years ago. At the time of this report, the pts outcome was unk. No product quality complaint was involved. Shingles was considered to be an other important medical event (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a pt who was vaccainted with Pneumococcal 23v polysaccharide vaccine (lot 651332/1049P). Subsequently the pt developed swelling, redness and painful local reaction and required an antihistamine a few hours after receiving the Pneumococcal 23v polysaccharide vaccination. The pt was hospitalized. At the time of the report, it was unk if the pt recovered. The physician requested a lot check. A lot check of concern has been requested. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Difficulty in walking, Hypokinesia, Pain, Pyrexia, Tachycardia
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old male with rhinitis and increased immunoglobulin E (IgE) levels at the time of vaccination with a history of immunology problems and fever with unspecified vaccinations who on 10/18/06 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). The medical assistant believed that the vaccination was given in the left leg but was unsure of what route and exact location. On 10/18/06, 12 hours after the vaccination, the pt developed left leg pain and fever. After 24 hours, the pain increased and the pt refused to walk. After 48 hours the pt became very febrile (exact temp was unk) and developed tachycardia. The pt was hospitalized for several days and treated with unspecified IV antibiotics. The medical assistant considered left leg pain, tachycardia and fever to be other important medical events (OMIC). The office reported that the vaccination was from a multi dose vial and reported that they would like a lot check. The office gave 4 dosed from the exact vial and no other reactions reported. The physician was concerned because they have other vials and do not feel comfortable giving those doses to children in their pediatric pulmonary office.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Inflammation, Malaise, Oedema
Clinical narrative: Pain, swelling, redness, inflammation, fever, chills, malaise. Admitted to ER 11/11/06. Admitted to a Med center 11/11/06 for 2 days. IV Antibiotics blood cultures, X ray. Rehab dressing change, wound care every 2 days beginning 11/15/2006.  1/9/07 Received medical records from hospital which reveal patient admitted 11/11-11/13/06 with an abscess of the right deltoid which started 2 days s/p flu vax at local pharmacy flu clinic.  Temp was 99.5 in ER.  An I&D was performed while in the ER & approx 100-150 ml of grayish pus was expelled.  Then patient was admitted for IV antibiotics.  Progressed well & was d/c to home with wound care clinic visits & oral antibiotics.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Pain, swelling, redness, inflammation, fever, chills, malaise. Admitted to ER 11/11/06. Admitted to a Med center 11/11/06 for 2 days. IV Antibiotics blood cultures, X ray. Rehab dressing change, wound care every 2 days beginning 11/15/2006.  1/9/07 Received medical records from hospital which reveal patient admitted 11/11-11/13/06 with an abscess of the right deltoid which started 2 days s/p flu vax at local pharmacy flu clinic.  Temp was 99.5 in ER.  An I&D was performed while in the ER & approx 100-150 ml of grayish pus was expelled.  Then patient was admitted for IV antibiotics.  Progressed well & was d/c to home with wound care clinic visits & oral antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Dyspnoea, Hypoxia
Clinical narrative: Developed cough thick secretions and SOB, O2 Sats 87% within 15-20 minute after injections. Received Epinephrine 1:1000 0.17 SQ x 2 Decadron 4mg IM X 1, Benadryl given be parent. Home on Orapred. MR received revealing well child check where child received DTap, IPV, and MMR. Shortly thereafter he c/o SOB and cough. Pox 87%. Given Epi SQ and Decadron IM. Pox up to 93%. 2nd dose of Epi given SQ. Child observed for several hours, no wheezing, no cough, no sx.  Sent home on Orapred.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Dehydration, Gastroenteritis, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever 14 1/2 hours after receiving influenza vaccine. Continued with vomiting and admitted to hospital 11/14 PM with dehydration.  12/8/06 Received medical records from hospital which reveal patient admitted 11/14/06 for abdominal pain & refractory vomiting.  Treated w/IVF & antiemetics as well as protonix.  Improved & had no pain or vomiting on d/c to home 11/15/06. Final Dx: gastroenteritis./ss
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Back pain, CSF test abnormal, Diabetes mellitus, Guillain-Barre syndrome, Headache
Clinical narrative: Numbness and tingling in both hands, headache, back pain. Hypertension 240/150. Developed respiratory failure and received mechanical ventilation, plasma pheresis and IVIG.  12/12/06 Received medical records from hospital which reveal patient admitted 10/30/06 for numbness, tingling, back pain, SOB, nausea, vomiting & headache for 3 days.  Originally patient seen in urgent care facility but with BP of 240/150 was transferred to ER.  Initial presentation in ER also had HTN of 226/126.  Admit dx: severe HTN; new onset DM; low potassium.  Admitted to ICU.  Respiratory status deteriorated & patient intubated.  Neuro, pulmo, cardio & nephro consults done for GBS & plasmapheresis when IVIG was ineffective.  Patient was trached 11/10, feeding tube & PICC line placed, bilateral chest tubes placed 11/15.  No D/C summary available at this time.   D/C on 11/20. Final Dx: GBS.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypertension, Hypoaesthesia, Laboratory test abnormal, Paraesthesia, Respiratory failure
Clinical narrative: Numbness and tingling in both hands, headache, back pain. Hypertension 240/150. Developed respiratory failure and received mechanical ventilation, plasma pheresis and IVIG.  12/12/06 Received medical records from hospital which reveal patient admitted 10/30/06 for numbness, tingling, back pain, SOB, nausea, vomiting & headache for 3 days.  Originally patient seen in urgent care facility but with BP of 240/150 was transferred to ER.  Initial presentation in ER also had HTN of 226/126.  Admit dx: severe HTN; new onset DM; low potassium.  Admitted to ICU.  Respiratory status deteriorated & patient intubated.  Neuro, pulmo, cardio & nephro consults done for GBS & plasmapheresis when IVIG was ineffective.  Patient was trached 11/10, feeding tube & PICC line placed, bilateral chest tubes placed 11/15.  No D/C summary available at this time.   D/C on 11/20. Final Dx: GBS.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Numbness and tingling in both hands, headache, back pain. Hypertension 240/150. Developed respiratory failure and received mechanical ventilation, plasma pheresis and IVIG.  12/12/06 Received medical records from hospital which reveal patient admitted 10/30/06 for numbness, tingling, back pain, SOB, nausea, vomiting & headache for 3 days.  Originally patient seen in urgent care facility but with BP of 240/150 was transferred to ER.  Initial presentation in ER also had HTN of 226/126.  Admit dx: severe HTN; new onset DM; low potassium.  Admitted to ICU.  Respiratory status deteriorated & patient intubated.  Neuro, pulmo, cardio & nephro consults done for GBS & plasmapheresis when IVIG was ineffective.  Patient was trached 11/10, feeding tube & PICC line placed, bilateral chest tubes placed 11/15.  No D/C summary available at this time.   D/C on 11/20. Final Dx: GBS.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Back pain, CSF test abnormal, Diabetes mellitus, Guillain-Barre syndrome, Headache
Clinical narrative: Clinic administered a flu vaccine to patient on 10/18/06 after he had appropriately filled out a consent form (provided in Spanish) - indicating he had no contraindications for receiving the flu vaccine. The vaccine was paid for by his employer. The clinic did not see this individual again after administering his vaccine.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypertension, Hypoaesthesia, Laboratory test abnormal, Paraesthesia, Respiratory failure
Clinical narrative: Clinic administered a flu vaccine to patient on 10/18/06 after he had appropriately filled out a consent form (provided in Spanish) - indicating he had no contraindications for receiving the flu vaccine. The vaccine was paid for by his employer. The clinic did not see this individual again after administering his vaccine.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Clinic administered a flu vaccine to patient on 10/18/06 after he had appropriately filled out a consent form (provided in Spanish) - indicating he had no contraindications for receiving the flu vaccine. The vaccine was paid for by his employer. The clinic did not see this individual again after administering his vaccine.
Age: 53.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Diplopia, Fatigue, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: (OMIC) 53 year old healthy male was given two vaccines (influenza and Dtap) on 10/25/2006. He developed a severe headache on 10/29. The headache persisted and he subsequently developed diplopia on 11/1. He had mild nausea, photophobia, neck tightness and fatigue. He had a normal.  Confirmed with reporter that Tdap (Adacel) was given, not Dtap. MR received revealing a 53 year old who was seen 3 days s/p Tdap and flu vax. with c/o right sided neck tightness, photophobia, nausea  and headache.  Pt. developed diplopia 3 days post vax.  PE: WNL with the exception of measurements of the degree of deviation of his eyes c/w a right 4th cranial nerve palsy upon opthalmologic exam. Using Motrin and Tylenol for h/a.  DX: New onset right 4th cranial nerve palsy associated with flu shot and headache.
Age: 53.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Paralysis, Photophobia, Vascular anomaly
Clinical narrative: (OMIC) 53 year old healthy male was given two vaccines (influenza and Dtap) on 10/25/2006. He developed a severe headache on 10/29. The headache persisted and he subsequently developed diplopia on 11/1. He had mild nausea, photophobia, neck tightness and fatigue. He had a normal.  Confirmed with reporter that Tdap (Adacel) was given, not Dtap. MR received revealing a 53 year old who was seen 3 days s/p Tdap and flu vax. with c/o right sided neck tightness, photophobia, nausea  and headache.  Pt. developed diplopia 3 days post vax.  PE: WNL with the exception of measurements of the degree of deviation of his eyes c/w a right 4th cranial nerve palsy upon opthalmologic exam. Using Motrin and Tylenol for h/a.  DX: New onset right 4th cranial nerve palsy associated with flu shot and headache.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Flushing, Hypertension, Malaise, Paraesthesia
Clinical narrative: Employee given a flu shot at 1030 AM on 11/13/06. She was staying for observation about 15 minutes. I began to feel tingly and flush. Checked B/P and it was 180/88. Employee stated she didn't feel well. Rash noted on arms. Continued to feel sick and was given Benadryl 50mg PO now.  B/P at 1040 AM 148/70 and at 1045 shot up to 180/90. Discharged morning has to check and O2 at 2 hours given. No complaints of difficulty breathing noted. BP at 1115 shot up to 200/100 and employee transported via ambulance to hospital. Employee given Decadron IV. Continue to have reaction on 11/14/06 and went back to doctor. She was given Decadron IV, Medrol dose pack, Zyrtec and Benadryl PRN and advised to stay home for 5 days. Diagnosis: anaphylaxis sustained reaction from flu shot.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Employee given a flu shot at 1030 AM on 11/13/06. She was staying for observation about 15 minutes. I began to feel tingly and flush. Checked B/P and it was 180/88. Employee stated she didn't feel well. Rash noted on arms. Continued to feel sick and was given Benadryl 50mg PO now.  B/P at 1040 AM 148/70 and at 1045 shot up to 180/90. Discharged morning has to check and O2 at 2 hours given. No complaints of difficulty breathing noted. BP at 1115 shot up to 200/100 and employee transported via ambulance to hospital. Employee given Decadron IV. Continue to have reaction on 11/14/06 and went back to doctor. She was given Decadron IV, Medrol dose pack, Zyrtec and Benadryl PRN and advised to stay home for 5 days. Diagnosis: anaphylaxis sustained reaction from flu shot.