chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site is reddened and raised. Circumference is approx. 2 inches in diameter.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Nausea, Tenderness
Clinical narrative: Redness, tenderness, nausea
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 1.02
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Break through.  Chicken pox 6-8-09 Lesions- neck- face.  hands + arms.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: pt c/o itching at menactra injection site within hours of administration. later same evening pt c/o heat swelling redness at site pt taken to care now dx with local cellulitis 24 hrs after vaccination treated with bactrim reassessed 6/15 with significant improvement. original area  of induration 3x4 inches. pt on daily prednisone and fluorinef fpr cong adrenal hyperplasia
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site warmth
Clinical narrative: pt c/o itching at menactra injection site within hours of administration. later same evening pt c/o heat swelling redness at site pt taken to care now dx with local cellulitis 24 hrs after vaccination treated with bactrim reassessed 6/15 with significant improvement. original area  of induration 3x4 inches. pt on daily prednisone and fluorinef fpr cong adrenal hyperplasia
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Borrelia burgdorferi serology, Immunoglobulins normal, Injection site discomfort, Injection site pain
Clinical narrative: member was given Typhoid at 0915 on 06/06/2009. He had onset of localized pain and discomfort at site. Approximately 1 hour later his pain spread to his joints, chest wall and right upper extremity, hip and knee joints. Pain increased with activity. Member had a history of being bit by a tick 5 days proior with no bullseye leision.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Pain in extremity
Clinical narrative: member was given Typhoid at 0915 on 06/06/2009. He had onset of localized pain and discomfort at site. Approximately 1 hour later his pain spread to his joints, chest wall and right upper extremity, hip and knee joints. Pain increased with activity. Member had a history of being bit by a tick 5 days proior with no bullseye leision.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 10/28/2008 with Pneumonia. Vaccination took place on 9/22/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  6/19/09 Received SAE hospitalization of 10/28-11/1/2008. FINAL DX: pneumonia Records reveal patient experienced increased work of breathing, fever, chills.  Tx w/IV antibiotics & steroids.  Improved & d/c to home on continued oral antibiotics & steroids. ICD9 codes: 486.00.
Age: 73.0
Sex: U
Vaccine: PPV
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 12/21/2008 with atrial fibrillation. Vaccination took place on 9/22/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 6/19/08 Received SAE for hospitalization of 12/21-12/24/2008. FINAL DX: atrial fibrillation Records reveal patient experienced sudden atrial fib w/rapid ventricular response & associated anginal pain.  Tx w/meds, no recurrence & d/c to home. ICD9 Codes: 427.31.
Age: 62.0
Sex: U
Vaccine: PNC
Symptoms: Small intestinal obstruction, Vertigo
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 3/26/2009 with vertigo and small bowel obstruction. Vaccination took place on 6/13/2007. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  6/19/09 Received SAE for hospitalization of 03/26-3/27/2009. FINAL DX: vertigo, diverticulitis, partial small bowel obstruction Records reveal patient experienced diarrhea, vomiting & vertigo.  ICD9 Codes: 386.9, 560.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Chills, Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: On the 12th and 13th day after receiving the MMR, Client experienced fever (She didn't take her temperature),chils, sore throat and tiredness. These symptoms resolved with two days after they began.   She also experienced very tiny blisters-mostly single spots on leg stomach and foot.  She developed 2-3 spots together on her arm.  These blisters did not itch or open.  They resolved on their own and she did not see a doctor for them.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Nerve injury
Clinical narrative: One month after injection the patient woke up with loss of function in her left arm. Went to ER and for therapy. She was told it was nerve damage, undetermined cause. She had a soft cast and was out of work for 2 months.
Age: 15.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Bacteraemia, Blood culture positive, CSF culture positive, Meningitis meningococcal
Clinical narrative: 3/29/2009 Was hospitalized with meningococcal meningitis and bacteremia.  6/24/09 Hospital ER records received DOS 3/29/09. Assessment: Meningitis, diabetes. Patient presents with worsening headache, stiff neck, photophobia, fever, malaise, nausea and vomiting. Petechial rash, purpura both ankles. Transfered to higher level facility.  6/18/09 ICD-9 codes received. 3209, 25001, V5567, 78060  7/8/09 Hospital records received DOS 3/29/09 to 4/1/09. Assessment: Neisseria meningitidis meninigitis, insulin dependent diabetes. Patient presented with 24 hour fever, nuchal rigidity, and rash with petechia and purpuric lesions on all extremities. Vomiting, minimal oral intake. Tachycardia. Thin, dehydrated, and poorly perfused. Lips dry. Warm, flushed, pink. Myalgia, chills.
Age: 29.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Injection site pain, Nausea, Palpitations, Vomiting
Clinical narrative: After Tdap given, employee experienced nausea, vomiting, dizziness, palpitations, pain @site. No swelling.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pt received smallpox vaccination on June 6, 2009, a Saturday. On the following Tuesday, his right arm started to hurt and gradually worsened. On Friday June 12th, his arm was very sore and swollen and he went to an emergency room for treatment. He received anti-inflammatory and pain medication and was sent home a few hours later.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: 6/03/09 1:10 p.m. - phone call from cl reporting he woke up at 3 a.m. this morning with severe muscle and joint pain in shoulders, elbows and hips.  Encouraged to call HCP - 6-14-09 8:30 a.m. - phone call from cl reporting less soreness this am adn feelling better
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Antineutrophil cytoplasmic antibody positive, Biopsy skin, Full blood count normal, Henoch-Schonlein purpura, Injection site rash
Clinical narrative: - patient developed rash over the left leg, where the vaccine was administered. the rash progressed to trunk and right arm.  pupura-violaceous.  differential includes HSP vs hemorrhagic edema of infancy vs serum sickness due to vaccine.  patient also neutropenic transiently.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Neonatal disorder, Neutropenia, Oedema, Serum sickness
Clinical narrative: - patient developed rash over the left leg, where the vaccine was administered. the rash progressed to trunk and right arm.  pupura-violaceous.  differential includes HSP vs hemorrhagic edema of infancy vs serum sickness due to vaccine.  patient also neutropenic transiently.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Full blood count normal, Metabolic function test normal, Muscular weakness, Myalgia
Clinical narrative: 1 month following 1st gardasil injection patient reports muscle weakness or pain, non-progressing. Also c/o fatigue.  Medical records received DOS 5/27/09 to 6/16/09. Assessment: Acne vulgaris, fatigue, multiple joint arthralgia, acute bronchitis, acute pharyngitis. Patient presents with acne, generalized fatigue, muscle cramping all over, pain multiple joints, oral contraceptives.  ICD-9 Codes: 706.1, 780.7, 719.49, 466.0. 462, V72.3
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: 1 month following 1st gardasil injection patient reports muscle weakness or pain, non-progressing. Also c/o fatigue.  Medical records received DOS 5/27/09 to 6/16/09. Assessment: Acne vulgaris, fatigue, multiple joint arthralgia, acute bronchitis, acute pharyngitis. Patient presents with acne, generalized fatigue, muscle cramping all over, pain multiple joints, oral contraceptives.  ICD-9 Codes: 706.1, 780.7, 719.49, 466.0. 462, V72.3
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Red, swollen, Painful, warm to touch. Symptoms started one hr after administration and continued for 7 days.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Hepatitis A vaccine instead of Hepatitis B vaccine
Age: 56.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abdominal pain upper, Fatigue, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: 6/12/09 9am: Two days after vaccination, patient reported that site of injection was red, swollen and warm to the touch. Pt reported that size of area of irritation was 1 to 1&1/4" diameter. patient did not feel any pain prior to discovery of adverse effect. However, after discovery patient noted that the area was tender to the touch and her pain increased                                            4:45pm: pharmacist called patient to check on how her arm was. patient stated that the area was bigger than a silver dollar size, pain was also more obvious, and area was red and swollen. patient also stated that she felt queasy,tired and her stomach felt like she was having car sickness. Patient had some nasal congestion, sore throat and post nasal drip at time of vaccines administration and continues to have these symptoms on this day. Patient was advised to take over the counter Ibuprofen 400mg to 600mg by mouth three times a day for pain relief.                                          6/16/2009: Spoke to patient and she states that she had a fever of 101F during the weekend(06/12/09-06/14/09). She took tylenol for the pain and fever which helped. Patient also stated on this day that she had congestion of the throat within 30 minutes after receiving vaccine, which she did not mention in previous conversations.  She took some vitamin C for it and that the congestion is now cleared. Patient has no pain today.
Age: 56.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pyrexia, Respiratory tract congestion
Clinical narrative: 6/12/09 9am: Two days after vaccination, patient reported that site of injection was red, swollen and warm to the touch. Pt reported that size of area of irritation was 1 to 1&1/4" diameter. patient did not feel any pain prior to discovery of adverse effect. However, after discovery patient noted that the area was tender to the touch and her pain increased                                            4:45pm: pharmacist called patient to check on how her arm was. patient stated that the area was bigger than a silver dollar size, pain was also more obvious, and area was red and swollen. patient also stated that she felt queasy,tired and her stomach felt like she was having car sickness. Patient had some nasal congestion, sore throat and post nasal drip at time of vaccines administration and continues to have these symptoms on this day. Patient was advised to take over the counter Ibuprofen 400mg to 600mg by mouth three times a day for pain relief.                                          6/16/2009: Spoke to patient and she states that she had a fever of 101F during the weekend(06/12/09-06/14/09). She took tylenol for the pain and fever which helped. Patient also stated on this day that she had congestion of the throat within 30 minutes after receiving vaccine, which she did not mention in previous conversations.  She took some vitamin C for it and that the congestion is now cleared. Patient has no pain today.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Hypophagia, Irritability, Pyrexia, Somnolence
Clinical narrative: Patient fell asleep on the car ride home (very unusual at that time of day). He then became feverish and fell asleep for the night at 7:00--two hours after his shot, which was much earlier than normal. He stopped eating any solid foods and reverted only to nursing. For 48 hours, patient was feverish, overly sleepy (falling asleep at inappropriate times), very cranky, and refused to eat any solids.
Age: 1.9
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Convulsion, Dyskinesia, Intensive care, Pyrexia, Staring
Clinical narrative: My son got his vaccinations on Thursday morning. Then on Saturday night he was sleeping, started vomiting, when I went to clean him up he was staring and would not respond to his name or anything. His right arm started jerking so around 11:30 pm we took him to the ER. He was given some medication for seizures and had a catscan. He was flown in the helicopter to hospital. Another catscan and MRI were done to him. The doctors had no logical explanation of why he had gotten the seizure. He was under ICU for several hours and admitted to the hospital until he was released on Monday 5/26/09. A few days after this incident he had fever and vomiting for several days.  6/29/09 Hospital records received DOS 5/24/09 to 5/25/09. Assessment: Seizures associated with new onset L cerebral hemorrhage. Patient presented with vomiting, shaking/twitching in right arm, left arm flaccid,  'glassy look in his eyes', right eye deviation. Body became stiff. Seizure. Does not open eyes. Deep tendon reflexes dimished. Somnolent and does not arouse to voice. Disconjugate gaze. Glasgow Coma Scale of 6. Cafe au lait spot neck. 6/30/09-ICD-9 codes 431, 348.8, 345.90 and 372.30.
Age: 1.9
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: My son got his vaccinations on Thursday morning. Then on Saturday night he was sleeping, started vomiting, when I went to clean him up he was staring and would not respond to his name or anything. His right arm started jerking so around 11:30 pm we took him to the ER. He was given some medication for seizures and had a catscan. He was flown in the helicopter to hospital. Another catscan and MRI were done to him. The doctors had no logical explanation of why he had gotten the seizure. He was under ICU for several hours and admitted to the hospital until he was released on Monday 5/26/09. A few days after this incident he had fever and vomiting for several days.  6/29/09 Hospital records received DOS 5/24/09 to 5/25/09. Assessment: Seizures associated with new onset L cerebral hemorrhage. Patient presented with vomiting, shaking/twitching in right arm, left arm flaccid,  'glassy look in his eyes', right eye deviation. Body became stiff. Seizure. Does not open eyes. Deep tendon reflexes dimished. Somnolent and does not arouse to voice. Disconjugate gaze. Glasgow Coma Scale of 6. Cafe au lait spot neck. 6/30/09-ICD-9 codes 431, 348.8, 345.90 and 372.30.
Age: 8.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Right Arm reddened, swollen and painful some itchy. Mother stated notice swelling last evening 6/16/09 at about 8.00pm. Mother did not massage arm after shot.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Pt. had vaccines on 6-5-09, and on 6-14-09 child began to have a rash that looked like clots on back, no drainage or raised areas. It is now everywhere
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Condition aggravated
Clinical narrative: MOC states child has been seizure free since 8/08. Has had 10 seizures since start of rabies vaccine series - Has 2 doses left. 1st dose given here others have been given in another state- after parents moved continued seizures
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Decreased appetite, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Shots given around 11am 6-12-09.  Mom called around 2pm- patient crying, unable to console.  Eft eg injection site swollen, red.  Advised to apply heat pack, tylenol.  Called back 1 hour later, same symptoms- benadryl advised.  6-15-09 pt lethargic x 24 hours, decreased appetite.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Laboratory test, Lethargy
Clinical narrative: Shots given around 11am 6-12-09.  Mom called around 2pm- patient crying, unable to console.  Eft eg injection site swollen, red.  Advised to apply heat pack, tylenol.  Called back 1 hour later, same symptoms- benadryl advised.  6-15-09 pt lethargic x 24 hours, decreased appetite.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 2" red area to injection site- Rt. leg (upper) started 9 days after vaccines.
Age: 63.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site rash, Myalgia
Clinical narrative: Information has been received from a 63 year old female patient who was on 17-DEC-2008 vaccinated with the first dose of GARDASIL 0.5 ML on bum. The patient experienced muscle pain, dizziness and rash at the injection after getting the second dose of GARDASIL on 18-FEB-2009. Concomitant therapy included Raloxifene hydrochloride, Sumatriptan, Paroxetine hydrochloride, Omeprazole (MSD), vitamin D6, Aspirin, Omega-3 marine triglycerides and Calcium. The patient had not recovered at the time of reporting. It's not reported that the patient sought any medical attention. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a 36 year old female patient who in 2006 was vaccinated with the three doses of GARDASIL. The patient was now HPV positive. The consumer stated that she had only one partner in her life and she was vaccinated with GARDASIL before having sexual relations. The patient had not recovered. The patient contacted her physician. Follow up information has been received from the physician, who reported that the patient on 15-NOV-2006 was vaccinated with first dose of GARDASIL (Lot number 653736/0868F), on 26-JAN-2007 with the second dose of GARDASIL (Lot number 653736/0868F). The physician reported that on concomitant vaccines were given. The patient was last seen in the office in 2007, at which time her PAP smear was negative for HPV. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Lethargy
Clinical narrative: Information has been received from a nurse concerning her daughter a 14 year old female with amoxicillin allergy and no other medical history who in June 2008, was vaccinated with her first dose of GARDASIL (site and route of administration not reported). In September 2008, the patient was vaccinated with her second dose of GARDASIL (site and route of administration not reported). Concomitant therapy included a low dose of hormonal contraceptives (unspecified) to regulate her periods. In June 2008, on the day she received her first dose of GARDASIL the patient experienced sore arm at the injection site. In September 2008, the day after received her second dose of GRADASIL the patient experienced lethargy, severe headache and sore arm at the injection site. The lethargy and severe headache lasted for 2 days, and during that time the patient could not attend to school. The patient's mother could not confirm that her daughter was not able to attend the school due to the event. Subsequently, the patient recovered from lethargy and severe headache. The patient did not seek medical attention. Follow up call information received from a medical office assistant and registered nurse revealed that on 06-MAR-2008 the patient received her first dose of GARDSIL (lot # 659962/1740U), and on 02-JUL-2008 received her second dose of GARDASIL. Sore arm at the injection site developed on the day that 1st and 2nd dose were received, 02-JUL-2008 and 06-MAR-2008, respectively; lethargy and severe headache the day after 2nd dose was received on 03-JUL-2008. The nurse also confirmed that no other vaccines were administered at the same time as the GARDASIL doses. Additional information is not expected.
Age: 24.0
Sex: U
Vaccine: ANTH
Symptoms: Guillain-Barre syndrome, Laboratory test, Muscle fatigue, Muscular weakness, Neuropathy peripheral
Clinical narrative: Guillain Barre Syndrome after ANTHRAX vaccine #3; residual muscle fatigue/weakness after each vaccine - no new symptoms since hospitalization abroad 1998. Neuropathy.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Pain in extremity, Swelling
Clinical narrative: Information has been received from medical records regarding a case in litigation for fosamax (MSD) (WAES 0705USA01442) from a physician concerning a 50 year old postmenopausal female who on 02-OCT-2002 was vaccinated with a dose of MMR II. Around 18-OCT-2002 or 19-OCT-2002, the patient developed pain and swelling of the wrists, fingers, and left knee. It was noted to be quite bad "on the weekend." The physician suggested DAYPRO because it was available in her house. This did not initially help, although when she was seen at the physician's office on 22-OCT-2002, she was feeling better. She did not have a rash or fever. A musculoskeletal examination revealed minimal swelling and stiffness of the wrists and fingers. The impression was "acute arthritis, as a reaction to vaccine." The patient was to follow-up on an as needed basis. No further information is available.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Blood thyroid stimulating hormone, Cardiac stress test, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Chest pain, dyspnea, palpitations post repeat vaccinia. Chest Heaviness.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Full blood count normal, Lipids normal, Metabolic function test, Palpitations
Clinical narrative: Chest pain, dyspnea, palpitations post repeat vaccinia. Chest Heaviness.
Age: 38.0
Sex: F
Vaccine: SMALL
Symptoms: Troponin
Clinical narrative: Chest pain, dyspnea, palpitations post repeat vaccinia. Chest Heaviness.
Age: 34.0
Sex: M
Vaccine: ANTH, HEP, MNQ
Symptoms: Allergy test negative, Peak expiratory flow rate, Rash macular, Rash pruritic, Skin lesion
Clinical narrative: Description:  diffuse puritic rash 2 days post anthrax, HBV, and meningococcal vaccines.  Comment:  Initial VAERS completed Oct 03.  Symptom:  Lesions, macule Start:  5/25/2003 End: 11/25/2003.  Comment:  inttermittent appearance/resolution.
Age: 0.8
Sex: U
Vaccine: FLUX
Symptoms: Death
Clinical narrative: We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to received trivalent influenza vaccination (TIV). To assess TIV vaccine safety, analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1439 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 9.6-month-old patient that was found dead in crib one day after influenza vaccination (manufacturer and batch no. unknown). Vaccine received with TIV: SYNAGIS. Medical history: Chronic lung disease, microcephaly, developmental delay. No autopsy had been done.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Ataxia, Computerised tomogram, Electrocardiogram normal, Fatigue
Clinical narrative: Inflammatory peripheral neuropathy (GBS) after primary BIOTHRAX vaccination. Gait abnormality Start: 10/17/2003 - truncal ataxia. Syncope Start: 10/17/2003 - episode X1. Fatigue, Malaise more than 60 days Start: 10/17/2003. Memory Loss, short term Start: 10/17/2003
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Full blood count normal, Gait disturbance, Guillain-Barre syndrome, Malaise, Metabolic function test normal
Clinical narrative: Inflammatory peripheral neuropathy (GBS) after primary BIOTHRAX vaccination. Gait abnormality Start: 10/17/2003 - truncal ataxia. Syncope Start: 10/17/2003 - episode X1. Fatigue, Malaise more than 60 days Start: 10/17/2003. Memory Loss, short term Start: 10/17/2003
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging, Spinal X-ray normal, Syncope
Clinical narrative: Inflammatory peripheral neuropathy (GBS) after primary BIOTHRAX vaccination. Gait abnormality Start: 10/17/2003 - truncal ataxia. Syncope Start: 10/17/2003 - episode X1. Fatigue, Malaise more than 60 days Start: 10/17/2003. Memory Loss, short term Start: 10/17/2003
Age: 1.3
Sex: U
Vaccine: DTAP, FLUX, HIBV
Symptoms: Autopsy, Death, Pseudomonal sepsis, Pyrexia, Respiratory distress
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive trivalent influenza vaccination TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438, MA2009-1440 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 15-month-old patient who developed fever, respiratory distress and shock one day after influenza vaccination (batch no. and manufacturer unknown). Vaccine received with TIV: DTaP/HIB. Medical history: Polycystic kidney disease, hypertension. Autopsy results: Pseudomonas sepsis and possible liver cyst/cholangitis.
Age: 1.3
Sex: U
Vaccine: DTAP, FLUX, HIBV
Symptoms: Shock
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive trivalent influenza vaccination TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438, MA2009-1440 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 15-month-old patient who developed fever, respiratory distress and shock one day after influenza vaccination (batch no. and manufacturer unknown). Vaccine received with TIV: DTaP/HIB. Medical history: Polycystic kidney disease, hypertension. Autopsy results: Pseudomonas sepsis and possible liver cyst/cholangitis.
Age: 0.5
Sex: U
Vaccine: DTAP, FLUX, IPV, PPV
Symptoms: Autopsy, Sudden infant death syndrome
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443 and MA2009-1447 to MA2009-1454). This case refers to a 6-month-old patient who was found dead in crib one day after influenza vaccination (batch no. and manufacturer unknown). Autopsy result: sudden infant death syndrome. Vaccine received with TIV: DTaP/IPV/PCV.
Age: 1.7
Sex: U
Vaccine: FLUX
Symptoms: Autopsy, Death, Pneumonia aspiration, Vomiting
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1440, MA2009-1442, MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 20-month-old patient who was found with vomiting in crib and developed aspiration pneumonia five days after influenza vaccination (batch no. and manufacturer unknown). Medical history: Chronic lung disease, gastroesophageal reflux, grade II intraventricular hemorrhage, cerebral palsy. Autopsy results: aspiration pneumonia.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Chest discomfort, Chest pain
Clinical narrative: Patient states that he received the SMALLPOX Vaccine on May 11, 2004. On May 19th, he woke up with fever, chills, flu-like symptoms, and muscle/joint pain. Denies nausea, vomiting, diarrhea or other associated symptoms. On May 20th states that his chest started hurting but he thought it was from being sick the day before. On May 21, the chest pain persisted and he had trouble sleeping because he was having trouble breathing. States that he was not really having any SOB but could not take any deep inspiration due to the chest pain. States that it hurt more to take a deep breath. His wife called the sick call desk to get an appointment and he was instructed to report to the ER. He describes the chest pain as a constant pressure like someone pushing on his chest. States that the pressure was localized about softball size right above the sternum in the center of the chest. On a pain scale from 0-10 the intensity of the pain was rated as a 4 when most intense. The chest pain now is rated as a 0.5 on pain scale 0-10 and only occurs on deep inspiration. There is no positional relationship and it is not associated with food.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Dyspnoea, Electrocardiogram, Electrocardiogram ST segment elevation, Influenza like illness
Clinical narrative: Patient states that he received the SMALLPOX Vaccine on May 11, 2004. On May 19th, he woke up with fever, chills, flu-like symptoms, and muscle/joint pain. Denies nausea, vomiting, diarrhea or other associated symptoms. On May 20th states that his chest started hurting but he thought it was from being sick the day before. On May 21, the chest pain persisted and he had trouble sleeping because he was having trouble breathing. States that he was not really having any SOB but could not take any deep inspiration due to the chest pain. States that it hurt more to take a deep breath. His wife called the sick call desk to get an appointment and he was instructed to report to the ER. He describes the chest pain as a constant pressure like someone pushing on his chest. States that the pressure was localized about softball size right above the sternum in the center of the chest. On a pain scale from 0-10 the intensity of the pain was rated as a 4 when most intense. The chest pain now is rated as a 0.5 on pain scale 0-10 and only occurs on deep inspiration. There is no positional relationship and it is not associated with food.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Insomnia, Myalgia, Pericarditis, Pyrexia, Troponin increased
Clinical narrative: Patient states that he received the SMALLPOX Vaccine on May 11, 2004. On May 19th, he woke up with fever, chills, flu-like symptoms, and muscle/joint pain. Denies nausea, vomiting, diarrhea or other associated symptoms. On May 20th states that his chest started hurting but he thought it was from being sick the day before. On May 21, the chest pain persisted and he had trouble sleeping because he was having trouble breathing. States that he was not really having any SOB but could not take any deep inspiration due to the chest pain. States that it hurt more to take a deep breath. His wife called the sick call desk to get an appointment and he was instructed to report to the ER. He describes the chest pain as a constant pressure like someone pushing on his chest. States that the pressure was localized about softball size right above the sternum in the center of the chest. On a pain scale from 0-10 the intensity of the pain was rated as a 4 when most intense. The chest pain now is rated as a 0.5 on pain scale 0-10 and only occurs on deep inspiration. There is no positional relationship and it is not associated with food.
Age: 0.5
Sex: U
Vaccine: DTAP, FLUX, IPV, PPV
Symptoms: Autopsy, Death
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438, MA2009-1439, MA2009-1441 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 6-month-old patient who was found dead in crib one day after influenza vaccination (batch no. and manufacturer unknown). Vaccine received with TIV: DTaP/IPV/PCV. Medical history: Joubert syndrome with apneic episodes. Autopsy results: Inconclusive.
Age: 0.8
Sex: U
Vaccine: FLUX
Symptoms: Convulsion, Death, Gastrointestinal disorder, Pyrexia, Rash
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1441, MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 10-month-old patient who developed fever after influenza vaccination (batch no. and manufacturer unknown) that progressed over 4 days to gastrointestinal illness, rash, seizure and respiratory distress. The patient died five days after vaccination.
Age: 0.8
Sex: U
Vaccine: FLUX
Symptoms: Respiratory distress
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1441, MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 10-month-old patient who developed fever after influenza vaccination (batch no. and manufacturer unknown) that progressed over 4 days to gastrointestinal illness, rash, seizure and respiratory distress. The patient died five days after vaccination.
Age: 1.5
Sex: U
Vaccine: FLUX
Symptoms: Autopsy, Bronchopneumonia, Unresponsive to stimuli
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445, MA2009-1447 to MA2009-1451 and MA2009-1453 to MA2009-1454). This case refers to a 18-month-old patient who was unresponsive in crib six days after influenza vaccination (batch no. and manufacturer unknown). Autopsy results: bronchopneumonia probably of bacterial origin.
Age: 0.5
Sex: U
Vaccine: DTAP, FLUX
Symptoms: Autopsy, Convulsion, Death, Gene mutation, Irritability
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445 and MA2009-1448 to MA2009-1454). This case refers to a 6-month-old patient who developed fever and irritability seven days as well as seizures 14 days after influenza vaccination (batch no. and manufacturer unknown). Patient lost all physical abilities and died 22 months after influenza vaccination. Vaccines received with TIV: DTaP. Autopsy results: diagnosed with white matter disease, gene mutation found.
Age: 0.5
Sex: U
Vaccine: DTAP, FLUX
Symptoms: Physical disability, Pyrexia
Clinical narrative: We received the following literature report: In 2002 with the documentation of a sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to receive TIV. To assess TIV vaccine safety, the committee and co-workers analyzed all of the adverse events (AE) reported to the Vaccine Adverse Event Reporting System (VAERS) after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess the cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following smallpox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445 and MA2009-1448 to MA2009-1454). This case refers to a 6-month-old patient who developed fever and irritability seven days as well as seizures 14 days after influenza vaccination (batch no. and manufacturer unknown). Patient lost all physical abilities and died 22 months after influenza vaccination. Vaccines received with TIV: DTaP. Autopsy results: diagnosed with white matter disease, gene mutation found.
Age: 1.0
Sex: U
Vaccine: FLUX, MMR, VARCEL
Symptoms: Autopsy, Cardio-respiratory arrest, Death
Clinical narrative: We received the following literature report: In 2002 with the documentation of the sizeable burden of influenza in children 6-23 months of age, the committee "encouraged" children in this age group to received trivalent influenza vaccination (TIV). To assess TIV vaccine safety, analyzed all of the adverse events reported to the Vaccine Adverse Event Reporting System after TIV in children less than 2 years of age between 1990 and June 2003. There were 15 reported deaths with the majority occurring in previously healthy children. Most had an autopsy to assess cause of death. A single case of myocarditis was reported and cannot be definitively linked to influenza vaccination. Although myocarditis and dilated cardiomyopathy have been reported following small pox vaccination, the pathologic findings reported in those cases differ from this case and TIV is an inactivated, not a live vaccine. The classification of 6 deaths as possibly related to TIV primarily reflects limitations of the individual case reports and causality assessment methods. Among the 15 fatalities, 6 were possibly related, 7 unlikely related, and 2 unrelated to TIV vaccination (please refer also to cases MA2009-1438 to MA2009-1443, MA2009-1445 and MA2009-1447 to MA2009-1454). This case refers to a 12-month-old patient who developed cardiorespiratory arrest two days after influenza vaccination (batch no. and manufacturer unknown). Vaccines received with TIV: varicella vaccine, MMR vaccine. Autopsy results: etiology is undetermined, patient had recent cold symptoms.