chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: Started running low grade fever 12 hours after injection. 2 days later pain noted in area. 3 days later pt came into office L forearm observed to be red, hot and painful to touch. Redness 4.5 in wide x 3.5 inches high.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Paraesthesia
Clinical narrative: -Anxiety, shortness of breath, increased heart rate, tingling of hands, fingers and feet - icepack applied to neck. Paramedics evaluated, patient's husband took home to relax
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Pt called the office on 1/20/10 with c/o hive like reaction on left leg above the knee. Per pt. he has had hives before in the past so he is sure this is what he has.  Pt was offered appointment same day to evaluate but declined, stating symptoms were subsiding. Pt was told to call the office with any changes/issues.
Age: 0.54
Sex: M
Vaccine: FLU(H1N1), HIBV, PNC, RV5
Symptoms: Cellulitis, Erythema, Induration, Injection site streaking
Clinical narrative: Pt dx with cellulitis.  +induration measuring 4cm X 2cm with some red streaking.  Pt tx'd with Cephalex.
Age: 54.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Cough, Pneumonia, Pyrexia
Clinical narrative: COUGHING, FEVER, CHILLS PNEUMONIA  ANTIBOTICS-AMOXIL-AMOXICILLIN 500 MG
Age: 47.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Sensation of heaviness
Clinical narrative: Very heavy left arm with needles in the fingers, went on for more than one hour.
Age: 1.0
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Mother noticed onset of right thigh lump and redness 1 week after administration of varicella vaccine.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Pruritus
Clinical narrative: Itching bilateral forearms, then experienced palpitations. Paramedics called. Advised to take Benadryl by paramedics.
Age: 82.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Patient reports pain and inflammation in the upper and lower arm.  Patient states that pain is so severe it has required 2 doctor visits over the last 2 weeks and has required medication.  Patient did not bring any documentation of these treatments when reporting to pharmacy/administrator.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest pain, Cough, Dizziness, Eye swelling, Headache
Clinical narrative: About 10 minutes after receiving the vaccine, I felt dizzy.  Four hours later, I started having a dry cough and my throat was itching.  When I woke up on the morning of 1/26/10, my face was swollen including my eyes, which were swollen half shut and red.  My chest was hurting and I had a terrible headache.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Ocular hyperaemia, Swelling face, Throat irritation
Clinical narrative: About 10 minutes after receiving the vaccine, I felt dizzy.  Four hours later, I started having a dry cough and my throat was itching.  When I woke up on the morning of 1/26/10, my face was swollen including my eyes, which were swollen half shut and red.  My chest was hurting and I had a terrible headache.
Age: 79.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Blood bicarbonate decreased, Blood creatinine increased, Blood potassium increased, Blood urea increased, Condition aggravated
Clinical narrative: pt was ill. fell and hit face.  was disoriented.  when presented to er had progound metabolic acidoses, hyperkalemia and severe renal failure just like 3 other H1N1 and flu vac cases this winter.
Age: 79.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Disorientation, Face injury, Fall, Hyperkalaemia, Malaise
Clinical narrative: pt was ill. fell and hit face.  was disoriented.  when presented to er had progound metabolic acidoses, hyperkalemia and severe renal failure just like 3 other H1N1 and flu vac cases this winter.
Age: 79.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Metabolic acidosis, Renal failure
Clinical narrative: pt was ill. fell and hit face.  was disoriented.  when presented to er had progound metabolic acidoses, hyperkalemia and severe renal failure just like 3 other H1N1 and flu vac cases this winter.
Age: 58.0
Sex: M
Vaccine: TTOX
Symptoms: Wrong drug administered
Clinical narrative: Patient was over the age of 50, Menactra was given but Menomune should have been given.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Anuria, Blood creatinine increased, Blood urea increased, Dependence on enabling machine or device, Fluid retention
Clinical narrative: kidney failure fluid retention anuria
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Renal failure
Clinical narrative: kidney failure fluid retention anuria
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia oral
Clinical narrative: Soon after injection complained of tongue being numb, dizziness.  Instructed to take Benadryl and to call MD to report her reaction.
Age: 58.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Chills, Cough, Hyperhidrosis, Myalgia
Clinical narrative: fever (not confirmed) shaking, sweats, chills, weakness, muscle aches, soreness in the diaphragm, L arm site soreness. Abdominal cramping/discomfort. Seasonal vaccine and H1N1 vaccine were done on the same day. Client has soreness in the L arm today(1/28) and diaphragm soreness which he relates to cough onset.
Age: 58.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: fever (not confirmed) shaking, sweats, chills, weakness, muscle aches, soreness in the diaphragm, L arm site soreness. Abdominal cramping/discomfort. Seasonal vaccine and H1N1 vaccine were done on the same day. Client has soreness in the L arm today(1/28) and diaphragm soreness which he relates to cough onset.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash, Stomatitis, Throat irritation
Clinical narrative: Pt. felt like his mouth was scalded by something hot. When he looked in his mouth, there were many white bumps all over inside his mouth. Soon after, felt like he had hair caught in his throat that he could not get rid of. As of today, the bumps are gone and the hair in the throat feeling is much less.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Asthma, Condition aggravated, Gait disturbance, Headache
Clinical narrative: Patient developed blurry vision Left eye and Left sided temporal headache with vomiting x 2 days. Also developed numbness of the L ankle and weakness that has progressed to dragging left leg on walking. Seen at a community clinic and was diagnosed as asthma, tachycardia and neuropathies. Blood tests ordered but not done. Patient denies resppiratory difficulties, bladder or urinary sypmtoms.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Hypoaesthesia, Neuropathy peripheral, Tachycardia, Vision blurred, Vomiting
Clinical narrative: Patient developed blurry vision Left eye and Left sided temporal headache with vomiting x 2 days. Also developed numbness of the L ankle and weakness that has progressed to dragging left leg on walking. Seen at a community clinic and was diagnosed as asthma, tachycardia and neuropathies. Blood tests ordered but not done. Patient denies resppiratory difficulties, bladder or urinary sypmtoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Developed warmth and redness at site of injection of IPV.  Required doctor visit and starting of antibiotics for mild cellulitis.
Age: 83.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Facial palsy
Clinical narrative: Bells Palsy Corticosteriods & acyclovir
Age: 82.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Facial palsy
Clinical narrative: BELLS PALSY, ACYCLOVIR 200 2 CAPS 5XD, PREDNISONE 5MG UD FOR 12 DAYS
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood calcium normal, Blood magnesium normal, Electrocardiogram normal, Full blood count normal, Metabolic function test normal
Clinical narrative: Syncope lasting approx. 5 seconds. Pt became stiff and turned pale.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Musculoskeletal stiffness, Pallor, Syncope
Clinical narrative: Syncope lasting approx. 5 seconds. Pt became stiff and turned pale.
Age: 64.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: rapid heartbeat, fever - 3 days  no treatment
Age: 39.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Dizziness (continual) and momentary quickened heart beat
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Decreased appetite, Pyrexia, Rash erythematous, Swelling face, Vomiting
Clinical narrative: Received H1N1 at school (2nd dose) Tuesday afternoon. Developed facial swelling and diffuse red rash later that night. Vomited that night. Fever to 102. Fever now gone. Gave ibuprofen. Remaining symptoms now (1/28 12pm)include the diffuse rash and facial swelling, decreased appetite and some vomiting.
Age: 0.51
Sex: F
Vaccine: DTP, HIBV, IPV, PPV
Symptoms: Blood test, Culture urine negative, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: 102.5 fever, vomiting, diarrhea.  Unable to eat for 3 days.  Was treated for Dehydration at local ER.
Age: 0.51
Sex: F
Vaccine: DTP, HIBV, IPV, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: 102.5 fever, vomiting, diarrhea.  Unable to eat for 3 days.  Was treated for Dehydration at local ER.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient c/o itching on torso, neck, arms with tightness of throat 15-20 min. after IM injection. BENADRYL liquid 12.5mg/5ml 20ml PO and Prednisone 20mg/tab 3 PO.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Blood glucose increased, Immediate post-injection reaction
Clinical narrative: Initial report received from a health care professional on 18 Jan 2010: This patient received a dose of H1N1 influenza virus vaccine (manufacturer and batch number unknown) on 11 Jan 2010. Almost immediately after vaccination, the patient's blood sugar levels jumped to 300 mg/dL. It was unknown whether the patient was a diabetic or had a previous history of high blood glucose levels. Outcome of the event was not reported.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Abdominal pain upper, Asthenia, Chest pain, Computerised tomogram
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 15-year-old female with no known allergy nor illness, who on 02-MAY-2007 was vaccinated IM in her left arm with the second dose of GARDASIL vaccine (lot # 658094/0524U). Concomitant medication included albuterol. On 24-JUN-2007, the patient experienced lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain. It was not reported whether medical attention was sought. In July of 2007 after the vaccination, she experienced all of these (lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain) plus severe hot flushes, sweats, severe muscle pain and weakness, collapsing and passing out as well as chest pain. According to the report: "she was now sick on a monthly basis and her sickness usually last 7-8 days. She also becomes delusional at times and spacey." The report also stated: "Several different lab studies, ultra sounds, x-rays, CT scans and an appointment with the endocrinologist which didn't do us any good. She was a perfectly healthy kid until she received this vaccine." The original reporting source was not provided. The VAERS ID # is 318483. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to released met all release specifications. The lot met the requirements of the research center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Delusion, Disorientation, Dizziness, Hot flush, Hyperhidrosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 15-year-old female with no known allergy nor illness, who on 02-MAY-2007 was vaccinated IM in her left arm with the second dose of GARDASIL vaccine (lot # 658094/0524U). Concomitant medication included albuterol. On 24-JUN-2007, the patient experienced lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain. It was not reported whether medical attention was sought. In July of 2007 after the vaccination, she experienced all of these (lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain) plus severe hot flushes, sweats, severe muscle pain and weakness, collapsing and passing out as well as chest pain. According to the report: "she was now sick on a monthly basis and her sickness usually last 7-8 days. She also becomes delusional at times and spacey." The report also stated: "Several different lab studies, ultra sounds, x-rays, CT scans and an appointment with the endocrinologist which didn't do us any good. She was a perfectly healthy kid until she received this vaccine." The original reporting source was not provided. The VAERS ID # is 318483. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to released met all release specifications. The lot met the requirements of the research center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise, Myalgia, Nausea, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 15-year-old female with no known allergy nor illness, who on 02-MAY-2007 was vaccinated IM in her left arm with the second dose of GARDASIL vaccine (lot # 658094/0524U). Concomitant medication included albuterol. On 24-JUN-2007, the patient experienced lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain. It was not reported whether medical attention was sought. In July of 2007 after the vaccination, she experienced all of these (lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain) plus severe hot flushes, sweats, severe muscle pain and weakness, collapsing and passing out as well as chest pain. According to the report: "she was now sick on a monthly basis and her sickness usually last 7-8 days. She also becomes delusional at times and spacey." The report also stated: "Several different lab studies, ultra sounds, x-rays, CT scans and an appointment with the endocrinologist which didn't do us any good. She was a perfectly healthy kid until she received this vaccine." The original reporting source was not provided. The VAERS ID # is 318483. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to released met all release specifications. The lot met the requirements of the research center and was released.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan, Visual impairment, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 15-year-old female with no known allergy nor illness, who on 02-MAY-2007 was vaccinated IM in her left arm with the second dose of GARDASIL vaccine (lot # 658094/0524U). Concomitant medication included albuterol. On 24-JUN-2007, the patient experienced lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain. It was not reported whether medical attention was sought. In July of 2007 after the vaccination, she experienced all of these (lightheadedness, dizzy, seeing spots, abdominal pain, nausea and left upper quad pain) plus severe hot flushes, sweats, severe muscle pain and weakness, collapsing and passing out as well as chest pain. According to the report: "she was now sick on a monthly basis and her sickness usually last 7-8 days. She also becomes delusional at times and spacey." The report also stated: "Several different lab studies, ultra sounds, x-rays, CT scans and an appointment with the endocrinologist which didn't do us any good. She was a perfectly healthy kid until she received this vaccine." The original reporting source was not provided. The VAERS ID # is 318483. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to released met all release specifications. The lot met the requirements of the research center and was released.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure decreased, Dizziness, Dyspnoea, Heart rate decreased, Hyperhidrosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company the FDA under the Freedom of Information Act. On 04-Aug-2009 a 16 year old female was vaccinated in the left arm with a first dose of GARDASIL (Lot #662518/0087Y). On the same day she was also vaccinated in the left arm with a first dose of HAVRIX (Lot #AHAVB249AD). Patient became dizzy 30 seconds after the shot. Patient was pale, diaphoretic and nauseous. Symptoms lasted about 45 minutes. Her blood pressure dropped to 90/50 and pulse to 50/minutes. On 20-Aug-2009 the primary care physician not was received ( date of service 04-Aug-2009). It was reported that after the shots, patient became nauseated, pale, diaphoretic, dizzy and had difficulty breathing. Blood pressure dropped to 90/50 and pulse into the 50's. The symptoms lasted about 45 minutes with return to baseline. Vaccine records stated patient "passed out." According to the PCP not received on 20-Aug-2009 (date of service 04-Aug-2009), the patient never experienced these symptoms with previous shots. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 354037-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Nausea, No reaction on previous exposure to drug, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company the FDA under the Freedom of Information Act. On 04-Aug-2009 a 16 year old female was vaccinated in the left arm with a first dose of GARDASIL (Lot #662518/0087Y). On the same day she was also vaccinated in the left arm with a first dose of HAVRIX (Lot #AHAVB249AD). Patient became dizzy 30 seconds after the shot. Patient was pale, diaphoretic and nauseous. Symptoms lasted about 45 minutes. Her blood pressure dropped to 90/50 and pulse to 50/minutes. On 20-Aug-2009 the primary care physician not was received ( date of service 04-Aug-2009). It was reported that after the shots, patient became nauseated, pale, diaphoretic, dizzy and had difficulty breathing. Blood pressure dropped to 90/50 and pulse into the 50's. The symptoms lasted about 45 minutes with return to baseline. Vaccine records stated patient "passed out." According to the PCP not received on 20-Aug-2009 (date of service 04-Aug-2009), the patient never experienced these symptoms with previous shots. The listing indicated that one or more of the events was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 354037-1. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Bronchiolitis, Dyspnoea, No reaction on previous exposure to drug, Pyrexia, Respiratory failure
Clinical narrative: Information has been received from a consumer concerning her son with allergies to wheat, diary, eggs and nuts who was vaccinated with the second dose of ACTHIB (dose, route, and lot# not reported). Concomitant therapy included DTAP (manufacturer unspecified). The patient had respiratory failure 3 days after the vaccines were given. The consumer stated her child vaccinated with a fever and runny nose and then later had trouble breathing. The consumer stated this reaction was to the booster dose (second dose) of the vaccines. No reaction was reported after the first dose of the vaccine. The patient was admitted to a hospital. On unspecified date, the patient recovered. Follow up information received from a medical assistant indicated that on 09-OCT-2009, the 28 month old patient received the second dose of ACTHIB (manufacturer Sanofi, lot# UF498AA) and the second dose of DTAP (manufacturer not reported, C2957AA). The patient was admitted to hospital on 14-OCT-2009. The patient was treated with Albuterol nebulizer treatments. The Medical Records from the hospital stated that the patient likely had an upper respiratory infection with a low grade fever and the URI was likely viral bronchiolitis. The patient was discharged on 16-OCT-2008. Follow-up information indicated that the patient was being treated with ACTHIB and not PEDVAXHIB as previously reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Rhinorrhoea, Upper respiratory tract infection, Viral infection
Clinical narrative: Information has been received from a consumer concerning her son with allergies to wheat, diary, eggs and nuts who was vaccinated with the second dose of ACTHIB (dose, route, and lot# not reported). Concomitant therapy included DTAP (manufacturer unspecified). The patient had respiratory failure 3 days after the vaccines were given. The consumer stated her child vaccinated with a fever and runny nose and then later had trouble breathing. The consumer stated this reaction was to the booster dose (second dose) of the vaccines. No reaction was reported after the first dose of the vaccine. The patient was admitted to a hospital. On unspecified date, the patient recovered. Follow up information received from a medical assistant indicated that on 09-OCT-2009, the 28 month old patient received the second dose of ACTHIB (manufacturer Sanofi, lot# UF498AA) and the second dose of DTAP (manufacturer not reported, C2957AA). The patient was admitted to hospital on 14-OCT-2009. The patient was treated with Albuterol nebulizer treatments. The Medical Records from the hospital stated that the patient likely had an upper respiratory infection with a low grade fever and the URI was likely viral bronchiolitis. The patient was discharged on 16-OCT-2008. Follow-up information indicated that the patient was being treated with ACTHIB and not PEDVAXHIB as previously reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Condition aggravated, Death, Pulmonary embolism
Clinical narrative: Initial report was received via scientific literature search on 29 December 2009 (Number US-SP-2010-00011). The Centers for Disease Control and prevention. Vaccine Adverse Event Reporting System received 13 reports of deaths occurring after receipt of H1N1 vaccine; three occurred after receipt of LAMV and 10 after receipt of MIV through 24 November 2009. This case involved one of 10 patients who experienced death following vaccination with MIV. Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00013, -00014, -00016, -00018, -00019, -00020. A 46-year-old female patient had received a dose of Pandemic Influenza H1N1 Vaccine on an unknown date in 2009. The trade name, lot number and site of administration was not reported. Vaccination to onset was reported as 2 days. The patient experienced pulmonary embolus which was negative for H1N1 in lung tissue and died. Medical history included hypertension, hyperlipidemia, pulmonary embolism, and deep vein thrombosis. No additional information was reported. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cardiovascular disorder, Death
Clinical narrative: Initial report was received via scientific literature search on 29 December 2009 (US-SP-2010-00011). Vaccine Adverse Event Reporting System (VAERS) received 13 reports of deaths occurring after receipt of H1N1 vaccine; three deaths occurred after receipt of live, attenuated monovalent vaccine (LAMV) and 10 after receipt of monovalent inactivated, split virus or subunit vaccines (MIV) through 24 November 2009. This case involves one of 10 patients who experienced death following vaccination with monovalent inactivated, split virus or subunit vaccines (MIV). Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00013, -00014, -00015, -00017, -00018, -00019, -00020. A 40-year-old female patient had received a dose of PANDEMIC INFLUENZA H1N1 VACCINE on an unknown date in 2009. The trade name, lot number, route and site of administration were not reported. Three days post-vaccination the patient experienced a suspected cardiovascular event and died. Medical history included type 2 diabetes, stroke, chronic obstructive pulmonary disease, emphysema, and substance abuse. No additional information was reported. Documents held by sender: None.
Age: 77.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Death, Myocardial infarction
Clinical narrative: Initial report was received via scientific literature search on 29 December 2009. (Agency number US-SP-2010-00011). Vaccine Adverse Event Reporting System (VAERS) received 13 reports of deaths occurring after receipt of H1N1 vaccine; three deaths occurred after receipt of LAMV and 10 after receipt of MIV through 24 November 2009. This case involves one of 10 patients who experienced death following vaccination with MIV. Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00013, -00014, -00015, -00016, -00017, -00018, -00019, -00020. A 77-year-old male patient had received a dose of Pandemic Influenza H1N1 Vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration was not reported. Two days post-vaccination the patient experienced suspected myocardial infarction resulting in death in 2009 (exact date of death not reported). Medical history included lung cancer, atrial fibrillation, recurrent deep venue thrombosis, hypertension and hyperlipidemia. No additional information was reported.
Age: 1.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Sudden death
Clinical narrative: Initial report was received via scientific literature search on 29 December 2009. VAERS received 13 reports of deaths occurring after receipt of LAMV and 10 after receipt of MIV through 24 November 2009. This case involves one of 10 patients who experienced death following vaccination with MIV. Information regarding the other 9 patients are captured in case numbers 2010-00012, -00013, -00014, -00015, -00016, -00017, -00018, -00019, -00020. A 1 year-old male patient had received a dose of Pandemic Influenza H1N1 Vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration were not reported. One day post-vaccination the patient experienced sudden death with no evidence of trauma. Medical history included febrile seizures (one after measles, mumps, and rubella vaccination). No additional information was reported. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Death
Clinical narrative: Initial report was received on 29 December 2009. The Centers for Disease Control and Prevention. Vaccine Adverse Event Reporting System received 13 reports of deaths occurring after receipt of H1N1 vaccine; three deaths occurred after receipt of LAMV and 10 after receipt of MIV through 24 November 2009. This case involved one of 10 patients who experienced death following vaccination with MIV. Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00013, -00014, -00015, -00016, -00017, -00018, -00019, -00020. . A 53-year-old female patient had received a dose of PANDEMIC INFLUENZA H1N1 vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration was not reported. Vaccination to onset was reported as 5 days; however, cause of death was not provided. The preliminary diagnosis/autopsy results were under review. Medical history included end-stage renal disease and atrial fibrillation. No additional information was reported.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Balance disorder, CSF glucose abnormal, Computerised tomogram normal, Dizziness
Clinical narrative: Initial case received from the Center for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 366959-1. A 51-year-old female patient was vaccinated at her place of employment with a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative ; lot number UP005AA, on 04 November 2009. About one month prior she had received a dose of FLUARIX (manufacturer GlaxoSmithKline, lot number AFLLA288AA) without incident. The patient's medical history included: breast cancer ten years ago with partial mastectomy and radiation therapy, hysterectomy, cholecystectomy, NKDA, fish allergy, food allergies, and C-section. On 04 November 2009, immediately following vaccination with the Influenza A (H1N1) vaccine, the patient felt flushed and dizzy but continued to work. The next day she had numbness and paresthesia of the right upper extremity, that seemed to pass. The following day she has stocking distribution numbness of the right lower extremity that began distally and ascended rapidly up to the clavicle. The numbness was completely right sided that interfered with the patient's ability to walk, and on occasion her knee would buckle, but she had no weakness. The patient presented to the emergency room on 07 November 2009 with right arm numbness and right lower extremity weakness with progressive numbness which started the morning after receiving vaccination. Per the patient, the weakness and numbness was causing difficulty in walking and her leg felt "wobbly." She was admitted to the hospital as inpatient and she had neurology and neurosurgical consults. She was afebrile in the ER with a normal exam with exception of right sided numbness. An MRI was completed of the entire neural axis and was essentially normal for her age. There was no evidence of cord compression. Neurosurgical impression was ascending transitory sensory polyradiculitis consistent with sensory GUILLAIN-BARRE syndrome with no motor abnormality, no track signs, and no evidence of CNS involvement. Laboratory data revealed CSF with abnormal glucose level. Diagnosis included atypical right lower extremity weakness and numbness. The patient was treated with steroids and symptoms improved. The patient was discharged to home on day 4 of hospitalization. The patient's symptoms had improved slightly, but persisted to the degree of hampering her ability to work. The patient presented to the health center on 20 November 2009 with mild arthralgias and was diagnosed with arthralgias and RAYNAUD'S phenomenon. At the time of this report, the patient had not recovered. It was noted that diagnostic tests included: MRI of cervical spine that revealed mild degenerative disc disease: EMG that revealed no electrophysiological evidence of GUILLAIN-BARRE syndrome, or other peripheral neuropathy process; CAT scan of head that was negative; CAT scan of chest that showed no pulmonary embolism or dissection; EMG nerve conduction test that was normal.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Electromyogram normal, Flushing, Gait disturbance, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Initial case received from the Center for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 366959-1. A 51-year-old female patient was vaccinated at her place of employment with a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative ; lot number UP005AA, on 04 November 2009. About one month prior she had received a dose of FLUARIX (manufacturer GlaxoSmithKline, lot number AFLLA288AA) without incident. The patient's medical history included: breast cancer ten years ago with partial mastectomy and radiation therapy, hysterectomy, cholecystectomy, NKDA, fish allergy, food allergies, and C-section. On 04 November 2009, immediately following vaccination with the Influenza A (H1N1) vaccine, the patient felt flushed and dizzy but continued to work. The next day she had numbness and paresthesia of the right upper extremity, that seemed to pass. The following day she has stocking distribution numbness of the right lower extremity that began distally and ascended rapidly up to the clavicle. The numbness was completely right sided that interfered with the patient's ability to walk, and on occasion her knee would buckle, but she had no weakness. The patient presented to the emergency room on 07 November 2009 with right arm numbness and right lower extremity weakness with progressive numbness which started the morning after receiving vaccination. Per the patient, the weakness and numbness was causing difficulty in walking and her leg felt "wobbly." She was admitted to the hospital as inpatient and she had neurology and neurosurgical consults. She was afebrile in the ER with a normal exam with exception of right sided numbness. An MRI was completed of the entire neural axis and was essentially normal for her age. There was no evidence of cord compression. Neurosurgical impression was ascending transitory sensory polyradiculitis consistent with sensory GUILLAIN-BARRE syndrome with no motor abnormality, no track signs, and no evidence of CNS involvement. Laboratory data revealed CSF with abnormal glucose level. Diagnosis included atypical right lower extremity weakness and numbness. The patient was treated with steroids and symptoms improved. The patient was discharged to home on day 4 of hospitalization. The patient's symptoms had improved slightly, but persisted to the degree of hampering her ability to work. The patient presented to the health center on 20 November 2009 with mild arthralgias and was diagnosed with arthralgias and RAYNAUD'S phenomenon. At the time of this report, the patient had not recovered. It was noted that diagnostic tests included: MRI of cervical spine that revealed mild degenerative disc disease: EMG that revealed no electrophysiological evidence of GUILLAIN-BARRE syndrome, or other peripheral neuropathy process; CAT scan of head that was negative; CAT scan of chest that showed no pulmonary embolism or dissection; EMG nerve conduction test that was normal.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Impaired work ability, Intervertebral disc disorder, Loss of control of legs, Muscular weakness, Nerve conduction studies normal
Clinical narrative: Initial case received from the Center for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 366959-1. A 51-year-old female patient was vaccinated at her place of employment with a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative ; lot number UP005AA, on 04 November 2009. About one month prior she had received a dose of FLUARIX (manufacturer GlaxoSmithKline, lot number AFLLA288AA) without incident. The patient's medical history included: breast cancer ten years ago with partial mastectomy and radiation therapy, hysterectomy, cholecystectomy, NKDA, fish allergy, food allergies, and C-section. On 04 November 2009, immediately following vaccination with the Influenza A (H1N1) vaccine, the patient felt flushed and dizzy but continued to work. The next day she had numbness and paresthesia of the right upper extremity, that seemed to pass. The following day she has stocking distribution numbness of the right lower extremity that began distally and ascended rapidly up to the clavicle. The numbness was completely right sided that interfered with the patient's ability to walk, and on occasion her knee would buckle, but she had no weakness. The patient presented to the emergency room on 07 November 2009 with right arm numbness and right lower extremity weakness with progressive numbness which started the morning after receiving vaccination. Per the patient, the weakness and numbness was causing difficulty in walking and her leg felt "wobbly." She was admitted to the hospital as inpatient and she had neurology and neurosurgical consults. She was afebrile in the ER with a normal exam with exception of right sided numbness. An MRI was completed of the entire neural axis and was essentially normal for her age. There was no evidence of cord compression. Neurosurgical impression was ascending transitory sensory polyradiculitis consistent with sensory GUILLAIN-BARRE syndrome with no motor abnormality, no track signs, and no evidence of CNS involvement. Laboratory data revealed CSF with abnormal glucose level. Diagnosis included atypical right lower extremity weakness and numbness. The patient was treated with steroids and symptoms improved. The patient was discharged to home on day 4 of hospitalization. The patient's symptoms had improved slightly, but persisted to the degree of hampering her ability to work. The patient presented to the health center on 20 November 2009 with mild arthralgias and was diagnosed with arthralgias and RAYNAUD'S phenomenon. At the time of this report, the patient had not recovered. It was noted that diagnostic tests included: MRI of cervical spine that revealed mild degenerative disc disease: EMG that revealed no electrophysiological evidence of GUILLAIN-BARRE syndrome, or other peripheral neuropathy process; CAT scan of head that was negative; CAT scan of chest that showed no pulmonary embolism or dissection; EMG nerve conduction test that was normal.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nerve root lesion, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging abnormal, Paraesthesia, Raynaud's phenomenon
Clinical narrative: Initial case received from the Center for Disease Control and Prevention (CDC) on 08 January 2010, under VAERS ID number 366959-1. A 51-year-old female patient was vaccinated at her place of employment with a dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative ; lot number UP005AA, on 04 November 2009. About one month prior she had received a dose of FLUARIX (manufacturer GlaxoSmithKline, lot number AFLLA288AA) without incident. The patient's medical history included: breast cancer ten years ago with partial mastectomy and radiation therapy, hysterectomy, cholecystectomy, NKDA, fish allergy, food allergies, and C-section. On 04 November 2009, immediately following vaccination with the Influenza A (H1N1) vaccine, the patient felt flushed and dizzy but continued to work. The next day she had numbness and paresthesia of the right upper extremity, that seemed to pass. The following day she has stocking distribution numbness of the right lower extremity that began distally and ascended rapidly up to the clavicle. The numbness was completely right sided that interfered with the patient's ability to walk, and on occasion her knee would buckle, but she had no weakness. The patient presented to the emergency room on 07 November 2009 with right arm numbness and right lower extremity weakness with progressive numbness which started the morning after receiving vaccination. Per the patient, the weakness and numbness was causing difficulty in walking and her leg felt "wobbly." She was admitted to the hospital as inpatient and she had neurology and neurosurgical consults. She was afebrile in the ER with a normal exam with exception of right sided numbness. An MRI was completed of the entire neural axis and was essentially normal for her age. There was no evidence of cord compression. Neurosurgical impression was ascending transitory sensory polyradiculitis consistent with sensory GUILLAIN-BARRE syndrome with no motor abnormality, no track signs, and no evidence of CNS involvement. Laboratory data revealed CSF with abnormal glucose level. Diagnosis included atypical right lower extremity weakness and numbness. The patient was treated with steroids and symptoms improved. The patient was discharged to home on day 4 of hospitalization. The patient's symptoms had improved slightly, but persisted to the degree of hampering her ability to work. The patient presented to the health center on 20 November 2009 with mild arthralgias and was diagnosed with arthralgias and RAYNAUD'S phenomenon. At the time of this report, the patient had not recovered. It was noted that diagnostic tests included: MRI of cervical spine that revealed mild degenerative disc disease: EMG that revealed no electrophysiological evidence of GUILLAIN-BARRE syndrome, or other peripheral neuropathy process; CAT scan of head that was negative; CAT scan of chest that showed no pulmonary embolism or dissection; EMG nerve conduction test that was normal.
Age: 61.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Bacterial sepsis, Cardio-respiratory arrest, Sepsis
Clinical narrative: Vaccine Adverse Event Report System (VAERS) received 13 reports of deaths occurring after receipt of H1N1 vaccine; three deaths occurred after receipt of live, attenuated monovalent vaccine (LAMV) and 10 after receipt of monovalent inactivated, split virus or subunit vaccine (MIV) through 24 November 2009. This case involves one of 10 patients who experienced death following vaccination with monovalent inactivated, split virus or subunit vaccine (MIV). Information regarding the other 9 patients are captured in case numbers 2010-00011, -00012, -00013, -00014, -00015, -00016, -00017, -00019, -00020. A 61-year-old male patient had received a dose of H1N1 vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration were not reported. Thirteen days post-vaccination the patient experienced cardiac/respiratory arrest, gram negative sepsis. Medical history included hypertension, diabetes, peripheral vascular disease, end stage renal disease. No additional information was reported. Documents held by sender: None.
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Initial report was received via scientific literature search on 29 December 2009. Vaccine Adverse Event Reporting System (VAERS) received 13 reports of deaths occurring after receipt of H1N1 vaccine; three deaths after receipt of live, attenuated monovalent (LAMV) and 10 after receipt of monovalent inactivated, split virus or subunit vaccines (MIV) through 24 November 2009. This case involved one of 10 patients who experienced death following vaccination with monovalent inactivated, split virus or subunit vaccines (MIV). Information regarding the other 9 patients are captured in case numbers 2010-00011, -00013, -00014, -00015, -00016, -00017, -00018, -00019, -00020. A 2-year-old female patient had received a dose of Pandemic Influenza H1N1 Vaccine on an unknown date in 2009. The trade name, lot number, route and site of administration was not reported. On the day of vaccination, the patient experienced sudden cardiopulmonary arrest and died (date of death was in 2009 - exact date not reported). Medical history included encephalopathy, central apnea, traumatic brain damage, and seizures. No additional information was reported. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Blood product transfusion, CSF protein increased, Condition aggravated, Differential white blood cell count abnormal, Dizziness
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Dysaesthesia, Dysarthria, Dysgeusia, Eosinophil percentage decreased, Exostosis
Clinical narrative: Initial case received from the Centers for Disease Control and Prevention on 08 January 2010, under VAERS ID number 367363-1. A 38-year-old female patient received a dose of FLUZONE No preservative 2009-2010 (lot number U3173CA) and H1N1 (lot number UP003AA) on 15 October 2009. The patient has a medical history of hypertension, headaches, depression, right breast biopsy, and herniated intervertebral disc. The patient became symptomatic approximately 2 to 2.5 weeks after vaccination (also reported as 14 days post-vaccination). The patient presented to the emergency department on 08 November 2009 with headache and numbness in toes/legs which was extending to the lower chest. The following were also reported: tingling in fingers/feet, gait instability, dizziness, abnormal taste to food, slurring of speech, and dysesthesias in the toes, finger tips, and tongue. Diagnostic  laboratory data performed during the course of hospitalization from 08 November 2009 to 16 November 2009 included: CSF-protein 96, CBC/WBC 11.0 thous, MPV 11.0 FL, neut 82.5%, lymph 15.3%, mono 1.2%, Eos 0.7%, neut ABS 9.1, chemistry (result not reported). The patient was diagnosed with Guillain-Barre Syndrome, hypertension and headache. She was treated with IVIG. The patient was discharged on 16 November 2009. Other adverse events coded in the report included exostosis, nuclear magnetic resonance imaging abnormal, and thyroxine free increased.