chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: HEP, IPV, HEP, IPV
Symptoms: Convulsion, Gaze palsy, Musculoskeletal stiffness, Screaming, Syncope
Clinical narrative: Initial report received on 26 February 2010 from a health care professional. A five-year-old female patient had received a fourth dose subcutaneous left arm injection of IPOL, lot number B0052 (lot number invalid) and a third dose intramuscular left deltoid injection of HEPATITIS B (manufacturer Merck, lot number 1678X) on 01 February 2010 as part of a well child visit, and during vaccination the patient screamed. Within a few minutes after receiving the vaccines, she became stiff and her eyes rolled back. No treatment was prescribed and all symptoms were fully resolved within 30 minutes. The physician diagnosis was syncope versus seizure. The patient had not received any other vaccines during the four previous weeks. Her past medical history included reactive airway disease and she had been taking albuterol prn. Outcome was recovered. No additional information was provided at the time of the report.
Age: 5.0
Sex: F
Vaccine: HEP, IPV, HEP, IPV
Symptoms: Convulsion, Gaze palsy, Muscle rigidity, Musculoskeletal stiffness, Screaming
Clinical narrative: Initial report received on 26 February 2010 from a health care professional. A five-year-old female patient had received a fourth dose subcutaneous left arm injection of IPOL, lot number B0052 (lot number invalid) and a third dose intramuscular left deltoid injection of HEPATITIS B (manufacturer Merck, lot number 1678X) on 01 February 2010 as part of a well child visit, and during vaccination the patient screamed. Within a few minutes after receiving the vaccines, she became stiff and her eyes rolled back. No treatment was prescribed and all symptoms were fully resolved within 30 minutes. The physician diagnosis was syncope versus seizure. The patient had not received any other vaccines during the four previous weeks. Her past medical history included reactive airway disease and she had been taking albuterol prn. Outcome was recovered. No additional information was provided at the time of the report.
Age: 5.0
Sex: F
Vaccine: HEP, IPV, HEP, IPV
Symptoms: Syncope
Clinical narrative: Initial report received on 26 February 2010 from a health care professional. A five-year-old female patient had received a fourth dose subcutaneous left arm injection of IPOL, lot number B0052 (lot number invalid) and a third dose intramuscular left deltoid injection of HEPATITIS B (manufacturer Merck, lot number 1678X) on 01 February 2010 as part of a well child visit, and during vaccination the patient screamed. Within a few minutes after receiving the vaccines, she became stiff and her eyes rolled back. No treatment was prescribed and all symptoms were fully resolved within 30 minutes. The physician diagnosis was syncope versus seizure. The patient had not received any other vaccines during the four previous weeks. Her past medical history included reactive airway disease and she had been taking albuterol prn. Outcome was recovered. No additional information was provided at the time of the report.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: RT. ARM RED, SWOLLEN AND WARM. TENDER TO TOUCH. TEMP-98.5. PT STATED SWELLING TO SIZE OF SOFTBALL. SEEN AT URGENT CARE, TREATED FOR REACTION TO VACCINE-COLD COMPRESSS/ BENADRYL 1TSP
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLUX, HEP, TYP
Symptoms: Erythema, Flushing, Heart rate decreased, Hypotension, Musculoskeletal stiffness
Clinical narrative: PATIENT FAINTED, THEN EYES OPENED BUT WAS NONRESPONSIVE, LEGS WERE STRETCHED OUT FEET TURN INWARD, ARM WAS STIFF INITIALLY FLUSHED RED IN COLOR THEN SUDDENLY PALE.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLUX, HEP, TYP
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: PATIENT FAINTED, THEN EYES OPENED BUT WAS NONRESPONSIVE, LEGS WERE STRETCHED OUT FEET TURN INWARD, ARM WAS STIFF INITIALLY FLUSHED RED IN COLOR THEN SUDDENLY PALE.
Age: 8.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Asthma, Intensive care, Respiratory disorder
Clinical narrative: Child had to be hospitalized for 6 days (3 days in ICU) for oxygen deficiency following respiratory problems developed exactly 2 weeks after the H1N1 mist administration.  The diagnosis, according to doctor, was asthma.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5cm x 5cm red, tender, warm swelling at the injection site
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Retching, Swelling face, Vomiting projectile
Clinical narrative: Face became swollen, slight temperature, experienced projectile vomiting and then dry heaves.  Attempted to take OTC medication but was not able to hold down.  Felt better approximately 24 hours later.
Age: 68.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Increased upper airway secretion, Influenza like illness, Oropharyngeal pain, Productive cough
Clinical narrative: Developed flu-like symptoms 2 days ago. He said that he had chills last night, but these have resolved. He has developed a moderate sore throat. He has a cough that is productive of yellowish phlegm and he feels much better after he coughs this out.
Age: 21.0
Sex: M
Vaccine: FLU(H1N1), HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node under L axilla
Age: 39.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS, PAIN AND SWELLING LEFT UPPER ARM 16cm WIDE x 12cm LONG. STARTED 03/05/2010 & MEASURED 03/09/2010. REPORTS NO DIFFERENCE IN SWELLING SINCE 03/05/2010. CHILLS ON 03/06/2010 PM.
Age: 72.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cold sweat, Speech disorder, Transient ischaemic attack
Clinical narrative: During evening, patient laid down then felt clammy. Had transient episode in which she couldn't talk, as if she was having a stroke. This spontaneous resolved shortly afterward.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased, Body temperature increased, Chills, Fatigue
Clinical narrative: elevated blood sugars in low 200's plus temp 100.3 with chills and fatigue x 48hrs. All started day after rec'd pneumococcal vaccine (polyvalent)
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Right arm deltoid swollen warm to touch (9cm x 9cm swelling).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt had received Hep A on Nov 6, 2009 at the clinic. He was scheduled to receive his 4 year old shots on 01/28/10. He received a 2nd Hep A on that date. There were no adverse events at that time. Mom called today (3/9/10) wanting to know why he received shot earlier than he should have.
Age: 14.0
Sex: U
Vaccine: FLU(H1N1), HEPA
Symptoms: Fall, Immediate post-injection reaction, Syncope
Clinical narrative: After immunization of H1N1 2, HAV 2 a few minutes later while child was standing fainted and fell down. After elevated legs resumed normal condition.
Age: 0.76
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Pyrexia
Clinical narrative: Mother reports fever of 104.0 F 4 days after immunization requiring a visit to the ER where workup was negative for any illness.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Pain
Clinical narrative: Pt had redness and itching at vaccination site LA and then increasing pain. SMZ-TMP Dg #20 1 tab PO BID x10 day given.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red knot, warm to touch.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Culture stool positive, Diarrhoea, Diarrhoea haemorrhagic, Rotavirus infection, Rotavirus test positive
Clinical narrative: This case was reported by a physician and described the occurrence of rotavirus in an 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and AMOXIL suspension for sinus infection. Concurrent medical conditions included sinus infection. Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on an unspecified date; ACTHIB (non-gsk); Sanofi; unknown; unknown given on an unspecified date; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on an unspecified date. There were no concurrent medications. On 26 August 2009 and 28 October 2009 the subject received 1st dose and 2nd dose of ROTARIX (1 ml, oral). On 25 February 2010 the patient started Amoxicillin trihydrate (oral), unknown dosing. On 25 February 2010, the same day the subject started Amoxicillin trihydrate for sinus infection,  4 months after 1st vaccination with ROTARIX, 6 months after 2nd vaccination with ROTARIX, the subject experienced diarrhea. A few days later, the subject developed bloody diarrhea and mucous diarrhea. On 04 March 2010, the subject experienced vaccination failure with a positive rotavirus test. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the rotavirus, bloody diarrhea, mucous diarrhea, diarrhea was unspecified. The healthcare professional considered the diarrhea was almost certainly related to treatment with AMOXIL. HCP reported that the infant received 2 doses of Rotavirus vaccination, but has tested positive for rotavirus on March 4, 2010. The patient was treated with AMOXIL and developed diarrhea one week ago on February 25, 2010. After a few days of antibiotic therapy he developed bloody diarrhea with mucous. Stool cultures and diagnostic tests were completed and the patient tested positive for rotavirus despite previous vaccination.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of rotavirus in an 8-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline) and AMOXIL suspension for sinus infection. Concurrent medical conditions included sinus infection. Previous and/or concurrent vaccination included PEDIARIX; GlaxoSmithKline; unknown; unknown given on an unspecified date; ACTHIB (non-gsk); Sanofi; unknown; unknown given on an unspecified date; PREVNAR (non-gsk); Wyeth Labs; unknown; unknown given on an unspecified date. There were no concurrent medications. On 26 August 2009 and 28 October 2009 the subject received 1st dose and 2nd dose of ROTARIX (1 ml, oral). On 25 February 2010 the patient started Amoxicillin trihydrate (oral), unknown dosing. On 25 February 2010, the same day the subject started Amoxicillin trihydrate for sinus infection,  4 months after 1st vaccination with ROTARIX, 6 months after 2nd vaccination with ROTARIX, the subject experienced diarrhea. A few days later, the subject developed bloody diarrhea and mucous diarrhea. On 04 March 2010, the subject experienced vaccination failure with a positive rotavirus test. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the rotavirus, bloody diarrhea, mucous diarrhea, diarrhea was unspecified. The healthcare professional considered the diarrhea was almost certainly related to treatment with AMOXIL. HCP reported that the infant received 2 doses of Rotavirus vaccination, but has tested positive for rotavirus on March 4, 2010. The patient was treated with AMOXIL and developed diarrhea one week ago on February 25, 2010. After a few days of antibiotic therapy he developed bloody diarrhea with mucous. Stool cultures and diagnostic tests were completed and the patient tested positive for rotavirus despite previous vaccination.
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt reports experiencing itching, hives and rash symptoms 4 hours after receiving vaccine. Visit to ER was given cream and pills. Resolved within 2 days.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Dermatitis contact, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Child went to her father's house right after the shots on Feb 23. Mom got her back on 3-1-10 & noticed the top of her right leg from knee to groin had a red lacey rash (smooth) & was "puffy" esp around the injection site. Mom states child could walk o.k. but leg was tender to touch. Child's father did not notice so he was unable to tell mother when sx began. I referred pt to Dr. Mom took child on 3-1-10 to family health clinic. The Dr said it was probably a local rxn and he thought the lacey rash was a contact dermatitis. Child was given a OTC hydrocortisone cream to use & was given an antibiotic for URI. Mom was also told to give BENADRYL. 3-9-10 PC to mom. Pt has recovered completely.
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Fatigue, Pallor, Rash papular
Clinical narrative: Health Department administered a Varicella and a MMR to client on 2/19/10.  On 3/2/2010 Health Department received phone call from Dr. regarding client. Dr. reported client had a temperature of 102.3, was acting more tired than usual, but had been eating and drinking fine. Doctor also reported a blanchable, raised rash on the face, hands and trunk, but no blisters were visible.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Pyrexia, Stillbirth
Clinical narrative: Initial report received from a health care professional via Health Authority on 02 Mar 2010: This patient was vaccinated with Influenza virus vaccine H1N1 (manufacturer unknown) for immunization at an unspecified dose on 24 Nov 2009. She was pregnant since an unspecified date. She had experienced pyrexia on 01 Dec 2009. Also stillbirth was also reported which occurred on 01 Dec 2009. The outcome of events was not reported. The seriousness criteria of the events were reported as serious and no further information was provided at the time of report.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Anti-GAD antibody negative, Antibody test positive, Autoantibody negative, Diabetic ketoacidosis, Fatigue
Clinical narrative: 25 yo male who developed symptoms of hyperglycemia in Jan-March 2009. Admitted to Hospital (17-20 March) with DKA and diagnosed with T1DM. No family history of T1DM except for maternal cousin. No history of infections preceding diagnosis. Symptoms: Polydipsia/increased thirst, Polyuria/Increased urination, Fatigue.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Glycosylated haemoglobin increased, Hyperglycaemia, Polydipsia, Polyuria, Thirst
Clinical narrative: 25 yo male who developed symptoms of hyperglycemia in Jan-March 2009. Admitted to Hospital (17-20 March) with DKA and diagnosed with T1DM. No family history of T1DM except for maternal cousin. No history of infections preceding diagnosis. Symptoms: Polydipsia/increased thirst, Polyuria/Increased urination, Fatigue.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Type 1 diabetes mellitus
Clinical narrative: 25 yo male who developed symptoms of hyperglycemia in Jan-March 2009. Admitted to Hospital (17-20 March) with DKA and diagnosed with T1DM. No family history of T1DM except for maternal cousin. No history of infections preceding diagnosis. Symptoms: Polydipsia/increased thirst, Polyuria/Increased urination, Fatigue.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Body temperature increased, Electromyogram abnormal, Headache, Hypoaesthesia
Clinical narrative: Numbness, paresthesias and weakness in lower extremities. Erythematous rash lower extremities. Difficulty bearing weight. Lower back pain, headache, low grade temperature.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture normal, Muscular weakness, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Numbness, paresthesias and weakness in lower extremities. Erythematous rash lower extremities. Difficulty bearing weight. Lower back pain, headache, low grade temperature.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Rash erythematous, Weight bearing difficulty
Clinical narrative: Numbness, paresthesias and weakness in lower extremities. Erythematous rash lower extremities. Difficulty bearing weight. Lower back pain, headache, low grade temperature.
Age: 17.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Became light headed when needle was uncapped. Vaccinated. Lightheadedness continued. Pt has dx of Tourette's was given orange juice and observed x 20 min.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Back pain, Blood pressure increased, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: 9:20A Pt came back to office c/o SOB, chest pain and lower back pain, administered O2 2Lpn, Benadryl 50mg PO EKG, P118, BP 142/90. 9:30A BP 140/90, P120. 9:40A BP 120/80, P84. 10:00A BP 124/80, P80. Dic O2. Dx: Tachypenia, tachycardia. Pt states "same reaction to ASA, Flexsit and Alleve.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Heart rate increased, Tachycardia, Tachypnoea
Clinical narrative: 9:20A Pt came back to office c/o SOB, chest pain and lower back pain, administered O2 2Lpn, Benadryl 50mg PO EKG, P118, BP 142/90. 9:30A BP 140/90, P120. 9:40A BP 120/80, P84. 10:00A BP 124/80, P80. Dic O2. Dx: Tachypenia, tachycardia. Pt states "same reaction to ASA, Flexsit and Alleve.
Age: 88.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dysphonia, Oropharyngeal pain, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: On evening of 3/8 sneezing, irritated throat, scratchy throat. By sleeping time nose running, sore throat. Temp normal. On 3/9 temp normal voice husky.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cold agglutinins positive, Cryoglobulins present, Full blood count, Haemolysis
Clinical narrative: began spontaneous hemolysis due to cold agglutinatin with cryoglobulin proteins present
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Arthralgia, Blood test, Computerised tomogram, Convulsion
Clinical narrative: Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fatigue, Mood swings, Nausea, Paraesthesia
Clinical narrative: Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Vomiting, X-ray with contrast lower gastrointestinal tract, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Amnesia, Anxiety, Cardiac arrest, Constipation
Clinical narrative: Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Laboratory test, Nausea, Photosensitivity reaction, Syncope
Clinical narrative: Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tilt table test, Vomiting
Clinical narrative: Extreme Fatigue, dizziness, nausea, fainting, seizures, vomiting, hair loss, joint pain, tingling in toes and fingers, mood swings. Have seen pediatrician, neurologist, endocrinologist, psychiatrist, cardiologist. Have had blood tests, cat scans, upper and lower GI.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Body temperature normal, Cardio-respiratory arrest, Condition aggravated, Glycosylated haemoglobin increased, Low density lipoprotein normal
Clinical narrative: Information has been received from an investigator and medical records as part of a study concerning a 72-year-old, widowed male with type 2 diabetes mellitus and a 10 year history of coronary artery disease. The patient had additional medical history of a prior myocardial infarction (1998), obesity (per measurement at patient's last medical visit weight was in "normal weight" range (ht 6'3", wt 199) as recently as 2005 weight was 306), hypertension, hyperlipidaemia, chronic mechanical low back pain (2006), surgery for herniated disc (2006), peripheral edema (August 2007), angina (August 2007). On 23-OCT-2007 the patient had routine lab work done. Based on results, patient's physician sent a letter indicating "both your diabetes and cholesterol are poorly controlled" and the physician requested an appointment. This appointment was the patient's last medical visit and day of vaccination (29-OCT-2007). According to the medical records the patient was diagnosed with hyperlipidaemia, type 2 diabetes and coronary artery disease. On 29-OCT-2007 the patient was vaccinated subcutaneously into the left arm with a first dose of ZOSTAVAX (Merck) (lot# 658209/1085U). Concomitant therapy given on the same date included the dose number twelve of FLUVIRIN (lot # 79898), given intramuscularly into the right deltoid. The patient expired suddenly on 10-DEC-2007, according to the coroner's report the immediate cause of death was cardiopulmonary arrest with secondary cause of 10 year history of Coronary Artery Disease. Diabetes Mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done. During the last medical visit, on 29-OCT-2007, the patient's physical examination was within normal limits; his blood pressure was 94/50, his pulse was 71 and temperature 97.6 degrees F. The patient started therapy with metformin 500 mg oral bid, famotidine (manufacturer unknown) 40 mg oral bid, metoprolol tartrate 100 mg bid, glipizide, 10 mg bid, captopril 100 mg TID, lovastatin 40 mg daily and furosemide 40 mg daily. The patient was also on therapy with simvastatin (MSD) 40 mg on 29-OCT-2007. The patient had a LDL was 159 and the Hga1c was 7.8%. At that time the patient was discharged with the following instructions: take 4 units NPH insulin in the morning, aim for a blood sugar of 140 or less before meals; stop lovastatin start simvastatin (MSD), check a 12 hr fasting blood test after 6 weeks of taking simvastatin (MSD), check a fasting blood test for diabetes/cholesterol. At this time, relationship of cardiopulmonary arrest to study therapy is unknown. A lot check has been initiated. Additional information is expected. All available medical records will be provided upon request.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Sudden death
Clinical narrative: Information has been received from an investigator and medical records as part of a study concerning a 72-year-old, widowed male with type 2 diabetes mellitus and a 10 year history of coronary artery disease. The patient had additional medical history of a prior myocardial infarction (1998), obesity (per measurement at patient's last medical visit weight was in "normal weight" range (ht 6'3", wt 199) as recently as 2005 weight was 306), hypertension, hyperlipidaemia, chronic mechanical low back pain (2006), surgery for herniated disc (2006), peripheral edema (August 2007), angina (August 2007). On 23-OCT-2007 the patient had routine lab work done. Based on results, patient's physician sent a letter indicating "both your diabetes and cholesterol are poorly controlled" and the physician requested an appointment. This appointment was the patient's last medical visit and day of vaccination (29-OCT-2007). According to the medical records the patient was diagnosed with hyperlipidaemia, type 2 diabetes and coronary artery disease. On 29-OCT-2007 the patient was vaccinated subcutaneously into the left arm with a first dose of ZOSTAVAX (Merck) (lot# 658209/1085U). Concomitant therapy given on the same date included the dose number twelve of FLUVIRIN (lot # 79898), given intramuscularly into the right deltoid. The patient expired suddenly on 10-DEC-2007, according to the coroner's report the immediate cause of death was cardiopulmonary arrest with secondary cause of 10 year history of Coronary Artery Disease. Diabetes Mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done. During the last medical visit, on 29-OCT-2007, the patient's physical examination was within normal limits; his blood pressure was 94/50, his pulse was 71 and temperature 97.6 degrees F. The patient started therapy with metformin 500 mg oral bid, famotidine (manufacturer unknown) 40 mg oral bid, metoprolol tartrate 100 mg bid, glipizide, 10 mg bid, captopril 100 mg TID, lovastatin 40 mg daily and furosemide 40 mg daily. The patient was also on therapy with simvastatin (MSD) 40 mg on 29-OCT-2007. The patient had a LDL was 159 and the Hga1c was 7.8%. At that time the patient was discharged with the following instructions: take 4 units NPH insulin in the morning, aim for a blood sugar of 140 or less before meals; stop lovastatin start simvastatin (MSD), check a 12 hr fasting blood test after 6 weeks of taking simvastatin (MSD), check a fasting blood test for diabetes/cholesterol. At this time, relationship of cardiopulmonary arrest to study therapy is unknown. A lot check has been initiated. Additional information is expected. All available medical records will be provided upon request.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Information has been received from an investigator and medical records as part of a study concerning a 72-year-old, widowed male with type 2 diabetes mellitus and a 10 year history of coronary artery disease. The patient had additional medical history of a prior myocardial infarction (1998), obesity (per measurement at patient's last medical visit weight was in "normal weight" range (ht 6'3", wt 199) as recently as 2005 weight was 306), hypertension, hyperlipidaemia, chronic mechanical low back pain (2006), surgery for herniated disc (2006), peripheral edema (August 2007), angina (August 2007). On 23-OCT-2007 the patient had routine lab work done. Based on results, patient's physician sent a letter indicating "both your diabetes and cholesterol are poorly controlled" and the physician requested an appointment. This appointment was the patient's last medical visit and day of vaccination (29-OCT-2007). According to the medical records the patient was diagnosed with hyperlipidaemia, type 2 diabetes and coronary artery disease. On 29-OCT-2007 the patient was vaccinated subcutaneously into the left arm with a first dose of ZOSTAVAX (Merck) (lot# 658209/1085U). Concomitant therapy given on the same date included the dose number twelve of FLUVIRIN (lot # 79898), given intramuscularly into the right deltoid. The patient expired suddenly on 10-DEC-2007, according to the coroner's report the immediate cause of death was cardiopulmonary arrest with secondary cause of 10 year history of Coronary Artery Disease. Diabetes Mellitus was reported to be a significant contributor. The patient expired in own home and no autopsy was done. During the last medical visit, on 29-OCT-2007, the patient's physical examination was within normal limits; his blood pressure was 94/50, his pulse was 71 and temperature 97.6 degrees F. The patient started therapy with metformin 500 mg oral bid, famotidine (manufacturer unknown) 40 mg oral bid, metoprolol tartrate 100 mg bid, glipizide, 10 mg bid, captopril 100 mg TID, lovastatin 40 mg daily and furosemide 40 mg daily. The patient was also on therapy with simvastatin (MSD) 40 mg on 29-OCT-2007. The patient had a LDL was 159 and the Hga1c was 7.8%. At that time the patient was discharged with the following instructions: take 4 units NPH insulin in the morning, aim for a blood sugar of 140 or less before meals; stop lovastatin start simvastatin (MSD), check a 12 hr fasting blood test after 6 weeks of taking simvastatin (MSD), check a fasting blood test for diabetes/cholesterol. At this time, relationship of cardiopulmonary arrest to study therapy is unknown. A lot check has been initiated. Additional information is expected. All available medical records will be provided upon request.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 75 year old female consumer with high blood pressure who on 17-FEB-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included TYLENOL extra strength. On 19-FEB-2010 the patient experienced a headache. It was reported that she needed to use ice packs constantly and that her symptoms were very similar to a sinus headache. The patient did not seek medical attention. At the time of the report, the patient's headache was still not gone. The headache was considered to be disabling by the consumer. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: HPV4
Symptoms: Ankyloglossia congenital, Apgar score normal, Drug exposure during pregnancy, Tongue tie operation
Clinical narrative: Information has been received from a nurse for the Pregnancy Registry for GARDASIL and pediatric medical records concerning a female infant whose mother in approximately November or December 2007, was vaccinated with her first dose of GARDASIL (lot# not reported). In February 2008, her mother was vaccinated with her second dose of GARDASIL (lot# not reported). On 28-APR-2008 her mother was vaccinated with her third dose of GARDASIL (lot# not reported) and found out that she was pregnant. The mother's LMP was 28-MAR-2008. The pregnancy was confirmed on an unspecified date by a positive pregnancy test and complete bloodwork. Concomitant therapy included allergenic extract (allergy shot once a month). On, the female infant was delivered via cesarean section with Apgars of 9 & 9 at 1 and 5 minutes respectively. On 29-JAN-2009, at 4 weeks well check, it was noted the infant was tongue tied. The infant was vaccinated with a second dose of hepatitis B vaccine (manufacturer unknown). The mother returned in February 2009 for her postpartum visit and she was breastfeeding the baby and there were "no problems" for her or the baby. She added the notes from the hospital and the office after the birth had no indication there were any problems. On 04-MAR-2009, at 4 month well check, the infant was vaccinated with a first dose of DT, ACTHIB, IPOL, PREVNAR (MSD). On 06-MAY-2009, at 2 month well check, the infant was vaccinated with the second dose of DT, ACTHIB, IPOL, PREVNAR and ROTATEQ (MSD) and tongue clip was performed. The infant's ankyloglossia was considered a congenital anomaly. The mother's experience has been captured in WAES # 0805USA00511. No further information is available. All medical records will be provided upon request.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Feeling hot, Pruritus generalised
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with no pertinent medical history and had an allergy with BIAXIN who on 08-SEP-2009 and 12-NOV-2009 was vaccinated intramuscularly with the first and second 0.5 mL dose of GARDASIL (dose 1 LOT# 0702X and dose 2 LOT# 0702X). There was no concomitant medication. Three hours after vaccination, the patient experienced body itching and body heat. At five hours after vaccination, the patient experienced chest pain and went to the emergency room. Subsequently, on an unspecified date the patient recovered from body itching, body heat and chest pain. The reporter considered the body itching, body heat and chest pain to be other important medical event due to the patient possibly received oxygen in the emergency room. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Full blood count normal, Laboratory test normal, Urine analysis normal, Vomiting
Clinical narrative: Vomit x 5 days. Dizziness x 2 weeks since vaccine. Pt was rechecked 3-9-10 - Dizziness may be s/p hypertension. Pt will f/u with PCP. No acute findings at present.
Age: 34.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Intra-uterine death, Labour induction, Vaginal haemorrhage
Clinical narrative: Patient received H1N1 vaccination on 11/6/09. Pt was 14 wks 3 days pregnant. On 12/21/09 pt started bleeding and was found to have 21 wk fetal demise an induction was done on 12/21/09 at local hospital.
Age: 18.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Erythema, Lacrimation increased, Nasal congestion, Rash generalised
Clinical narrative: @ 10:38 AM FELT WATERY EYES, NASAL CONGESTION PT USED HIS OWN INHALER AT THIS TIME 2 PUFFS.THEN MOM TOLD ME TO COME SEE HIM. AT THIS TIME THE PATIENT WAS RED RED AND A RASH HAD BEGUN TO COVER HIS BODY  @ 10:43 AM WAS GIVE IM BENADRYL PER DR. GIVEN BY RN. @ 11:15 AM WAS GIVEN 0.4 CC EPPIE BY RN PER DR. @ 11:25 AM WAS GIVEN ALBUTROL BY NEB PER DR. @ 11:30 GIVEN 60 MG OF PREDNISONE BY DR.
Age: 18.0
Sex: M
Vaccine: HPV4, TDAP, VARCEL, HPV4, TDAP, VARCEL
Symptoms: Hypersensitivity, Swelling
Clinical narrative: @ 10:38 AM FELT WATERY EYES, NASAL CONGESTION PT USED HIS OWN INHALER AT THIS TIME 2 PUFFS.THEN MOM TOLD ME TO COME SEE HIM. AT THIS TIME THE PATIENT WAS RED RED AND A RASH HAD BEGUN TO COVER HIS BODY  @ 10:43 AM WAS GIVE IM BENADRYL PER DR. GIVEN BY RN. @ 11:15 AM WAS GIVEN 0.4 CC EPPIE BY RN PER DR. @ 11:25 AM WAS GIVEN ALBUTROL BY NEB PER DR. @ 11:30 GIVEN 60 MG OF PREDNISONE BY DR.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash pustular
Clinical narrative: Small, slightly red, bumps on abdominals and back. Suspected non-viral pustulosis.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Lost mobility in my right arm. Can not throw a ball anymore. Shoulder is painful in certain positions and I cannot sleep on. Started physical therpy this month (March 2010).
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RVX
Symptoms: Intestinal resection, Intussusception, Vomiting
Clinical narrative: Patient developed intussusception with vomiting starting 3/5/2010 and requiring surgery for intussusception with bowel resection on 3/8/2010
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RVX
Symptoms: Appendicectomy, Blood test, Dehydration, Gastrointestinal disorder, Intussusception
Clinical narrative: Patient developed intussusception with vomiting starting 3/5/2010 and requiring surgery for intussusception with bowel resection on 3/8/2010
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RVX
Symptoms: Pyrexia, Surgery, Ultrasound scan abnormal, Vomiting projectile, X-ray
Clinical narrative: Patient developed intussusception with vomiting starting 3/5/2010 and requiring surgery for intussusception with bowel resection on 3/8/2010
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AND PAIN THE FIRST DAY AND SWOLLEN AROUND VACCINATION SITE RA THE NEXT DAY
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Dizziness, Fatigue, Heart rate increased
Clinical narrative: Dizziness, fast heart beat, weakness, paleness, really tired.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor
Clinical narrative: Dizziness, fast heart beat, weakness, paleness, really tired.
Age: 37.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Back pain, Hyperaesthesia, Pain of skin
Clinical narrative: Skin pain, back pain, skin sensitive to the touch, very painfull still until today
Age: 37.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Activities of daily living impaired, Back pain, Pain
Clinical narrative: Skin pain, back pain, skin sensitive to the touch, very painfull still until today
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: intense abdominal pains, diahrrhea, headaches, migraines, loss of appetite, fatigue and moderate to intense join pain for months and now years since vaccinations.  did get hpv #1 and vairvax on same day - previous report submitted (e42249 vares file) din't have the hpv vaccination recorded.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Headache, Laboratory test, Migraine
Clinical narrative: intense abdominal pains, diahrrhea, headaches, migraines, loss of appetite, fatigue and moderate to intense join pain for months and now years since vaccinations.  did get hpv #1 and vairvax on same day - previous report submitted (e42249 vares file) din't have the hpv vaccination recorded.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills, Fever, Severe Headache, rest and pain reliever
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Somnolence
Clinical narrative: As the day went on I began to feel more tired. I felt that I just wanted to lay down and sleep.
Age: 26.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Hypersensitivity, Injection site pain
Clinical narrative: Bad pain starting at injection sight (left deltoid) and radiating down to wrist, lasting about 2 hours
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Dizziness, Electroencephalogram, Fatigue, Headache
Clinical narrative: Patient was sick when on vaccation with headache, dizziness and being nauseated.  Once she had the second shot almost a month later the dizziness came immediately and has continued to be present on and off depending on how she is feeling  (tired, illness, etc)
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Nausea, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Patient was sick when on vaccation with headache, dizziness and being nauseated.  Once she had the second shot almost a month later the dizziness came immediately and has continued to be present on and off depending on how she is feeling  (tired, illness, etc)
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I mistakenly gave this young lady a ENGERIX instead of the TDAP vaccine for which she had come. No ill effects were reported in a call 2/25/10.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV, TYP, YF
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Pruritus, Rash
Clinical narrative: skin rash and itching; sore throat swelling
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Somnolence
Clinical narrative: Patient got very sleepy after 20 mins. Was okay prior.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Somnolence
Clinical narrative: Patient got very sleepy after 20 mins. Was okay prior.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt developed swelling and redness on left arm on 02/17/10 which resolved in 24-48 hours.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Blood count normal, Pyelonephritis, Urine analysis abnormal
Clinical narrative: This case was downloaded from the US FDA Vaccine Adverse Event Reporting System, VAERS ID: 341666 on 15.Jul.2009. The initial case was reported to VAERS on 12.Mar.2009 and concerns 19-year old female patient who received VIVOTIF (batch: unk) on 04.Mar.2009. Next day she developed mild case of pyelonephritis and abnormal urine analysis.
Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Alopecia, Pruritus, Urticaria
Clinical narrative: This case was forwarded on 06.Oct.2009. This 63-year old male patient (initials: JS) was vaccinated with oral Vivotif (batch no.: 3001583) on 05.Sep.2009. One day before on 04.Sep.2009 he was vaccinated with DTP (batch no.: C3247AA) im., in left arm and Flu vaccine (batch no.: 213191AA) im., in right arm. Few days later after completion of Vivotif vaccination about 09.Sep.2009 the patient developed HAIR FALLING OUT on right side of head, HIVES and ITCH on chest and under arm. The events continue to date of this report.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Alopecia, Arthralgia, Blood test, Computerised tomogram, Convulsion
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who by April 2008 was vaccinated with all three doses of GARDASIL (Lot# not reported). In September 2009, the patient experienced fatigue, seizures, headaches, nausea, throwing up, dizziness, numbness of the lower extremity of the toes and feet, memory loss, diarrhea, constipation, had fainted three times and had photosensitivity. It was reported that the patient had been in and out of the hospital (name and address not specified) since September 2009. It was also reported that in October 2009, while at college, the patient had a tilt table test done to check her blood pressure and during this procedure she had a seizure, her heart stopped and they had to do compressions. The patient's mother also mentioned that the patient had three seizures since then and she had seen a neurologist a neurologist, psychologist, and an endocrinologist. Multiple tests (unspecified) have been performed, with no results provided. The patient had to drop out of college and was put on some medication to help with the anxiousness she was experiencing. The reporter mentioned that her daughter had been taken off of all medication. At the time of the report, the patient had not recovered. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fatigue, Mood swings, Nausea, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who by April 2008 was vaccinated with all three doses of GARDASIL (Lot# not reported). In September 2009, the patient experienced fatigue, seizures, headaches, nausea, throwing up, dizziness, numbness of the lower extremity of the toes and feet, memory loss, diarrhea, constipation, had fainted three times and had photosensitivity. It was reported that the patient had been in and out of the hospital (name and address not specified) since September 2009. It was also reported that in October 2009, while at college, the patient had a tilt table test done to check her blood pressure and during this procedure she had a seizure, her heart stopped and they had to do compressions. The patient's mother also mentioned that the patient had three seizures since then and she had seen a neurologist a neurologist, psychologist, and an endocrinologist. Multiple tests (unspecified) have been performed, with no results provided. The patient had to drop out of college and was put on some medication to help with the anxiousness she was experiencing. The reporter mentioned that her daughter had been taken off of all medication. At the time of the report, the patient had not recovered. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Vomiting, X-ray with contrast lower gastrointestinal tract, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who by April 2008 was vaccinated with all three doses of GARDASIL (Lot# not reported). In September 2009, the patient experienced fatigue, seizures, headaches, nausea, throwing up, dizziness, numbness of the lower extremity of the toes and feet, memory loss, diarrhea, constipation, had fainted three times and had photosensitivity. It was reported that the patient had been in and out of the hospital (name and address not specified) since September 2009. It was also reported that in October 2009, while at college, the patient had a tilt table test done to check her blood pressure and during this procedure she had a seizure, her heart stopped and they had to do compressions. The patient's mother also mentioned that the patient had three seizures since then and she had seen a neurologist a neurologist, psychologist, and an endocrinologist. Multiple tests (unspecified) have been performed, with no results provided. The patient had to drop out of college and was put on some medication to help with the anxiousness she was experiencing. The reporter mentioned that her daughter had been taken off of all medication. At the time of the report, the patient had not recovered. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Amnesia, Anxiety, Cardiac arrest, Constipation
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter who by April 2008 was vaccinated with all three doses of GARDASIL (Lot# not reported). In September 2009, the patient experienced fatigue, seizures, headaches, nausea, throwing up, dizziness, numbness of the lower extremity of the toes and feet, memory loss, diarrhea, constipation, had fainted three times and had photosensitivity. It was reported that the patient had been in and out of the hospital (name and address not specified) since September 2009. It was also reported that in October 2009, while at college, the patient had a tilt table test done to check her blood pressure and during this procedure she had a seizure, her heart stopped and they had to do compressions. The patient's mother also mentioned that the patient had three seizures since then and she had seen a neurologist a neurologist, psychologist, and an endocrinologist. Multiple tests (unspecified) have been performed, with no results provided. The patient had to drop out of college and was put on some medication to help with the anxiousness she was experiencing. The reporter mentioned that her daughter had been taken off of all medication. At the time of the report, the patient had not recovered. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.