chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Patient developed fever, headache, sore throat and myalgias 4 hours after receiving Inactivated Influenza Vaccine. Evaluated the following day.  Physical exam was within normal limits except for fever of 101.  Seen 1 day later with continued fever and intense headache. Referred to the Emergency Department for further evaluation
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Feeling abnormal, Headache
Clinical narrative: Injection site pain 7 days. Patient c/o joint pain states"fuzzy feeling", difficulty concentrating, congested sinus, dull head throb, and fatigue onset 24 hours after receiving vaccine.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Sinus congestion
Clinical narrative: Injection site pain 7 days. Patient c/o joint pain states"fuzzy feeling", difficulty concentrating, congested sinus, dull head throb, and fatigue onset 24 hours after receiving vaccine.
Age: 80.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: Patient reports a lot of itching in her L upper arm after the injection.  She noted pain and swelling in her L upper arm when she got home from her MD appt.  Morning of 11/6 pt noticed the redness was going past her elbow, MD recommended inpatient admission for IV antibiotic treatment.  Pt reports no hx of reaction to any vaccines in the past.  12/02/08 Reviewed hospital medical records of 11/06-11/10/2008. FINAL DX: acute LUE cellulitis vx immunologic reaction to pneumovax; sudden onset tachycardia & SOB; HTN; acute left parotitis secondary to dehydration & dry mouth secondary to benadryl. Records reveal patient experienced left arm spreading redness, itching, swelling & pain, nausea, malaise, HA s/p pneumovax injection in LA & flu injection RA.  No reaction to prior vaccinations w/pneumovax, flu or any other vaccines.  Tx w/IV antibiotics.  ENT consult done for left parotitis.  Improved & d/c to home on continued oral antibiotics.
Age: 46.0
Sex: M
Vaccine: FLUN3
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: I developed severe chills, fever up to 102.2 (oral) diffuse myalgias, headache, and fatigue. I still have all of these symptoms now and I'm taking ibuprofen to help.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Dyspnoea, Feeling abnormal, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: On Nov. 6th I was administered the flu vaccine at my job....It was given to me around 6:30am..around 3:30pm - 4:30pm I started breaking out in sweat. I was hot then cold...My teeth was knocking I was so cold. My temp. got up to 101 before I started taking tylenol. The symptoms last about 3:30pm til about 8:30pm when I finally feel asleep. I felt awful. My wife tells me I was having a diffcult time breathing in my sleep.
Age: 32.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: On Nov. 6th I was administered the flu vaccine at my job....It was given to me around 6:30am..around 3:30pm - 4:30pm I started breaking out in sweat. I was hot then cold...My teeth was knocking I was so cold. My temp. got up to 101 before I started taking tylenol. The symptoms last about 3:30pm til about 8:30pm when I finally feel asleep. I felt awful. My wife tells me I was having a diffcult time breathing in my sleep.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Heart rate increased, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Approx. 30 mins after receiving the flu shot, pt. reported pain and numbness in L arm, fingers, and hand.  Pt also fely VERY dizzy & light headed, to the point of nearly blacking out.  Patient also experienced rapid heart beat. There was no redness or swelling in the area the vaccine was administered. There was some decrease in mobility of L arm, fingers and hand. Pt. suffered extreme pain and soreness in the area around the injection for 6 days. Pt indicated she would take Aleve & come to the CHD for evaluation, but did not come in.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity, Presyncope
Clinical narrative: Approx. 30 mins after receiving the flu shot, pt. reported pain and numbness in L arm, fingers, and hand.  Pt also fely VERY dizzy & light headed, to the point of nearly blacking out.  Patient also experienced rapid heart beat. There was no redness or swelling in the area the vaccine was administered. There was some decrease in mobility of L arm, fingers and hand. Pt. suffered extreme pain and soreness in the area around the injection for 6 days. Pt indicated she would take Aleve & come to the CHD for evaluation, but did not come in.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: PATIENT DEVELOPED A RED RASH ON ARMS AND ABDOMEN WITHIN AN HOUR AFTER ADMINISTRATION OF INFLUENZA VACCINE. THE PROVIDER ADMINISTERED AN ORAL BENEDRYL. THE PATIENT WAS MONITORED FOR AT LEAST ANOTHER HOUR BEFORE SHE WAS RELEASED.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Dizziness, Flushing, Injection site erythema, Injection site pain
Clinical narrative: 5pm started felling nauseated, 7pm started feeling flush, fever of 100.9, arm started aching, hive appeared a size of a quarter, and felt dizzy. 8:30pm asthma problems(took normal asthma medication) and all symptoms got worse fever 102.4. 8am hive and arm pain worse, pain and redness at injection site, called doctor. Nurse called back at 3pm was told to take benadryrl and to go to the hospital if things get worse. 5pm took benadryl did not help. 10pm took benadryl did not help. Four days later and the hive and injection site redness is starting to get a little lighter no more fever. Arm is still extremely sore.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Urticaria
Clinical narrative: 5pm started felling nauseated, 7pm started feeling flush, fever of 100.9, arm started aching, hive appeared a size of a quarter, and felt dizzy. 8:30pm asthma problems(took normal asthma medication) and all symptoms got worse fever 102.4. 8am hive and arm pain worse, pain and redness at injection site, called doctor. Nurse called back at 3pm was told to take benadryrl and to go to the hospital if things get worse. 5pm took benadryl did not help. 10pm took benadryl did not help. Four days later and the hive and injection site redness is starting to get a little lighter no more fever. Arm is still extremely sore.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: NAUSEA, HEADACHE, STOMACH PAIN, AND FATIGUE START A WEEK AFTER INJECTION MOTHER STATE SHE TOOK CHILD FOR LAB WORK AND CT SCAN. MOTHER NOTIFY ME ON FRIDAY 11/07/2008 IN AM.  12/23/08 Reviewed PCP medical records from 6/08-11/08. FINAL DX: none provided Records reveal patient experienced intermittent nausea, epigastric abdominal pain, HA, fatigue, tiredness & hematochezia(NSAID induced) while out of country.  No weight loss.  Sleep disturbance w/pain.  Missed several days of school.  GI consult done.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Chest pain, Nausea
Clinical narrative: NAUSEA, HEADACHE, STOMACH PAIN, AND FATIGUE START A WEEK AFTER INJECTION MOTHER STATE SHE TOOK CHILD FOR LAB WORK AND CT SCAN. MOTHER NOTIFY ME ON FRIDAY 11/07/2008 IN AM.  12/23/08 Reviewed PCP medical records from 6/08-11/08. FINAL DX: none provided Records reveal patient experienced intermittent nausea, epigastric abdominal pain, HA, fatigue, tiredness & hematochezia(NSAID induced) while out of country.  No weight loss.  Sleep disturbance w/pain.  Missed several days of school.  GI consult done.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Flu shot was given on the 7th of Nov, 2008, at approx. 12:noon; @ approx. time between 6:30 to 7:30 p.m, side effects began with muscle aches, fatigue, chills, nausea (but no vomiting occured), weakness,   exact symptom as if with extreme high fever.  However, temperture is normal.  At this point, I took two tylenol (extra strength)for my aches & pain.  As time passes within an hour or so, hives occured all on the left side of facial & neck, beginning with left side of tongue.  Another hour passes, and right side of tongue had tingling feeling, as if swelling is about to begin.  I ate warm broth with noodles for dinner, and with my personal remedy that it could help reduce the swelling.  Another hour passed after dinner, and the swelling reduced on the left side of tongue, facial & neck, and tingling feeling on the right side of tongue has stopped.  Woke up this morning (following day), with occuring muscle aches and headache.  Reluctant to take another dose of tylenol on a empty stomach, I drank two cups of hot coffee instead (my usual routine in the morning). Headache seem to go away, but occuring muscle aches were still present.  As I type this description, my muscle aches seem to be reducing.  At this point, I think I'll be fine now, otherwise, I'll be back to report more side-effects.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Paraesthesia oral, Urticaria
Clinical narrative: Flu shot was given on the 7th of Nov, 2008, at approx. 12:noon; @ approx. time between 6:30 to 7:30 p.m, side effects began with muscle aches, fatigue, chills, nausea (but no vomiting occured), weakness,   exact symptom as if with extreme high fever.  However, temperture is normal.  At this point, I took two tylenol (extra strength)for my aches & pain.  As time passes within an hour or so, hives occured all on the left side of facial & neck, beginning with left side of tongue.  Another hour passes, and right side of tongue had tingling feeling, as if swelling is about to begin.  I ate warm broth with noodles for dinner, and with my personal remedy that it could help reduce the swelling.  Another hour passed after dinner, and the swelling reduced on the left side of tongue, facial & neck, and tingling feeling on the right side of tongue has stopped.  Woke up this morning (following day), with occuring muscle aches and headache.  Reluctant to take another dose of tylenol on a empty stomach, I drank two cups of hot coffee instead (my usual routine in the morning). Headache seem to go away, but occuring muscle aches were still present.  As I type this description, my muscle aches seem to be reducing.  At this point, I think I'll be fine now, otherwise, I'll be back to report more side-effects.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Approx. 2min after vaccine was administered to the left deltoid, swelling/redness developed  (4cm diameter) at injection site. Patient was imediately given 50mg of diphenhydramine, the swelling/redness decreased in size, to 3cm, within 30 min. Patient sent home w/ 50mg diphenhydramine q6h x2d w/ 600mg ibuprofen q6h prn pain. Followed-up 3 days later, patient stated arm was still tender, slightly swollen and a bruised color; patient did not take any OTC pain medication or seek any other medical attention. Followed-up 5 days later, patient stated arm was still tender and turning a yellow color, pain was tolerable and she did not need to take any over the counter pain medication.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary mass, Axillary pain, Chest pain, Feeling hot
Clinical narrative: Received vaccine in right deltoid--3 to 5 minutes later developed hot sensation in rt shoulder radiating into middle of rt chest. Pain developed across chest and persisted to some extent until evening, then moved more into rt axillary area. Was sore with every position change. Developed palm size swelling in rt axilla that remains soft. No rash, no breathing difficulties, no fever. Rx consisted of ibuprofen for soreness.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: NONE
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Pt given vaccine on 11/4/08, returned to clinic on 11/7/08 with papular, vesicular rash on left side of neck and both hands.
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Blood culture, Culture throat, Fatigue, Full blood count, Laboratory test
Clinical narrative: vaccine 7/6/08night time sore throat, fatigue, malaise, fever. today fever 101. achey. throat red. rapid strept negative. cbc, cmp, blood and throat culture taken. ceftin prescribed as may have bacterial throat infection.
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Malaise, Pain, Pharyngeal erythema, Pyrexia, Streptococcal identification test negative
Clinical narrative: vaccine 7/6/08night time sore throat, fatigue, malaise, fever. today fever 101. achey. throat red. rapid strept negative. cbc, cmp, blood and throat culture taken. ceftin prescribed as may have bacterial throat infection.
Age: 63.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site pustule, Injection site rash, Injection site reaction, Injection site urticaria, Musculoskeletal pain
Clinical narrative: pt developed welts at the injection site on theright deltoid and a stiff right neck about 6 days after the injection.He then developed pain at the shoulder and pustules at the rash. A few days later bumps behind right ear appeared as well as bumps on right arm.
Age: 63.0
Sex: U
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: pt developed welts at the injection site on theright deltoid and a stiff right neck about 6 days after the injection.He then developed pain at the shoulder and pustules at the rash. A few days later bumps behind right ear appeared as well as bumps on right arm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Consciousness fluctuating, Dizziness, Hypotension, Mydriasis, Pallor
Clinical narrative: Patient at first fine, then complained of feeling light headed. After a few minutes head became wobbly. Eyes, became dilated, hands became very cold. Seemed to be going in and out of conciousness. Patient also became very pale. Speech became very quiet also. Checked blood pressure and was very low. Initial reading was 70/47. Then on second reading 77/58. Third reading 86/59, Final reading 91/67. Readings done over a 15 minute period. Did use ammonium salts to wake up patient. EMs was called at start of reaction. On arriving patient was looking better. She did get checked over by EMS and they cleared her.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral coldness, Speech disorder
Clinical narrative: Patient at first fine, then complained of feeling light headed. After a few minutes head became wobbly. Eyes, became dilated, hands became very cold. Seemed to be going in and out of conciousness. Patient also became very pale. Speech became very quiet also. Checked blood pressure and was very low. Initial reading was 70/47. Then on second reading 77/58. Third reading 86/59, Final reading 91/67. Readings done over a 15 minute period. Did use ammonium salts to wake up patient. EMs was called at start of reaction. On arriving patient was looking better. She did get checked over by EMS and they cleared her.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Ocular hyperaemia, Sensation of foreign body, Wheezing
Clinical narrative: PATIENT DESCRIBED EXPERIENCING A LUMP IN THROAT AND DIFFICULTY SWALLOWING, WHEEZING, AND RED EYES,SEVERAL HOURS (ABOUT 6 HOURS) AFTER RECEIVING VACCINE. ALSO SAID SHE HAS A LOT OF FOOD ALLERGIES BUT DOES EAT EGGS WITHOUT REACTING. SHE TOOK 2 DOSES OF 2 BENADRYL 25MG AND THAT WORKED TO RELIEVE THE SYMPTOMS
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hypoaesthesia, Immediate post-injection reaction, Influenza, Pain
Clinical narrative: I got a flu shot at 5pm on 11/6/08. Almost immediately, I had severe pain in the arm the shot was given in. It followed with pain in my legs and numbness in both of my hands. Then I broke out in hives from head to toe. My throat began to feel like it was closing up. This lasted for several hours. The next day, I was extremely tired and ached all over. I still had some pain in my back and legs. It was like I had the flu. I took nothing and hoped that it would go away. I called my doctor's office the next morning (11/7/08) and spoke to a nurse, who told me that if needed to take a Benadryl and go to the ER if needed. She said she would put it in my chart, but was unconcerned with the event.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Throat tightness, Urticaria
Clinical narrative: I got a flu shot at 5pm on 11/6/08. Almost immediately, I had severe pain in the arm the shot was given in. It followed with pain in my legs and numbness in both of my hands. Then I broke out in hives from head to toe. My throat began to feel like it was closing up. This lasted for several hours. The next day, I was extremely tired and ached all over. I still had some pain in my back and legs. It was like I had the flu. I took nothing and hoped that it would go away. I called my doctor's office the next morning (11/7/08) and spoke to a nurse, who told me that if needed to take a Benadryl and go to the ER if needed. She said she would put it in my chart, but was unconcerned with the event.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Antinuclear antibody negative, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Blood pressure decreased
Clinical narrative: 10/22 received flumist  10/23-pt had all over body aches t-102, chills, temp returned to normal with tylenol and motrin. 10/27-finally felt well enough to go to work.  shaky with walking, heavy head, hands, feet, tired.  11/4-chest pain radiating up to neck and left arm. nausea diarrhea x5 decreased heart rate and b/p.  admitted to hospital.  2/17/09 Received hospital medical records of 11/4-11/6/2008. FINAL DX: suspect viral syndrome possibly secondary to nasal flu vaccine; rhabdomyolysis possibly secondary to above; left bundle branch block; mild congestive cardiomyopathy w/LV dysfunction; bradycardia; diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort.  Cardio & Neuro consult done.  Improved w/IVF & d/c to home w/serial labs.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood thyroid stimulating hormone normal, Bundle branch block left, C-reactive protein normal, Cardioactive drug level decreased, Catheterisation cardiac abnormal
Clinical narrative: 10/22 received flumist  10/23-pt had all over body aches t-102, chills, temp returned to normal with tylenol and motrin. 10/27-finally felt well enough to go to work.  shaky with walking, heavy head, hands, feet, tired.  11/4-chest pain radiating up to neck and left arm. nausea diarrhea x5 decreased heart rate and b/p.  admitted to hospital.  2/17/09 Received hospital medical records of 11/4-11/6/2008. FINAL DX: suspect viral syndrome possibly secondary to nasal flu vaccine; rhabdomyolysis possibly secondary to above; left bundle branch block; mild congestive cardiomyopathy w/LV dysfunction; bradycardia; diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort.  Cardio & Neuro consult done.  Improved w/IVF & d/c to home w/serial labs.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest pain, Chills, Computerised tomogram abnormal, Diarrhoea, Fatigue
Clinical narrative: 10/22 received flumist  10/23-pt had all over body aches t-102, chills, temp returned to normal with tylenol and motrin. 10/27-finally felt well enough to go to work.  shaky with walking, heavy head, hands, feet, tired.  11/4-chest pain radiating up to neck and left arm. nausea diarrhea x5 decreased heart rate and b/p.  admitted to hospital.  2/17/09 Received hospital medical records of 11/4-11/6/2008. FINAL DX: suspect viral syndrome possibly secondary to nasal flu vaccine; rhabdomyolysis possibly secondary to above; left bundle branch block; mild congestive cardiomyopathy w/LV dysfunction; bradycardia; diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort.  Cardio & Neuro consult done.  Improved w/IVF & d/c to home w/serial labs.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Full blood count normal, Gait disturbance, Head discomfort, Heart rate decreased, Metabolic function test normal
Clinical narrative: 10/22 received flumist  10/23-pt had all over body aches t-102, chills, temp returned to normal with tylenol and motrin. 10/27-finally felt well enough to go to work.  shaky with walking, heavy head, hands, feet, tired.  11/4-chest pain radiating up to neck and left arm. nausea diarrhea x5 decreased heart rate and b/p.  admitted to hospital.  2/17/09 Received hospital medical records of 11/4-11/6/2008. FINAL DX: suspect viral syndrome possibly secondary to nasal flu vaccine; rhabdomyolysis possibly secondary to above; left bundle branch block; mild congestive cardiomyopathy w/LV dysfunction; bradycardia; diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort.  Cardio & Neuro consult done.  Improved w/IVF & d/c to home w/serial labs.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Nausea, Neck pain, Pain, Pain in extremity, Rheumatoid factor negative
Clinical narrative: 10/22 received flumist  10/23-pt had all over body aches t-102, chills, temp returned to normal with tylenol and motrin. 10/27-finally felt well enough to go to work.  shaky with walking, heavy head, hands, feet, tired.  11/4-chest pain radiating up to neck and left arm. nausea diarrhea x5 decreased heart rate and b/p.  admitted to hospital.  2/17/09 Received hospital medical records of 11/4-11/6/2008. FINAL DX: suspect viral syndrome possibly secondary to nasal flu vaccine; rhabdomyolysis possibly secondary to above; left bundle branch block; mild congestive cardiomyopathy w/LV dysfunction; bradycardia; diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort.  Cardio & Neuro consult done.  Improved w/IVF & d/c to home w/serial labs.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Sensation of heaviness, Tri-iodothyronine decreased, Ultrasound scan normal, Urine analysis normal
Clinical narrative: 10/22 received flumist  10/23-pt had all over body aches t-102, chills, temp returned to normal with tylenol and motrin. 10/27-finally felt well enough to go to work.  shaky with walking, heavy head, hands, feet, tired.  11/4-chest pain radiating up to neck and left arm. nausea diarrhea x5 decreased heart rate and b/p.  admitted to hospital.  2/17/09 Received hospital medical records of 11/4-11/6/2008. FINAL DX: suspect viral syndrome possibly secondary to nasal flu vaccine; rhabdomyolysis possibly secondary to above; left bundle branch block; mild congestive cardiomyopathy w/LV dysfunction; bradycardia; diarrhea. Records reveal patient experienced chest pressure, nausea, lightheadedness, general discomfort.  Cardio & Neuro consult done.  Improved w/IVF & d/c to home w/serial labs.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Bed rest, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Started about 4-6 hours after vaccination:  Dizziness (30 min), shortness of breath (1 hour), sweating (2-4 hours), fatigue (24 hours), weak feeling (24 hours), high fever (lasted all night, 4-6 hours), head ache (2-4 hours) and body aches (2-4 hours).  Treatment: tylenol to break fever and head/body ache and bed rest (24 hours).
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Started about 4-6 hours after vaccination:  Dizziness (30 min), shortness of breath (1 hour), sweating (2-4 hours), fatigue (24 hours), weak feeling (24 hours), high fever (lasted all night, 4-6 hours), head ache (2-4 hours) and body aches (2-4 hours).  Treatment: tylenol to break fever and head/body ache and bed rest (24 hours).
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Biopsy heart, Blood culture negative, Body temperature increased, Chills
Clinical narrative: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Chromaturia, Culture stool negative, Culture throat negative, Culture urine negative, Echocardiogram abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Eosinophilic myocarditis, Epstein-Barr virus antibody negative, Heart rate increased, Hepatitis B core antigen, Hepatitis B surface antigen negative
Clinical narrative: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Hepatosplenomegaly, Influenza serology negative, Leukocytoclastic vasculitis, Mycoplasma serology, Myocarditis
Clinical narrative: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Necrosis, Oliguria, Oxygen saturation normal, Pyrexia, Rash erythematous
Clinical narrative: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Rash maculo-papular, Renal failure, Respiratory rate increased, Shock, Virus serology test
Clinical narrative: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of eosinophilic myocarditis in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no history of vaccine reaction, drug allergy and was healthy. No concomitant medication. Previous vaccination included ENGERIX B (GlaxoSmithKline, unknown route) given on an unspecified date. On an unspecified date, the subject received 2nd dose of ENGERIX B (unknown route, lot number not provided). 1 day after vaccination with ENGERIX B, the subject experienced fever, weakness and chills. The following day, she experienced vomiting, dark colored urine and oliguria. 3 days after vaccination the subject received ADVIL. Laboratory tests were performed and showed: Body temperature: 38.7 deg C; Heart rate: 120/min; Blood pressure: 84/50 mmHg; Respiratory rate: 22/min; Oxygen saturation: 100%. At Clinical examination: No murmurs, rub, or gallop rhythm were detected. Her chest was clear on auscultation. Hepatosplenomegaly was found and erythematous maculopapular rash. Echocardiography showed moderately diminished biventricular function (ejection fraction of 30%), consistent with a diagnosis of myocarditis. Histopathology examination of a myocardial biopsy showed eosinophilic infiltration in the presence of myocyte necrosis. Histologic examination of a skin biopsy specimen revealed perivascular lymphocytic infiltrates, coupled with the myocardial biopsy findings, this supported a diagnosis of hypersensitivity vasculitis. Hepatitis B core antibody: negative; Stool culture: negative; Throat culture: negative: serology for Mycoplasma: negative; Epstein-Barr virus: negative; Adenovirus: negative; Influenza test: negative; Blood culture: negative; Urine culture: negative; The subject was admitted to the intensive care unit on hospital on day 7 after immunization, with renal failure and shock. The subject was treated with milrinone, ceftriaxone, methylprednisolone, prednisone, and dobutamine. No further antibiotics were given as her fever abated promptly, cultures were negative, and her findings were consistent with a hypersensitivity reaction. At the time of reporting the events were improved. Clinical improvement was observed by day 7 of corticosteroid therapy with gradual normalization of cardiac function in the ensuing 8 weeks. The author considered the events were related to vaccination with ENGERIX B. No additional information expected therefore the case has been closed.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 89-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included arthritis, depression, drug allergy, gastritis, hypertension and polymyalgia rheumatica. Concurrent medications included Unknown (Concurrent medications). At the time of event, the subject was already hospitalized for altered mental status, abdominal pain and unsteady gait. On 3 November 2008 at 01:00 the subject received a dose of FLUARIX at 0.5 ml, intravenously, through a peripheral intravenous line in the left wrist. This was the wrong route of administration. FLUARIX should be administered intramuscularly. It was reported that the subject was hospitalised due to the event or that the event prolonged hospitalization. The pharmacist did, however, comment that the event unlikely extended the admission.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Biopsy muscle abnormal, Coagulopathy, Embolism, Malaise, Myalgia
Clinical narrative: This case was reported by the daughter of a consumer and described the occurrence of multiple venous clots in a 65-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline), Pneumonia vaccine. A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose of Flu vaccine (unknown GSK vaccine) and unspecified dose of Pneumonia vaccine (unknown). On the same date of vaccination with Flu vaccine and Pneumonia vaccine, the subject developed muscle pain. She became very ill and was hospitalized. It was discovered through muscle biopsy that the subjects veins were throwing clots everywhere. At the time of reporting, the subject was still hospitalised and myocitis was ruled out. Physicians were still not able to determine the cause of the subjects clotting disorder. At the time of reporting the events were unresolved.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Venous thrombosis
Clinical narrative: This case was reported by the daughter of a consumer and described the occurrence of multiple venous clots in a 65-year-old female subject who was vaccinated with Flu vaccine (GlaxoSmithKline), Pneumonia vaccine. A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose of Flu vaccine (unknown GSK vaccine) and unspecified dose of Pneumonia vaccine (unknown). On the same date of vaccination with Flu vaccine and Pneumonia vaccine, the subject developed muscle pain. She became very ill and was hospitalized. It was discovered through muscle biopsy that the subjects veins were throwing clots everywhere. At the time of reporting, the subject was still hospitalised and myocitis was ruled out. Physicians were still not able to determine the cause of the subjects clotting disorder. At the time of reporting the events were unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypertension, Tachycardia
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hypertension in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). There were no concurrent medications. On 31 October 2008 the subject received a dose of FLUARIX at 0.5 ml. On 31 October 2008, less than one day after vaccination with FLUARIX, the subject experienced hypertension, trouble breathing and tachycardia. She was seen in the emergency room and was treated and released. The pharmacist considered the events were clinically significant (or requiring intervention). On 1 November 2008, the events were resolved. The pharmacist considered the events were possibly related to vaccination with FLUARIX.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Body temperature increased, CSF glucose normal, CSF protein normal, Computerised tomogram normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Temp 103 within 6 hours, vomiting next day, ataxia on second day after vaccines.  12/5/08 Reviewed hospital medical records of 11/2-11/5/2008. FINAL DX: fever & acute cerebellar ataxia on admit.  No d/c summary available Records reveal patient experienced fever, diarrhea & abnormal gait on day of vaccination after nap.  Seen in urgent care center & released.  Seen in ER same day & released.  Fever continued & began vomiting, lethargic, tiredness.  Returned to ER, tx w/IVF & meds & released.  Irritable & weak.  Then developed difficulty standing & falling w/walking, crawling  & sitting w/intermittent screaming & inconsolable crying, diarrhea.  Multiple people in family sick w/URI symptoms.
Age: 1.25
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Nuclear magnetic resonance imaging normal, Scan brain, Vomiting
Clinical narrative: Temp 103 within 6 hours, vomiting next day, ataxia on second day after vaccines.  12/5/08 Reviewed hospital medical records of 11/2-11/5/2008. FINAL DX: fever & acute cerebellar ataxia on admit.  No d/c summary available Records reveal patient experienced fever, diarrhea & abnormal gait on day of vaccination after nap.  Seen in urgent care center & released.  Seen in ER same day & released.  Fever continued & began vomiting, lethargic, tiredness.  Returned to ER, tx w/IVF & meds & released.  Irritable & weak.  Then developed difficulty standing & falling w/walking, crawling  & sitting w/intermittent screaming & inconsolable crying, diarrhea.  Multiple people in family sick w/URI symptoms.