chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: F
Vaccine: FLU(H1N1), MMR, PNC, VARCEL
Symptoms: Crying, Fall, Hypokinesia
Clinical narrative: Unwitnessed fall to the floor.  Pt was standing when mom turned to get belongings.  Mom heard a "thump" and turned to see pt laying face down on floor motionless.  She picked pt up who was awake and immediately began crying.  This all happened in one minute or less, and occurred several minutes after child received vaccinations because mom put pants, socks, shoes, and coat on child before putting her on the floor.  Child was examined after the fall and was found to be appropriate, neurologically intact and with no injury that needed further treatment.  She was allowed to go home with mom.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Vomiting
Clinical narrative: nausea & vomiting that night resolved by next am
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Pt. states on 11/30/09 that she has rash and itching at site of shingles vaccination. Started on 11/19 and continues. Rash hard to visualize. She visited physician office-nurses there recommended Calamine lotion during the day and Benedryl at night.
Age: 42.0
Sex: F
Vaccine: FLUN3, FLUX(H1N1)
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: PATIENT RECEIVED FLUMIST SEASONAL AND H1N1 BOTH LAST TUESDAY (11/2/09) SINCE THEN HAS HAD HEADACHE, NAUSEA, AND DIARRHEA. FEELS TERRIBLE THIS MORNING 11/9.  CALLED PATIENT 12/2 FOR FOLLOW-UP.  SHE SAID THAT LATER ON THE DAY OF THE INJECTION, SHE HAD AN UNUSUALLY BAD HEADACHE, LIGHTHEADEDNESS AND FAINTING FEELING.  SYMPTOMS LASTED ALMOST A WEEK.  CALLED DOCTOR.  DOCTOR TOLD HER THAT A LOT OF PEOPLE WERE  HAVING REACTIONS-MOSTLY OLDER FOLKS.  DAUGHTER HAD SAME COMBINATION SAME DAY WITH NO ILL EFFECTS.
Age: 10.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Erythema, Malaise, Rash
Clinical narrative: At 9:30 AM, mild redness noted to left side of neck. Mom called, she is out of town who verified patient has NO allergies and she stated pt is upset because she's out of town.  25 mg Benadryl given PO. VS: T 98.7, P 80, R 20, BP110/60 At 9:45 pt c/o dizziness, rash subsiding, BP 110/6, pt lying down on cot. At 9:55 Pt states she feel feels better, "a little bit dizzy-thats all" and chose to return to class. Pt then returned at approx. 10:15 AM and c/o not feeling well, no redness, grandfather called and coming to pick pt. up from school.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Back pain, Headache, Immediate post-injection reaction, Oropharyngeal pain, Rash
Clinical narrative: Immediate back pain, sore throat, and headache. Approx.4 days later, patient awoke with hives/rash across chest, legs, and arms. She went to the ER where she was given a medrol dose pack and Benadryl cream which temporarily subsided the rash. It did return 48 hours later.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Immediate back pain, sore throat, and headache. Approx.4 days later, patient awoke with hives/rash across chest, legs, and arms. She went to the ER where she was given a medrol dose pack and Benadryl cream which temporarily subsided the rash. It did return 48 hours later.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue
Clinical narrative: Migratory polyarthralgia-hips,shoulders,wrists,ankles,feet,knees and fatique
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TD, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: From 11/21/09 legs pain, fever AM.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Local erythema and swelling, no tenderness, no fever. Occurred during first 24 hrs of giving vaccine to left deltoid.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Fatigue, Musculoskeletal pain, Neck pain, Paraesthesia
Clinical narrative: Mother reports that son developed symptoms of fatigue, tingling sensation in left ankle/leg with single episode nonbilious/nonbloody vomitus with achiness in neck and shoulder region around day #2-3 after vaccine given with full recovery in 1-2 days. Mother reports child with ill contacts with symptoms of vomiting/diarrhea.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: Mother reports that son developed symptoms of fatigue, tingling sensation in left ankle/leg with single episode nonbilious/nonbloody vomitus with achiness in neck and shoulder region around day #2-3 after vaccine given with full recovery in 1-2 days. Mother reports child with ill contacts with symptoms of vomiting/diarrhea.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Headache, Pain
Clinical narrative: Diarrhea, headache, body aches.
Age: 0.63
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site abscess, Injection site discolouration
Clinical narrative: Pt has no temp, area not reddened, not irritated, not warm to the touch. There is a small area where the needle was inserted that has a gray to silver particle that is raised, but it seems to be interdermal. Mom noticed this right after the blood & scab went away- about 1 week- Inj site is Lt lateral thigh.
Age: 0.63
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site discolouration
Clinical narrative: Pt has no temp, area not reddened, not irritated, not warm to the touch. There is a small area where the needle was inserted that has a gray to silver particle that is raised, but it seems to be interdermal. Mom noticed this right after the blood & scab went away- about 1 week- Inj site is Lt lateral thigh.
Age: 30.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abnormal behaviour, Amnesia, Back pain, Blood test, Dissociation
Clinical narrative: Behavior changes. Tingling and numbness in left arm and both legs. Cold sensations throughout body. Pressure headaches as well as being lethargic. Trouble remembering things and trouble making decisions. Feeling distorted, trouble concentrating. Needs to have directions repeated. Muscle twitching and lower back pain. Weak pulse and low blood pressure.
Age: 30.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Disturbance in attention, Feeling cold, Headache, Hypoaesthesia, Hypotension
Clinical narrative: Behavior changes. Tingling and numbness in left arm and both legs. Cold sensations throughout body. Pressure headaches as well as being lethargic. Trouble remembering things and trouble making decisions. Feeling distorted, trouble concentrating. Needs to have directions repeated. Muscle twitching and lower back pain. Weak pulse and low blood pressure.
Age: 30.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Lethargy, Muscle twitching, Paraesthesia, Pulse pressure decreased, Vision blurred
Clinical narrative: Behavior changes. Tingling and numbness in left arm and both legs. Cold sensations throughout body. Pressure headaches as well as being lethargic. Trouble remembering things and trouble making decisions. Feeling distorted, trouble concentrating. Needs to have directions repeated. Muscle twitching and lower back pain. Weak pulse and low blood pressure.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Decreased appetite, Full blood count normal, Headache, Influenza serology negative
Clinical narrative: Headache, falling in sleep fever (up to 103), vomiting, pharyngitis, cough, body aches, decrease in appetite. Pt received shot in afternoon, sx started that evening. Rapid strep negative, Rapid flu negative, CBC within normal limits.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain, Pharyngitis, Pyrexia, Somnolence, Streptococcal identification test
Clinical narrative: Headache, falling in sleep fever (up to 103), vomiting, pharyngitis, cough, body aches, decrease in appetite. Pt received shot in afternoon, sx started that evening. Rapid strep negative, Rapid flu negative, CBC within normal limits.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: Headache, falling in sleep fever (up to 103), vomiting, pharyngitis, cough, body aches, decrease in appetite. Pt received shot in afternoon, sx started that evening. Rapid strep negative, Rapid flu negative, CBC within normal limits.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU(H1N1), IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 3 cm area of redness developed at site developed next morning. (Likely at site of varicella).
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site abscess, Injection site discolouration
Clinical narrative: Pt has no temp, area not reddened, not irritated, not warm to touch. There is a small area where the needle was inserted, that has a grey to silver particle that is just under the skin. Area is not raised mom noticed this the next night when she was giving daughter a bath - Inj site at lower lateral thigh.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site discolouration, Injection site reaction
Clinical narrative: Pt has no temp, area not reddened, not irritated, not warm to touch. There is a small area where the needle was inserted, that has a grey to silver particle that is just under the skin. Area is not raised mom noticed this the next night when she was giving daughter a bath - Inj site at lower lateral thigh.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Formication, Muscular weakness, Skin exfoliation
Clinical narrative: Onset 1 day after vaccination C/O peeling "like my skin is crawling" "antsy" "arms weak" - states symptoms are "from the waist up".
Age: 38.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Erythema, HIV test negative, Oedema peripheral, Pyrexia, Rash erythematous
Clinical narrative: 11/21/09 evening-fever; 11/22/09 ~ 4am hives both arms, upper legs & lower back; 11/23/2009 (L) arm swollen & red, low grade fever hives both arms.
Age: 38.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Swelling, Tachycardia, Urticaria, Weight decreased
Clinical narrative: 11/21/09 evening-fever; 11/22/09 ~ 4am hives both arms, upper legs & lower back; 11/23/2009 (L) arm swollen & red, low grade fever hives both arms.
Age: 83.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Demyelinating polyneuropathy, Electromyogram abnormal, Guillain-Barre syndrome, Nerve conduction studies abnormal
Clinical narrative: GUILLAIN-BARRE-Syndrome onset 5-7 days after H1N1 vaccine injection. Diagnosis - Clinical and EMG/NCS. Treatment IVIG 0.4 gram/kg x 5 days - Rehabilitation.  12/3/09, 12/21/09, and 12/22/09 Hospital records and discharge summary received. Service dates 11/21/09 to 11/30/09. Assessment: Guillain-Barre Syndrome, Cervical spinal cord stenosis, Recurrent bladder cancer. Recently discharged from hospital where he was treated for pneumonia and received H1N1 vaccine. Developed pain in neck, muscle weakness, observed and discharged at another facility. Difficulty walking. Legs gave out and fell. Patient presented with ascending weakness of his extremities. Cough. Diminished breath sounds. Deep tendon reflexes hypoactive. Tremor upper and lower extremities. Umbilical hernia. IVIG administered. Developed acute renal failure. Anemia. Hypercapnia. Transferred to rehabilitation.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Computerised tomogram, Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: - 36 hours after vaccine he had seizure - taken to emergency room - absence seizure - admitted to hospital for 24 hours - transferred to another hospital. 12/4 and 12/10/2009 ED record for 11/11/2009, patient with sx of unresponsiveness and a blank stare. Transferred to another facility which had pediatric service Neuro exam wnl but abnormal EEG rx'd Diastat DC DX Seizure d/o 12/31/2009 Pediatric H&P and Neuro Consult records for 11/11/2009, no changes to VAERS.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Petit mal epilepsy
Clinical narrative: - 36 hours after vaccine he had seizure - taken to emergency room - absence seizure - admitted to hospital for 24 hours - transferred to another hospital. 12/4 and 12/10/2009 ED record for 11/11/2009, patient with sx of unresponsiveness and a blank stare. Transferred to another facility which had pediatric service Neuro exam wnl but abnormal EEG rx'd Diastat DC DX Seizure d/o 12/31/2009 Pediatric H&P and Neuro Consult records for 11/11/2009, no changes to VAERS.
Age: 53.0
Sex: F
Vaccine: FLUX, HEP, HEPA, MMR
Symptoms: Arthralgia, Musculoskeletal stiffness, Swelling
Clinical narrative: Joint pain, swelling, stiffness in the am, part all days. 2 weeks after shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient received ZOSTAVAX on 2/5/07 she was diagnosed with shingles on the first week of October.
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Rash generalised
Clinical narrative: Pt broke out in a patchy, rash all over body. 5 ml of BENADRYL was given and he was fine after that.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity
Clinical narrative: Received the H1N1 on 11-20-09. Received the injection around 2:30- arm was sore  by 4 PM.Arm sore up and down- worse soreness on 11-21-09. Still some soreness on 11-23-09 but no swelling, redness,or warmth to touch.
Age: 8.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: 8 YEAR OLD PATIENT WAS GIVEN H1N1 VACCINE AT SCHOOL 11/23/09 AT 1500 ALONG WITH OTHER CLASSMATES.  PATIENT BEGAN TO HAVE ACHES IN LEFT SHOULDER AND UPPER BACK ON LEFT SIDE OPPOSITE THE SIDE THAT THE INJECTION WAS GIVEN.  PAIN IS CONSTANT, WORSE AT NIGHT.  WENT TO LOCAL HEALTH CARE FACILITY AND RECEIVED A PRESCRIPTION FOR TYLENOL #3.  12/2/09 BACK AND SHOULDER ARE STILL PAINFUL.  HASN'T FULLY RECOVERED BUT USING LESS PAIN MEDICINE.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: At 2:15 PM, student c/o itching around the face, 2-3 hives noted on right jaw, localized reaction noted at injection site, ice pack applied, lungs clear, denies itching in throat area, no swelling noted on face or lips. Attempted to call father, message left on cellphone. At 2:20 PM, 30mg IM Bendadryl given.  At 2:25PM P78, BP 120/70 denies tingling, numbness of tongue and mouth, respirations even and non-labored, 20/min.  At 2:30 PM Student states she is not itching anymore, injection site less reddened At 2:35 PM, spoke to grandmother and explained situation and asked her to try to reach parents. At 3:05PM, mother here to pick up student, instructions given to mother and what s/s to watch for. Student says itching is gone, respirations even and non-labored.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cold compress therapy, Heat therapy, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Immediately upon vaccination pt had sharp pain in elbow, wrist, and fingers. Pt took tylenol and motrin, applied cold and hot packs, and massage therapy all with little relief.  Pain remains constant and increases with movement.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nasopharyngitis, Neck pain
Clinical narrative: Father called to state that the child had cold symptons the day following her H1N1 vaccination and also had a "crick" in her neck.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysgeusia
Clinical narrative: ABOUT 30 MINUTS AFTER VACCINE, PATIENT REPORTS STRANGE TASTE IN HER MOUTH.  STATES FOOD NOW TASTES "FUNNY"-DOESN'T TASTE THE WAY IT USED TO.  SYMPTOMS ONGOING.  DID NOT SEEK MEDICAL ATTENTION.
Age: 14.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, Dyspnoea, Erythema, Somnolence, Urticaria
Clinical narrative: Pt c/o hives, redness, and abdominal pain, 25 mg of PO Benadryl given. Update report information to include: Adverse evernt-- Adominal pain right side. Shortness of breath. Sleepy. Mom did not take patient to pediatrician.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Facial palsy, Feeling abnormal
Clinical narrative: ABOUT SIX HOURS AFTER RECEIVING VACCINE, FELT UPPER LIP DROOPING AND FELT LIKE SHE WAS "SPACING OUT."  SYMPTOMS LASTED ABOUT 48 HOURS THEN RESOLVED SPONTANEOUSLY.  DID NOT SEEK MEDICAL ATTENTION.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Dizziness, Dysphagia, Nausea, Pyrexia
Clinical narrative: Fever, Nausea, Hives, Not able to swallow, Chest Tightness, Hot to the touch, Dizziness, Swelling 12/11/2009 ED records for 12/1/2009, patient with c/o's red itchy rash, facial swelling,  SOB, heart racing, tx'd with IV Solu-Medrol and Benadryl, DC DX Allergic reaction
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Fever, Nausea, Hives, Not able to swallow, Chest Tightness, Hot to the touch, Dizziness, Swelling 12/11/2009 ED records for 12/1/2009, patient with c/o's red itchy rash, facial swelling,  SOB, heart racing, tx'd with IV Solu-Medrol and Benadryl, DC DX Allergic reaction
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Pt C/O redness, itching, and feeling hot. Pt given 25 mg PO Benadryl at 9:00AM, pt's mother called and at 9:25 AM, pt's mother said to give her another 25 mg dose of Benadryl.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Pruritus, Throat irritation, Urticaria
Clinical narrative: HAD SHOT ON 11/19/09 ABOUT 2:30PM.  STARTED ITCHING FRIDAY 11/20/09.  WOKE UP SATURDAY 11/21/09 WITH HIVES AND ITCHING AND THROAT WAS SCRATCHY AND FELT LIKE I WAS SHORT OF BREATH SO WENT TO ER.  WENT TO MD ON 11/23/09 FOR CONT. RX.  Still had hives on 11/23/09 so her private doctor increased the prednisone given to her at the ER to 80 mg. Doctor also incresed her Tagamet to 80mg and gave her Adara 50 mg. 11/27/09 patient went directly to hospital and was admitted staying until 12/3. Feels the increased increased prednisone and Tagamet caused issues and she felt that she had increased heart issues. Patient will be going back to ER today. Claims to have "blood clots" in one arm causing swell. Claims other arm is also swelling. "Popeye arms." Patient had H1N1 vaccination because she had a heart attack in August 209 and wanted to prevent illness. Feels she is allergic to H1N1. Is not allergic to eggs or chicken. Has not had seasonal flu shot this year."   12/10/09:  ED records, discharge summary and hospital records received for dates of service 11/27/09 to 12/3/09:  Dx:  H1N1 Reaction, presumptive serum sickness, anxiety, DVT, non-cardiac chest pain, HTN.    24-48 hrs. after H1N1 developed full body erythema and welts with itching, also c/o chest discomfort, anxiety and difficulty swallowing. Cardiology consult concluded non-cardiac chest pain, EKG reassuring. Also c/o of R forearm pain and warmth.  US showed R cephalic vein thrombus.  Treated with warm compresses. Discharged on prednisone taper.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Autopsy, Cardiac arrest, Death, Resuscitation
Clinical narrative: Unexpected death. Patient was asymptomatic except for skipping lunch. Took his usual afternoon nap but expired during sleep. Autopsy today did not reveal a cause.  01/07/2010. Autopsy received. DOD 1201/2009. Cause of Death: 1. Undetermined. Manner of Death: Undetermined. Additional Information Abstracted: I. [History of Febrile Seizures]: Cerebral Edema and Congestion. II. Pulmonary Edema and Congestion. II. Postmortem Toxicology Results: A. Blood: 1. Atropine = 870 NG/ML. B. Vitreous Humor: 1. Sodium = 137 MEQ/L. 2. Potassium = 17.8 MEQ/L. 3. Chloride = Creatinine = 0.8 MG/DL. 5. Urea Nitrogen = 7 MG/DL. 6. Glucose = <20 MG/DL.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Pt c/o itching, reddened and warm skin. 25 mg of Benadryl PO given
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood pressure increased, Blood test normal, Chest X-ray normal, Chest pain, Chills
Clinical narrative: After receiving vaccination, complained of dizziness, lightheadedness, cold chills and aching and dull chest pain, non-radiating.  Given O2 by nasal cannula, BP 160/90, HR 90.  Laid on cot to wait for husband.  He took her to ER for further evaluation.  Per patient, she had tests done at the hospital (EKG, chest xray, bloodwork).  All tests normal. After one hour in ER, temperature spiked to 101 degrees F and became itchy.  Started on Benadryl and sent home.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Electrocardiogram normal, Nasopharyngitis, Oxygen supplementation, Pain
Clinical narrative: After receiving vaccination, complained of dizziness, lightheadedness, cold chills and aching and dull chest pain, non-radiating.  Given O2 by nasal cannula, BP 160/90, HR 90.  Laid on cot to wait for husband.  He took her to ER for further evaluation.  Per patient, she had tests done at the hospital (EKG, chest xray, bloodwork).  All tests normal. After one hour in ER, temperature spiked to 101 degrees F and became itchy.  Started on Benadryl and sent home.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: After receiving vaccination, complained of dizziness, lightheadedness, cold chills and aching and dull chest pain, non-radiating.  Given O2 by nasal cannula, BP 160/90, HR 90.  Laid on cot to wait for husband.  He took her to ER for further evaluation.  Per patient, she had tests done at the hospital (EKG, chest xray, bloodwork).  All tests normal. After one hour in ER, temperature spiked to 101 degrees F and became itchy.  Started on Benadryl and sent home.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: H1N1 vaccine administered by nurse at school.  Within several minutes of receiving shot student c/o of vomiting.  Temperature 98.4, Pulse 82, Blood pressure 120/78.  School nurse monitored child in office for 30 minutes.  Notified parent and child returned to class with no complaints.  About 11:30 am  Blood pressure 118/78, Pulse 82, Temperature 98.2 and respirations 16.  No complaints from student.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus generalised, Rash erythematous
Clinical narrative: WITHIN APPROXIMATELY 20 MINUTES OF RECEIVING INACTIVATED H1N1 FLU VACCINE.  DEVELOPED GENERALIZED ITCHING AND FLAT RED RASH ON TRUNK, ARMS, AND FACE.  MOST PRONOUNCED ON ARM NEAR SITE OF INJECTION.  ORAL DIPHENHYDRAMINE AT 2:30 PM AND 3:00 PM.  AT 5:00 PM, MINIMAL ITCHING AND SLIGHT REDNESS NEAR INJECTION SITE.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Computerised tomogram, Convulsion, Dizziness, Electrocardiogram
Clinical narrative: DIZZINESS, NAUSEA AND SWOLLEN TONGUE, PASSED OUT FOLLOWED BY SUBSEQUENT SEIZURES (MULTIPLE) OVER 48 HOUR PERIOD.  HOSPITALIZED FOR 72 HOURS (3 DAYS)  12/03/09 MR and DC summary received for DOS 11/12/09. Final DX: Vasovagal syncope with increased stress and depression  Pt presented with syncope and seizure like episodes.  On examination: pseudoseizures, dehydration, and leukocytosis.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Electroencephalogram, Loss of consciousness, Nausea, Swollen tongue, Ultrasound scan
Clinical narrative: DIZZINESS, NAUSEA AND SWOLLEN TONGUE, PASSED OUT FOLLOWED BY SUBSEQUENT SEIZURES (MULTIPLE) OVER 48 HOUR PERIOD.  HOSPITALIZED FOR 72 HOURS (3 DAYS)  12/03/09 MR and DC summary received for DOS 11/12/09. Final DX: Vasovagal syncope with increased stress and depression  Pt presented with syncope and seizure like episodes.  On examination: pseudoseizures, dehydration, and leukocytosis.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Shot administered by nurse at school.  Student started vomiting within a few minutes after receiving vaccine.  Temperature 98.4.  Pulse 80.  Blood Pressure 108/60.  Observed by school nurse for 30 minutes.  Parent notified and child sent back to class with no complaints.  About 11:30 am  Blood pressure 106/72.  Pulse 80.  Temperature 98.  Respirations 16.  States she thew up again and no one saw it.  States she still has stomache ache.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Blood creatine phosphokinase increased, Myalgia, Pain
Clinical narrative: Body and Muscle pain, elevated CK.   12/4/09:  Discharge summary and hospital records received for dates of service 5/7/09 to 5/8/09.  Dx:  Allergic reaction to pertussis vaccine, rhabdomyolysis, hypothyroid, SLE.  Presented experiencing upper body aches, pain in UE's with active ROM, pain in neck, headache and chills, myalgias and trouble sleeping.
Age: 60.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 60 yr old male received LAIV H1N1 Vaccine.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1), FLUN3, HEPA, HPV4
Symptoms: Hypersensitivity, Oedema peripheral, Rhinorrhoea, Sneezing, Swelling face
Clinical narrative: RECEIVED 3:00 PM IV 3/09.  LATER IN THE EVENING RUNNING NOSE, ALLERGY SYMPTOMS 6:00 PM.  11/4/09 1:00 AM NEXT MORNING, WOKE UP WITH SWOLLEN FEET AND TOES.  SWOLLEN FACE AND PUFFINESS AROUND JAM AND CHECK AND NOSE. SNEEZING.  ON NECK AROUND COLLAR AREA HAD HIVES.  SELF TREATED WITH BENADRYL AND CALLED POISON CONTROL THAT MORNING.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1), FLUN3, HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: RECEIVED 3:00 PM IV 3/09.  LATER IN THE EVENING RUNNING NOSE, ALLERGY SYMPTOMS 6:00 PM.  11/4/09 1:00 AM NEXT MORNING, WOKE UP WITH SWOLLEN FEET AND TOES.  SWOLLEN FACE AND PUFFINESS AROUND JAM AND CHECK AND NOSE. SNEEZING.  ON NECK AROUND COLLAR AREA HAD HIVES.  SELF TREATED WITH BENADRYL AND CALLED POISON CONTROL THAT MORNING.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Burning sensation, Cold compress therapy
Clinical narrative: MOTHER EXPLAINED PATIENT EXPERIENCED BURNING SENSATION DOWN ARM FOR AT LEAST 3-4 HOURS.  USED COLD COMPRESSES AND TYLENOL.  BECAUSE OF PRE-EXISTING CONDITION, MOTHER DID NOT RELEASE PATIENT'S NAME OR DATE OF BIRTH 01/01/2005 WAS ENTERED BECAUSE THE SYSTEM WILL NOT ACCEPT INFORMATION WITHOUT A BIRTH DATE.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Miscarriage at 9 weeks, embryo appeared to have stopped developing two weeks before, right around the time I received the vaccination. My six week ultrasound revealed a healthy embryo with a heartbeat.  12/07/09 ED received for DOS 12/01/09 DX: Recurrent and missed abortion  Pt presented to hospital with miscarriage. Fetal demise by week 7. Pt went to OR for evacuation. Curettage and suction performed. Samples of conception and placental tissues were taken. Pt discharged home.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: I was diagnosed with shingles. I was prescribed a week's worh of Famvir, an antiviral.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Pain in extremity, Sensation of heaviness
Clinical narrative: Pt had a sore arm that felt very heavy to her.  Her left deltoid area bruised up 3days after adminstering the vaccination.  She went to urgent care and the Dr. there said to take motrin and it would get better in a couple of weeks.  To this date, it still hasn't gotten better and she went to follow up and dr said the same thing as the first time.
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Urticaria
Clinical narrative: Not symptomatic until Monday AM - developed hives to both arms, neck, and face - red, raised wells - Pt self treated with benedryl and hydrocortisone cream
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Brachial plexopathy, Electromyogram, Nuclear magnetic resonance imaging
Clinical narrative: L brachial plexopathy.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness
Clinical narrative: Sudden onset of dizziness lasting app 4 min. She had just gotten done with her donation. And received her injection. She states she had not eaten breakfast today and states she has had previous Tetanus injections, without any problems. She was monitored for 15 min, and left after eating crackers, feeling fine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Developed left Bells Palsy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium increased, Blood test, Chest discomfort, Chills, Cough
Clinical narrative: 10/26/09-received Flu Shot (TIV) at elementary School. Client was feeling fine no illness on day of vaccination. 10/27/09- Came to school and went to health Room to talk to Health Aide. Advised Health Aide she was sick with a sore throat, cough, headache, body aches, and chest tightness, no fever. Health Aide recommended to follow up with PCP. 10/30/09- Went to PCP for scheduled 6-months appointment. Advised PCP that she had received a flu shot on 10/26/09. Stated her ribs hurt, no fever. PCP scheduled appointment for next 6-month visit. No further action concerning current symptoms subsequent to flu shot. 10/31/09- Went out during the evening. That night she had chills, fever (does not have a thermometer, but said her nightgown was wet), her right side hurt, and her urine was orange. She was well hydrated, but was not eating. Her daughter whom she lives with wanted to take her to ER. Client refused. 11/04/09- Went back to PCP. Had EKG, X-ray. PCP wanted to admit client hospital. Client refused and advised she was able to care for self, comply with medication regimen, and had her daughter to assist her at home. Given antibiotics, LEVAQUIN 500mg, 10 day course. 11/06/09-Returned to PCP: diagnosed with pneumonia (type unknown). Still on antibiotics until 11/12/09. After completing course of antibiotics, she is to contact PCP to schedule another X-ray within one month. Per client, PCP advised blood test run previously showed high potassium. She was put on Klor-con (may have misunderstood whether her K was high or low). Note: There is some confusion concerning dates of ER visits and what was done in ER due to telephone calls to client from two PHN's. Stories differed somewhat. The above is the information obtained from the last telephone call with client.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Electrocardiogram, Headache, Malaise, Musculoskeletal chest pain
Clinical narrative: 10/26/09-received Flu Shot (TIV) at elementary School. Client was feeling fine no illness on day of vaccination. 10/27/09- Came to school and went to health Room to talk to Health Aide. Advised Health Aide she was sick with a sore throat, cough, headache, body aches, and chest tightness, no fever. Health Aide recommended to follow up with PCP. 10/30/09- Went to PCP for scheduled 6-months appointment. Advised PCP that she had received a flu shot on 10/26/09. Stated her ribs hurt, no fever. PCP scheduled appointment for next 6-month visit. No further action concerning current symptoms subsequent to flu shot. 10/31/09- Went out during the evening. That night she had chills, fever (does not have a thermometer, but said her nightgown was wet), her right side hurt, and her urine was orange. She was well hydrated, but was not eating. Her daughter whom she lives with wanted to take her to ER. Client refused. 11/04/09- Went back to PCP. Had EKG, X-ray. PCP wanted to admit client hospital. Client refused and advised she was able to care for self, comply with medication regimen, and had her daughter to assist her at home. Given antibiotics, LEVAQUIN 500mg, 10 day course. 11/06/09-Returned to PCP: diagnosed with pneumonia (type unknown). Still on antibiotics until 11/12/09. After completing course of antibiotics, she is to contact PCP to schedule another X-ray within one month. Per client, PCP advised blood test run previously showed high potassium. She was put on Klor-con (may have misunderstood whether her K was high or low). Note: There is some confusion concerning dates of ER visits and what was done in ER due to telephone calls to client from two PHN's. Stories differed somewhat. The above is the information obtained from the last telephone call with client.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pneumonia, Pyrexia, Urine colour abnormal
Clinical narrative: 10/26/09-received Flu Shot (TIV) at elementary School. Client was feeling fine no illness on day of vaccination. 10/27/09- Came to school and went to health Room to talk to Health Aide. Advised Health Aide she was sick with a sore throat, cough, headache, body aches, and chest tightness, no fever. Health Aide recommended to follow up with PCP. 10/30/09- Went to PCP for scheduled 6-months appointment. Advised PCP that she had received a flu shot on 10/26/09. Stated her ribs hurt, no fever. PCP scheduled appointment for next 6-month visit. No further action concerning current symptoms subsequent to flu shot. 10/31/09- Went out during the evening. That night she had chills, fever (does not have a thermometer, but said her nightgown was wet), her right side hurt, and her urine was orange. She was well hydrated, but was not eating. Her daughter whom she lives with wanted to take her to ER. Client refused. 11/04/09- Went back to PCP. Had EKG, X-ray. PCP wanted to admit client hospital. Client refused and advised she was able to care for self, comply with medication regimen, and had her daughter to assist her at home. Given antibiotics, LEVAQUIN 500mg, 10 day course. 11/06/09-Returned to PCP: diagnosed with pneumonia (type unknown). Still on antibiotics until 11/12/09. After completing course of antibiotics, she is to contact PCP to schedule another X-ray within one month. Per client, PCP advised blood test run previously showed high potassium. She was put on Klor-con (may have misunderstood whether her K was high or low). Note: There is some confusion concerning dates of ER visits and what was done in ER due to telephone calls to client from two PHN's. Stories differed somewhat. The above is the information obtained from the last telephone call with client.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: 10/26/09-received Flu Shot (TIV) at elementary School. Client was feeling fine no illness on day of vaccination. 10/27/09- Came to school and went to health Room to talk to Health Aide. Advised Health Aide she was sick with a sore throat, cough, headache, body aches, and chest tightness, no fever. Health Aide recommended to follow up with PCP. 10/30/09- Went to PCP for scheduled 6-months appointment. Advised PCP that she had received a flu shot on 10/26/09. Stated her ribs hurt, no fever. PCP scheduled appointment for next 6-month visit. No further action concerning current symptoms subsequent to flu shot. 10/31/09- Went out during the evening. That night she had chills, fever (does not have a thermometer, but said her nightgown was wet), her right side hurt, and her urine was orange. She was well hydrated, but was not eating. Her daughter whom she lives with wanted to take her to ER. Client refused. 11/04/09- Went back to PCP. Had EKG, X-ray. PCP wanted to admit client hospital. Client refused and advised she was able to care for self, comply with medication regimen, and had her daughter to assist her at home. Given antibiotics, LEVAQUIN 500mg, 10 day course. 11/06/09-Returned to PCP: diagnosed with pneumonia (type unknown). Still on antibiotics until 11/12/09. After completing course of antibiotics, she is to contact PCP to schedule another X-ray within one month. Per client, PCP advised blood test run previously showed high potassium. She was put on Klor-con (may have misunderstood whether her K was high or low). Note: There is some confusion concerning dates of ER visits and what was done in ER due to telephone calls to client from two PHN's. Stories differed somewhat. The above is the information obtained from the last telephone call with client.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Rash, Rash macular
Clinical narrative: 10:30 AM pt. broke out with red blotches on face. Blotches appeared within 5 minutes of injection, oral BENADRYL 3 ml given at 1045. Rash almost resolved at discharge.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia
Clinical narrative: Unable to raise her hand above her head.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia
Clinical narrative: Unable to raise L hand.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eyelid disorder, No reaction on previous exposure to drug
Clinical narrative: 12/2/09 1:30pm T.C. received by nurse from pt's daughter that pt c/o dizziness and her eyes are "purple" on eyelids. Pt gets flu shot every year without reaction. Daughter denies SOB or difficulty breathing or any other symptoms. At 2:15pm pt came to PHC with daughter and seen by nurse. No purple eyelids noted and dizziness, oriented x3, skin color fine.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Rash
Clinical narrative: Shingles like rash with pain developed 2 days after receiving vaccine on right medial aspect knee, calf along dermatome.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN(H1N1)
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/ or concurrent vaccination included pandemic vaccine H1N1 (non-GSK) ; non-GSK manufacturer; intranasal given on 26 October 2009. There were no concurrent medications. On 26 October 2009 at 16:00 the subject received unspecified dose of KINRIX. On 27 October 2009, 1 day after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness, injection site pruritus and local delayed type hypersensitivity response. At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with KINIRIX. The subject consulted a health care professional regarding the events. The reporting physician is the subject's father.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Pulmonary embolism
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with a history of appendicectomy and previous smoker was vaccinated with the first dose of GARDASIL in May 2008 and was vaccinated with the second dose of GARDASIL (lot # 0294Y) in left arm on 28-MAY-2009. Concomitant therapy included NUVARING. On 14-JUL-2009 the patient experienced chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection and was hospitalized. Hospital records was received for dates 14-JUL-2009 to 21-JUL-2009. Coumadin/CT scan showed bilateral pulmonary embolism. D-dimer was 844, electrocardiogram (EKG) was abnormal, cardiac echo was within normal limits, chest X-ray (-), troponin was within normal limits, urinalysis test (+) white blood cell count (+) blood, whole blood hematocrit was 34L and platelets was within normal limits. The diagnosis was bilateral pulmonary embolism and urinary tract infection. The symptoms were chest pain for 1 week, shortness of breath, lightheadedness, "almost fainting" feeling. Assessment: relatively normal would perform lab/diagnostics. The patient had desk job and 2 short flights within past week. Patient was treated with anticoagulation therapy and discharged. Chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection were considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 358630.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram abnormal, Dizziness, Dyspnoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with a history of appendicectomy and previous smoker was vaccinated with the first dose of GARDASIL in May 2008 and was vaccinated with the second dose of GARDASIL (lot # 0294Y) in left arm on 28-MAY-2009. Concomitant therapy included NUVARING. On 14-JUL-2009 the patient experienced chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection and was hospitalized. Hospital records was received for dates 14-JUL-2009 to 21-JUL-2009. Coumadin/CT scan showed bilateral pulmonary embolism. D-dimer was 844, electrocardiogram (EKG) was abnormal, cardiac echo was within normal limits, chest X-ray (-), troponin was within normal limits, urinalysis test (+) white blood cell count (+) blood, whole blood hematocrit was 34L and platelets was within normal limits. The diagnosis was bilateral pulmonary embolism and urinary tract infection. The symptoms were chest pain for 1 week, shortness of breath, lightheadedness, "almost fainting" feeling. Assessment: relatively normal would perform lab/diagnostics. The patient had desk job and 2 short flights within past week. Patient was treated with anticoagulation therapy and discharged. Chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection were considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 358630.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Fibrin D dimer increased, Haematocrit decreased, Platelet count normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with a history of appendicectomy and previous smoker was vaccinated with the first dose of GARDASIL in May 2008 and was vaccinated with the second dose of GARDASIL (lot # 0294Y) in left arm on 28-MAY-2009. Concomitant therapy included NUVARING. On 14-JUL-2009 the patient experienced chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection and was hospitalized. Hospital records was received for dates 14-JUL-2009 to 21-JUL-2009. Coumadin/CT scan showed bilateral pulmonary embolism. D-dimer was 844, electrocardiogram (EKG) was abnormal, cardiac echo was within normal limits, chest X-ray (-), troponin was within normal limits, urinalysis test (+) white blood cell count (+) blood, whole blood hematocrit was 34L and platelets was within normal limits. The diagnosis was bilateral pulmonary embolism and urinary tract infection. The symptoms were chest pain for 1 week, shortness of breath, lightheadedness, "almost fainting" feeling. Assessment: relatively normal would perform lab/diagnostics. The patient had desk job and 2 short flights within past week. Patient was treated with anticoagulation therapy and discharged. Chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection were considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 358630.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulmonary embolism, Troponin T, Urinary tract infection, Urine analysis abnormal, White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with a history of appendicectomy and previous smoker was vaccinated with the first dose of GARDASIL in May 2008 and was vaccinated with the second dose of GARDASIL (lot # 0294Y) in left arm on 28-MAY-2009. Concomitant therapy included NUVARING. On 14-JUL-2009 the patient experienced chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection and was hospitalized. Hospital records was received for dates 14-JUL-2009 to 21-JUL-2009. Coumadin/CT scan showed bilateral pulmonary embolism. D-dimer was 844, electrocardiogram (EKG) was abnormal, cardiac echo was within normal limits, chest X-ray (-), troponin was within normal limits, urinalysis test (+) white blood cell count (+) blood, whole blood hematocrit was 34L and platelets was within normal limits. The diagnosis was bilateral pulmonary embolism and urinary tract infection. The symptoms were chest pain for 1 week, shortness of breath, lightheadedness, "almost fainting" feeling. Assessment: relatively normal would perform lab/diagnostics. The patient had desk job and 2 short flights within past week. Patient was treated with anticoagulation therapy and discharged. Chest pain, dizziness, dyspnoea, pulmonary embolism and urinary tract infection were considered to be immediately life-threatening. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. The original reporting source was not provided. The VAERS ID # is 358630.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Bed rest, Computerised tomogram abnormal, Femoral artery embolism, Intensive care, Pulmonary embolism
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with no previous illness or medical history who on 12-JUN-2009 was vaccinated with a second dose of GARDASIL intramuscularly into the left arm (lot # 659655/0940X), a first dose of HAVRIX intramuscularly into the right arm (lot # AHAVB330CA) and a first dose of VARIVAX (Merck) subcutaneously into the right arm (lot # 663759/0492Y). 84 days post the vaccination, on 04-SEP-2009 the patient experienced bed rest, femoral artery embolism, intensive care and pulmonary embolism and was hospitalized. It was reported that the patient developed emboli in lungs and in a large part of the femoral artery. The patient was hospitalized at a medical center and in intensive care unit for a number of days. It was reported that the patient was not treated at this facility. Diagnosis occurred by CT scan showing large femoral artery thrombosis on 08-SEP-2009. The patient was currently at home on strict bed rest and being monitored with COUMADIN therapy. The listing indicated that one or more of the events required hospitalization, extended hospital stay and was considered to be immediately life-threatening. No further information is available. The original reporter was not provided. The VAERS ID # is 358985. A standard lot check investigation for VARIVAX (Merck) (lot # 663759/0492Y) was finalized. All in-process quality checks for the lot number (lot # 663759/0492Y) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot (VARIVAX (Merck), lot # 663759/0492Y) met the requirements of the Agency and was released.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Head injury, Loss of consciousness, Orthostatic hypotension
Clinical narrative: Syncope/persistent orthostatic hypertension with history of same in past. IVF 2 liters and IV BENADRYL.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Condition aggravated, Fluid replacement, Orthostatic hypertension, Syncope
Clinical narrative: Syncope/persistent orthostatic hypertension with history of same in past. IVF 2 liters and IV BENADRYL.