chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Flushing, Skin warm
Clinical narrative: Flush face and warm to touch. BENADRYL 50 mg PO taken as per ordered by doctor. S/sx relieved after 1 hour.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Epistaxis
Clinical narrative: Bloody Nare after applying mist.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash, Urticaria
Clinical narrative: Noticed mosquito-bite looking whelps which got worse overnight. Took her to the ER 11/29/09 at 7:30 PM. Treated with Benadryl, Tylenol, Epinephrine, steroid injection. On 11/30/09 Mom states whelps are still present, some areas are worse. Rash on all parts of body except head and face.
Age: 59.0
Sex: F
Vaccine: FLUN(H1N1), TDAP
Symptoms: Mass, Musculoskeletal stiffness, Pain
Clinical narrative: Noticed "lumps" over collar bone, increased soreness and stiffness, described pain as 4/10.  "Lumps" spread to neck, shoulder, upper back throughout the day.  Tylenol x1 to treat pain.  Did not seek medical treatment.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Wheeze, cough, fever.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Respiratory disorder, Swelling, Urticaria
Clinical narrative: Respiratory tightness; Swelling and hives behind right ear.  Child taken to emergency room.  Doctor adminstered Benadryl. 12/3/09 Hospital recs received for date 11/19/09. DX: acute allergic reaction. Pt. c/o SOB, swelling behind left ear approx 40 min after receiving H1N1 vax. Assessment: swelling with mild erythema of left ear posterior to pinna.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site streaking, Tenderness, Ultrasound scan
Clinical narrative: 11-25-09 burning/itching/pain in R deltoid with streaking from inferior aspect of deltoid in mid arm to anterior axillary fold: tenderness and R mid arm measured 29 cm, L mid arm 28 cm.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Blood glucose increased, Drug exposure during pregnancy, Full blood count normal, Presyncope
Clinical narrative: Rec'd H1N1 on 11/18/09. Reports near syncope on 11/19/09 - AM. Event lasted about 30seconds.  12/02/09 OB visit notes for DOS 11/18/09  12/01/09: Near syncope  Pt c/o near syncope episode that lasted 30 sec.  The event resolved.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Contraindication to vaccination, Oropharyngeal pain, Vomiting
Clinical narrative: Child came home 1 hour after vaccine running temp of 102.5 vomited x2 and sore throat. Temp stays down with TYLENOL and MOTRING alternated every 4 hours. Still running temp this am at 102.0. Mom States she thought child wouldn't get mist because of asthma. Mom's form checked asthma - no. Child not having symptoms of respiratory distress.
Age: 24.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Nail bed bleeding
Clinical narrative: Returned 1 hr after receiving H1N1 flu vaccine in left delt. Complaining that her nails on her left hand had blood around the edges. Very minute notice bleeding in corner of nails. Advised to see doctor or ER.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Cough, Fatigue, Musculoskeletal pain, Pain in extremity
Clinical narrative: 11/16 approx. 2 days after shot had chills - No fever - Aching in shoulder and legs - Slight cough. TC to CL. 11-16-09 PM - feels better - Just feels tired. She will contact her PMD if gets concerned.
Age: 1.25
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Got H1N1 injection 11/17/09 in arm. Noon today,11/18/09, developed hives on butt, went to Dr., stated adverse reaction to H1N1. Rx BENADRYL.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood glucose increased, Cough, Dizziness, Dysgeusia, Headache
Clinical narrative: Immediately after injection pt got metallic taste in mouth, burning in back of throat, dizziness. Blood sugar at 220. Pt dizziness increased went to ER 1 hr later, blood sugar remained high. Her B/P low x2, able to increase with laying flat. Pt with Hx of hypotension. Pt began to get HA about 2 hrs after IM. Pt released from ER & at home had temperature high for three days. Highest 102.4 degrees. Headache x 3 days, cough x 1 week. 12/4/2009 ED records for 10/29/2009, patient with c/o's lightheadedness, scratchy throat, fever, chills and a metallic taste in the mouth, Tx IVF, IV Ativan DC DX allergic reaction to vaccine 12/7/2009 PCP visit for 11/3/2009 for c/o's cough, tx: rest and fluids
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypotension, Pyrexia, Throat irritation
Clinical narrative: Immediately after injection pt got metallic taste in mouth, burning in back of throat, dizziness. Blood sugar at 220. Pt dizziness increased went to ER 1 hr later, blood sugar remained high. Her B/P low x2, able to increase with laying flat. Pt with Hx of hypotension. Pt began to get HA about 2 hrs after IM. Pt released from ER & at home had temperature high for three days. Highest 102.4 degrees. Headache x 3 days, cough x 1 week. 12/4/2009 ED records for 10/29/2009, patient with c/o's lightheadedness, scratchy throat, fever, chills and a metallic taste in the mouth, Tx IVF, IV Ativan DC DX allergic reaction to vaccine 12/7/2009 PCP visit for 11/3/2009 for c/o's cough, tx: rest and fluids
Age: 30.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Blister, Dry eye
Clinical narrative: Patient called 24 hours after receiving the vaccine and stated she had dry eyes or blisters in her eyes. Instructed her to go to her primary physician. Primary physician stated she had dry eyes and gave her eye drops. Unsure if related to FLUMIST.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Hypoaesthesia facial
Clinical narrative: Was feeling numbness in the face, chest stated hurting right after the shot was given.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Erythema, Full blood count, Metabolic function test, Oedema peripheral
Clinical narrative: 2 weeks after started administering H1N1 mist severe exacerbation of RA. Extreme redness, swelling, pain in hands. PREDNISONE increased to 15 mg QD, naproxyn sodium added. Joints calmed down 11/12/09.  12/08/09 Rheumatology consult notes for DOS 11/09/09. Pt c/o flare up of arthritis in hands with swelling, redness and pain. Physician's impression: mixed connective tissue disease with Raynaud's phenomenon (joint flare probably related to live vaccine intranasal), acute arthropathy of hands nondeforming. Tx: steroids, which may be discontinued, NSAID and pain medications.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Urine analysis
Clinical narrative: 2 weeks after started administering H1N1 mist severe exacerbation of RA. Extreme redness, swelling, pain in hands. PREDNISONE increased to 15 mg QD, naproxyn sodium added. Joints calmed down 11/12/09.  12/08/09 Rheumatology consult notes for DOS 11/09/09. Pt c/o flare up of arthritis in hands with swelling, redness and pain. Physician's impression: mixed connective tissue disease with Raynaud's phenomenon (joint flare probably related to live vaccine intranasal), acute arthropathy of hands nondeforming. Tx: steroids, which may be discontinued, NSAID and pain medications.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure, Allergy test, Aphonia, Dysphonia, Laryngitis
Clinical narrative: Complete laryngitis occurred on 10/9/09- No other symptoms. Voice began to return on 11/2/09. Hoarseness continues 11/16/ Visits to 3 different mds. Conflicting dx. My symptoms began 48 hrs after I started giving H1N1 vaccine to pediatric patients in health dept. My voice was completely absent for 3 1/2 weeks with continued hoarseness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Laryngoscopy
Clinical narrative: Complete laryngitis occurred on 10/9/09- No other symptoms. Voice began to return on 11/2/09. Hoarseness continues 11/16/ Visits to 3 different mds. Conflicting dx. My symptoms began 48 hrs after I started giving H1N1 vaccine to pediatric patients in health dept. My voice was completely absent for 3 1/2 weeks with continued hoarseness.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody negative, Arthralgia, Joint swelling, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Both knees swollen - 2 wks after started administering H1N1 Mist. Dr Appt 10-19-09 - Dr - ? reason - for swelling and pain - 10-29-09 Dr - ? diagnosis - take ALEVE. Finally given MEDROL dose pk 11-6-09
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Dizziness, Headache
Clinical narrative: C/o mild dizziness/headache that resolved after about 15  minutes. Child returned to class.  410 PM phone call to mother to inform of mild reaction. Child fine as far as she knows. Vaccine event report done per recommendation of Dr.
Age: 47.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Eye swelling, Ocular hyperaemia
Clinical narrative: Redness swelling around R eye 24hrs after injection coughing and chest congestion.      12/7/09 Medical records received for DOS 11/18/09. FINAL DX: URI recent H1N1, allergic reaction.  R eye edema 24 hrs s/p H1N1.  C/O sinus congestion, nonproductive cough. Cervical adenopathy. Allergic rxn and URI. Abx therapy and Benadryl as tx.
Age: 5.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia, Unevaluable event
Clinical narrative: none stated
Age: 0.05
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash on right / left foot then over the day progressed to right and left leg. Very itchy.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Wheezing
Clinical narrative: Wheeze, cough.
Age: 67.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cardiac failure congestive, Chills, Confusional state, Dizziness, Fatigue
Clinical narrative: Achy, tired, high fever, confusion, sweating, chills, dizziness, nausea, could not eat. Currently with hospitalized with severe pneumonia and congestive heart failure.  12/03/09, 12/07/09, 12/17/09 DC Summary, ED, and hospital records received for DOS 11/27/09-12/05/09.  Pt. received H1N1 vaccine and following day developed diffuse body aches and muscle pains.  Over next several days developed cough, shortness of breath and fever. Presented to ED with confusion, poor appetite, and was found to have bilateral pneumonia. ID consult obtained and treated with antibiotics; tested positive for Legionella.    Nephrology consult for elevated BUN and creatinine. Insulin adjustment partially cleared confusion. Discharged home with supplemental oxygen, continued antibiotics and insulin changes. DX: pneumonia; hypoxic respiratory failure; mental status change
Age: 67.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Hyperhidrosis, Hypophagia, Myocardial infarction, Nausea, Pain
Clinical narrative: Achy, tired, high fever, confusion, sweating, chills, dizziness, nausea, could not eat. Currently with hospitalized with severe pneumonia and congestive heart failure.  12/03/09, 12/07/09, 12/17/09 DC Summary, ED, and hospital records received for DOS 11/27/09-12/05/09.  Pt. received H1N1 vaccine and following day developed diffuse body aches and muscle pains.  Over next several days developed cough, shortness of breath and fever. Presented to ED with confusion, poor appetite, and was found to have bilateral pneumonia. ID consult obtained and treated with antibiotics; tested positive for Legionella.    Nephrology consult for elevated BUN and creatinine. Insulin adjustment partially cleared confusion. Discharged home with supplemental oxygen, continued antibiotics and insulin changes. DX: pneumonia; hypoxic respiratory failure; mental status change
Age: 67.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia
Clinical narrative: Achy, tired, high fever, confusion, sweating, chills, dizziness, nausea, could not eat. Currently with hospitalized with severe pneumonia and congestive heart failure.  12/03/09, 12/07/09, 12/17/09 DC Summary, ED, and hospital records received for DOS 11/27/09-12/05/09.  Pt. received H1N1 vaccine and following day developed diffuse body aches and muscle pains.  Over next several days developed cough, shortness of breath and fever. Presented to ED with confusion, poor appetite, and was found to have bilateral pneumonia. ID consult obtained and treated with antibiotics; tested positive for Legionella.    Nephrology consult for elevated BUN and creatinine. Insulin adjustment partially cleared confusion. Discharged home with supplemental oxygen, continued antibiotics and insulin changes. DX: pneumonia; hypoxic respiratory failure; mental status change
Age: 41.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase, Blood bilirubin increased, Gamma-glutamyltransferase increased
Clinical narrative: Pt has begun an unexplained Liver Failure.12/17/2009 Admission note and orders for 11/30/2009, increased bilirubin, LFT's 2-3x normal, c/o's extreme fatigue and diarrhea, MRI + for Hepatosplenomegaly, PE + for hepatomegaly. Will order GI consult, Morphine for pain.
Age: 41.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Hepatic failure
Clinical narrative: Pt has begun an unexplained Liver Failure.12/17/2009 Admission note and orders for 11/30/2009, increased bilirubin, LFT's 2-3x normal, c/o's extreme fatigue and diarrhea, MRI + for Hepatosplenomegaly, PE + for hepatomegaly. Will order GI consult, Morphine for pain.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abnormal behaviour, Aggression, Crying
Clinical narrative: BEHAVIORAL CHANGES MANIFESTED BY TEMPER TANTRUMS, WAKING UP CRYING IN THE NIGHT, SEEMINGLY INCONSOLABLE LASTING FOR 3 DAYS.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Severe pain in left arm, hard to lift, aches all the time. No swelling or redness pain seems to be coming from within the arm shoots up into shoulder at times. Can still use it but aches most when resting have not visited dr yet but will make appt at first contributed it to just the shot but not after 10 days.
Age: 0.33
Sex: M
Vaccine: 6VAX-F, PPV
Symptoms: Erythema, Feeling hot, Induration, Oedema peripheral, Pyrexia
Clinical narrative: Started running fever of 102 and leg started swelling. Ran 102 fever for about 24 hours and right leg became very red and extreamly swollen, tender, and hot. Leg remained with red and tenderness for 4 days and knot stayed in leg for over 3 weeks.
Age: 0.33
Sex: M
Vaccine: 6VAX-F, PPV
Symptoms: Tenderness
Clinical narrative: Started running fever of 102 and leg started swelling. Ran 102 fever for about 24 hours and right leg became very red and extreamly swollen, tender, and hot. Leg remained with red and tenderness for 4 days and knot stayed in leg for over 3 weeks.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Blood test normal, Computerised tomogram normal, Headache, Malaise, Muscle spasms
Clinical narrative: My son started having uncontrollable twitching of his right leg. My husband massaged his leg & then the twitching started in his left leg. We took him to his pediatrician. The doctor checked his vitals & said it could be a spasm, but wanted him checked out by a neuro. He would make an appointment for us & call us first thing Monday morning. That same evening my son started having panic attacks & said his head was hurting & complaining that he did not feel well, then the twitching in his left leg started up again. We immediately rushed him to the hospital. The physician at the hospital ordered blood work & a CT scan of the head. All test came back negative. But to date my son is still complaining of headaches, he tells me he does not feel well & his legs still twitch. All this came about after he received the H1N1 virus vaccine. He only received 1 dose of the vaccine.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Muscle twitching, Panic attack
Clinical narrative: My son started having uncontrollable twitching of his right leg. My husband massaged his leg & then the twitching started in his left leg. We took him to his pediatrician. The doctor checked his vitals & said it could be a spasm, but wanted him checked out by a neuro. He would make an appointment for us & call us first thing Monday morning. That same evening my son started having panic attacks & said his head was hurting & complaining that he did not feel well, then the twitching in his left leg started up again. We immediately rushed him to the hospital. The physician at the hospital ordered blood work & a CT scan of the head. All test came back negative. But to date my son is still complaining of headaches, he tells me he does not feel well & his legs still twitch. All this came about after he received the H1N1 virus vaccine. He only received 1 dose of the vaccine.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Borrelia burgdorferi serology negative, Facial palsy
Clinical narrative: 11/20/09 Symptoms of L side Bells Palsy. Saw MD, Lymes titer negative. Treated with prednisone. 11/30/09 Symptoms getting better. 12/2/09 Medical records received for date 11/25/09. DX: Bell's palsy. Consultation for new onset of bell's palsy. Pt was seen by this consulting MD approx 48hrs ago. Pt c/o occurrence of bells palsy as a result of receiving H1N1 vax. Assessment: left sided facial droop, ptosis on left. Neuro consult 11/20/09 DX:paresthesia and pain rt.antierior neck. No significant neurological disorder found.
Age: 70.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Angioedema
Clinical narrative: 11/20/09 developed angioedema. 12/1/09 Medical records and discharge summary received for DOS  11/20/09. Final DX: Acute angioedema, diabetes, elevated cholesterol Reaction to azithromycin.  tongue swelling.  Concern for patent airway. Improved w/tx. Concomitant URI.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dry throat, Dyspnoea, Erythema, Flushing, Hypoaesthesia
Clinical narrative: Initial Sx - face flushed, SOB, numbness, dry throat, ETC -SOB, hives, itching, redness, bites arms and swelling. Discharge home after 2 hours.  12/04/09 ED received for DOS 11/25/09. DX: Allergic reaction, urticaria.  Pt presented with hives and maculopapular rash on neck and both arms, SOB and dryness of throat, rash, redness, itching and swelling.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Initial Sx - face flushed, SOB, numbness, dry throat, ETC -SOB, hives, itching, redness, bites arms and swelling. Discharge home after 2 hours.  12/04/09 ED received for DOS 11/25/09. DX: Allergic reaction, urticaria.  Pt presented with hives and maculopapular rash on neck and both arms, SOB and dryness of throat, rash, redness, itching and swelling.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema
Clinical narrative: Allergic reaction. Erythema and edema around area of vaccines.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dyspnoea
Clinical narrative: C/O difficulty breathing, slight dizziness. Had pt. sit down for a few minutes, gave juice. BP 132/50, HR 60, R 16. Tolerated juice well and reported that dizziness was gone and breathing eased. Lungs clear, no wheezing noted.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Heart rate increased, Heart rate irregular, Wheezing
Clinical narrative: Wheezing, rapid irregular HR, 911 called, paramedics arrived, mom present. Child evaluated by paramedics; observed for > 1 hour.; became stable; sent home in care of mother.
Age: 1.86
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 22 month old child received live nasal H1N1 vaccine intended for age 2-49 years. No problems per patient on 11-17-09.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Electrocardiogram, Fall, Heart rate irregular
Clinical narrative: HR 86, BP 98/52, AP 86, PR 22, C/O dizziness, fell in bathroom, mother called . Mother arrived and took child home. Child alert and stable at discharge. End of Sept ITP.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Rash macular, Rash pruritic
Clinical narrative: 12x13cm macular erythema. Positive pruritic.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Injection site pain, Pain in extremity
Clinical narrative: Pt. c/o dizziness and pain in L arm near injection site and radiating to fingers, lasting less than 10 minutes. Pt. stated felt better and returned to class.
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Stomach ache, muscle ache, headache, nausea and vomiting. Mild fever 99.1. Received -Tamiflu, Lortab and Dilaudid and Phenergan.
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Stomach ache, muscle ache, headache, nausea and vomiting. Mild fever 99.1. Received -Tamiflu, Lortab and Dilaudid and Phenergan.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Back pain, Death, Influenza like illness, Pain, White blood cell count increased
Clinical narrative: Patient reported to ER 1 day after receiving H1N1 vaccine with "flu like symptoms", "hurting all over". VS and lab stable - treated for lower back pain. Sent home with instructions to report back if problems continue. Patient reported to ER on 11-20-09. Report is not available. Sister states pt. was treated and sent home. Boyfriend discovered pt. dead at home after returning home from store. 12/2/2009 ED record for 11/19/2009  and 11/20/2009 and dialysis records for 11/13, 11/16 and 11/18/2009. Patient presented to ED with c/o's  flu-like sx: "aching and pain all over", no other sx noted. PE was negative. Tx: IM pain meds Morphine and Dilaudid, po Zofran. Dc'd with Rx for Lortab On 11/20/2009 presented to another ED with c/o's "hurting all over and with c/o's nausea/vomiting. Tx: Demerol and Vistaril Dc''d with dx of chronic back pain.  Notes state that later on 11/20/2009 patient expired at home.  1/7/2010 Death Certificate received. DOD 1120/09. Cause of Death: Acute Myocardial Infarction. Additional information abstracted: Other Significant Conditions - Diabetes.
Age: 31.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Influenza
Clinical narrative: Pt with Dx of H1N1 influenza beginning 6 days after intranasal vaccination; unclear if got virus from vaccine or they were exposed before immunity complete.
Age: 35.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Headache, Vomiting
Clinical narrative: vomiting a few hours after getting the vaccination. Along with diarrhea, headache, dizziness, and abdominal pain.
Age: 43.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Genital lesion, Oral disorder, Rash erythematous, Rash pruritic
Clinical narrative: A day or two after receiving H1N1 injection, pt. noticed itchy red pimple - sized bumps on her face, arms, chest; now has 1 in her mouth and 2 "in my private area." C/o severe itching - referred to MD.
Age: 11.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Got H1N1 mist and noted rash on body few hours later. Confluent pink on body, sl raised tiny papules on ext. Treated with antihistamine - No sequelae.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Ear infection, Pyrexia, Rash erythematous
Clinical narrative: Mother reported on 11/23/09 that child developed little red bumps on her neck around 4 days after vaccine. Developed fever on 11/15 or 11/16/09. MA dx'ed on 11/17 as ear infection. Put on antibiotic.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Body temperature increased, Chest X-ray normal, Convulsion, Influenza serology negative
Clinical narrative: Parents awakened to sound of pt having a seizure. Seizure lasted 1-2 minutes. Called 911. Taken to hospital by ambulance. Temperature > 101. Axillary for ambulance staff. No further seizures. Sent home with family when temperature reduced.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Injected limb mobility decreased, Malaise, Myalgia, Pain
Clinical narrative: I received H1N1 vaccine on 10/29/09. On 10/30/09 my R arm was very sore. All muscles in my body sore. Difficult and painful to raise arms over head. Pain continues as of 11/10/09. I have had no fever, headache or other symptoms. I have tried ADVIL and acupuncture. I continue to feel ill with very sore, achy joints and muscles.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity
Clinical narrative: I received H1N1 vaccine on 10/29/09. On 10/30/09 my R arm was very sore. All muscles in my body sore. Difficult and painful to raise arms over head. Pain continues as of 11/10/09. I have had no fever, headache or other symptoms. I have tried ADVIL and acupuncture. I continue to feel ill with very sore, achy joints and muscles.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia
Clinical narrative: C/O "can't feel Lt. arm". (Injection site Rt arm). Observation x 15".
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain, Cough, Full blood count normal, Metabolic function test, Pain in extremity
Clinical narrative: 20 minutes after vaccine pt developed severe abdominal pain, leg pain - cough and fever to 101 degrees seen in ED, followed here this am.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: 20 minutes after vaccine pt developed severe abdominal pain, leg pain - cough and fever to 101 degrees seen in ED, followed here this am.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: H1N1 Flumist given instead of injectable H1N1. Pt is pregnant.  12/07/09 MR received for DOS 11/09/09. Pt received flu mist vaccine instead of injection. Pt was 13 weeks pregnant at the time of vaccination.  EDD: 05/16/10.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rash papular
Clinical narrative: X 1 wk. after H1N1 nasal vaccine, grandmother described raised small bumps all over body, areas without redness or itching. Has not seen his doctor.
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: "dizzy" - juice given; observed
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 5 yr old received AFLURIA 0.5cc preservative pre-filled syringe, parent notified of incident. Parent reports child not having any problems or reactions post vaccine. Report received do not indicate any adverse event, they were apparently submitted because Afluria was given in each instance to a child prior to FDA's approval for use in persons as young as 6 months of age.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Felt faint - moved to floor. Given juice drink. Observation x 15".
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 7 yr old male received H1N1 vaccine (AFLURIA) 0.5cc preservative pre-filled syringe LT. Parent notified of incident. Parent reports child not having any problems or reactions post vaccine.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea, Vertigo
Clinical narrative: C/o head spinning, sl. nauseous 30" after immunization - hydrated well. T 97 degrees.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 4 yo male received .5cc AFLURIA H1N1 vaccine @ P.P. office. Parent notified, no adverse reactions reported. DR notified HD. Follow-up with CSL Biotherapies advised no further action to be taken.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: C/O itchy Rt hand-site of wk stamp. Rx-observation x 15".
Age: 12.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal discomfort, Pyrexia
Clinical narrative: "upset stomach" T 100.0 Sent home due to fever.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Muscle spasms, Neck pain, Pain, Sensation of foreign body, Tenderness
Clinical narrative: 3 days after vaccine, feeling in throat (lump in throat) lower near breast, twinges of pain, spasm last a few seconds in back. Denies difficulty breathing. Continues 1 x daily sore neck and tenderness.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea. Onset 1-2 hrs after vaccine administration.
Age: 35.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: 11/10/09 Given H1N1 nasal LAIV although pregnant with history of asthma. Had visit scheduled next day with OB/GYN. Left 2 messages but did not return call. 12/03/09 Antepartum Medical record received for DOS 09/11/09, 10/15/09; 11/11/09.  EDC: 04/01/10
Age: 13.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea
Clinical narrative: Nausea, T 98.5. Observed-hydrated, rested in nurse's office.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Received H1N1 LAIV although asthma marked on consent. Spoke with mom next day when error noted. No untoward effects.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Chills, Myalgia, Pyrexia
Clinical narrative: Hx of Rt breast cancer with mastectomy. Had H1N1 vn (R) arm, beginning Sun. PM c/o chills, fever and muscle aches. Temp 102.3 today. Denies swelling, pain or discomfort with (R) arm. Denies hx of any lymphedema, forgot to tell nurse not to use (R) arm.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Bronchial hyperreactivity, Full blood count, Granulocyte count, Pyrexia, Screaming
Clinical narrative: Child with fever and screaming all night after injections. Mom unable to console. Slight local reaction on skin . In office, UB < 20.0. Gran 8.3. URI/RAD - Amoxil 250/5ml. 1/2 tsp P.O. BID x 10 days. Quiet and asleep
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Skin reaction, Upper respiratory tract infection, White blood cell count
Clinical narrative: Child with fever and screaming all night after injections. Mom unable to console. Slight local reaction on skin . In office, UB < 20.0. Gran 8.3. URI/RAD - Amoxil 250/5ml. 1/2 tsp P.O. BID x 10 days. Quiet and asleep
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Throat tightness, Urticaria
Clinical narrative: Employee states 24hrs after injection she had hives, tightness in throat, itching.  12/03/09 ED notes for DOS 11/20/09. DX: Allergic reaction for H1N1 vaccine  Pt c/o rash at injection site, arms leg, hives, tightness in throat and itching. Tx: Benadryl, prednisolone and Pepcid. Pt improved and discharged home.
Age: 10.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Rash pruritic
Clinical narrative: Per patient's mother, child developed a fine rash within 24 hours of vaccination. Patient still has rash today. Rash is "fine" "very itchy" and extends from clavicle to hip bone with more rash on the anterior. No other symptoms. She was evaluated by her pediatrician. 11/23/09 for infectious cause. Mother states rash is not hives.
Age: 34.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Fatigue, Influenza, Pyrexia, Respiratory tract congestion
Clinical narrative: Got the flu. Fever, tired, congestion, coughing.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chills, Dyspnoea, Fatigue
Clinical narrative: Sore throat, fever 101 degrees and chills, difficulty breathing, weakness, shaking, too tired to put books in back pack. Tearful and unable to sleep. Allergy pill and TYLENOL administered for nasal drip and high temp. Better this am. No M. D. consult or E.R. visit.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Insomnia, Nasal congestion, Oropharyngeal pain, Pyrexia, Tearfulness
Clinical narrative: Sore throat, fever 101 degrees and chills, difficulty breathing, weakness, shaking, too tired to put books in back pack. Tearful and unable to sleep. Allergy pill and TYLENOL administered for nasal drip and high temp. Better this am. No M. D. consult or E.R. visit.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Tremor
Clinical narrative: Sore throat, fever 101 degrees and chills, difficulty breathing, weakness, shaking, too tired to put books in back pack. Tearful and unable to sleep. Allergy pill and TYLENOL administered for nasal drip and high temp. Better this am. No M. D. consult or E.R. visit.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), MMR
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Received a KINRIX in left arm on 11/18/09. On 11/21/09 mom brought pt by the clinic. Arm with redness and swelling from top of shoulder to elbow, very warm to touch and bruised at injection site. Dr prescribed BACTRIM 1tsp bid x10 days.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Migraine, Pyrexia, Tooth abscess
Clinical narrative: Migraine, Fever 100.6 F, tooth abscess.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site vesicles
Clinical narrative: Received H1N1 vaccine on 11-7-09, L arm 0.5 ml-when removed band-aid on 11-9-09 noted approx 5mm blister at injection site (filled with fluid) which was mid posterior left arm. Was seen by PP-advised not to break blister, site dressed by P.P., to follow-up if any further problems.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Dyspnoea, Paraesthesia
Clinical narrative: Had H1N1 injection at 10:05. Walked back to office which was next building and started to fell as if breathing was somewhat restricted and skin felt "prickly". Sensation felt like when she had pneumonia not asthma. Patient checked at 11:05. Patient alert, NAD, c/o mild tightness in chest. Color good, resp 16 min, HR80/min, lungs clear, good BS, no wheezing, rales or bronchi. Patient observed for 25 min. No change, patient refused EPI PEN and returned to work. Advised to seek medical help if symptoms worsened. 12/3/09 Medical records received for date 11/2/09. Pt c/o warm prickly feeling in face, difficulty breathing after H1N1 vax. Assessment: no wheezing, lungs clear.
Age: 33.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rash
Clinical narrative: Truncal rash seen in ED Rx with IV steroids in ED and 1wk po script to follow.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea, dizzy. Well hydrated. 97.5 T.
Age: 75.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Mobility decreased, Myalgia
Clinical narrative: 11/18/09 I began to have muscle and pint pain which became seriously painful to a point. I could hardly move. Could not get up from sitting position without pulling up to another chair. So painful I thought I must be having a serious arthritic episode even though I never been diagnosed with arthritis - this lasted night and day for 4 days and gradually stopped.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a medical assistant concerning an 85 year old female with chronic obstructive pulmonary disease, hypertension, potassium low, "chronic back pain-problems with disc disorder", atrial fibrillation and penicillin allergy, who in 2000 was vaccinated with the first dose of PNEUMOVAX 23, in 2005 the second dose and on 11-NOV-2009 the third dose (lot # 664000/0621Y, 0.5ml, IM). The vaccination was recommended every 5 years because the patient had chronic obstructive pulmonary disease. There are "quite a few" unspecified concomitant medications. On 12-NOV-2009 the patient experienced injection site reaction with redness, swelling, and painful that was at the top of the shoulder area to the most top of the elbow all the way around the arm. The patient's reaction was cellulitis like. The medical assistant felt the patient need an antibiotic as an intervention. There were no labs and diagnostic tests performed. The patient received the first dose and the second dose of PNEUMOVAX 23 with no reactions. The patient visited office and recovered on 17-NOV-2009. The medical assistant considered the redness, swelling and pain that was at the top of the shoulder area to almost to the top of the elbow were other important medical events. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning an 85 year old female with chronic obstructive pulmonary disease, hypertension, potassium low, "chronic back pain-problems with disc disorder", atrial fibrillation and penicillin allergy, who in 2000 was vaccinated with the first dose of PNEUMOVAX 23, in 2005 the second dose and on 11-NOV-2009 the third dose (lot # 664000/0621Y, 0.5ml, IM). The vaccination was recommended every 5 years because the patient had chronic obstructive pulmonary disease. There are "quite a few" unspecified concomitant medications. On 12-NOV-2009 the patient experienced injection site reaction with redness, swelling, and painful that was at the top of the shoulder area to the most top of the elbow all the way around the arm. The patient's reaction was cellulitis like. The medical assistant felt the patient need an antibiotic as an intervention. There were no labs and diagnostic tests performed. The patient received the first dose and the second dose of PNEUMOVAX 23 with no reactions. The patient visited office and recovered on 17-NOV-2009. The medical assistant considered the redness, swelling and pain that was at the top of the shoulder area to almost to the top of the elbow were other important medical events. This is one of several reports received from the same source. A lot check has been initiated. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, Asthenia, Decreased appetite, Diet refusal, Fatigue
Clinical narrative: After 3 vaccines in 4 wks - child of 42 lbs, very healthy, (swims, skates - hockey etc) stopped eating & drinking & complained of abdominal pain - starting Nov 15 for 4 days - complete loss of appetite, weakness, tired, pain.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pain
Clinical narrative: After 3 vaccines in 4 wks - child of 42 lbs, very healthy, (swims, skates - hockey etc) stopped eating & drinking & complained of abdominal pain - starting Nov 15 for 4 days - complete loss of appetite, weakness, tired, pain.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Flushing, Lethargy
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with no pertinent medical history or drug reactions/allergies, who on an unspecified date was vaccinated with a dose of PNEUMOVAX. There was no concomitant medication. Within 1 and 1/2 hours of vaccination the patient was very lethargic, very dizzy and flushed. The PNEUMOVAX was given by an unspecified primary care physician. The nurse felt patient given BENADRYL was intervention to prevent serious criteria. The patient recovered the same day of vaccination, but later in the day. No laboratory diagnostics studies were performed. The patient sought medical attention (office visit). Very lethargic, very dizzy and flushed were considered to be disabling, immediately life-threatening and other important medical events. A lot check has been initiated. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: C/O dizziness, lightheaded. Well hydrated. 98.3.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Lightheaded after eating lunch. Observed - sent back to class x 15".
Age: 95.0
Sex: M
Vaccine: PPV
Symptoms: Confusional state, Disorientation, Mental status changes, Metabolic function test
Clinical narrative: pharmacist concerning a 95 year old male with no allergies who on 02-NOV-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot number. 665300/1314Y) there was no history of the patient receiving PNEUMOVAX 23 in the past. Concomitant therapy included ROBITUSSIN, LASIX, PROTONIX AND aspirin. The reporter mentioned that on 15-NOV-2009 a patient very active and oriented, experienced altered mental status with confusion and disorientation. The patient was admitted to the hospital for the symptoms. The reporter stated that no urinary tract infection was noted and no change in environment until hospitalization. The patient was being treated with CIPRO and SEROQUEL. A complete metabolic blood test was performed with no results reported. The pharmacist mentioned that the patient remains in the hospital and he has not recovered at the time of reporting. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Dehydration, Diet refusal, Restlessness, Rubella antibody positive
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient with Epstein Barr syndrome, natural killer cell deficiency and allergy to egg white and milk who on 18-Mar-2006 was vaccinated with first dose of MMRII (lot No. not reported). Concomitant therapy included VALTREX. In approximately July 2009 the patient was restless, running around trees and "did not come when called". A rubella titer done in July 2009 showed a rubella titer of 407. The patient was placed on therapy with Amantadine, Ribavirin and TAMIFLU for 21 days. Subsequently the behavioral symptoms resolved and a rubella titer performed which was 4.7. When the children's behavioral symptoms returned a rubella titer performed on 11-Nov-2009 was 259. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. The physician also reported that during the patient's lifetime, the patient had been hospitalized five times for dehydration because he had refused to eat or drink when he has had a cold. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient with Epstein Barr syndrome, natural killer cell deficiency and allergy to egg white and milk who on 18-Mar-2006 was vaccinated with first dose of MMRII (lot No. not reported). Concomitant therapy included VALTREX. In approximately July 2009 the patient was restless, running around trees and "did not come when called". A rubella titer done in July 2009 showed a rubella titer of 407. The patient was placed on therapy with Amantadine, Ribavirin and TAMIFLU for 21 days. Subsequently the behavioral symptoms resolved and a rubella titer performed which was 4.7. When the children's behavioral symptoms returned a rubella titer performed on 11-Nov-2009 was 259. The patient sought medical attention by an office visit. At the time of the report, the outcome of the patient was unknown. The physician also reported that during the patient's lifetime, the patient had been hospitalized five times for dehydration because he had refused to eat or drink when he has had a cold. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Dyspepsia
Clinical narrative: 30 minutes after injection - lightheaded + felt acid stomach. T 97.5.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Head injury, Syncope
Clinical narrative: Fainted after injection. Hit Lt side of head on table. No c/o headache. Hydrated and observed x 20". 1040 AM T 99.5 / T. 99.8 1052 AM T 99.6 @ 1105.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Lightheaded + sl. stomach ache" onset 10:40 am Observed x15 "> OK. T976
Age: 64.0
Sex: M
Vaccine: DT
Symptoms: Guillain-Barre syndrome, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Initial case received from a health care professional on 18 November 2009. It involves a case of overdose, i.e. vaccine administered twice in a 24 hour period. A 64-year-old male patient received an intramuscular injection of DECAVAC (lot not reported) on 05 November 2009, and again on 06 November 2009. On 16 November 2009, eleven days after vaccination, the patient presented to the emergency department with complaints of increasing lower limb weakness. The patient had a leg laceration at the time of vaccination, and had a history of hypertension, hyperlipidemia, gout, and penicillin allergy. Concomitant medications included LISINOPRIL, NORVASC, NIACIN, ALLOPURINOL, GABAPENTIN, aspirin, and PREVACID. He was admitted to the hospital with Guillain-Barre Syndrome vs transverse myelitis. The patient had undergone an MRI and was being followed by neurology; no additional information was available. At the time of the report, the patient had been hospitalized for three days, and the event was ongoing. Documents held by sender: none.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Hypoaesthesia
Clinical narrative: C/o injection arm "numb. Upset stomach. Observation X 10 hours.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Fatigue, Somnolence
Clinical narrative: Tired, drowsy, lightheaded - 5" after injection. Felt tired this AM. T 98.3. Rx - hydration.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Influenza
Clinical narrative: Initial report received on 20 November 2009, sanofi pasteur employee became aware of this event at a conference. The attendee who provided this information learned about the adverse event from a consumer. it was reported that two children received PANDEMIC INFLUENZA H1N1 VACCINE and then got the "flu". The trade name, manufacturer, lot number, route and site of administration were not reported. Additional information was requested from the consumer, but the only information he had at the time was that the children had returned to school. The consumer stated he would forward any additional information to the company representative if obtained. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Headache, Sensation of heaviness
Clinical narrative: Rt arm "feels heavy" , dizzy, head hurts, T 97.4. Rx- hydration. Sent to class 10:14 a.m.
Age: 1.8
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Rash generalised
Clinical narrative: Initial report received on 20 November 2009 from a health care professional. A 20-month-old male patient received an initial right thigh dose of INFLUENZA A H1N1 2009 Monovalent Vaccine - No Preservative (lot number UT029BA) on 17 November 2009. The patient had concurrent illnesses, pre-existing medical conditions, and concomitant medications. That night after vaccination, the patient had a rash on his body. The patient was evaluated by a physician three days later with persistent rash, and at that time the patient had temperature of 100.0 degrees Fahrenheit. He was prescribed BENADRYL and PREDNISONE that day. There were no relevant diagnostics tests or laboratory data performed. At the time of the report, the patient had not recovered. Document held by sender: None.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthma, Condition aggravated, Cough, Influenza, Oropharyngeal pain
Clinical narrative: Flu: EXTREMELY achy, cough, sore throat, mucus.  Cough is still present as of 11/30/2009 (causing asthma attacks).
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain, Rhinorrhoea
Clinical narrative: Flu: EXTREMELY achy, cough, sore throat, mucus.  Cough is still present as of 11/30/2009 (causing asthma attacks).
Age: 54.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Headache, Rhinorrhoea
Clinical narrative: Severe headache with runny nose lasting 12 hours.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Pt woke up on 11/24/2009 with a red pin point rash behind both ears, on chest, & on back.  Pt complained of itching.  Pt was given Benadryl, which decreased the itching.  On 11/25/2009, the rash was still present, but the rash no longer itches.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site induration, Injection site urticaria
Clinical narrative: Baby began to run a fever of 101F. Then baby lost appetite. Then baby developed a 1" diameter welt at location of injection on uppermost LT. Very red and angry looking and very hard. Symptoms continued until 11/25/09 and family came back to get assessment from PH Department. Injection was either the PCV7 or the ACTHIB. Family stated that breathing was not affected. Family stated that baby did develop diarrhea on 11/24/09 and it continued for about 12 hours.