chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: fever of 103
Age: 34.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Blood pressure increased, Dizziness, Immediate post-injection reaction, Presyncope
Clinical narrative: Became dizzy immediately after receiving intranasal H1N1 vaccine. Transported to ER where BP was monitored for a few hours. Was told she had a vagal response.
Age: 9.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives began a few hours after shot  *but had hives off and on earlier in week.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Flushing, Joint stiffness, Pain, Radioallergosorbent test
Clinical narrative: 48 hours after receiving H1N1 #2 developed pain, redness and stiffness hands and feet, face flushed. No difficulty breathing. Pt developed lines on face next day (1/18/2010). Mom gave BENADRYL, rash improved. No further problem.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Arthralgia, Gait disturbance, Pain
Clinical narrative: 24 hrs after receiving HEP A & MENACTRA pt. felt achy, left knee pain - occasional limp
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: Received H1N1 vaccine on 1/16/2010. Returned to clinic on 1/22/2010 with moderate macular-papular rash. Patient says hives appeared 1/21/2010 and much improved today. Mild itching. *No treatment prescribed.
Age: 37.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Lethargy, Myalgia, Nausea, Neck pain
Clinical narrative: Severe muscle aches, nausea, neck pain. Lethargy.
Age: 25.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Rash macular, Urticaria
Clinical narrative: Macular rash on all extremities, torso, neck and face which also led to urticaria on day #2.
Age: 4.0
Sex: M
Vaccine: DTP, IPV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Erythema and urticaria of L Ant thigh at injection site - no cellulitis. Tx - XYZAL.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site calcification, Injection site dryness, Injection site erythema, Injection site haematoma, Scab
Clinical narrative: Pt. received HIBERIX to R thigh on 1/8/10, that evening had vomiting. Next am large 6 cm area of redness at vaccine site. Redness slowly resolved but area still bruised, and overlying dry, crusty skin. Feels like a calcified hematoma under injection site.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt. received HIBERIX to R thigh on 1/8/10, that evening had vomiting. Next am large 6 cm area of redness at vaccine site. Redness slowly resolved but area still bruised, and overlying dry, crusty skin. Feels like a calcified hematoma under injection site.
Age: 0.38
Sex: M
Vaccine: HIBV
Symptoms: Activities of daily living impaired, Crying, Developmental delay, Feeling abnormal, Hypotonia
Clinical narrative: Screamming high pitch cry for 4 days.  After that limp, pale, and seems dazed and out of it.  Stopped smiling, rolling over, just laid there, with no intercation or reaction.  Brought him in to doctor, I think on the 4th or 5th day to see if there was some other reason he was acting this way.  The doctor could not find any infection or cause for his stop in development, lethargy and loss in reaction and interaction.  Just sent me home.  When I went in back in January, the doctor told me that they would never give him another DPT shot, instead they would only give him a DT shot.  He had a reaction to that as well.  Softball size raised hot swollen rash at injection site that covered his whole thigh.  The nurse commented that she was glad she would not have to give him another shot.  It took him several months to get back to smiling and rolling over and interacting.  We spent months interacting with him excessively to get him to come out of this trance like state he was in.
Age: 0.38
Sex: M
Vaccine: HIBV
Symptoms: Lethargy, Pallor, Screaming
Clinical narrative: Screamming high pitch cry for 4 days.  After that limp, pale, and seems dazed and out of it.  Stopped smiling, rolling over, just laid there, with no intercation or reaction.  Brought him in to doctor, I think on the 4th or 5th day to see if there was some other reason he was acting this way.  The doctor could not find any infection or cause for his stop in development, lethargy and loss in reaction and interaction.  Just sent me home.  When I went in back in January, the doctor told me that they would never give him another DPT shot, instead they would only give him a DT shot.  He had a reaction to that as well.  Softball size raised hot swollen rash at injection site that covered his whole thigh.  The nurse commented that she was glad she would not have to give him another shot.  It took him several months to get back to smiling and rolling over and interacting.  We spent months interacting with him excessively to get him to come out of this trance like state he was in.
Age: 43.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: 43 yr old female employee presented to employee health clinic for H1N1 influenza vaccination injection. Immediately after the pt c/o tingling to right cheekbone, throat and eye. there was no SOB or tongue swelling.  She was given diphenhydramine 25mg po X 1 at 10:15am and at 12 noon her symptoms were resolved. No SOB or difficulty breathing.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Itching, hives, SOB
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Headache, Hypoaesthesia, Nasal congestion, Salivary gland enlargement, Swelling face
Clinical narrative: Left arm above elbow was numb, nose stuffy, cheeks and tongue swollen, salivary glands in front of ears swollen, headache Client took oral benadryl every 3 hours to relieve symptoms and rested in bed Total symptom duration: 2 days Symptoms mostly resolved by day of call on 1/20/2010
Age: 51.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Swollen tongue
Clinical narrative: Left arm above elbow was numb, nose stuffy, cheeks and tongue swollen, salivary glands in front of ears swollen, headache Client took oral benadryl every 3 hours to relieve symptoms and rested in bed Total symptom duration: 2 days Symptoms mostly resolved by day of call on 1/20/2010
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling of body temperature change, Pyrexia
Clinical narrative: Student reported to health room (after clinic had broken down). Per the school nurse, she was not feeling well and had a temp. of 101.1F. Was reportedly feeling fine before receiving inactivated vaccine. Student was sent home with mother. She was also abesent from school on 1/21. The school nurse followed up with student's mom--child was feeling better; had no temp; did not go to MD.
Age: 0.55
Sex: M
Vaccine: HIBV
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Softball size hot red swollen raised rash at injeciton site.
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Blood test abnormal, Pollakiuria, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: stomach pain, weight loss, urinating often, no treatment until wed. jan 20th 2010.
Age: 14.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Blood test, Chest pain, Dyspnoea, Ear infection
Clinical narrative: Took to emergency, had 2 ear infections, throat infection, respiratory infection, gave antibiotic, sudefed, and mucinex. 2nd time at ER complaining of chest pain, did EKG, took blood, xray-nothing, went to doctor with chest pain, had nose infection, said just sore muscles, said to take motrin. 2nd time at doctors 01/21/2010-had chest pain, hard to breathe, weak-gave motrin and musle relaxants--said sore muscles from coughing.
Age: 14.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Electrocardiogram normal, Gallbladder disorder, Myalgia, Pharyngitis, Respiratory tract infection
Clinical narrative: Took to emergency, had 2 ear infections, throat infection, respiratory infection, gave antibiotic, sudefed, and mucinex. 2nd time at ER complaining of chest pain, did EKG, took blood, xray-nothing, went to doctor with chest pain, had nose infection, said just sore muscles, said to take motrin. 2nd time at doctors 01/21/2010-had chest pain, hard to breathe, weak-gave motrin and musle relaxants--said sore muscles from coughing.
Age: 14.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Rhinitis, X-ray
Clinical narrative: Took to emergency, had 2 ear infections, throat infection, respiratory infection, gave antibiotic, sudefed, and mucinex. 2nd time at ER complaining of chest pain, did EKG, took blood, xray-nothing, went to doctor with chest pain, had nose infection, said just sore muscles, said to take motrin. 2nd time at doctors 01/21/2010-had chest pain, hard to breathe, weak-gave motrin and musle relaxants--said sore muscles from coughing.
Age: 1.69
Sex: M
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Cellulitis, Erythema
Clinical narrative: Large reddened area that appeared to be cellulitis 10x12 cm area on right thigh.
Age: 0.38
Sex: F
Vaccine: HIBV, OPV
Symptoms: Pyrexia
Clinical narrative: Got 105.5 fever
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotension, Loss of consciousness, Presyncope
Clinical narrative: Patient recieved #2 of #3 HPV vaccine and within 3 minutes, had a vasovagal reaction.  She lost conciousness and was lowered to the floor. Patient became conscious about 30 seconds later and was having difficulty responding.  Her legs were elevated and a cold pack was applied to her forehead. Her blood pressure was low and the Provider felt that she needed IV fluids and was transferred to the Emergency Department.  She was discharged the same day in satisfactory condition.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate decreased, Hypertension, Laryngeal oedema, Rash generalised
Clinical narrative: Information has been received from a nurse concerning a 64 year old female patient with hypertension, hypothyroidism, paroxysmal atrial fibrillation, microscopic haematuria, penicillin and amiodarone allergy who on 18-JAN-2010 was vaccinated SC with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapies included "thyroid medication", enalapril maleate (manufacturer unknown), furosemide (manufacturer unknown), potassium supplement (manufacturer unknown), diltiazem HCL (manufacturer unknown), atenolol (manufacturer unknown), simvastatin (manufacturer unknown), calcium (unspecified), warfarin (manufacturer unknown) and propafenone HCl (manufacturer unknown). On 18-JAN-2010 within one hour of the vaccination the patient experienced shortness of breath while driving home from the office. She drove herself to the medical center and was evaluated in the emergency room and was found to have a widespread rash, low pulse, hypotension, and laryngeal edema. The patient was administered oxygen and unspecified medication and was scheduled to be admitted to the hospital. At the time of report the patient's status was not recovered. The patient's shortness of breath, widespread rash, low pulse, hypotension and laryngeal edema were considered to be immediately life-threatening, significant disabling, hospitalization and other important medical events. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Diabetes mellitus
Clinical narrative: Information has been received from a male consumer who on an unspecified date was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). The consumer indicated that he had received "a pneumonia vaccine once a year since it first came out, I don't know the name of the vaccine but it begins with a 'p'". The consumer also reported that he developed diabetes after he started getting vaccinated yearly and was hospitalized for diabetes in May of 1990. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 78.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Contusion, Pain in extremity
Clinical narrative: Patient received H1N1 Lot 102141P1 exp 4/10 on 1-11-2010 in left deltoid returned on 1-21-10 with sore arm and bruise approx 6 inches in diameter orange in color.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cold sweat, Dizziness, Feeling cold, Syncope
Clinical narrative: (1) Dizziness unresolved after observation - (2) Cool/clammy -  collapsed to floor - (3) IV - (4) 911 -> Pru Rescue.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives on arms and back x2wks worse after vaccine Benadryl 50mg po
Age: 15.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Vision blurred
Clinical narrative: Blurred vision - Mom P/u @ School.
Age: 66.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Swollen tongue
Clinical narrative: One-half tongue swelled - Noticed about 4 AM 1/22/2010 - Self treated with BENADRYL - Patient reported with no complaints
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Hypoaesthesia, Pyrexia
Clinical narrative: Pt received vaccine at 5 PM. Went home after 15 min observation. Returned to school at 6 PM with c/o fever, chills and numbness of both arms. TYLENOL administered 320 mg PO for temp 103.8. Transported via Rescue.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia
Clinical narrative: 24 hours after receiving vaccine, child had fever of 104 degrees for 2 days.
Age: 78.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Injection site discolouration, Injection site haematoma, Injection site pain
Clinical narrative: Patient received H1N1 lot 102141P exp 4/10 on 1-11-2010 in left deltoid. Returned on 1-21-10 with sore arm and bruise approx. 6 inches in diameter orange in color.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site vesicles, Skin discolouration
Clinical narrative: Blister noticed by client at site of injection on 1/7/10. Bandage had remained in place from time of injection. Currently, an area measuring approximately 5 x 9 mm appears dark red with a discolored area immediately above. New bandage applied. Area is not hot to touch, there is no rash. Client denies pain. There is no discharge.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site discolouration, Injection site erythema, Injection site vesicles
Clinical narrative: Blister noticed by client at site of injection on 1/7/10. Bandage had remained in place from time of injection. Currently, an area measuring approximately 5 x 9 mm appears dark red with a discolored area immediately above. New bandage applied. Area is not hot to touch, there is no rash. Client denies pain. There is no discharge.
Age: 71.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Burning sensation, Myalgia, Nausea, Oedema peripheral
Clinical narrative: Swelling, both hands swollen and burning as if on fire . Nauseous and throwing up. Muscles and joint pain.
Age: 71.0
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Swelling, Vomiting
Clinical narrative: Swelling, both hands swollen and burning as if on fire . Nauseous and throwing up. Muscles and joint pain.
Age: 54.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site nodule, Injection site papule, Swelling
Clinical narrative: After injection, hard bump formed at injection site. Asked patient to stay for monitoring, but refused and stated that he was doing okay. Called patient later in evening claimed to be okay without additional swelling.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Heterophoria
Clinical narrative: I was driving suddenly everything in front of me went vertical (cars looked like they were standing on end). Happened twice, lasting a few seconds then stopped.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Myalgia, Paraesthesia
Clinical narrative: Patient initially reported lightheadedness after vaccine was administered. She was then instructed to put her head between her knees which she did. Shortly after she reported intense pain in her arm muscle which radiated down her arm and also tingling. After 20 min. the tingling subsided, but the pain remained.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), HPV4
Symptoms: Abdomen scan, Abdominal pain, Injection site pain, Injection site papule, Ultrasound abdomen
Clinical narrative: 12-22-09 Complained arm left deltoid pain and bump. 12-24-09 Vomit and abdominal pain. ER visit 12/24/09. IVF and IV pain med. 1-17-10 Vomit and abdominal pain.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), HPV4
Symptoms: Ultrasound pelvis, Vomiting
Clinical narrative: 12-22-09 Complained arm left deltoid pain and bump. 12-24-09 Vomit and abdominal pain. ER visit 12/24/09. IVF and IV pain med. 1-17-10 Vomit and abdominal pain.
Age: 53.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: itching = small hives required BENADRYL
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Injection site-right arm red, hot tender 19 X 23 cm redness well demaruted, fever 102, malaise.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Throat tightness, Urticaria
Clinical narrative: Throat tightening on 1/14/10, hives appeared 1/15/10, resolving as of 1/19/10. Treated herself with BENADRYL.
Age: 27.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Eye pruritus, Swelling face
Clinical narrative: 1/2 hour after receiving H1N1 vaccine patient developed swelling on both sides on the cheek near the eye with itching - got worse this morning and was getting better when he saw me.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Injection site pruritus, Injection site warmth
Clinical narrative: 2 pm c/o (R) upper arm itching and headache - no rash/hives present. 2:05 pm 50 mg BENADRYL given - 2:10 BP 122/78 Pulse=62 - 2:15 pm R upper arm around injection site c/o feeling hot but no longer itching. 2:20 pm c/o numbness (R) hand fingers. No itching - 2:25 pm grandfather pick her up - report with s/s to watch for and when to go to MD if needed.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Immediate post-injection reaction, Injection site vesicles
Clinical narrative: Pt never had flu vaccine. So she did not answer q #3. Upon adminins. she immed. developed "bubble" on her L arm and 5 minutes a/f that she became lightheaded and dizzy. I called EMT.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: Pt complains of itchiness, lightheaded, administered 25 mg followed by 12.5 mg. Pt stated relief. O2 10L NRB. Pt then stated she was having hard time breathing. Pt transported by Resc.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Affective disorder, Mood swings, Oppositional defiant disorder
Clinical narrative: Development behavioral changes, mood swings which mother believes began after 1st HPV, given 2/5/08. Ultimately hospitalized and diagnosed with Oppositional Defiant Disorder and Mood Disorder.
Age: 12.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: No c/o of SOB, c/p. Pt. states he vomited aprx. 20 minutes ago in bathroom. VSS 112/70, 84, 22, lung sounds clear.
Age: 14.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Erythema, Pallor, Rash, Rash macular
Clinical narrative: Pt. presented with severe rash and pallor->noticed blotching and red areas on back, chest and extremities->pt. also c/o of dizziness; no SOB or edema in/within airway->administered 50 mg. BENADRYL->continued to monitor pt for D->including BLVS and continuing VS->administered 0.3 EPI 1:1K L Deltoid->called rescue->transferred care.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Hyperhidrosis, Pallor, Pruritus, Swelling face
Clinical narrative: Pt. presented with pallor->itchiness on thigh area->no SOB; some puffiness under eyes->some redness around nose->mom says daughter not acting herself->pt also presented with diaphoresis. 911->hosp.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Fever 103 degrees, wheeze cough.
Age: 42.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Received H1N1 on 1-14-10. Broke out in hives 1/16/10. Itches. Patient was instructed to take Benadryl by health care provider and to call if situation became worse. Patient states itching is slightly less and hives not as pronounced during the phone follow up on 1/19/10.
Age: 70.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Feeling hot, Oedema peripheral, Pain in extremity, Rash macular
Clinical narrative: 1/15/10 arm developed blotches, was hot to the touch and swollen. 1/14/10 arm became sore in the evening.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Hypersomnia, Irritability, Pain in extremity, Pyrexia
Clinical narrative: Mom says she took child to Emergency Room following vomiting, not eating, irritable, pain in leg, fever. Mom does not report redness or swelling at the injection site. Child has had seasonal influenza vaccine in the past with no reactions and has no known allergies. On date of form completion illness continues, fever has broke, child sleeps frequently.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Mom says she took child to Emergency Room following vomiting, not eating, irritable, pain in leg, fever. Mom does not report redness or swelling at the injection site. Child has had seasonal influenza vaccine in the past with no reactions and has no known allergies. On date of form completion illness continues, fever has broke, child sleeps frequently.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Red, swollen at site, day after vaccine. Two days from vaccine site was red swollen and hot covers area about 6 inches diameter. Started to have hives on back - Mother treated with BENADRYL, and fever reliever. Temp 98.7
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Antibody test, Blood culture negative, CSF glucose normal, CSF protein normal, CSF white blood cell count negative
Clinical narrative: Rash, intermittent fevers, vomiting, decreased activity, increased sleep and lethargy beginning approximately 24 hours after 11/13/09 vaccinations, then 12/4/09 had tonic activity head deviated to left x 5 min, then limp, minimal responsiveness x 40 min. Transferred to Hospital for seizure. Temp 99.8, also AOM.
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Computerised tomogram head, Culture urine, Cytomegalovirus antibody, Decreased activity, Depressed level of consciousness
Clinical narrative: Rash, intermittent fevers, vomiting, decreased activity, increased sleep and lethargy beginning approximately 24 hours after 11/13/09 vaccinations, then 12/4/09 had tonic activity head deviated to left x 5 min, then limp, minimal responsiveness x 40 min. Transferred to Hospital for seizure. Temp 99.8, also AOM.
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Ear disorder, Electroencephalogram normal, Enterovirus serology test negative, Epstein-Barr virus antibody, Herpes simplex serology negative
Clinical narrative: Rash, intermittent fevers, vomiting, decreased activity, increased sleep and lethargy beginning approximately 24 hours after 11/13/09 vaccinations, then 12/4/09 had tonic activity head deviated to left x 5 min, then limp, minimal responsiveness x 40 min. Transferred to Hospital for seizure. Temp 99.8, also AOM.
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypersomnia, Hypotonia, Influenza serology, Lethargy, Mycoplasma serology
Clinical narrative: Rash, intermittent fevers, vomiting, decreased activity, increased sleep and lethargy beginning approximately 24 hours after 11/13/09 vaccinations, then 12/4/09 had tonic activity head deviated to left x 5 min, then limp, minimal responsiveness x 40 min. Transferred to Hospital for seizure. Temp 99.8, also AOM.
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Nuclear magnetic resonance imaging normal, Otitis media acute, Pyrexia, Rash, Red blood cells CSF positive
Clinical narrative: Rash, intermittent fevers, vomiting, decreased activity, increased sleep and lethargy beginning approximately 24 hours after 11/13/09 vaccinations, then 12/4/09 had tonic activity head deviated to left x 5 min, then limp, minimal responsiveness x 40 min. Transferred to Hospital for seizure. Temp 99.8, also AOM.
Age: 1.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Respiratory syncytial virus test positive, Sinus disorder, Tonic clonic movements, Virus serology test negative, Vomiting
Clinical narrative: Rash, intermittent fevers, vomiting, decreased activity, increased sleep and lethargy beginning approximately 24 hours after 11/13/09 vaccinations, then 12/4/09 had tonic activity head deviated to left x 5 min, then limp, minimal responsiveness x 40 min. Transferred to Hospital for seizure. Temp 99.8, also AOM.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction
Clinical narrative: local site reaction beginning <24 h post vaccination. Tx with compress/BENADRYL
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Feeding disorder, Irritability, Nodule
Clinical narrative: Increased fussiness, not wanting to breast feed, "large knots in legs." was taken to the ER
Age: 1.82
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Rash papular
Clinical narrative: small red non pruritic papules on face and trunk
Age: 0.3
Sex: M
Vaccine: OPV
Symptoms: Crying
Clinical narrative: High pitched crying and inconsolable for 2 days
Age: 17.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Person received H1N1 vaccine on 10/13/2009 and received another on 11/13/2009, did not need two doses because of age.
Age: 50.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: continued soreness in arm, and irritated, redness at injection site approximately size of a nickle. somewhat itchy
Age: 28.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Feeling hot, Pruritus, Rash pruritic
Clinical narrative: Itchy face.  Developed small bumps/rash under mouth and on left side cheek.  Rash was itchy, warm.
Age: 17.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Paraesthesia, Rash papular
Clinical narrative: Rt deltoid swelling w/small central red papule. Tx w/ice/heat, MEDROL dose pack also numbness, tingling in hand
Age: 17.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Grip strength decreased, Hypoaesthesia, Injection site pain, Injection site swelling, Pain
Clinical narrative: Rt deltoid swelling w/small central red papule. Tx w/ice/heat, MEDROL dose pack also numbness, tingling in hand
Age: 17.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Paraesthesia
Clinical narrative: Rt deltoid swelling w/small central red papule. Tx w/ice/heat, MEDROL dose pack also numbness, tingling in hand
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Asthenia, Confusional state, Dizziness, Heart rate increased
Clinical narrative: Approx 2:10 pm, 01/19/10 Pt was administered a ZOSTAVAX vaccination. Pt passed the screening process and stated that she had not exhibited a reaction to any previous vaccinations. After vaccination she was advised that she needed to stay in the pharmacy for 15 minutes following the vaccination for observation. Approx 2:20 pm pt complained of dizziness. She was advised to sit in a chair. Over the next 5 minutes, her condition became worse. Initial assessment indicated marked anxiety, shallow/rapid respiration, confusion with out loss of consciousness, rapid/weak pulse, weakness, confusion and apprehension. Pt was placed in the shock position with legs elevated. EMS contacted and assistance was requested from the medical staff. In house emergency equipment was brought to the scene. Initial vitals, BP: 130/75, pulse rapid and shallow at the radial artery, carotid pulse in excess of 100. Resp: 64. Approx 2:27 staff RN and others arrived on scene with an EPIPEN, adult 0.3 mg and oxygen. Oxygen applied with mask at 4L per min, Pt increased in apprehension, pulse remained rapid, BP: 109/55, respirations rapid and shallow. Assumed anaphylaxis. EPIPEN administered anterior lateral thigh. 0.3 ml of 1:1000. Pt improved within 4 minutes. Approx 2:35 pm. EMS arrived. Patient respiration slowing, confusion and apprehension decreasing. BP: 185/95, resp:25, pulse not taken. Pass of to EMS. Pt was transported via ambulance to hospital ER. Held for observation and released after 7PM, 01/19/10. Pts practitioner, was consulted and told of pt's sisters report. That had several episodes of dizziness and ashen skin pallor while shopping. Pt's practitioner recommended that the patient make an appointment to be seen as soon as possible after release.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pulse pressure decreased, Respiration abnormal
Clinical narrative: Approx 2:10 pm, 01/19/10 Pt was administered a ZOSTAVAX vaccination. Pt passed the screening process and stated that she had not exhibited a reaction to any previous vaccinations. After vaccination she was advised that she needed to stay in the pharmacy for 15 minutes following the vaccination for observation. Approx 2:20 pm pt complained of dizziness. She was advised to sit in a chair. Over the next 5 minutes, her condition became worse. Initial assessment indicated marked anxiety, shallow/rapid respiration, confusion with out loss of consciousness, rapid/weak pulse, weakness, confusion and apprehension. Pt was placed in the shock position with legs elevated. EMS contacted and assistance was requested from the medical staff. In house emergency equipment was brought to the scene. Initial vitals, BP: 130/75, pulse rapid and shallow at the radial artery, carotid pulse in excess of 100. Resp: 64. Approx 2:27 staff RN and others arrived on scene with an EPIPEN, adult 0.3 mg and oxygen. Oxygen applied with mask at 4L per min, Pt increased in apprehension, pulse remained rapid, BP: 109/55, respirations rapid and shallow. Assumed anaphylaxis. EPIPEN administered anterior lateral thigh. 0.3 ml of 1:1000. Pt improved within 4 minutes. Approx 2:35 pm. EMS arrived. Patient respiration slowing, confusion and apprehension decreasing. BP: 185/95, resp:25, pulse not taken. Pass of to EMS. Pt was transported via ambulance to hospital ER. Held for observation and released after 7PM, 01/19/10. Pts practitioner, was consulted and told of pt's sisters report. That had several episodes of dizziness and ashen skin pallor while shopping. Pt's practitioner recommended that the patient make an appointment to be seen as soon as possible after release.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic shock, Anxiety, Asthenia, Confusional state, Dizziness
Clinical narrative: Approx 2:10 pm, 01/19/10 Pt was administered a ZOSTAVAX vaccination. Pt passed the screening process and stated that she had not exhibited a reaction to any previous vaccinations. After vaccination she was advised that she needed to stay in the pharmacy for 15 minutes following the vaccination for observation. Approx 2:20 pm pt complained of dizziness. She was advised to sit in a chair. Over the next 5 minutes, her condition became worse. Initial assessment indicated marked anxiety, shallow/rapid respiration, confusion with out loss of consciousness, rapid/weak pulse, weakness, confusion and apprehension. Pt was placed in the shock position with legs elevated. EMS contacted and assistance was requested from the medical staff. In house emergency equipment was brought to the scene. Initial vitals, BP: 130/75, pulse rapid and shallow at the radial artery, carotid pulse in excess of 100. Resp: 64. Approx 2:27 staff RN and others arrived on scene with an EPIPEN, adult 0.3 mg and oxygen. Oxygen applied with mask at 4L per min, Pt increased in apprehension, pulse remained rapid, BP: 109/55, respirations rapid and shallow. Assumed anaphylaxis. EPIPEN administered anterior lateral thigh. 0.3 ml of 1:1000. Pt improved within 4 minutes. Approx 2:35 pm. EMS arrived. Patient respiration slowing, confusion and apprehension decreasing. BP: 185/95, resp:25, pulse not taken. Pass of to EMS. Pt was transported via ambulance to hospital ER. Held for observation and released after 7PM, 01/19/10. Pts practitioner, was consulted and told of pt's sisters report. That had several episodes of dizziness and ashen skin pallor while shopping. Pt's practitioner recommended that the patient make an appointment to be seen as soon as possible after release.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Hypoventilation, No reaction on previous exposure to drug, Pallor, Presyncope
Clinical narrative: Approx 2:10 pm, 01/19/10 Pt was administered a ZOSTAVAX vaccination. Pt passed the screening process and stated that she had not exhibited a reaction to any previous vaccinations. After vaccination she was advised that she needed to stay in the pharmacy for 15 minutes following the vaccination for observation. Approx 2:20 pm pt complained of dizziness. She was advised to sit in a chair. Over the next 5 minutes, her condition became worse. Initial assessment indicated marked anxiety, shallow/rapid respiration, confusion with out loss of consciousness, rapid/weak pulse, weakness, confusion and apprehension. Pt was placed in the shock position with legs elevated. EMS contacted and assistance was requested from the medical staff. In house emergency equipment was brought to the scene. Initial vitals, BP: 130/75, pulse rapid and shallow at the radial artery, carotid pulse in excess of 100. Resp: 64. Approx 2:27 staff RN and others arrived on scene with an EPIPEN, adult 0.3 mg and oxygen. Oxygen applied with mask at 4L per min, Pt increased in apprehension, pulse remained rapid, BP: 109/55, respirations rapid and shallow. Assumed anaphylaxis. EPIPEN administered anterior lateral thigh. 0.3 ml of 1:1000. Pt improved within 4 minutes. Approx 2:35 pm. EMS arrived. Patient respiration slowing, confusion and apprehension decreasing. BP: 185/95, resp:25, pulse not taken. Pass of to EMS. Pt was transported via ambulance to hospital ER. Held for observation and released after 7PM, 01/19/10. Pts practitioner, was consulted and told of pt's sisters report. That had several episodes of dizziness and ashen skin pallor while shopping. Pt's practitioner recommended that the patient make an appointment to be seen as soon as possible after release.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pulse pressure decreased, Respiratory rate increased
Clinical narrative: Approx 2:10 pm, 01/19/10 Pt was administered a ZOSTAVAX vaccination. Pt passed the screening process and stated that she had not exhibited a reaction to any previous vaccinations. After vaccination she was advised that she needed to stay in the pharmacy for 15 minutes following the vaccination for observation. Approx 2:20 pm pt complained of dizziness. She was advised to sit in a chair. Over the next 5 minutes, her condition became worse. Initial assessment indicated marked anxiety, shallow/rapid respiration, confusion with out loss of consciousness, rapid/weak pulse, weakness, confusion and apprehension. Pt was placed in the shock position with legs elevated. EMS contacted and assistance was requested from the medical staff. In house emergency equipment was brought to the scene. Initial vitals, BP: 130/75, pulse rapid and shallow at the radial artery, carotid pulse in excess of 100. Resp: 64. Approx 2:27 staff RN and others arrived on scene with an EPIPEN, adult 0.3 mg and oxygen. Oxygen applied with mask at 4L per min, Pt increased in apprehension, pulse remained rapid, BP: 109/55, respirations rapid and shallow. Assumed anaphylaxis. EPIPEN administered anterior lateral thigh. 0.3 ml of 1:1000. Pt improved within 4 minutes. Approx 2:35 pm. EMS arrived. Patient respiration slowing, confusion and apprehension decreasing. BP: 185/95, resp:25, pulse not taken. Pass of to EMS. Pt was transported via ambulance to hospital ER. Held for observation and released after 7PM, 01/19/10. Pts practitioner, was consulted and told of pt's sisters report. That had several episodes of dizziness and ashen skin pallor while shopping. Pt's practitioner recommended that the patient make an appointment to be seen as soon as possible after release.
Age: 31.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Dizziness, Feeling hot, Influenza like illness, Nausea
Clinical narrative: 3-4 hours after injection donor had nausea, dizziness felt feverish w/chills. Also had a rash on his left lower arm for 1 day. s/s were resolved in 2 days. Donor rested and treated at home - he became sick w/flulike symptoms a couple day after these s/s were resolved.
Age: 31.0
Sex: M
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: 3-4 hours after injection donor had nausea, dizziness felt feverish w/chills. Also had a rash on his left lower arm for 1 day. s/s were resolved in 2 days. Donor rested and treated at home - he became sick w/flulike symptoms a couple day after these s/s were resolved.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: The shot was jammed into deltoideus. Pain came on shortly and continuous to date. Couple of weeks after shot my latissimus dorsi became so painful I was unable to get up or down for 33 days Latissimus Dorsi is still aches at times.
Age: 29.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness
Clinical narrative: Donor became dizzy within a minute of getting the shot. Dizziness lasted about 5 minutes. Donor was in MSA office for about 15 minutes before he left center. No other s/s reported.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aptyalism, Computerised tomogram abnormal, Diarrhoea haemorrhagic, Dry eye, Ear discomfort
Clinical narrative: This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of bloody diarrhea in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease, high blood pressure and irritable bowel syndrome. Concurrent medications included PRILOSEC and lisinopril. On 1 December 2008 at 11:20 the subject received unspecified dose of FLULAVAL at 0.5 ml in the right arm. On 2 December 2008, at 18:00, the subject experienced bloody diarrhea. Also on 02 December 2008, the subject's injection site was very swollen and red due to the medical assistant not properly administering the vaccine into the deltoid muscle. This was considered to be an incorrect route of drug administration. On 03 December 2008, the subject experienced very loud ringing in both ears which she never experienced before. This persisted constantly and was still continuing at the time of reporting. Following the next several days, the subject experienced excruciating pain (even hurt her ears to talk) and pressure in the left ear with sensitivity to noise and sound. She reported that "even her own voice sounded strange." It was reported that her left ear was slightly worse than her right. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). She visited an otolaryngologist who placed a slit in her tympanic membrane which did not help. She was placed on low dose course of prednisone with no change. Then she was placed on a 14 day high dose of steroid course and 10 day course of AUGMENTIN with no relief. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. In January 2009 and MRI was normal. A CT scan showed bilateral semicircular canal dehiscence which she had a plugging surgery  on 31 July 2009. This resulted in no symptom improvement except she no longer felt eye movement. It hurt to talk or to listen and hear. In December 2009, she stopped producing saliva and tears due to damage to her salivary glands. This resulted in dry gritty eyes and she was only able to produce 5 ml of tears in five minutes. She also experienced gum recession and sores in her mouth due to this affect on salivary glands. Attribution of these later events to treatment with FLULAVAL was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ear disorder, Ear operation, Ear pain, Eye movement disorder, Foreign body sensation in eyes
Clinical narrative: This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of bloody diarrhea in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease, high blood pressure and irritable bowel syndrome. Concurrent medications included PRILOSEC and lisinopril. On 1 December 2008 at 11:20 the subject received unspecified dose of FLULAVAL at 0.5 ml in the right arm. On 2 December 2008, at 18:00, the subject experienced bloody diarrhea. Also on 02 December 2008, the subject's injection site was very swollen and red due to the medical assistant not properly administering the vaccine into the deltoid muscle. This was considered to be an incorrect route of drug administration. On 03 December 2008, the subject experienced very loud ringing in both ears which she never experienced before. This persisted constantly and was still continuing at the time of reporting. Following the next several days, the subject experienced excruciating pain (even hurt her ears to talk) and pressure in the left ear with sensitivity to noise and sound. She reported that "even her own voice sounded strange." It was reported that her left ear was slightly worse than her right. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). She visited an otolaryngologist who placed a slit in her tympanic membrane which did not help. She was placed on low dose course of prednisone with no change. Then she was placed on a 14 day high dose of steroid course and 10 day course of AUGMENTIN with no relief. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. In January 2009 and MRI was normal. A CT scan showed bilateral semicircular canal dehiscence which she had a plugging surgery  on 31 July 2009. This resulted in no symptom improvement except she no longer felt eye movement. It hurt to talk or to listen and hear. In December 2009, she stopped producing saliva and tears due to damage to her salivary glands. This resulted in dry gritty eyes and she was only able to produce 5 ml of tears in five minutes. She also experienced gum recession and sores in her mouth due to this affect on salivary glands. Attribution of these later events to treatment with FLULAVAL was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gingival recession, Hyperacusis, Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of bloody diarrhea in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease, high blood pressure and irritable bowel syndrome. Concurrent medications included PRILOSEC and lisinopril. On 1 December 2008 at 11:20 the subject received unspecified dose of FLULAVAL at 0.5 ml in the right arm. On 2 December 2008, at 18:00, the subject experienced bloody diarrhea. Also on 02 December 2008, the subject's injection site was very swollen and red due to the medical assistant not properly administering the vaccine into the deltoid muscle. This was considered to be an incorrect route of drug administration. On 03 December 2008, the subject experienced very loud ringing in both ears which she never experienced before. This persisted constantly and was still continuing at the time of reporting. Following the next several days, the subject experienced excruciating pain (even hurt her ears to talk) and pressure in the left ear with sensitivity to noise and sound. She reported that "even her own voice sounded strange." It was reported that her left ear was slightly worse than her right. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). She visited an otolaryngologist who placed a slit in her tympanic membrane which did not help. She was placed on low dose course of prednisone with no change. Then she was placed on a 14 day high dose of steroid course and 10 day course of AUGMENTIN with no relief. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. In January 2009 and MRI was normal. A CT scan showed bilateral semicircular canal dehiscence which she had a plugging surgery  on 31 July 2009. This resulted in no symptom improvement except she no longer felt eye movement. It hurt to talk or to listen and hear. In December 2009, she stopped producing saliva and tears due to damage to her salivary glands. This resulted in dry gritty eyes and she was only able to produce 5 ml of tears in five minutes. She also experienced gum recession and sores in her mouth due to this affect on salivary glands. Attribution of these later events to treatment with FLULAVAL was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Labyrinthine fistula, Lacrimation decreased, Nuclear magnetic resonance imaging normal, Salivary gland disorder, Stomatitis
Clinical narrative: This case was reported by a healthcare professional (a nurse, also the subject) and described the occurrence of bloody diarrhea in a 51-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease, high blood pressure and irritable bowel syndrome. Concurrent medications included PRILOSEC and lisinopril. On 1 December 2008 at 11:20 the subject received unspecified dose of FLULAVAL at 0.5 ml in the right arm. On 2 December 2008, at 18:00, the subject experienced bloody diarrhea. Also on 02 December 2008, the subject's injection site was very swollen and red due to the medical assistant not properly administering the vaccine into the deltoid muscle. This was considered to be an incorrect route of drug administration. On 03 December 2008, the subject experienced very loud ringing in both ears which she never experienced before. This persisted constantly and was still continuing at the time of reporting. Following the next several days, the subject experienced excruciating pain (even hurt her ears to talk) and pressure in the left ear with sensitivity to noise and sound. She reported that "even her own voice sounded strange." It was reported that her left ear was slightly worse than her right. The subject was hospitalised and the healthcare professional considered the events were disabling, life threatening and clinically significant (or requiring intervention). She visited an otolaryngologist who placed a slit in her tympanic membrane which did not help. She was placed on low dose course of prednisone with no change. Then she was placed on a 14 day high dose of steroid course and 10 day course of AUGMENTIN with no relief. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. In January 2009 and MRI was normal. A CT scan showed bilateral semicircular canal dehiscence which she had a plugging surgery  on 31 July 2009. This resulted in no symptom improvement except she no longer felt eye movement. It hurt to talk or to listen and hear. In December 2009, she stopped producing saliva and tears due to damage to her salivary glands. This resulted in dry gritty eyes and she was only able to produce 5 ml of tears in five minutes. She also experienced gum recession and sores in her mouth due to this affect on salivary glands. Attribution of these later events to treatment with FLULAVAL was not reported.