chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Myalgia, Ocular hyperaemia, Pyrexia, Respiratory tract congestion
Clinical narrative: Muscles aches, uncontrollable chills, weak, feverish; within 3-6 hours after injection then headache, congestion, ear aches; red eyes, dizzy within 4 days after injection. Still weak and headaches, etc. after 13 days. Follow-up information received Jan 19, 2010. Patient states was not able to obtain the manufacturer of this H1N1 vaccine. St Mary's Immunization Clinic told patient reactions were "normal" for a new vaccine she had never had.
Age: 38.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Began having shotness of breath, tightness in chest. Went to emergency room as worried her throat may be closing. Was given prednisone and released. Three days later still having symptoms and seen at her clinic where she was given inhaler, cough med and antibiotic.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest pain, Confusional state, Dyspnoea, Feeling abnormal, Nausea
Clinical narrative: Difficulty breathing, loopy, confused, fainted, chest pain going into my arm and jaw, nausea.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in jaw, Syncope
Clinical narrative: Difficulty breathing, loopy, confused, fainted, chest pain going into my arm and jaw, nausea.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Blood product transfusion, Chest pain, Dyspnoea, Hypoaesthesia facial, Nausea
Clinical narrative: Had flu shot at mass event. 4 hrs later had chest pain, nausea and SOB. Numbness to right side of her face. To ER. Admitted to hospital for assessment for 10 days.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Clinical narrative: Unknown
Age: 93.0
Sex: M
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Pt's nurse suspects brown spot all over right arm maybe the result of flu vaccination given to him back in Sept.
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Arthralgia, Impaired work ability, Inflammation, Joint range of motion decreased
Clinical narrative: Vaccine administer 11/23/09 around 7:30 pm at the Clinic.  When the lady placed the shot in my arm it was placed too high and she was unable to get the plunger to go in so she moved the needle around a little (while in my arm) and then pushed very hard on the plunger and the vaccine went in.  I thought to myself, that didn't seem right but didn't say anything at the time.  However, the nurse did make a comment that it was weird that the plunger wouldn't go in.  The next morning (11/24/09) I noticed pain in my shoulder joint and told my husband about it, explaining that it was not normal muscle soreness felt after a shot but rather pain in my joint.  I let it go a little more than a week and finally made an appt with PA at the Doctor's Office (12/03/09).  The pain had gotten pretty bad and I had limited range of motion in that arm. I explained what happened and she agreed that there was inflammation in the shoulder and that it sounded like the shot was administered in a tendon or the bursa sac of the shoulder.  Provider suggested ice, rest, and Ibuprofen.  I explained that my husband and I were trying to get pregnant and there was a chance that I might be pregnant, so we discussed Tylenol for pain instead of Ibuprofen since it's contraindicated in pregnancy.  The pain continued to worsen and that night I had difficulty carrying out tasks at my clinical site.  The next day I had trouble getting myself dressed and undressed and still had very limited range of motion that seemed to be getting worse.  I called The Doctor's Office that day (12/04/09) and attempted to make an appt for Saturday morning but they were closed for the weekend so I made an appt for Monday afternoon.  I called off work for the weekend (12/5/09 and 12/06/09) to allow my shoulder to rest.  By Monday my shoulder was a little better, so I cancelled my appt, hoping the pain would continue to get better.  Unfortunately, the pain has continued through the month of December and now into January.  I made another appt with the provider and saw her again today, 01/04/2010.  Provider xrayed my shoulder and ruled out a break but suggested I see an orthopedic specialist.  I have made an appt for 01/13/2010. The pain I am now experiencing is not unbearable but it is bothersome and is a nuisance. I have pain when completing everyday tasks like talking on the phone, driving, getting dressed/undressed, taking my coat off and putting it on, pulling the covers up while in bed, etc... I am also unable to sleep on my left side because if I am on that side for too long the pain becomes too great from the pressure on that shoulder. In addition, if I use that arm too much throughout the day I end up going to bed with a burning pain all over my shoulder area.  These are just some examples of the pain I am feeling from this injury and I'm scared becuase it doesn't seem to be getting all that much better with time.
Age: 30.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Myalgia, Pain, X-ray
Clinical narrative: Vaccine administer 11/23/09 around 7:30 pm at the Clinic.  When the lady placed the shot in my arm it was placed too high and she was unable to get the plunger to go in so she moved the needle around a little (while in my arm) and then pushed very hard on the plunger and the vaccine went in.  I thought to myself, that didn't seem right but didn't say anything at the time.  However, the nurse did make a comment that it was weird that the plunger wouldn't go in.  The next morning (11/24/09) I noticed pain in my shoulder joint and told my husband about it, explaining that it was not normal muscle soreness felt after a shot but rather pain in my joint.  I let it go a little more than a week and finally made an appt with PA at the Doctor's Office (12/03/09).  The pain had gotten pretty bad and I had limited range of motion in that arm. I explained what happened and she agreed that there was inflammation in the shoulder and that it sounded like the shot was administered in a tendon or the bursa sac of the shoulder.  Provider suggested ice, rest, and Ibuprofen.  I explained that my husband and I were trying to get pregnant and there was a chance that I might be pregnant, so we discussed Tylenol for pain instead of Ibuprofen since it's contraindicated in pregnancy.  The pain continued to worsen and that night I had difficulty carrying out tasks at my clinical site.  The next day I had trouble getting myself dressed and undressed and still had very limited range of motion that seemed to be getting worse.  I called The Doctor's Office that day (12/04/09) and attempted to make an appt for Saturday morning but they were closed for the weekend so I made an appt for Monday afternoon.  I called off work for the weekend (12/5/09 and 12/06/09) to allow my shoulder to rest.  By Monday my shoulder was a little better, so I cancelled my appt, hoping the pain would continue to get better.  Unfortunately, the pain has continued through the month of December and now into January.  I made another appt with the provider and saw her again today, 01/04/2010.  Provider xrayed my shoulder and ruled out a break but suggested I see an orthopedic specialist.  I have made an appt for 01/13/2010. The pain I am now experiencing is not unbearable but it is bothersome and is a nuisance. I have pain when completing everyday tasks like talking on the phone, driving, getting dressed/undressed, taking my coat off and putting it on, pulling the covers up while in bed, etc... I am also unable to sleep on my left side because if I am on that side for too long the pain becomes too great from the pressure on that shoulder. In addition, if I use that arm too much throughout the day I end up going to bed with a burning pain all over my shoulder area.  These are just some examples of the pain I am feeling from this injury and I'm scared becuase it doesn't seem to be getting all that much better with time.
Age: 64.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Cough, Fatigue, Rash
Clinical narrative: Rash on head and face. Continued to worsen for the next 5-6 days. Associated with fatigue and cough. Fatigue persisted for 10-12 days. Cough ongoing.
Age: 14.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Tinnitus
Clinical narrative: Student complained of ringing in the right ear.  Ringing lasted for about 10 minutes.  Monitored student for a hour for futher symptoms.
Age: 0.77
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: Hives appeared by 7PM that evening, by 12/20/2009 wheezing and coughing controlled by albuterol, 12/24/2009 still on steroids, antihistamines, not responding to albuterol breathing treatments, taken to ER for shot of epinephren.  As of 1/4/2010 still has hives and continues to be on antihistamines.
Age: 26.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Chills, Pyrexia, Stomatitis
Clinical narrative: 6 hours after vaccination, patient developed fever and chills, sores inside mouth
Age: 18.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: "Pt states 4 days of all over headache and about an hour also c/o a neck pain"; stiff neck
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Miscarriage.
Age: 0.51
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Apnoea, Blood electrolytes normal, CSF test normal, Convulsion, Cyanosis
Clinical narrative: Onset of seizure disorder (multiple grand mal and tonic-clonic seizures with associated apnea and cyanosis 10 days after 1st flu and H1N1 shots 1 week after 2nd flu shots had further seizure.
Age: 0.51
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Electroencephalogram abnormal, Grand mal convulsion, Laboratory test, Scan brain
Clinical narrative: Onset of seizure disorder (multiple grand mal and tonic-clonic seizures with associated apnea and cyanosis 10 days after 1st flu and H1N1 shots 1 week after 2nd flu shots had further seizure.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, itchy injection site. Not raised.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyskinesia, Neck pain, Syncope, Tic
Clinical narrative: Vaccine 12/9/09 - within 2 days complained of neck pain and by 12/20 started to have involuntary head movements which became more severe by 12/25/09. Seen in the emergency room and then pediatricians 12/26 who diagnosed her with a tic. Follow-up: Added note: After the tic, she has now developed possible seizures. Neurological work-up in progress as well as cardiology work-up. Syncopal episode 2/3/10 and again 2/5/10.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Pt. received PNEUMOVAX on 12-28. On 12-29 had temp of 100, sore arm and achy all over. 12-30 saw provider. Large area redness at inj. site and temp of 103 on 12-29.
Age: 3.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Amblyopia, Eye disorder, Nuclear magnetic resonance imaging normal, VIth nerve paralysis
Clinical narrative: Date above approximate as no exact date given.  Received H1N1 Flu mist at County clinic.  2 days later developed sudden left eye crossing with subsequent 6th CN Palsy dx.  Seen by ED and then  Opthalmology.  MRI done and normal.  Previous hx of Left 6th nerve palsy at 9 months of age which resolved spontaneously. Mild amblyopia of Left eye also dx'd by Ophthalomologist.  Patching of eye treatment being done.  Peds Neurologist saw and felt dx was isolated and neuropathic.  Doubted any intracranial pressure.  Felt it would resolve over the next several weeks.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Oropharyngeal pain, Somnolence, Throat irritation, Vomiting
Clinical narrative: 24 hrs later, sore throat. It has gone away. Went to nurse today - red throat, vomiting, diarrhea. Has been sleeping since home from school.
Age: 40.0
Sex: F
Vaccine: FLUN3, FLUN(H1N1)
Symptoms: Laboratory test, Myalgia, Paraesthesia
Clinical narrative: 2 days after receiving vaccine, had muscle pain left arm and leg. No tingling sensation. 1st 2-3 days mild sensation. Last 5 days, feet "really hurt". No muscle weakness, just tingling sensations and some pain. Bothers her more at night.
Age: 40.0
Sex: F
Vaccine: FLUN3, FLUN(H1N1)
Symptoms: Blood test normal, Fatigue, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: 2 days after receiving vaccine, had muscle pain left arm and leg. No tingling sensation. 1st 2-3 days mild sensation. Last 5 days, feet "really hurt". No muscle weakness, just tingling sensations and some pain. Bothers her more at night.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Cough, Rhinorrhoea, Vomiting
Clinical narrative: 2 y/o female received #2 of H1N1 - later that evening vomited x 1, T=100.2. Next day @ 6am vomited x 1 T=100.2. Went to ER on 1/3/10. Pt was still active, has rhinorrhea and cough
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Erythema, Mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: C/O pain R arm, swelling, ROM decreased, redness, warmth. Iced and reaction did resolve a few days later. She did not have this evaluated nor did she call office. Her daughter works in office and reported the reaction.
Age: 48.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: C/O pain R arm, swelling, ROM decreased, redness, warmth. Iced and reaction did resolve a few days later. She did not have this evaluated nor did she call office. Her daughter works in office and reported the reaction.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Bacterial culture, Blister, Erythema, Herpes simplex serology positive, Paraesthesia
Clinical narrative: 25 y/o USAF AD female developed facial skin lesions onset approximately 9 days following receipt primary SPV & AVA#2 given on 12/8/2009. Pt first noticed redness over her nose & cheeks, followed by tingling grouped papular eruptions around upper & lower lip borders; by next day, a few more isolated eruptions appeared on forehead, right cheek & left outer ear. No oral lesions or painful swallowing; by day 10, papules increased around lips. Lesions remained tingly, otherwise non............. covering SPV site until after day 5 or so when she noted a vesicle at site; pt denied scratching/rubbing site & has kept it covered since. She was well day of vaccination but reported a fever blister left lower lip that lasted 3 days & just resolved the day before vaccination. She had childhood history VZ; no prior vaccine-related reactions. Immunization record indicated positive titers to MMR, VZV, & HBV. Initial medical evaluation by PCM was on 12/17/2009 at which time pt was afebrile & other than skin lesions, was well-appearing. She was evaluated by derm on 12/18/2009, at which time lesions were as follows: multiple grouped papules distributed around upper & lower lips borders, some on erythematous bases, some mildly coalesced; 2-2 papules above upper lip, 1 on left outer ear; 1 one vesicle on right cheek; 2 papules on forehead; shiny macular plaque across nose & both cheeks; SPV site appeared c/w robust take reaction with reported mild tenderness left axillary area. No other cutaneous findings. Preliminary diagnosis was possible autoinoculation; Valtrex was prescribed. Symptoms: Lesions, papule, Lesions, macule, Lesions, Vesicle.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pyrexia, Rash macular, Rash papular, Skin lesion, Tenderness
Clinical narrative: 25 y/o USAF AD female developed facial skin lesions onset approximately 9 days following receipt primary SPV & AVA#2 given on 12/8/2009. Pt first noticed redness over her nose & cheeks, followed by tingling grouped papular eruptions around upper & lower lip borders; by next day, a few more isolated eruptions appeared on forehead, right cheek & left outer ear. No oral lesions or painful swallowing; by day 10, papules increased around lips. Lesions remained tingly, otherwise non............. covering SPV site until after day 5 or so when she noted a vesicle at site; pt denied scratching/rubbing site & has kept it covered since. She was well day of vaccination but reported a fever blister left lower lip that lasted 3 days & just resolved the day before vaccination. She had childhood history VZ; no prior vaccine-related reactions. Immunization record indicated positive titers to MMR, VZV, & HBV. Initial medical evaluation by PCM was on 12/17/2009 at which time pt was afebrile & other than skin lesions, was well-appearing. She was evaluated by derm on 12/18/2009, at which time lesions were as follows: multiple grouped papules distributed around upper & lower lips borders, some on erythematous bases, some mildly coalesced; 2-2 papules above upper lip, 1 on left outer ear; 1 one vesicle on right cheek; 2 papules on forehead; shiny macular plaque across nose & both cheeks; SPV site appeared c/w robust take reaction with reported mild tenderness left axillary area. No other cutaneous findings. Preliminary diagnosis was possible autoinoculation; Valtrex was prescribed. Symptoms: Lesions, papule, Lesions, macule, Lesions, Vesicle.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Bacterial test negative, Cardiac pacemaker insertion, Erythema, Herpes simplex serology positive, Injection site pain
Clinical narrative: 25 y/o USAF AD female developed facial skin lesions onset approximately 9 days following receipt primary SPV & AVA#2 given on 12/8/2009. Pt first noticed redness over her nose & cheeks, followed by tingling grouped papular eruptions around upper & lower lip borders; by next day, a few more isolated eruptions appeared on forehead, right cheek & left outer ear. No oral lesions or painful swallowing; by day 10, papules increased around lips. Lesions remained tingly, otherwise non............. covering SPV site until after day 5 or so when she noted a vesicle at site; pt denied scratching/rubbing site & has kept it covered since. She was well day of vaccination but reported a fever blister left lower lip that lasted 3 days & just resolved the day before vaccination. She had childhood history VZ; no prior vaccine-related reactions. Immunization record indicated positive titers to MMR, VZV, & HBV. Initial medical evaluation by PCM was on 12/17/2009 at which time pt was afebrile & other than skin lesions, was well-appearing. She was evaluated by derm on 12/18/2009, at which time lesions were as follows: multiple grouped papules distributed around upper & lower lips borders, some on erythematous bases, some mildly coalesced; 2-2 papules above upper lip, 1 on left outer ear; 1 one vesicle on right cheek; 2 papules on forehead; shiny macular plaque across nose & both cheeks; SPV site appeared c/w robust take reaction with reported mild tenderness left axillary area. No other cutaneous findings. Preliminary diagnosis was possible autoinoculation; Valtrex was prescribed. Symptoms: Lesions, papule, Lesions, macule, Lesions, Vesicle.
Age: 26.0
Sex: F
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Injection site vesicles, Paraesthesia, Polymerase chain reaction, Rash papular, Robust take following exposure to vaccinia virus
Clinical narrative: 25 y/o USAF AD female developed facial skin lesions onset approximately 9 days following receipt primary SPV & AVA#2 given on 12/8/2009. Pt first noticed redness over her nose & cheeks, followed by tingling grouped papular eruptions around upper & lower lip borders; by next day, a few more isolated eruptions appeared on forehead, right cheek & left outer ear. No oral lesions or painful swallowing; by day 10, papules increased around lips. Lesions remained tingly, otherwise non............. covering SPV site until after day 5 or so when she noted a vesicle at site; pt denied scratching/rubbing site & has kept it covered since. She was well day of vaccination but reported a fever blister left lower lip that lasted 3 days & just resolved the day before vaccination. She had childhood history VZ; no prior vaccine-related reactions. Immunization record indicated positive titers to MMR, VZV, & HBV. Initial medical evaluation by PCM was on 12/17/2009 at which time pt was afebrile & other than skin lesions, was well-appearing. She was evaluated by derm on 12/18/2009, at which time lesions were as follows: multiple grouped papules distributed around upper & lower lips borders, some on erythematous bases, some mildly coalesced; 2-2 papules above upper lip, 1 on left outer ear; 1 one vesicle on right cheek; 2 papules on forehead; shiny macular plaque across nose & both cheeks; SPV site appeared c/w robust take reaction with reported mild tenderness left axillary area. No other cutaneous findings. Preliminary diagnosis was possible autoinoculation; Valtrex was prescribed. Symptoms: Lesions, papule, Lesions, macule, Lesions, Vesicle.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: C/O pain to L upper arm, redness, swelling, tenderness, warmth, and difficulty moving extremity due to pain and tenderness. Day of vaccination arm was sore and then the next day arm revealed above signs and symptoms. Instructed to use ice and TYLENOL and to go to ER if increased redness, pain and or streaking. Area marked by PA who saw patient.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: C/O pain to L upper arm, redness, swelling, tenderness, warmth, and difficulty moving extremity due to pain and tenderness. Day of vaccination arm was sore and then the next day arm revealed above signs and symptoms. Instructed to use ice and TYLENOL and to go to ER if increased redness, pain and or streaking. Area marked by PA who saw patient.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pruritus
Clinical narrative: Severe itching on left shoulder. Patient did not go to doctor. The patient took BENDADRYL, CORDIZONE spray and 30 min later patient applied BENADRYL gel over the next 3 to 4 hrs.
Age: 66.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Contusion, Erythema
Clinical narrative: Large contusion approx 3 inch diameter. Purple and deep red in appearance. Patient states no pain, no soreness. Recommended ice be applied to area.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling from shoulder to elbow right arm.
Age: 66.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood creatine phosphokinase, Dysstasia, Muscular weakness, Myalgia
Clinical narrative: Muscle weakness to legs, muscle aches to thigh, buttock. Pt only mildly weak to leg on exam. Cannot get out of chair. Gait nl. Follow up information received - DOB, manufacturer, and  lot number.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Ear pain, Hypoaesthesia oral, Pain in extremity
Clinical narrative: 10:30am Pt stated had pain to R arm radiating to ear. Feels tongue numb R side; dizzy 10:45 - Numbness going away 1:50pm - No numbness to tongue, not dizzy, very little pain to arm.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash, Rash pruritic, Rash vesicular, Skin lesion
Clinical narrative: Pt seen at Health Center with c/o facial rash. Pt noted to have vesicular like lesions around both nostrils and above top lip with 1 sm lesion to L cheek. Mother says pt received varicella vaccine on 12/9/09. Rash started 12/20/09. Itchy and painful. ATARAX ordered for itching.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis developed at injection site of either PNEUMOVAX or Td. Pt received both injections in same arm on same day due to previous axillary LN removal on unilateral side. Treated with antibiotics-KEFLEX and ROCEPHIN.
Age: 75.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea
Clinical narrative: Diarrhea 4 hours after receiving vaccination.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Convulsion, Electroencephalogram abnormal, Intensive care, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: H1N1 vaccination given 12/11/09. He had 20 minute seizure on 12/12/09, admitted to PICU. He has history of Cerebral Palsy but no known history of seizure disorder. No fever and extensive infectious workup including lumbar puncture negative.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Scan brain
Clinical narrative: H1N1 vaccination given 12/11/09. He had 20 minute seizure on 12/12/09, admitted to PICU. He has history of Cerebral Palsy but no known history of seizure disorder. No fever and extensive infectious workup including lumbar puncture negative.
Age: 1.27
Sex: F
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Blood culture negative, CSF test normal, Inappropriate schedule of drug administration, Intracranial pressure increased, Pyrexia
Clinical narrative: Febrile from 12/18-12/21 and then from 12/28-12/30. Emesis from day after vaccine (12/19) until 1/1 daily. First evaluated in our ER 12/29 and found to be encephalopathic with increased intracranial pressure. 1/6/10 Received hospital medical records for 12/30. FINAL DX: viral syndrome; meniningitic/encephalitis; Redman's syndrome. Records reveal patient experienced weakness & fever with seizure.  Initial fever started on 12/18, lasted 3-4 days.  Irritable.  Vomited daily x 2 wks.  After 1 wk emesis, seen in ER on 12/25, 26 & 27.  Dx w/otitis media & tx w/antibiotics (both oral & injectable).  Became progressively weaker until unable to stand w/o support.  Fever returned 12/29 & continued daily emesis & holding of head.  No BM x 5 days.  Weight loss, decreased urine output.  Exam revealed extensive weakness, unsteady gait, increased muscle tone & decreased reflexes.  LP done w/opening pressure >36(H).  Admitted.  Tx w/IVF, IV antibiotics, antivirals.  Neuro, ID, Ophtho, genetics consults done.  Developed mild drooping right eyelid & photophobia; macular erythematous pruritic rash.    1/20/10 Received hospital medical records 12/29/2009-1/8/2010. FINAL DX: pseudotumor cerebri, seizure disorder & anemia. Repeat LP done & continued to be elevated at 30, CSF WNL.  Tx w/diamox.  Gradually improved & d/c to home w/Neuro f/u.
Age: 1.27
Sex: F
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Vomiting
Clinical narrative: Febrile from 12/18-12/21 and then from 12/28-12/30. Emesis from day after vaccine (12/19) until 1/1 daily. First evaluated in our ER 12/29 and found to be encephalopathic with increased intracranial pressure. 1/6/10 Received hospital medical records for 12/30. FINAL DX: viral syndrome; meniningitic/encephalitis; Redman's syndrome. Records reveal patient experienced weakness & fever with seizure.  Initial fever started on 12/18, lasted 3-4 days.  Irritable.  Vomited daily x 2 wks.  After 1 wk emesis, seen in ER on 12/25, 26 & 27.  Dx w/otitis media & tx w/antibiotics (both oral & injectable).  Became progressively weaker until unable to stand w/o support.  Fever returned 12/29 & continued daily emesis & holding of head.  No BM x 5 days.  Weight loss, decreased urine output.  Exam revealed extensive weakness, unsteady gait, increased muscle tone & decreased reflexes.  LP done w/opening pressure >36(H).  Admitted.  Tx w/IVF, IV antibiotics, antivirals.  Neuro, ID, Ophtho, genetics consults done.  Developed mild drooping right eyelid & photophobia; macular erythematous pruritic rash.    1/20/10 Received hospital medical records 12/29/2009-1/8/2010. FINAL DX: pseudotumor cerebri, seizure disorder & anemia. Repeat LP done & continued to be elevated at 30, CSF WNL.  Tx w/diamox.  Gradually improved & d/c to home w/Neuro f/u.
Age: 32.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Sore arm, neck, and shoulder.  Tingling feelings in my arm and fingertips.
Age: 16.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, MNQ
Symptoms: Abasia, Acute disseminated encephalomyelitis, Asthenia, Dehydration, Dysstasia
Clinical narrative: 9/21/2009 Sent home from school bad headache, nausea, muscle aches, weakness. 9/29/2009  not allowed to give blood came home early from school nausea & vomiting weak feels numbness all over 9/30/2009 stayed home from school, weak nausea & vomiting feels weak, numbness in legs, difficulty walking 10/1/2009 home from school tingling from trunk into legs, weak, nausea vomiting, difficulty walking 10/2/2009 Back to school, tired weak, numbness 10/3/2009 Resumed vomiting again in the evening 10/5/2009 to pediatrician difficulty walking, nausea, weakness 10/6/2009 ER RX Zofran for nausea sent home 10/7/2009 ER IV hydration sent home 10/8/2009 weakness worsens 10/9/2009 to pediatrician vomiting dehydrated admitted to hospital from pediatrician's office unable to walk/stand. Dr. noted enlarged thyroid U/S thyroid and abdominal -- normal Ct Scan abdomen -- normal 10/10 Blurred vision in left eye 10/11/2009 MRI back -- transverse myelitis 10/12/2009 MRI brain--lesions in brain consistent with A.D.E.M. Spinal tap and start IV Steroids transfer to Hospital 10/13/2009 Diagnosed with Acute Disseminated Encephalomyelitis and Transverse Myelitis Infectious Disease ruled out a viral cause and states consistent with vaccination reaction. 11/05/2009 Consultation at Hospital Multiple Sclerosis Center and A.D.E.M. diagnosis confirmed by pediatric neurologist.    1/6/2010 ED records for 10/6 and 10/8/2009 patient with c/o's nausea/vomiting and diarrhea, IVF, IV Zofran 1/6 and 1/7/2010 MR for 10/9-10/12/2009 patient admitted nausea. vomiting and progressive weakness transferred to another facility for continued care on 10/12/2009 1/6/2010 MR and DC summary for 10/12-10/16/2009, patient with c/o's numbness, weakness, ataxia, nausea/vomiting, tingling and hand tremors, diplopia  LP, Neuro and Opthalmology, ID consults, IV Solu-Medrol x 5 days with resolution of sx. dc'd home on steroid taper and f/up with PCP DC DX: Weakness, improving. Ataxia, improving. Numbness improving. Demyelinating disease of CNS.
Age: 16.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, MNQ
Symptoms: Fatigue, Gait disturbance, Goitre, Headache, Hypoaesthesia
Clinical narrative: 9/21/2009 Sent home from school bad headache, nausea, muscle aches, weakness. 9/29/2009  not allowed to give blood came home early from school nausea & vomiting weak feels numbness all over 9/30/2009 stayed home from school, weak nausea & vomiting feels weak, numbness in legs, difficulty walking 10/1/2009 home from school tingling from trunk into legs, weak, nausea vomiting, difficulty walking 10/2/2009 Back to school, tired weak, numbness 10/3/2009 Resumed vomiting again in the evening 10/5/2009 to pediatrician difficulty walking, nausea, weakness 10/6/2009 ER RX Zofran for nausea sent home 10/7/2009 ER IV hydration sent home 10/8/2009 weakness worsens 10/9/2009 to pediatrician vomiting dehydrated admitted to hospital from pediatrician's office unable to walk/stand. Dr. noted enlarged thyroid U/S thyroid and abdominal -- normal Ct Scan abdomen -- normal 10/10 Blurred vision in left eye 10/11/2009 MRI back -- transverse myelitis 10/12/2009 MRI brain--lesions in brain consistent with A.D.E.M. Spinal tap and start IV Steroids transfer to Hospital 10/13/2009 Diagnosed with Acute Disseminated Encephalomyelitis and Transverse Myelitis Infectious Disease ruled out a viral cause and states consistent with vaccination reaction. 11/05/2009 Consultation at Hospital Multiple Sclerosis Center and A.D.E.M. diagnosis confirmed by pediatric neurologist.    1/6/2010 ED records for 10/6 and 10/8/2009 patient with c/o's nausea/vomiting and diarrhea, IVF, IV Zofran 1/6 and 1/7/2010 MR for 10/9-10/12/2009 patient admitted nausea. vomiting and progressive weakness transferred to another facility for continued care on 10/12/2009 1/6/2010 MR and DC summary for 10/12-10/16/2009, patient with c/o's numbness, weakness, ataxia, nausea/vomiting, tingling and hand tremors, diplopia  LP, Neuro and Opthalmology, ID consults, IV Solu-Medrol x 5 days with resolution of sx. dc'd home on steroid taper and f/up with PCP DC DX: Weakness, improving. Ataxia, improving. Numbness improving. Demyelinating disease of CNS.
Age: 16.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, MNQ
Symptoms: Lumbar puncture, Myalgia, Nausea, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: 9/21/2009 Sent home from school bad headache, nausea, muscle aches, weakness. 9/29/2009  not allowed to give blood came home early from school nausea & vomiting weak feels numbness all over 9/30/2009 stayed home from school, weak nausea & vomiting feels weak, numbness in legs, difficulty walking 10/1/2009 home from school tingling from trunk into legs, weak, nausea vomiting, difficulty walking 10/2/2009 Back to school, tired weak, numbness 10/3/2009 Resumed vomiting again in the evening 10/5/2009 to pediatrician difficulty walking, nausea, weakness 10/6/2009 ER RX Zofran for nausea sent home 10/7/2009 ER IV hydration sent home 10/8/2009 weakness worsens 10/9/2009 to pediatrician vomiting dehydrated admitted to hospital from pediatrician's office unable to walk/stand. Dr. noted enlarged thyroid U/S thyroid and abdominal -- normal Ct Scan abdomen -- normal 10/10 Blurred vision in left eye 10/11/2009 MRI back -- transverse myelitis 10/12/2009 MRI brain--lesions in brain consistent with A.D.E.M. Spinal tap and start IV Steroids transfer to Hospital 10/13/2009 Diagnosed with Acute Disseminated Encephalomyelitis and Transverse Myelitis Infectious Disease ruled out a viral cause and states consistent with vaccination reaction. 11/05/2009 Consultation at Hospital Multiple Sclerosis Center and A.D.E.M. diagnosis confirmed by pediatric neurologist.    1/6/2010 ED records for 10/6 and 10/8/2009 patient with c/o's nausea/vomiting and diarrhea, IVF, IV Zofran 1/6 and 1/7/2010 MR for 10/9-10/12/2009 patient admitted nausea. vomiting and progressive weakness transferred to another facility for continued care on 10/12/2009 1/6/2010 MR and DC summary for 10/12-10/16/2009, patient with c/o's numbness, weakness, ataxia, nausea/vomiting, tingling and hand tremors, diplopia  LP, Neuro and Opthalmology, ID consults, IV Solu-Medrol x 5 days with resolution of sx. dc'd home on steroid taper and f/up with PCP DC DX: Weakness, improving. Ataxia, improving. Numbness improving. Demyelinating disease of CNS.
Age: 16.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, MNQ
Symptoms: Paraesthesia, Ultrasound thyroid abnormal, Vaccination complication, Vision blurred, Vomiting
Clinical narrative: 9/21/2009 Sent home from school bad headache, nausea, muscle aches, weakness. 9/29/2009  not allowed to give blood came home early from school nausea & vomiting weak feels numbness all over 9/30/2009 stayed home from school, weak nausea & vomiting feels weak, numbness in legs, difficulty walking 10/1/2009 home from school tingling from trunk into legs, weak, nausea vomiting, difficulty walking 10/2/2009 Back to school, tired weak, numbness 10/3/2009 Resumed vomiting again in the evening 10/5/2009 to pediatrician difficulty walking, nausea, weakness 10/6/2009 ER RX Zofran for nausea sent home 10/7/2009 ER IV hydration sent home 10/8/2009 weakness worsens 10/9/2009 to pediatrician vomiting dehydrated admitted to hospital from pediatrician's office unable to walk/stand. Dr. noted enlarged thyroid U/S thyroid and abdominal -- normal Ct Scan abdomen -- normal 10/10 Blurred vision in left eye 10/11/2009 MRI back -- transverse myelitis 10/12/2009 MRI brain--lesions in brain consistent with A.D.E.M. Spinal tap and start IV Steroids transfer to Hospital 10/13/2009 Diagnosed with Acute Disseminated Encephalomyelitis and Transverse Myelitis Infectious Disease ruled out a viral cause and states consistent with vaccination reaction. 11/05/2009 Consultation at Hospital Multiple Sclerosis Center and A.D.E.M. diagnosis confirmed by pediatric neurologist.    1/6/2010 ED records for 10/6 and 10/8/2009 patient with c/o's nausea/vomiting and diarrhea, IVF, IV Zofran 1/6 and 1/7/2010 MR for 10/9-10/12/2009 patient admitted nausea. vomiting and progressive weakness transferred to another facility for continued care on 10/12/2009 1/6/2010 MR and DC summary for 10/12-10/16/2009, patient with c/o's numbness, weakness, ataxia, nausea/vomiting, tingling and hand tremors, diplopia  LP, Neuro and Opthalmology, ID consults, IV Solu-Medrol x 5 days with resolution of sx. dc'd home on steroid taper and f/up with PCP DC DX: Weakness, improving. Ataxia, improving. Numbness improving. Demyelinating disease of CNS.
Age: 46.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dyspnoea
Clinical narrative: Trouble breathing, tightening of chest, usual asthma attack symptoms. Had 2 attacks within 4 days of symptoms starting. Took three weeks to get over. Worst asthma I've had in many years. Took Advair; Combivent every 4 hrs for three weeks, then went back to Proair every 4 hours for another week.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 01/01/10 MOTHER REPORTED BY PHONE 2"x3" AREA OF HARD SWELLING, WARMTH & REDNESS AT INJECTION SITE ON LEFT THIGH. PARENT WAS ADVISED BY DR. TO GIVE 1TSP CHILDREN'S BENABRYL P.O. PRN. 01/04/10 PER MOM BY PHONE, AREA HAD INCREASED IN SIZE TO 4"x4" BUT SEEMED TO BE IMPROVING. MOM WILL CONTINUE BENADRYL PRN, BUT COME IN WITH PATIENT THIS WEEK FOR EVAL IF NOT IMPROVING.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Back pain, Chest discomfort, Cough, Dyspnoea, Feeling cold
Clinical narrative: H1N1 vaccination at school. Initially complained of SOB, cold flashes, chest tightness;10 minutes later c/o staying cold, nausea with 2 bouts of vomiting; pain between scapula in back; occasional cough. At 9:50 a.m. BP 150/82, P 72, R 45; Epinephrine .3cc SQ L arm administered at 9:54 A.M. Reported slight improvement in breathing effort at 10:10 AM. Transported by EMS to Hospital at 10:16 a.m. Follow up with parent on today states that at the hospital they told her the child had allergic reaction to vaccination.  States they sent him home and he is fine now.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea, Vaccination complication, Vomiting
Clinical narrative: H1N1 vaccination at school. Initially complained of SOB, cold flashes, chest tightness;10 minutes later c/o staying cold, nausea with 2 bouts of vomiting; pain between scapula in back; occasional cough. At 9:50 a.m. BP 150/82, P 72, R 45; Epinephrine .3cc SQ L arm administered at 9:54 A.M. Reported slight improvement in breathing effort at 10:10 AM. Transported by EMS to Hospital at 10:16 a.m. Follow up with parent on today states that at the hospital they told her the child had allergic reaction to vaccination.  States they sent him home and he is fine now.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Autism, Convulsion, Immediate post-injection reaction, Laboratory test abnormal, Porphyrins urine abnormal
Clinical narrative: Seizure right after injection, doctor used smelling salts and he eventually came to.
Age: 71.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: 4 X 4 IN HARD ITCHY LUMP AT SITE OF INJECTION
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Aldolase increased, Antinuclear antibody negative, Blood creatine phosphokinase increased, Myalgia, Tremor
Clinical narrative: Gradual onset of tremor, then aching of proximal muscles.  After office visit and multiple phone calls, aldolase, CK checked -- these were mildly elevated.  Now have returned to normal.  Still getting work up.  ANA negative.  Has rheumatology visit pending.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Joint range of motion decreased, Neck pain
Clinical narrative: Pt c/o sore neck on the right side. Limited ROM. Pt was given seasonal influenza 0.5 ml injection on the right side and H1N1 0.5 ml injection on the left side.
Age: 2.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives
Age: 68.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Hypersensitivity
Clinical narrative: Damn!   I can sleep. Am 68, live alone. Husband in nursing care. Goodnight. No more. Later, can't close this after all this work to report this...
Age: 7.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Rash erythematous
Clinical narrative: RED ITCHY SPOTS ON LEGS, ARMS, HANDS, BACK.  ER SAID ALLERGIC REACTION.  NO RECENT CHANGE IN FOODS, DETERGENT, SOAP OR ANY THING ELSE.  RECIEVED VACCINE WAS H1N1 SHOT.  HAVE GOTTEN WORSE SINCE ONSET.  2ND DOCTOR WANTS TO SET UP CONSULT WITH IMMUNIZATIONS CLINIC.
Age: 36.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Balance disorder, Dizziness
Clinical narrative: On 12/13/09, I had an episode of pronounced dizziness lasting approx. 1 hour.  Since then, I have had similar episodes lasting 1-2 hours on 12/16/09, 12/28/09, 12/31/09, and 1/4/10, as well as frequent momentary dizziness or imbalance.  Treatment for these symptoms has been to increase the dosage on my migraine preventive medication for the last 1 1/2 weeks.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood human chorionic gonadotropin, Drug exposure during pregnancy, Muscle spasms, Ultrasound scan abnormal, Vaginal haemorrhage
Clinical narrative: *Cramping and light vaginal bleeding (12/24 PM) *Severe cramping and light vaginal bleeding (12/25 AM & PM) multiple tests run (Ultrasound, pelvic exam, blood and urine tests) in E.R.  *Severe cramping and moderate vaginal bleeding (12/26 AM & PM) *Moderate cramping and moderate vaginal bleeding (12/27 AM & PM) Ultrasound and blood test for HCG level indicate miscarriage *Light cramping and moderate vaginal bleeding (12/28 AM & PM) *Severe cramping and moderate vaginal bleeding (12/29 AM & PM) Follow up with family physician for pelvic exam and blood test for HCG levels (continuing to drop) *Moderate cramping and moderate vaginal bleeding (12/30 and 12/31 AM & PM) Ultrasound at Hospital on 12/30) *Light vaginal bleeding (1/1/10-1/4/10 AM & PM)
Age: 7.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Broke out in Hives mainly around lower waist, armpits and neck spreading to his chest, stomach and back.  Gave him Zyrtec (allergy med) and it cleared in a couple of hours.
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP, MMR, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Asthma, Condition aggravated
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of asthmatic attack in a 15-month-old male subject who was vaccinated with PEDIARIX. Concurrent medical conditions included asthma and gluten intolerance. Previous and/or concurrent vaccination included PEDIARIX, GlaxoSmithKline unknown; unknown given on 14 September 2009; mmr vaccine (non-gsk); Merck;unknown; unknown. On 12 November 2009 the subject received 2nd dose of PEDIARIX (.5ml, unknown, left thigh). On 13 November 2009, one day after vaccination with PEDIARIX, the subject experienced asthmatic attack. The healthcare professional considered the event was disabling. At the time of reporting the outcome of the asthma attack was resolved. The healthcare professional considered the events was possibly related to vaccination with PEDIARIX.
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP, MMR, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Asthma, Condition aggravated, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of asthmatic attack in a 15-month-old male subject who was vaccinated with PEDIARIX. Concurrent medical conditions included asthma and gluten intolerance. Previous and/or concurrent vaccination included PEDIARIX, GlaxoSmithKline unknown; unknown given on 14 September 2009; mmr vaccine (non-gsk); Merck;unknown; unknown. On 12 November 2009 the subject received 2nd dose of PEDIARIX (.5ml, unknown, left thigh). On 13 November 2009, one day after vaccination with PEDIARIX, the subject experienced asthmatic attack. The healthcare professional considered the event was disabling. At the time of reporting the outcome of the asthma attack was resolved. The healthcare professional considered the events was possibly related to vaccination with PEDIARIX.
Age: 1.26
Sex: M
Vaccine: DTAPHEPBIP, MMR, DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Asthma
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of asthmatic attack in a 15-month-old male subject who was vaccinated with PEDIARIX. Concurrent medical conditions included asthma and gluten intolerance. Previous and/or concurrent vaccination included PEDIARIX, GlaxoSmithKline unknown; unknown given on 14 September 2009; mmr vaccine (non-gsk); Merck;unknown; unknown. On 12 November 2009 the subject received 2nd dose of PEDIARIX (.5ml, unknown, left thigh). On 13 November 2009, one day after vaccination with PEDIARIX, the subject experienced asthmatic attack. The healthcare professional considered the event was disabling. At the time of reporting the outcome of the asthma attack was resolved. The healthcare professional considered the events was possibly related to vaccination with PEDIARIX.
Age: 0.23
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, PNC
Symptoms: Feeling hot, Oedema peripheral, Pyrexia
Clinical narrative: Left thigh swollen and hot to the touch - Pt given BENADRYL and alternating Ibuprofen and Tylenol for fevers.
Age: 0.23
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, PNC
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swollen and hot to the touch - Pt given BENADRYL and alternating Ibuprofen and Tylenol for fevers.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Dyspnoea, Flushing, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Severe sore throat x24 hours- 1-1-10. flushing 12/30/09, diarrhea-12-31-09, heavy cold symptoms-12-31-09, some shortness of breath 12/31, chest conjection-12-23-09.
Age: 45.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Upper respiratory tract congestion
Clinical narrative: Severe sore throat x24 hours- 1-1-10. flushing 12/30/09, diarrhea-12-31-09, heavy cold symptoms-12-31-09, some shortness of breath 12/31, chest conjection-12-23-09.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site pain, Muscular weakness, Sensation of heaviness
Clinical narrative: Initial report received on 07 December 2009 from a health care professional in the United States. A 52 year old female patient complained of pain at the injection site immediately after she received a first time dose of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP010AA) intramuscularly in the left deltoid on 02 December 2009. The patient's right arm became heavy with decreased strength and weakness which has worsened. There is no redness or hardness at the injection site. The patient required a doctor's visit, no further information was provided. The patient had also received an influenza vaccine in September 2009, manufacturer was not reported. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Initial report received on 07 December 2009 from a consumer, who is the patient's parent. A 33 month old female patient, with allergies to OMNICET, BACTRIM, and formaldehyde, received a first left thigh intramuscular injection of Influenza A (H1N1) 2009 Monovalent Vaccine - No Preservative (lot number UT014FA) on 23 October 2009. Two hours post-vaccination, the patient developed itching and broke out in hives. She was given ZYRTEC, which resolved the symptoms. However, for the following two weeks, the hives continued to return after the ZYRTEC wore off. The patient's pediatrician felt that this was a possible allergy to something else. The patient was seen by an ENT the week previous to the report. The patient had not been evaluated by an allergist, but she was to have allergy testing on 08 December 2009. At the time of the report, the patient had not recovered. Follow-up information received on 14 December 2009 from a consumer, who is the patient's parent. At the time of the report, the patient still had hives.