chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Feeling abnormal, Head discomfort, Throat irritation
Clinical narrative: 15-30 minutes after receiving vaccine noticed a fuzzy feeling in throat, chest felt swollen, head felt funny. Took allergy medicine but no relief, so took BENADRYL 60mg PO. No relief. Went to ER at 6pm + given Epinephrine 0.3 mg SQ. PREDNISONE with relief. Chest still feeling swollen to day- sent home with Rx. BENADRYL + PREDNISONE 60mg x 5d. On 10/23/09 did vaccine Seasonal flu vaccine - No problems. 12/11/09 ED Records received for DOS 12/02/09; 12/04/04. Pt presented with throat swelling and difficulty breathing following vaccination.  Self-medicated with benadryl with some improvement. Tx. in ED with epinephrine, steroids; symptoms improved. Presented to ED again on 12/04/09 with skin rash, persistent throat swelling. Treated with Vistaril. Symptoms improved. Assessment: angioedema involving the larynx; delayed allergic reaction to swine flu shot
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Horrible headache, naucious, dizzy, fever/chills. Slept from 3pm to 8am.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Somnolence
Clinical narrative: Horrible headache, naucious, dizzy, fever/chills. Slept from 3pm to 8am.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), HIBV
Symptoms: Body temperature increased, Grand mal convulsion, Lip disorder, Postictal state, Streptococcal identification test negative
Clinical narrative: Pt developed quivering lips 10-15 minutes after immunization. Then developed a temp of 101.7 at 6 pm. At 7:30 pm pt began tonic/clonic seizure, approx 15 minutes total time of seizure with extended post ictal. Pt transported to ER by EMS. Pt was discharged after evaluation at ER later that night.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), HIBV
Symptoms: Urine analysis
Clinical narrative: Pt developed quivering lips 10-15 minutes after immunization. Then developed a temp of 101.7 at 6 pm. At 7:30 pm pt began tonic/clonic seizure, approx 15 minutes total time of seizure with extended post ictal. Pt transported to ER by EMS. Pt was discharged after evaluation at ER later that night.
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Pruritus, Rash macular, Urticaria, Vaccination complication
Clinical narrative: Red blotches/hives on face, arms and then started itching within 2-3 minutes of getting intranasal vaccine. Family gave her BENADRYL which resolved allergic reaction.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: Inj arm itches as well as stomach BENADRYL 2mg & ZANTAC take 1 pm & one in am.
Age: 62.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dry mouth, Dysphagia, Dyspnoea, Headache, Pruritus generalised
Clinical narrative: 11/23/09 hives on upper body, neck, head and arms, itching all over on said parts above. 11/24/09 - severe dry mouth at 530 AM - jumped out of bed - could not swallow or breathe needed to swallow lots of water, also severe wheezing. Symptoms recede on 11/27 except for severe head aches.
Age: 62.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Urticaria, Wheezing
Clinical narrative: 11/23/09 hives on upper body, neck, head and arms, itching all over on said parts above. 11/24/09 - severe dry mouth at 530 AM - jumped out of bed - could not swallow or breathe needed to swallow lots of water, also severe wheezing. Symptoms recede on 11/27 except for severe head aches.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Erythema, Eye swelling, Headache, Lip swelling
Clinical narrative: About 30 mins after vaccination - light-headed, sl headache, R hand redder than left. Tx'd with ibuprofen. @ 3pm student called mom @ work c/o tingling/swollen lips, 1 eye swelling. @ 430pm mom home - student with increased facial swelling, eyes swelling, throat itchy, "splotches all over" went to ER IV BENADRYL 12/1/09 8 am - eyes still sl swollen, few blotches - 10:30 am appears clear.
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia oral, Rash macular, Swelling face, Throat irritation
Clinical narrative: About 30 mins after vaccination - light-headed, sl headache, R hand redder than left. Tx'd with ibuprofen. @ 3pm student called mom @ work c/o tingling/swollen lips, 1 eye swelling. @ 430pm mom home - student with increased facial swelling, eyes swelling, throat itchy, "splotches all over" went to ER IV BENADRYL 12/1/09 8 am - eyes still sl swollen, few blotches - 10:30 am appears clear.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anxiety, Chest discomfort, Dizziness, Tremor
Clinical narrative: 10:20 received H1N1 flu shot in left arm. At 10:30 am, c/o lightheadedness, chest heaviness, shakiness, and anxious. Positioned her on lying on floor, elevated knees; gave water after vital taken. VSS taken at 1030, 1045, 1100, and 1115 am. RR 18-20 bpm, BP 130/98. Progressively felt better over 45 minutes of monitoring. At 11:20 AM felt completely better and teacher returned to work (classroom). Case manager called back 2 hrs later and reported she is feeling fine.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Epstein-Barr virus antibody, Full blood count, Nasopharyngitis, Pyrexia
Clinical narrative: High temp of 102-103, severe cough and cold.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Urine analysis
Clinical narrative: High temp of 102-103, severe cough and cold.
Age: 13.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Fatigue, Paraesthesia
Clinical narrative: Felt weak after vaccine admin. 24 hrs later chest pressure, feeling of shortness breath, parasthesias arms, hands, calves. General fatigue persists.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Asthenia, Diarrhoea, Laboratory test
Clinical narrative: Vaccine administered Nov 4, 2009-developed diarrhea on Mon Nov 9, 2009. Diarrhea lasted 7 days after which I developed severe joint pain and weakness. Still ongoing today 11-30-09.
Age: 40.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Rash, Urticaria
Clinical narrative: Severe rash and bumps welts on arms and stomach and legs.
Age: 35.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Rash generalised, Rash pruritic
Clinical narrative: One day after receiving H1N1 vaccine, pt began to develop a fine red itchy rash all over his limbs and trunk. He is using BENADRYL cream to control his symptoms but rash is spreading.
Age: 4.0
Sex: F
Vaccine: FLU3, IPV, MMR
Symptoms: Dysarthria, Fall, Gait disturbance, Guillain-Barre syndrome, Insomnia
Clinical narrative: Pt diagnosed with Guillain-Barre-symptoms developed on 11/12/09. Pt c/o leg pain, unsteady gait, slurred speech, tremors, falling down, up all night screaming. Referred to ER.  12/08/09, 12/29/09 MR and DC summary for DOS 11/14/09  11/23/09. DX: GBS Pt presented with difficulty walking, unsteady gait with 7-10 days hx. On examination: alert, fluent speech, cranial nerves intact, strength 5/5 in upper extremities, low. Tx: IVIg therapy, Neurontin. Pt improved and discharged home with an OT appointment.  12/22/09 and 12/28/09 MR received for 11/27/09 and 12/03/09 Pt c/o weakness, tremor, difficulty sleeping. Pt to continue Neurontin and started Claritin.
Age: 4.0
Sex: F
Vaccine: FLU3, IPV, MMR
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Screaming, Tremor
Clinical narrative: Pt diagnosed with Guillain-Barre-symptoms developed on 11/12/09. Pt c/o leg pain, unsteady gait, slurred speech, tremors, falling down, up all night screaming. Referred to ER.  12/08/09, 12/29/09 MR and DC summary for DOS 11/14/09  11/23/09. DX: GBS Pt presented with difficulty walking, unsteady gait with 7-10 days hx. On examination: alert, fluent speech, cranial nerves intact, strength 5/5 in upper extremities, low. Tx: IVIg therapy, Neurontin. Pt improved and discharged home with an OT appointment.  12/22/09 and 12/28/09 MR received for 11/27/09 and 12/03/09 Pt c/o weakness, tremor, difficulty sleeping. Pt to continue Neurontin and started Claritin.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Pt. administered vaccine on 11/30/09; developed rash on top of both thighs on 11/20/09. Rash has continued thru 12/3/09. Pt taking over the counter BENADRYL and applying topical CORTISONE cream to areas.
Age: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Pyrexia
Clinical narrative: Fevers of 103, cough x 2-3 days. Took TYLENOL and cough med. Sibling had similar symptoms.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood calcium normal, Blood glucose normal, Blood magnesium normal, Blood potassium increased, Blood sodium normal
Clinical narrative: About 30-40 min after receiving PEDIARIX, PREVNAR, ROTATEQ, and ACTHIB, mom said baby was not responsive. No color change noted, but baby was difficult to arouse. Vitals were stable, never desated. Back to baseline when came to.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Depressed level of consciousness, Electroencephalogram, Unresponsive to stimuli
Clinical narrative: About 30-40 min after receiving PEDIARIX, PREVNAR, ROTATEQ, and ACTHIB, mom said baby was not responsive. No color change noted, but baby was difficult to arouse. Vitals were stable, never desated. Back to baseline when came to.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest pain, Cough, Dizziness, Headache, Pyrexia
Clinical narrative: Lightheaded, chest pain, cough, headache, fever 101 degrees for 2 days.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Oral herpes, Pain, Rhinorrhoea
Clinical narrative: Fever blisters, two in nose 3 days after injection. On Wed Nov 18th I received a shingles vaccine injection at clinic. Three days later, two fever blisters, or cold sores broke out inside my left nostril. They were very painful and the one that was highest up inside the nose was like a running sore that oozed clear fluid mixed with bright red blood for over 9 days. The sore highest in the nostril never did scab up or dry up. It did run less and less each day and seems to be healing somewhat by Sunday Nov 29th. I went on the internet to see if there was any connection between the shingles vaccine and the break out of cold sores. I couldn't find anything, but I know that a break out of blisters is a side effect of other vaccines, so it is not unheard of. I just wanted to let you know what happened to me.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Feeling abnormal, Full blood count, Incoherent, Moaning
Clinical narrative: 7:30 PM Vomiting, fever 101.7, limp, groaning, not coherent. Taken to ER. Blood work, MOTRIN, discharged home. 12/2/09 3 PM Still running temp 100 degrees, coherent, on TYLENOL, MOTRIN and albuterol currently.
Age: 5.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Vomiting
Clinical narrative: 7:30 PM Vomiting, fever 101.7, limp, groaning, not coherent. Taken to ER. Blood work, MOTRIN, discharged home. 12/2/09 3 PM Still running temp 100 degrees, coherent, on TYLENOL, MOTRIN and albuterol currently.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: 1915 c/o itchiness, VS HR 76 RR 14 B/P 106/68, no difficulty breathing, able to talk. Observed until 1955 and released with instructions to take BENDARYL 50-100mg as directed. OTC medication for age and weight, take by mouth, parents verbalize understanding and agree to comply, phone # given for follow-up, 2115 contacted parent via telephone. He indicated that patient reports feeling better; itching decreased, no rash or hives no difficulty breathing. Parent sts 2 tabs BENADRYL given to patient - total dose 50mg. Recommended to cont. to observe for further reaction, if symptoms persist in AM to contact primary physician, parent agreed.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure to communicable disease, Fatigue, Pallor, Pyrexia
Clinical narrative: Symptoms-fever 99-very fatigued, pale skin lasted 24 hours, took him to CNP at clinic. Was not tested but brother tested positive for Influenza A-he received TAMIFLU for 10 days.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Respiration abnormal
Clinical narrative: Increased SOB, chest tightness & light headedness. 9 am unlabored but shallow respirations, tight breath sounds. Rest 9:25 am PROVENTIL (2 inh) inh & ADVAIR Diskus puffs 250/50mg. 9:45 am improved ease of respiratory effort & breath sounds unL.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Injury, Syncope
Clinical narrative: Syncopal episode approx 10 mins s/p vaccine at check out desk. + trauma to head-immediate return to consciousness. Symptomatic care with ice, snack, H2O. Normal vital signs and neuro exam after 30 mins observation.
Age: 12.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Injection site pruritus
Clinical narrative: 1710 pt c/o itching (generalized (R) arm, vaccine administered (R) deltoid. Itching increased to both arms. HR 60 RR20 BP 128/94. Diphenhydramine 50mg po given. 1725-130/95, HR 85, 20. Itching to (R) arms and upper back, no difficulty breathing no change in LOC. 1740-120/90, 70, 20, pt claims itchiness has gone away. No change LOC. 1745- instructed parent to monitor for symptoms and notify emergency personnel if symptoms worsen.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza serology positive, Miosis, Pallor, Pyrexia
Clinical narrative: Symptoms-fever 103 degrees F, pale skin, constricted pupils lasted for 24 hrs took him to nurse in clinic. He tested positive for influenza received TAMIFLU for 10 days, after 10 days recovered completely.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nausea
Clinical narrative: She had nausea the evening and morning 12/2/09 after vaccine 12/01/09.
Age: 44.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pulse absent, Quadriplegia, Traumatic brain injury, Unresponsive to stimuli
Clinical narrative: Received H1N1 on 11/30/2009; on 12/1/09 at 23:20 was found unresponsive, pulseless; was transferred to local emergency department for treatment.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: H1N1 vaccine given in (L) deltoid @ 1045 AM. At 11AM rash noted to (L) arm about 6 cm. Rash approx. 3 cm to (L) cheek & across tops of shoulders. 12.5mg BENEDRYL given. DECADRON 2mg & DECADRON la 4mg given IM at 12 noon. Rash resolved by 12 noon.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis, Cough, Lethargy, Pyrexia
Clinical narrative: About 5-7 days after shot pt developed cough, fever, lethargy. Visited emergency room and was diagnosed with bronchitis. Patient was treated with antibiotic (unknown to reporter) and still has residual cough. Pt feels that bronchitis was direct result of shot at Walgreens b/c sister in different state experienced similar reaction.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site pain, X-ray limb normal
Clinical narrative: Left arm pain reported on 11-18-09 with no known injury + received Flu shot 6 wks prior. Took MOTRIN 600mg TID x 6 wks. Pain still persisting at left deltoid. No swelling fever + pain with ROM. Left shoulder/humerus. MOTRIN D/C, Treatment: Naprosyn 500mg 20# BID/Phys therapy, U.S., iontophoresis with dexamethasone.
Age: 77.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lip swelling
Clinical narrative: approx 30-45 min after injection, pt stated she felt lips swelling. Tx SOLU-MEDROL, BENADRYL, ZANTA. Breathing tx @ ER
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Tendon disorder
Clinical narrative: Saw Dr 11-10-09 left shoulder pain/tenderness lateral shoulder, full ext/int rotation, decreased ahd 90 degrees, no redness or tenderness over deltoid. Pain - shoulder to elbow. Pt used ALEVE with same relief. Exam. Treatment - RELAFEN 750mg 20# BID.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Redness, swelling, induration x 3 days. Afebrile. BENADRYL given day 2.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Felt dizzy within 15 mins after vaccine no loss of consciousness. No N/V, sinus good and equal sight. so x3. BP 120/80 complaints resolved with five minutes of rest.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Physical examination, Skin warm, Tenderness, Wound
Clinical narrative: Restrictions - No shoulder work, no lifting > 10 pounds. Onset on pain left arm 5 days before 10-26-09 with increasing pain tenderness over anterior shoulder along bicepital tendon. Heated puncture wound over deltoid without erythema tenderness and swelling. Not related to flu shot per physician.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Excoriation, Loss of consciousness
Clinical narrative: Administered vaccine on 11/23/09 at a school located vaccination clinic. Tolerated well and was observed for 15 minutes post-vaccination. As student was leaving, he passed out. Did receive minor abrasions to left side of face. Father noticed and picked him up. Did not require any intervention.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Fall, Hyperhidrosis, Pallor
Clinical narrative: Pt given ADACEL injection in (L) deltoid, then GARDASIL in (R) deltoid, was talking to nurse while sitting on exam table. (Approx 3 min after vaccine given) pt fell back against wall, then flopped to side on exam table. Nurse moved forward, swung legs onto table and placed on side. Noted pallor, diaphoresis. Responsive after 30 sec. Placed supine, feet elevated, given iced tea recovered well over few minutes.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood pressure increased, Blood test normal, Cardiac function test normal, Chest discomfort, Dizziness
Clinical narrative: Patient returned to clinic at 12N reporting chest tightness, light headedness, nausea, transient shortness of breath, pain from injection site L deltoid to L fingertips, "heavy band" around L arm. Vitals stable 97.9 - 76 - 20, 140/96 - elevated. Speaking calmly. To ER.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Electrocardiogram normal, Injection site pain, Nausea, Pain in extremity
Clinical narrative: Patient returned to clinic at 12N reporting chest tightness, light headedness, nausea, transient shortness of breath, pain from injection site L deltoid to L fingertips, "heavy band" around L arm. Vitals stable 97.9 - 76 - 20, 140/96 - elevated. Speaking calmly. To ER.
Age: 46.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Sensation of heaviness
Clinical narrative: Patient returned to clinic at 12N reporting chest tightness, light headedness, nausea, transient shortness of breath, pain from injection site L deltoid to L fingertips, "heavy band" around L arm. Vitals stable 97.9 - 76 - 20, 140/96 - elevated. Speaking calmly. To ER.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Nightmare
Clinical narrative: Mother describes severe nightmares on night of receiving vaccine with violent episodes. Patient has a history of mental illness with nightmares but mother states this event was much more severe than any previous. Saw on VIS behavior changes as a possible reaction to vaccine.
Age: 1.47
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC, VARCEL
Symptoms: Convulsion, Eye rolling, Muscle rigidity, Pyrexia
Clinical narrative: MOC reports seizure like activity evening after receiving immunizations. At time of episode was febrile to 101 per mother. MOC describes episode when patient "rigid" and "eyes rolled back." Parents did not take patient to emergency room.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, Erythema, Rash, Throat tightness
Clinical narrative: Received injection @ 5:29 pm. Approx 14 minutes after developed rash on back with itching. Was given 25 mg BENADRYL. Dev SOB and stated throat closing. Transferred to ER and released same day. Epi-pen administered. Mother reported rash on buttock/ red face x 2 days.
Age: 63.0
Sex: F
Vaccine: FLU3
Clinical narrative: None stated
Age: 28.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Activities of daily living impaired, Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: W/in 15 min of receiving vaccine I was sick, sore throat, URI symptoms, tummy, all flu symptoms. I missed 1 full day of work. Was sick for 6 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Local swelling
Clinical narrative: Patient states that she had a flu shot to the left deltoid area and the next day she had swelling at the site that radiated up her arm to her post neck area.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Systemic rash.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electrocardiogram QT prolonged, Full blood count normal, Loss of consciousness, Metabolic function test, Syncope
Clinical narrative: Syncope 15 min after receiving vaccine with LOC.
Age: 62.0
Sex: M
Vaccine: FLU(H1N1)
Clinical narrative: None stated.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Gait disturbance, Hypokinesia, Muscle spasms
Clinical narrative: First muscle cramp escalates to impairment use of hands, arms and legs. Extremely difficult to walk, dress, unable to lay on either site. Treated with Tylenol, deep heat, chiropractor. Currently taking Cipro antibiotics and PrioGenetics Quarter Body Tent.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever to 103 degrees F about 12 hours after seasonal flu vaccine. Also, mild redness @ injection site. Responded to TYLENOL.
Age: 2.0
Sex: F
Vaccine: FLU3, HIBV
Symptoms: Blood test normal, Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: Pt had fever same day at 7:00 pm. Fever was 101. She has fever again at 4:00 a.m. I gave her MOTRIN both time. Next day at 11:00 am. fever was 103.6 and she has seizures. 20 min after she has another seizures. She was diagnosed seizure, febrile in ED
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Eye disorder, Eyelid disorder, Full blood count normal, Headache, Hypoaesthesia eye
Clinical narrative: Within 10 minutes of admin - severe headache, L eye pulling/drooping. L sided facial numbness and swelling. ER admin IV SOLUMEDROL and PEPCID with no improvement. CBC/ Chem panel WNL/ MRI brain WNL. PCP visit for eval and also had neuro consult -WNL.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia facial, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Swelling face
Clinical narrative: Within 10 minutes of admin - severe headache, L eye pulling/drooping. L sided facial numbness and swelling. ER admin IV SOLUMEDROL and PEPCID with no improvement. CBC/ Chem panel WNL/ MRI brain WNL. PCP visit for eval and also had neuro consult -WNL.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Dyspnoea, Fatigue, Headache, Muscle spasms
Clinical narrative: Headache, breathing problems, leg cramps (severe), body aches, tiredness, neckache, upset stomache (4 days) still having difficulty breathing 12/2/09
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Neck pain, Pain
Clinical narrative: Headache, breathing problems, leg cramps (severe), body aches, tiredness, neckache, upset stomache (4 days) still having difficulty breathing 12/2/09
Age: 0.47
Sex: M
Vaccine: HIBV, PNC
Symptoms: Culture stool positive, Haematochezia
Clinical narrative: Pt developed bloody stool - large amount.
Age: 0.58
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bronchiolitis, Chest X-ray normal, Pyrexia, Respiratory syncytial virus test positive
Clinical narrative: High fever 24 hours after shots. Seen in Emergency Room and MD office x 2. Diagnosed bronchiolitis. RSV +. CXR -.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approximately 2 hrs after receiving a pneumonia injection in my left shoulder, my arm below the site, (bicep area) began turning red and with considerable pain. The next morning my whole bicep area had swollen to 1 1/2 to 2 inches its normal size, that afternoon I went to the ER.
Age: 3.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chills, Pyrexia, Streptococcal identification test negative
Clinical narrative: Fever/Chills x2 days
Age: 4.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Dysphonia, Pruritus, Urticaria
Clinical narrative: Severe skin itching, hives x 4 days (so far) cough, hoarse voice. Taking BENADRYL for itching and hives. 12/10/09 Pediatric Office Records received for DOS 05/13/09. 08/13/09, 10/10/09, 10/17/09. 12/04/09 On 12/04/09 Mother called to report itching, hives morning after H1N1 flumist. Also reported cough, hoarseness which began evening of vaccine. Treating with Benadryl.
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: Given 1.5 ml of H1N1 inactivated flu vaccine instead of 0.5 ml. No adverse reaction. No complaints from patient. Observed for 45 minutes. Vital signs stable.
Age: 11.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Wheezing
Clinical narrative: Auscultation done post injection. Slight bilateral wheezes decreased lobes. Pt denies difficulty breathing. No nasal flare observed. No angioedema observed. No rash  - EMS called breathing treatment administered by EMS 11:10 am transferred to hospital and parent left with EMS 11;26 a.m.
Age: 8.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema
Clinical narrative: L injection site redness, no itchiness noted 3 cm diam - reddened area noted. Given 7.5 cc BENADRYL ELIXIR PO x 1 about 4:40 pm
Age: 7.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Feeling hot, Flushing, Injection site erythema
Clinical narrative: Pt. became flushed, felt warm-minor redness at injection site VSS. BS clear and equal bilaterally-no loss of consciousness. Evaluated by MD give 7.5 mg Benadryl po.
Age: 12.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Rec'd vaccination @ 1745 - No problems - Returned to clinic at 1900 with c/o itching that began @ 1830; Returned to clinic with hives on R arm only. BP 128/80 decrease 112/60 P 72. Examined by MD - given 50mg po BENADRYL.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Sore in site where shot was given. Getting progressively worse as time has gone by, now, 2 months later I have constant and stronger pain in general area where shot was given. It has spread to a larger area around shot location.
Age: 17.0
Sex: F
Vaccine: FLUN(H1N1)
Clinical narrative: None known. 12/9/2009 OB-GYN records, patient is pregnant, EDD 3/29/2010, no side effects reported from vaccine.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: PATIENT COMPLAINED OF DIZZINESS (HX OF PSYCHOACTIVE MEDICATION INTAKE WIH POOR FOOD INGESTION).
Age: 16.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode less than 3 minutes after recieving injection. Eased pt down to the floor. Fanned patient off and gave her soda to drink. Took patient to room to lay down for 15 minutes. BP 98/58. Patient voiced no signs or symptoms of any further abnormal/adverse reaction 15 minutes after Gardasil injection.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: Pain in lower extremities with difficult ambulation.  Mother to call family physician.
Age: 8.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash erythematous
Clinical narrative: Woke up 12/3/09 with itchy raised rash. Rash on L deltoid, L side of face, L side of abdomen and around to back, L leg and foot. No fever. Used Benadryl topical and then later Benadryl po. Rash resolved on 12/4/09.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Throat irritation
Clinical narrative: PATIENT REFERS ITCH IN MOUTH, ARMS AND LEGS. ITCH IN THROAT. WAS TREATED WITH BENADRYL AND EPIPEN 0.3 MG.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Bronchitis, Cough, Insomnia, Oropharyngeal pain, Upper respiratory tract congestion
Clinical narrative: Sore throat, chest congestion, dry cough, difficulty to sleep, probably starting bronchitis.
Age: 49.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: RASH LIKE ON WAIST BOTH SIDES, WENT TO DERMATOLOGIST ON 11/18/2009 RECVD CREAM THEN OVER THE COURSE OF WEEK SPREAD TO ARMS THEN LEGS THIGHS  AND CALFS WENT BACK RECVD ANTIHIS 12/3/2009 RECVD ANTIHIS THEN MOVE TO MY BACK.
Age: 78.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood creatinine increased, Blood test, Dizziness, Glomerular filtration rate, Hypotension
Clinical narrative: dizziness, hypotension, BP 74/41
Age: 78.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Laboratory test abnormal
Clinical narrative: dizziness, hypotension, BP 74/41
Age: 8.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Chest discomfort, Cough, Croup infectious, Nasal congestion, Pyrexia
Clinical narrative: Low grade fever, croup cough, stuffy nose. I'm currently giving him breathing treatments every 4 hours for the tightness he seems to have.
Age: 44.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Diffuse muscle aches and fatigue with mild SOB.  Treated with Motrin 600mg BID.  Symptoms have been persistent now for over one month.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Feeling hot
Clinical narrative: 5cc H1N1 vaccine IM L deltoid @ 4:20. 4:25 report arm hot about 10cm diameter redness gave 50mg po BENADRYL, decrease redness, decrease warmth.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Local reaction
Clinical narrative: C/o burning and soreness at injection site 15min after injection-local reaction noted. BP 120/80 P 80 RR 14.
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Rash macular, Skin warm
Clinical narrative: C/o (L) arm felt red and warm to touch. Bright red macular blotches on chest and face. Denies itching of throat, no swelling. Given Benadryl 50mg IM (R) arm. BP 120/72 P100. Monitored Q 15 min.
Age: 1.27
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Petechiae, Weight bearing difficulty
Clinical narrative: PETECHIAE RASH NOTED 12-04-2009 ON PALMS OF HANDS.  BY 12-05-2009 BODY WIDE RASH NOTED ON ENTIRE BODY (TRUNK, FACE, LIMBS) ALSO HAD DIFFICULT WEIGHT-BEARING ON LEFT LEG WHERE INJECTION WAS ADMINISTERED.  SX/SZ RESOLVED BY 12-06-2009 AND MOTHER REPORTED APPROPRIATE RESPONSE TO ANELGESICS AND ANTIHISTAMINES WHEN GIVEN.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAS A RAISED RED SPOT AT THE INJECTION SITE.  THE SITE IS WARM TO TOUCH AND SORE.  BENADRYL GIVEN ON 12/05/2009, AND CORTISONE CREAM APPLIED TO THE AFFECTED AREA.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Ear discomfort, Eye swelling
Clinical narrative: 1:30 pm client complaining of "lungs hurting", cough, pressure in the head, ears.  5:30 pm fever of 103 F, lips and eyes swelling, difficulty breathing.  She took 6.25 mg of Benadryl and motrin.  Fever broke at 11:00 pm and has not had one since. Lips still swollen today.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Headache, Lip swelling, Pyrexia
Clinical narrative: 1:30 pm client complaining of "lungs hurting", cough, pressure in the head, ears.  5:30 pm fever of 103 F, lips and eyes swelling, difficulty breathing.  She took 6.25 mg of Benadryl and motrin.  Fever broke at 11:00 pm and has not had one since. Lips still swollen today.
Age: 67.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: Dizziness (not severe).
Age: 18.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Malaise, Pyrexia
Clinical narrative: She received the H1N1 flu nasal mist.  She began coughing and looking ill the next day; continued for several days, then got much worse after 5-6 days. Fever rose to about 100, coughing persisted.  She is better now (after 7 days) but still has a persistent, frequent cough.
Age: 44.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Eye pain, Eye pruritus, Eye swelling
Clinical narrative: Left eye became swollen, itchy and painful and remained that way for several days, despite the use of antihistamines.
Age: 67.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Feeling abnormal, Nausea
Clinical narrative: Person called reported having a reaction to the H1N1 vaccine. Stated she had chills and nausea for three days after receiving the shot. Felt bad, stayed in bed for about 3 days.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness
Clinical narrative: PATIENT REFERS DIZZINESS AFTER VACCINE ADMINISTRATION.
Age: 16.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Condition aggravated, Convulsion, Hemicephalalgia, Myoclonus
Clinical narrative: Patient started with a headache on the right side of his head the night he received the vaccine. Friday he started having myoclonic jerks, seizures.  They lasted for hours with no relief until he was put on a low dose of Valium for 3 days.
Age: 37.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chest discomfort, Pain
Clinical narrative: Patient reported that about 3 hours after receiving injection, she developed body aches and chest heaviness.  No shortness of breath.
Age: 12.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Headache
Clinical narrative: PATIENT REFERS HEADACHE AFTER VACCINATION.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anaphylactic reaction, Asthma, Condition aggravated, Dyspnoea, Impaired work ability
Clinical narrative: Hives with scratchy throat.  Went to emergency room. Received IV Benadryl and steroids. Follow-up Information - 07-JAN-09: Subsequent medical treatment required according to patient: 12/9/09: Office visit to PCP for recurrence of rash. 12/11/09: Emergency room visit for continued urticarial rash. 12/15/09: Office visit to PCP for treatment: "difficulty breathing and rash on face." Later on 12/15/09: Hospital admission for anaphylactic-type reaction to H1N1 vaccine w/asthma exacerbation. 12/18/09: Discharge from hospital. Patient reports having missed work while hospitalized and is currently off work.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash, Throat irritation, Urticaria
Clinical narrative: Hives with scratchy throat.  Went to emergency room. Received IV Benadryl and steroids. Follow-up Information - 07-JAN-09: Subsequent medical treatment required according to patient: 12/9/09: Office visit to PCP for recurrence of rash. 12/11/09: Emergency room visit for continued urticarial rash. 12/15/09: Office visit to PCP for treatment: "difficulty breathing and rash on face." Later on 12/15/09: Hospital admission for anaphylactic-type reaction to H1N1 vaccine w/asthma exacerbation. 12/18/09: Discharge from hospital. Patient reports having missed work while hospitalized and is currently off work.
Age: 10.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache
Clinical narrative: PATIENT REFERS STRONG HEADACHE AFTER VACCINATION.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Oedema peripheral, Pruritus generalised, Skin disorder
Clinical narrative: TC from patient.  C/O itching all over.  Denies rash. C/O head throbbing, skin sensitive, swelling in hands and breathing problems.  Advised to go to ER.  12/07/2009  TC to patient.  She tells Nurse that she took Benadryl 2 tabs before going to ER.  Then went to ER.  ER ordered Methylprednisolone 4 mg. Day 1 6 tabs, Day 2 5 tabs, Day 3 4 tabs, Day 4 3 tabs, Day 5 2 tabs, and Day 6 1 tab.  Patient states that today she still has headache, and has itching that she takes Benadryl prn for. Advised to do follow-up with primary physician.
Age: 37.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blood test, Hypoaesthesia, Injection site movement impairment, Muscle twitching, Nervous system disorder
Clinical narrative: Awoke to left arm twiching at the site of the injection, left hand and left foot had severe tingling or numbness, twiching in brain in central area of brain.  Twiching in brain more noticeable and severe when eyes closed and has continued to increase in frequency to about at least once an hour lasting approx. 15 seconds.  Tingling in hands and feet also include right side of body as week went on and only occurs after sleeping for approx. 3 hours or more.  Week 3 was the start of slight cold insensitivity in hands, twitching in brain continues, numbness in hands and feet occurs approx. every other night and only during sleep.
Age: 37.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Paraesthesia, Peripheral coldness, Sensory loss
Clinical narrative: Awoke to left arm twiching at the site of the injection, left hand and left foot had severe tingling or numbness, twiching in brain in central area of brain.  Twiching in brain more noticeable and severe when eyes closed and has continued to increase in frequency to about at least once an hour lasting approx. 15 seconds.  Tingling in hands and feet also include right side of body as week went on and only occurs after sleeping for approx. 3 hours or more.  Week 3 was the start of slight cold insensitivity in hands, twitching in brain continues, numbness in hands and feet occurs approx. every other night and only during sleep.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Herpes zoster, Pruritus, Rash
Clinical narrative: Information has been received from a consumer concerning her 73 year old mother with allergies to AZITHROMYCIN, ANCEF, CODEINE, "DELOITTE", CEPHALEXIN and a history of knee replacement, who on 14-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included LIPITOR, PLAVIX, ENAPRIL, SYNTHROID and baby ASPIRIN. The caller stated that on 30-NOV-2009 her mother developed shingles after getting the ZOSTAVAX (Merck). She started with the rash and itch on her back on the left side and breast. The reporter indicated that the patient was hospitalized. The patient had a CT scan test done (results not reported). At the time of this report the patient had not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Felt break-out by left shoulder blade.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chest X-ray, Death, Respiratory arrest, Tachycardia
Clinical narrative: 12/03/09 Temp. 98.9-Flu vaccine given (Influenza) on 7-3 shift. 8:45 PM 12/3/09 Temp. 102.9, pulse 145-Dr. notified-CIPRO 500 mg via GT given as an order BID. Change to ROCEPHIN 1 gm IM x 7 days, TYLENOL given, cold compresses. 12:20 AM 12/04/09 resident ceased to breathe. 12/9/2009 Death certificate received. DOD 12/4/09. Cause of Death: Pneumonia. Traumatic Encephalopathy.
Sex: U
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning "several patients" who were vaccinated with GARDASIL. The nurse reported that after receiving GARDASIL the patient fainted. The patients sought unspecified medical attention. Follow-up information has been received from the nurse practitioner. One patient (age and gender not reported) had a known seizure disorder. The nurse practitioner could not confirm that these events were definitely related to vaccination with GARDASIL. The practice began observing the patient for 15 minutes after the patient received vaccination as a result of the event. Upon internal review, seizure disorder was determined to be an other important medical event. This is one of three reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Oropharyngeal pain, Pharyngeal oedema, Vomiting
Clinical narrative: Throat became swollen and painful, vomited, stomach pains.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oedema peripheral, Rash macular, Swelling face, Urticaria
Clinical narrative: Patient developed swelling of hands and then face.  Her skin became red and blotchy.  Hives developed.  The vaccine was given around 11am and symptoms began about 1 hour later.  She continues to have hives 2 days later.  She was seen in the emergency room on the same afternoon as the vaccination.  The physician is questioning a latex allergy.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Body temperature increased, Decreased appetite, Eyelid oedema, Flushing, Lethargy
Clinical narrative: 24 hours later 99.5 temp. Flushed, pale, lethargic, eye lids swollen, loss of appetite, nausea, rash (no itch) raised and flat red bumps, started on trunk and by next day spread to limbs, neck (no face) temp up to 101.1.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea, Pallor, Rash erythematous
Clinical narrative: 24 hours later 99.5 temp. Flushed, pale, lethargic, eye lids swollen, loss of appetite, nausea, rash (no itch) raised and flat red bumps, started on trunk and by next day spread to limbs, neck (no face) temp up to 101.1.
Sex: F
Vaccine: HPV4
Symptoms: Idiopathic thrombocytopenic purpura
Clinical narrative: Information has been received from a physician's assistant concerning her friend's daughter who on an unknown date was vaccinated with the first dose of GARDASIL (lot # not given). On an unspecified date, after receiving GARDASIL, the patient experienced idiopathic thrombocytopenic purpura "ITP". Subsequently, on an unknown date, the patient recovered. The patient sought unspecified medical attention. It was reported that the patient will not receive further doses of GARDASIL. Upon internal review idiopathic thrombocytopenic purpura "ITP" was considered to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Myalgia, Vomiting
Clinical narrative: vomited twice within 1 hour of shot muscle pain - 24 hours in bed
Age: 12.0
Sex: F
Vaccine: FLUX(H1N1), HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 23-NOV-2009 was vaccinated with a second 0.5 ml dose of GARDASIL (route, site and lot # not reported). Concomitant vaccine included a dose of MENACTRA and a dose of H1N1 on the same day (23-NOV-2009). The physician reported that the patient experienced fainting and seizure for 15 seconds after getting the second dose of GARDASIL on 23-NOV-2009. At the time of the report the outcome of the patient was recovered on an unspecified date. The patient sought unspecified medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dermatitis contact, Injection site rash, Rash papular
Clinical narrative: Rash on upper arm around vaccine site (pink, discrete papules) a couple papules near clavicle. I suspect band aid adhesive contact dermatitis.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Blood pressure decreased
Clinical narrative: Initial information received on 23 November 2009 from an affiliate; the initial reporter was a consumer. A female adult patient reported that she experienced an anaphylactic reaction after receiving an INFLUENZA VACCINE (lot number and manufacturer were not reported) in 1969 (also reported as 20-25 years ago). Her blood pressure dropped to 60/40 and as a result required EPINEPHRINE and BENADRYL. The patient recovered from the event. She reported a medical history of diabetes, 3 leaky heart valves, high blood pressure, kidney cancer, a solitary kidney and a history of egg, milk, wheat, and multiple drug allergies including PENICILLIN. However, it was not specified whether these conditions existed at the time of the event. No further information was provided. List of Documents held by Sender: none.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema, Haemorrhage, Insomnia, No reaction on previous exposure to drug, Pruritus
Clinical narrative: Initial report received on 23 November 2009 from a consumer who is a physician. A 49-year-old male patient received a dose of H1N1 (lot number UP013AA) on 28 October 2009. The patient had no concurrent illnesses. Medical history includes allergy to celery, carrots, apples and tree nuts: but no known drug allergies. Concomitant medications include CRESTOR and LOVAZA. Approximately one week post-vaccination, the patient experienced itching all over his body especially in skin fold areas such as armpits and elbow areas, but also between legs and behind knees. He was so itchy in some spots that he scratched till he bled. No diagnostic tests or laboratory data were performed. As of 23 November 2009, the patient still had itching. Recovery status is unknown. Follow-up information received on 24 November 2009 from a patient who is a physician. Due to the following new information, the case was upgraded to serious. Per the reporter, a couple of days prior to vaccination, the patient changed his water softener. Testing of the water revealed water softness was better than before. One week post-vaccination, the patient developed severe pruritus accompanied by erythema and areas of fine maculopapular rash similar to contact dermatitis. The itching was so severe it resulted in bleeding in areas where he kept scratching. The pruritus worsened over time interrupting his sleep to where he was only getting about 2 hours of sleep a night. The patient tried changing soaps and detergents to no avail. Treatment with prednisone was started three weeks after vaccination, and at the time of this report, the pruritus had resolved; however it was not reported whether erythema and maculopapular rash had resolved. The patient had received influenza vaccine many times without any adverse events. Documents held by sender: None.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pruritus generalised, Rash maculo-papular
Clinical narrative: Initial report received on 23 November 2009 from a consumer who is a physician. A 49-year-old male patient received a dose of H1N1 (lot number UP013AA) on 28 October 2009. The patient had no concurrent illnesses. Medical history includes allergy to celery, carrots, apples and tree nuts: but no known drug allergies. Concomitant medications include CRESTOR and LOVAZA. Approximately one week post-vaccination, the patient experienced itching all over his body especially in skin fold areas such as armpits and elbow areas, but also between legs and behind knees. He was so itchy in some spots that he scratched till he bled. No diagnostic tests or laboratory data were performed. As of 23 November 2009, the patient still had itching. Recovery status is unknown. Follow-up information received on 24 November 2009 from a patient who is a physician. Due to the following new information, the case was upgraded to serious. Per the reporter, a couple of days prior to vaccination, the patient changed his water softener. Testing of the water revealed water softness was better than before. One week post-vaccination, the patient developed severe pruritus accompanied by erythema and areas of fine maculopapular rash similar to contact dermatitis. The itching was so severe it resulted in bleeding in areas where he kept scratching. The pruritus worsened over time interrupting his sleep to where he was only getting about 2 hours of sleep a night. The patient tried changing soaps and detergents to no avail. Treatment with prednisone was started three weeks after vaccination, and at the time of this report, the pruritus had resolved; however it was not reported whether erythema and maculopapular rash had resolved. The patient had received influenza vaccine many times without any adverse events. Documents held by sender: None.
Age: 7.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of R thigh - IM antibiotic, ice packs, Ibuprofen use and oral antibiotic, and recheck.
Age: 36.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Injection site oedema
Clinical narrative: Pt received H1N1 in L deltoid at public clinic Saturday Dec 5, 2009. He noticed on December 7, 2009 generalized edema L arm (LUE). No erythema or adenopathy in the axillary cervical or upper extremities. Good circulatory perfusion. Bowel and kidney fxn. No medication changes. Normal appetite. Consistent sleeping posture. Mentally alert. Impression: Apparent post Imm. Reaction. Tx: observe closely and notify if any changes. Expect diminution of swelling and return if no better in one week.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Hypoaesthesia, Paraesthesia
Clinical narrative: Within 45min of receiving H1N1 vaccination in (R) deltoid, she experienced tingling and numbness right hand and forearm and erythema hands and feet. Resolved in 24 hrs. Rx antihistamines and Advair/Atenolol.