chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Oral herpes
Clinical narrative: On 09-17-2010 patient broke out into herpes labialis.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oral pruritus, Pruritus, Throat tightness
Clinical narrative: Flu vaccine given IM in (L) deltoid at 2:28pm. At 5:15p or 5:30p developed a feeling of something stuck in throat. Then developed upper lip swelling and itching of tongue, mouth and hands. Pt did not take anything for symptoms. This am resolved except hand itching. Gone later am.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness at inj. site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm, going up to neck.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia
Clinical narrative: Severe fever (105-106) within an hour of getting shot. Completely back to normal within 4-5 hours.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Rash, Respiratory tract congestion
Clinical narrative: RASH ON HANDS & FEET, CONGESTION, ABDOMINAL PAIN.
Age: 5.0
Sex: M
Vaccine: DTAP, FLUN3, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Skin lesion
Clinical narrative: Left arm red and warm to touch. Left deltoid with 6 cm long X 4.5 cm wide pink macular lesion. Some slight induration centrally.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dyspnoea, Screaming, Syncope
Clinical narrative: Anxiety attack. Prior to receiving vaccine, pt had altercation with front desk staff. Pt has a history of becoming upset with staff and hyperventilating. EMS was called. Pt collapsed to floor screaming repeatedly: "I can't breathe!" O2 sat was 99% throughout episode. EMS transported pt to hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Abasia, Immediate post-injection reaction, Sneezing, Wheezing
Clinical narrative: Client started sneezing right after vaccines administered but no other problems, about 10 minutes after vaccines administered, clients father called the health department and was transferred to a nurse and he stated he was still in the parking lot and his son was wheezing and unable to walk to the car, the nurse instructed the dad to bring client back in and at the time the client was given some oxygen and 911 was called, the client was being monitored by nurses at the health department until EMS arrived and took child to ER.
Age: 44.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Computerised tomogram head, No reaction on previous exposure to drug, Swelling face
Clinical narrative: Received nasal vaccine in clinic.  Previously received injectable vaccine without any reaction.  6 days later, c/o sudden onset facial swelling.  PE showed soft tissue swelling mid-forehead extending down to bridge of nose, no uvular edema or tongue swelling.  Head CT unremarkable.  Rxed with methylpred, diphenhydramine & famotidine with good response.  Discharged home on prednisone & diphenhydramine.
Age: 43.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: Blister at site of influenza injection. Presently about 1.5 cm on 9/21/10.  Also itches.  Tdap given in other arm; fine.
Age: 2.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Dizziness, Dysphonia, Pyrexia
Clinical narrative: Low Grade Fever, treated with Ibuprofen for 24 hours Hoarseness and Dizziness for 24 hours
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Injection site rash
Clinical narrative: Rash in deltoid/posterior left arm region.  Patient feels improved since yesterday.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Fatigue, Pyrexia
Clinical narrative: Cold sweats fever range 101.7 to 102.9 fatigue
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: PT ADMINISTERED SMALLPOX AND HE DID NOT NEED IT.  PT WAS VACCINATED IN SEPTEMBER 2008 WITH SMALLPOX.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction, warmth, redness.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: fever, ache, congestion
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 8/24, afebrile, however: L upper arm:  erythema & swelling long axes - 9 cm x 7 cm R upper arm:  erythema & swelling long axes - 3 cm x 4 cm RX - OTC ibuprofen (mom has at home); may continue Claritin. 8/31 - PC to mother:  child completely recovered by 8/27; without redness, swelling or itching.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: quarter sized hard red lump on right leg that is warm to touch
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Immediate swelling at injection site, pt reports swelling has gone away by 9/21/10.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Parotitis
Clinical narrative: Awoke with left cheek swelling (parotitis) w/o signs of other infection (i.e. otitis/mouth infxn)
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nausea, Pain in extremity, Scan
Clinical narrative: radiating pain down both arms nausea difficulty breathing
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: rash, shortness of breath, itching
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Fainted after leaving the clinic.  Mom took him to Hospital who transferred him to another facility for observation.  He was released the 16th.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Night sweats, Visual acuity reduced
Clinical narrative: VISION WENT BAD HEAD HURT CHILLS NIGHT SWEATS AND FEELING WEAK
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Pyrexia, Tongue coated
Clinical narrative: Fever 102 degrees F and coating on tongue and painful tongue for 48 hours.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Malaise, Nasopharyngitis, Pyrexia
Clinical narrative: FEVER, FATIGUE, COLD TYPE SYMPTOMS, MALAISE.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Dizziness, Dysphonia, Eye pain
Clinical narrative: Pressure on throat, wheezing, coughing, dizziness, weakness, sore eyes, exhaustion, hoarseness
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Sensation of pressure, Wheezing
Clinical narrative: Pressure on throat, wheezing, coughing, dizziness, weakness, sore eyes, exhaustion, hoarseness
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Headache and upset stomach.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient developed upper body shakes/tremors.  She called 911, ambulance arrived. Patient decided not to go to the hospital and went to her family physician who administered Benadryl to stop symptoms.
Age: 67.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chills, Dizziness, Fatigue, Heart rate increased, Nausea
Clinical narrative: dizziness, chills, nausea, exhaustion, rapid heartbeat Symptoms lasted approximately 24 hours.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLUX, HEP, HIBV, MMRV
Symptoms: Pyrexia
Clinical narrative: High Fever of 103.7.  The high fever reduced to 101.5 with one dose of children's acetaminophen.  His fever continued for 24 hours and was over by 3:00 PM on 9/18/2010.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: intense pain in left shoulder, unable to raise left arm above shoulder
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Fatigue, Lymphadenopathy, No reaction on previous exposure to drug, Odynophagia
Clinical narrative: Pt stated she noticed her glands in her neck are swollen and it hurts to swallow.  She is very tired today.  She had no reactions to the vaccine last year.  She also stated it was difficult to swallow because very dry mouth/pasty.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site discolouration, Nausea, Pruritus, Rash
Clinical narrative: Patient developed whelps/rash on the underside of arm where injection, of Fluvirin 2010/2011 by Novartis, was given as well as on the front of both thighs.  The injection site was not raised, only a little darker than the rest of the arm.  She began itching and noticed the rash. She is unclear as to whether or not the itching was prior to shot.  She did complain of nausea and dizziness.  She will first try Benadryl. As of now, she is breathing fine.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient developed whelps/rash on the underside of arm where injection, of Fluvirin 2010/2011 by Novartis, was given as well as on the front of both thighs.  The injection site was not raised, only a little darker than the rest of the arm.  She began itching and noticed the rash. She is unclear as to whether or not the itching was prior to shot.  She did complain of nausea and dizziness.  She will first try Benadryl. As of now, she is breathing fine.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Erythema, Throat irritation
Clinical narrative: FACE TURNED RED-STARTED COUGHING, SHIVERING AND DIFFICULTY BREATHING-PATIENT STATES THAT SHE FELT LIKE FISHBONE STUCK IN HER THROAT
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Chest discomfort, Dyspnoea
Clinical narrative: Hard time breathing, heavy chest first 2 hours; rested uneasy for another 2 then severe not being able to breathe, felt like heart attack; chest tight and heavy; hyperventilated; almost passed out; all body weakness. Blood pressure when arrival at ER was 142/89.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Electrocardiogram normal, Hyperventilation, Restlessness, Sensation of heaviness, Urine analysis normal
Clinical narrative: Hard time breathing, heavy chest first 2 hours; rested uneasy for another 2 then severe not being able to breathe, felt like heart attack; chest tight and heavy; hyperventilated; almost passed out; all body weakness. Blood pressure when arrival at ER was 142/89.
Age: 39.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The area at the injection site is hot, raised and red about the size of of a dime.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac flutter, Cough, Dry mouth, Pyrexia
Clinical narrative: After 5 hrs pt had high fever, cough, dry mouth. After 8 hrs her heart was flittering. Then she went to trauma center. They gave her 50mg of BENADRYL.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Headache, Heart rate increased, Pyrexia
Clinical narrative: After 2 hours, pt's heart rate increased, cough. After 8 hrs pt has high fever, headache. After 10 hours, pt feels very dizzy, pt had to take aspirin for her headache. Headache still remain on 9/21/10.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, Full blood count normal, Injection site haemorrhage, Petechiae, Prothrombin time normal
Clinical narrative: Pt developed petechiae in a traumatic pattern on upper arms, upper thighs CBC x 2 WNL. PT, PTT WNL.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Oedema peripheral, Rash, Skin warm
Clinical narrative: Patient began having swelling of left arm & underarm on Monday AM. She also has a rash on her arm (warm to the touch). Patient has also had a headache since Monday AM (9-20-10).
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Redness at the (L) arm where pt was injected 'erythema' no induration at site of injection 4-5 " in (L) - (status going down day 4).
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Patient felt sweaty, dizzy and had some nausea. This lasted most of the afternoon.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haematoma
Clinical narrative: Pt called pharmacy on 9-20-10 reporting a "hematoma" that looks greenish/purple/blue, about 3" across, and painless at injection site. He said it appeared about 2 days after receiving immunization, which was on 9/12/10, and is still very apparent 8 days later.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Painful, red, warm to the touch, redness size of a quarter.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Pruritus, Skin warm
Clinical narrative: Arm turned bright red and severe itching warm to touch and red at injection site X 6 days. Itching and redness started 20 min after injection.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Grapefruit size red swollen at injection site. Hot to touch. Very sore more than usual.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Soreness, redness, some itching some swelling.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Pt has received influenza vaccination in the past but not PNEUMOVAX 23. Pt was unable to get the vaccine in the left arm due to lymph node removal. Pt developed a swollen arm that was hot to the touch. Saw her physician and was prescribed KEFLEX and MEDROL DOSE PAK.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Myalgia, Visual impairment
Clinical narrative: "Dizziness", "glaring lights", "muscle aches all over body".
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus
Clinical narrative: 1 hr 35 minutes after shot, pt came back to pharmacy stating her legs were "tingling" - denied any itch - gave 50 mg Diphenhydramine at 12:50 pm - at 1:15 pm had tingling in fingers but not in legs - at 3:15 pm had itch - sent to Urgent Care.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: ZOSTAVAX was injected erroneously intramuscularly (correct IZ subcutaneous)
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis Rt buttock. Had shot 9-13-10.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Lymphadenitis, Lymphadenopathy
Clinical narrative: Significant edema & erythema at injection site at 48 hours; significant axillary lymphadenopathy (vs adenitis) 48 hours after injection.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and mild swelling at deltoid area - at injection site. Prednisone 20 mg x 3 days 10 mg x 3 days 5 mg x 3 days.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Wound
Clinical narrative: Patient received vaccines in the office on 09/20/2010 after vaccines (15 minutes) went to check vaccines left leg with red/purple large (3cmx2cm) tender indurated lesion with puncture wound (R) lateral thigh with small red, tender knot with visible puncture wound.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Compartment syndrome, Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Pt. received GARDASIL #2 at 8:30 this AM. She returned with severe pain & swelling of the entire right arm. The shot was given in the (R) deltoid. Most of her pain & swelling however was in the (R) forearm. She was very sensitive to touch, (+) paresthesias. She was referred to the ER for concern of compartment syndrome.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Pt. received GARDASIL #2 at 8:30 this AM. She returned with severe pain & swelling of the entire right arm. The shot was given in the (R) deltoid. Most of her pain & swelling however was in the (R) forearm. She was very sensitive to touch, (+) paresthesias. She was referred to the ER for concern of compartment syndrome.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Wound
Clinical narrative: Area of erythema, edema, warm. Tenderness left upper arm covering 1/3 of the area between shoulder & elbow. Central puncture site.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Large area (13 cm x 12 cm) of warm erythematous itchy skin around vaccine site.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema at site. BENADRYL given- decreased RXN.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Angioedema, Anti-thyroid antibody positive, Antinuclear antibody negative, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone normal
Clinical narrative: The patient received AVA #1 on 11/4/98 in his right upper arm at 1800. (Pt is right handed.) At the time he was healthy and taking no medications. At 2000 he noted that his lower lip was "tingling". When he woke in the am his lower lip was swollen. The pt wore braces at the time so he was referred to dental. (The pt wore braces from 1997-2000. He denies rash when wearing watch, rings, or metal belt buckles-no hx of nickel allergy). He was treated with resolution of sx in about two days. The pt denied having any other facial swelling, hives, SOB, N, V, diarrhea, congestion, rhinorrhea, cough, dysphagia, sneezing, watery eyes, lightheadedness, myalgias, arthralgias, swelling of the scrotum or penis. He also denied any recent dental work, trauma to lip, recent illness or recent consumption of cold/hot liquids. On 11/18/98 the pt received his second AVA. Within about 10 minutes he noted lower lip swelling (no SOB, chest pain, tingling, hives, or other constitutional sx). The pt went to dental and was escorted to medical where he was treated with IV SOLU-MEDROL and BENADRYL IM and admitted to the ward. The swelling subsided the next day. The pt continued with multiple episodes of facial swelling treated with episodic antihistamines and steroids. All lab tests have been negative. These episodes were not associated with a vaccination, food, drink, injury, or illness. He was referred to the Allergy Clinic on 4/26/99. CH50 was negative. The pt was diagnosed with recurrent angioedema and prescribed ZYRTEC 10mg qhs and an EpiPen. 6/02 the pt reported an episode where he woke up during the night with difficulty swallowing and breathing. According to this wife the pt's "throat/uvula" was swollen (no lip swelling or hives). She administered one dose of epinephrine and took the pt to the ER where he was treated with IV medications (records are not available). The pt was seen in follow-up on 6/27/02 and at that time he again had swelling of the lower lip. He was referred back to the Allergy Clinic. CBC, ESR, CH50, C4, C3, C1Q, TSH, T4, Thyroid Ab panel, RF and ANA were wnl. The was prescribed ZYRTEC, ATARAX 25mg qhs prn and PREDNISONE 20mg bid X 3 days as needed. It was recommended that the pt "avoid" ACE inhibitors for hypertension management (pt was on MONOPRIL at the time). He has been on an antihistamine daily since. The pt was again evaluated by an Allergist on 5/11/10. He reported taking MOBIC (started in 2005) and LISINOPRIL (he has taken an ACEI intermittently since 2002). He stated that he has not had an episode of angioedema in 4 years. ESR, TSH, CH50, Thyroid Ab panel, ANA and C1 Esterase Inhibitor wnl. Angioedema determined to be not related to NSAIDs or ACEI. Continue with ZYRTEC qd, MEDROL DOSEPAK and EpiPen prn.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: C-reactive protein increased, C1 esterase inhibitor test, Complement factor C3 increased, Complement factor C4, Complement factor decreased
Clinical narrative: The patient received AVA #1 on 11/4/98 in his right upper arm at 1800. (Pt is right handed.) At the time he was healthy and taking no medications. At 2000 he noted that his lower lip was "tingling". When he woke in the am his lower lip was swollen. The pt wore braces at the time so he was referred to dental. (The pt wore braces from 1997-2000. He denies rash when wearing watch, rings, or metal belt buckles-no hx of nickel allergy). He was treated with resolution of sx in about two days. The pt denied having any other facial swelling, hives, SOB, N, V, diarrhea, congestion, rhinorrhea, cough, dysphagia, sneezing, watery eyes, lightheadedness, myalgias, arthralgias, swelling of the scrotum or penis. He also denied any recent dental work, trauma to lip, recent illness or recent consumption of cold/hot liquids. On 11/18/98 the pt received his second AVA. Within about 10 minutes he noted lower lip swelling (no SOB, chest pain, tingling, hives, or other constitutional sx). The pt went to dental and was escorted to medical where he was treated with IV SOLU-MEDROL and BENADRYL IM and admitted to the ward. The swelling subsided the next day. The pt continued with multiple episodes of facial swelling treated with episodic antihistamines and steroids. All lab tests have been negative. These episodes were not associated with a vaccination, food, drink, injury, or illness. He was referred to the Allergy Clinic on 4/26/99. CH50 was negative. The pt was diagnosed with recurrent angioedema and prescribed ZYRTEC 10mg qhs and an EpiPen. 6/02 the pt reported an episode where he woke up during the night with difficulty swallowing and breathing. According to this wife the pt's "throat/uvula" was swollen (no lip swelling or hives). She administered one dose of epinephrine and took the pt to the ER where he was treated with IV medications (records are not available). The pt was seen in follow-up on 6/27/02 and at that time he again had swelling of the lower lip. He was referred back to the Allergy Clinic. CBC, ESR, CH50, C4, C3, C1Q, TSH, T4, Thyroid Ab panel, RF and ANA were wnl. The was prescribed ZYRTEC, ATARAX 25mg qhs prn and PREDNISONE 20mg bid X 3 days as needed. It was recommended that the pt "avoid" ACE inhibitors for hypertension management (pt was on MONOPRIL at the time). He has been on an antihistamine daily since. The pt was again evaluated by an Allergist on 5/11/10. He reported taking MOBIC (started in 2005) and LISINOPRIL (he has taken an ACEI intermittently since 2002). He stated that he has not had an episode of angioedema in 4 years. ESR, TSH, CH50, Thyroid Ab panel, ANA and C1 Esterase Inhibitor wnl. Angioedema determined to be not related to NSAIDs or ACEI. Continue with ZYRTEC qd, MEDROL DOSEPAK and EpiPen prn.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Dysphagia, Dyspnoea, Enlarged uvula, Full blood count normal, Immune complex assay
Clinical narrative: The patient received AVA #1 on 11/4/98 in his right upper arm at 1800. (Pt is right handed.) At the time he was healthy and taking no medications. At 2000 he noted that his lower lip was "tingling". When he woke in the am his lower lip was swollen. The pt wore braces at the time so he was referred to dental. (The pt wore braces from 1997-2000. He denies rash when wearing watch, rings, or metal belt buckles-no hx of nickel allergy). He was treated with resolution of sx in about two days. The pt denied having any other facial swelling, hives, SOB, N, V, diarrhea, congestion, rhinorrhea, cough, dysphagia, sneezing, watery eyes, lightheadedness, myalgias, arthralgias, swelling of the scrotum or penis. He also denied any recent dental work, trauma to lip, recent illness or recent consumption of cold/hot liquids. On 11/18/98 the pt received his second AVA. Within about 10 minutes he noted lower lip swelling (no SOB, chest pain, tingling, hives, or other constitutional sx). The pt went to dental and was escorted to medical where he was treated with IV SOLU-MEDROL and BENADRYL IM and admitted to the ward. The swelling subsided the next day. The pt continued with multiple episodes of facial swelling treated with episodic antihistamines and steroids. All lab tests have been negative. These episodes were not associated with a vaccination, food, drink, injury, or illness. He was referred to the Allergy Clinic on 4/26/99. CH50 was negative. The pt was diagnosed with recurrent angioedema and prescribed ZYRTEC 10mg qhs and an EpiPen. 6/02 the pt reported an episode where he woke up during the night with difficulty swallowing and breathing. According to this wife the pt's "throat/uvula" was swollen (no lip swelling or hives). She administered one dose of epinephrine and took the pt to the ER where he was treated with IV medications (records are not available). The pt was seen in follow-up on 6/27/02 and at that time he again had swelling of the lower lip. He was referred back to the Allergy Clinic. CBC, ESR, CH50, C4, C3, C1Q, TSH, T4, Thyroid Ab panel, RF and ANA were wnl. The was prescribed ZYRTEC, ATARAX 25mg qhs prn and PREDNISONE 20mg bid X 3 days as needed. It was recommended that the pt "avoid" ACE inhibitors for hypertension management (pt was on MONOPRIL at the time). He has been on an antihistamine daily since. The pt was again evaluated by an Allergist on 5/11/10. He reported taking MOBIC (started in 2005) and LISINOPRIL (he has taken an ACEI intermittently since 2002). He stated that he has not had an episode of angioedema in 4 years. ESR, TSH, CH50, Thyroid Ab panel, ANA and C1 Esterase Inhibitor wnl. Angioedema determined to be not related to NSAIDs or ACEI. Continue with ZYRTEC qd, MEDROL DOSEPAK and EpiPen prn.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Lip swelling, Paraesthesia oral, Pharyngeal oedema, Red blood cell sedimentation rate normal, Rheumatoid factor increased
Clinical narrative: The patient received AVA #1 on 11/4/98 in his right upper arm at 1800. (Pt is right handed.) At the time he was healthy and taking no medications. At 2000 he noted that his lower lip was "tingling". When he woke in the am his lower lip was swollen. The pt wore braces at the time so he was referred to dental. (The pt wore braces from 1997-2000. He denies rash when wearing watch, rings, or metal belt buckles-no hx of nickel allergy). He was treated with resolution of sx in about two days. The pt denied having any other facial swelling, hives, SOB, N, V, diarrhea, congestion, rhinorrhea, cough, dysphagia, sneezing, watery eyes, lightheadedness, myalgias, arthralgias, swelling of the scrotum or penis. He also denied any recent dental work, trauma to lip, recent illness or recent consumption of cold/hot liquids. On 11/18/98 the pt received his second AVA. Within about 10 minutes he noted lower lip swelling (no SOB, chest pain, tingling, hives, or other constitutional sx). The pt went to dental and was escorted to medical where he was treated with IV SOLU-MEDROL and BENADRYL IM and admitted to the ward. The swelling subsided the next day. The pt continued with multiple episodes of facial swelling treated with episodic antihistamines and steroids. All lab tests have been negative. These episodes were not associated with a vaccination, food, drink, injury, or illness. He was referred to the Allergy Clinic on 4/26/99. CH50 was negative. The pt was diagnosed with recurrent angioedema and prescribed ZYRTEC 10mg qhs and an EpiPen. 6/02 the pt reported an episode where he woke up during the night with difficulty swallowing and breathing. According to this wife the pt's "throat/uvula" was swollen (no lip swelling or hives). She administered one dose of epinephrine and took the pt to the ER where he was treated with IV medications (records are not available). The pt was seen in follow-up on 6/27/02 and at that time he again had swelling of the lower lip. He was referred back to the Allergy Clinic. CBC, ESR, CH50, C4, C3, C1Q, TSH, T4, Thyroid Ab panel, RF and ANA were wnl. The was prescribed ZYRTEC, ATARAX 25mg qhs prn and PREDNISONE 20mg bid X 3 days as needed. It was recommended that the pt "avoid" ACE inhibitors for hypertension management (pt was on MONOPRIL at the time). He has been on an antihistamine daily since. The pt was again evaluated by an Allergist on 5/11/10. He reported taking MOBIC (started in 2005) and LISINOPRIL (he has taken an ACEI intermittently since 2002). He stated that he has not had an episode of angioedema in 4 years. ESR, TSH, CH50, Thyroid Ab panel, ANA and C1 Esterase Inhibitor wnl. Angioedema determined to be not related to NSAIDs or ACEI. Continue with ZYRTEC qd, MEDROL DOSEPAK and EpiPen prn.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling face, Thyroxine free normal, Vaccine positive rechallenge
Clinical narrative: The patient received AVA #1 on 11/4/98 in his right upper arm at 1800. (Pt is right handed.) At the time he was healthy and taking no medications. At 2000 he noted that his lower lip was "tingling". When he woke in the am his lower lip was swollen. The pt wore braces at the time so he was referred to dental. (The pt wore braces from 1997-2000. He denies rash when wearing watch, rings, or metal belt buckles-no hx of nickel allergy). He was treated with resolution of sx in about two days. The pt denied having any other facial swelling, hives, SOB, N, V, diarrhea, congestion, rhinorrhea, cough, dysphagia, sneezing, watery eyes, lightheadedness, myalgias, arthralgias, swelling of the scrotum or penis. He also denied any recent dental work, trauma to lip, recent illness or recent consumption of cold/hot liquids. On 11/18/98 the pt received his second AVA. Within about 10 minutes he noted lower lip swelling (no SOB, chest pain, tingling, hives, or other constitutional sx). The pt went to dental and was escorted to medical where he was treated with IV SOLU-MEDROL and BENADRYL IM and admitted to the ward. The swelling subsided the next day. The pt continued with multiple episodes of facial swelling treated with episodic antihistamines and steroids. All lab tests have been negative. These episodes were not associated with a vaccination, food, drink, injury, or illness. He was referred to the Allergy Clinic on 4/26/99. CH50 was negative. The pt was diagnosed with recurrent angioedema and prescribed ZYRTEC 10mg qhs and an EpiPen. 6/02 the pt reported an episode where he woke up during the night with difficulty swallowing and breathing. According to this wife the pt's "throat/uvula" was swollen (no lip swelling or hives). She administered one dose of epinephrine and took the pt to the ER where he was treated with IV medications (records are not available). The pt was seen in follow-up on 6/27/02 and at that time he again had swelling of the lower lip. He was referred back to the Allergy Clinic. CBC, ESR, CH50, C4, C3, C1Q, TSH, T4, Thyroid Ab panel, RF and ANA were wnl. The was prescribed ZYRTEC, ATARAX 25mg qhs prn and PREDNISONE 20mg bid X 3 days as needed. It was recommended that the pt "avoid" ACE inhibitors for hypertension management (pt was on MONOPRIL at the time). He has been on an antihistamine daily since. The pt was again evaluated by an Allergist on 5/11/10. He reported taking MOBIC (started in 2005) and LISINOPRIL (he has taken an ACEI intermittently since 2002). He stated that he has not had an episode of angioedema in 4 years. ESR, TSH, CH50, Thyroid Ab panel, ANA and C1 Esterase Inhibitor wnl. Angioedema determined to be not related to NSAIDs or ACEI. Continue with ZYRTEC qd, MEDROL DOSEPAK and EpiPen prn.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Arthralgia, Colonoscopy normal, Dizziness
Clinical narrative: My daughter was given GARDASIL and within days she began having stomach pain and horrible hot flashes. After these initial symptoms, horrible joint pain, extreme fatigue, dizzy spells, extreme nausea and stomach pain all began. It has been 21 months, and we have spent countless in hours visiting numerous specialists, hospital visits, ER visits trying to find a diagnosis. I have questioned GARDASIL to all the doctors, and until yesterday I have been told there is no connection between my daughter's illness and the shot she received. The Chronic Pain Doctor we saw yesterday agrees that my daughter's illness was caused by the shot. My daughter will have to live with these symptoms, multiple daily medications, and therapies for the rest of her life all because of a shot that hadn't been fully investigated before it had been pushed on young girls.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Fibromyalgia, Hot flush, Laboratory test normal, Nausea
Clinical narrative: My daughter was given GARDASIL and within days she began having stomach pain and horrible hot flashes. After these initial symptoms, horrible joint pain, extreme fatigue, dizzy spells, extreme nausea and stomach pain all began. It has been 21 months, and we have spent countless in hours visiting numerous specialists, hospital visits, ER visits trying to find a diagnosis. I have questioned GARDASIL to all the doctors, and until yesterday I have been told there is no connection between my daughter's illness and the shot she received. The Chronic Pain Doctor we saw yesterday agrees that my daughter's illness was caused by the shot. My daughter will have to live with these symptoms, multiple daily medications, and therapies for the rest of her life all because of a shot that hadn't been fully investigated before it had been pushed on young girls.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: X-ray normal
Clinical narrative: My daughter was given GARDASIL and within days she began having stomach pain and horrible hot flashes. After these initial symptoms, horrible joint pain, extreme fatigue, dizzy spells, extreme nausea and stomach pain all began. It has been 21 months, and we have spent countless in hours visiting numerous specialists, hospital visits, ER visits trying to find a diagnosis. I have questioned GARDASIL to all the doctors, and until yesterday I have been told there is no connection between my daughter's illness and the shot she received. The Chronic Pain Doctor we saw yesterday agrees that my daughter's illness was caused by the shot. My daughter will have to live with these symptoms, multiple daily medications, and therapies for the rest of her life all because of a shot that hadn't been fully investigated before it had been pushed on young girls.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Chest discomfort, Cough, Oxygen saturation decreased, Wheezing
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cough in a 10-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), VARIVAX (non-gsk). The subject's medical history included sleep apnea (which was resolved). Concurrent medical conditions included bed wetting. Concurrent medications included multivitamins. On 13 September 2010 at 10:05 the subject received 2nd dose of HAVRIX at 0.5 ml in the left arm as well as a 2nd dose of VARIVAX (unknown). On 13 September 2010, less than one day after vaccination with HAVRIX, at an unspecified time after vaccination with VARIVAX, the subject experienced cough, wheezing, shortness of breath and decreased oxygen level. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was in the emergency room at the time of reporting. The events reportedly occurred right around the time of vaccinations, however, the time from vaccination to onset of events was not clear. At the time of reporting, the cough was improved and the other events were unresolved. In the reporter's opinion, the events were probably related to treatment with HAVRIX.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Cough, Dyspnoea, Oxygen saturation decreased, Wheezing
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cough in a 10-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), VARIVAX (non-gsk). The subject's medical history included sleep apnea (which was resolved). Concurrent medical conditions included bed wetting. Concurrent medications included multivitamins. On 13 September 2010 at 10:05 the subject received 2nd dose of HAVRIX at 0.5 ml in the left arm as well as a 2nd dose of VARIVAX (unknown). On 13 September 2010, less than one day after vaccination with HAVRIX, at an unspecified time after vaccination with VARIVAX, the subject experienced cough, wheezing, shortness of breath and decreased oxygen level. The healthcare professional considered the events were life threatening and clinically significant (or requiring intervention). The subject was in the emergency room at the time of reporting. The events reportedly occurred right around the time of vaccinations, however, the time from vaccination to onset of events was not clear. At the time of reporting, the cough was improved and the other events were unresolved. In the reporter's opinion, the events were probably related to treatment with HAVRIX.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Dizziness, Hypersensitivity, Throat tightness
Clinical narrative: Allergic reaction throat tightness, light-headed and dizziness, tightening in chest.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye pain, Hypoaesthesia, Pharyngeal oedema
Clinical narrative: The same day of vaccination in evening swollen throat/hoarse voice, "achy" eyes. That night she woke up with numb fingers on both hands - next morning sx resolved.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: Had hives on the (R) deltoid, on the shoulder/clavicle, on back, described them as big red itchy. Patient took BENADRYL has recovered.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Had hives on the (R) deltoid, on the shoulder/clavicle, on back, described them as big red itchy. Patient took BENADRYL has recovered.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: 5 x 6 cm. redness & swelling.
Age: 33.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal X-ray, Abdominal discomfort, Abdominal pain, Body temperature increased, Chills
Clinical narrative: 16 SEP-started to get upset stomach 17 SEP- upset stomach 18 SEP- lwr abd cramps, nausea, vomiting, diarrhea, chills, elev temp  19 SEP- lwr abd cramps, nausea, diarrhea, chills,  20 SEP- lwr abd cramps, some diarrhea, seen by doc with dx of viral syndrome- sick in quarters x 1 day. 21 SEP- back to normal 22 SEP- 1st solid stool -AM
Age: 33.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Full blood count, Nausea, Urine analysis, Viral infection
Clinical narrative: 16 SEP-started to get upset stomach 17 SEP- upset stomach 18 SEP- lwr abd cramps, nausea, vomiting, diarrhea, chills, elev temp  19 SEP- lwr abd cramps, nausea, diarrhea, chills,  20 SEP- lwr abd cramps, some diarrhea, seen by doc with dx of viral syndrome- sick in quarters x 1 day. 21 SEP- back to normal 22 SEP- 1st solid stool -AM
Age: 33.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: 16 SEP-started to get upset stomach 17 SEP- upset stomach 18 SEP- lwr abd cramps, nausea, vomiting, diarrhea, chills, elev temp  19 SEP- lwr abd cramps, nausea, diarrhea, chills,  20 SEP- lwr abd cramps, some diarrhea, seen by doc with dx of viral syndrome- sick in quarters x 1 day. 21 SEP- back to normal 22 SEP- 1st solid stool -AM
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Paraesthesia, Peripheral coldness
Clinical narrative: Tingling to bilateral feet, spreading into bilateral ankles starting an 10:00 PM and increasing in intensity. Feet also very cold to touch. Attempted to warm them with increase in tingling sensation as well as pain. Took Motrin at 11:30 PM which improved the pain. Continued tingling to present time.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood electrolytes abnormal, Borrelia test, Chills, Decreased appetite
Clinical narrative: Lost appetite, felt very weak and tired and had a fever of 101. Fever went up to 102 by evening and stayed at 102 for the next 24 hours. I contacted doctor's office twice and told them that I felt I had had a reaction to the shot. They told me that it must be something else that already existed when I came in. They asked me to come back in on 9/16/2010 ...I did. They did additional blood work and an ekg. The blood work showed that my electrolytes were a mess and I had a slightly elevated white blood cell count. They gave me Zithromax 250mill to take 2 the first day and one each day after for four more days. They also told me to take Tylenol for the fever.  I took the meds and stayed in bed. I continued to have fever and take Tylenol. I felt better but still weak on Sat. (they had me back in on Sat. for another blood work) Saturday evening my fever went up to 104 with no other symptoms. It was 104 for 14 hours along with severe chills. I finally was able to get it down to 101 and I put a call in to the doctor. This was on Sunday 9/19/2010. He told me not to take any more Tylenol and if the fever went back up to go to the emergency room. The fever gradually went back up to 104.2 and I arrived at the emergency room at 5:30 AM on Monday 9/20/2010. I have been until now..Wed. 9/22/2010 and am still waiting for some of the test results. They have not yet been able to determine what has caused my fever.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Influenza virus test, Pyrexia
Clinical narrative: Lost appetite, felt very weak and tired and had a fever of 101. Fever went up to 102 by evening and stayed at 102 for the next 24 hours. I contacted doctor's office twice and told them that I felt I had had a reaction to the shot. They told me that it must be something else that already existed when I came in. They asked me to come back in on 9/16/2010 ...I did. They did additional blood work and an ekg. The blood work showed that my electrolytes were a mess and I had a slightly elevated white blood cell count. They gave me Zithromax 250mill to take 2 the first day and one each day after for four more days. They also told me to take Tylenol for the fever.  I took the meds and stayed in bed. I continued to have fever and take Tylenol. I felt better but still weak on Sat. (they had me back in on Sat. for another blood work) Saturday evening my fever went up to 104 with no other symptoms. It was 104 for 14 hours along with severe chills. I finally was able to get it down to 101 and I put a call in to the doctor. This was on Sunday 9/19/2010. He told me not to take any more Tylenol and if the fever went back up to go to the emergency room. The fever gradually went back up to 104.2 and I arrived at the emergency room at 5:30 AM on Monday 9/20/2010. I have been until now..Wed. 9/22/2010 and am still waiting for some of the test results. They have not yet been able to determine what has caused my fever.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Viral test, White blood cell count increased
Clinical narrative: Lost appetite, felt very weak and tired and had a fever of 101. Fever went up to 102 by evening and stayed at 102 for the next 24 hours. I contacted doctor's office twice and told them that I felt I had had a reaction to the shot. They told me that it must be something else that already existed when I came in. They asked me to come back in on 9/16/2010 ...I did. They did additional blood work and an ekg. The blood work showed that my electrolytes were a mess and I had a slightly elevated white blood cell count. They gave me Zithromax 250mill to take 2 the first day and one each day after for four more days. They also told me to take Tylenol for the fever.  I took the meds and stayed in bed. I continued to have fever and take Tylenol. I felt better but still weak on Sat. (they had me back in on Sat. for another blood work) Saturday evening my fever went up to 104 with no other symptoms. It was 104 for 14 hours along with severe chills. I finally was able to get it down to 101 and I put a call in to the doctor. This was on Sunday 9/19/2010. He told me not to take any more Tylenol and if the fever went back up to go to the emergency room. The fever gradually went back up to 104.2 and I arrived at the emergency room at 5:30 AM on Monday 9/20/2010. I have been until now..Wed. 9/22/2010 and am still waiting for some of the test results. They have not yet been able to determine what has caused my fever.
Age: 1.46
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site increased redness/swollen/warm to touch
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction. Area became swollen and red, and also painful to the touch.
Age: 10.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Blood glucose increased, Body temperature increased, Chills, Decreased appetite, Influenza like illness
Clinical narrative: Flu-like symptoms - chills, achiness, poor appetite, temp 99.6. Blood sugar 411 (very elevated).
Age: 10.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Pain
Clinical narrative: Flu-like symptoms - chills, achiness, poor appetite, temp 99.6. Blood sugar 411 (very elevated).
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Inflammation, Tenderness
Clinical narrative: Inflamed right arm (inner upper arm & elbow area). Looks like cellulitis. Pt denies of fever but tender.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Local reaction
Clinical narrative: Large local reaction.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site movement impairment, Injection site pain
Clinical narrative: Severe pain, inability to use arm. Fever Tm = 103.7. Induration, erythema, swelling lasting x 4 days.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Severe pain, inability to use arm. Fever Tm = 103.7. Induration, erythema, swelling lasting x 4 days.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: TDAP 9/14/10 11AM - 12. Rash noted this AM. States friend saw rash 2-3d ago. Red, raised neck, back, chest.
Sex: M
Vaccine: PNC
Symptoms: Convulsion, Electroencephalogram abnormal, Infantile spasms, Unresponsive to stimuli
Clinical narrative: This case was considered medical important. Information regarding PREVENAR was received from a physician regarding an 11-month-old male patient who experienced seizure and infantile spasms. The patient received the second dose on 13-May-2010. The patient experienced seizure in May-2010, about 5 days after vaccination and infantile spasms on 19-May-2010. The mother described the seizures as the child was bearing down as if to have a bowel movement and would fling his arms around, then he was unresponsive for a few minutes. On an unknown date in May, the patient was taken to the Emergency Department and was admitted to the hospital. An EEG was performed on 19-May-2010, and the child was diagnosed with infantile spasms. He was treated with an unknown medication that did not seem to work. He was then started on a ketogenic diet, which seemed to help. The patient had no more seizures. The outcome of seizures and infantile spasms was resolved. No additional information was available at the time of this report.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Physical examination abnormal, VIIth nerve paralysis
Clinical narrative: paralysis of muscles on the left side of face, also known as Bell's Palsy