chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 73 year old male patient with pre-hypertension, hyperlipidaemia, disc degeneration, allergy to DARVON and a history of myalgia with simvastatin (MSD, WAES 1003USA01423) and LIPITOR, who on 01-MAR-2010, was vaccinated intramuscularly with a dose of PNEUMOVAX (lot number 663999/0624Y). Concomitant therapy included fish oil and red rice yeast pills. It was stated that the patient reported to his physician that he probably had not received PNEUMOVAX vaccine in the past. Two days later the patient saw the physician and reported left upper extremity redness and soreness that began on the night of 01-MAR-2010, and got progressive worse. The patient also reported that he might have received PNEUMOVAX vaccine before, prior to 01-MAR-2010. The physician gave DEPO-MEDROL 40 mg for 1 dose, ROCEPHIM 1 g 1 dose, KEFLEX 500 mg four times a day for 7 days and over the counter BENADRYL to resolve the adverse event. The adverse event resolved on 05-MAR-2010. No laboratory diagnostic studies were performed. Upon internal review left upper extremity redness and soreness was considered to be an other important medical event. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: R deltoid muscle soreness - worse with abduction of shoulder Follow-up: Patient stated "soreness started ever since she got the flu shot. Soreness when she bends her arm. Injection given 12/10/09.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Increased upper airway secretion, Irritability, Productive cough, Pyrexia
Clinical narrative: States child developed a fever that evening of 103 degrees. States had a slight cough and then later saw a visible rash on chest, back and legs. States child continue with a fever for several days and treated him with Tylenol every few hours. Mother did not seek medical attention or called her pediatrician. States did not want to go to ED on Saturday night because they would treat the child with Tylenol and release. Child was fussy but was always alert and drinking fluids well and urinating his normal amt. Child is awake, alert and cooperative. I was able to examine the rash which is on his face, back, chest, buttocks, upper legs. Rash are like tiny bumps, no redness or is not itchy and same size. Temp taken at clinic in ear was 97.6. Lungs are clear. Awake and alert and drinking orange juice from a sippy cup. States child has a fever for 3 days but did not recall how high it was since Saturday. States child cough up some yellowish phlegm a couple of days ago.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rash
Clinical narrative: States child developed a fever that evening of 103 degrees. States had a slight cough and then later saw a visible rash on chest, back and legs. States child continue with a fever for several days and treated him with Tylenol every few hours. Mother did not seek medical attention or called her pediatrician. States did not want to go to ED on Saturday night because they would treat the child with Tylenol and release. Child was fussy but was always alert and drinking fluids well and urinating his normal amt. Child is awake, alert and cooperative. I was able to examine the rash which is on his face, back, chest, buttocks, upper legs. Rash are like tiny bumps, no redness or is not itchy and same size. Temp taken at clinic in ear was 97.6. Lungs are clear. Awake and alert and drinking orange juice from a sippy cup. States child has a fever for 3 days but did not recall how high it was since Saturday. States child cough up some yellowish phlegm a couple of days ago.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, OPV, PPV, RVX
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: UNCONTROLLABLE MUSCLE MOVEMENTS, JERKING, FEVER OF 101.5 TEMPORAL WITH CHILDREN'S TYLENOL. UNCONTROLLED MUSCLE MOVEMENTS LASTING 3 DAYS.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: RASH, FEVER, LOSS OF APPETITE.  IRRITABLE
Age: 40.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: I took my vaccine on febr 15. The next day I began feeling extreme pain in my arm and its continue since now...  this is my 5th weeks  I can moved my arm good. I was taking ibuprofen I went to the doctor I went to the neurology and I'm in the process to know what I have...  doctors doesn't understand my pain.... I can Drive car, write, cook, I can sleep on night the pain is constantly, I will like to know how to procedure     the laboratory is Novartis.  Can you help me please.  I'm desperate with this...
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Local swelling, Lymph gland infection, Restlessness
Clinical narrative: Patient woke-up around 5:00 am and parent noticed swelling behind patient's right ear (approx size of a golf ball).  Patient had a very restless night sleep.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Mother noticed childs arm warm and swollen compared to other arm, which was also vaccinated, with no reaction.
Age: 82.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dizziness postural
Clinical narrative: Dizziness when getting out of bed this morning
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Seizure
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Dizziness, Headache, Pyrexia, Urine analysis normal
Clinical narrative: She had a fever of 103 the night of 3/16/2010 and 102 in the morning of 3/17/2010. She has bitemporal headache and little appetite. Denies dysuria, cough, or any irritation on site of vaccination. She is somewhat dizzy. No fever in office at 10:45 AM on 3/17/2010.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: fainted for appx 20 seconds
Age: 60.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chest X-ray, Ear, nose and throat examination, Electrocardiogram, Oropharyngeal pain
Clinical narrative: Woke up with a sore throat
Age: 50.0
Sex: F
Vaccine: HEPAB, MNQ, TYP
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Neck pain, Pain
Clinical narrative: Patient reported sharp generalized pain in entire right arm, with shooting pains up neck with warmth; felt lightheaded, had mild shortness of breath. Denied redness, swelling, and site tenderness of right deltoid; referred to urgent care after calling PCP; EKG performed to rule out cardiac event. Oral OTC pain medicine recommended.
Age: 50.0
Sex: F
Vaccine: HEPAB, MNQ, TYP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Patient reported sharp generalized pain in entire right arm, with shooting pains up neck with warmth; felt lightheaded, had mild shortness of breath. Denied redness, swelling, and site tenderness of right deltoid; referred to urgent care after calling PCP; EKG performed to rule out cardiac event. Oral OTC pain medicine recommended.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 12cm round red area to right deltoid (injection site) hot and tender to touch. Resp. even and unlabored. Lung field clear to auscultation. Patient alert and responsive, orientated x3. Treatment BENADRYL.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase increased, Gait disturbance, Injection site pain, Injection site swelling, Muscle fatigue
Clinical narrative: Left arm where I had the injection had been sore from the 1st day but increase got more sore. Then on 12/6/2009 it started to swell a little bit and by 12/12/2009 it was really swollen and my shoulder hurt pretty bad and I had a lot of fatigue in my muscles (upper arms and thighs). Scheduled and appoint with my general practioner but was unable to get in until the 12/21/09 by 12/18 my arm was more swollen my shoulder pain was unbearable along with fatigue. By the 12/21 I could barely walk the stairs. On 1/4/2010 finally some blood work was done and my CPK was 1505 and they put me on steroids, but would not say it was the result of the flu shot. I have been in an out of the doctors offices, general prationers, rheumatoglist and still have an elevated CPK at 240 to date (3/17/2009).  I wanted to report this because I believe it is related to my flu shot and would like to know if anyone else has experienced this and if so how long will it take to be well again.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm where I had the injection had been sore from the 1st day but increase got more sore. Then on 12/6/2009 it started to swell a little bit and by 12/12/2009 it was really swollen and my shoulder hurt pretty bad and I had a lot of fatigue in my muscles (upper arms and thighs). Scheduled and appoint with my general practioner but was unable to get in until the 12/21/09 by 12/18 my arm was more swollen my shoulder pain was unbearable along with fatigue. By the 12/21 I could barely walk the stairs. On 1/4/2010 finally some blood work was done and my CPK was 1505 and they put me on steroids, but would not say it was the result of the flu shot. I have been in an out of the doctors offices, general prationers, rheumatoglist and still have an elevated CPK at 240 to date (3/17/2009).  I wanted to report this because I believe it is related to my flu shot and would like to know if anyone else has experienced this and if so how long will it take to be well again.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hyporeflexia, Immunoglobulin therapy
Clinical narrative: Pt presented to the hospital with progressive weakness. Pt has bilateral and symmetrical weakness and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Lumbar puncture abnormal, Protein total increased
Clinical narrative: Pt presented to the hospital with progressive weakness. Pt has bilateral and symmetrical weakness and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Age: 1.53
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Syncope
Clinical narrative: Fever a few hours after vaccine administered. Fever of aprox 105.0  Fahrenheit for 5 days. Pt fainted 2 times on 3/16/10. Rash on face and chest developed on 3/15/10.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Hypoaesthesia, Malaise, Pallor
Clinical narrative: Patient felt "sick," dizzy, and developed numbness in her fingers. this lasted for 30 seconds. She felt as though she was going to "pass out," but she never lost consciousness or vision. She was provided water and orange juice, and she felt better. Her systolic blood pressure dropped from 90s to 70s, but went back up to the 90s over an hour or two. Pallor, but no rashes. no cough, wheezing, nausea, vomiting, diarrhea, chest pain, or headache.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Patient felt "sick," dizzy, and developed numbness in her fingers. this lasted for 30 seconds. She felt as though she was going to "pass out," but she never lost consciousness or vision. She was provided water and orange juice, and she felt better. Her systolic blood pressure dropped from 90s to 70s, but went back up to the 90s over an hour or two. Pallor, but no rashes. no cough, wheezing, nausea, vomiting, diarrhea, chest pain, or headache.
Age: 41.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Acute myocardial infarction, Electrocardiogram abnormal
Clinical narrative: This report was received from the investigator in the above mentioned trial on 05 March 2010. A 41-year-old male subject received ACAM2000 (lot number not reported) on 14 May 2009. Two days prior, on 12 May 2009, the subject received anthrax vaccine (manufacturer and lot number were not reported). Thirteen days after receipt of ACAM2000, the subject reportedly experienced an acute myocardial infarction. An electrocardiogram, performed Day 13, was reported as abnormal. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 58.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, CSF protein abnormal, Chest pain, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: Pt presented to the hospital with chest pain. Pt had bilateral and symmetrical weakness and decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome after rule out of myocardial infarction.
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Lip swelling, Oral herpes
Clinical narrative: Fever blisters on top of upper lip on the right side of her mouth. Self treated with Benadryl. Lip is swollen also.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Borrelia test negative, Dysphagia, Facial palsy, Facial paresis, Hypoaesthesia
Clinical narrative: On 01/12/2010, patient experienced numbness and tingling in three fingers of her right handand right side of her face which made it difficult for her to eat and swallow.  The patient was evaluated on 1/14/2010 at the facility at which time the Nurse practioner noted the numbness and weakness of the facial muscles and included Bells Palsy in the differential diagnosis.  Patient was evaluated by a neurologist who was aware of the vaccination history but made no mention of the correlation or temporal association.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia facial, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: On 01/12/2010, patient experienced numbness and tingling in three fingers of her right handand right side of her face which made it difficult for her to eat and swallow.  The patient was evaluated on 1/14/2010 at the facility at which time the Nurse practioner noted the numbness and weakness of the facial muscles and included Bells Palsy in the differential diagnosis.  Patient was evaluated by a neurologist who was aware of the vaccination history but made no mention of the correlation or temporal association.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphemia, Speech disorder
Clinical narrative: Our 2-year-old son has begun to repeat his words when speaking at the beginning of sentences. It is somewhat like a stutter except it is the whole word and not just the initial sound. I know that may not seem like such a big deal since he is only two but this child has been forming sentences since October '09 (1 year, 9 months in age) and has not exhibited any trouble with his speech. I haven't read anything about this being a possible side effect but there is a direct correlation between his receiving the Hep A vaccine and his compulsion to repeat the first word in his sentences. What do I do? Will this go away? It's been 2 weeks and he's still doing it. Should he get the follow-up dose? Has anyone else had this problem? Please help.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Balance disorder, Blood cholesterol, Blood test, Borrelia test
Clinical narrative: flu like symptons,  high fever, pain, spasms,tremmors, hot,cold sweats,loss of balance, numbness in extremetys,tingling in extremetrys, partial paralisis, respitory loss 2/3, extreme weakness, loss of bowl and bladder control, incomplete evacuation  feeling,partial loss of vision, went to Doctor office 7 or 8 times in 10 wks, emergency room 2 times onnce by ambulance, no one could find anything wrong, treatment was morphine in E Room, and norco pain pills by Dr.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Cold sweat, Colonoscopy, Computerised tomogram, Electrocardiogram, Faecal incontinence
Clinical narrative: flu like symptons,  high fever, pain, spasms,tremmors, hot,cold sweats,loss of balance, numbness in extremetys,tingling in extremetrys, partial paralisis, respitory loss 2/3, extreme weakness, loss of bowl and bladder control, incomplete evacuation  feeling,partial loss of vision, went to Doctor office 7 or 8 times in 10 wks, emergency room 2 times onnce by ambulance, no one could find anything wrong, treatment was morphine in E Room, and norco pain pills by Dr.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Hyperhidrosis, Hypoaesthesia, Influenza like illness, Lumbar puncture
Clinical narrative: flu like symptons,  high fever, pain, spasms,tremmors, hot,cold sweats,loss of balance, numbness in extremetys,tingling in extremetrys, partial paralisis, respitory loss 2/3, extreme weakness, loss of bowl and bladder control, incomplete evacuation  feeling,partial loss of vision, went to Doctor office 7 or 8 times in 10 wks, emergency room 2 times onnce by ambulance, no one could find anything wrong, treatment was morphine in E Room, and norco pain pills by Dr.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Muscle spasms, Nuclear magnetic resonance imaging, Pain, Paraesthesia, Paralysis
Clinical narrative: flu like symptons,  high fever, pain, spasms,tremmors, hot,cold sweats,loss of balance, numbness in extremetys,tingling in extremetrys, partial paralisis, respitory loss 2/3, extreme weakness, loss of bowl and bladder control, incomplete evacuation  feeling,partial loss of vision, went to Doctor office 7 or 8 times in 10 wks, emergency room 2 times onnce by ambulance, no one could find anything wrong, treatment was morphine in E Room, and norco pain pills by Dr.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Respiratory disorder, Scan, Sleep study, Spirometry
Clinical narrative: flu like symptons,  high fever, pain, spasms,tremmors, hot,cold sweats,loss of balance, numbness in extremetys,tingling in extremetrys, partial paralisis, respitory loss 2/3, extreme weakness, loss of bowl and bladder control, incomplete evacuation  feeling,partial loss of vision, went to Doctor office 7 or 8 times in 10 wks, emergency room 2 times onnce by ambulance, no one could find anything wrong, treatment was morphine in E Room, and norco pain pills by Dr.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Tremor, Urinary incontinence, Urine analysis, Visual acuity reduced, X-ray
Clinical narrative: flu like symptons,  high fever, pain, spasms,tremmors, hot,cold sweats,loss of balance, numbness in extremetys,tingling in extremetrys, partial paralisis, respitory loss 2/3, extreme weakness, loss of bowl and bladder control, incomplete evacuation  feeling,partial loss of vision, went to Doctor office 7 or 8 times in 10 wks, emergency room 2 times onnce by ambulance, no one could find anything wrong, treatment was morphine in E Room, and norco pain pills by Dr.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood test, Dizziness, Headache, Hypersomnia, Influenza like illness
Clinical narrative: Severe flu-like symptoms within 24 hours including body aches, stiffness, headaches and dizziness. Began sleeping 16 hours/day. Saw FNP on 2/18 advised to go to emergency. Was diagnosed with viral meningitis at emergency hospital.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lumbar puncture, Meningitis viral, Musculoskeletal stiffness, Pain
Clinical narrative: Severe flu-like symptoms within 24 hours including body aches, stiffness, headaches and dizziness. Began sleeping 16 hours/day. Saw FNP on 2/18 advised to go to emergency. Was diagnosed with viral meningitis at emergency hospital.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody positive, Biopsy skin abnormal, C-reactive protein decreased, Listless, Oedema peripheral
Clinical narrative: Initial health authority (NO-NOMAADVRE-FHI-2010-10087b) received on 12 Mar 2010. This patient with medical history of eczema to sun, was vaccinated with influenza virus vaccine (manufacturer unknown) on 01 Nov 2008. The patient presented with Sjogren's syndrome and systemic sclerosis on 15 Nov 2008. The patient also presented with listlessness, pain in forearm and swelling of hand after one month of vaccination. Debut of specific symptoms was relatively acute after vaccination. Final outcome of the events was reported as condition unchanged. Health authority causality was reported as possible.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sjogren's syndrome, Systemic sclerosis
Clinical narrative: Initial health authority (NO-NOMAADVRE-FHI-2010-10087b) received on 12 Mar 2010. This patient with medical history of eczema to sun, was vaccinated with influenza virus vaccine (manufacturer unknown) on 01 Nov 2008. The patient presented with Sjogren's syndrome and systemic sclerosis on 15 Nov 2008. The patient also presented with listlessness, pain in forearm and swelling of hand after one month of vaccination. Debut of specific symptoms was relatively acute after vaccination. Final outcome of the events was reported as condition unchanged. Health authority causality was reported as possible.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site vesicles, Skin lesion
Clinical narrative: Vesicular lesion x2 developed at the site of the vaccination around 10 days after administration. 3/17/10 spoke with mother, pt did not develop more pox.
Age: 0.01
Sex: F
Vaccine: MMR, TDAP, VARCEL, VARCEL
Symptoms: Culture positive, Polymerase chain reaction, Skin lesion, Varicella
Clinical narrative: Mom received VARIVAX shot postpartum in hospital on Jan 25, 23 day old infant dtr became infected with chickenpox. Lab confirmed case on lesions 2/14 afebrile, had mild case with no complications. Possible vaccine induced chickenpox from VARIVAX given to mom.
Age: 0.01
Sex: F
Vaccine: MMR, TDAP, VARCEL, VARCEL
Symptoms: Full blood count normal, Genotype drug resistance test positive, Polymerase chain reaction, Rash vesicular, Skin lesion
Clinical narrative: Mom received VARIVAX shot postpartum in hospital on Jan 25, 23 day old infant dtr became infected with chickenpox. Lab confirmed case on lesions 2/14 afebrile, had mild case with no complications. Possible vaccine induced chickenpox from VARIVAX given to mom.
Age: 0.01
Sex: F
Vaccine: MMR, TDAP, VARCEL, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Mom received VARIVAX shot postpartum in hospital on Jan 25, 23 day old infant dtr became infected with chickenpox. Lab confirmed case on lesions 2/14 afebrile, had mild case with no complications. Possible vaccine induced chickenpox from VARIVAX given to mom.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pyrexia, Tenderness
Clinical narrative: Received shot on 11/04/09. That evening had fever with redness and swelling at site. Her fever increased to 104 degrees F on 11/05/09. That day the redness expanded to approximately 20 cm. She also complained of shortness of breath starting one day after administration. She began taking BENADRYL & Ibuprofen two days after injection. Still complains of tenderness & redness six days later.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Cough, Erythema, Eye pain, Headache, Injection site erythema
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site oedema, Injection site pain, Injection site pruritus, Injection site streaking, Oropharyngeal pain
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Pruritus, Rhinorrhoea, Skin warm, Swelling, Tenderness
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Tinnitus
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Arthralgia, Erythema, Eye pain, Feeling hot, Headache
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site reaction, Injection site streaking
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Lymph node pain, Lymphadenopathy, Musculoskeletal pain, Oropharyngeal pain, Pruritus
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 23.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rhinorrhoea, Somnolence, Tinnitus, Wound secretion
Clinical narrative: 3 day onset of increasing redness with streaking, axillary swelling and tenderness, and headache following receipt of 3/4/10 SPV vaccine to left deltoid. She advised she had a mild cold (runny nose) when given vaccine..had had on and off for a few months. Pt reported normal take with pustule until 3/11/10 when she noted increased swelling/tenderness to left axillary region (nodes), site itching, redness and oozing and mild ache to top of left shoulder (point to trapizus muscle). On 3/13/10 she began to feel warm (no fever), had a sore throat, runny nose, and her ears were popping (similar to past colds). Her headache (dull ache to top of head/forehead) was worse and her eyes hurt to move. She denied any n/v/d, photo/phonophobia, sob, cp, limitation in ROM left arm, neck pain or any paresthesia left arm. By 3/14 the redness had extended past the dressing site and was streaking to axillary area. There was no change in HA or shoulder discomfort. She slept all day. She reported to medical on 3/15/10 concerned about site redness and streaking. She took 1600 mg MOTRIN with food for HA and shoulder pain with improvement. Symptoms: edema @ injection site <30 mm, headache, general joint pain, isolated, erythema, pruritus.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Mass, Pain in extremity, Tenderness
Clinical narrative: Received 1st GARDASIL inj 3/4 arm has been sore since, noticed lump 3/9 - tender when trying to exercise pt informed to call Mon and make appt if not better or sooner if nec. 3/12 pt called with numbness in arm instructed to go to ER - seen in ER 3/12 made appt to be seen in office for follow-up 3/12/10 pt called and cancelled appt she made.
Age: 9.0
Sex: F
Vaccine: FLUN(H1N1), VARCEL
Symptoms: Dermatitis, Rash, Rash pruritic
Clinical narrative: 3/9/10 Rash appeared on trunk, back, face, arms and legs. Fine rash, itchy at first. Used Calamine lotion. 3/10/10 patient taken to Hosp. ER and Dx Dermatitis, Hydrocortisone cream recommended and used. Follow up with PCP recommended. Appointment scheduled for pt with Dr.  3/18/10.
Age: 25.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Facial palsy
Clinical narrative: Sx of Bells' Palsy
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Pain
Clinical narrative: Pt complained of headache and body aches.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Blood test, Body temperature fluctuation, Cold sweat
Clinical narrative: High fever, big knot on R arm, redness, rash, loss of bowel control, trembling, numbness in extremities, tingling, severe nerve pain, partial loss of vision, spasms, cramps, loss of balance, weakness, loss of full respiratory function, hot and cold sweats, sub normal temp 95.4, to high of 104 degrees F.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Erythema, Faecal incontinence, Hyperhidrosis, Hypoaesthesia
Clinical narrative: High fever, big knot on R arm, redness, rash, loss of bowel control, trembling, numbness in extremities, tingling, severe nerve pain, partial loss of vision, spasms, cramps, loss of balance, weakness, loss of full respiratory function, hot and cold sweats, sub normal temp 95.4, to high of 104 degrees F.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscle spasms, Neuralgia, Nodule, Nuclear magnetic resonance imaging
Clinical narrative: High fever, big knot on R arm, redness, rash, loss of bowel control, trembling, numbness in extremities, tingling, severe nerve pain, partial loss of vision, spasms, cramps, loss of balance, weakness, loss of full respiratory function, hot and cold sweats, sub normal temp 95.4, to high of 104 degrees F.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pyrexia, Rash, Respiratory disorder, Tremor
Clinical narrative: High fever, big knot on R arm, redness, rash, loss of bowel control, trembling, numbness in extremities, tingling, severe nerve pain, partial loss of vision, spasms, cramps, loss of balance, weakness, loss of full respiratory function, hot and cold sweats, sub normal temp 95.4, to high of 104 degrees F.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis, Visual acuity reduced, X-ray
Clinical narrative: High fever, big knot on R arm, redness, rash, loss of bowel control, trembling, numbness in extremities, tingling, severe nerve pain, partial loss of vision, spasms, cramps, loss of balance, weakness, loss of full respiratory function, hot and cold sweats, sub normal temp 95.4, to high of 104 degrees F.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Hypoaesthesia, Muscular weakness, Pain in extremity
Clinical narrative: Feet began to hurt 3/1/10. With steadily increasing discomfort over several days. Feet and fingers progressively became numb. By 3/10/10 hands and feet to mid calves were numb and weak.
Age: 1.26
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Had varicella vaccine and developed chickenpox from vaccine. Lesions
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pallor
Clinical narrative: Localized 6 cm x 6 cm red blanching area over right deltoid, slightly warm, nontender.
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Myalgia, Nausea, Oedema peripheral, Rash
Clinical narrative: Moderate pain in muscle of arm 8/10 even after ibuprofen, swelling, rash on arm, tiredness, mild nausea
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Erythema, Fatigue, Induration, Nausea, Skin warm
Clinical narrative: Moderate pain in muscle of arm 8/10 even after ibuprofen, swelling, rash on arm, tiredness, mild nausea
Age: 11.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Tenderness
Clinical narrative: Moderate pain in muscle of arm 8/10 even after ibuprofen, swelling, rash on arm, tiredness, mild nausea
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned to Urgent Care 6 days after administration stating that hardness, redness, swelling, warmth to area she received her tetanus immunization has increased daily since 2 days after receiving immunization.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Myoclonus, Pyrexia
Clinical narrative: Fever and myoclonic jerks the day after the vaccines were given. The jerks quit after his fever was treated and he recovered.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: 10cmx10cm swelling.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, Medication error
Clinical narrative: A non- serious event of "we gave expired vaccine to a four-year-old patient" was received from a health professional concerning a four-year-old female patient. The patient's medical history was not provided. On 04-Feb-2010, the patient was inadvertently administered FluMist that expired on 24-Jan-2010. There was no adverse associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FluMist.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired dose of FLUMIST was received from a healthcare professional concerning a 36-month-old female. The product expired on 05-Feb-2010 and the patient received the expired product on 11-Feb-2010. There were no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Bacterial test positive, Constipation, Decreased appetite, Nitrite urine present
Clinical narrative: A serious report of urinary tract infection, constipation and tachycardia has been received from a study investigator concerning a 33-month-old female participating in a post-marketing study for FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The subject's medical history and concomitant medications were not reported. The subject received FluMist nasally, 0.25 ml per nostril, on 08-Oct-2009. The subject received one dose before the onset of the event. On 13-Nov-2009, the subject was admitted to the hospital for abdominal pain. In the morning of the admission day, she was in usual state of health and ate breakfast. Later, the subject did not eat as much as usual and then complained of abdominal pain around her belly button and preferred to be still and lie in a ball. On arrival in Emergency room, she was relaxed and lying with her legs extended. The subject was learning to potty-train and apparently held her urine because did not like to use toilet. She denied any fever, vomiting, diarrhea, runny nose, cough or other symptoms, but had tachycardia. She also had constipation and was admitted for observation. The subject was given glycerin suppository, and abdominal pain was resolved. She was also started on Cephalexin. On 14-Nov-2009, the subject was discharged from the hospital. The events of tract infections, constipation and tachycardia were resolved on 14-Nov-2009. The investigator assessed the causality for the events to FluMist as not related. The severity of the events was mild. Alternative etiology for the events was toilet training. The sponsor also assessed the causality for the events as not related to FluMist.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Red blood cells urine, Tachycardia, Urinary tract infection, Urine leukocyte esterase, White blood cells urine positive
Clinical narrative: A serious report of urinary tract infection, constipation and tachycardia has been received from a study investigator concerning a 33-month-old female participating in a post-marketing study for FluMist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The subject's medical history and concomitant medications were not reported. The subject received FluMist nasally, 0.25 ml per nostril, on 08-Oct-2009. The subject received one dose before the onset of the event. On 13-Nov-2009, the subject was admitted to the hospital for abdominal pain. In the morning of the admission day, she was in usual state of health and ate breakfast. Later, the subject did not eat as much as usual and then complained of abdominal pain around her belly button and preferred to be still and lie in a ball. On arrival in Emergency room, she was relaxed and lying with her legs extended. The subject was learning to potty-train and apparently held her urine because did not like to use toilet. She denied any fever, vomiting, diarrhea, runny nose, cough or other symptoms, but had tachycardia. She also had constipation and was admitted for observation. The subject was given glycerin suppository, and abdominal pain was resolved. She was also started on Cephalexin. On 14-Nov-2009, the subject was discharged from the hospital. The events of tract infections, constipation and tachycardia were resolved on 14-Nov-2009. The investigator assessed the causality for the events to FluMist as not related. The severity of the events was mild. Alternative etiology for the events was toilet training. The sponsor also assessed the causality for the events as not related to FluMist.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest X-ray abnormal, Condition aggravated, Cough, Dehydration, Dyspnoea
Clinical narrative: A serious report of pneumonia, pleural effusion, and dehydration has been received from a study investigator concerning a 34-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. The subject received FLUMIST nasally, 0.25 ml per nostril, on 06-Oct-2009. The subject received one dose before the onset of the event. The subject presented to the Emergency department with respiratory distress. Initial symptoms of fever, cough, rhinorrhea, vomiting, and body ache began approximately ten days prior to admission, and this was thought to be influenza. No treatment was initiated at that time. The subject returned four days later with increased work of breathing and continued fever. Chest x-ray demonstrated right lower lobe (RLL) infiltrate, and the subject started on OMNICEF. His fever subsided shortly thereafter, though his breathing continued worsen. The subject's parents noted shallow rapid breathing and difficulty to breath. This prompted their visit to the Emergency department on 30-Oct-2009. At the Emergency department, the subject had tachypnea and shallow breathing, although 02 saturation were stable. He received salbutamol for poor aeration on the right without much improvement. Repeat chest x-rays demonstrated worsening RLL pneumonia and pleural effusion. The subject was treated with intravenous antibiotics. The events were resolved on 03-Nov-2009. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. Alternative etiology for the events was natural causes. The sponsor also assessed the causality for the events as not related to FLUMIST.