chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Skin warm
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 72 year old white female patient with anxiety, cholesterol, hypertension and diabetes mellitus who in 2003 was vaccinated with a dose of Pneumovax 23 and on 15-NOV-2007 received IM another dose of Pneumovax 23 lot # 654977/0888F. Concomitant therapy included EFFEXOR, LIPITOR, fosinopril sodium, lorazepam and metformin. The nurse reported that on 16-NOV-2007 the patient called and complained of discomfort in inner aspect of right arm with redness and warmth (Bicep). Injection site was unremarkable. Azithromycin (Z pack) was given to her and warm compress was recommended. The patient recovered. The reporter felt that the patient getting Azithromycin (Z pack) and recommending her warm compress was to prevent patient from being serious and considered this as a serious other medical event. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: DT, HEPA
Symptoms: Malaise, Pain, Pyrexia, Swelling
Clinical narrative: Vaccine was administered in deltoid muscles, one each side.  On the day following the vaccinations, both sides of jaw were noted by spouse to be swollen; confirmed by patient and complains of pain upon opening mouth widely.  Also general malaise and fever.  Consulted personal MD office by phone and was advised to seek emergency care if symptoms worsened.  Symptoms seemed to subside toward evening, but returned the next day.  Went to personal physician - diagnosis vaccine reaction; Rx rest, oral fluids, aspirin prn pain or discomfort; expect complete recovery in several days.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: Had Intranasal Flu vaccine at around 2:00 p.m. and went back to school, after receiving 2 tsp. Ibuprofen syrup.  Mother brought him back about 4 p.m. saying he got off the bus itching and with hives on neck, chest, abdomen, back, no difficulty breathing.  We gave him Zyrtec 7.5 ml. and kept him about 40 minutes.  He developed no further symptoms but remained with hives.  Sent him home with Benadryl chewable tablets to take at bedtime for hives. Called mother this morning, she said he was fine, hives were gone by time they got home yesterday.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy, Ophthalmoplegia
Clinical narrative: facial assymetry, Drooping of unilateral eye/corner of mouth.  Only able to close one eye, other has to be taped shut at night. 12/12/07-records received-11/9/07-Bell's Palsy-presented with C/O pain left side of mouth and twitching of face. Facial drooping on left began 4 days after vaccination. Unable to close her left eye. In office no facial twitching noted.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: 7 cm area of erythema,edema and tenderness to site of vaccination.Low grade fever.              Vaccination was 12/5/07.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dry mouth, Oedema peripheral, Pain, Skin warm, Tinnitus
Clinical narrative: Client went to see physician this AM.  when he started having symptoms of ringing in ears and dry mouth, and feeling achy early this AM.  At that time his left arm and axillary area started swelling and became hot to touch. He received Toredol IM for pain and was sent home with an RX for Toredol.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Patient complains of soreness at sight of injection.  Needs over the counter medicine to relieve pain.  States he takes tylenol each morning for the pain.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: 12/6/07 Patient observed with right deltoid having 5 x 8 cm. area with significant swelling, redness, nontender, warm to touch. Following injection in the AM 12/05/07 patient went swimming that evening. 12/7/07 patient rechecked and area with less redness but increased swelling.  Benadryl given in office 12/6/07 and instructions to continue every 4-6 hours in additon to applications of cold/ice to area.  To follow-up if worsens.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, HEAT, SWELLING AROUND INJECTION SITE ,PATIENT NOTICED 3 DAYS AFTER INJECTION GIVEN.                                           FAMILY PHYSICIAN ON DAY 4 AFTER INJECTION TREATED PATIENT WITH PREDNISONE 20MG QD X3D, ZYRTEC 10MG QD X3D, AND AUGMENTIN 500MG BID X5D
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, FLUN3, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: entire left upper arm is red after the vaccine was given (12/4/07) with darker red area where it was more swollen yesterday.  Immunization site noted in center of the erythematous area. Given Benadryl by mother. Advised cold compresses.
Age: 23.0
Sex: F
Vaccine: FLUN3, HEPAB, YF, FLUN3, HEPAB, YF
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Patient exhibited hives difficulty breathing and felt like her throat was closing up greater than a hour after receiving vaccinations. Pt went to facility and recieved Benadryl, Solumedrol and epinephrine and albuterol nebulizer and IV Fluids.
Age: 23.0
Sex: F
Vaccine: FLUN3, HEPAB, YF, FLUN3, HEPAB, YF
Symptoms: Cough, Dyspnoea, Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Patient exhibited hives difficulty breathing and felt like her throat was closing up greater than a hour after receiving vaccinations. Pt went to facility and recieved Benadryl, Solumedrol and epinephrine and albuterol nebulizer and IV Fluids.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal oedema
Clinical narrative: throat swelled hard to breathe,I was rushed  to the hospital and on route to the hospital I was given a shot and in the hospital I was given another shot to stop and prevent any further swelling of my throat
Age: 13.0
Sex: F
Vaccine: DTAP, FLU3, HPV4
Symptoms: Medication error, Wrong drug administered
Clinical narrative: DTap administered inadvertently as adolescent dose of tetanus/diphtheria/pertussis vaccine (instead of Tdap). No known adverse event associated as of 12/7/2007.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Adnexa uteri pain, Anaemia, Arthralgia, Diarrhoea, Dizziness
Clinical narrative: I received my first Gardasil vaccine Sept. 12, 2007 and reluctantly received my second one on Nov. 12, 2007. I also had blood work done while I was at the Dr's. office Sept. 12, 2007 which came back completely normal. On Sept. 30, 2007 I began to have horrible pain in my lower abdomen (mainly my ovaries). I then began having irregular periods-to every extreme of irregular. The timing is off-way off, the flow is extremely heavy-I have clots in my blood now, the length of my periods has almost doubled, the pain is so severe-I can not even get out of bed half of the time, I began having nausea and vomiting, headaches, fever, diarrhea, dizziness, aneamia, weight gain, and major pain in the joint of the middle toe on my left foot. These symptoms have not subsided since Sept. 30th. I made a visit to my gynecologist  and reported the symptoms and told him that I think it is linked with the vaccine and he said that it was just a coincidence and acted like it was no big deal. I have had 8 periods from Sept. 30th-Dec. 7th-to me that is a big deal. I had to go to the emergency room Nov. 18th, 2007 because the symptoms and bleeding were so severe-the e.r. doctor did blood work and said my blood count was pretty low and that I was aneamic and told me to begin iron supplements. He also gave me prescriptions for ibuprofen, provera, and phenergan and told me to see my gyno asap. I did not take the provera. I got in with my gynecologist two days later and he still acted like it was not a big deal. He did an ultrasound and put me on birth control. Since then I have still not gotten any relief and I made a call to his office two days ago to let them know and his nurse told me that if it is not better by Mon. (Dec. 10th) to call back. It is now Friday (Dec. 7th,2007)and my period is just as heavy and painful today as it was last Monday (Dec. 3rd). I have NEVER had ANY health concerns and I have never been sexually active, I am a virgin-so I thought the vaccine would be beneficial for me. I think I made a major mistake by getting this vaccine. I now have major concerns about my current health. I am worried and scared that I may never be able to have children and that this is going to do permanent damage. I have NEVER had any irregular periods in all of my years of having them. I really hate that this is happening to me and that no one can give me any answers-but most of all I would hate for this to happen to others. I have a strong feeling that Gardasil is the cause of all of my problems because I have discovered some people that have the same symptoms that have received this vaccine. This needs to be researched. Please help me.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Menorrhagia, Menstruation irregular, Nausea, Pyrexia
Clinical narrative: I received my first Gardasil vaccine Sept. 12, 2007 and reluctantly received my second one on Nov. 12, 2007. I also had blood work done while I was at the Dr's. office Sept. 12, 2007 which came back completely normal. On Sept. 30, 2007 I began to have horrible pain in my lower abdomen (mainly my ovaries). I then began having irregular periods-to every extreme of irregular. The timing is off-way off, the flow is extremely heavy-I have clots in my blood now, the length of my periods has almost doubled, the pain is so severe-I can not even get out of bed half of the time, I began having nausea and vomiting, headaches, fever, diarrhea, dizziness, aneamia, weight gain, and major pain in the joint of the middle toe on my left foot. These symptoms have not subsided since Sept. 30th. I made a visit to my gynecologist  and reported the symptoms and told him that I think it is linked with the vaccine and he said that it was just a coincidence and acted like it was no big deal. I have had 8 periods from Sept. 30th-Dec. 7th-to me that is a big deal. I had to go to the emergency room Nov. 18th, 2007 because the symptoms and bleeding were so severe-the e.r. doctor did blood work and said my blood count was pretty low and that I was aneamic and told me to begin iron supplements. He also gave me prescriptions for ibuprofen, provera, and phenergan and told me to see my gyno asap. I did not take the provera. I got in with my gynecologist two days later and he still acted like it was not a big deal. He did an ultrasound and put me on birth control. Since then I have still not gotten any relief and I made a call to his office two days ago to let them know and his nurse told me that if it is not better by Mon. (Dec. 10th) to call back. It is now Friday (Dec. 7th,2007)and my period is just as heavy and painful today as it was last Monday (Dec. 3rd). I have NEVER had ANY health concerns and I have never been sexually active, I am a virgin-so I thought the vaccine would be beneficial for me. I think I made a major mistake by getting this vaccine. I now have major concerns about my current health. I am worried and scared that I may never be able to have children and that this is going to do permanent damage. I have NEVER had any irregular periods in all of my years of having them. I really hate that this is happening to me and that no one can give me any answers-but most of all I would hate for this to happen to others. I have a strong feeling that Gardasil is the cause of all of my problems because I have discovered some people that have the same symptoms that have received this vaccine. This needs to be researched. Please help me.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Thrombosis, Vomiting, Weight increased
Clinical narrative: I received my first Gardasil vaccine Sept. 12, 2007 and reluctantly received my second one on Nov. 12, 2007. I also had blood work done while I was at the Dr's. office Sept. 12, 2007 which came back completely normal. On Sept. 30, 2007 I began to have horrible pain in my lower abdomen (mainly my ovaries). I then began having irregular periods-to every extreme of irregular. The timing is off-way off, the flow is extremely heavy-I have clots in my blood now, the length of my periods has almost doubled, the pain is so severe-I can not even get out of bed half of the time, I began having nausea and vomiting, headaches, fever, diarrhea, dizziness, aneamia, weight gain, and major pain in the joint of the middle toe on my left foot. These symptoms have not subsided since Sept. 30th. I made a visit to my gynecologist  and reported the symptoms and told him that I think it is linked with the vaccine and he said that it was just a coincidence and acted like it was no big deal. I have had 8 periods from Sept. 30th-Dec. 7th-to me that is a big deal. I had to go to the emergency room Nov. 18th, 2007 because the symptoms and bleeding were so severe-the e.r. doctor did blood work and said my blood count was pretty low and that I was aneamic and told me to begin iron supplements. He also gave me prescriptions for ibuprofen, provera, and phenergan and told me to see my gyno asap. I did not take the provera. I got in with my gynecologist two days later and he still acted like it was not a big deal. He did an ultrasound and put me on birth control. Since then I have still not gotten any relief and I made a call to his office two days ago to let them know and his nurse told me that if it is not better by Mon. (Dec. 10th) to call back. It is now Friday (Dec. 7th,2007)and my period is just as heavy and painful today as it was last Monday (Dec. 3rd). I have NEVER had ANY health concerns and I have never been sexually active, I am a virgin-so I thought the vaccine would be beneficial for me. I think I made a major mistake by getting this vaccine. I now have major concerns about my current health. I am worried and scared that I may never be able to have children and that this is going to do permanent damage. I have NEVER had any irregular periods in all of my years of having them. I really hate that this is happening to me and that no one can give me any answers-but most of all I would hate for this to happen to others. I have a strong feeling that Gardasil is the cause of all of my problems because I have discovered some people that have the same symptoms that have received this vaccine. This needs to be researched. Please help me.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mother called AM of 11/15/07 and stated patient could not move his arm.  When questioned further she state patient can move arm but complaining of pain at injection site, redness and swelling. Injection site was right arm
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day after vaccine given site was black and blue, next day red and swollen about 2 inches diameter, tender. Patient took Sudafed.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Cold sweat, Hypersomnia, Injection site oedema, Pain in extremity
Clinical narrative: Pt received injection 12/5/07 at 1PM- per pt, around 4PM edema around injection site, severe Left arm pain- "could barely move it", facial swelling-periorbital edema and 'tingling lips'. No SOB or difficulty swallowing. Felt 'weak and clammy'. Pt took 800mg of IB and slept most of the day. No residual symptoms. Advised pt to take Benedryl. No further treatment. Pt states "back in the 80's I had a reaction to a rubella vaccination where my knee swelled up to 3 times its normal size."
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Paraesthesia oral, Periorbital oedema, Swelling face
Clinical narrative: Pt received injection 12/5/07 at 1PM- per pt, around 4PM edema around injection site, severe Left arm pain- "could barely move it", facial swelling-periorbital edema and 'tingling lips'. No SOB or difficulty swallowing. Felt 'weak and clammy'. Pt took 800mg of IB and slept most of the day. No residual symptoms. Advised pt to take Benedryl. No further treatment. Pt states "back in the 80's I had a reaction to a rubella vaccination where my knee swelled up to 3 times its normal size."
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site erythema, Injection site warmth
Clinical narrative: Pt reported redness and heat at injection site and several weeks later reports shingles outbreak on one side of her back.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Gait disturbance, Irritability, Pain, Weight bearing difficulty
Clinical narrative: Patient developed left leg limping several days after vaccine administration.  No ambulation for 1 - 2 days.  Remained afebrile.  She was somewhat fussy and appeared in pain whenever she was put down to walk.  On follow-up examination, she ambulated well, but with a mild limped gait favoring the left leg.  Vital signs were stable.  Naproxen 100 mg every 8 hours was prescribed for 1 week duration.  A follow up appointment was recommended when her Naproxen medication course was complete, or sooner if fever develops and/or no symptomatic improvement results.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Anthrax vax given in left arm.  Approx 3 days later, experienced itching and swelling in left arm.  Seen 5 days after vaccination in Internal Medicine Clinic -- edema in left arm extending below left elbow, no other lesions, erythema noted. No systemic symptoms.  Treated symptomatically -- benadryl for itching, limited activity in arm, ice as needed.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Nausea, Visual disturbance, Vomiting
Clinical narrative: Violent nausea and Vomiting, Severe Migraine that only lasted 6 hours, and Hindered vision.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Lethargy, Somnolence, Vomiting
Clinical narrative: hyporesponsive, extremely sleey with poor feeds, vomited a few times that started a few hours after shots waxed and waned and continued for 24-36
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Condition aggravated, Convulsion, Diarrhoea, Dyspnoea, Electroencephalogram
Clinical narrative: My child has been hospitalized 3 times since this vaccine was given to her with severe cluster migraines, passing out, seizures, vomiting, and diarrhea  Difficulty breathing, Hot red cheeks, and ears.  12/17/2007 MR received for DOS 8/6-10/2007 and 11/27/2007.  D/C DX for 8/10/07: Migraines with marked histrionic overtures. Pt was transfered from local hospital with dx of seizures. Pt reports having migraines from March 2007 following Menactra vax to May 2007, which resumed recently, with vomiting, photophobia and phonophobia. Pt had seizure activity several days prior to admission txd with Ativan. Seen again 11/27/2007 for c/o headache with passing out. Increasing cluster H/As noted with change in medication.  Pt had witnessed screaming then uncontrollable shaking followed by limpness.  Assessment:  Possible Cluster Headaches vs seizure (temporal lobe). 03/07/08 MR received for DOS 3/23-26/2007 with DX:  S/P dehydration resolved, headache, possible migraine vs histamine. Pt presented with several day hx of fever, gasping for breath, rash, and headache. Sent to ER for IVF and observation for orthostasis after several trips to ER over 48hrs. Pt had several episodes of headache, especially after IVF stopped. ? Allergy to Menactra vaccine. 03/07/2008 ER visits from 3/26/07, 3/27/07, and 8/17/07 with DX: Headache, Near Syncope and recurrent headache, near syncope and syncope, headache respectively. 03/11/2008 Additional records received for ER visit 8/3-4/07 with DX: Seizure event. Pt c/o severe H/A with syncopal episode preceded by vomiting. Convulsions reported by mom.  Severe H/a and photophobia noted on exam.  Per 60 day follow up: She has now become allergic to wheat, milk, apples & chicken, and also several chemicals. She continues to pass out in "seizure like" states. No warning signs before episodes. Yes-this is very traumatic. We don't know what affects it or when it is going to happen. This changed her diet drastically -episodes still happen. She can't eat anything pre-packaged or with preservatives.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Hypersensitivity, Loss of consciousness, Migraine, Nuclear magnetic resonance imaging
Clinical narrative: My child has been hospitalized 3 times since this vaccine was given to her with severe cluster migraines, passing out, seizures, vomiting, and diarrhea  Difficulty breathing, Hot red cheeks, and ears.  12/17/2007 MR received for DOS 8/6-10/2007 and 11/27/2007.  D/C DX for 8/10/07: Migraines with marked histrionic overtures. Pt was transfered from local hospital with dx of seizures. Pt reports having migraines from March 2007 following Menactra vax to May 2007, which resumed recently, with vomiting, photophobia and phonophobia. Pt had seizure activity several days prior to admission txd with Ativan. Seen again 11/27/2007 for c/o headache with passing out. Increasing cluster H/As noted with change in medication.  Pt had witnessed screaming then uncontrollable shaking followed by limpness.  Assessment:  Possible Cluster Headaches vs seizure (temporal lobe). 03/07/08 MR received for DOS 3/23-26/2007 with DX:  S/P dehydration resolved, headache, possible migraine vs histamine. Pt presented with several day hx of fever, gasping for breath, rash, and headache. Sent to ER for IVF and observation for orthostasis after several trips to ER over 48hrs. Pt had several episodes of headache, especially after IVF stopped. ? Allergy to Menactra vaccine. 03/07/2008 ER visits from 3/26/07, 3/27/07, and 8/17/07 with DX: Headache, Near Syncope and recurrent headache, near syncope and syncope, headache respectively. 03/11/2008 Additional records received for ER visit 8/3-4/07 with DX: Seizure event. Pt c/o severe H/A with syncopal episode preceded by vomiting. Convulsions reported by mom.  Severe H/a and photophobia noted on exam.  Per 60 day follow up: She has now become allergic to wheat, milk, apples & chicken, and also several chemicals. She continues to pass out in "seizure like" states. No warning signs before episodes. Yes-this is very traumatic. We don't know what affects it or when it is going to happen. This changed her diet drastically -episodes still happen. She can't eat anything pre-packaged or with preservatives.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: My child has been hospitalized 3 times since this vaccine was given to her with severe cluster migraines, passing out, seizures, vomiting, and diarrhea  Difficulty breathing, Hot red cheeks, and ears.  12/17/2007 MR received for DOS 8/6-10/2007 and 11/27/2007.  D/C DX for 8/10/07: Migraines with marked histrionic overtures. Pt was transfered from local hospital with dx of seizures. Pt reports having migraines from March 2007 following Menactra vax to May 2007, which resumed recently, with vomiting, photophobia and phonophobia. Pt had seizure activity several days prior to admission txd with Ativan. Seen again 11/27/2007 for c/o headache with passing out. Increasing cluster H/As noted with change in medication.  Pt had witnessed screaming then uncontrollable shaking followed by limpness.  Assessment:  Possible Cluster Headaches vs seizure (temporal lobe). 03/07/08 MR received for DOS 3/23-26/2007 with DX:  S/P dehydration resolved, headache, possible migraine vs histamine. Pt presented with several day hx of fever, gasping for breath, rash, and headache. Sent to ER for IVF and observation for orthostasis after several trips to ER over 48hrs. Pt had several episodes of headache, especially after IVF stopped. ? Allergy to Menactra vaccine. 03/07/2008 ER visits from 3/26/07, 3/27/07, and 8/17/07 with DX: Headache, Near Syncope and recurrent headache, near syncope and syncope, headache respectively. 03/11/2008 Additional records received for ER visit 8/3-4/07 with DX: Seizure event. Pt c/o severe H/A with syncopal episode preceded by vomiting. Convulsions reported by mom.  Severe H/a and photophobia noted on exam.  Per 60 day follow up: She has now become allergic to wheat, milk, apples & chicken, and also several chemicals. She continues to pass out in "seizure like" states. No warning signs before episodes. Yes-this is very traumatic. We don't know what affects it or when it is going to happen. This changed her diet drastically -episodes still happen. She can't eat anything pre-packaged or with preservatives.
Age: 0.4
Sex: M
Vaccine: DTAPH, IPV, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: No adverse events or treatments
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pain, Paraesthesia
Clinical narrative: Pain, Ecchymosis at injection site-occ. Tingling- (L) middle finger
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Blood creatinine decreased, Cerebrovascular accident, Coagulation test, Hypokinesia, Irritability
Clinical narrative: on 11/22/07 increased fussiness and decreased movement of (L) extremities <24 hr after; immunization. Symptoms persisted >48 hr resulting in ER visit and evaluation on 11/24/07 of - MRI an that date revealed (R) hemisphere MCA stroke.  12/18/2007 D/C summary received in addition to MR received yesterday for DOS 11/24-12/12/2007 with D/C DX: Acute middle cerebral artery infarct and stroke, etiology thought to be thrombotic. Left hemiparesis.   Infant presented to ER on 11/24/2007 after parents noted pt was not moving L side of body.  Pt had been fussy and running a fever since the morning following vax.  Pt was seen on 11/23/07 by PCP, but sx had improved and no significant neurological impairment noted other than decreased strength in RUE.  Pt brought to ER with abnormal looking smile.  Asymmetry noted on PE with L sided weakness.  Decreased tone and spontaneous movement on L side.  On assessment stroke is gauged to be 2 or more days old and possibly clinically improving.  Repiratory difficulty/apnea noted and pt intubated. Extubated 12/1/07. No eveidence of seizures. Consults by neurology, physical med & rehab, pediatric hematology. Txd with Lovenox.  D/C on ASA and Lovenox. 1/15/2010 Patient still has sequelae from adverse event and physician believes he always will. Patient is able to use left side and appendages but reports they are weaker and slower than right side.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Scan brain
Clinical narrative: on 11/22/07 increased fussiness and decreased movement of (L) extremities <24 hr after; immunization. Symptoms persisted >48 hr resulting in ER visit and evaluation on 11/24/07 of - MRI an that date revealed (R) hemisphere MCA stroke.  12/18/2007 D/C summary received in addition to MR received yesterday for DOS 11/24-12/12/2007 with D/C DX: Acute middle cerebral artery infarct and stroke, etiology thought to be thrombotic. Left hemiparesis.   Infant presented to ER on 11/24/2007 after parents noted pt was not moving L side of body.  Pt had been fussy and running a fever since the morning following vax.  Pt was seen on 11/23/07 by PCP, but sx had improved and no significant neurological impairment noted other than decreased strength in RUE.  Pt brought to ER with abnormal looking smile.  Asymmetry noted on PE with L sided weakness.  Decreased tone and spontaneous movement on L side.  On assessment stroke is gauged to be 2 or more days old and possibly clinically improving.  Repiratory difficulty/apnea noted and pt intubated. Extubated 12/1/07. No eveidence of seizures. Consults by neurology, physical med & rehab, pediatric hematology. Txd with Lovenox.  D/C on ASA and Lovenox. 1/15/2010 Patient still has sequelae from adverse event and physician believes he always will. Patient is able to use left side and appendages but reports they are weaker and slower than right side.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2x3 cm area erythema and induration of right lower thigh at site of Varivax administration. Tx analgesic prn.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Facial palsy
Clinical narrative: Developed Bell's Palsy 3 weeks after receipt of the inactivated influenza vaccine.  12/28/07 Reviewed medical records which reveal patient experienced left facial weakness, left eye tearing & left facial droop 11/11/07, 3 wks s/p flu vax.  Saw pcp on 11/13 for sinusitis then later tx w/antiviral & steroids. Returned to clinic 12/3 w/dry cough x 2 wks & was dx w/acute ethmoidal sinusitis.  FINAL DX: Bell's palsy.
Age: 16.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Erythema, Fatigue, Oedema peripheral, Pyrexia
Clinical narrative: Fatigue, fever 103 degrees, redness, swelling of arm.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: (L) arm redness 4 cm patch
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Varivax given in right post. arm 11/30/07.  Began with redness and swelling later that continued to progress.  Was seen 12/3/07, area measured 14cm x 15cm, was red & hot.  Suspected cellulitis.  Started on Duricef 1gm twice daily.
Age: 5.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Gait disturbance, Injection site erythema
Clinical narrative: Patients mother took child to Urgent Care 11-17-07 for limping - redness to site of vaccines. They measured a 5 x 2 1/2" reddened area to (L) anterior mid thigh. Injections given 1 1/2" measured apart sites.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Vomiting
Clinical narrative: About 6 hours after the shot I began vomiting and had the chills-bad. This lasted all night and into following day
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: On 11-10-07 at 700 AM mother noted swelling, redness and tenderness at injection site. On 11-11-07 the area had increased in diameter with slight bruising in the center. On 11-12-07 entire thigh was swollen, reddened and itchy. Seen by PCP on 11-12-07 who diagnosed this as an allergic reaction and prescribed Benadryl.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: On 11-10-07 at 700 AM mother noted swelling, redness and tenderness at injection site. On 11-11-07 the area had increased in diameter with slight bruising in the center. On 11-12-07 entire thigh was swollen, reddened and itchy. Seen by PCP on 11-12-07 who diagnosed this as an allergic reaction and prescribed Benadryl.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood test, Borrelia burgdorferi serology, Facial palsy, Musculoskeletal stiffness
Clinical narrative: Stiff neck Wed 11/28 gradually progressed - required visit to Emergency Room.  Dx Bells Palsy by doctor at hospital - visited 12/1/01. 1/18/08 Reviewed ER medical records which reveal patient experienced left lateral neck pain, left side of lips numb, left facial droop x 1 day.  Left eye tearing & unable to close left eye tightly or lift left eyebrow as high as right.  No treatment provided.  Referred to neurologist & opthalmologist for f/u upon d/c from ER w/o any prescriptions. FINAL DX: Left Bell's palsy.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Expired drug administered, Eyelid oedema, Lip swelling, Swelling face
Clinical narrative: 2006 flu shot mistakenly administered (instead of 2007 shot). Lips, eyes, face swelled. Required adult dose of antihistamine. Mild swelling of eyelids continued into next day.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Hives and swelling of injection site (R) thigh and (L) thigh. Given Benadryl 3 ml q 7 hours PRN.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given 0.5 ml Fluzone regular instead of 0.25 ml Fluzone with preservative. No adverse event.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Burning sensation, Erythema, Hypoaesthesia, Pain in extremity, Tenderness
Clinical narrative: Patient noted within 1 week developed numbness and waves of burning, stinging pain down arm into left thumb.  Mild redness that comes and goes.  No papules or blisters.  Over this last week, less frequent episodes.  Mild tenderness at base of nail.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Fall, Gait disturbance, Vision blurred
Clinical narrative: Patient walking and seemed to be walking to the (R) right after vaccination. The next day mom said pt fell 4 x, complained of blurred vision. I advised pt go to ER but pt. didn't go.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Oedema peripheral, Rash, Swelling face, Urticaria
Clinical narrative: pt developed rash-Hives approximately 5 hours following vaccination. Approx. 36 hours following vaccination rash progressed and pt developed swelling of face and hands. Rash resolved day 5 following vaccination. Tx w/Benadryl
Age: 4.0
Sex: F
Vaccine: DPP, FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Crying, Eye swelling, Insomnia, Lacrimation increased, Pyrexia
Clinical narrative: Swollen watery eyes, runny nose, chest congestion, fever 102.2 Sleeplessness, Crying uncontrollably for short periods of time. My child had the vaccines on a Tue. and was very sick by Thursday evening. Today is Sat. and my child is feeling somewhat better without fever but continues to be congested.
Age: 4.0
Sex: F
Vaccine: DPP, FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Swollen watery eyes, runny nose, chest congestion, fever 102.2 Sleeplessness, Crying uncontrollably for short periods of time. My child had the vaccines on a Tue. and was very sick by Thursday evening. Today is Sat. and my child is feeling somewhat better without fever but continues to be congested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Vaccination was administered 12/6/07 at 2:30pm Noticed redness and itching on 12/8/07 at 5:00am.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Ataxia, Blood thyroid stimulating hormone, Dizziness, Headache, Hypoaesthesia
Clinical narrative: Within one week of vaccination--numbness to right side of face, throat, progressed to right arm, right leg and left leg within a few days. Had right sided headache, and became dizzy and ataxic.  Symptoms have slowly resolved over approximately 1 month, with residual right leg weakness and intermittent headache.  12/28/07 Reviewed pcp medical records which reveal patient experienced numbness of right side, numbness & tingling of right hand/arm, HA,  difficulty walking.  Improved w/steroids. No neuro consult done. FINAL DX: limited right polyneuropathy.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia facial
Clinical narrative: Within one week of vaccination--numbness to right side of face, throat, progressed to right arm, right leg and left leg within a few days. Had right sided headache, and became dizzy and ataxic.  Symptoms have slowly resolved over approximately 1 month, with residual right leg weakness and intermittent headache.  12/28/07 Reviewed pcp medical records which reveal patient experienced numbness of right side, numbness & tingling of right hand/arm, HA,  difficulty walking.  Improved w/steroids. No neuro consult done. FINAL DX: limited right polyneuropathy.
Age: 0.2
Sex: F
Vaccine: FLUX
Symptoms: Chills, Feeling of body temperature change, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: On Friday, November 16, I requested a flu shot on a routine office visit.(my fourth year)The vaccine information statement notes that it is Inactivated Influenza Vaccine. For the next week, I had some pain/discomfort in my upper left arm.On Thursday evening, November 29, stabbing/jabbing pain in my left upper arm awakened me and I could not turn over. I took two extra strenth tylenol, rubbed flex-all 454 on my arm and went to work Friday. I could not lift my left arm at work. Upon returning home from work, I started having chills and cold/hot. I crawled up on the couch, I asked my son to get some advil so I could treat the pain with extra strength tylenol or inflamation with ibuprofen.This stabbing/jabbing/throbbing pain continued Saturday and Sunday.On Saturday, December 1, I called facility and an advice nurse called me back. I told her about the stabbing/jabbing pain, She asked if I had a elevated temp., I told her no. I told her how I was treating this pain. She said if it did not subside to come to urgent care at the Southwood facility.I used two absorpbine, jr. heating pads The pain decreased, the stiffness, range and motion was slow to return and Friday of this week, December 7, was my best day for movement, lifting my left arm. It has been a challenge getting dressed, especially putting on my bra. This has been a most physically painful experience.
Age: 0.2
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: On Friday, November 16, I requested a flu shot on a routine office visit.(my fourth year)The vaccine information statement notes that it is Inactivated Influenza Vaccine. For the next week, I had some pain/discomfort in my upper left arm.On Thursday evening, November 29, stabbing/jabbing pain in my left upper arm awakened me and I could not turn over. I took two extra strenth tylenol, rubbed flex-all 454 on my arm and went to work Friday. I could not lift my left arm at work. Upon returning home from work, I started having chills and cold/hot. I crawled up on the couch, I asked my son to get some advil so I could treat the pain with extra strength tylenol or inflamation with ibuprofen.This stabbing/jabbing/throbbing pain continued Saturday and Sunday.On Saturday, December 1, I called facility and an advice nurse called me back. I told her about the stabbing/jabbing pain, She asked if I had a elevated temp., I told her no. I told her how I was treating this pain. She said if it did not subside to come to urgent care at the Southwood facility.I used two absorpbine, jr. heating pads The pain decreased, the stiffness, range and motion was slow to return and Friday of this week, December 7, was my best day for movement, lifting my left arm. It has been a challenge getting dressed, especially putting on my bra. This has been a most physically painful experience.
Age: 16.0
Sex: F
Vaccine: HPVX, TDAP
Symptoms: Crying, Headache, Pain in extremity, Pyrexia
Clinical narrative: C/O pain in both arms and legs, severe headache and fever....crying...gave tylenol and slept for 16 hours
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Aphasia, Asthenia, Malaise, Nasopharyngitis
Clinical narrative: Within twelve hours after patient received vaccinations for FLU and PNEUMONIA simultaneouly, she suffered naso/pharyngeal inflamation and loss of speech and general malaise and weakness. She received medical care from her primary care physician who prescribed prednisone therapy.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis in L deltoid and L arm.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Chest X-ray, Cough, Fatigue
Clinical narrative: Two days after getting the flu shot, I started to feel sick with flu like symptoms. On Saturday and Sunday (20 -21 October 07) I was weak and started a mild cough and spent the weekend resting.  For the next week, in the mornings I felt ok, but by early afternoon was weak, tired coughing, and ended up going home from work early on a number of days.  On the following weekend I was so sick I stayed in bed resting.  On 30 October, at about 0900 hrs the left side of my head started hurting so bad I called for an immediate doctor's appointment.  I went in at 1400 hrs.  I was examined by Dr. and she ordered a chest x-ray and prescribed a two week regiment of antibiotics to combat a sinus infection.  After about three days on the drugs I started to feel better but continued to be weak and tired and had a strong cough.  On 28 November, I went back to the doctor and was examined by Dr. who put me on a five day regiment of antibiotics, and ordered another chest x-ray to insure I did not have pneumonia.    As of today, 9 Dec 07, I feel almost normal.  I believe the treatment from my doctors to be excellent.  However, I believe my six plus week illness to be directly related to the flu shot I received.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Influenza like illness, Malaise, Sinusitis
Clinical narrative: Two days after getting the flu shot, I started to feel sick with flu like symptoms. On Saturday and Sunday (20 -21 October 07) I was weak and started a mild cough and spent the weekend resting.  For the next week, in the mornings I felt ok, but by early afternoon was weak, tired coughing, and ended up going home from work early on a number of days.  On the following weekend I was so sick I stayed in bed resting.  On 30 October, at about 0900 hrs the left side of my head started hurting so bad I called for an immediate doctor's appointment.  I went in at 1400 hrs.  I was examined by Dr. and she ordered a chest x-ray and prescribed a two week regiment of antibiotics to combat a sinus infection.  After about three days on the drugs I started to feel better but continued to be weak and tired and had a strong cough.  On 28 November, I went back to the doctor and was examined by Dr. who put me on a five day regiment of antibiotics, and ordered another chest x-ray to insure I did not have pneumonia.    As of today, 9 Dec 07, I feel almost normal.  I believe the treatment from my doctors to be excellent.  However, I believe my six plus week illness to be directly related to the flu shot I received.
Age: 45.0
Sex: M
Vaccine: YF
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Continuoius muscle pain under/around left scapula, extending into left Bicep and tricep, with limited range of motion when truning head to the left. Contcted physician who stated that these are not side effects of teh drug, even though listed on CDC site. Pain has continued for more than 2 weeks, wil be seeking additonal medical treatment.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Chills, Dizziness, Ear pain, Facial pain
Clinical narrative: 4 DAYS, 6 HRS. AFTER FLU VACCINE, I SUDDENLY HAD CHILLS AND SHIVERING. I WENT TO BED AND FELL ASLEEP; WOKE UP IN THE MIDDLE OF THE NIGHT FEELING HOT AND HAD STIFF AND TIRED MUSCLES. AT THIS TIME, I TOOK MY TEMPERATURE AND FOUND IT TO BE 101.5.  I STAYED IN BED FOR A TOTAL OF 19 HRS. AT WHICH TIME MY TEMPERATURE WAS 99.  AFTER GETTING UP I FELT PRETTY MUCH NORMAL BUT I STILL HAD STIFF MUSCLES, A LIGHT HEAD AND SHOOTING PAINS IN MY HEAD, EARS. AND FACE.  WHILE IN BED I WAS ASLEEP NEARLY THE ENTIRE TIME.  AT HIS TIME (ABOUT 40 HRS. AFTER THE INITIAL CHILLS) I FEEL NORMAL.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Feeling hot, Headache, Hypersomnia, Muscle fatigue, Musculoskeletal stiffness
Clinical narrative: 4 DAYS, 6 HRS. AFTER FLU VACCINE, I SUDDENLY HAD CHILLS AND SHIVERING. I WENT TO BED AND FELL ASLEEP; WOKE UP IN THE MIDDLE OF THE NIGHT FEELING HOT AND HAD STIFF AND TIRED MUSCLES. AT THIS TIME, I TOOK MY TEMPERATURE AND FOUND IT TO BE 101.5.  I STAYED IN BED FOR A TOTAL OF 19 HRS. AT WHICH TIME MY TEMPERATURE WAS 99.  AFTER GETTING UP I FELT PRETTY MUCH NORMAL BUT I STILL HAD STIFF MUSCLES, A LIGHT HEAD AND SHOOTING PAINS IN MY HEAD, EARS. AND FACE.  WHILE IN BED I WAS ASLEEP NEARLY THE ENTIRE TIME.  AT HIS TIME (ABOUT 40 HRS. AFTER THE INITIAL CHILLS) I FEEL NORMAL.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: 4 DAYS, 6 HRS. AFTER FLU VACCINE, I SUDDENLY HAD CHILLS AND SHIVERING. I WENT TO BED AND FELL ASLEEP; WOKE UP IN THE MIDDLE OF THE NIGHT FEELING HOT AND HAD STIFF AND TIRED MUSCLES. AT THIS TIME, I TOOK MY TEMPERATURE AND FOUND IT TO BE 101.5.  I STAYED IN BED FOR A TOTAL OF 19 HRS. AT WHICH TIME MY TEMPERATURE WAS 99.  AFTER GETTING UP I FELT PRETTY MUCH NORMAL BUT I STILL HAD STIFF MUSCLES, A LIGHT HEAD AND SHOOTING PAINS IN MY HEAD, EARS. AND FACE.  WHILE IN BED I WAS ASLEEP NEARLY THE ENTIRE TIME.  AT HIS TIME (ABOUT 40 HRS. AFTER THE INITIAL CHILLS) I FEEL NORMAL.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Anorexia, Lethargy, Pyrexia
Clinical narrative: 102 Degree fever.  General lethargy.  Lack of appetite.  Symptoms presented themselves within hours of the vaccine and have continued for 2 days so far.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Headache
Clinical narrative: estomacal pain/headache
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Blood test, Cold sweat, Convulsion, Dizziness, Dyspnoea
Clinical narrative: Initial report received on 26 November 2007 from another manufacturer (report # A0695247A) who had received the original report from the Food and Drug Administration (VAERS # 287108). Verbatim from report: "This case was reported by a regulatory authority (Food and Drug Administration (US) # 287108) and described the occurrence of could not breathe in a 15-year-old female subject who was vaccinated with Havrix, and Menactra for prophylaxis. On 01 August 2007, the subject received unspecified dose of Havrix (unknown) and unspecified dose of Menactra (unknown). On 01 August 2007, 3 minutes after vaccination with Havrix and Menactra, the subject experienced inability to breathe, dizziness, syncope, and seizure. The subject was seen in an emergency room. The subject's vital signs were normal and she was discharged from the emergency room. The verbatim text of the report indicated that: Client states can't hardly breathe, after sitting client down complained of dizziness on sitting back client started with tremors like seizure activity, pale, clammy, placed on floor unresponsive, responsive while on floor complained about being hot, brought in fan, elevated feet, gave Sprite (carbonated beverage). The reporter also noted that it was "hard to tell whether (the events were) vasovagal response, anxiety or allergic reaction." At the time of reporting the events were resolved. Comment: Syncope, seizure and vasovagal response were assessed as medically serious. The lot number for the Havrix was reported as AHAVB163AB. The lot number for the Menactra was unknown. The routes and sites of administration of both vaccines were unknown.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Feeling hot, Pallor, Scan brain, Thyroid function test normal, Tremor
Clinical narrative: Initial report received on 26 November 2007 from another manufacturer (report # A0695247A) who had received the original report from the Food and Drug Administration (VAERS # 287108). Verbatim from report: "This case was reported by a regulatory authority (Food and Drug Administration (US) # 287108) and described the occurrence of could not breathe in a 15-year-old female subject who was vaccinated with Havrix, and Menactra for prophylaxis. On 01 August 2007, the subject received unspecified dose of Havrix (unknown) and unspecified dose of Menactra (unknown). On 01 August 2007, 3 minutes after vaccination with Havrix and Menactra, the subject experienced inability to breathe, dizziness, syncope, and seizure. The subject was seen in an emergency room. The subject's vital signs were normal and she was discharged from the emergency room. The verbatim text of the report indicated that: Client states can't hardly breathe, after sitting client down complained of dizziness on sitting back client started with tremors like seizure activity, pale, clammy, placed on floor unresponsive, responsive while on floor complained about being hot, brought in fan, elevated feet, gave Sprite (carbonated beverage). The reporter also noted that it was "hard to tell whether (the events were) vasovagal response, anxiety or allergic reaction." At the time of reporting the events were resolved. Comment: Syncope, seizure and vasovagal response were assessed as medically serious. The lot number for the Havrix was reported as AHAVB163AB. The lot number for the Menactra was unknown. The routes and sites of administration of both vaccines were unknown.