chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.03
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Patient came in for his Immunizations yesterday and his parents bring him in today with a large reaction at the site on the left anterior thigh. He had received DTAP's in the past with out difficulty. Yesterday he got an MMR on the right side, DTAP and HIB on the left. Has not had fever. Has been his normal active happy self. Well appearing and playful boy. Left anterior thigh shows a large area of erythema, induration, and warmth which measures 7.0x 11.0 cm 1). Large local reaction to immunizations likely HIB. P: Discussed with RN, who will file an Immunization report, although this is clearly just a local reaction and even though it is fairly significant, should not be a problem as far as completing the course of Immunizations. Parents are reassured. Follow up PRN.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness, swelling 10 x 12 cm right upper arm, non-tender. Fever day after immunizations none today.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Injection site mass, Injection site warmth
Clinical narrative: Quarter sized red firm warm area on Left thigh. Dime sized red firm areas on right thigh.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Headache, Upper respiratory tract infection
Clinical narrative: Fatigue (frequent) Headaches (frequent-lasting for days) Upper respiratory difficulty
Age: 0.34
Sex: F
Vaccine: DT, HBHEPB, IPV, PNC
Symptoms: Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Right thigh and 1" below puncture site of immunization Nickel size, red warm, some swelling, advised to apply alternate cool and warm compress and Tylenol.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site mass, Urticaria
Clinical narrative: Injection site small nodule and small red dot. Hives on face first noted 03/23/2005. Pt seen in our office 03/23/2005, Treatment with Benadryl 1/2 tsp Q6H and referred to allergist.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash on both face and arms and hands. Rash appeared a few hours after I received vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia, Vomiting
Clinical narrative: Vomiting x1. Fever 101 degrees Fahrenheit for 24 hours, inflammation, redness, at injection site for 48 hours.
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: Rash approximately 20-30 lesions on trunk and arms. No treatment.
Age: 4.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Pt had red, raised , warm area 3" in diameter on left arm where immunization was given. Applied ice and mother gave Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Oedema peripheral, Swelling
Clinical narrative: Mother telephoned c/o child had swollen, reddened left arm, feels very hot and warm. "Swollen about four times it's normal size", afebrile, no limited ROM noted to this arm. MMR vaccine had been given in this site approximately 30 hours previous to this condition. Encouraged cold compress and to notify physician for follow up.
Sex: M
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: client complained of chest pain-shooting down left arm, rapid heart rate, lightheadedness, shortness of breath.
Age: 0.37
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye disorder, Pityriasis rosea
Clinical narrative: Patient had an eye infection first and then he developed pityriasis rosacea (diagnosed by the child's pediatrician) rash was treated with a topical cream (containing nystatin and a corticosteroid). Rash has not yet resolved.
Age: 1.32
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Hypersensitivity, Rash erythematous
Clinical narrative: Hospital called and said pt in on 03/19/2005 to ER for allergic reaction to immunization. States was on left leg-was reddened, 03.25cm medial and 5 cm from injection site. Dr recommended Benadryl and cool compress to the site. TC to mom and said she was right leg and fever, but better now.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Rash pruritic
Clinical narrative: One day after receiving MMR vaccine patient reported she developed itchy rash with small fluid filled bumps.  Patient has no known allergies.  Rash lasted approximately 10 days.  Patient did not seek medical attention and did not take any medications.
Age: 56.0
Sex: M
Vaccine: TD
Symptoms: Anxiety
Clinical narrative: Client called in 24 hours after shot to report a "feeling of overall anxiety" that began approx. 2 hours after shot and continued into the next day. Now feels that is resolving. State arm was not sore or swollen. Reviewed other possible adverse reactions which client denies. Client states is usually very sensitive to medications, even OTC items like vitamins can make him feel odd. Informed client we would document his experience and advise that next shot he could wait at office after shot to monitor for any anaphalactic reactions.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Laboratory test abnormal, Viral infection
Clinical narrative: 18 days after receiving vaccine, patient developed typical varicella rash on back, chest and legs.  No fever was reported.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Autism, Depressed level of consciousness, Gastrointestinal disorder, Hypersensitivity, Hypotonia
Clinical narrative: Hypotonia, Developmental Delay, Speech Delay, Sensory Integration Dysfunction, Allergies, GI Reflux.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Neurodevelopmental disorder, Speech disorder
Clinical narrative: Hypotonia, Developmental Delay, Speech Delay, Sensory Integration Dysfunction, Allergies, GI Reflux.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Rash, Swelling
Clinical narrative: Received PPV 3/12/05 at 9:50AM upon discharge from the hospital. Rt arm at site became very sore within two hours. 6 hours later the entire upper arm was swollen and very sore. 3/13/05 upon arising the entire right arm was swollen two times the normal size and entire body was engulfed with a diffused bright red rash. Temp elevation was 100 orally. Right arm was terribly sore and unable to use it. 3/14/05 temp elevation continued at 99.7 and rash continues. White count went from 5.6 on 3/12/05 to 15.6 on 3/13/05. Saw Family Doctor. Treated with Benedryal 50 mg. q. 6 hours. Amoxicillin started for 10 days. Seen by Dr. 3/15/05 rash continues but starting to dissipate on upper body, but very red on thighs and legs. Blood test done on 3/16/05, white count down. Seen by Dr. on 3/18/05 and rash continues slightly over the body, right upper arm back to normal size, lower arm from ellbow to wrist still swollen slightly. Continued on Benadryl until 3/27/03, rash gone completely and arm back to normal size.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: 4 year old female with localized erythema, swelling right leg on 3/26/05. Admitted 3/27/05 for cellulitis. Treated with antibiotics and recovery.
Age: 31.0
Sex: F
Vaccine: FLUN3, PPV
Symptoms: Inflammation, Pain, Pyrexia
Clinical narrative: Pt reports arm inflammed, painful, fever-did not call office to report or be seen. Pt was checked in office after 15 minutes with no reaction.
Sex: U
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site vesicles, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Pt received 1st series of shots IPV, DTaP, Comvax. That evening, had fever, and was very cranky-then blisters to inferior with red for 2-3 days no swelling, tired looking per mom and  stuffy nose till now 03/16/2005
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Contusion, Erythema, Injection site induration, Pyrexia
Clinical narrative: Morning after shots, had fever of 102.8 degrees Fahrenheit. That evening arm red, from shoulder to half was down arm, and bruise at injection site. Arm felt hard, rash on chest. Went to ER told her to take Benadryl, thoguht reaction was from DTaP. Next morning redness had spread gave more Benadryl and seemed to be working no more fever.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash
Clinical narrative: Morning after shots, had fever of 102.8 degrees Fahrenheit. That evening arm red, from shoulder to half was down arm, and bruise at injection site. Arm felt hard, rash on chest. Went to ER told her to take Benadryl, thoguht reaction was from DTaP. Next morning redness had spread gave more Benadryl and seemed to be working no more fever.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Urticaria
Clinical narrative: 1/2 hour after administration of vaccine pt calls c/o rash, itching, and dizziness. Referred to PCP. T/C later that night, Pt states "taking Benadryl and getting better at home"
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Cellulitis, Injection site induration
Clinical narrative: Cellulitis LFA with 6mmx5mm induration. (there were 3 other similar cases)
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Cellulitis, Erythema, Injection site induration, Oedema, Urticaria
Clinical narrative: 03/09/2005 Pt returned to clinic with 2cm x 2cm Erythema edema at PPD site, PPD reading (+) with 12mm x 12mm induration. Tx Benadryl 12.5mg 2 tsp PO BID and Keflex 250mg/5ml. Keflex discontinued on 03/10/2005 due to hives. Returned 03/16/2005 CXR negative. Cellulitis improving. (3 other cases)
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration
Clinical narrative: Area red with induration of 6mm
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash-red round, 3-4mm raised, scattered down through diaper region, crossing midline at umbilicus, right thigh.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Bacterial infection, Epiglottitis, Oedema, Pharyngeal oedema, Viral infection
Clinical narrative: Extreme tiredness, could not swallow saliva. Virus? Epiglottis? Discharge diagnosis unknown.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysphagia, Fatigue, Pharyngitis, Viral infection
Clinical narrative: Extreme tiredness, could not swallow saliva. Virus? Epiglottis? Discharge diagnosis unknown.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Fatigue, Throat tightness, Weight decreased
Clinical narrative: Extreme tiredness, could not swallow saliva. Virus? Epiglottis? Discharge diagnosis unknown.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Somnolence
Clinical narrative: Prolonged fever for 4 days. Sleepiness reported by parents.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Headache, Paraesthesia, Pyrexia
Clinical narrative: Fever, arthralgias, headache, tingling in fingers.
Age: 45.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Malaise, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: This is a non serious spontaneous case from a consumer who reports nasal congestion after receiving FluMist. The reporter did not provide causality between events and FluMist. This case is submitted according to the agreement for FluMist. On 08Mar05 a 45 year old male received FluMist IN and subsequently three days later experienced runny nose, nasal congestion, cough, and malaise. He treated himself with an unspecified over the counter medication for his nasal congestion. On 14Mar05, the pt claimed his symptoms are worse. The pt also developed fever of 102 degrees F on 14Mar05. On 15Mar05, the pt stated he is feeling better. The pt has not yet recovered. The reporter did not provide causality between events and FluMist vaccination.
Age: 1.59
Sex: F
Vaccine: DT, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 103 degrees Fahrenheit the next day following vaccine immunizations resulting in visit to ED. Developed Rash on torso and legs 03/22 which spread to face and back the next day. (03/23)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: 10cm x 12cm area of redness with warmth at DTaP site Left arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large, red, warm to touch area including entire deltoid muscle extending underneath arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Parent reported redness size of three half dollars on left deltoid, warm to touch. Treatment with Benadryl 1 1/2 tsp PO Q 6-8H PRN next 24 hours use warm compresses.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site urticaria
Clinical narrative: Urticaria developed 6hrs after vaccines pt seen in office for eval on 03/16/2005
Age: 1.57
Sex: F
Vaccine: DTAPH, PNC, VARCEL
Symptoms: Erythema, Injection site induration
Clinical narrative: Immunizations at Clinic approx 4:00pm 03/21/2005 Left arm upper injected. Reddened, hard, not swollen approximately 2"x3 "area.
Age: 21.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: Pt received small pox vaccine on 03/21/2005. Pt came into clinic at about 9:45 on 03/22/2005 complaining of severe arm pain from the shoulder to the elbow he said that it hurts to bend the elbow and he couldn't raise his arm above his head.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Large Area of Erythema mild swelling On Anterior Left shoulder and medial lateral left upper arm No cellulitis, fever or pain.
Age: 29.0
Sex: M
Vaccine: MMR, TTOX, VARCEL
Symptoms: Blood pressure, Dizziness, Feeling hot, Heart rate, Oxygen saturation
Clinical narrative: While waiting in line to pay for vaccines, patient stated he felt "hot" and "lightheaded" Pt appeared to be pale and shaking. Brought to exam room BP=110/80, R=28, P=88, Lying down, Rescue called O2 Sat. on RA 100% Client taken by rescue squad to ambulance. Client rested in ambulance and was not transported to hospital. Returned to pay for vaccines.
Age: 29.0
Sex: M
Vaccine: MMR, TTOX, VARCEL
Symptoms: Pallor, Tremor
Clinical narrative: While waiting in line to pay for vaccines, patient stated he felt "hot" and "lightheaded" Pt appeared to be pale and shaking. Brought to exam room BP=110/80, R=28, P=88, Lying down, Rescue called O2 Sat. on RA 100% Client taken by rescue squad to ambulance. Client rested in ambulance and was not transported to hospital. Returned to pay for vaccines.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Difficulty in walking, Screaming
Clinical narrative: DTaP/HIB vaccine administered 03/22/2005 in afternoon. Child had uncontrollable crying every night. Would not bear weight on both legs.
Age: 71.0
Sex: M
Vaccine: PPV, TD
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling
Clinical narrative: Mild erythematous and swelling, hot no cellulitis, Temperature 100 degrees Fahrenheit no lymphadenopathy, no streaking.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Injection site reaction, Injection site urticaria
Clinical narrative: Localized Urticaria at injection site of varivax.  Totally resolved after a dose of Benadryl.
Age: 20.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: 10 minutes after shot given donor became sweaty with slight dizziness. Donor layed on bed  with legs elevated- cool cloth and juice given 10 minutes after onset symptoms resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Edema, redness of left thigh. Treatment with Benadryl. Will f/u on 03/24/2005.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 3cm x 6 cm warm, erythematous macule on Left deltoid at site of DTaP, and IPV. Suspected Vaccine Reaction vs Cellulitis.
Age: 1.23
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: No adverse event reported.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site mass
Clinical narrative: Tetanus and Diptheria toxioid was given @ 0.5cc SC in place of a PPD injection. Area had increased swelling with warmth and tenderness that day. After 3 days of Levoquin 500mg, swelling, and tenderness had decreased, site where inj was administered is hard to touch and some skin sloughy.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and redness at site and upper arm (deltoid area)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: 7cmx10cm red raised hot to touch area on right lateral thigh. Dr ordered cool compresses and Benadryl 1 1/2 tsp PO Q 4-6 H PRN.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: 2/4/05 t/c to mother of client, client was given Ibuprofen in ER and fever broke that night. Mother explained that Dr told her his body did not tolerate a shot (unk which one). Matter states client is fine now.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema, Tenderness
Clinical narrative: 7"x 7" swelling right outter thigh, St tender5x5 rounded center erythema rrigt out thigh. No limp mp adempaptahy.
Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Joint stiffness
Clinical narrative: Arthritis- large joints, feet, and back. Went to chiropractor, and doctor. Went on Vioxx, symptoms started after vaccine. Only recently did I find out the Lymerix arthritis could be related. Follow up: I went to family Dr for joint pain. He sent me to chiropracter after I was not feeling better. I then went on Vioxx and bought an inversion table to help with the pain. Chiro did not help. Now I just live with the pain.
Age: 0.61
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Upper respiratory tract infection
Clinical narrative: PT WENT TO THE EMERGENCY DEPT ON 03/13/05 D/T UPPER RESP INFECTION ALSO C/O FEVER AND SWELLING AT INJECTION SITE WHERE IMMUNIZATIONS WERE GIVEN 5 DAYS PREVIOUSLY. FOLLOWED UP HERE ON 03/15/05 AND STILL HAD SOME INDURATION ON LEFT THIGH AREA. WAS GIVEN AMOXIL IN WHICH PT IS ALLERGIC & WAS DISCONTINUED.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Electroencephalogram normal, Eye movement disorder, Grand mal convulsion, Laboratory test abnormal, Learning disability
Clinical narrative: Patient began having seizures eight days after vaccination. Grand Mal seizure began at aproximately 9 PM and lasted for greater than an hour. Patient was transported by ambulance and anti-seizure medication was administered rectally. Initial diagnosis was "febrile seizure". Patient was admitted to the hospital for one night. Upon release from the hospital, patient seemed fine for 24 hours then began having focal seizures in the P.M. Patient was taken to the E.R. and no adverse conditions were noted. The following A.M.patient was found in her crib having a Grand Mal seizure. Patient was transported by parents to E.R. and was subsequently transported to hospital. Patient was admitted for seven days for testing. Per follow up report received 06/23/2005:  Patient no longer has seizures and no longer takes medication but she now has a lesion on her left temporal lobe that has resulted in her having delayed expressive communications. Information from 2 discharge summaries state nystagmus, fever, Urinary tract infection, lethergy; chewing motion, visual deviation, contraction of face. msv 1/25/2010 Speech delay, learning disability, currently being tested for autism.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lethargy, Leukocytosis, Lumbar puncture, Muscle contractions involuntary, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient began having seizures eight days after vaccination. Grand Mal seizure began at aproximately 9 PM and lasted for greater than an hour. Patient was transported by ambulance and anti-seizure medication was administered rectally. Initial diagnosis was "febrile seizure". Patient was admitted to the hospital for one night. Upon release from the hospital, patient seemed fine for 24 hours then began having focal seizures in the P.M. Patient was taken to the E.R. and no adverse conditions were noted. The following A.M.patient was found in her crib having a Grand Mal seizure. Patient was transported by parents to E.R. and was subsequently transported to hospital. Patient was admitted for seven days for testing. Per follow up report received 06/23/2005:  Patient no longer has seizures and no longer takes medication but she now has a lesion on her left temporal lobe that has resulted in her having delayed expressive communications. Information from 2 discharge summaries state nystagmus, fever, Urinary tract infection, lethergy; chewing motion, visual deviation, contraction of face. msv 1/25/2010 Speech delay, learning disability, currently being tested for autism.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Nystagmus, Pyrexia, Speech disorder developmental, Strabismus, Urinary tract infection
Clinical narrative: Patient began having seizures eight days after vaccination. Grand Mal seizure began at aproximately 9 PM and lasted for greater than an hour. Patient was transported by ambulance and anti-seizure medication was administered rectally. Initial diagnosis was "febrile seizure". Patient was admitted to the hospital for one night. Upon release from the hospital, patient seemed fine for 24 hours then began having focal seizures in the P.M. Patient was taken to the E.R. and no adverse conditions were noted. The following A.M.patient was found in her crib having a Grand Mal seizure. Patient was transported by parents to E.R. and was subsequently transported to hospital. Patient was admitted for seven days for testing. Per follow up report received 06/23/2005:  Patient no longer has seizures and no longer takes medication but she now has a lesion on her left temporal lobe that has resulted in her having delayed expressive communications. Information from 2 discharge summaries state nystagmus, fever, Urinary tract infection, lethergy; chewing motion, visual deviation, contraction of face. msv 1/25/2010 Speech delay, learning disability, currently being tested for autism.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Multiple sclerosis
Clinical narrative: I have a rare form of Multiple Sclerosis.
Age: 0.22
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying, Injection site erythema, Irritability, Tenderness
Clinical narrative: 1530:  Localized erythema bilaterally at injection sites, irritability. IZ's given at ~11am, slept about 1 hour, took 6 oz & for part 45 minutes difficulty consoling, crying. Mom states legs seem tender.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 2 month old infant who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. Medical history included gastroesophageal reflux disease. Concurrently the patient had gastroenteritis. On 1/21/05, the patient received the first dose of Pediarix (lot AC21A007AA). Approximately 36 hours later, on 1/22/05, following the administration of Pediarix, the patient experienced a fever greater than 103 degrees F. The patient was seen at a physician's office. On 1/22/05, a complete blood count showed increased white blood cells. The patient was hospitalized. Urine and blood cultures were negative. The fever resolved on 1/23/05. As of 3/21/05, the outcome of the increased white blood cells was unknown. The reporting health professional considered the events to be life-threatening. The reporting health professional also considered the fever to possibly be related to vaccination with Pediarix.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in a 2 month old infant who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined. Medical history included gastroesophageal reflux disease. Concurrently the patient had gastroenteritis. On 1/21/05, the patient received the first dose of Pediarix (lot AC21A007AA). Approximately 36 hours later, on 1/22/05, following the administration of Pediarix, the patient experienced a fever greater than 103 degrees F. The patient was seen at a physician's office. On 1/22/05, a complete blood count showed increased white blood cells. The patient was hospitalized. Urine and blood cultures were negative. The fever resolved on 1/23/05. As of 3/21/05, the outcome of the increased white blood cells was unknown. The reporting health professional considered the events to be life-threatening. The reporting health professional also considered the fever to possibly be related to vaccination with Pediarix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Face oedema, Urticaria, Vomiting
Clinical narrative: -vomiting immediately, -hives with facial edema given Benadryl PO, -Cough croup like Decadion IM
Age: 0.98
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site pain, Irritability, Pyrexia
Clinical narrative: High fever cranky, sore leg (right right leg_ 102.6
Age: 0.98
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Pain, Pyrexia
Clinical narrative: High fever cranky, sore leg (right right leg_ 102.6
Age: 0.81
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site pain, Irritability, Pyrexia
Clinical narrative: HIGH FEVER (102.6) VERY CRANKY AND SORE RIGHT LEG PER MOM REPORT.
Age: 0.81
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Pain, Pyrexia
Clinical narrative: HIGH FEVER (102.6) VERY CRANKY AND SORE RIGHT LEG PER MOM REPORT.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema
Clinical narrative: Red and Swollen- give Motrin PRN and use a cool pack.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site oedema
Clinical narrative: Shot- red and swollen. Treatment- cool pack and to watch for s/s of infection.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site mass
Clinical narrative: Red softball size treatment- cool compress and Tylenol.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm area around injection site. Advised treatment, cool packs, and Tylenol or Motrin, PRN.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, Warm, area around injection site.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Hypokinesia, Joint range of motion decreased, Muscular weakness, Myalgia, Pain
Clinical narrative: Sore from day 1. In a few days the patient developed muscle weakness in the Left arm and decreased ROM. This weakness has lasted 6 months. Pt hobby is archery and he can not pull back his elbow, which he could prior to shot.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Collagen disorder, Lung disorder
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am terminal with Mixed Connective Tissue Disease and Interstitial Lung Disease that I am convinced was caused by the Anthrax Vaccine given to me by the military in 1991 and again in 1998. I am dying as are many others because I was genetically predisposed to severe reactions to the concoction in this vaccine. It is not right for use by everyone. Please do not allow this to blindly continue.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Arthralgia, Asthenia, Collagen disorder, Hypersensitivity
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am terminal with Mixed Connective Tissue Disease and Interstitial Lung Disease that I am convinced was caused by the Anthrax Vaccine given to me by the military in 1991 and again in 1998. I am dying as are many others because I was genetically predisposed to severe reactions to the concoction in this vaccine. It is not right for use by everyone. Please do not allow this to blindly continue.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Lung disorder, Neuropathy, Rash
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am terminal with Mixed Connective Tissue Disease and Interstitial Lung Disease that I am convinced was caused by the Anthrax Vaccine given to me by the military in 1991 and again in 1998. I am dying as are many others because I was genetically predisposed to severe reactions to the concoction in this vaccine. It is not right for use by everyone. Please do not allow this to blindly continue.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Collagen disorder, Lung disorder
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received Vaccine A during our preparations to deploy in 1991. No annotations were made to my shot record even though I and several others asked for it. We were told that the sheet roster they were making us log in on would be retained for that purpose. To date no one I can find has knowledge of that logs location. I came back from the desert in 1991, and had a butterfly rash on my face, and rash on both shins. Neuropathy in both hands and feet, and moderate pain in joints and soft tissue, memory issues, and chronic fatigue. My blood was tested by my doctor and tested positive for Squalene antibodies, but due to a deployment , I did not learn of the test results until after receiving three shots of the anthrax vaccine in 1998. (Lots FAV303, FAV030, and FAV031). My neuropathy flared, my joints and soft tissue began to burn and constantly ached. I was told I had an allergic reaction to the shots, and then a week later, was told by the same doctor she had not said that. Since the 1998 shots, I have had colorectal cancer, developed mixed connective tissue disease, and interstitial lung disease, and a myriad of other medical conditions that I believe are a direct result of the anthrax vaccine. My chronic fatigue has also increased exponentially. I am now unable to work at even the simplest of tasks, or enjoy most of life due to being tethered to an oxygen line 24 hours a day, and the pain and fatigue. Most likely I am terminal at age 52. All I believe due to the wonders of the Anthrax vaccine program and my body's reaction to these shots. I have been told my only hope for any life expectancy is a double lung transplant.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Amnesia, Arthralgia, Asthenia, Collagen disorder, Hypersensitivity
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received Vaccine A during our preparations to deploy in 1991. No annotations were made to my shot record even though I and several others asked for it. We were told that the sheet roster they were making us log in on would be retained for that purpose. To date no one I can find has knowledge of that logs location. I came back from the desert in 1991, and had a butterfly rash on my face, and rash on both shins. Neuropathy in both hands and feet, and moderate pain in joints and soft tissue, memory issues, and chronic fatigue. My blood was tested by my doctor and tested positive for Squalene antibodies, but due to a deployment , I did not learn of the test results until after receiving three shots of the anthrax vaccine in 1998. (Lots FAV303, FAV030, and FAV031). My neuropathy flared, my joints and soft tissue began to burn and constantly ached. I was told I had an allergic reaction to the shots, and then a week later, was told by the same doctor she had not said that. Since the 1998 shots, I have had colorectal cancer, developed mixed connective tissue disease, and interstitial lung disease, and a myriad of other medical conditions that I believe are a direct result of the anthrax vaccine. My chronic fatigue has also increased exponentially. I am now unable to work at even the simplest of tasks, or enjoy most of life due to being tethered to an oxygen line 24 hours a day, and the pain and fatigue. Most likely I am terminal at age 52. All I believe due to the wonders of the Anthrax vaccine program and my body's reaction to these shots. I have been told my only hope for any life expectancy is a double lung transplant.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Lung disorder, Neuropathy, Rash
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received Vaccine A during our preparations to deploy in 1991. No annotations were made to my shot record even though I and several others asked for it. We were told that the sheet roster they were making us log in on would be retained for that purpose. To date no one I can find has knowledge of that logs location. I came back from the desert in 1991, and had a butterfly rash on my face, and rash on both shins. Neuropathy in both hands and feet, and moderate pain in joints and soft tissue, memory issues, and chronic fatigue. My blood was tested by my doctor and tested positive for Squalene antibodies, but due to a deployment , I did not learn of the test results until after receiving three shots of the anthrax vaccine in 1998. (Lots FAV303, FAV030, and FAV031). My neuropathy flared, my joints and soft tissue began to burn and constantly ached. I was told I had an allergic reaction to the shots, and then a week later, was told by the same doctor she had not said that. Since the 1998 shots, I have had colorectal cancer, developed mixed connective tissue disease, and interstitial lung disease, and a myriad of other medical conditions that I believe are a direct result of the anthrax vaccine. My chronic fatigue has also increased exponentially. I am now unable to work at even the simplest of tasks, or enjoy most of life due to being tethered to an oxygen line 24 hours a day, and the pain and fatigue. Most likely I am terminal at age 52. All I believe due to the wonders of the Anthrax vaccine program and my body's reaction to these shots. I have been told my only hope for any life expectancy is a double lung transplant.
Sex: F
Vaccine: ANTH
Symptoms: Multiple sclerosis
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. After my fourth anthrax shot, I was diagnosed with multiple sclerosis. I was a specialist in the military. I was medically retired from the military in December 1999. The problem I have with the anthrax shots is that I was taught about anthrax in lab school while in the military. I never wanted to take the vaccine and the only reason I took it was because I had no other choice if I wanted to keep my job and the ironic thing about it is after I took the vaccine shot, I got sick and still lost my job. If this matters any the military doctor that diagnosed me with MS is also the one who related the vaccine with my illness. One more thing, I received certain lots of the vaccine that you all had ordered to be destroyed. Now tell me why is it a issue about why the manufacturer should not be allowed to manufacture any more of this vaccine.
Sex: M
Vaccine: ANTH
Symptoms: Dermatitis bullous, Immune system disorder, Vaccine positive rechallenge
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. These vaccines should not be given to our soldiers since they are hurting people and have not been evaluated correctly. To me, it gave me a autoimmune disease called Pemphigus vulgaris and it has changed my life completely.  At this time since I had to take the anthrax vaccine, my health is in the worst of my entire life and nobody wants to take the responsibility after it messed me up. Discontinue it until real evidence that it protect and does not do any arm to people. And if it does, take the responsibility to take care of that patient in all aspects.
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Arthritis, Asthenia, Coordination abnormal
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received 3 anthrax vaccinations in January - February 2000 (five years ago now) while serving in the military. Since the first day of my first shot, my health started deteriorating. In July 2003, I was finally diagnosed with Chronic Fatigue Syndrome and Fibromyalgia. These two diagnosis are the came as Gulf War Illness. These are very debilitating and I cannot work. I suffer with dizziness, balance difficulty, cognitive problems (memory, concentration, decision making, etc.), chronic fatigue, muscle and joint pain, arthritis. I know the anthrax vaccine caused my illness, somehow. I will probably be ill for the rest of my life. This has changed my life totally forever.
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Myalgia, Thinking abnormal
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I received 3 anthrax vaccinations in January - February 2000 (five years ago now) while serving in the military. Since the first day of my first shot, my health started deteriorating. In July 2003, I was finally diagnosed with Chronic Fatigue Syndrome and Fibromyalgia. These two diagnosis are the came as Gulf War Illness. These are very debilitating and I cannot work. I suffer with dizziness, balance difficulty, cognitive problems (memory, concentration, decision making, etc.), chronic fatigue, muscle and joint pain, arthritis. I know the anthrax vaccine caused my illness, somehow. I will probably be ill for the rest of my life. This has changed my life totally forever.
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Unevaluable event
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am submitting this comment on behalf of our daughter now deceased from Anthrax vaccine shots. She died in October 2001 from rapid onset ALS. Before she passed away, she talked personally with a senior advisor. In their conversation, she asked him to stop the Anthrax program because she knew it was the four Anthrax vaccine shots that she had received that caused her illness. She did not want anyone else to suffer the consequences of an unsafe and dangerous product, as she had suffered. Her plea fell on deaf ears because our military continued to be assaulted with Anthrax vaccine. To expound a little bit on this horrific disease (rapid-onset ALS): it is akin to being buried alive - literally. Even to the point where she had to be on a ventilator to breathe for 10 months before she died. May God guide your conscience as you consider licensing this unsafe product. Your actions carry grave consequences for our military and civilians who deserve so much better than this.
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Nervous system disorder
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am submitting this comment on behalf of our daughter now deceased from Anthrax vaccine shots. She died in October 2001 from rapid onset ALS. Before she passed away, she talked personally with a senior advisor. In their conversation, she asked him to stop the Anthrax program because she knew it was the four Anthrax vaccine shots that she had received that caused her illness. She did not want anyone else to suffer the consequences of an unsafe and dangerous product, as she had suffered. Her plea fell on deaf ears because our military continued to be assaulted with Anthrax vaccine. To expound a little bit on this horrific disease (rapid-onset ALS): it is akin to being buried alive - literally. Even to the point where she had to be on a ventilator to breathe for 10 months before she died. May God guide your conscience as you consider licensing this unsafe product. Your actions carry grave consequences for our military and civilians who deserve so much better than this.
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Pain
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was ordered to take three Anthrax vaccines in October and November 1999. Lot numbers 043 and two from 024. Since that time, I have had serious health problems, most of which cannot be diagnosed. Those consist of constant and sometimes excruciating migrating pain all over my body and chronic fatigue syndrome, as well as many other symptoms. I have always been healthy with no known health problems before the vaccine. I didn't attribute my symptoms to the vaccine for almost a year, when I started hearing of others suffering from similar if not identical symptoms. There is no doubt in my mind that the Anthrax vaccine is unsafe and has caused this decrease in the quality of my life. I have been made exempt from any future vaccinations with Anthrax, but I am constantly fighting the medical board to keep my career in the military. I am very disappointed in the manner in which this vaccine has been viewed by the FDA and our government. I am currently taking 10 prescription drugs daily because of the symptoms I suffer and I worry that they may not have been scrutinized any better.
Sex: F
Vaccine: ANTH
Symptoms: Hypokinesia, Thinking abnormal
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I was forced to take the anthrax vaccine in May of 2000 and I have been very ill ever since. With no answers or help in getting my health back because nobody will take accountability to what this vaccine does to people. I have been told that there is no cure for my illness and all the doctors can do is try to make me comfortable with many different medications. Because no one is willing to admit that this vaccine is unsafe. Instead of saving lives it is taking lives. I loved my career in the military and it was taken from me along with my health and am unable to work or do anything I use to do. I went from being very active and healthy to barely being able to get out of bed and some days I don't make it out of bed. Please stop this vaccine from destroying more lives. If I could turn back time, there is no way I would take the shot. I'd rather go to jail or get a dishonorable discharge from the career that I loved, than be so unhealthy and miserable as I am now. If it wasn't for my sister, I would have killed myself a couple of years ago. That is how unbearable my life is thanks to the anthrax vaccine that shouldn't be. I'm going on five years of trying to get my life back and was told recently that was never going to happen.
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I'm writing to report two reactions I had to the anthrax shots I was required to take as an military reservist.  On 6/3/04, I received my second anthrax shot (FAV074). Approximately 1 day after, an area 6" in radius around the shot turned red, with a dark border and was warm to the touch. I went to my doctor upon returning home on or about 6/7/03. He submitted a report. The swelling lasted a full week. On 10/16/04, after my fifth shot (FAV082), I had the same reaction. The radius was only about 3 inches. The swelling lasted three days and I did not see the doctor. However, about a week later, I experienced an unexplained rash on both legs after completing a 4 mile run. The rash went away after about 4 hours with no further occurrence.
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site mass
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal.  In regards to the Anthrax vaccine, I am against it. On 10/4/03, I received my fourth injection of the series. Since then, my life has changed for the worse. At first, the side affects I had were the same as the first 3 injections (fever, chills, body ache, fatigue, and a large nodule at the injection site). The day after things got progressively worse. I was at the point that it took everything I had to even get up and walk. I ached everywhere. It felt like the worst case of the flu I had ever experienced; only it wasn't the flu. Joint pains, muscle aches, headaches, fever, chills, fatigue. I felt like I was going to die. I slept for approximately 36 hours out of the next 48. I did report it and have been dealing with the VHC ever since. I am currently on a Line of Duty with the reserves. I have been seeing doctors in the private sector ever since, and continue to see them to date. At this point I still have not recovered although the symptoms have somewhat improved over the last 17 months. I am no where near being where I was prior to the injections. I have been in a light duty status and still can't be on my feet for lengthy periods of time and continue to have muscle aches, joint pains, and chronic fatigue. I have also had a severe increase in sinus trouble and even had surgery to remove Sinus Polyps. The physicians I have been seeing have found medications that help with daily life; however, the huge problem is that no none can seem to diagnose a specific cause for the ailments. No one seems to know what to test for. Therefore, there doesn't appear to be a specific cure for what doesn't exist.
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Nasal polyps, Pain, Pyrexia
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal.  In regards to the Anthrax vaccine, I am against it. On 10/4/03, I received my fourth injection of the series. Since then, my life has changed for the worse. At first, the side affects I had were the same as the first 3 injections (fever, chills, body ache, fatigue, and a large nodule at the injection site). The day after things got progressively worse. I was at the point that it took everything I had to even get up and walk. I ached everywhere. It felt like the worst case of the flu I had ever experienced; only it wasn't the flu. Joint pains, muscle aches, headaches, fever, chills, fatigue. I felt like I was going to die. I slept for approximately 36 hours out of the next 48. I did report it and have been dealing with the VHC ever since. I am currently on a Line of Duty with the reserves. I have been seeing doctors in the private sector ever since, and continue to see them to date. At this point I still have not recovered although the symptoms have somewhat improved over the last 17 months. I am no where near being where I was prior to the injections. I have been in a light duty status and still can't be on my feet for lengthy periods of time and continue to have muscle aches, joint pains, and chronic fatigue. I have also had a severe increase in sinus trouble and even had surgery to remove Sinus Polyps. The physicians I have been seeing have found medications that help with daily life; however, the huge problem is that no none can seem to diagnose a specific cause for the ailments. No one seems to know what to test for. Therefore, there doesn't appear to be a specific cure for what doesn't exist.