chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site swelling, Lymphadenopathy, Nonspecific reaction, Pruritus, Pyrexia
Clinical narrative: 02/18/2003- Anthrax (2), given in left arm: Local: Experienced local reaction similar to that following first anthrax vaccine ( minimal redness, swelling and tenderness surrounding vaccine site for  (approximately 2-3 days). Also, developed pruritic knot at vaccine site which did not resolve before the next anthrax vaccine was given in her left arm. Systemic: Does not recall experiencing chills, headaches, muscle aches, or joint pain following vaccine. Within the first week of vaccine receipt, experienced onset of mild fever, significant fatigue and swollen glands in her neck. The fatigue has persisted, and the mild fevers with lymphadenopathy have recurred intermittently.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Tenderness
Clinical narrative: 02/18/2003- Anthrax (2), given in left arm: Local: Experienced local reaction similar to that following first anthrax vaccine ( minimal redness, swelling and tenderness surrounding vaccine site for  (approximately 2-3 days). Also, developed pruritic knot at vaccine site which did not resolve before the next anthrax vaccine was given in her left arm. Systemic: Does not recall experiencing chills, headaches, muscle aches, or joint pain following vaccine. Within the first week of vaccine receipt, experienced onset of mild fever, significant fatigue and swollen glands in her neck. The fatigue has persisted, and the mild fevers with lymphadenopathy have recurred intermittently.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site induration, Tenderness
Clinical narrative: 5"x4" red, indurated, site tender area right anterior thigh at site of DTaP-Hib injection. No adenopathy, illness, fever or temp. Child acts well.
Age: 1.03
Sex: M
Vaccine: PNC
Symptoms: Rash vesicular
Clinical narrative: Chicken Pox
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Hyperhidrosis, Injection site erythema, Nausea, Rash macular
Clinical narrative: Hypo-, diaphoretic, nauseated, blotchy redness at injection site. All resolved within one hour after Benadryl 25mg IM. Received follow up care by MD at CWU Student Health Center.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient c/o redness, swelling, hardness above, pain and warmth on right arm at site of injection of Pediarix vaccine.
Age: 54.0
Sex: M
Vaccine: TD
Symptoms: Agitation, Anxiety, Paranoia, Phobia
Clinical narrative: Severe anxiety reaction ( panic attack, beginning about 1 hour later. Feelings of anxiety, agitation, fears, symptoms gradually resolved over about 10 hours. Seen by Emergency Mental Health Counselor.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Oedema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: 03/23/2005- low grade intermittent fever 03/24/2005- Maculo papular erythematous exanthema- trunk, limbs, non-pemphigus, swollen retro auricular nodes bilaterally.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pruritus, Skin reaction
Clinical narrative: Redness right upper arm above the elbow to deltoid. Pink above arm swollen, soft and with itchiness.
Age: 0.76
Sex: F
Vaccine: HIBV
Symptoms: Cough, Sneezing, Vomiting
Clinical narrative: Began sneezing and coughing within minutes of the shot, and began vomiting within 5 minutes of the shot. Vomiting continued at the doctor's office for 2.5 hours, occurring regularly every 10-15 minutes. Child was ver lethargic and fell asleep in between episodes of vomiting. Doctor administered rectal suppository "tebamide" to suppress vomiting. Vomiting continued for 12 hours at home ever 30 to 45 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: arm red and swollen.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: 03/29/2005- Diagnosed with having Chicken Pox. Had received vaccine on 09/06/2001.
Age: 1.25
Sex: M
Vaccine: DTAPH, IPV, MMR, PNC
Symptoms: Pyrexia, Rash erythematous, Rash papular
Clinical narrative: Erythematous Papular rash, fever.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Pt developed chicken pox/varicella lesions on trunk, face, and extremeties. Genitals also involved. No exposure to anyone with varicella or zoster.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site reaction
Clinical narrative: Localized Erythema
Age: 65.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Herpes zoster
Clinical narrative: I awoke on 03/17/05, with shingles, diagnosis confirmed by my private physician. I was prescribed Famvir, two a day for 10 days. Shingles are on left side, sternum to spine. Still recovering.
Age: 22.0
Sex: M
Vaccine: MMR, TD
Symptoms: Urticaria
Clinical narrative: Client came in to clinic and reported that he had developed hives two days after receiving injections of Td and MMR. Client did seek medical care and was instructed by MD to use Benadryl which he could buy at local drugstore. Client was told he would need a note from MD in the future before receiving any vaccines at clinic. 03/15/2005- P/C made to follow up client completely resolved.
Age: 1.16
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Malaise, Pyrexia, Skin ulcer
Clinical narrative: Fever and malaise 03/22/2005 followed by outbreak of lesions on neck and torso 03/23/2005
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: 03/23/2005- Right arm itchy, red, and swollen. Treatment with Benadryl- good results
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Break through chicken pox.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dystonia, Syncope vasovagal
Clinical narrative: Pt had vaso vagal reaction when "coming to " pt had dystonic reaction. Vitals stable, Follow up  at Urgent Care.
Age: 46.0
Sex: F
Vaccine: TD
Symptoms: Joint range of motion decreased, Neck pain, Pain
Clinical narrative: 2 weeks of severe left deltoid muscle pain radiating down arm and up into neck. Difficulty abducting left shoulder.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, IPV, PNC
Symptoms: Pyrexia, Skin reaction
Clinical narrative: 1 day after DTaP/ Comvax/ IPV/ Prevnar pt developed bumps on Left and right thighs bilaterally. Temp = 101 degrees Fahrenheit, resolved in the next day. No fussiness, Normal Behavior.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, IPV, PNC
Symptoms: Pyrexia, Rash papular, Upper respiratory tract infection
Clinical narrative: 1 day after DTaP/ Comvax/ IPV/ Prevnar pt developed bumps on Left and right thighs bilaterally. Temp = 101 degrees Fahrenheit, resolved in the next day. No fussiness, Normal Behavior.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at vaccination site.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt states injection site became sore and red 30 minutes after vaccine administration.  Site was nickle sized and stayed that way for 3 days, it then slowly shrank down to pea size as of 21 Mar 05.  Redness has lasted for 3 weeks at the site of the injection.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Pain, Swelling
Clinical narrative: pt received flu vaccine on 2/23/05. after that time experienced swelling and pain and decreased range of motion in right shoulder. presented on 3/4/05 with a frozen right shoulder. was referred to the emergency department. Since that time patient has regained full range of motion in shoulder and trend of improvement of his symptoms.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Apnoea, Crying, Cyanosis, Diarrhoea
Clinical narrative: My son die the next day after receiving his vaccines.  I gave him .8ml of tylenol about 4:45pm and he had a bottle an hour earlier. It was time for his nap because he was crying but never thought he wouldn't wakeup again. My oldest son (18) pick him up and found that he wasn't breathing and blue he called 911.  He was rushed to hospital.  This was about 7:30 pm. Follow up report received 04/07/2005:  On the day following vaccination, child had loose stool in AM and was more fussy than usual.  When son found him not breathing, he was lying on the chest of his 12 year old sister with his face turned toward the back of the sofa and his nose pressed against the sofa. Received medical records from PCP & ER. Autopsy Report received which revealed COD as SIDS while cosleeping.  Therapeutic level of pseudoephedrine (0.87 mg/L) was found on autopsy.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Sudden infant death syndrome
Clinical narrative: My son die the next day after receiving his vaccines.  I gave him .8ml of tylenol about 4:45pm and he had a bottle an hour earlier. It was time for his nap because he was crying but never thought he wouldn't wakeup again. My oldest son (18) pick him up and found that he wasn't breathing and blue he called 911.  He was rushed to hospital.  This was about 7:30 pm. Follow up report received 04/07/2005:  On the day following vaccination, child had loose stool in AM and was more fussy than usual.  When son found him not breathing, he was lying on the chest of his 12 year old sister with his face turned toward the back of the sofa and his nose pressed against the sofa. Received medical records from PCP & ER. Autopsy Report received which revealed COD as SIDS while cosleeping.  Therapeutic level of pseudoephedrine (0.87 mg/L) was found on autopsy.
Age: 75.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Red, swollen, warm upper arm, right. no Fevers.
Age: 0.42
Sex: M
Vaccine: DT, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Temp. greater than 102 rectally, fussy, irritability with no other focus of infection, approximately 2 hours after administration. patient had previous immunization @ 2 months of age with same symptoms patient was given pediatric dt with his hx. instead of dtap.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Cardio-respiratory arrest
Clinical narrative: (See Box 8) Received ER medical records which state patient was in full arrest upon arrival & was unable to be resuscitated. Autopsy report received which revealed COD was undetermined.  Patient was cosleeping with parents in bed which was significantly concave & had blood stains in middle of sheet per investigative report.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Febrile convulsion, Irritability
Clinical narrative: Patient became fussy. Had febrile seizure with a temperature of 102.
Age: 1.2
Sex: F
Vaccine: MMR, MMR
Symptoms: Rash, Rash erythematous
Clinical narrative: Approximatley six to seven days after MMR was given patient broke out in rash-red raised bumps on face and body.
Age: 1.2
Sex: F
Vaccine: MMR, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Approximatley six to seven days after MMR was given patient broke out in rash-red raised bumps on face and body.
Age: 28.0
Sex: F
Vaccine: ANTH, CHOL, DPP, TYP, YF
Symptoms: Alopecia, Arthralgia, Bone pain, Diarrhoea, Fatigue
Clinical narrative: Bone pain, muscle pain, chronic diarrhea, joint pain. Per follow up report received on 06/09/2005:  Multiple arthralgia, neurological effects, fibromyalgia, skin rashes, hair loss, menstrual disorders, chronic fatigue.
Age: 28.0
Sex: F
Vaccine: ANTH, CHOL, DPP, TYP, YF
Symptoms: Fibromyalgia, Menstrual disorder, Myalgia, Neurological symptom, Rash
Clinical narrative: Bone pain, muscle pain, chronic diarrhea, joint pain. Per follow up report received on 06/09/2005:  Multiple arthralgia, neurological effects, fibromyalgia, skin rashes, hair loss, menstrual disorders, chronic fatigue.
Age: 46.0
Sex: M
Vaccine: HEP, TTOX, VARCEL
Symptoms: Arthralgia, Malaise, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: Varicella vaccine given March 10th 2005. March 28 morning, malaise. March 28 evening, 100 degree temperature. March 29 all day, joint aches but temperature is normal. March 30 afternoon, I feel fine but I have raised bumps that itch, mostly on chest and back. March 31 more bumps on head with a couple on face and arms. None of the red bumps break open but they do have a raised point in the center.... they itch a lot. April 1-2 I don't seem to see any new bumps but the ones I have still itch and a few have tiny little scabs.... like extremely mild chickenpox says my mom. Otherwise I have felt fine since March 30.
Age: 46.0
Sex: M
Vaccine: HEP, TTOX, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella vaccine given March 10th 2005. March 28 morning, malaise. March 28 evening, 100 degree temperature. March 29 all day, joint aches but temperature is normal. March 30 afternoon, I feel fine but I have raised bumps that itch, mostly on chest and back. March 31 more bumps on head with a couple on face and arms. None of the red bumps break open but they do have a raised point in the center.... they itch a lot. April 1-2 I don't seem to see any new bumps but the ones I have still itch and a few have tiny little scabs.... like extremely mild chickenpox says my mom. Otherwise I have felt fine since March 30.
Age: 0.53
Sex: M
Vaccine: DTP, HIBV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102.0-102.9 onset by evening of shot, fever persistent and lasted until evening 5 days later.  Rash developed on head and neck on day 6.  Tylenol was given for fever as well as using damp washcloths to cool skin.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Anxiety, Depression, Headache, Injection site hypersensitivity, Injection site reaction
Clinical narrative: Area injection site has been repeatedly sensitive with itching, scabbing. Also, experiences headaches, nausea and chest conjestion with flare-ups. Flare-ups started about 90 days after injection and recurr approx every 60-90 days thereafter. Experiencing unexplained anxiety/depression ocurring approx 120 days after injection. Recurs 60-90 days.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Nasal congestion, Nausea, Pruritus
Clinical narrative: Area injection site has been repeatedly sensitive with itching, scabbing. Also, experiences headaches, nausea and chest conjestion with flare-ups. Flare-ups started about 90 days after injection and recurr approx every 60-90 days thereafter. Experiencing unexplained anxiety/depression ocurring approx 120 days after injection. Recurs 60-90 days.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Hypersensitivity, Injection site rash, Injection site swelling, Vaccination complication
Clinical narrative: Symptoms included significant swelling around the vaccination site and a rash.  The use of band-aids resulted in breaking of the skin.  Autoinoculation occurred approximately one centimeter away from the original vaccination site.  Duration of symptoms was approximately one and a half days.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Skin ulcer
Clinical narrative: 22 year-old male with skin rash X 3 weeks found only on anterior trunk from the umbilicus to his pubic area.  The lesions are non-pruritic without erythema, no pain, no discharge associated with these lesions.  Patient reports the lesions appeared just a few at a time and are spreading downward toward his genitalia.  He reports the lesions appeared 7-14 days after receiving smallpox vaccine.   20-30 individual pustular lesions along anterior trunk down into pubic hair area without surrounding erythema, scale, or drainage.  Lesions appear to be post-vaccinia follicular pustulosis.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox
Clinical narrative: Generalized vaccinia rash.
Age: 69.0
Sex: F
Vaccine: HEPA, IPV, TD, TYP
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Pruritus
Clinical narrative: Received injections on 03/23/05. TD given IM in the left deltoid. IPV and Havrix given in right deltoid. Also given oral Typhoid. On 03/25/05, noted slight itching with slight reddened area below TD injection site. Admits to scratching vigorously at times throughout the next week. Returned to clinic on 03/30/05 for HBV #1. Showed left arm to RN. Slightly red area noted below injection site with dry skin. HBV # 1 given in right deltoid. Called office on 03/31/05, stating that left upper arm had an area the size of a grapefruit below injection site of TD, continued itching and hot to touch. Had appointment with doctor that afternoon, asked to call clinic with update after appointment. At doctor's office, she states the entire left arm was red, swollen and hot to touch. Given Zyrtec and cream to apply to arm. At present arm is less red and less itchy. Will call in 3 days for follow up. Patient recovered on 04/04/05.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Child given immunizations of HIB and Prevnar in the right leg on 03/31/05. Patient seen in the office on 04/01/05 with fever of 103-104, right leg swollen 20x30 cm. Need direction on what to give for next immunizations.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oedema peripheral
Clinical narrative: Vaccine administered in right thigh. Next day, area was warm, red, swollen and tender approximately 4 cm in diameter.
Age: 36.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal stiffness, Oedema peripheral, Rash
Clinical narrative: Pt described development of stiff neck and increased stiffness and soreness of joints (specialized/occurring on 3/25/2005). She developed an ascending rash which started from legs and noted swelling of lower extremities. Evaluated in ER on 3/26 and admitted. Addendum: Above named pt was admitted to hospital on 3/26/2005 for what she described as a reaction to MMR given 2/26/2005. She reports she was informed of this by the attending physicians; however, I am enclosing the final discharge diagnosis that indicates exanthem. At this time she is on steroid therapy for this condition and is pending follow up testing if symptoms reoccur. Per follow up report received on 06/14/2005:  Patient's recovery status is still unknown.
Age: 63.0
Sex: F
Vaccine: FLU3, IPV, MMR, PPV
Symptoms: Arthralgia, Erythema, Hypokinesia, Oedema peripheral, Pain
Clinical narrative: Patient stated about 7 days had right arm soreness, with redness and rash on arms, face and stomach. Rash subsided but had "painful walking", "bottom of feet hurt", soreness of joints in neck, knees, arms and swelling of hands. Stated joints are better now but hands sore and swollen some. Encouraged patient to see doctor. Reported no medication on date of consult.
Age: 63.0
Sex: F
Vaccine: FLU3, IPV, MMR, PPV
Symptoms: Rash
Clinical narrative: Patient stated about 7 days had right arm soreness, with redness and rash on arms, face and stomach. Rash subsided but had "painful walking", "bottom of feet hurt", soreness of joints in neck, knees, arms and swelling of hands. Stated joints are better now but hands sore and swollen some. Encouraged patient to see doctor. Reported no medication on date of consult.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Decreased appetite, Electroencephalogram abnormal, Encephalopathy, Febrile convulsion, Hypoacusis
Clinical narrative: Patient had fever and febrile seizures, was admitted to hospital. Continues to have seizures and has had 2 other admissions as a result. From discharge summary information of eyes twitching, tonic, clonic seizures, increased somnolance. msv Medical records state questional encephalopathy, decreased appetite, decreased hearing. msv
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Somnolence
Clinical narrative: Patient had fever and febrile seizures, was admitted to hospital. Continues to have seizures and has had 2 other admissions as a result. From discharge summary information of eyes twitching, tonic, clonic seizures, increased somnolance. msv Medical records state questional encephalopathy, decreased appetite, decreased hearing. msv
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Conversion disorder, Delusion, Pyrexia, Screaming
Clinical narrative: Patient given Hepatitis A vaccine on 03/23/05. On 03/24/05 patient had a fever of 103, screaming hysterically, delusional (complaining of spiders everywhere). This resolved in about 24 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large local reaction, swelling, erythema from shoulder to just above elbow of left arm. DTaP, IPV given in this arm and PPD to forearm.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 5cm x 6cm area of non-tender erythema around injection site, no induration, no warmth and joints normal.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: On 03/23/05, right upper arm swollen and red, temperature 99 degrees and rash on body. Saw doctor for already scheduled appointment and NP noticed arm. Mother not concerned about arm until NP questioned her about shots.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Swelling of upper arm from shoulder to elbow day of shots lasting 2 days.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Pruritus
Clinical narrative: Child presented with varicella illness to office on 03/23/2005. No fever known but some itching.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Syncope vasovagal
Clinical narrative: Patient had vasovagal syncope after immunization given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to upper arm (deltoid), DTaP and IPV given in this site.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Fever of 104 degrees, unconsolable crying for 2 to days. Fever of 102 degrees for 2-3 days more.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Anorexia, Crying, Irritability, Somnolence, Vomiting
Clinical narrative: 03/14/05: Per mother patient became fussy, weepy, tired, within 30 minutes of vaccinations. She had decreased appetite and increased sleeping on the 11th, 12th 13th and 14ht; vomited once on the 14th. No fever. Called PCP who referred mom to health department. 03/15/05 telephone call to mom, who reports child improving, will not follow up with PCP. Had 3 grand mal seizures at age 1, not related to vaccine. No medications given. No seizures since then, mom reported this on 03/11/05 on questionairre.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Itchy at site right of immunization. Woke up with upper left thigh reddened. Seen by doctor at 14:00. Reddened area localized to left anterior thigh, 6"x4", outlined. Area was iced and medications ordered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Received immunizations 3/24/, next day (03/25 2:30 pm) noted left arm deltoid area was red, swollen and had a hard area 12cm x 12cm. Temperature 99.5. Physician treated with tylenol, motrin and benadryl. Arm improved by 03/28, arm nearly normal.
Age: 1.05
Sex: U
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Given Benadryl for symptoms.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: Patient returned to clinic ten days post vaccination with 2 day history of fever and fussiness. Slight tonsil node swelling. No noted rash.
Age: 27.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Nausea, dizziness and sweating.
Age: 0.52
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema
Clinical narrative: Red local skin reaction at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral, Swelling
Clinical narrative: Received immunization on 03/10/05. Developed swelling and redness of the right thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Pain, induration, erythema and warmth of left upper arm.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Patient developed fever and vomiting. Redness and induration at injection site. Site tender to touch. Patient 25 mg tab of Benadryl.
Age: 37.0
Sex: F
Vaccine: TTOX
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient complained of tenderness at injection site. Tenderness and mild pain when moving arm. Complains of tenderness when palpating under arm. Skin at site is hot to the touch, red and a 3" nodule formed. I suggest she use warm moist heat to site and will schedule a time for her to see the doctor.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed redness and swelling at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Swelling, edema, heat, firm cellulitis (scapula, shoulder and arm) to left arm. Shots given one on top of each other.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Left thigh red, warm to touch and swollen. Treated with hot pack, Benadryl and  Augmentin. Father has had problems in past with immunizations.
Age: 60.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF
Symptoms: Headache, Influenza like illness, Myalgia
Clinical narrative: Muscle Aches in Head , neck, legs, back.   Flu like symptoms, headache. Afebrile. Started 4/2/05. Advised to seek medical attention.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: RECEIVED PNEUMOVAX 3/31/05 @ APPROX 0830.  PATIENT CALLED 4/2/05 @ 0359 had developed five hives 3 inches below injection site, left deltoid, and one hive near left axilla.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Left upper arm pain immediately after injection. Still having pain over four months later. Very upset. Saw me (her primary MD) today for evaluation. Referred for physical therapy.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Fatigue, Haematochezia, Headache
Clinical narrative: Received AVA #1 on Jan 11, 2003. in R arm. there was no burning at the time of injection, there was a slight amount of swelling later that day. The next morning he awoke with aches everywhere in joints. No headache, no dizziness, did have weakness. Drove from his home and spoke with his senior who told him to check with the flight chief and go to clinic. He was given 24 hours rest and sent home, he had no meds at that time. The aching continued "everywhere" throughout Jan and Feb. He went to a civilian MD, was tried on Vioxx, Mobic, Celebrex, Naproxen. Was combining prescriptions to try to obtain relief. Experienced Bloody stools, quit naproxen, then quit Celebrex. Developed skin condition requiring dermatological consult due to overuse of hot water to relieve pain in joints and back. He is now unable to change tires, or hold his arms up long enough to check an aircraft. He is able to hold a full time job, but due to problems with short term memory must make frequent use of note taking, and is unable to pass tests to requalify for upper levels of aircraft technician. Although his level of symptoms has not decreased, he has developed coping skills that have allowed an improvement in his mental status scores on SF36 evaluation. 3/14/06-Review of 9-page clinical summary indicates the final assessment was chronic joint pain, malaise & fatigue, insomnia, headache, and short-term memory loss all with onset temporally related to receipt of anthrax vaccine.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Insomnia, Laboratory test abnormal, Malaise, Memory impairment, Pain
Clinical narrative: Received AVA #1 on Jan 11, 2003. in R arm. there was no burning at the time of injection, there was a slight amount of swelling later that day. The next morning he awoke with aches everywhere in joints. No headache, no dizziness, did have weakness. Drove from his home and spoke with his senior who told him to check with the flight chief and go to clinic. He was given 24 hours rest and sent home, he had no meds at that time. The aching continued "everywhere" throughout Jan and Feb. He went to a civilian MD, was tried on Vioxx, Mobic, Celebrex, Naproxen. Was combining prescriptions to try to obtain relief. Experienced Bloody stools, quit naproxen, then quit Celebrex. Developed skin condition requiring dermatological consult due to overuse of hot water to relieve pain in joints and back. He is now unable to change tires, or hold his arms up long enough to check an aircraft. He is able to hold a full time job, but due to problems with short term memory must make frequent use of note taking, and is unable to pass tests to requalify for upper levels of aircraft technician. Although his level of symptoms has not decreased, he has developed coping skills that have allowed an improvement in his mental status scores on SF36 evaluation. 3/14/06-Review of 9-page clinical summary indicates the final assessment was chronic joint pain, malaise & fatigue, insomnia, headache, and short-term memory loss all with onset temporally related to receipt of anthrax vaccine.
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Received AVA #1 on Jan 11, 2003. in R arm. there was no burning at the time of injection, there was a slight amount of swelling later that day. The next morning he awoke with aches everywhere in joints. No headache, no dizziness, did have weakness. Drove from his home and spoke with his senior who told him to check with the flight chief and go to clinic. He was given 24 hours rest and sent home, he had no meds at that time. The aching continued "everywhere" throughout Jan and Feb. He went to a civilian MD, was tried on Vioxx, Mobic, Celebrex, Naproxen. Was combining prescriptions to try to obtain relief. Experienced Bloody stools, quit naproxen, then quit Celebrex. Developed skin condition requiring dermatological consult due to overuse of hot water to relieve pain in joints and back. He is now unable to change tires, or hold his arms up long enough to check an aircraft. He is able to hold a full time job, but due to problems with short term memory must make frequent use of note taking, and is unable to pass tests to requalify for upper levels of aircraft technician. Although his level of symptoms has not decreased, he has developed coping skills that have allowed an improvement in his mental status scores on SF36 evaluation. 3/14/06-Review of 9-page clinical summary indicates the final assessment was chronic joint pain, malaise & fatigue, insomnia, headache, and short-term memory loss all with onset temporally related to receipt of anthrax vaccine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abasia, Erythema, Feeling hot, Swelling
Clinical narrative: The DTaP shot was given in the right leg on Friday.  By Sunday it was swollen twice the size as the left leg and extremely red and hot.  He was unable to walk on it.  Taken to clinic and they treated him with some steriods.  Leg is still swollen today but not red.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Pain, Swelling
Clinical narrative: 5 days of swelling, pain, can't raise arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Diarrhoea, Erythema, Pruritus, Pyrexia, Urticaria
Clinical narrative: Approx 1 hr after shots for MMR SQ, IPVSQ, and DTaP IM, my son developed severe hives over entire body...starting at ears, back, neck stomache to arms and legs, bright  red ears, fever...itching everywhere.   I gave him Benadryl which subsided these affects about 1 hour later he went to sleep.  My son has a kidney transplant and I now hear from my nephrologist that immun supp. pts on steriods and immun dep drugs should not even be given MMR.  He may now develop these viruses for they are live viruses in the shot.. As per annual follow up report child also went stool 3x within 10 minutes 1 hour after very loose stool.
Age: 0.34
Sex: M
Vaccine: DTP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Thirteen days after receiving vaccinations, he had a seizure, called 911, went to hospital. Had second seizure in ER, then admitted, throughout next 30 hours had 9 seizures. All tests came back negative. Now on Phenobarbital & dylantin. No seizure since taking medicines.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Increased temp, seizures, air vac to med center. Given Diastek 5 mg suppositories for seizures.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blood glucose increased, CSF test abnormal, Eosinophilia, Irritability, Lymphocytosis
Clinical narrative: High fever, irritability, poor feeding. Full sepsis work up 6/19 - negative. IV ABX (Ampicillin, Claforan). Multiple labs.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Oral intake reduced, Pyrexia, White blood cell count increased
Clinical narrative: High fever, irritability, poor feeding. Full sepsis work up 6/19 - negative. IV ABX (Ampicillin, Claforan). Multiple labs.
Age: 1.27
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Loss of consciousness, Otitis media, Pyrexia
Clinical narrative: Per patient's mother, she had a episod of unconsciousness with fever of 105 degrees F.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: On 04/01/05, 2 days after receiving hepatitis B vaccine (Engerix B), she developed mild pruritic erythematous rash, involving the trunk, extremities and sparing face. This patient reported mild URI symptoms which started 1 day prior to vaccination; felt well, no fever on date of vaccination. Lesions have continued to appear through 04/03/05. No fever, no urticaria, no medication. Has not recovered yet.
Age: 1.03
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: On 04/01/05, had bump at site of vaccination. 04/02/05-04/04/05 had 12 macular papular lesions (1 vesicular) on the right flank and buttock. A new one appearing on right wrist that is pruritic. Prescribed calamine lotion.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to area around injection site. Ice applied to area.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: From initial information received on 23Feb04 from another manf (control HQWYE954112FEB03) regarding an adverse event occurring, it was initially reported by a health care professional that a four month old male pt received a dose of Acthib lot number UE084AA, a dose of Daptacel, lot number C1606AA, and a dose of Ipol, lot number X0367 (routes and sites of admin not reported) on 30Jan04. The following day, the pt developed hives, which resolved in four days. From additional information received on 07Mar04 from the initial reporter, additional physician information was provided. It was reported that the pt also received a second dose of Prevnar, lot 495888, IM in the right leg on 30Jan04. On 26Mar04, he received follow up doses of Dtap, Comvax and Ipol with no reactions. The lot numbers and routes of admin were not reported for the vaccines given on 26Mar04. No further information is anticipated, this case is considered closed.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Chest pain, Difficulty in walking, Fatigue, Hypoaesthesia, Hypokinesia
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. January 2003, my son was called to active duty. Within 24 hours after receiving his first set of inoculations (FAV065) Anthrax, he experienced tingling and numbness on the left side of his body. He told his superior. In the next three weeks, he still had numbness but was given two more series of shots. His superior asked if he wanted to get the fourth series. He declined. He was tested and told that there was some nerve damage. His equipment, all packed, went overseas without him.  He was pulled off active duty. His condition has worsened. I've lost track of all the doctors he has seen and all the tests he has taken. None will give an answer as to what actually is wrong with him or how to help. Sometimes he seems OK, then there are times when it is obvious by looking at him that he is in pain, which he says is constant. He is gaunt and has lost weight. He has trouble sleeping and can hardly get out of bed. His wife at times has to help dress and feed him. He uses a cane to walk. When he tries to do anything like now the lawn or get back into his exercise and calisthenics routine he is totally spent and suffers greatly. A couple of times we have dad to take him to the hospital with chest pains.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Insomnia, Nerve injury, Pain, Paraesthesia
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. January 2003, my son was called to active duty. Within 24 hours after receiving his first set of inoculations (FAV065) Anthrax, he experienced tingling and numbness on the left side of his body. He told his superior. In the next three weeks, he still had numbness but was given two more series of shots. His superior asked if he wanted to get the fourth series. He declined. He was tested and told that there was some nerve damage. His equipment, all packed, went overseas without him.  He was pulled off active duty. His condition has worsened. I've lost track of all the doctors he has seen and all the tests he has taken. None will give an answer as to what actually is wrong with him or how to help. Sometimes he seems OK, then there are times when it is obvious by looking at him that he is in pain, which he says is constant. He is gaunt and has lost weight. He has trouble sleeping and can hardly get out of bed. His wife at times has to help dress and feed him. He uses a cane to walk. When he tries to do anything like now the lawn or get back into his exercise and calisthenics routine he is totally spent and suffers greatly. A couple of times we have dad to take him to the hospital with chest pains.
Age: 28.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Difficulty in walking, Fatigue, Paraesthesia
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. January 2003, my son was called to active duty. Within 24 hours after receiving his first set of inoculations (FAV065) Anthrax, he experienced tingling and numbness on the left side of his body. He told his superior. In the next three weeks, he still had numbness but was given two more series of shots. His superior asked if he wanted to get the fourth series. He declined. He was tested and told that there was some nerve damage. His equipment, all packed, went overseas without him.  He was pulled off active duty. His condition has worsened. I've lost track of all the doctors he has seen and all the tests he has taken. None will give an answer as to what actually is wrong with him or how to help. Sometimes he seems OK, then there are times when it is obvious by looking at him that he is in pain, which he says is constant. He is gaunt and has lost weight. He has trouble sleeping and can hardly get out of bed. His wife at times has to help dress and feed him. He uses a cane to walk. When he tries to do anything like now the lawn or get back into his exercise and calisthenics routine he is totally spent and suffers greatly. A couple of times we have dad to take him to the hospital with chest pains.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Crying, Pyrexia, Screaming, Somnolence
Clinical narrative: From initial information received on 11Aug04 from a health care professional regarding an adverse event occurring, it was reported that a two month old female pt received her first dose of Acthib, lot X0806, Daptacel lot C1663AA, IPOL X0800, Hep B lot 0465P and Prevnar lot A57553E on 05Aug04. The route and sites of admin of the products were not provided. Reportedly at 10:30PM that same day the pt had a high pitched scream and was sleeping alot. There was no swelling at the injection sites. The next morning at 9:30AM, the pt was okay, there was seen by a physician and she cried when she was moved. The pt was taken to the ER where a blood culture was done and came back negative. On 10Aug04, per the pt's mother, the pt had a temp of 102 degrees F and was having fevers off and on since 05Aug04. The pt's recovery status is currently unk. From additional information received on 08Dec04 from the initial reporter, it was reported that the pt recovered from these events. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter of cases 200402656, 200402657, and 200402659.
Age: 0.34
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: From initial information received on 11Aug04 from the vaccine provider regarding an adverse event occurring it was reported that a four month old female pt received an Acthib vaccination, lot numberX0870, a Daptacel vaccine, lot C1663AA, an Ipol vaccination, lot number X0800, a hep b vaccination, lot number 0465P, and a Prevnar vaccination, lot A515532, on 09Aug04. The same night, the pt developed a fever of 101 degree Fahrenheit. It was reported that the shot area was fine. On 10Aug04, the pt was still running a temp of 101 degrees and sleeping a lot. It is unk if the pt recovered from these events. From additional information received on 08Dec04 from a health care professional, it was reported that the pt recovered from the events. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter as cases 200402656, 200402658 and 200402659.
Age: 0.17
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Screaming
Clinical narrative: From initial information received on 18Jun04 from (HQWYE162702JUN04) regarding an adverse event occurring, it was reported that a two month old female pt received an ACTHIB vaccination, lot number 1250N, route of administration not reported on 27May04. The same day the pt experienced excessive crying and thrashing of legs. The recovery status of the pt was reported as unk. Note: Lot number provided does not match any manf lot number.
Age: 0.17
Sex: F
Vaccine: HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Decreased appetite, Diarrhoea, Screaming
Clinical narrative: From initial information received on 18Jun04 from (HQWYE162702JUN04) regarding an adverse event occurring, it was reported that a two month old female pt received an ACTHIB vaccination, lot number 1250N, route of administration not reported on 27May04. The same day the pt experienced excessive crying and thrashing of legs. The recovery status of the pt was reported as unk. Note: Lot number provided does not match any manf lot number.
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Respiratory distress, Urticaria
Clinical narrative: From initial information received on 11/17/2004 from a registered nurse regarding an adverse event  occurring in the USA, it was reported that a six month old female patient received her 3rd dose of Act Hib, lot numberUE084AA (Aventis Pasteur SA lot #X0076-2), administered IM in the right lower thigh, her 3rd dose of Daptacel, Lot number C2044AA, administered IM in the right upper thigh, her 1st dose of Fluzone SV '2004-'2005 USP Pediatric dose, lot number C1415AA (this lot number does not match a known Aventis Pasture product) administered IM in the lower LT and a 3rd dose of Prevnar (manufacturer Lederle) lot numbers A79659B, administered IM in the left upper thigh at 11:00 AM on 11/12/2004. Within two minutes the patient was covered with hives from head to tie. No anaphalaxus or respiratory distress was noted. The patient remained alert and playful she was treated with oral Benadryl 2.75ml and the hives faded within 20 minutes. The pt was sent home and is to follow up with an allergist. The pt recovered form this event
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Apnoea, Convulsion, Hypotonia, Pyrexia, Tremor
Clinical narrative: On 4/2 had an episode of flaccidity and apnea just prior she had a chilling shake.  thought by EMS and ER to be a febrile seizure.  Temp at ER 101.8.
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Parotid gland enlargement, Skin nodule
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I'll tell you my experience. I got sick right after receiving my second shot in March of 2000 from FAV044. I consider myself lucky because the only permanent damage done was to my parotid gland. The vaccine caused my immune system to turn on itself and attack healthy cells. I'll have an uncomfortable lump below my right ear lobe for the rest of my life. The joint pain and chronic fatigue went away after a couple of years and thousands of dollars out of my own pocket to pay for a homeopath that knew effective treatments for people that have been poisoned by such things.
Sex: M
Vaccine: ANTH
Symptoms: Hyperaesthesia, Injection site mass, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I have received 8 Anthrax shots as ordered by the military. While with some of the shots, I have not had much in the way of adverse reactions, the last two shots I received in 2002 and 2003 have caused significant adverse reactions. Both times, I had tenderness, touch sensations (ants crawling), heat, a large rash about 4 inches in diameter and a lump at the injection site. The symptoms lasted from 2 to 4 weeks. The lump would last months. I would like to see the Anthrax vaccine be listed as Category II (unsafe, ineffective, or misbranded), or at the very least, Category IIIB (off the market pending completion of studies permitting a determination of effectiveness).