chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Chest pain, Feeling cold, Headache, Prostatic specific antigen increased
Clinical narrative: Experienced severe pain in chest cavity right side, headache, abdominal pain, feeling very cold. Abdominal and chest pain subsided in early morning following day. Headache subsided around noon. Does not think temp elevated. Was seen by his urologist 5 days later after Cystoscopy and PSA blood work. PSA elevated from 4.6 - 5.6. PSA to be repeated as MD thought flu shot or cystoscopy could account for PSA elevation. Was not 1st flu shot. No adverse reaction in past to flu vaccine.
Age: 0.09
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Infant less than 2 months of age received Flu Vac.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Medication error
Clinical narrative: Vaccine error, Localizes erythema.
Age: 0.36
Sex: M
Vaccine: DTAPH, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Chicken pox, about 20 lesions DX by DR.
Age: 1.05
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Rash papular, Rash pruritic, Viral infection
Clinical narrative: Varicella vaccine breakthrough. Started with itchy rash on 12/11/2005. No fever. Seen in our office on 12/12/05 and diagnosed by Dr with varicella. had 20-30 scattered papules on trunk and extremities, some with scabs. Vaccine given on 07/17/2000.
Age: 13.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abscess, Cough, Injection site induration, Pyrexia
Clinical narrative: On 06/2/2005 mom brought patient in with chief complaint of lump on left leg, possibly from vaccine given 3 weeks prior to visit. Referred to surgery. 6/8/05 pt was seen for fever, cough and abscess on thigh was given Keflex. pt did not return for follow up.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Sunburn, Viral infection, Vomiting
Clinical narrative: Mother reports temp 101-103 12/8 abd 12/9/05. 12/10 vomiting, sunburn rash, temp 101-103. Rash on trunk, neck, arms, thighs 12/11/2005. Noted 2 pox marks on chin. 12/12/05 temp 100's no new pox areas. Sunburn rash fading child seen at prompt care 12/10/05.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site rash
Clinical narrative: Rash on thigh, where injection where given no itching.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Swelling and redness at arm where DTaP and IPV were given. Swelling is from shoulder to elbow according to mom.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: An adult patient was administered Prevnar pediatric pneumococcal vaccine instead of Pneumovax an adult pneumococcal vaccine. The reporter stated the products are confusing especially to new pharmacy tech because the generic names are on the first line of their pharmacy labels. The attached cover letter has additional information and Wyeth Reference #.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Dx'd as Cellulitis in ER however my review of  this case and other cases that arrived at same time leads me to believe that it was vigorous PVAX local reaction.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis diagnosed by the ER but review of chart by me along with other reports of acute cellulitis diagnosed in ER in post vaccinees makes me think most likely scenario is vigorous local reaction.  Clindamycin prescribed.  Swelling started one day after vaccine and extended above shoulder and below arm
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Anorexia, Lethargy, Pyrexia
Clinical narrative: Vaccine administered Monday 12/12/2005 at 12:20pm.  Mild fever (101) on day 2 & 3.  Treated with acetaminophen 160mg every 4-6 hours.  On day 4, lethargic with loss of appetite, still feverish with medicine wears off.  Day 5, Friday, woke up feverish after a bad night's sleep.  Whiny and groaning.  Complained a little that tummy hurt.  Acetaminophen is reducing the fever, but appetite is still decreased and child appears to be miserable.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Nausea, Pain, Throat tightness
Clinical narrative: Approximately 3-4 hours after receving vaccine developed achiness and general malaise. Woke next morning with fullness in throat, nausea, achey, chills. No respiratory difficulty nor wheezing.
Age: 1.34
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Hypokinesia, Injection site erythema, Injection site warmth, Irritability, Lethargy
Clinical narrative: Received injections @ 0900 on 12/15/05. Fussy around 1500. Bilateral thighs red and warm to touch, R>L. Vomiting x1 @ 1730. Lethargic and irritable. Would not move legs.
Age: 1.34
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Vomiting
Clinical narrative: Received injections @ 0900 on 12/15/05. Fussy around 1500. Bilateral thighs red and warm to touch, R>L. Vomiting x1 @ 1730. Lethargic and irritable. Would not move legs.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Blood pressure increased, Chills, Dizziness, Hot flush, Lethargy
Clinical narrative: Pt. states that 24 hours after receving vaccine that he started to feel bad he got dizzy then lethargic ran into a door went to fire department and they check his b/p it was 200/120 then pt went home. Did not go to ER or Doctor. Pt came back 1 wk. later for 2nd vaccine went over reaction with nurse supervisor pt. state that he need vaccine for job gave 2nd vaccine. Then pt come in for 3rd vaccine 2 wks. later states he did ok had some nausea and vomiting about 24 hours later but did not feel bad like he did after the first vaccine. Pt. comes into office 24 hours later after recieveing 3rd vaccine states had chills, hot flashes, dizzness. b/p 140/90 HR 80 instructed to take benadryl call MD if needed instructed not to ever take rabies vaccine booster.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Pt. states that 24 hours after receving vaccine that he started to feel bad he got dizzy then lethargic ran into a door went to fire department and they check his b/p it was 200/120 then pt went home. Did not go to ER or Doctor. Pt came back 1 wk. later for 2nd vaccine went over reaction with nurse supervisor pt. state that he need vaccine for job gave 2nd vaccine. Then pt come in for 3rd vaccine 2 wks. later states he did ok had some nausea and vomiting about 24 hours later but did not feel bad like he did after the first vaccine. Pt. comes into office 24 hours later after recieveing 3rd vaccine states had chills, hot flashes, dizzness. b/p 140/90 HR 80 instructed to take benadryl call MD if needed instructed not to ever take rabies vaccine booster.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Tues 13 DEC PM - Fatigue, muscle and headaches, late PM fever 102 deg. Wed 14 DEC AM - 102 deg. fever, nausea, sore throat, fatigue, dizzy, muscle and headaches, and PM vomiting, sweats and chills. Thu 15 DEC AM - nausea, sweats and chills, sore throat, fatigue, dizzy, muscle and headaches. Early PM temp 98.6 Fri 16 DEC - fatigue, dizzy, muscle and headaches. Treated with OTC medications 3 days of work lost.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Vomiting
Clinical narrative: Tues 13 DEC PM - Fatigue, muscle and headaches, late PM fever 102 deg. Wed 14 DEC AM - 102 deg. fever, nausea, sore throat, fatigue, dizzy, muscle and headaches, and PM vomiting, sweats and chills. Thu 15 DEC AM - nausea, sweats and chills, sore throat, fatigue, dizzy, muscle and headaches. Early PM temp 98.6 Fri 16 DEC - fatigue, dizzy, muscle and headaches. Treated with OTC medications 3 days of work lost.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Outer aspect entire upper arm painful, mildly swollen, 7x7 cm area of redness. Limited range of motion of upper extremity for 48 hours. Pruritus requiring diphenhydramine. No hives visible.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Within 12 hours developed pain, redness and induration at site, Within 24 hours, increased pain, 8 cm diameter induration, increasing cellulitis, spread over posterior upper arm, to elbow and forearm, fever/chills, Temp 101 F, nausea. Treatment: Ibuprofen 400m g tid
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Nausea, Pyrexia
Clinical narrative: Within 12 hours developed pain, redness and induration at site, Within 24 hours, increased pain, 8 cm diameter induration, increasing cellulitis, spread over posterior upper arm, to elbow and forearm, fever/chills, Temp 101 F, nausea. Treatment: Ibuprofen 400m g tid
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Diabetes mellitus
Clinical narrative: Diagnosed with new onset Diabetes Mellitus, Type I (December 11, 2005).
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Pruritus
Clinical narrative: Five days after vaccine administered as 0.5mL SQ in R upper arm, patient developed itching and redness at the site of injection.  Area of erythema and induration measured 10 x 6 cm on the day after onset.  She was treated with diphenydramine and the redness resolved after 5 days.  Four other vaccines (Hep A, influenza, Typhoid Vi, MMR) administered in PMD's office on 11-23-05.  Yellow fever ordered by PMD and at SHS.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Complained of vertigo. She is subject to vertigo but it was so bad she went to the Emergency room.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Diarrhoea, Dizziness, Heart rate increased, Hyperhidrosis
Clinical narrative: 12/12/05 BP today at 160/98 Pulse 98bpm.  Cient presents today with c/o adverse reaction from influenza vaccine she received on 12/5/05 at our office.  Noted area to left deltoid at ~2" x 3/4" with faint yellowish-green area appearing to be old bruise.  Client states that within 30 minutes after receiving flu shot, she became symptomatic with dizziness, heart palpitations, swollen tongue, whelps to tongue, and nausea.  States later in day developed loose stools that persisted for ~1 week.  Discussed VIS information including recommendations to follow-up with PCP for such symptoms.  Client voiced understanding.  States she feels it was a reaction to the vaccine and nothing else was different in her daily routine, intake, or encounters to cause a reaction except this vaccine.  States symptoms persist today including occasional palpitations, dizziness, occasional nausea, and sweating.  Discussed increased pulse and BP findings and encouraged follow-up with PCP immediately for evaluation.  Client voiced understanding.  Plans to seek medical care today with PCP.  Discussed need to avoid flu vaccine in future until allergic reaction ruled out by PCP.   Client states at onset of symptoms after shot received, she took P.O. Benadryl with relief of swelling.  Has not taken any other medication or done any further interventions for tx since 12/5/05.   12/16/05  T.C. to client.  States she went for appt with NP and was told that it would be greater than 1 week before appt date so she decided to go home and see if symptoms stopped.  States she is no longer experiencing problems and does not plan further follow-up.  States she will no longer take flu shot in future. Questions encouraged.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Palpitations, Tongue oedema, Urticaria
Clinical narrative: 12/12/05 BP today at 160/98 Pulse 98bpm.  Cient presents today with c/o adverse reaction from influenza vaccine she received on 12/5/05 at our office.  Noted area to left deltoid at ~2" x 3/4" with faint yellowish-green area appearing to be old bruise.  Client states that within 30 minutes after receiving flu shot, she became symptomatic with dizziness, heart palpitations, swollen tongue, whelps to tongue, and nausea.  States later in day developed loose stools that persisted for ~1 week.  Discussed VIS information including recommendations to follow-up with PCP for such symptoms.  Client voiced understanding.  States she feels it was a reaction to the vaccine and nothing else was different in her daily routine, intake, or encounters to cause a reaction except this vaccine.  States symptoms persist today including occasional palpitations, dizziness, occasional nausea, and sweating.  Discussed increased pulse and BP findings and encouraged follow-up with PCP immediately for evaluation.  Client voiced understanding.  Plans to seek medical care today with PCP.  Discussed need to avoid flu vaccine in future until allergic reaction ruled out by PCP.   Client states at onset of symptoms after shot received, she took P.O. Benadryl with relief of swelling.  Has not taken any other medication or done any further interventions for tx since 12/5/05.   12/16/05  T.C. to client.  States she went for appt with NP and was told that it would be greater than 1 week before appt date so she decided to go home and see if symptoms stopped.  States she is no longer experiencing problems and does not plan further follow-up.  States she will no longer take flu shot in future. Questions encouraged.
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Injection site mass, Injection site pain, Paraesthesia
Clinical narrative: Patient received vaccine on 11/9/05 afternoon and states on the morning of 11/10/05 she experienced severe pain in the injection site of the L deltoid, radiating upward to the L shoulder and neck area, as well as radiating downward to the wrist area with numbing and tingling of the middle finger. Patient states the injection site, beneath the skin is 'lumpy.' Note - Patient reported adverse event to Health Department on 12/16/05.
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Hypokinesia, Injection site mass, Pain, Paraesthesia
Clinical narrative: Patient received vaccine on 11/9/05 afternoon and states on the morning of 11/10/05 she experienced severe pain in the injection site of the L deltoid, radiating upward to the L shoulder and neck area, as well as radiating downward to the wrist area with numbing and tingling of the middle finger. Patient states the injection site, beneath the skin is 'lumpy.' Note - Patient reported adverse event to Health Department on 12/16/05.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Cerebral infarction, Cerebrovascular accident, Fall, Gait disturbance, Injury
Clinical narrative: Two weeks after my second anthrax vaccine shot, I lost the strength in my right leg and could not use the ships ladders. I was flown for medical testing, then sent to another location for more testing. There, I was misdiagnosed, to having conversion disorder so I could get back state side. My mild-stroke was found when I was state side. I had an annual stroke the following two years. The second mild-stroke took more arm strength on my right side and the third mild-stroke switched sides took left ear and steady tingling in left arm.  - 4/28/06 Review of medical records indicates final diagnosis of cerebral infarction with residual RLE weakness, hypothyroidism, and hypercholesterolemia. Also experienced falls with injury due to unsteady gait. Per review of correspondence from patient, he states 2nd anthrax was received on 8/8/96 and AE began approximately 2 weeks later or 8/30/96. His stroke was diagnosed on 6/2/97.   First stroke gave my right foot drop second stroke took my speak third stroke gave my left arm tingle and some lose hearing in left ear The vaccine should not be given.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia
Clinical narrative: Two weeks after my second anthrax vaccine shot, I lost the strength in my right leg and could not use the ships ladders. I was flown for medical testing, then sent to another location for more testing. There, I was misdiagnosed, to having conversion disorder so I could get back state side. My mild-stroke was found when I was state side. I had an annual stroke the following two years. The second mild-stroke took more arm strength on my right side and the third mild-stroke switched sides took left ear and steady tingling in left arm.  - 4/28/06 Review of medical records indicates final diagnosis of cerebral infarction with residual RLE weakness, hypothyroidism, and hypercholesterolemia. Also experienced falls with injury due to unsteady gait. Per review of correspondence from patient, he states 2nd anthrax was received on 8/8/96 and AE began approximately 2 weeks later or 8/30/96. His stroke was diagnosed on 6/2/97.   First stroke gave my right foot drop second stroke took my speak third stroke gave my left arm tingle and some lose hearing in left ear The vaccine should not be given.
Age: 20.0
Sex: M
Vaccine: FLU3, SMALL, TYP
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient states he noticed "faded red spots" around the Smallpox vaccination site which were hot to the touch when he changed his bandaid at 0700 hours on Wednesday, 14 Dec 2005.  Patient states "spots were more solid and zit-like", dark red, and hot to his touch when he checked the same site on Thursday, 15 Dec 2005, at 0700 hours.  Patient presented to this Immunization Clinic at 0940 hours on Friday, 16 Dec 2005 requesting to have his Smallpox sited checked.  After viewing the site we asked the PAC to also view the site.  The PAC viewed the site and had the patient return with her to the clinic where the patient underwent an office visit with the PAC.  See diagnosis and prescription information in box 12.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Pallor, Syncope
Clinical narrative: Syncope x 2, pallor, and lethargy 16 hours post administration of influenza vaccine.  CBC and comprehensive metabolic panel obtained, results normal, treated with IV hydration x 2 hours and monitored closely in clinic, condition stable, discharged home.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: Started around 2:00 am severe chills, sweats, fever, nausea, body aches continues with symptoms at time of documenting this.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Breath holding, Bruxism, Coma, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Child was vaccinated within 1-2 minutes collapsed was lowered to ground by mom and nurse, had stiffening of right arm, clenching teeth, held breath, unresponsive lasted about 20-30 seconds, recover completely within 90 minutes.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Angioneurotic oedema, Erythema
Clinical narrative: Swelling arm erythema of right arm with angioedema near injection site.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Pyrexia, Skin nodule
Clinical narrative: Developed a fever of 100-101 7 days after Varicella which lasted 2-3 days then went up to 103-104 for 4 days. She also had 2 red bumps on her scalp, her chest and her hands. All symptoms have resolved. She still has a slightly diminished appetite.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Neck pain, Pain, Pain in jaw
Clinical narrative: Received pneumovax right arm on Fri. By saturday am arm was sore. By Sunday am, could not raise arm. Had burning, sharp pain radiating from jaw down neck, to injection site, to elbow, thumb and 1st 2 fingers of right hand. Is wearing sling on advice of physical therapy friend; taking ibuprofen and icing arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Eye swelling, Headache, Myalgia
Clinical narrative: Vaccine taken at 10:40 AM.  Fatigue within 30 minutes.  Fever, muscle aches, headache, cough, chest congestion, and sore throat began at approximately 3:30 PM.  Left eye became very red, itchy, and swollen at about 8 PM.  None of these symptoms were present before the vaccination.  Treated fever with Tylenol.  Treated eye symptoms with Elestat.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Ocular hyperaemia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Vaccine taken at 10:40 AM.  Fatigue within 30 minutes.  Fever, muscle aches, headache, cough, chest congestion, and sore throat began at approximately 3:30 PM.  Left eye became very red, itchy, and swollen at about 8 PM.  None of these symptoms were present before the vaccination.  Treated fever with Tylenol.  Treated eye symptoms with Elestat.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Fall, Grand mal convulsion, Infection, Influenza like illness
Clinical narrative: Reporter states that the subject passed away in June of 2003, unexpectedly having a grand mal seizure. The subject reportedly took 3 out of the 6 shots and had to quit. According to the report the following events occurred. almost immediately after taking the first one, he had red spots on his legs and arms that got infected and would break open. About 6 months after taking his first shot, he had a major seizure and fell down a set of stairs. Along with the seizures, he had times where he would fall and not know it. He had mood swings, muscle pains, times where he would just feel flu symptoms and loss of eye sight. His left eye lost about 1/2 of its sight and the right had some loss also. All of these things happening within a period of about 2 years.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Mood swings, Myalgia, Skin ulcer, Visual disturbance
Clinical narrative: Reporter states that the subject passed away in June of 2003, unexpectedly having a grand mal seizure. The subject reportedly took 3 out of the 6 shots and had to quit. According to the report the following events occurred. almost immediately after taking the first one, he had red spots on his legs and arms that got infected and would break open. About 6 months after taking his first shot, he had a major seizure and fell down a set of stairs. Along with the seizures, he had times where he would fall and not know it. He had mood swings, muscle pains, times where he would just feel flu symptoms and loss of eye sight. His left eye lost about 1/2 of its sight and the right had some loss also. All of these things happening within a period of about 2 years.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blindness, Erythema, Fall, Grand mal convulsion, Infection
Clinical narrative: Reporter states that the subject passed away in June of 2003, unexpectedly having a grand mal seizure. The subject reportedly took 3 out of the 6 shots and had to quit. According to the report the following events occurred. almost immediately after taking the first one, he had red spots on his legs and arms that got infected and would break open. About 6 months after taking his first shot, he had a major seizure and fell down a set of stairs. Along with the seizures, he had times where he would fall and not know it. He had mood swings, muscle pains, times where he would just feel flu symptoms and loss of eye sight. His left eye lost about 1/2 of its sight and the right had some loss also. All of these things happening within a period of about 2 years.
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Influenza like illness, Mood swings, Myalgia, Rash maculo-papular, Similar reaction on previous exposure to drug
Clinical narrative: Reporter states that the subject passed away in June of 2003, unexpectedly having a grand mal seizure. The subject reportedly took 3 out of the 6 shots and had to quit. According to the report the following events occurred. almost immediately after taking the first one, he had red spots on his legs and arms that got infected and would break open. About 6 months after taking his first shot, he had a major seizure and fell down a set of stairs. Along with the seizures, he had times where he would fall and not know it. He had mood swings, muscle pains, times where he would just feel flu symptoms and loss of eye sight. His left eye lost about 1/2 of its sight and the right had some loss also. All of these things happening within a period of about 2 years.
Age: 37.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Myocardial infarction
Clinical narrative: The reporter states that a 37 year old male medical technician died of a heart attack in February 2000.
Age: 30.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Biliary neoplasm, Neoplasm malignant
Clinical narrative: The reporter states that a 30 year old male died on 05/31/02. He developed a rare bile duct (liver) cancer following anthrax vaccination.
Age: 30.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Bile duct cancer
Clinical narrative: The reporter states that a 30 year old male died on 05/31/02. He developed a rare bile duct (liver) cancer following anthrax vaccination.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Initial report received on Dec 2 2005 from health care professional. A two month old infant had received an administration (route, site not reported) of ACHIB, lot number UE682AA, Prevnar (route, site and lot number not reported), and Pediarix (route, site and lot number not reported) on an unspecified date. The infant died at an unspecified time later. Per the reporter, the cause of death may possibly be contributed to sudden Infant death syndrome.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Initial report received on Dec 2 2005 from health care professional. A two month old infant had received an administration (route, site not reported) of ACHIB, lot number UE682AA, Prevnar (route, site and lot number not reported), and Pediarix (route, site and lot number not reported) on an unspecified date. The infant died at an unspecified time later. Per the reporter, the cause of death may possibly be contributed to sudden Infant death syndrome.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site mass, Pruritus
Clinical narrative: 1/2 dollar size firm lump at site of anthrax vaccine #2 x5 days.  Started with lump, expanding area of redness and mild itching.  Redness has completely disapeared.  Lump is visable and palpable (firm to touch).  No systemic symptoms.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis versus vaccine drug. Pt seen 12/15/05 after receiving inj. 12/12/05 right deltoid.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Insomnia, Pruritus, Pyrexia, Rash papular
Clinical narrative: Client developed fever around 100-101 on 12/10/05. Developed a rash on 12/13/05. 1/16-1/5 inch papular rash, mildly itching, non-tanden, non-vakicular on upper torso, arms, face, legs. Feels fatigued. Is unable to sleep. No insurance, no PCP. Symptoms relieved with benadryl and tylenol. 12/16/05
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Lymphadenopathy
Clinical narrative: Noted swollen lymph glands in neck the same evening as vaccine given Right side of neck and vaccine given on right arm (shoulder) Right deltoid.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Necrosis
Clinical narrative: For 3 month's following injection ______ to feel area an evolving fat necrosis
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 9mm x 7mm warm, reddened area to left upper arm, no treatment done.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Domiciliary patient seen in scheduled psych session. Noted redness around site of Pneumococcal injection given 6/10/05. Prescribed APAP 650mg PO Q 4 H PRN and Diphenhydramine 25mg PO Q 6H PRN.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Bronchitis, Burning sensation, Chest X-ray abnormal, Chest pain, Chills
Clinical narrative: Beginning in Sept 2005, the subject noticed coughing, voice problems/hoarseness, and malaise. Subsequently she note that she was short of breath. On 11/18/2005 she presented to the ER with severe respiratory distress and was admitted. She was hospitalized for 5 days. Her doctors told her that her illness was a process over time (past couple of months) and she was given a general diagnosis of interstitial lung disease. A lung biopsy is being scheduled for further define a diagnosis. The subject was placed on high dosed of IV Prednisone (later switched to oral Prednisone) and given Xopanex breathing treatments. Following treatment an enlarged lymph node in her chest shrank. Subject states that she was healthy at the time of vaccination. On 11/12/05  the subject developed severe bronchitis and flu like condition. On 11/15/05 her physician prescribed Ketek and Advair. Current symptoms include, muscle aches, malaise, a dry cough, wheezing, difficulty talking (coughing and shortness of breath are accentuated), shortness of breath upon any exertion (as simple as walking a short distance) and a mild burning sensation in her upper chest. The subject also reports that 2 out of 3 nights she has chills in the evening followed by a very low grade fever, which sometimes breaks with a sweat during the night. The subject has also noted that there is a wavy line/ grove on her nails and that the ends of her nail have become flaky. As indicated on the initial report, the onset of symptoms began in September of 2005. The subject noted no specific onset date. BioPort submitted a follow-up report on December 29, 2005. BioPort has no further information on this case. In the event that additional relevant medical information is received a follow-up report will be submitted.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Computerised tomogram abnormal, Cough, Dysphonia, Dyspnoea, Hyperhidrosis
Clinical narrative: Beginning in Sept 2005, the subject noticed coughing, voice problems/hoarseness, and malaise. Subsequently she note that she was short of breath. On 11/18/2005 she presented to the ER with severe respiratory distress and was admitted. She was hospitalized for 5 days. Her doctors told her that her illness was a process over time (past couple of months) and she was given a general diagnosis of interstitial lung disease. A lung biopsy is being scheduled for further define a diagnosis. The subject was placed on high dosed of IV Prednisone (later switched to oral Prednisone) and given Xopanex breathing treatments. Following treatment an enlarged lymph node in her chest shrank. Subject states that she was healthy at the time of vaccination. On 11/12/05  the subject developed severe bronchitis and flu like condition. On 11/15/05 her physician prescribed Ketek and Advair. Current symptoms include, muscle aches, malaise, a dry cough, wheezing, difficulty talking (coughing and shortness of breath are accentuated), shortness of breath upon any exertion (as simple as walking a short distance) and a mild burning sensation in her upper chest. The subject also reports that 2 out of 3 nights she has chills in the evening followed by a very low grade fever, which sometimes breaks with a sweat during the night. The subject has also noted that there is a wavy line/ grove on her nails and that the ends of her nail have become flaky. As indicated on the initial report, the onset of symptoms began in September of 2005. The subject noted no specific onset date. BioPort submitted a follow-up report on December 29, 2005. BioPort has no further information on this case. In the event that additional relevant medical information is received a follow-up report will be submitted.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Influenza like illness, Interstitial lung disease, Lung disorder, Lymphadenopathy, Malaise
Clinical narrative: Beginning in Sept 2005, the subject noticed coughing, voice problems/hoarseness, and malaise. Subsequently she note that she was short of breath. On 11/18/2005 she presented to the ER with severe respiratory distress and was admitted. She was hospitalized for 5 days. Her doctors told her that her illness was a process over time (past couple of months) and she was given a general diagnosis of interstitial lung disease. A lung biopsy is being scheduled for further define a diagnosis. The subject was placed on high dosed of IV Prednisone (later switched to oral Prednisone) and given Xopanex breathing treatments. Following treatment an enlarged lymph node in her chest shrank. Subject states that she was healthy at the time of vaccination. On 11/12/05  the subject developed severe bronchitis and flu like condition. On 11/15/05 her physician prescribed Ketek and Advair. Current symptoms include, muscle aches, malaise, a dry cough, wheezing, difficulty talking (coughing and shortness of breath are accentuated), shortness of breath upon any exertion (as simple as walking a short distance) and a mild burning sensation in her upper chest. The subject also reports that 2 out of 3 nights she has chills in the evening followed by a very low grade fever, which sometimes breaks with a sweat during the night. The subject has also noted that there is a wavy line/ grove on her nails and that the ends of her nail have become flaky. As indicated on the initial report, the onset of symptoms began in September of 2005. The subject noted no specific onset date. BioPort submitted a follow-up report on December 29, 2005. BioPort has no further information on this case. In the event that additional relevant medical information is received a follow-up report will be submitted.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Nail disorder, Pyrexia, Respiratory distress, Wheezing
Clinical narrative: Beginning in Sept 2005, the subject noticed coughing, voice problems/hoarseness, and malaise. Subsequently she note that she was short of breath. On 11/18/2005 she presented to the ER with severe respiratory distress and was admitted. She was hospitalized for 5 days. Her doctors told her that her illness was a process over time (past couple of months) and she was given a general diagnosis of interstitial lung disease. A lung biopsy is being scheduled for further define a diagnosis. The subject was placed on high dosed of IV Prednisone (later switched to oral Prednisone) and given Xopanex breathing treatments. Following treatment an enlarged lymph node in her chest shrank. Subject states that she was healthy at the time of vaccination. On 11/12/05  the subject developed severe bronchitis and flu like condition. On 11/15/05 her physician prescribed Ketek and Advair. Current symptoms include, muscle aches, malaise, a dry cough, wheezing, difficulty talking (coughing and shortness of breath are accentuated), shortness of breath upon any exertion (as simple as walking a short distance) and a mild burning sensation in her upper chest. The subject also reports that 2 out of 3 nights she has chills in the evening followed by a very low grade fever, which sometimes breaks with a sweat during the night. The subject has also noted that there is a wavy line/ grove on her nails and that the ends of her nail have become flaky. As indicated on the initial report, the onset of symptoms began in September of 2005. The subject noted no specific onset date. BioPort submitted a follow-up report on December 29, 2005. BioPort has no further information on this case. In the event that additional relevant medical information is received a follow-up report will be submitted.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a physician concerning a 61 year old male who was vaccinated a few months ago, with a dose of Pneumococcal 23v polysaccharide vaccine. A few hours after vaccination the patient suffered a stroke and was hospitalized. The patient was hospitalized for an unknown period of time and fully recovered. No product quality complaint was involved. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Guillain-Barre syndrome, Respiratory failure
Clinical narrative: On 10/21 rushed to ER to above hospital. Diagnosed with Guillain Barr syndrome. Was in ICU till 11/28. Transferred to rehab as of 12/13 still there. Discharge summary states respiratory failure. msv Per 60 day follow up report- She had Guillian Barre syndrome. At this time she is home, but still working on walking again. She was paralyzed in ICU for about 2 months. The muscles are still weak.  She has recently contracted a virus, which is making her phyical weak, trembling hands where she needs 2 hands to hold glass.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Asperger's disorder, Autism, Autism
Clinical narrative: I have been telling the doctors since he was 1 year old he has been acting autistic. Soon after the 1 year old shots he was intolerant to noise/music. He is now getting diagnosed with Aspergers and will be going to hospital on January 20th 2006. Per 60 day follow up report- He has been diagnosed with Aspergers -an autistic spectrum disorder. He has been acting Autistic since his 1 year old shots. He remains autistic  He started his Authistic behavior after his one year old shots (noise intolerance etc...) the last shots he received just hapended to be his 4 y/o shots.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Atelectasis, Back pain, Balance disorder, CSF test abnormal
Clinical narrative: Admitted to hospital with Guillain Barre syndrome. Onset of symptoms 11/29/2005 tingling extremities. 12/01 difficulty walking, 12/03 admitted to hospital due to low back pain and difficulty walking. 12/05 numbness in lower extremities, limited range of motion, weakness in all extremities. Transferred to different hospital on 12/05/2005. Discharge summary states pain of skin, atelecticsis, respiratiory insufficency. msv Per 60 day follow up report- Continues to receive IVIG every other week. Condition gradually improving. Still has impaired mobility. Foley cath remains anchored PEG tube removed 2-28-06. Was a swing bed patient at out facility 1/10/06 to 2/7/06. Currently continuing recovery at home. 02/08/2007 per patient repat- states has rediual effects including diminished sensation in feet from the ankles down.  Still has some balance problems.  One numb finger.  He has returned to work.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Joint range of motion decreased, Laboratory test abnormal
Clinical narrative: Admitted to hospital with Guillain Barre syndrome. Onset of symptoms 11/29/2005 tingling extremities. 12/01 difficulty walking, 12/03 admitted to hospital due to low back pain and difficulty walking. 12/05 numbness in lower extremities, limited range of motion, weakness in all extremities. Transferred to different hospital on 12/05/2005. Discharge summary states pain of skin, atelecticsis, respiratiory insufficency. msv Per 60 day follow up report- Continues to receive IVIG every other week. Condition gradually improving. Still has impaired mobility. Foley cath remains anchored PEG tube removed 2-28-06. Was a swing bed patient at out facility 1/10/06 to 2/7/06. Currently continuing recovery at home. 02/08/2007 per patient repat- states has rediual effects including diminished sensation in feet from the ankles down.  Still has some balance problems.  One numb finger.  He has returned to work.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Respiratory failure
Clinical narrative: Admitted to hospital with Guillain Barre syndrome. Onset of symptoms 11/29/2005 tingling extremities. 12/01 difficulty walking, 12/03 admitted to hospital due to low back pain and difficulty walking. 12/05 numbness in lower extremities, limited range of motion, weakness in all extremities. Transferred to different hospital on 12/05/2005. Discharge summary states pain of skin, atelecticsis, respiratiory insufficency. msv Per 60 day follow up report- Continues to receive IVIG every other week. Condition gradually improving. Still has impaired mobility. Foley cath remains anchored PEG tube removed 2-28-06. Was a swing bed patient at out facility 1/10/06 to 2/7/06. Currently continuing recovery at home. 02/08/2007 per patient repat- states has rediual effects including diminished sensation in feet from the ankles down.  Still has some balance problems.  One numb finger.  He has returned to work.
Age: 23.0
Sex: F
Vaccine: HEP, MMR
Symptoms: CSF test abnormal, Guillain-Barre syndrome
Clinical narrative: Guillain Syndrome onset 10/12/2005
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt diagnosed with Chicken pox disease on 12/15/2005 in office.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Rash macular, Tenderness
Clinical narrative: 2.5" macular rash with tenderness at upper arm. Flu shot administered 23 hours earlier at another facility.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Nasal congestion, Pain, Pyrexia
Clinical narrative: High fever, all body aches, pain, severe congestion, coughing, fatigue. Received Advil 200mg IT PO Q 4-6 hours. Ocean Spray, increased fluid intake.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain, Myalgia, Pain
Clinical narrative: Patient complained that injection hurt more than usual when received it on 11/18/05. Stated when woke up next morning, 11/19/05, arm hurt to move it certain way or to lift anything. Stated continues to have this same sore muscle ache now when moves deltoid muscle or lifts anything. Has been taking Advil for pain. Stated no fever nor other symptoms noted; just the pain at injection site for 3.5 weeks. States area does not hurt when pushed on. Plans to follow up with physician for evaluation.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Client came into our office; left upper arm swollen, redden and warm to touch. No harden area. Instructed client to call her MD to be seen and to apply cool compress to area for relief. 12/9 Client saw MD; he prescribed antihistamine, prednisone and Keflex 500mg BID for 10 days. Spoke to client 12/13. She is doing well; no redness or swelling noted.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: 2 hours past receiving vaccine, started with chills, fever 99-100, edema from armpit to lower lateral arm, redness and pain. Symptoms subsided 3 days later.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain, Lethargy
Clinical narrative: Vaccine given at approximately 10 AM 11/3/05. BY evening, client reports fever 102, edema from armpit to elbow, diaphoresis, pain and redness at left injection site. Next day, client extremely lethargic and tired - slept all day. Continued with intermittent fever for 4 days. 11/7/05 Symptoms subsiding.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Vaccine given at approximately 10 AM 11/3/05. BY evening, client reports fever 102, edema from armpit to elbow, diaphoresis, pain and redness at left injection site. Next day, client extremely lethargic and tired - slept all day. Continued with intermittent fever for 4 days. 11/7/05 Symptoms subsiding.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Pruritus, Tongue oedema, Urticaria
Clinical narrative: Vaccine administered 10:00 AM. Became itchy around 3:00 PM and developed welt on abdomen. Around 5:00 PM, she went to ER when she developed tongue swelling. Has history of 5 throat closures due to bee stings and other allergies. Received Albuterol, Prednisone and Benadryl from ER visit. Discharged without further complications 12/14/05.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Pruritus, Tongue oedema, Urticaria
Clinical narrative: Vaccine administered 10:00 am. Became itchy around 3:00 pm and developed "welt" on abdomen. Rounded 5 am she went to ER when she developed tongue swelling. Has history of "5" throat closure due to bee stings and other allergies. Received albuterol , prednisone, epinephrine and Benadryl from  ER Visit. Discharged without further complications.H/O 12/19/05
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10cmx7cm area of erythema, swelling and warmth of injection site. Resolved with Benadryl.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Skin discolouration
Clinical narrative: Large, purplish area of swelling (16cm x 8cm) at injection site.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11/9/05 Flu vaccine administered. 11/11/05 Half of thigh swollen, red, warm to touch. Resolved with Benadryl.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Flat affect, Hypoaesthesia
Clinical narrative: Mouth with numbness inside and left arm had strange feeling also two fingers on left arm that lasted for 2 hours.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypoaesthesia
Clinical narrative: Lips became numb and right eyelid for short time. Lips stayed numb. C/O starting to have chills. Lasted x 3 hrs. Also numbness left arm and little two fingers. C/O on 10/29/2005 level numbness of lips.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Mild muscular pain (at rest) with moderate pain on movement days 2-4 following flu shot. Resolved on day 4. One week post flu shot, following light workout, left arm with moderate to severe pain radiating to socket and occasionally down left arm. Left arm pain subsided over next 4 days. Pain somewhat relieved by 400 mg ibuprofen. Resolved 12/11/05
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient has been experiencing pain in the right arm where her flu shot has been given since of vaccine. It sometimes goes down her arm and neck. She has been using a warm compress and Aleve without any relief.
Age: 1.51
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Oedema
Clinical narrative: Right arm upper swollen and extended to shoulder neck, and right cheek. reaction occurred first 24-48 hours. Patient went to ER, Benadryl given. No shortness of breath. F/U at PMD, with decreased swelling localized right deltoid and clavicular area. Continued Benadryl and cool compressed.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Pain, Pruritus, Rash, Rash maculo-papular
Clinical narrative: On 11/16/2005 Starting with pruritus on back. On 11/17/2005 developed a patchy area on back, pruritic it raised with blisters forming. Saw MD on 11/25/05 due to additional raised patches on mid back and right ribs and pain. Placed on RX acyclovir 5 QD for 7 days. Out of work 11/28/08 to 12/02/05. Saw MD again 11/29/05 for increased pain, placed on Gabapentin. As of 12/08/2005 done with acyclovir and off Gabapentin and returned to work 12/05/05. Has pain on and off now. Continues with pruritus and rash resolving, blisters are resolved.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Herpes zoster, Myalgia
Clinical narrative: Reported 6 hours after received flu shot had pretty intense myalgia. This was relieved: motrin and a night's rest. On 11/21/05 Patient wondered if it was possible to develop herpes zoster without blisters. She was diagnosed with this after seeing her MD for right hip pain. I called CDC NIP hotline and informed no known correlation between flu shot and development og herpes zosters. I left a message on the CDC hotline and never got a call back. I called VAERS and only got a recording. I would have like to have beneficial to speak to someone from VAERS to see if completion of this form was necessary.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site hypersensitivity, Injection site oedema, Injection site pain, Insomnia
Clinical narrative: 11/02/2005 pain at injection site all night. Unable to sleep went to ER 11/03/2005am. Redness around site 3-4" swollen. Given IV antibiotics in ER, home with Keflex prescription and Percocet. 11/04/05 appt with own MD ? allergic reaction. Became sick on Keflex and was discontinued.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: 11/02/2005 pain at injection site all night. Unable to sleep went to ER 11/03/2005am. Redness around site 3-4" swollen. Given IV antibiotics in ER, home with Keflex prescription and Percocet. 11/04/05 appt with own MD ? allergic reaction. Became sick on Keflex and was discontinued.