chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Asthenia, Dysphagia, Electromyogram, Endoscopy
Clinical narrative: About 1 week after receiving Flu vaccine, pt started developing weakness in her feet which progressed in an ascending fashion to involvement of bilateral upper extremities. Pt has lumbar puncture which showed albuminocytolocic dissociation, and an EMG that was consistent with GUILLAIN BARRE syndrome with motor and sensory axonal neuropathy. Pt was endotracheally intubated due to impending respiratory failure and initially had signs of autonomic instability with labile blood pressure, which eventually stabilized. Pt received IVIG daily for 5 days. Pt was discharged to a rehabilitation center requiring PEG placement for tube feedings. Pt was normally healthy, walked daily prior to events above. 02/09/07-records received and reviewed from Harborview Medical Center for DOS 11/28-12/17/06-DC DX: GUILLIAN-BARRE syndrome (acute motor and sensory axonal neuropathy). Non-ST elevated myocardial infarction. Postmenopausal bleed. Type 2 diabetes 9new diagnosis), Hypertension, Urinary tract infection, Anemia or chronic disease, Dysphagia. Percutancious endoscopic GT inserted. CT Chest:partial collapse of lower lobes. HX present illness: Six days prior to admission noted weakness in feet progressed in an ascending fashion and at time of presentation involved bilateral upper extremities. Symptoms of tingling and numbness began about the same time and progressed in similar distribution. Seen in ER and admitted to SNF where she was diagnosed with type 2 diabetes.  PMH:new diagnosis of type 2 diabetes, hypertension. PE: bilateral ptosis, variable facial sensory exam, bilateral facial motor weakness, especially with puffing out her cheeks. Weak gag reflex, trapezius symmetrically strong but somewhat weak. Decreased light touch pinprick and temperature sensation throughout especially below her clavicles bilaterally. Stocking pattern in feet. Respiratory failure on admission required intubation and subsequently extubated.   RX with 5 days of IVIG. Per annual follow up: As of 12/17/2006 pt was discharged to skilled nursing facility with significant improvement of weakness but has not been seen at our hospital since that time. Pt still had dysphagia and required P.E.G. placement for tube feeding.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Endotracheal intubation, Guillain-Barre syndrome, Hypertension, Hypokinesia, Hypoxia
Clinical narrative: About 1 week after receiving Flu vaccine, pt started developing weakness in her feet which progressed in an ascending fashion to involvement of bilateral upper extremities. Pt has lumbar puncture which showed albuminocytolocic dissociation, and an EMG that was consistent with GUILLAIN BARRE syndrome with motor and sensory axonal neuropathy. Pt was endotracheally intubated due to impending respiratory failure and initially had signs of autonomic instability with labile blood pressure, which eventually stabilized. Pt received IVIG daily for 5 days. Pt was discharged to a rehabilitation center requiring PEG placement for tube feedings. Pt was normally healthy, walked daily prior to events above. 02/09/07-records received and reviewed from Harborview Medical Center for DOS 11/28-12/17/06-DC DX: GUILLIAN-BARRE syndrome (acute motor and sensory axonal neuropathy). Non-ST elevated myocardial infarction. Postmenopausal bleed. Type 2 diabetes 9new diagnosis), Hypertension, Urinary tract infection, Anemia or chronic disease, Dysphagia. Percutancious endoscopic GT inserted. CT Chest:partial collapse of lower lobes. HX present illness: Six days prior to admission noted weakness in feet progressed in an ascending fashion and at time of presentation involved bilateral upper extremities. Symptoms of tingling and numbness began about the same time and progressed in similar distribution. Seen in ER and admitted to SNF where she was diagnosed with type 2 diabetes.  PMH:new diagnosis of type 2 diabetes, hypertension. PE: bilateral ptosis, variable facial sensory exam, bilateral facial motor weakness, especially with puffing out her cheeks. Weak gag reflex, trapezius symmetrically strong but somewhat weak. Decreased light touch pinprick and temperature sensation throughout especially below her clavicles bilaterally. Stocking pattern in feet. Respiratory failure on admission required intubation and subsequently extubated.   RX with 5 days of IVIG. Per annual follow up: As of 12/17/2006 pt was discharged to skilled nursing facility with significant improvement of weakness but has not been seen at our hospital since that time. Pt still had dysphagia and required P.E.G. placement for tube feeding.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test abnormal, Lumbar puncture, Myocardial infarction, Neuropathy, Postmenopausal haemorrhage
Clinical narrative: About 1 week after receiving Flu vaccine, pt started developing weakness in her feet which progressed in an ascending fashion to involvement of bilateral upper extremities. Pt has lumbar puncture which showed albuminocytolocic dissociation, and an EMG that was consistent with GUILLAIN BARRE syndrome with motor and sensory axonal neuropathy. Pt was endotracheally intubated due to impending respiratory failure and initially had signs of autonomic instability with labile blood pressure, which eventually stabilized. Pt received IVIG daily for 5 days. Pt was discharged to a rehabilitation center requiring PEG placement for tube feedings. Pt was normally healthy, walked daily prior to events above. 02/09/07-records received and reviewed from Harborview Medical Center for DOS 11/28-12/17/06-DC DX: GUILLIAN-BARRE syndrome (acute motor and sensory axonal neuropathy). Non-ST elevated myocardial infarction. Postmenopausal bleed. Type 2 diabetes 9new diagnosis), Hypertension, Urinary tract infection, Anemia or chronic disease, Dysphagia. Percutancious endoscopic GT inserted. CT Chest:partial collapse of lower lobes. HX present illness: Six days prior to admission noted weakness in feet progressed in an ascending fashion and at time of presentation involved bilateral upper extremities. Symptoms of tingling and numbness began about the same time and progressed in similar distribution. Seen in ER and admitted to SNF where she was diagnosed with type 2 diabetes.  PMH:new diagnosis of type 2 diabetes, hypertension. PE: bilateral ptosis, variable facial sensory exam, bilateral facial motor weakness, especially with puffing out her cheeks. Weak gag reflex, trapezius symmetrically strong but somewhat weak. Decreased light touch pinprick and temperature sensation throughout especially below her clavicles bilaterally. Stocking pattern in feet. Respiratory failure on admission required intubation and subsequently extubated.   RX with 5 days of IVIG. Per annual follow up: As of 12/17/2006 pt was discharged to skilled nursing facility with significant improvement of weakness but has not been seen at our hospital since that time. Pt still had dysphagia and required P.E.G. placement for tube feeding.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory failure, Sensory disturbance, Urinary tract infection
Clinical narrative: About 1 week after receiving Flu vaccine, pt started developing weakness in her feet which progressed in an ascending fashion to involvement of bilateral upper extremities. Pt has lumbar puncture which showed albuminocytolocic dissociation, and an EMG that was consistent with GUILLAIN BARRE syndrome with motor and sensory axonal neuropathy. Pt was endotracheally intubated due to impending respiratory failure and initially had signs of autonomic instability with labile blood pressure, which eventually stabilized. Pt received IVIG daily for 5 days. Pt was discharged to a rehabilitation center requiring PEG placement for tube feedings. Pt was normally healthy, walked daily prior to events above. 02/09/07-records received and reviewed from Harborview Medical Center for DOS 11/28-12/17/06-DC DX: GUILLIAN-BARRE syndrome (acute motor and sensory axonal neuropathy). Non-ST elevated myocardial infarction. Postmenopausal bleed. Type 2 diabetes 9new diagnosis), Hypertension, Urinary tract infection, Anemia or chronic disease, Dysphagia. Percutancious endoscopic GT inserted. CT Chest:partial collapse of lower lobes. HX present illness: Six days prior to admission noted weakness in feet progressed in an ascending fashion and at time of presentation involved bilateral upper extremities. Symptoms of tingling and numbness began about the same time and progressed in similar distribution. Seen in ER and admitted to SNF where she was diagnosed with type 2 diabetes.  PMH:new diagnosis of type 2 diabetes, hypertension. PE: bilateral ptosis, variable facial sensory exam, bilateral facial motor weakness, especially with puffing out her cheeks. Weak gag reflex, trapezius symmetrically strong but somewhat weak. Decreased light touch pinprick and temperature sensation throughout especially below her clavicles bilaterally. Stocking pattern in feet. Respiratory failure on admission required intubation and subsequently extubated.   RX with 5 days of IVIG. Per annual follow up: As of 12/17/2006 pt was discharged to skilled nursing facility with significant improvement of weakness but has not been seen at our hospital since that time. Pt still had dysphagia and required P.E.G. placement for tube feeding.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Blood potassium increased, Chest pain, Cough, Erythema, Headache
Clinical narrative: 24 yo F with PMH of SLE, ESRD on HD and HTN presented to ED on 10/17/06 with RUE cellulitis at injection site after getting a flu shot 3 days PTA at clinic. Over two days she experienced increased R arm pain, redness and swelling. She also had a fever of 101, Mild HA and chest pain, In ED, she denied dysuria, cough, SOB, orthopnea, PND and joint swelling. U/S of arm showed no abscess. She was admitted and was given amocixillin/Clavulanic acid 500/125 mg po once. Additional doses would be given post HD. 02/07/07-records received and reviewed for DOS 10/16-10/17/06 DC DX: Cellulitis Medical records document that administered vaccine was pneumovax on Friday 10/13/06 prior to admission and not flu vaccine.  Seen in ER with temperature 101.3 at home in ER temp 98.3. Upper respiratory symptoms including rhinorrhea, nasal congestion, nonproductive cough. Left sided chest pain and right deltoid redness at site of pneumovax injection. PE: right deltoid with 10cm area of erythema and induration.  Follow-up: The pt rec'd flu shot on 10/14/06 @ HD clinic.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Nasal congestion, Oedema peripheral
Clinical narrative: 24 yo F with PMH of SLE, ESRD on HD and HTN presented to ED on 10/17/06 with RUE cellulitis at injection site after getting a flu shot 3 days PTA at clinic. Over two days she experienced increased R arm pain, redness and swelling. She also had a fever of 101, Mild HA and chest pain, In ED, she denied dysuria, cough, SOB, orthopnea, PND and joint swelling. U/S of arm showed no abscess. She was admitted and was given amocixillin/Clavulanic acid 500/125 mg po once. Additional doses would be given post HD. 02/07/07-records received and reviewed for DOS 10/16-10/17/06 DC DX: Cellulitis Medical records document that administered vaccine was pneumovax on Friday 10/13/06 prior to admission and not flu vaccine.  Seen in ER with temperature 101.3 at home in ER temp 98.3. Upper respiratory symptoms including rhinorrhea, nasal congestion, nonproductive cough. Left sided chest pain and right deltoid redness at site of pneumovax injection. PE: right deltoid with 10cm area of erythema and induration.  Follow-up: The pt rec'd flu shot on 10/14/06 @ HD clinic.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea, Ultrasound scan normal, White blood cell count normal
Clinical narrative: 24 yo F with PMH of SLE, ESRD on HD and HTN presented to ED on 10/17/06 with RUE cellulitis at injection site after getting a flu shot 3 days PTA at clinic. Over two days she experienced increased R arm pain, redness and swelling. She also had a fever of 101, Mild HA and chest pain, In ED, she denied dysuria, cough, SOB, orthopnea, PND and joint swelling. U/S of arm showed no abscess. She was admitted and was given amocixillin/Clavulanic acid 500/125 mg po once. Additional doses would be given post HD. 02/07/07-records received and reviewed for DOS 10/16-10/17/06 DC DX: Cellulitis Medical records document that administered vaccine was pneumovax on Friday 10/13/06 prior to admission and not flu vaccine.  Seen in ER with temperature 101.3 at home in ER temp 98.3. Upper respiratory symptoms including rhinorrhea, nasal congestion, nonproductive cough. Left sided chest pain and right deltoid redness at site of pneumovax injection. PE: right deltoid with 10cm area of erythema and induration.  Follow-up: The pt rec'd flu shot on 10/14/06 @ HD clinic.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Breast pain, Chest pain, Fatigue, Injection site reaction, Laboratory test abnormal
Clinical narrative: Pt is a 22 year old female who received her primary smallpox vaccination on 2 Dec 06, because of a no take she was revaccinated on 9 Dec 06 and 15 jabs. Within a couple of days she began to notice a reaction at the site. She denied fever but stated she felt tired and noticed increase lymph nodes. Six days following repeat immunization on 15 Dec she noticed pain in the left of her sternum and under her left breast. The pain would last a second or two and the subside. Pain would occur approx 2 times daily and would either be under her breast or left of her sternum. Pain not associated with activity or changes with change in position. She stated that the pain would take her breath away for about 1 second. No diaphoresis, SOB, N/V or radiation. She states that she never had pain like this before. She was advised to seek medical treatment and went to the hospital on 19 Dec. She stated they did and EKG and drew blood. Because her D Dimer was elevated she had a CT done and that was neg. She was told that she had atypical chest pain. Currently she states that her vaccination site is healing well and starting to scab over. She states that her pain is decreasing and did not have any pain today. Symptoms chest pain start 12/15/2006 comment sharp, L of sternum under L breast.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Lymphadenopathy, Respiratory disorder
Clinical narrative: Pt is a 22 year old female who received her primary smallpox vaccination on 2 Dec 06, because of a no take she was revaccinated on 9 Dec 06 and 15 jabs. Within a couple of days she began to notice a reaction at the site. She denied fever but stated she felt tired and noticed increase lymph nodes. Six days following repeat immunization on 15 Dec she noticed pain in the left of her sternum and under her left breast. The pain would last a second or two and the subside. Pain would occur approx 2 times daily and would either be under her breast or left of her sternum. Pain not associated with activity or changes with change in position. She stated that the pain would take her breath away for about 1 second. No diaphoresis, SOB, N/V or radiation. She states that she never had pain like this before. She was advised to seek medical treatment and went to the hospital on 19 Dec. She stated they did and EKG and drew blood. Because her D Dimer was elevated she had a CT done and that was neg. She was told that she had atypical chest pain. Currently she states that her vaccination site is healing well and starting to scab over. She states that her pain is decreasing and did not have any pain today. Symptoms chest pain start 12/15/2006 comment sharp, L of sternum under L breast.
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Vaccine was administered on Friday 01/05/07, On Monday 1/8/07. Patient developed a rash and itching over trunk, back, behind knees. Mother administered Benadryl rash has subside. No fever.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: 01/05/07 pt called c/p left arm still sore after 2 weeks after receiving vaccine unable to raise arm over head denies redness or swelling.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Pain in left arm at and around injection site since day after immunization on 11/28/06.
Age: 5.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Eyelid oedema, Rhinorrhoea, Sneezing
Clinical narrative: Pt developed rhinorrhea, sneezing, eyelid swelling about 20 after vaccination. Pt given dose of Benadryl then returned to office 20 persistent eyelid swelling. Received Benadryl, PN, Observe closely
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Oedema peripheral
Clinical narrative: Flu shot given 11/16/06 joint pain and swelling. Both ankles sore and swollen for 3-4 days.
Sex: U
Vaccine: TDAP, TDAP
Symptoms: Medication error
Clinical narrative: Boostrix vaccine (Tdap) was given to adults. It is licensed for administration to adolescents age 11-18. Both Boostrix and Adacel (licensed for ages 11-64) were kept in the vaccine refrigerator. No adverse reactions. Physician called CDC who informed her that there should be no adverse reaction other than local reactions one would expect from the vaccine itself; and re-vaccination of the patients was not needed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site oedema, Irritability, Pyrexia
Clinical narrative: L arm very swollen from wrist to shoulder, Temp 99.8, irritable x 3 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Heart rate irregular, Pallor, Pyrexia, Vomiting
Clinical narrative: Mom described 1/3/07 awoke in am, Pale, weak pulse, vomited, moist cough, fever to 103.
Age: 0.76
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC
Symptoms: Medication error
Clinical narrative: No adverse reactions noted, Pt given pediatric doses  of Hep A at 9 month of age vaccine not valid until 12 mo of age.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Medication error
Clinical narrative: Immunization ordered as per one of two documents which was incomplete. RN used DTaP, IPV, Hep B combo vaccine for DTaP which was ordered. Child received DTaP and Hep B which were not needed. IPV was needed, but not ordered.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: About 5-7 days after infection had upper right arm pain  and pain lifting arm above shoulder level.  Arms are sore when lifted, painful when lifted above shoulders or stretching to side.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Dyspnoea, Nausea, Wheezing
Clinical narrative: Pt c/o back pain, nausea around 1am day after injection then around 5am c/o trouble breathing, wheezing. Pt called office at 8:30am, told pt to go to ED due to not having a physician in office.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: local induration with redness 2.5cm x 4cm (SL local reaction).
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Non stop crying over 5 hours, started immediately after giving the vaccines.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Crying for a long time.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: Facial flushing; itching of the face, neck and arms; fine rash on arms.  Benadryl taken.
Age: 0.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Mother noticed hard bright red lump on Left arm, she said that it was the size of a baseball, hard, red and hot. Noticed it 2 days after Immunizations, son had not complained. Reported it to Health Department 5 days after Immunizations. At this time size and warmth are the same but it is now pink instead of bright red.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Discomfort, Pyrexia, Rash morbilliform
Clinical narrative: Pt had childhood type breakout of measles. 3 days bed rest, Tylenol prescribed. A mass immunization of the live influenza mist was administered 6 days prior to patient visting clinic for MMR vaccine. Pt was unaware nasal influenza mist was a live virus and failed to notify vaccinator of receiving the flu mist on 12/12/06. He was then administered the live MMR vaccine on 12/18/06. (lot #0255F) Pt reported that 3 days following vaccination he visited a doctor on vacation and was diagnosed with childhood measles and put on bed rest for three days and given Tylenol for discomfort and fever.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Redness, swelling, warmth to right upper arm x2 days. Atarax 1tsp tid, Keflex.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Contusion, Injection site erythema, Injection site inflammation, Injection site warmth, Pruritus
Clinical narrative: Patient received DTaP#5 and Hep A #1 in (R) lateral thigh on 08 Jan 07, using 25g 5/8in needles; two staff and Father needed to subdue patient and complete injections. Father noted bruising and redness at DTaP injection site the morning of 09 Jan 07. Patient was returned to clinic 10 Jan 07 when injection site became increasingly inflamed, itchy and warm to touch. Patient was afebrile with a reddened, warm area 6cmx5cm, extending from inferior / lateral edge of injection site outward. No hx of adverse reaction to any previous vaccinations. ** Patient received other vaccinations FIVE weeks prior (01Dec06) at parents' request that immunizations be divided: Varicella#2 (L) thigh, MMR#2 (L) thigh, and Influenza#4 (R) thigh. Patient was experiencing a viral URI at that time. ** Miralax has been discontinued due to diarrhea and "cold-like symptoms". Benadryl is for PRN emergency use secondary to food allergies. Zyrtec for chronic allergic rhinitis. ** Patient is of adoption, no birth or biological family hx available.
Age: 2.0
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Injection site vesicles, Rash
Clinical narrative: Child received immunization of Varicella on 12/13/2006.  Grandma reported that he developed a blister at site of immunization. States it is all dried up now. Also stated he had a rash over his body, but could not tell me what type or when. She states it is gone now. Date she called was 01/05/07.
Age: 3.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Varicella vaccine received on 1/04/07 along with influenza vaccine.  Mother reported seeing a couple spots on his chest, back, and diaper area on 1/06/07.  Mother stated rash increased on 1/07/07, but it was totally covering his chest, back, and diaper area on 1/08/07 with itching.  Child was taken to family MD on 1/08/07, and physician verified the rash as varicella.  Treatment was for symptoms:  Tylenol was ordered for temperature, and Benadryl liquid for itching.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema, Rash pruritic
Clinical narrative: MOTHER THAT APPROXIMATELY 30 MIN. AFTER RECIEVING THE FLU VACCINE THAT SHE HAD SWELLING OF THE LIPS WITH SOME ITCHING.  PT. CAME FOR THE FLU VACCINE AT APPROXIMATELY 4:30 P.M. AND DURING DINNER TIME SWELLING WAS NOTICED.  THE HELATH DEPT. WAS CLOSED BY THEN . PT. DID NOT GO TO THE ED BUT RETURNED TO THE HEALTH DEPT. ON 12/20/06 @ APPROXIMATELY 9:30.  THE SWELLING WAS REPORTED AS DECREASED WHEN SHE ARRIVED- LOWER LIP NO LONGER SWOLLEN BUT UPPER LIP SLIGHTLY SWOLLEN. PT. REPORTED NO ALLERGIES TO EGGS OF MEDICINE ON THE REGISTRATION FORM AND AT THIS RETURN VISIT. BP 98/64 AND WT. 74 LBS. GIVEN BENADRYL 25 MG.
Age: 1.01
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Difficulty in walking, Injection site mass
Clinical narrative: Vaccine are not listed below as options and are as follows: Date Given 9/6/06 DTaP4 - ID - R. Leg PCV4 - ID - R. Leg MMR1 - IM - L. Leg HIB4 - ID - R. Leg  At on site of MMR1, lump formed.  Was inforred by provider that injection went into musle and to use heat pad and massage to reduce lump.  On 9/12/06, returned to Dr. Office with lump still present.  Dr. notes state: Lumps remaining from immunizat.  lump which began several days ago.  it was located on the left anterior thigh.  She characterized the quality as hard superfiial bump at site of MMR given.  Severity was described as very slight and improving.  Duration is constant.  The timing was progressive and gradual onset.  Assessment: Foreign Body Reaction of the Skin Nos".  On 10/23/06 shea was seen for illness and repeatly seen in office 6 times with 9 emergency room visits and 2 required hospitalization stay totaling 9 days.  01/11/2007: MR received from local hospital documenting 3 ER visits between 11/21/2006 and 12/09/2006. DXs: 1st visit: DX: upper respiratory infection.  2nd visit: DX Pneumonia. 3rd visit:  1) leg pain 2) syndrome, viral. 01/22/2007: MR received from PCP which included multiple office visits and several hospital reports for multiple ER visits and one admission. Well child check (12 mon.) on 09/06/2006 when vax. were given.   Office visit  09/12/2006 for c/o lumps remaining from immunizations. PE describes firm, non-tender, palpable lump at site of MMR (left anterior thigh)-minimal redness, no heat.  Moist heat recommended. Assessment:  Foreign body reaction of the skin (NOS). Additional records received for hospital admission 01/03-07/2007 for c/o fever and diarrhea. Discharge DX:  1) Bilateral Otitis Media  2)  Influenza infection.   02/02/2007 Reporter/parent called with updated information and requests that records be requested and added to file. Records requested per request. 02/12/2007 MR received for 4 day hospital stay (1/23/07) for fevers and refusal to walk.  Consults with Pediatric ID and orthopedic surgery are included.  History as above.  No evidence of osteomyelitis. D/C DX: Fever resolved, likely due to CMV infection (resolved). 04/27/2007 MRs received from hospital visit for insertion of myringotomy tubes on 2/3/07 and for an ER visit for c/o diarrhea and fever on 12/29/2006.  DX:  Febrile Illness. Diarrhea.  Subject continues to have severe health issues, hospitalized without reason or why she is continued to get sick.  Several work ups of test have come back negative. Subject was accepted by a research hospital.  She will begain her cane (exam & even diagnosis) done on Feb. 4, 2008.  Please follow- as we are hoping to see if we can find why subject continues to get ill.  Followup 3/30/2010 We are currently being treated by several doctors/specialists including, care out side the state of Arizona and went to Stanford University in CA.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Flu vaccine administered in pm of 1/9/07. In am of 1/10/07 patient was noted to have a 4x4.5 cm swelling on her left arm at the site of injection.  No redness, fever, or other symptoms were noted.  She received a flu vaccine last year with no problems.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Flushing, Headache, Lymphadenopathy
Clinical narrative: Moderate to severe headache. Chills, lymph node swelling and facial redness lasting about 24 hours.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Fracture, Lethargy, Oral intake reduced, Renal failure
Clinical narrative: 78 y/o female who was a resident of a long-term-care facility for 3+ years, rec'd influenza vaccine on 11/4/06.  On aprox 11/17/06 patient's husband stated that the patient became lethargic, refusing food. 11/19/06 patient expired. Patient's huband stated "she died of dehydration and kidney failure".
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes on back of head/neck.  Left hand went completely numb for 2 days, sensation is gradually returning.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Feeling hot
Clinical narrative: Bilateral reaction to lower extremities, R lower extremity warm to touch.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Influenza like illness, Pain
Clinical narrative: Pain both arms including forearms, beginning 3 hours after injection. Arms felt as if them were constricted. She constantly had to rub them.  Felt like she had flu. Pain remains in left deltoid. Pain with ROM any direction.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt has dizziness and then pass out at the office. She was kept for observation her; VS were stable and then discharge home. She still feeling dizziness after later phone call.
Age: 0.58
Sex: F
Vaccine: HIBV, PNC
Symptoms: Blood potassium increased, Convulsion, Dyskinesia, Hypotonia, White blood cell count increased
Clinical narrative: Infant had a siezure, MOC describes infants eyes as rapidly moving, jaw opening and shutting, head, arms, body, and legs shaking, head arched posteriorly.  Episode lasted approximately 8-10 minutes.  Immediately following episode infant went limp.  Moc drove infant to the ER, they performed multiple tests.  Ct spent 5-6 hrs in the ER and then released.  Infant has had no more seizure activity since this time.
Age: 1.24
Sex: M
Vaccine: MMRV
Symptoms: Hypoxia, Pyrexia, Rhinorrhoea
Clinical narrative: Approx 5 days after shot my son developed a runny nose followed by fever.  We took him to his doctor immediately.  Doctor gave him antibiotics and told me to come back next day.  Next day doctor evaluated and ordered a hospital stay.  A day later son was trasported by ambulance from one hospital to another hospital.  Required intubation and 11 day hospital stay.  Total of 12 days in hospital.  MR received from local hospital for a direct admit for increasing respiratory distress and resistance to eat/drink on 10/17/2006. Rocephin, Zithromax, and Xopenex neb started 1 day prior to admission. PE: Congestion with noisy respirations noted.  T'=100.6'F. Nasal congestion with mucoid d/c. Swollen tonsils. Cervical adenitis. Respiratory intercostal retractions, wheezing and rales bilaterally. Tachycardia. Still having problem with visual alignment of the eyes. Impression:  1) Acute bronchopneumonia 2) Acute tonsillitis and cervical adenitis 3) dehydration.  01/22/2007: MR received from treating hospital after transfer.  HPI as above, child had runny nose x1-2 weeks which progressed to fever and a deep,  hoarse cough.  He was transfered to this hospital for further treatment. Despite treatment with steroids, antibiotics and neb treatments he continued to show increased respiratory distress( intercostal retractions, flaring nostrils, and increased need for O2)  which neccessitated a broncoscopy.  Erythema of the airway was noted c/w tracheitis.  He was intubated and transfered to PICU. He was extubated 3 days later, however required a protracted course to return to full consciousness, and decreased eye/hand co-ordination was noted.  Neurology consult was done. He gradually improved and was discharged on day 10. Discharge Diagnosis: Viral Tracheitis.  02/22/2007 MR received from PCP.  15 month well baby check on 10/10/2006 where baby received DTaP and Prevnar.  Most recent MMR and Varicella on 07/13/2006 (not 10/05/2006 as stated on VAERS report from parent).  PE WNL except continued problem with his vision still noted.  Child must accomodate his eyes when he is going to focus on something. Next visit is 10/16/2006 with c/o fever (103'F), with coughing and nasal congestion.  PE  showed tonsils to be bright red and swollen.  Lungs sounds with rhonchi, gross rales, and a few fine rales on both lung fields.    DX: Very severe tonsillitis. Bronchopneumonia.  TXd with Rocephin IM and po Zithromax. Seen the following day (10/17/2007) for Acute Bronchopneumonia, tonsillitis, dehydration and admitted to hospital. (See above). F/U exam 10/30/2007 follwing hospital D/C.  PE: shows lungs clear, and mild nasal congestion. Two more episodes of tonsillitis in November and several reports of diarrhea.  An influenza syndrome in December. Several episodes of runny nose, cough, and wheezing in January and February. DXs include: rhinitis, upper and lower respiratory infections.
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Intestinal gangrene, Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: Initial report received on 27 December 2006 from another manufacturer, report number WAES0612USA01553. A female patient, with no previous illness, was vaccinated on 27 November 2006 with a dose of IPOL (lot number unknown), an oral 2 ml first dose of ROtateq (lot #655863/1034F) a dose of Prevnar (unknown lot number), PedvaxHib (unknown lot number) and an unspecified vaccine of Dtap (unknown manufacturer and lot number). On 29 November 2006, two days post vaccination the patient began vomiting. An ultrasound on 01 December 2006 showed signs of obstruction and missing abdomen. The patient was hospitalized. Surgery on 01 December 2006 revealed intussusception and gangrenous ascending and transverse colon. After colectomy of involved segment the patient was reassessed and was doing well. The patients experience was considered to be other important medical event by the reporter (OMIC). A lot check (for Rotateq) has been requested. The records of testing prior to release of the lot in question (Rotateq) has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.18
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Viral infection, Vomiting
Clinical narrative: Initial report received on 27 December 2006 from another manufacturer, report number WAES0612USA00949. The initial reporter was a health care professional.  A 9 week old female patient, with no medical history and no allergies, received on 27 November 2006 a dose of IPOL (lot number unknown), the first dose of Rotateq (lot # 654794/0776F), a dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (manufacturer unknown), a dose of PedvaxHib (manufacturer unknown) and a dose of Prevnar. Three days post vaccination, on 30-NOV-2006, the patient developed severe diarrhea and vomiting. The patient was taken to the emergency room where a stool culture showed that the patient had rotavirus. The patient was not hospitalized and subsequently recovered. The physician felt that the patient's experience was related to vaccination with Rotateq as none of the patient's family members had been ill and since she (the physician) did not see many rotavirus cases that time of year. No product quality complaint was involved for Rotateq and the records of testing prior to release of the lot (Rotateq) in question had been rechecked, found to be satisfactory and met the requirements and was released. The reporter considered the patient's experience to be disabling and immediately life-threatening. No other information was provided.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Hypoaesthesia, Muscle rigidity, Neck pain
Clinical narrative: Initial report received on 03 January 2007 from a health care professional. A 17 year old female patient, with unknown past medical history, had received a left deltoid injection of Menactra vaccine, lot number U1974AB, and a right deltoid injection of Gardasil vaccine, lot number 0961F, on 28 December 2006. Five days post-immunization, the patient reported pain in her neck and head, non specific bilateral numbness sensation and pain in her lower extremities (thighs, calves, and feet (soles)), and bilateral knee and ankle tendon reflexes. Additional information was obtained from the treated physician by the manufacturer on 04 January 2007. The treating physician reported the patient's condition had worsened and now had areflexia. Treatments received and diagnostic tests performed were not provided. At the time of this report, the patient had not recovered. This report was referred by the CBC to the Clinical Immunization Safety Assessment network for follow up. The reporter of this case is the same as for non-serious case 2007-00057, involving a tingling sensation in the feet and thighs following the receipt of Menactra and Gardasil. The patient in case 2007-00057 is the sister of the patient reported in case 2007-00033. (OMIC) 02/01/07-records received and reviewed for DOS 01/04-01/06/07 DC DX:Guillain Barre Syndrome Chief complaint, pain and weakness of lower extremities bilaterally, 8 out of 10 in intensity shooting from below buttock to knew and from heel to toes as well as bilateral calf pain. Paresthesias in her feet bilaterally. Onset was day prior to admission.  PE:Neuro:strength 5/5 in all 4 extremities, sensation intact coordination intact, bilateral toes downgoing, gait steady, Romberg negative.  RX with neurotin and IVIG.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Hypoaesthesia, Hyporeflexia, Neck pain
Clinical narrative: Initial report received on 03 January 2007 from a health care professional. A 17 year old female patient, with unknown past medical history, had received a left deltoid injection of Menactra vaccine, lot number U1974AB, and a right deltoid injection of Gardasil vaccine, lot number 0961F, on 28 December 2006. Five days post-immunization, the patient reported pain in her neck and head, non specific bilateral numbness sensation and pain in her lower extremities (thighs, calves, and feet (soles)), and bilateral knee and ankle tendon reflexes. Additional information was obtained from the treated physician by the manufacturer on 04 January 2007. The treating physician reported the patient's condition had worsened and now had areflexia. Treatments received and diagnostic tests performed were not provided. At the time of this report, the patient had not recovered. This report was referred by the CBC to the Clinical Immunization Safety Assessment network for follow up. The reporter of this case is the same as for non-serious case 2007-00057, involving a tingling sensation in the feet and thighs following the receipt of Menactra and Gardasil. The patient in case 2007-00057 is the sister of the patient reported in case 2007-00033. (OMIC) 02/01/07-records received and reviewed for DOS 01/04-01/06/07 DC DX:Guillain Barre Syndrome Chief complaint, pain and weakness of lower extremities bilaterally, 8 out of 10 in intensity shooting from below buttock to knew and from heel to toes as well as bilateral calf pain. Paresthesias in her feet bilaterally. Onset was day prior to admission.  PE:Neuro:strength 5/5 in all 4 extremities, sensation intact coordination intact, bilateral toes downgoing, gait steady, Romberg negative.  RX with neurotin and IVIG.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Clinical narrative: Left hand swelling and contracture 01/12/07-records received and reviewed for DOS 11-7-07-1-//9-07 C/O contractures mostly of upper extremities. Recent UTI,  PE: exhibits considerable contractures to left wrist and hand as well as right arm.   Ten days after flu shot complained of contractures to wrists, muscle pain in shoulders arms legs and back, headaches. Psychiatric medications increased and rigidity got worse. Medication decreased and contractions in wrists are present. RX with levaquin for UTI. Assessment, unsure if contractures are due to Flu shot no longer believes it is from medications. Plan for neurology consult in near future. Pt moved to another facility.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Blood electrolytes decreased, Erythema, Immune system disorder, Pain, Pyrexia
Clinical narrative: Took flu shot lat Oct, 1 1/2 - 2 weeks later developed rash dark pink macule all over body, had fever and body aches. 11/27/06 rash still visible, skin reddening no itching. Family Doctor sent for test results, MD doesn't think related to shot. Unsure what it is. Rash is improving.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash macular, Viral infection
Clinical narrative: Took flu shot lat Oct, 1 1/2 - 2 weeks later developed rash dark pink macule all over body, had fever and body aches. 11/27/06 rash still visible, skin reddening no itching. Family Doctor sent for test results, MD doesn't think related to shot. Unsure what it is. Rash is improving.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Hyperhidrosis
Clinical narrative: Pt c/o being hot and sweaty. Pt laid down on exam bed and given water. Pt stayed in clinic for 30 mins and stated she was feeling fine.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Hives
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: 15 x 17cm area of redness, mild swelling, tenderness right deltoid area 4 days after Tdap given in right deltoid. Pt already on Augmentin x 4 days due to injury requiring vaccine. Septra added to Augmentin. OTC Advil.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever to 102.7 after immunization s given on 1/9/07. Fever lasted <24 hours. Child also was irritable.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: 01/08/2007 patient received Pneumovax and developed fevers up to 104, body ache, injection site warmth, not red.
Age: 65.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: 01/08/2007 patient received Pneumovax and developed fevers up to 104, body ache, injection site warmth, not red.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Gastrointestinal disorder, Lymphadenopathy
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with no pertinent medical history and no drug reactions or allergies who on 11 Oct 2006 was vaccinated with the first, 0.5 ml dose of HPV vaccine. Concomitant therapy included YAZ. On 11 Dec 2006, the patient received the second, 0.5ml dose of HPV vaccine (lot 653650/0696F). About three weeks after the first dose, approximately 01 Nov 2006, the patient experienced Gastrointestinal problems including, diarrhea, vomiting and decreased appetite. The patient had a swollen right intraglandular lymph node. The patient had lost 12 pounds since the start of her symptoms. The patient was hospitalized overnight and treated for dehydration with intravenous fluids on 12 Nov 2006, 18 Nov 2006 and 31 Dec 2006. laboratory evaluation revealed normal complete blood count and normal ultrasound of the pelvic area. The patient was referred to a gastrointestinal physician but had not been examined yet. At the time of the report, the patient had not recovered. The patient sought medical attention. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be disabling. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be other important medical events (OMIC). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, Weight decreased
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with no pertinent medical history and no drug reactions or allergies who on 11 Oct 2006 was vaccinated with the first, 0.5 ml dose of HPV vaccine. Concomitant therapy included YAZ. On 11 Dec 2006, the patient received the second, 0.5ml dose of HPV vaccine (lot 653650/0696F). About three weeks after the first dose, approximately 01 Nov 2006, the patient experienced Gastrointestinal problems including, diarrhea, vomiting and decreased appetite. The patient had a swollen right intraglandular lymph node. The patient had lost 12 pounds since the start of her symptoms. The patient was hospitalized overnight and treated for dehydration with intravenous fluids on 12 Nov 2006, 18 Nov 2006 and 31 Dec 2006. laboratory evaluation revealed normal complete blood count and normal ultrasound of the pelvic area. The patient was referred to a gastrointestinal physician but had not been examined yet. At the time of the report, the patient had not recovered. The patient sought medical attention. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be disabling. The reporter considered the patients gastrointestinal problems, diarrhea, vomiting, decreased appetite, swollen right intraglandular lymph node, lost 12 pounds, and dehydration to be other important medical events (OMIC). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule
Clinical narrative: Mother stated that patient received large lump at the injection site 24 hours after vaccine. Patient was not in any discomfort. Mother took patient to urgent care where she was treated with allergic reaction with Benadryl which dissolved lump.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: Right deltoid erythematous, warm and tender.
Age: 8.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Injection Thursday PM. Friday AM-"fever and red bump on arm 2" x1" per mother. Took to urgent care Friday pm due to "increased redness and large red streak up arm". Started Benadryl and Tylenol. Took child to Urgent care again Saturday. Temp 101F. Started on Cephalexin for 10 days.
Sex: U
Vaccine: ANTH, FLUX, HEP
Symptoms: Anorexia, Arthralgia, Fatigue, Muscle spasms, Myalgia
Clinical narrative: fatigue, muscle aches, joint aches, appetite loss, body cramps. Currently on medication hold.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Paraesthesia
Clinical narrative: Left sided (facial, arm, leg) parasthesias; Left arm erythema; dysphagia
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Skin burning sensation, Swelling
Clinical narrative: Received flu shot arm bled 11/21/06; woke up itching, burning, tongue, mouth swelling 11/22/06; took Benadryl called doc on call told to take Benadryl twice and Pepcid 11/25/06; Went to doctor given Cortisone and Prednisone; back to doctor given shot again and Dexpak; back to doctor told to take Zyrtec and prescribed Triamcinclone cream; Still going to doctor still itching and burning.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Pain
Clinical narrative: Patient received Menactra, and had routine blood draw 1/4/07. 48hours later developed pain in Right arm. Greatest in lower arm. Movement of wrist triggers pain through extremity. No fever, swelling, redness. Treatment Ibuprofen, heat, rest, observation.
Age: 34.0
Sex: M
Vaccine: FLUN3
Symptoms: Cough, Headache, Lethargy, Nasal congestion, Pain
Clinical narrative: Received nasal flu vaccine on 11/15/06. Later that day developed headache, achiness, lethargy. Next day nasal congestion. Over next few days developed chest congestion, cough. Felt feverish but did not take temp. Coughing produced greenish sputum. Did not see doctor talked to doctor. Symptoms continued on and off for 2 weeks. Recovered when talked to him 12/28/06.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Scratched arm where vaccine administered during night while asleep. In morning felt pain and more itching. Next day had redness and small blisters over area about the size of a quarter.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Alopecia, Hypotrichosis, Laboratory test abnormal
Clinical narrative: Loss/thinning of hair top of head from anterior to posterior (crown)=2 1/2 months after shot.
Age: 1.13
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria on legs since 1/6/07
Age: 47.0
Sex: M
Vaccine: FLU3, HEP, YF
Symptoms: Anxiety, Arthralgia, Chest pain, Depression, Eye irritation
Clinical narrative: Headache, still on treatment; anxiety disorder, depression-on treatment; chest pain-on treatment; feet, knee, hand joint painful; eyes difficult, itching, allergy, pain-on treatment.
Age: 47.0
Sex: M
Vaccine: FLU3, HEP, YF
Symptoms: Headache, Hypersensitivity, Laboratory test abnormal, Pain, Pruritus
Clinical narrative: Headache, still on treatment; anxiety disorder, depression-on treatment; chest pain-on treatment; feet, knee, hand joint painful; eyes difficult, itching, allergy, pain-on treatment.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left deltoid area swollen red, warm 3cmx5cm.