chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Pyrexia, Respiratory rate increased, Urine analysis normal, Viral upper respiratory tract infection, Virus serology test
Clinical narrative: Evening after vax given fever 103.2, increased RR - seen in urgent care clinic where O2 sat initially 98%, fairly quickly decreased to 40's with cyanosis and child described as being "out of it". No area sz activity. Coughed and then O2 sat increased. TX = O2. Has incurred viral URI. 05/15/07-records recevied for DOS 4/16-4/17/07-DC DX: fever. Syncope and collapse. Severe desaturation event in clinic O2sat 40% on room air. Perioral cyanosis. Non responsive but not apneic. Febrile to 103.
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: 4cm/4cm square of erythemous hot tissue.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Client received a Tdap Adacel immunization on 091606. Client called health department on 042007 stating that she has had severe pain in left arm since receiving the immunization. Sometimes it keeps her up at night. Hurts when she rolls over on that arm. Still has achey feeling in that area.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Eye oedema, Swelling face
Clinical narrative: Puffiness to face and eyes starting 8 hours after vaccine administration, continued into the next day. Benadryl given. Symptoms resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: L leg with swelling/rash
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Redness, swelling on upper extremity from elbow to shoulder, Warmth.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle spasms, Muscular weakness, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain
Clinical narrative: Pt is in with left arm pain. She said she used to get some cramps or charley horse occasionally somewhere in her hand between the third and fourth digits kind of "like toe cramps". Subsequently she got more cramps the day of the shot and then started developing an allusive pain in the anterior shoulder across the pectoral region and anterior deltoid and then down the arm into the radial forearm and into the hand. The pain migrates a little bit worse with use. It dose not keep her from sleeping at night. She notes that her hand is somewhat weaker and it has been progressively getting worse for the last 2 weeks. She has not had any neck pain. Denies any loss of sensation. No color change. No temperature change or coldness or circulatory symptoms. She received the Gardasil on 04-06-07 left deltoid. 2 months ago she was Indian wrestling and somewhat wrenched her neck a little bit and had some minor discomfort and when she extends her head she has a little bit of pain or discomfort at the base of her neck. No history of neck pain. No history of cervical disk problems, any other injury, or trauma to the left upper extremity. No other neurologic symptoms. No fevers. No URI symptoms, respiratory complaints, no cough, wheezy, dyspnea, no cardiac complaints. No abdominal pain, diarrhea or vomiting. No urinary frequency, dysuria or change, No gross weight change or any constitutional symptoms. No swelling of the extremities. No skin rashes or unusual markings.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Pt is in with left arm pain. She said she used to get some cramps or charley horse occasionally somewhere in her hand between the third and fourth digits kind of "like toe cramps". Subsequently she got more cramps the day of the shot and then started developing an allusive pain in the anterior shoulder across the pectoral region and anterior deltoid and then down the arm into the radial forearm and into the hand. The pain migrates a little bit worse with use. It dose not keep her from sleeping at night. She notes that her hand is somewhat weaker and it has been progressively getting worse for the last 2 weeks. She has not had any neck pain. Denies any loss of sensation. No color change. No temperature change or coldness or circulatory symptoms. She received the Gardasil on 04-06-07 left deltoid. 2 months ago she was Indian wrestling and somewhat wrenched her neck a little bit and had some minor discomfort and when she extends her head she has a little bit of pain or discomfort at the base of her neck. No history of neck pain. No history of cervical disk problems, any other injury, or trauma to the left upper extremity. No other neurologic symptoms. No fevers. No URI symptoms, respiratory complaints, no cough, wheezy, dyspnea, no cardiac complaints. No abdominal pain, diarrhea or vomiting. No urinary frequency, dysuria or change, No gross weight change or any constitutional symptoms. No swelling of the extremities. No skin rashes or unusual markings.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L thigh redness, swelling
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Local reaction, Oedema peripheral
Clinical narrative: intense local reaction-redness and swelling 8 cm x 4 cm on upper arm (Left)
Age: 5.6
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness (~ 3-4 inches) warm to touch
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Painful rash x 2 days LT. T9 distribution above umbilicus. TX Valtrex (1gram tid x 7 days) Calamine lotion.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Pyrexia, Varicella
Clinical narrative: child was given proquad at 1 year well child visit on 4-12-07. On 4-21-07 child developed 102.8 fever with about 10 large chickenpox and multiple red dots without pustules. No treatment given. Just observed and used Tylenol.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC, HIBV, MMRV, PNC
Symptoms: Body temperature increased, Rash erythematous, Rash pustular
Clinical narrative: child was given proquad at 1 year well child visit on 4-12-07. On 4-21-07 child developed 102.8 fever with about 10 large chickenpox and multiple red dots without pustules. No treatment given. Just observed and used Tylenol.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Pain at injection site
Age: 1.1
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Body temperature increased, Skin lesion, Varicella
Clinical narrative: 9 days after vaccination-temp of 102 and multiple chickenpox lesions on face and trunk-multiple lesions
Age: 1.33
Sex: M
Vaccine: DTAPH, MMRV
Symptoms: Injection site erythema, Injection site papule, Injection site swelling
Clinical narrative: Patient noticed red, papular swelling over injection site with 2 other lesion near the site hour after injection and no soreness or urticaria response.
Sex: F
Vaccine: DTAP, HEP, IPV, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient developed 3-4 cm area of redness, swelling and induration to left upper thigh at area of DTaP vaccination, 3 days after vaccine. Pt was treated with Keflex to cover possible cellulitis however this may have been a simple shot reaction.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Pruritus, Rash
Clinical narrative: Adacel given afternoon 4/11/07. Patient states itch started that evening. Presents on 4/19 with red raised warm rash on left upper arm. There is 3 separate area 1 at injection site 2nd 2 below. Skin expected to return to normal
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) leg left thigh Red/swollen and indented, 9 cm x 8 cm in size, occurred with 24-48 of immunization.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Excoriation, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: After receiving Tdap 3-27-07 for knee abrasion that occurred 2d. prior, pt. developed red, swollen induration at injection site which became sensitive and painful resulting in muscle spasm and tingling. Also had concomitant Id. Hx fever to 105 w/viral URI.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Paraesthesia, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: After receiving Tdap 3-27-07 for knee abrasion that occurred 2d. prior, pt. developed red, swollen induration at injection site which became sensitive and painful resulting in muscle spasm and tingling. Also had concomitant Id. Hx fever to 105 w/viral URI.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram normal, Fatigue, Sinusitis, Syncope
Clinical narrative: patient fainted in office approx 10 min. after injection. Patient rested a few minutes then went home. About 3:30pm mother reported child was feeling fatigued and was sleeping. Pt had ER visit later. 2-21-07 pt had a followup appt
Age: 14.0
Sex: M
Vaccine: HBHEPB, MMRV, VARCEL
Symptoms: Blood culture negative, Body temperature increased, Chest X-ray normal, Convulsion, Culture urine negative
Clinical narrative: Febrile - Temp 105 seizure 8 days after MMR, Varivax, Hib-Hep B, Hep A
Age: 14.0
Sex: M
Vaccine: HBHEPB, MMRV, VARCEL
Symptoms: Full blood count normal
Clinical narrative: Febrile - Temp 105 seizure 8 days after MMR, Varivax, Hib-Hep B, Hep A
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia
Clinical narrative: Blood in stool
Sex: F
Vaccine: SMALL
Symptoms: Hypersensitivity
Clinical narrative: This case was considered medically important. Information regarding Dryvax was received from a consumer, regarding a female patient (age unknown) who experienced a severe allergic reaction. The patient received a dose on an unspecified date. The patient experienced a severe allergic reaction on an unspecified date. No further information was provided.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Antinuclear antibody, Coombs direct test negative, Ear pain, Full blood count, Petechiae
Clinical narrative: Seen on 1-22-07 with an overnight Hx sore throat and ear pain while swallowing. Parent were all sick, was afebrile at visit non-toxic, not ill-affecting, no exudates/lesions on tonsils. Pt was due for Varicella #2. Throat cultures done and Varivax #2 given. Pt returned on 1-25-07 with the Hx skin rash from 1/24/07. 1-25-07 petechial rash seen. plts-21c. Bleeding gum (+) Pt taking medications. Platelets remained low 2/5/07 and then unproved. No urine retention.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pharyngolaryngeal pain, Rash
Clinical narrative: Seen on 1-22-07 with an overnight Hx sore throat and ear pain while swallowing. Parent were all sick, was afebrile at visit non-toxic, not ill-affecting, no exudates/lesions on tonsils. Pt was due for Varicella #2. Throat cultures done and Varivax #2 given. Pt returned on 1-25-07 with the Hx skin rash from 1/24/07. 1-25-07 petechial rash seen. plts-21c. Bleeding gum (+) Pt taking medications. Platelets remained low 2/5/07 and then unproved. No urine retention.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pruritus
Clinical narrative: Varicella vaccine given 4-2-07. W/I on 4/4/07 c/o swelling and itching left arm. Has approx 70mm of erythematous area with increased temp.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: swelling, redness and hives on left upper arm and arm
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Large red swollen area about size of orange on (L) upper arm. Warm compresses and Benadryl
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Right deltoid erythema at site of Varivax-reassurance
Age: 0.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash generalised
Clinical narrative: pink rash all over body 2 days after vaccines
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: 4/9/2007, Neck glands on both sides - swollen and hard. resolved by 4/15/2007. 4/10/2007 - Rash started and progressed (face , shoulders, abdomen, Arms and back) resolved by 4/13/2007. * (hydrocortisone) cream for itching.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Swelling
Clinical narrative: swelling; redness at site of inj; fever at site; palm size; no streaking-Dr. looked at site and Rx Keflex 250 TID x 7 day
Age: 5.8
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) thigh red and swollen upper thigh to knee
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Localized (L) thigh redness and swelling. Allergic
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2" redness and swelling around 3" top injection site right arm. Ice to area, Tylenol po q4-6. 4/24/07 at 0830
Age: 1.9
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: C/O rash on arms, legs and back x 4/18/07 AM. Benadryl and Loratadine and Moisturize with Lotion/cream.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Urticarial rash 48 hrs after receiving Dtap, Hib, Pcv-7, IPV.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymph node pain, Lymphadenopathy, Nodule, Pain
Clinical narrative: Large red rash on arm - 3.5" x 4" with a red finger leading to arm pit. 1/2" raised bump the size of silver dollar. Swollen and painful under arm - lymph nodes. Pain scale to touch = 8.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Large red rash on arm - 3.5" x 4" with a red finger leading to arm pit. 1/2" raised bump the size of silver dollar. Swollen and painful under arm - lymph nodes. Pain scale to touch = 8.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Red, raised bumps with fluid all over
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Burning sensation, Pain
Clinical narrative: Received his anthrax vaccine (6) in his arm in the triceps area. He describes this anthrax vaccine as feeling 'different' in that with the first five anthrax vaccines, he noted a burning sensation and just after immunization. He denies any unusual or prolonged vaccines sites reactions or systemic symptoms after any use of his first five anthrax vaccine. With his sixth anthrax vaccine, he experienced the usual burning sensation with injection plus a 'real sharp pain that never went away' and that went' right to my elbow'. For two days, the elbow ached constantly and then resolved. He did not note any redness, swelling or increased warmth at the elbow. He did not experience any numbness or tingling in that extremity. There was no persistent subcutaneous nodule. After the first 2 days, he continued to experience pain described as 'knife-life pain' that is noted 'when there is something pressing against the elbow' or as 'sensitive to touch'. He rates the level of pain intensity as a level 7-8/10 using a pain scale from 0 (=no pain) to 10 (=worst pain ever experienced). Joint Pain, isolated right elbow
Age: 37.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Injection site infection, White blood cell count normal
Clinical narrative: Small pox injection arm became infected with a red streak traveling under the armpit. Notices on 18 Apr 07. Given antibiotics to take.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: Fever, per non unable to walk
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, myalgia
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms after 2nd Gardasil injection  10/21/08 Reviewed endocrine clinic records of 2/10/06-3/11/2008. FINAL DX: Hashimoto's thyroiditis, hypothyroidism, dysfunctional uterine bleeding, poor circulation in feet Records reveal patient experienced rapid weight gain, irregular periods, dysfunctional uterine bleeding.  Tx w/thyroxine replacement therapy (synthroid).  Dx w/Hashimoto's thyroiditis w/hypothyroidism 2/2006.  10/10/08 Reviewed OB/GYN notes of 1/11/06-8/26/2008. FINAL DX: goiter, dysfunctional uterine bleeding,  Records reveal thyroid enlarged.  Referred to endocrinologist.  4/19/07 parent called office w/reports of body aches, dizziness, chest congestion, HA starting after 2nd HPV vaccine on 4/7/07.  Improved w/NSAIDS.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Injection site pain
Clinical narrative: In addition to mild tenderness at injection site, flu like symptoms; headache, light headed, chills. No SOB. Milder symptoms with prior Gardasil (Both) symptomatic treatment and reassurance.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: In addition to mild tenderness at injection site, flu like symptoms; headache, light headed, chills. No SOB. Milder symptoms with prior Gardasil (Both) symptomatic treatment and reassurance.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right deltoid swelling, redness, warm to touch
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Electroencephalogram, Pyrexia, Tremor
Clinical narrative: On Wed 4/18/07 Patient received imms on 4/19/07. Patient had tactile fever, which continued on 4/20/07 patient had episode of decreased tone, shakin and asymmetry of jaw movement tactile fever persists afebrile in clinic otherwise doing well. Residual asymmetry of lower legs.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Soldier was given Smallpox vaccination on 4/24/07 in error. SM has diagnoses of dermatitis. No adverse events have been noted since vaccine administration. Orders given for Claritin, Hydrocortizone 0.05% cream bid as needed.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Nasal congestion, Pain in extremity, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: APPROXIMATELY 7 HOURS AFTER RECEIVING ADACEL (04/11/2007) PT COMPLAINED THAT HER THROAT FELT LIKE IT WAS CLOSING AND ARM PAIN - HOWEVER, PT CALLED OUR OFFICE 04/13/2007 COMPLAINING OF SORE THROAT, COUGH, C0NGESTION AND FEVER OF 102 DEGREES.  PT INSTRUCTED TO APPLY ICE TO ARM, TAKE ADVIL AND CALL WITH AN UPDATED THE NEXT MORNING.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: APPROXIMATELY 7 HOURS AFTER RECEIVING ADACEL (04/11/2007) PT COMPLAINED THAT HER THROAT FELT LIKE IT WAS CLOSING AND ARM PAIN - HOWEVER, PT CALLED OUR OFFICE 04/13/2007 COMPLAINING OF SORE THROAT, COUGH, C0NGESTION AND FEVER OF 102 DEGREES.  PT INSTRUCTED TO APPLY ICE TO ARM, TAKE ADVIL AND CALL WITH AN UPDATED THE NEXT MORNING.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: The morninfg after recieving Adacel, patient reported diffuse myalgias in back, arms, legs. Treated with ibuprofen 800mg Q8 hours.
Age: 1.56
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Crying, Erythema, Pruritus, Pyrexia, Sleep disorder
Clinical narrative: Patient had her MMR, Varicella and DTaP vaccines at the end of March. At the time, I told the nurse that patient is severely allergic to milk, eggs and peanuts. (She was tested at 12 mos of age) So, I asked if the any of the vaccines should not be given because of her allergies, specifically the egg allergy.  She said she thought the MMR might be one that is questionable so she went into the hall and asked someone (not sure if it was the doctor or not) and they said it should be fine.  Ever since the immunizations, she has not been sleeping well, she had a fever of 103.7 every few days until last week and has been itching very badly on her arms and stomach to the point of breaking the skin.  Her bottom has been red and she cries at times when she wets her diaper.  Until last night, I wasn't sure what was going on and then I read from my book, BIRTH TO AGE FIVE by the AAP that if a child has egg allergies she should not be given the MMR.  I believe she is continuing to react to this vaccine because of her food allergy and should never have been given this.  I haven't treated her with anything yet, but am calling her allergist this morning to find out what to do, if anything.  I truly believe she is suffering because of this MMR vaccine.
Age: 48.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Rash on face, neck, upper chest, upper back and left arm
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Muscle spasms, Myalgia, Paraesthesia
Clinical narrative: Fatigue, muscle aches and spasms, tingling in hands and arms.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest pain, Echocardiogram, Myocarditis, Myopericarditis
Clinical narrative: Chest Pain secondary to myocarditis.  Chest pain developed 10 days after vaccination and then lasted for 6 hours until Toradol was given.  Pt was diagnosed with myopericarditis and started on ibuprofen.  07/02/2007 MR received for o/n admission 4/29-30/2007 for c/o substernal chest pain w/ associated diaphoresis.  Pain worse with lying down and deep inspiration. Txd with Motrin and rest. DX: Myopericarditis as a rxn to smallpox vaccine.
Age: 42.0
Sex: F
Vaccine: TTOX
Symptoms: Pain, Swelling
Clinical narrative: Day of vaccine I had intense throbbing in my armpit. Two days later I realized it was swollen to the size of a tennis ball. My whole upper arm was swollen as well.  The swelling is slowly going down and the pain is gone.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: SMALL RED SPOTS APPEARED ON TRUNK 1 WEEK AFTER  RECEIVING VACCINES.  SPREAD TO FACE. PRESENT FOR  2 DAYS.  AFEBRILE.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Rash
Clinical narrative: PT WAS ADMINISTERED THE TDAP VACCINE (ADACEL) ON 4/16/07.  ON THE EVENING OF 4/26/07 SHE DEVELOPED A RASH ON HER TRUNK AND UPPER THIGHS, MIGRATORY JOINT PAIN AND WEAKNESS.  HER FAMILY PHYSICIAN STARTED HER ON A MEDROL DOSE PAK ON 4/28/07 AND REPORTS SHE FELT MUCH BETTER WITHIN TWO HOURS OF THE FIRST DOSE.  SYMPTOMS HAVE CONTINUED TO RESOLVE.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: 4" DIAMETER OF REDNESS AND ITCHING. PT INFORMED TO USE BENADRYL AND TOPICAL HYDROCORTISONE AND RTO IF WORSENING
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure, Headache, Heart rate, Injected limb mobility decreased, Injection site erythema
Clinical narrative: complains of headache, pain, swelling and redness at Tdap injection site which started 5 days post vaccination. No fever and no aches. 6 days post Tdap vaccination she reports having 2 episodes of tachycardia (120-140) while at work and questions if related to Tdap vaccination. When evaluated Pulse was 96 and BP 110/84. Left deltoid was tender to touch and red and slightly swollen; limited ROM due to discomfort; afebrile. Obivious localized reaction from Tdap. Consulted CDC help line for any reports of tachycardia with Tdap and none aware.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Tachycardia
Clinical narrative: complains of headache, pain, swelling and redness at Tdap injection site which started 5 days post vaccination. No fever and no aches. 6 days post Tdap vaccination she reports having 2 episodes of tachycardia (120-140) while at work and questions if related to Tdap vaccination. When evaluated Pulse was 96 and BP 110/84. Left deltoid was tender to touch and red and slightly swollen; limited ROM due to discomfort; afebrile. Obivious localized reaction from Tdap. Consulted CDC help line for any reports of tachycardia with Tdap and none aware.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Deafness unilateral
Clinical narrative: Patient called and stated that he lost hearing in his left ear on 03/21/07.  He went to see an ENT doctor  on 03/27/07 and was given steroids.  He reports his hearing is not improved at this point.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Deafness, Ear, nose and throat examination, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Patient called and stated that he lost hearing in his left ear on 03/21/07.  He went to see an ENT doctor  on 03/27/07 and was given steroids.  He reports his hearing is not improved at this point.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Body temperature, Cough, Dizziness, Headache, Pharyngolaryngeal pain
Clinical narrative: Within 12 hours of vaccine, patient had 102 degree fever.  First day symptoms were also headache, dizzy, sore throat. Morning fever last multiple days. Today, 6 days later, fever is gone, throat is raw with cough, strep test is negative, patient is ill.  Dr. believes it is a viral infection, but cannot determine if related to vaccine or independent cause.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Pyrexia, Streptococcal identification test negative, Viral infection
Clinical narrative: Within 12 hours of vaccine, patient had 102 degree fever.  First day symptoms were also headache, dizzy, sore throat. Morning fever last multiple days. Today, 6 days later, fever is gone, throat is raw with cough, strep test is negative, patient is ill.  Dr. believes it is a viral infection, but cannot determine if related to vaccine or independent cause.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: CSF culture positive, Culture stool negative, Meningitis salmonella, Pyrexia, Salmonellosis
Clinical narrative: Fever - Salmonella Meningitis IV antibiotics and hospitalization. 6/25/07 Received hospital med recs which reveal patient experienced fever, loose stools & poor oral intake.  Was also irritable & inconsolable.  Seen in PCP office on day of admit & UA, urine c/s, blood c/s, CBC were done & pt sent home.  Later same day, WBC was 26.8 w/left shift & patient was direct admit to hospital 4/13-5/9/07.  Admit exam revealed full anterior fontelle & increased irritability w/neck manipulation.  LP was done which produced purulent CSF. Admitted to PICU on multiple antibiotics.  Developed seizures.  Neuro & ID consults done.  Gradually stabilized & transferred to floor.   FINAL DX: Salmonella meningitis.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Diarrhea.  5/4/07 Received vax rec from PCP which confirms RO info on VAERS form.  6/26/07 Received hospital ER records which reveal patient seen only in ER & kept overnight for observation 4/26-4/27 for vomiting & diarrhea, fever, nasal congestion x 2 days.  Both parents had been ill w/vomiting/diarrhea as well.  Tx w/IVF & slowly progressed to pedialyte. FINAL DX: Gastroenteritis & dehydration.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Was given
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Pruritus, Skin burning sensation
Clinical narrative: 4x5cm Induration and redness at injection site. Itchy and burning. Feels hot to the touch. (irritation was at site of Dtap injection).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Skin warm
Clinical narrative: 4x5cm Induration and redness at injection site. Itchy and burning. Feels hot to the touch. (irritation was at site of Dtap injection).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling/redness at site of Dtap right arm IM 4x5 cm induration - itchy and burning. Feels hot to touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site warmth, Pruritus
Clinical narrative: Swelling/redness at site of Dtap right arm IM 4x5 cm induration - itchy and burning. Feels hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Skin warm
Clinical narrative: Received vaccines 4/27/07. Starting 4/27/07 had redness, swelling and warmth at injection site right arm. Redness persists as well as warmth and itching, No hives, swelling resolved.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Hives within 5 min of vaccine admin. TX with Benadryl PO no wheezing no angio edema.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Dysphonia, Dyspnoea
Clinical narrative: Gardasil - 1st inj 2/27/07 10-11 AM -03:00 pm could not breath, swallow - voice deep- hoarse. Did not go to ER - Fri AM took Benadryl, Baby ASA, throat spray. Lasted 2-3 days office today for 2nd inj told reaction after 1st inj.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Injection given in left deltoid region. Patient received Tdap vaccination on 4/25/07; on 4/26/07 evening pt noted area around injection site looked like a "welt, very reddened, sliver dollar size and itchy." Pt directed to primary doctor for further instruction; patient stated she already notified him. Information per RN.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Rash to chest area and complained of general discomfort.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, IPV, PPV
Symptoms: Drug administered at inappropriate site, Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: My son was injected in rear of his legs. Two shots in each let. Instantly swelling the size of golf balls on the back of each leg. I asked for a doctor to come look at my son. The doctor asked nurse who done this to this child? The nurse could of damaged my sons nerves and paralyzed my son. She injected in the wrong place of his legs.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: R upper arm localized, redness, swelling, tenderness, warmth developed within 24 hrs of vaccination, improving by 72 hours after vaccination.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Ear, nose and throat examination, Feeling hot and cold, Injection site pain, Local reaction, Sudden hearing loss
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old male with hypertension who on 22-JAN-2007 was vaccinated at his primary physician's office with a dose of Pneumovax. Concomitant therapy included losartan potassium, aspirin and PRILOSEC. On 22-JAN-2007, the patient experienced hearing loss 12 hours post vaccination. The reporting nurse's office specialized in otolaryngology and had given the patient hearing tests prior to and after the administration of Pneumovax. The nurse reported that the patient's hearing was impaired after vaccination. At the time of this report, the patient had not recovered. The patient's hearing loss was considered to be disabling by the reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Acoustic stimulation tests abnormal, Deafness, Hearing impaired
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old male with hypertension who on 22-JAN-2007 was vaccinated at his primary physician's office with a dose of Pneumovax. Concomitant therapy included losartan potassium, aspirin and PRILOSEC. On 22-JAN-2007, the patient experienced hearing loss 12 hours post vaccination. The reporting nurse's office specialized in otolaryngology and had given the patient hearing tests prior to and after the administration of Pneumovax. The nurse reported that the patient's hearing was impaired after vaccination. At the time of this report, the patient had not recovered. The patient's hearing loss was considered to be disabling by the reporter. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Body temperature increased, Chills, Erythema, Hyperhidrosis, Induration
Clinical narrative: Pt developed pain at injection site 24 hours after immunization. Advised to use Tylenol as needed. CB if any fever/redness/warmth at site. Pt CB next day with temp 102-13. Eval by MD in office. Treated with  Cephalexin 500 mg TID x 7 d.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pt developed pain at injection site 24 hours after immunization. Advised to use Tylenol as needed. CB if any fever/redness/warmth at site. Pt CB next day with temp 102-13. Eval by MD in office. Treated with  Cephalexin 500 mg TID x 7 d.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pt developed pain at injection site 24 hours after immunization. Advised to use Tylenol as needed. CB if any fever/redness/warmth at site. Pt CB next day with temp 102-13. Eval by MD in office. Treated with  Cephalexin 500 mg TID x 7 d.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Body temperature fluctuation, Body temperature increased, Chills, Erythema, Hyperhidrosis
Clinical narrative: Pt developed pain at injection site 24 hours after immunization. Advised to use Tylenol as needed. CB if any fever/redness/warmth at site. Pt CB next day with temp 102-13. Eval by MD in office. Treated with  Cephalexin 500 mg TID x 7 d.
Age: 47.0
Sex: M
Vaccine: PPV, TDAP, PPV, PPV, TDAP
Symptoms: Induration, Myalgia, Pyrexia
Clinical narrative: Pt developed pain at injection site 24 hours after immunization. Advised to use Tylenol as needed. CB if any fever/redness/warmth at site. Pt CB next day with temp 102-13. Eval by MD in office. Treated with  Cephalexin 500 mg TID x 7 d.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Neck pain, Pyrexia
Clinical narrative: High fever with severe back and neck pain during night.  Much less pain and temp 99 normal in am.  No local site redness or swelling.
Age: 18.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Angiogram, Headache, Lumbar puncture, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: Pt developed fever and severe headache within 24 hrs of administration of yellow fever vaccine. Fever subsided. Headache persists (continues even at time of this report). All diagnostics including spinal tap, MRI, and MRA have been negative. Symptomatic treatment offered.  05/07/2007 MR received for several ER visits (2 on 4/4/07 and one on 4/6/07  which resulted in a 3 day admission for c/o fever and intractable H/A first noted shortly after receiving Yellow Fever vaccine.  Initially dx with post-vaccine fever. H/A increased in intensity over several days.  Lymphadenopathy noted on PE on 4/6/07. Principal Discharge DX:  Reaction to Yellow Fever Vaccine.  2ndary DX:  Intractable H/A 2' to vaccine.
Age: 18.0
Sex: F
Vaccine: YF, HEPA, YF
Symptoms: Angiogram, Headache, Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Pt developed fever and severe headache within 24 hrs of administration of yellow fever vaccine. Fever subsided. Headache persists (continues even at time of this report). All diagnostics including spinal tap, MRI, and MRA have been negative. Symptomatic treatment offered.  05/07/2007 MR received for several ER visits (2 on 4/4/07 and one on 4/6/07  which resulted in a 3 day admission for c/o fever and intractable H/A first noted shortly after receiving Yellow Fever vaccine.  Initially dx with post-vaccine fever. H/A increased in intensity over several days.  Lymphadenopathy noted on PE on 4/6/07. Principal Discharge DX:  Reaction to Yellow Fever Vaccine.  2ndary DX:  Intractable H/A 2' to vaccine.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose increased, Diabetes mellitus insulin-dependent, Glycosylated haemoglobin increased
Clinical narrative: Patient was diagnosed with Type I diabetes 4/24/07. Hemoglobin A1C of 11.6% suggest at least 3 month history. No relation to vaccine suspected.  06/05/2007 MR received for an o/n admission 4/24-25/2007 for c/o blurred vision and frequent urination. Mom reported wt. loss as well. Discharge DX: Type 1 diabetes-new onset.  No signs of infection.  No ketoacidosis.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Atrial flutter, Cardiac stress test, Electrocardiogram, Gastroenteritis viral, Influenza
Clinical narrative: MEDI-0005739 is a serious (Important Medical Event), spontaneous case from a 44-year-old male consumer involving atrial flutter. The patient indicated that he had been in excellent physical condition prior to developing atrial flutter. He denied having any relevant cardiac disorders in the past and denied having any family history of heart conditions. The patient indicated that he had been on Warfarin. it was unclear whether the above medication was started prior to developing atrial flutter or as a treatment of atrial flutter. The patient stated that he received FluMist either on 22-Oct-2006 or on 29-Oct-2006. Five days after receiving FluMist, the patient experienced atrial flutter which lasted for nearly ten hours. On the following day, the patient felt ill and developed a mild flu which lasted for the subsequent three weeks. During that time, the patient continued to experience intermittent atrial flutter. In early November 2006, the patient was seen by an internist for his symptom. An electrocardiogram revealed that the patient had the flutter. The patient was referred to a cardiologist. Stress test, echocardiogram and heart scan test results were all negative. The atrial flutter subsided and the patient did not experience any further problems. However, on 12-Mar-2007, the patient developed a stomach virus. And on 24-Mar-2007, the patient had another 10 to 12 hour episode of atrial flutter. The patient indicated that the above symptom still persisted and that the symptom had been occurring nearly on a daily basis. The patient provided no causality assessment for the event of atrial flutter. Per 60 day follow up: Spoke with reporter via phone-states atrial flutter still ongoing-occurrs "rarely"-had only one episode since July 2007-last episode "few weeks ago" lasting "only a few minutes-exercise induced-no other associated sxs-not currently on any cardiac meds-no other medical complaints.
Age: 44.0
Sex: M
Vaccine: FLUN3
Symptoms: Malaise
Clinical narrative: MEDI-0005739 is a serious (Important Medical Event), spontaneous case from a 44-year-old male consumer involving atrial flutter. The patient indicated that he had been in excellent physical condition prior to developing atrial flutter. He denied having any relevant cardiac disorders in the past and denied having any family history of heart conditions. The patient indicated that he had been on Warfarin. it was unclear whether the above medication was started prior to developing atrial flutter or as a treatment of atrial flutter. The patient stated that he received FluMist either on 22-Oct-2006 or on 29-Oct-2006. Five days after receiving FluMist, the patient experienced atrial flutter which lasted for nearly ten hours. On the following day, the patient felt ill and developed a mild flu which lasted for the subsequent three weeks. During that time, the patient continued to experience intermittent atrial flutter. In early November 2006, the patient was seen by an internist for his symptom. An electrocardiogram revealed that the patient had the flutter. The patient was referred to a cardiologist. Stress test, echocardiogram and heart scan test results were all negative. The atrial flutter subsided and the patient did not experience any further problems. However, on 12-Mar-2007, the patient developed a stomach virus. And on 24-Mar-2007, the patient had another 10 to 12 hour episode of atrial flutter. The patient indicated that the above symptom still persisted and that the symptom had been occurring nearly on a daily basis. The patient provided no causality assessment for the event of atrial flutter. Per 60 day follow up: Spoke with reporter via phone-states atrial flutter still ongoing-occurrs "rarely"-had only one episode since July 2007-last episode "few weeks ago" lasting "only a few minutes-exercise induced-no other associated sxs-not currently on any cardiac meds-no other medical complaints.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein increased, Joint swelling, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning his daughter, a 23 year old female with no drug reactions or allergies with acne who on 31-AUG-2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (Lot # 653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified) and doxycycline. On 30-OCT-2006, the patient was vaccinated, intramuscularly with the second 0.5 ml dose of Gardasil. On approximately 31-OCT-2006, "two months after the first dose", the patient experienced arthralgia, with progressive pain in her knees, and wrists, and left wrist swelling. On 26-FEB-2007, the patient was vaccinated, intramuscularly with the third 0.5 ml dose of Gardasil. The patient sought unspecified medical attention. Laboratory evaluation revealed elevated sedimentation rate (sed rate), elevated C-reactive protein, negative rheumatoid factor, and antinuclear antibodies (ANA) pending. The physician reported that he believed the pain was causing the patient significant disability as she could not participate in former activities. The patient was treated with ADVIL. At the time of the report, the patient had not recovered. The physician considered the patient's arthralgia with progressive pain in her knees and wrists and left wrist swelling to be disabling. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor negative
Clinical narrative: Information has been received from a physician concerning his daughter, a 23 year old female with no drug reactions or allergies with acne who on 31-AUG-2006 was vaccinated intramuscularly with the first 0.5 ml dose of Gardasil (Lot # 653736/0689F). Concomitant therapy included hormonal contraceptives (unspecified) and doxycycline. On 30-OCT-2006, the patient was vaccinated, intramuscularly with the second 0.5 ml dose of Gardasil. On approximately 31-OCT-2006, "two months after the first dose", the patient experienced arthralgia, with progressive pain in her knees, and wrists, and left wrist swelling. On 26-FEB-2007, the patient was vaccinated, intramuscularly with the third 0.5 ml dose of Gardasil. The patient sought unspecified medical attention. Laboratory evaluation revealed elevated sedimentation rate (sed rate), elevated C-reactive protein, negative rheumatoid factor, and antinuclear antibodies (ANA) pending. The physician reported that he believed the pain was causing the patient significant disability as she could not participate in former activities. The patient was treated with ADVIL. At the time of the report, the patient had not recovered. The physician considered the patient's arthralgia with progressive pain in her knees and wrists and left wrist swelling to be disabling. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Hypotension, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 16 year old female with no pertinent medical history who on 23-APR-2007 was vaccinated, intramuscularly, with a 0.5 ml first dose Gardasil (lot #653736/0014U). There were no concomitant medication. On 23-APR-2007, while attempting to leave the physician's office, the patient "appeared to have a seizure" and lost consciousness. It was reported that the incident lasted only a few seconds. When the patient regained consciousness it was discovered that her blood pressure was low. On 23-APR-2007, the patient recovered and was able to leave the physician's office with her mother. Upon internal review, "appeared to have a seizure" was considered to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Drug exposure during pregnancy
Clinical narrative: Information has been received via the Merck pregnancy registry, from a licensed practical nurse, concerning a 19 year old female patient who was vaccinated with a first and second dose of Gardasil (dates unspecified), and during the vaccination series discovered she was pregnant (date of the LMP and estimated date of delivery were unspecified). The nurse reported that the patient elected to undergo an abortion for personal reasons, and clarified that this decision was "totally unrelated to receiving Gardasil." Upon internal review, elected to undergo an abortion was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy, Hypoaesthesia facial
Clinical narrative: Information has been received from a consumer concerning her 18 year old female, daughter with chronic sinusitis and herpes simplex (cold sores in her mouth) and a history of ear infections who in February 2007 was vaccinated by injection with the first dose of Gardasil. Concomitant therapy included VALTREX. On 20-APR-2007, the patient was vaccinated by injection with the second dose of Gardasil. Within a few hours, after receiving the second dose of approximately, 20-APR-2007, the patient felt something strange on the right side of her face. Initially, she felt some numbness. Subsequently, the numbness was accompanied by some paralysis on the right side of her face. She went to her physician and she was diagnosed with a mild case of bells palsy. At the time of the report, the patient had not recovered. Upon internal review, it was determined that Bell's palsy was considered on other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Benign hydatidiform mole, Blighted ovum, Drug exposure during pregnancy
Clinical narrative: Information has been received via the pregnancy registry, from a consumer concerning her 16 year old daughter, who was pregnant with an estimated date of conception on 05-JAN-2007, and on 09-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. On 29-MAR-2007, the mother reported that her daughter, who was then "12 weeks pregnant," experienced a miscarriage; the mother added that the pregnancy was considered to be a blighted ovum, which she also referred to as a "mole pregnancy." The mother added that in April 2007, her daughter received the second dose of Gardasil. At the time of this report, it was unknown if the patient had recovered from the events. Upon internal review, blighted ovum, "mole pregnancy" and miscarriage were determined to be an other important medical event. Additional information has been requested.