chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Sustained fever for 3 days, 102 average, 103.1 at peak, sore throat, fatigue
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Mild rash. questionable cause. rash could have been secondary to viral illness.  Will RTC 24-48 hours if not better.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site swelling, Nodule
Clinical narrative: Administered vaccine and immediatly his where I injected became like a hard ball.  Swelled, hard nodule.  No treatment.  Monitored pt.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Tremor
Clinical narrative: Patient complained of the shakes and anxiety after vaccination.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, PNC, RV5
Symptoms: Coronary artery dilatation, Kawasaki's disease
Clinical narrative: 06/25/2007-Pt was hosp last week at HC  for 2 days sec to Atypical Kawasakis. He received IVIG and defervesed immediately, he has L ant desc. coronary art dilitation, and will f/u with Kawasaki Dz Team in 1 week. Spoke with Dr who rec no live vac including Rotavirus for 1 year. Infant is back to nl per MOm. He receives ASA 81mg tab 2 po q 6, but will dec to 1/2 tab q 6 on 6/29/07. 10/25/07-records received for DOS 6/19-6/21/07-DC DX: Kawasaki disease. Admitted with history of pyuria and fever after treatment with ceftriaxone. Six days prior to admission developed diarrhea with temperatures upwards of 104 and mild upper respiratory symptoms. urinalysis significant for white blood cells and many bacteria, diagnosed at outside facility with pyelonephritis. On day of admission temperature 102 and markedly irritable. Mottled skin with poor distal perfusion at intake, capillary leak with subsequent third spacing, dehydration and tachycardia.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Received flu vaccine on 10/12/07 around 1:45pm. On 10/13/07 around 4 pm noticed back itching. The next morning 10/14/07 noticed "hives" under arms, on chest and uppr abdomen and itching of entire torso and groin. He went to the emergency room around 4pm because of intensity of symptoms and received a shot of prednisone and a prescription for oral prednisone.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm red and swollen - found that night after shots given.  Mother stated on 10/5/07 that it is "getting better".
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Scar
Clinical narrative: Vaccination given on left arm 1" above smallpox vaccination scar. 1/2 hr after injection, area around smallpox scar raised, red, & warm to touch. 2 days later, area still (1-1/2 diameter) red, warm & tender to touch. Is the smallpox vaccination scar related to this?
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: SWELLING AND WARMTH AROUND GIRTH OF RIGHT ARM, STARTED THE DAY AFTER VACCINE ADMINISTERED
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac arrest, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient received influenza vaccine at 1105 AM 10/15/2007 and was found asystolic and unresponsive in the parking lot at 1138 AM.  Resuscitative efforts were unsuccessful.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: approximately 6 hours after shot,arm very swollen and sore started getting chills, fever, headache felt nauseaus and felt kind of dizzy, chills got worse within couple hours and breating labored, also heartbeat very rapid this lasted for about 7 hours before finally subsiding into slight congestion low grade fever and runny nose and arm still a little sore
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oedema peripheral, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: approximately 6 hours after shot,arm very swollen and sore started getting chills, fever, headache felt nauseaus and felt kind of dizzy, chills got worse within couple hours and breating labored, also heartbeat very rapid this lasted for about 7 hours before finally subsiding into slight congestion low grade fever and runny nose and arm still a little sore
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: approximately 6 hours after shot,arm very swollen and sore started getting chills, fever, headache felt nauseaus and felt kind of dizzy, chills got worse within couple hours and breating labored, also heartbeat very rapid this lasted for about 7 hours before finally subsiding into slight congestion low grade fever and runny nose and arm still a little sore
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: reddness and swelling noted below site area, none notes at injection site
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Drug hypersensitivity, Rash erythematous, Rash pruritic
Clinical narrative: Pt called 10/15 to complain of flattened red itchy itch rash that started around 10/12-13/07 on tops of arms and has spread to abdomen & chest areas as well.  Has not been seen by usual health care provider yet but has appt later in the week.  Pt feels is related to flu shot though he gets them annually and has never had reaction before.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Immediately developed hives around site of this vaccine.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diarrhoea, Pyrexia, Rash, Rotavirus test positive, Vomiting
Clinical narrative: Had emesis after returning to daycare on date of administration of 2nd dose (9/13/2007).  Developed diarrhea 10/4/2007 with low grade fever to 100.1.  Tx with pedialyte.  10/9 developed rash on right side of torso and continued with diarrhea/low grade fever.  Tested positive for rotavirus at that time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Anorexia, Diarrhoea, Gastroenteritis rotavirus, Pyrexia, Rotavirus test positive
Clinical narrative: Had emesis after returning to daycare on date of administration of 2nd dose (9/13/2007).  Developed diarrhea 10/4/2007 with low grade fever to 100.1.  Tx with pedialyte.  10/9 developed rash on right side of torso and continued with diarrhea/low grade fever.  Tested positive for rotavirus at that time.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Underdose, Vomiting
Clinical narrative: Had emesis after returning to daycare on date of administration of 2nd dose (9/13/2007).  Developed diarrhea 10/4/2007 with low grade fever to 100.1.  Tx with pedialyte.  10/9 developed rash on right side of torso and continued with diarrhea/low grade fever.  Tested positive for rotavirus at that time.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, fever, achyness, weakness, headache
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Face oedema, Herpes simplex, Herpes zoster, Skin lesion
Clinical narrative: ZOSTAVAX given 9-27-07, SQ. Left side of nose developed lesion, left face puffy, left lower lip lesion: 10-11-07. Saw me (primary physician) 10-15-07. Lesions consistent with herpes zoster or herpes simplex of left face. Treated with FAMVIR 500 mg tid x 7 days.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Facial paresis, Rash papular, Swelling face, Varicella zoster virus serology positive
Clinical narrative: ZOSTAVAX given 9-27-07, SQ. Left side of nose developed lesion, left face puffy, left lower lip lesion: 10-11-07. Saw me (primary physician) 10-15-07. Lesions consistent with herpes zoster or herpes simplex of left face. Treated with FAMVIR 500 mg tid x 7 days.
Age: 69.0
Sex: F
Vaccine: YF
Symptoms: Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: Pt. called PPHD on 10/15/07 to report that she had a reaction to the Yellow Fever vaccination admin. on 10/1/07. Pt. stated that she had a localized rash with urticaria also stating "numbness" in arm 1-2 days afterwards. Pt. went to see PMD on 10/11/07 who measured the puritic area to be 8.5cm x 10cm on left arm. Pt. stated that rash was "getting better" but wanted to have the reaction reported to VAERS.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Biopsy, Lichen planus
Clinical narrative: lichen planus occurring in 1999 after starting series of anthrax immunizations. military stopped anthrax vaccinations and the problem resolved. has recurred again several months after restarting the anthrax vaccinations in 2006
Age: 32.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: INITIAL PAINFUL AREA AT SITE WITH REDNESS AND SWELLING LARGER THAN 5 INCHES IN DIAMETER; TINGLING IN HANDS AND FINGERS; SEVERE HEADACHES; UNUSUAL FATIGUE; LATER HARD LUMP APPROX. 3.5 - INCHES IN DIAMETER WITH REDNESS AND ITCHING.
Age: 32.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site swelling, Mass, Paraesthesia, Pruritus
Clinical narrative: INITIAL PAINFUL AREA AT SITE WITH REDNESS AND SWELLING LARGER THAN 5 INCHES IN DIAMETER; TINGLING IN HANDS AND FINGERS; SEVERE HEADACHES; UNUSUAL FATIGUE; LATER HARD LUMP APPROX. 3.5 - INCHES IN DIAMETER WITH REDNESS AND ITCHING.
Age: 71.0
Sex: F
Vaccine: YF
Symptoms: Pruritus
Clinical narrative: 9/27/07 Received Yellow Fever vaccination. TC on 10/11/07 c/o 2 days post vaccine itching to buttocks, breasts, legs. Has hx of hives. F/U with MD 10/24/07.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Musculoskeletal pain, Rash
Clinical narrative: 6 days after administration - broke out in a rash - around shoulders, under arm, then chest right side of body - jabby pains right shoulder - blistery. ER on 10/6.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Oedema peripheral, Pain in extremity
Clinical narrative: Pt experienced itching at bedtime on 10/9/07 at the site of injection. Upon waking in the morning on 10/10/07, arm was sore and swollen; spoke w/ pt on 10/12/07. Symptoms had improved.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient had a flu shot on 10-12-2007. On the day, she was fine. Next day she had pain on her left arm. On 10-14-07 pain to wrist, said she could barely move her arm.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye movement disorder, Headache, Musculoskeletal stiffness, Pyrexia, Vaccination complication
Clinical narrative: 24 hrs post Menactra, child woke up with 102 T, severe headache, "stiff", can't open eyes. Sent to ED. Dx vaccine reaction (Menactra), discharged.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Lip swelling, Pharyngeal oedema, Pruritus, Swelling face
Clinical narrative: Facial swelling, itching, throat feels thick, swollen lips.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Pt called complaining of shortness of breath and chest pain. Pt advised to proceed to Emergency department.
Age: 68.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Erythema, Incorrect drug dosage form administered, Oedema peripheral, Tenderness
Clinical narrative: (L) upper arm swelling/redness/tenderness - developed ~ 1 day after injection (Seen in office 2d after injection).Tx'd with Loratadine/cool packs. Likely reaction to Pneumovax (tolerated flu shots in past).
Age: 1.6
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Injection site swelling
Clinical narrative: Mom reports (R) leg sl. swollen, non-tender at site of vaccine. Denies lg. hardened area, child is afebrile and acting fine. Gave Mom S/S of sterile abscess and cellulitis. She will observe and call with concerns or questions.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Localized swelling, redness, pain and itching
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: High fever (>105), headache, achiness
Age: 24.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Myalgia
Clinical narrative: Pt had myalgia of (R) UE where vaccines have been given. No induration, erythema.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus, Pyrexia, Skin warm
Clinical narrative: 3 days after pt deltoid red; fever, itch. 10 cm oval red patch with indur, warmth, itch.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Dose given on 10/2/07. Came to office 10/8/07 arm red, swollen at injection site. Placed on antibiotic.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Tdap injection on 9-6-07, afternoon. Friday morning, I had pain in my shoulder above injection site, which radiated into my neck on the left side. Had pain on left side. Symptoms lasted ~ 4 days, improving gradually after 2 days. No treatment.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Contusion, Injection site urticaria, Urticaria
Clinical narrative: 9/20/07 pm - TC from mother. Lt. arm sore today. Looks like "one big hive" around where shots were given. Hive appeared about an hour after shots were given. Otherwise, feeling ok. Told to take a dose of Benadryl. 9/21/07 pm - TC to mother to see how client was doing. Stated school just called and client has hives from head to toe. Instructed mom to take her right in to PMD/Urgent Care/ER. 9/24/07 TC to residence. Left message. No response. 9/25/07 TC to residence. Left message. No response. 10/9/07 - TC to mother. Stated PMD was not available so went to Urgent Care Clinic. Was told to keep on Benadryl q4-6h (2 tsp) X 4 days. Mom reports hives went away within a day. Took about 6 days for "the big hive" on lt arm to go away. When it started to go away, white circle noticed around area and then turned to a bruise. Mother plans to make a "Well Child" appointment with PMD to discuss situation and future shots.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose fluctuation, Blood pressure increased, Dyspnoea, Hyperhidrosis, Injection site pain
Clinical narrative: Pain (severe) at inj site, no numbness and tingling in all extremities. High BP for her 137/94, usual 106/60. Blood sugar 164 down to 118 in 20 minutes (may not be same issue). Labored breathing, cold, sweaty, shaking.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Paraesthesia, Tremor
Clinical narrative: Pain (severe) at inj site, no numbness and tingling in all extremities. High BP for her 137/94, usual 106/60. Blood sugar 164 down to 118 in 20 minutes (may not be same issue). Labored breathing, cold, sweaty, shaking.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Lower quadrant left arm swelling approx size of egg with erythema, warm to touch - warm compresses. Benadryl if worsens.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Erythema, Rash
Clinical narrative: Patient received the vaccine on 09/11/07 and on 09/22/07 a rash (tiny red bumps) showed up all over her body. It didn't bother her at all and it went way by 09/25/07. She had no other symptoms and we did not treat it in any way.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Left shoulder and arm soreness. Pain with ROM persistent after 1 week. Advised trial of Tylenol or Advil. Call if sx don't resolve.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt was given Adacel instead of Tdap despite fact Tdap was ordered - no adverse events occurred.
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Pt developed shingles 11 months after vaccine administered. NO known hx of chicken pox.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Patient had prescription for the preservative free product. Thimerosal containing product was entered in computer and administered by immunizing RPh. No adverse event recorded. Just noting improper administration.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Diarrhoea, Weight decreased
Clinical narrative: Pt experienced excessive diarrhea and loss of appetite, wt loss.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Erythema, Pruritus, Urticaria
Clinical narrative: Red hives on abdomen (7) and breast (5), hips (3) back (2) itching, burning.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Marked swelling of arm distal to injection site with circumferential red, warm skin. Pt was on Biaxin at time of injections.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fatigue
Clinical narrative: Fatigue and dizziness.
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Pallor, Visual acuity reduced, Vomiting
Clinical narrative: Patient received Tdap on 9/21/07 at approximately 2:40 PM. At approximately 2:50 PM, child complained of dizziness, decrease of vision, nausea, and vomiting. Child appeared very pale and had a B/P of 82/58, P 60, R 18. After five minutes, B/P was 90/60. EMT was called. Child stated he did feel better. Mother took child to E.R. Was told by E.R. doctor child may have had reaction.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea
Clinical narrative: Nausea
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: Pt reported "numbness" on back portion of tongue about 2 min after vaccine administered. No swelling of lips/tongue or oral mucosa seen. Vital signs WNL and stable. No other signs/symptoms noted. Issue resolved spontaneously after about 1/2 hour. No sequelae reported.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Peripheral coldness
Clinical narrative: Fatigue, cold legs, flu like symptoms, heavy feeling in head and neck, body feels warm. P 8, BP 96/58. Dx: imm. associated myalgia. Watch for GBS Syndrome. 10/07/07-spoke with reporter, patient had a full recovery, no adverse effects other than myalgia. No GBS.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Skin warm
Clinical narrative: Fatigue, cold legs, flu like symptoms, heavy feeling in head and neck, body feels warm. P 8, BP 96/58. Dx: imm. associated myalgia. Watch for GBS Syndrome. 10/07/07-spoke with reporter, patient had a full recovery, no adverse effects other than myalgia. No GBS.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Pyrexia, Swelling, Vision blurred
Clinical narrative: Headache, high fever 102.0, blurred vision, swelling.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Tenderness
Clinical narrative: Localized erythema and tenderness w/in 24 hrs of injection.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Localized erythema and tenderness w/in 24 hrs of injection.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Muscular weakness, Pain, Pruritus, Rash
Clinical narrative: Rec'd shingles shot - 2/12/07 - Shingles pain started on 7/23/07 followed by severe rash on left arm, shoulder and upper back. To date, pain and itch still occurs - left arm and hand are weak.
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness, nausea
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Large patch of erythema on (L) arm. From arm to top of shoulder. Heat/redness.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash macular
Clinical narrative: (L) upper arm erythematous macular spot after 24 hours. Placed on Keflex.
Age: 1.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Oedema peripheral
Clinical narrative: Diffuse swelling of (R) thigh progressively worse over 3 days. Prescribed abx, Motrin, Benadryl.
Age: 1.8
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives approximately 2 min after vaccine. Benadryl given and resolved.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Irritability, Rash, Somnolence, Vomiting
Clinical narrative: Rec'd vaccines 9/24/07. Slept all day. 9/25/07 Fussy, cried all day. Vomited all night. 9/26/07 Vomited in A.M. - rash on chest, abdomen.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Red, hard and swollen
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Mother stated pt had fever of 101 around 4 pm on the day he received Hepatitis A vaccine. No redness or swelling at injection site. No rashes. Pt took Tylenol and Motrin as directed by primary MD. Fever subsided by evening.
Age: 8.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: MCIR website was down. So I had to look at the vaccine rec. for shots due. Did not notice DTaP-hib shots. I thought she was overdue for DTaP. Administered DTaP shot. Was told afterward by another nurse that children over 7 yrs old get Td not DTaP. Called mom told her she stated child was fine.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: 31 yo male presents with swelling, redness, pain, and itching to R upper arm x 2 days. 3 days ago received 6th Anthrax vaccination. Sx external from mild upper arm to proximal forearm measuring 29x21 cm.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Local reaction, Nausea, Pain
Clinical narrative: Lrg reaction extending below elbow with pain. Also with nausea. Prednisone x 5 days.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Erythema, Oedema peripheral, Pain, Paraesthesia
Clinical narrative: 40 yo male with erythema and edema from middle of (R) arm down past elbow with total area >120mm. Pt c/o local paresthesia and pain. Body wide aches and joint pain. Pt treated with Allegra and 5 days of Prednisone.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Child began itching on 8/6/07 - Mother noticed hive type rash on 8/7/07. Denies trouble breathing. Rash spreading per mother. Rash does not look like chicken pox. Denies any other symptoms of illness. Referred pt to MD/ER for evaluation.
Age: 1.8
Sex: M
Vaccine: HIBV, PNC
Symptoms: Body temperature increased, Ear infection, Hypotonia, Lethargy
Clinical narrative: Client received HIB and PCV at clinic on 9/18/07 at6:40 PM. Child was at daycare and mom received phone call that he was lethargic and limp with temp 105. Mom called after taking to see pediatrician. Child had an ear infection and was receiving Benadryl and Amoxicillin due to possible reaction in past after with other antibiotics. Child was then sent home. Mom states at that time was playing with temp and more active. Mom states MD thought he may have had a reaction due to all the medications.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Swollen, red, warm, tender (L) upper arm - cellulitis. Keflex 250 BID x 1 wk.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Erythema/swelling and few vesicles around site of injection and tenderness.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome.  12/11/07 Reviewed hospital medical records which reveal patient experienced runny nose for approx 2 weeks, non-weightbearing, unsteady ataxic wide based gait, decreased appetite w/weight loss, difficulty sleeping due to pain in legs x 5 days with at least 1 fall where she hit her head & was seen in ER. X-ray of hips & CT of head were normal.  D/C home w/dx of toxic synovitis.  Did not improve & went to a 2nd ER & was admitted 7/10-7/31/2007.  Peds neuro, ortho, PT/OT/ST consult .  LP done.  Tx w/IVIG x 5 doses.  Improved slowly & had inpatient rehab. FINAL DX: Guillain Barre syndrome.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Laboratory test, Paraesthesia
Clinical narrative: Within 45 minutes of vaccine, my left leg went numb. 2 days after my left cheek went numb. I had vaccine on 8/2/07 and I am still experiencing worsening symptoms on 8/9/07. I now have tingling "electric" feeling in leg and arm.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Oedema peripheral
Clinical narrative: Arm vaccine administered in became swollen within 5 hours of vaccine. Swollen painful joints - shoulder, elbow, wrist redness on whole arm. Resolved in 3 days. No treatment.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: 5cm x 7cm localized red area to (R) upper thigh - examined by doctor.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Influenza like illness, Liver function test normal, Malaise, Rhinorrhoea
Clinical narrative: From nasal discharge c/o flu-like symptoms general non well ness occurring w/ 12 hr after vax. Cont for 1 mo.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Hyperaesthesia, Induration, Oedema peripheral, Skin warm
Clinical narrative: Entire Rt arm swollen, hot to touch, hurts to touch. Forearm: swollen reddened, anterior and posterior. Blister 2 1/2 cm by 1.5 cm noted, that has ruptured - skin raw. Indurated area, red, 12cm x 7 1/2 cm. Full limb swollen.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Chest pain, Cough, Eye pruritus, Ocular hyperaemia, Pruritus
Clinical narrative: 10-5-03 1135 a.m. adm Varicella/ Hep A to patient about 2-3 minutes later patient began sneezing - left office but came back 5 minutes later, coughing and itching. Doctor informed also c/o chest pain - eye itchy and red. Nebulizer treatment with 1.25 Xopenex given + Zyrtec 10mgm given 12 noon Patient responded well to treatment and sent home on Benadryl 25mg PO q4-6 hours. Prednisone 20mg PO O.D. x 2 days return to office if not better.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Sneezing
Clinical narrative: 10-5-03 1135 a.m. adm Varicella/ Hep A to patient about 2-3 minutes later patient began sneezing - left office but came back 5 minutes later, coughing and itching. Doctor informed also c/o chest pain - eye itchy and red. Nebulizer treatment with 1.25 Xopenex given + Zyrtec 10mgm given 12 noon Patient responded well to treatment and sent home on Benadryl 25mg PO q4-6 hours. Prednisone 20mg PO O.D. x 2 days return to office if not better.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pain
Clinical narrative: Patient called 10/11/2007 complaining of red arm swelling, pain & high grade temperature. Patient did not have thermometer to take temp, but presumed it has high. Advised her to make appointment with doctor.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Injection site redness, hardness, aching (in right arm), tiredness. Reaction cleared in week and half.
Sex: U
Vaccine: RV5
Symptoms: Condition aggravated, Immediate post-injection reaction, Underdose, Vomiting
Clinical narrative: Information has been received from a physician concerning an infant with a history of vomiting, who was vaccinated with an oral dose of Rotateq.  Upon administration, the patient vomited immediately and received a partial dose.  Medical attention was sought in the physician's office.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Accidental exposure, Eye burns, Ocular hyperaemia
Clinical narrative: Information has been received from a registered nurse concerning a nurse who on 11-SEP-2007 administered a dose of Rotateq to an infant.  Subsequently the infant spit up the dose and it went into the nurse's eye.  The eye was rinsed and flushed with water, but continued burning and was red.  Medical attention was sought through examination by the nurse practitioner.  Subsequently, the patient was noted to be "ok" after eye was flushed with water and the eye redness "cleared up".  There was no product quality complaint.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007.   Follow-up information has been received from a nurse indicating that there was no adverse experience for the administering nurse.  The vaccine of ROTATEQ was spat into nurse's eye only.  This is one of several reports from the same source.  Additional  information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 2 month old female who on 27-AUG-2007 was vaccinated with her first dose of Rotateq (lot# 657522/0769U).  On 28-AUG-2007 the patient developed diarrhea that has persisted to 11-SEP-2007.  Unspecified medical attention was sought.  No cultures or lab tests were performed.  As of 11-SEP-2007 the patient's diarrhea persisted.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Breast feeding, Vomiting projectile
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old breastfed patient who was vaccinated with a dose of Rotateq.  Subsequently the patient experienced projectile vomiting.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 4 month old patient who on 11-SEP-2007 was vaccinated with a 2.0ml oral dose of Rotateq (no lot number provided).  On that same day, the patient developed severe vomiting and diarrhea after vaccination.  Unspecified medical attention was sought.  The patient's recovery status was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Vomiting projectile
Clinical narrative: Information has been received from a medical assistant concerning a 2 month old breastfed patient who was vaccinated with a dose of ROTATEQ. Subsequently the patient experienced projectile vomiting. It was unknown whether medical attention was sought. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Breast feeding, Vomiting projectile
Clinical narrative: Information has been received from a medical assistant concerning a 4 month old breastfed patient who was vaccinated with the second dose of Rotateq.  Subsequently the patient experienced projectile vomiting.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Bowel movement irregularity, Inappropriate schedule of drug administration, Irritability
Clinical narrative: Information has been received from a registered nurse concerning a 4 month old male with no pertinent medical history or drug allergies, who on 03-JUL-2007 was vaccinated with his first 2.0ml oral dose of Rotateq.  Concomitant vaccinations administered on that day included a dose of ACTHIB, a dose of PREVNAR and a dose of PEDIARIX.  On that same day, the patient developed abdominal pain, fussiness and no bowel movement for 5 days. Medical attention was sought at the next office visit.  No labs or diagnostic studies were performed.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated with Rotateq (date not reported).  The physician reported that the patient had received the initial dose of vaccine at another office beyond 12 weeks of age.  No problems were reported.  A product quality complaint was not reported.  No further information was provided.  Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 5 month old female with a history of premature birth who was vaccinated PO with her first dose of Rotateq (lot# 655483/1116F).  Subsequently the patient experienced diarrhea "4 days after the dose."  Unspecified medical attention was sought.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested. Additional information from the reporting physician indicated that the 25 week old female with retinopathy of prematurity and "GEX" and a history of premature birth who on 22-MAY-2007 at 14:30 was vaccinated PO with her first dose ROTATEQ (lot # 655483/1116F). On 26-MAY-2007 the patient experienced acute diarrhea 4 days after administration. A laboratory test also confirmed that the patient tested positive for rotavirus. It was noted that the patinet was progressively getting worse (previously reported as recovered from diarrhea). Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 2 month old female who was vaccinated PO with her first dose of Rotateq.  Concomitant vaccinations administered "at the same visit" included a dose of Comvax (OMPC) (MSD), a dose of PREVNAR, and dose of DTaP and a dose of IPV (unspecified).  Other concomitant medication included ZANTAC one week prior to vaccination.  Subsequently the patient developed diarrhea 2 days after the first dose of Rotateq lasting for 4 weeks.  The patient also developed a fever (course and duration not specified).  Medical attention was sought through contacting the physician's office.  The patient was treated with TYLENOL.  The patient's recovery status was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 34 week old patient who on 23-MAR-2007, 29-MAY-2007 and 19-SEP-2007 was vaccinated PO with the first, second and third dose of Rotateq.  At 34 weeks old the patient was administered the third dose.  No adverse experience was related to this event.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated PO with his first dose of Rotateq.  Several hours after administration, the patient experienced severe vomiting.  No medical attention was sought.  Subsequently, the patient fully recovered without requiring treatment.  There was no product quality complaint.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 week old male who on 10-SEP-2007 at 16:00 was vaccinated PO with his second 2.0 ml dose of Rotateq (lot# 657510/0970U).  On 12-SEP-2007 at 02:00 the patient experienced vomiting which lasted 3 days or longer.  Unspecified medical attention was sought.  On 13-SEP-2007 the patient recovered.  The date of administration for the first dose was not available.  There was no product quality complaint.  Additional information is not expected.
Age: 0.6
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 33-week-old female with no medical history who on 29-MAR-2007, 31-MAY-2007 and 20-SEP-2007 was vaccinated PO with the first, second and third (lot #656707/0410U) 2.0 mL doses, respectively, of Rotateq.  It was unknown if medical attention was sought.  No symptoms were reported.  Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated PO with his first 2.0 ml dose of ROTATEQ. Subsequently the patient developed diarrhea a "couple of days" after vaccination which lasted 2-3 weeks. Medical attention was sought at the next office visit. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a male who on 09-JUL-2007 was vaccinated with the first dose of Rotateq.  On 24-SEP-2007 the patient was in the office to get the second dose of Rotateq.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 15-week-old patient who on 06-AUG-2007 was vaccinated PO with the first dose of Rotateq.  There were no problems reported.  No further information was available.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old female with no pertinent medical history and no known drug reactions/allergies who on 13-SEP-2007 was vaccinated with first 2 ml oral dose of Rotateq (Lot # 657291/0669U). Concomitant therapy that day included PEDIARIX (Lot # AC21B124BA), PEDVAXHIB (Lot # 656521/0436U) and PREVNAR (Lot # B26510F108). Subsequently within a few days of vaccination, the patient experienced diarrhea for about 10 days. The patient's diarrhea persisted. On 21-SEP-2007, the patient was seen in the office for diarrhea and diaper rash. The patient required no treatment and continued with routine feedings (Isomil formula). No stool cultures were done. The physician noted that no lab test were needed at this time. The outcome was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning a 2 month old male who was vaccinated with an oral 2 ml first dose of Rotateq.  Subsequently, "7 days after administration." the patient experienced diarrhea.  The patient visited the physician and an unspecified test was done and the results were negative for rotavirus.  It was reported that the patient recovered.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Breast feeding, Faeces discoloured, Stool analysis
Clinical narrative: Information has been received from a physician concerning a 4 month old male who on 21-SEP-2007 was vaccinated with a second oral dose of ROTATEQ. Concomitant vaccine included a dose of PEDIARIX. On 24-SEP-2007 the patient had discoloration of stools were black in color. The patient was seen on by the physician on 24-SEP-2007 and the stools were normal. It was noted that the patient was only breast milk. No product quality complaint was involved. No other informtion was provided. Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Dermatitis diaper, Diarrhoea, Rotavirus infection
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her son who was vaccinated with one dose of Rotateq.  There was no concomitant medication.  She reported that after vaccination her son experienced two episodes of rotavirus.  The date of the first episode was unknown and the second episode occurred in August 2007.  Her son experienced very watery diarrhea, up to 20 times per day; a bad diaper rash; and a "specific smell that is indicative of rotavirus infection".  Her son's physician diagnosed rotavirus over the phone based on the symptoms.  There was no diagnosis with a stool sample.  He was treated with PEDIALYTE during the second episode to keep him hydrated and he recovered within 9 days.  The nurse could not remember what was done during the first episode but her son recovered within 10 days.  Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Melaena, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a "happy and healthy" 17-week-old female who on 25-JUN-2007 and 29-AUG-2007 was vaccinated with a first and second dose, respectively, of ROTATEQ (lot# 656390/0236U, 657459/0509U). Within 24 hours of the second vaccination, on approximately 29-AUG-2007, the patient experienced dark tarry stools. Medical attention was sought, the patient's parents phoned the office. Subsequently, the patient recovered from dark tarry stools within 5 days onset. No product quality complaint was involved. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist concerning a 6 month old patient who was vaccinated with the first dose of Rotateq past 12 weeks of age.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2-month-old male with no medical history or allergies who on 20-SEP-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq.  There was no concomitant therapy.  The physician reported that on 21-SEP-2007, the patient developed diarrhea.  On 25-SEP-2007, the patient's diarrhea resolved.  on 28-SEP-2007, the patient experienced abdominal pain and distress.  The patient was seen in the physician's office on that same day.  No other symptoms were reported.  No laboratory/diagnostic tests were performed.  At the time of this report, the patient's abdominal pain and distress persisted.  Additional information has been requested.
Sex: U
Vaccine: RV5, UNK
Symptoms: Diarrhoea, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning a child who on 06-SEP-2007 was vaccinated with a dose of Rotateq. Concomitant therapy on the same day may have included "other vaccines." On 07-SEP-2007 the patient developed severe diarrhea and was hospitalized over the weekend. Unspecified medical attention was sought. A rotavirus test was performed and the result was negative for rotavirus. The patient's treatment was unknown. The patient was noted to be doing better and was released from the hospital. There was no product quality complaint. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Conjunctivitis, Coronary artery dilatation, Echocardiogram abnormal, Full blood count normal, Immunoglobulins
Clinical narrative: Information has been received from a physician concerning a 20 week old male with no pertinent medical history or drug allergies, who on 13-MAR-2007, 15-MAY-2007, and 20-JUN-2007 was vaccinated PO with the first (lot# 656381/0875U) 2.0 ml doses of Rotateq. There was no concomitant medication. After the second dose of vaccination on 05-JUN-2007, the patient first experienced the symptoms of Kawasaki's disease and was hospitalized. Lab diagnostic studies performed included a "CBC," blood culture, urine culture, blood chemistry, and urinalysis. The patient was treated with "IVIG." It was noted by the physician that the vaccination series was completed after recovery in July 2007. There was no product quality complaint. Follow-up information has been received by the physician indicating that on 05-JUN-2007 the patient was seen for persistent fever, papular rash, bright red chapped lips, and right eye conjunctivitis. There was no evidence of strawberry tongue. On that same day blood chemistry results showed an abnormal sedimentation rate of 14 mm/h and urine culture results showed significant levels of staph aureus in urine. (10,000-30,000 range). The patient was treated with ZITHROMAX (dose not provided). On 07-JUN-2007 the patient was hospitalized for approximately 2 days and diagnosed with Kawasaki's disease by infectious disease specialists. Lab diagnostic tests performed in the ER included a normal blood culture and urinalysis, but the CBC revealed a platelet count of 525 x 10 3ml and an increased sedimentation rate to 22.9 mm/h. The patient was treated with IV ROCEPHIN and AUGMENTIN (dose not provided) but did not respond to antibiotic treatment. On 08-JUN-20007, an echocardiography was performed which revealed prominent left main coronary artery. The patient was then treated with IV immune globulin. On 20-JUN-2007 the patient was seen by the physician and was noted to be recovered. On 21-JUN-2007 a repeat echocardiography was performed and the results were normal. Additional information is not expected.  12/4/07 Received hospital medical records which reveal patient experienced fever x 6 days, rash x 4 days & conjunctivitis x 4 days. Seen by pcp & started on antibiotics.  Admitted 6/8-6/11/2007. On admit, hepatomegaly, cracked lips & red tongue, palmar erythema & rash noted.  ID & cardio consults done.  Tx w/IVIG & high dose ASA.  Improved & d/c to home on continued low dose ASA & f/u by ID & cardio. FINAL DX: Kawasaki disease.   1/11/08 Received vax record from provider which confirms RO dose & lot & adds additional vax: Daptacel #2, 02570BA; ActHib #2 UF091AA; Prevnar #2 B47442C; IPV #1, Sanofi, Y103Z.