chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RVX
Symptoms: Pyrexia
Clinical narrative: Initial information received on 9/29/06 from another company regarding a subject who was enrolled in a clinical trial sponsored by the other company. A two month old female subject was enrolled in the prophylactic open study 10531. On 7/11/06, the subject received initial doses of the following vaccine, ActHib, Pediarix, and Prevnar. The vaccine were administered intra muscularly in the thigh. The subject also received a dose of Rotavirus vaccine, administered per OS on the same date. The lot numbers were not reported for any of the vaccines. The subject had a history of gastrointestinal reflux disease, which started on 6/29/06 and continued at the time of reporting. On 7/20/06, nine days after the first dosed of Rotavirus vaccine, ActHib, Pediarix and Prevnar, and 20 days after the last dose of lansoprazole, the subject developed a fever of unk origin (temp of 38.9 deg C) and was hospitalized. Relevant tests on 7/20/06 included a lumbar puncture, as well as blood and urine cultures. The lumbar puncture was negative and all cultures were neg. No details of relevant assessments were available. The subject was treated with paracetamol, ampicillin trihydrate, ceftriaxone sodium and cefotaxime. The subject was discharged from the hospital on 7/22/06. The investigator considered that there was a reasonable possibility that the fever may have been caused by rotavirus vaccine, Pediarix, ActHib and Prevnar, and that the event was possibly due to the concomitant medication with lansoprazole and the subjects medical condition of gastroesophageal reflux disease, the investigator also replied that although it is possible the childs fever was due to the rotavirus vaccine, he believes that the possibility is quite small and more likely attributable to a viral syndrome.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: Wrong vaccine used - used Dtap instead of Tdap. No adverse event occurred - See attached notes.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: Wrong vaccine used, used Dtap instead of Tdap.
Age: 0.56
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: See attaches notes from office visits 8/10/06, 10/02/06
Age: 30.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Lymphadenopathy, Pyrexia, Tenderness
Clinical narrative: Developed bilateral axillary lymphadenopathy 2 days post vaccination started having fever 3 days after vaccination. Worsening tenderness in axillary lymphadenopathy on day 5 post vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Ear pain, Pharyngolaryngeal pain
Clinical narrative: got the shot at 10:45 am. it was administered in my right deltoid. felt fine when i went to sleep about 10p. woke up at approx 2am with very sore throat (right side) and very sore right ear. the ear pain subsided for the most part on 10-12 and as of today 10-13 the pain in both my throat and ear have greatly lessened but is still noticable. on 10-12 i was so weak that i spent most of the day in bed sleeping. i continue to feel weak today, but not as weak as yesterday.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain
Clinical narrative: Pain, swelling and itching at site within 8 hours. Temperature 99.9 (taking Advil around the clock for another problem) Hand felt numb but residing. on day three the area was 3 inches in diameter of redness and 2 inches of induration.  Employee states her mother said it looks like her shots when she was a child. Left Deltoid.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Pain, swelling and itching at site within 8 hours. Temperature 99.9 (taking Advil around the clock for another problem) Hand felt numb but residing. on day three the area was 3 inches in diameter of redness and 2 inches of induration.  Employee states her mother said it looks like her shots when she was a child. Left Deltoid.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: 24 hours after vaccination given in Left deltoid, patient developed painful, left axillary swelling.  Patient given Ibuprofen, compresses and Keflex.
Age: 21.0
Sex: M
Vaccine: HEPAB
Symptoms: Eye irritation, Eye oedema, Nasal congestion, Pruritus
Clinical narrative: Mouth and eyes started to itch, then left eye became swollen.  Nose was stuffy but no breathing problems. Advised to go to ER. Did not go. Placed warm compress on left eye.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site warmth, Pain
Clinical narrative: Area of right deltoid shows redness with erythmea, patient instructs very pain and warm to touch, instructed to apply cold compresses to site, use Benadryl and prescription of pain medication given if needed.
Age: 0.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal stiffness, Nausea, Pyrexia, Swelling
Clinical narrative: At the moment of injection I said that the fluid going in really burned.  She said that was normal.  About 15 minutes later the front and back muscles in my upper arm were getting stiff.  I asked the nurse that gave me my shot and she said to keep moving my arm.  I went home and took a tylenol and laid down.  4 hours later (almost 5 hours after injection), my arm muscles were really hard and my arm was stiff.  I took another tylenol and went to bed.  The stiffness in my arm (and now in my left chest too) woke me up throughout the night.  I got up in the morning and my arm had a 3 1/3"X 2" patch of hives on my upper front muscle with a 'finger' line going into my arm pit.  My upper arm was stiff and swollen.  I put ice on it.  I had a low grade fever, nausia, stiff arm and now chest muscle stiffness.  (26 hours after injection)I called my insurance company 24 hour number and spoke to a nurse.  She suggested that I get to an urgent care center as soon as possible.  (34 hours after injection)I went to the urgent care center.  The doctor said I was having a reaction to my shot and gave me some Benedril to take every 4 hours and advised me to ice my arm every hour and to be seen for follow up visit.  (72 hours after injection) After the Benadryl and ice took affect, my swelling went down, the redness started going away and the pain was gone.  All of the redness and swelling finally was gone a week after injection.  The hives did not itch or burn.
Age: 0.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: At the moment of injection I said that the fluid going in really burned.  She said that was normal.  About 15 minutes later the front and back muscles in my upper arm were getting stiff.  I asked the nurse that gave me my shot and she said to keep moving my arm.  I went home and took a tylenol and laid down.  4 hours later (almost 5 hours after injection), my arm muscles were really hard and my arm was stiff.  I took another tylenol and went to bed.  The stiffness in my arm (and now in my left chest too) woke me up throughout the night.  I got up in the morning and my arm had a 3 1/3"X 2" patch of hives on my upper front muscle with a 'finger' line going into my arm pit.  My upper arm was stiff and swollen.  I put ice on it.  I had a low grade fever, nausia, stiff arm and now chest muscle stiffness.  (26 hours after injection)I called my insurance company 24 hour number and spoke to a nurse.  She suggested that I get to an urgent care center as soon as possible.  (34 hours after injection)I went to the urgent care center.  The doctor said I was having a reaction to my shot and gave me some Benedril to take every 4 hours and advised me to ice my arm every hour and to be seen for follow up visit.  (72 hours after injection) After the Benadryl and ice took affect, my swelling went down, the redness started going away and the pain was gone.  All of the redness and swelling finally was gone a week after injection.  The hives did not itch or burn.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Dry eye, Dyspnoea, Eye swelling, Headache, Ocular hyperaemia
Clinical narrative: Received flu shot at 2:00 at work (free flu shots); this was my first flu shot ever. Throat started getting scratchy at about 4:00. Throat started tightening and started wheezing by 6:00.  One eye felt dried out.  By 8:00 had severe body aches, difficulty breathing, eyes red & puffy, bad headache.  Took inhaler (I have mild allergy to cats) to help with breathing, and took ibuproferin.  Told husband to keep an eye on me & went to bed.  Besides a slight headache & mild body aches, I felt better in the morning. I have not visited an emergency room since I was 5 yrs old and I seriously considered going that evening.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pharyngolaryngeal pain, Throat tightness, Wheezing
Clinical narrative: Received flu shot at 2:00 at work (free flu shots); this was my first flu shot ever. Throat started getting scratchy at about 4:00. Throat started tightening and started wheezing by 6:00.  One eye felt dried out.  By 8:00 had severe body aches, difficulty breathing, eyes red & puffy, bad headache.  Took inhaler (I have mild allergy to cats) to help with breathing, and took ibuproferin.  Told husband to keep an eye on me & went to bed.  Besides a slight headache & mild body aches, I felt better in the morning. I have not visited an emergency room since I was 5 yrs old and I seriously considered going that evening.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Patient received Pneumovax injection on 10/11/06. He called in on 10/12/06, reporting he woke up with left arm swelling and soreness. Patient thinks arm is "almost twice normal size". No redness or fever. MD recommended acetaminophen for pain, diphenhydramine and ice pack. Patient was advised to come to ER/UCU for evaluation if no better/worse.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Eye oedema, Face oedema, Rash
Clinical narrative: 10/9/2006: (3 DAYS POST INJECTION) DEVELOPED RED RASH, SWELLING OF FACE, EYES, LIPS, WITH COUGHING. 10/10/2006 TREATED IN PHYSICIAN OFFICE GIVEN TUSSIONEX FOR COUGH LAB DRAWN 10/11/2006: BECAME INCREASINGLY WORSE WENT TO THE EMERGENCY ROOM TREATED WITH EPI 1:1000 0.3ML, SOLUMEDROL 125 MGM IV, BENADRYL 50 MGM IV, PEPCID 20 MGM IV, SINGULAIR 10 MGM PO, ALBUTEROL UPDRAFT TIMES TWO. DISCHARGED WITH PRESCRIPTION FOR SINGULAIR 10 MGM DAILY, BENADRYL 50 MGM BY MOUTH EVERY 6 HOURS TIMES 4 DOSES, PREDNISONE 40 MGM X DAYS 1 & 2, 30MGM TIMES DYS 3 & 4, 20 MGM TIMES DAYS 5 & 6 AND 10 MGM DAYS 7& 8.  10/13/06: REFERRED TO A DERMATOLOGIST FOR EVALUATION.
Age: 35.0
Sex: F
Vaccine: HEPA, TTOX
Symptoms: Eye swelling, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: For first 24 hours had nausea and vomiting, puffy eyes and low grade temp for 24 hours.  On 9/06 called and reported arm has been sore since shot administered-describes pain as a muscle type ache that radiates to shoulder and down to wrist.  Went to massage therapist to get deep muscle massage.
Age: 35.0
Sex: F
Vaccine: HEPA, TTOX
Symptoms: Vomiting
Clinical narrative: For first 24 hours had nausea and vomiting, puffy eyes and low grade temp for 24 hours.  On 9/06 called and reported arm has been sore since shot administered-describes pain as a muscle type ache that radiates to shoulder and down to wrist.  Went to massage therapist to get deep muscle massage.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Reaction localized to R anterolateral thigh (site of MMR & DTaP injection) consisting of swelling and erythema measuring 5.5 x 5.5cm with central area of increased erythema and induration measuring 2 x 3cm.  Area with increased warmth but not tender.  Patient not complaining of pain.  No associated fever, chills, or other systemic symptoms.  Otherwise at baseline.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Medication error
Clinical narrative: Reaction localized to R anterolateral thigh (site of MMR & DTaP injection) consisting of swelling and erythema measuring 5.5 x 5.5cm with central area of increased erythema and induration measuring 2 x 3cm.  Area with increased warmth but not tender.  Patient not complaining of pain.  No associated fever, chills, or other systemic symptoms.  Otherwise at baseline.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema, Pruritus, Pyrexia
Clinical narrative: Patient received vaccine on Monday (10.09.06) patient complained to pharmacy on or about Wednesday (10.11.06).  Patient described edema, redness and swelling on left arm.  Patient complained to physician of itching, chills, fever prior to report.  Patient saw PA on Wednesday and allergist on Thursday.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient received vaccine on Monday (10.09.06) patient complained to pharmacy on or about Wednesday (10.11.06).  Patient described edema, redness and swelling on left arm.  Patient complained to physician of itching, chills, fever prior to report.  Patient saw PA on Wednesday and allergist on Thursday.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Convulsion, Pyrexia, Urinary tract infection
Clinical narrative: About 12 hours after vaccines, 2 seizures (3 minutes and 10 minutes long). Fever of 106 noted in ambulance. Since the urine culture was lost we are not sure if fever was from a UTI or from vaccines.  DOS 10/11-10/12/06 DC DX: Fever, probably UTI. Cultures pending, if cultures are negative fever may have been secondary to immunization reaction. final cultures not submitted. Temp in ER 99.8 (R). Temp in ambulance 106 (R). Episode during night approximately 3 minutes then second episode approximately 10 minutes, no noted eye deviation. Pt on ceftriaxone for possible pyelonephritis.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Onset of hives approx one hour after receiving vaccine.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Pt said that she slept most of today, but woke up this afternoon with left arm swollen to elbow, hot to the touch and painful. She said she could lift arm and that swelling has not worsened since she woke up. I advised her to continue her anti inflammatory medicine, take a couple of Benadryl and to place cold compress on left arm. I also advised her to have a family member or friend with her over next few hours and to contact doctor or go to ER if swelling worsens or dose not get better by the next day.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Face oedema
Clinical narrative: Pt called c/o top lip swollen 3 hrs post injection. Pharmacist advised 50 mg Benadryl if no improvement go to ER.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Bursitis, Injection site pain
Clinical narrative: Pain to area of injection x 3 weeks. Developed bursitis, reported weakness, inability to dress comfortable.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Cyanosis, Dyspnoea, Hypoxia, Injection site pain
Clinical narrative: 10/12/06 15:08 pt began to c/o left arm and neck pain after immunization, difficulty breathing, color became dusky appeared to have trouble catching breath, O2 at 9L per face mask applied Benadryl 50 mg/ml administered 15:09, Dr paged, 1510 pt c/o chest pain Nitro stat 0.4mg administered sublingually pulse oximeter @ 98% HR 89, BP 150/96, HR 82 15:30 EKG started, pt feeling better as stated by him, chest pain resolved, breathing normally, HR 82 pulse ox 97%, color pink.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: 10/12/06 15:08 pt began to c/o left arm and neck pain after immunization, difficulty breathing, color became dusky appeared to have trouble catching breath, O2 at 9L per face mask applied Benadryl 50 mg/ml administered 15:09, Dr paged, 1510 pt c/o chest pain Nitro stat 0.4mg administered sublingually pulse oximeter @ 98% HR 89, BP 150/96, HR 82 15:30 EKG started, pt feeling better as stated by him, chest pain resolved, breathing normally, HR 82 pulse ox 97%, color pink.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abdominal discomfort, Crying, Grunting, Screaming, Tension
Clinical narrative: Uncontrollable screaming, grunting, groaning, firm, tense and abdomen, admitted to hospital. Numerous diagnostic studies done. Lasted 14-16 hours. DC DX: adverse reaction to DTAP.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Facial palsy, Visual disturbance
Clinical narrative: Bell's Palsy Developed 3 days after being given Flu mist in my office, symptoms 95% resolved in 6 days from onset. 10/16/06 Received medical records from PCP which reveal patient on track developmentally on 6/8/06 visit.  Received FluMist on 10/4/06.  On 10/6 had difficulty visualizing at school with right eye.  On 10/9/06 noted to have 2 days of erythematous right infra orbital area with slight facial asymmetry which increased on 10/8 & was taken to ER.  Labs & CT scan were reported as WNL. ER started patient on antibiotics, antivirals & steroids with improvement noted on 10/9 office visit.  Dx: Bells Palsy, r/o Lyme, virus & AE to FluMist.  Right eye was patched for protection.  Seen again on 10/13/06.  continued on same meds.  Was much improved: frown symmetrical & smile only slightly asymmetrical.  Able to close both eyelids tightly. Dx: Idiopathic Bells Palsy, almost completely resolved. 12/7/06 Received medical records from hospital which patient seen in ER on 10/8 w/right facial paralysis since 10/7.  Tx w/antibiotics, antiviral & steroids. CT scan of head was WNL.  Only lab included in records was partial CBC which was WNL.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypokinesia, Pyrexia
Clinical narrative: Fever, large area of erythema, 8x3", unable to use rt arm to get out of chair.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Fever, pain, erythema of skin on right upper arm, swelling of right upper arm.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Blood pressure increased, Cold sweat, Heart rate increased, Nausea
Clinical narrative: Approx 5 minutes after administration pt complained of racing heart, nausea, tingling fingers, and clamminess. Her breathing was not labored, and blood pressure was 138/78 with pulse of 90. 911 was called. Paramedics arrived and checked her out. Her blood pressure normalized to 118 over 70. Paramedics advised her to go to hospital, but did not take her in the ambulance. Reaction was suspect to be anxiety/adrenalin reaction. Pt then left the store.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Approx 5 minutes after administration pt complained of racing heart, nausea, tingling fingers, and clamminess. Her breathing was not labored, and blood pressure was 138/78 with pulse of 90. 911 was called. Paramedics arrived and checked her out. Her blood pressure normalized to 118 over 70. Paramedics advised her to go to hospital, but did not take her in the ambulance. Reaction was suspect to be anxiety/adrenalin reaction. Pt then left the store.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: RN gave shot at 2:45 pm, pt went to work at 3:00, began to notice chest getting tight and SOB. Pt told other staff who passed it off. One employee told he to contact RN at 3:48 was reported to RN. RN told her to get to her employee Nurse office where she work. PT looked okay no rash not cyanotic, but pt said chest felt tight and she couldn't breath, Rn took her to ER at 3:50 (where she works). The gave Xopenex breathing treatment 3:55 and IV Solumedrol 125 mg at 3:50. They watched her gave her a prescription for Medrol dose pack. Pt went home at 5:00pm released into care of aunt who is LPN (works at hospital too), Pt said she was fine when she left, no chest tightness, no SOB. RN told her to never take a flu shot again. Pt mother was deceased about 1 month ago Others said PT RN did not believe it to be from cancer.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Within 48 hours red, edematous injection site.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Decreased appetite, Nasal congestion, Pyrexia, Rhinorrhoea, Swelling
Clinical narrative: On 10/13/06 patient woke up at 0600 with temperature of 101.8.  Parents administered TYLENOL, took temperature 1 hour later which was 102.3.  Patient's soft spot was swollen and bulging.  Appetite decreased, spit up 3 ounce bottle this am.  Patient has runny nose with congestion, and yellow nasal drainage.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Erythema, Swelling
Clinical narrative: Left deltoid, red, slight swollen: no fever.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling around DTaP injection site.  Patient on ZYRTEC will add BENADRYL. Site marked with ink pen to see if still reacting.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: Redness, swelling, tenderness, warm to touch at site of injection.  Treatment-cold compress and BENADRYL.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Headache, Injection site warmth, Rash
Clinical narrative: 2 hours after shot complain of headache-several hours later warm, complain of rash-arms and back feeling bad next day continue to complain of rash red, warm to touch, headache, temperature 98.6.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Chills, Dizziness, Erythema, Hypoaesthesia, Pain
Clinical narrative: 12:05 pm red skin, itching, hand numbness upper body ache and light headed, 152/96 pulse 18. 12:25 pm increase vertigo, chills, moderate back/shoulder pain resulted in severe pain. 12:37 BENADRYL 25 mg by mouth 12:45 no change BENADRYL 25 by mouth. 12:50 balance returned tingling, pruritus, rash decreasing.
Age: 41.0
Sex: M
Vaccine: HEPAB
Symptoms: Paraesthesia, Pruritus, Rash, Shoulder pain, Vertigo
Clinical narrative: 12:05 pm red skin, itching, hand numbness upper body ache and light headed, 152/96 pulse 18. 12:25 pm increase vertigo, chills, moderate back/shoulder pain resulted in severe pain. 12:37 BENADRYL 25 mg by mouth 12:45 no change BENADRYL 25 by mouth. 12:50 balance returned tingling, pruritus, rash decreasing.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Redness and knot at site of injection.  Treatment included cold compress and BENADRYL.
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Hypokinesia
Clinical narrative: Dizziness (vertigo) and  moderately severe fatigue beginning approximately 10 minutes after influenza immunization. More severe by suppertime. Could not stand. Severe the following day. Gradually improved. Immunized Oct. 9,2006. Mild residual symptoms Oct. 14.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Malaise, Pallor, Visual disturbance, Vomiting
Clinical narrative: HAD VACCINE YESTERDAY AFTERNOON. IN EVENING NOT FEELING WELL AND BECOMING VERY PALE. IN MORNING WOKE UP AT 7 AM VOMITING AND VERY PALE. COMPLAINING ABOUT DIZZINESS, BAD VISION AND VOMITING A LOT THROUGHOUT DAY! MOSTLY VOMITING CLEAR FLUIDS. NOT REPORTED TO PEDEATRICIAN AS IT IS WEEKEND. FATHER MD HIMSELF AND TREATING PATIENT.
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Alopecia
Clinical narrative: Approximately 1 month following the vaccinations he started losing hair rapidly. He was diagnosed with Telogen Effluvium. No treatment at present time.
Age: 43.0
Sex: F
Vaccine: MEN, YF
Symptoms: Balance disorder, Dizziness, Headache, Muscle twitching, Neck pain
Clinical narrative: Patient experienced dizziness, loss of balance, neck pain and headache two days after receiving her vaccine. She also experienced eye twitching two days after the vaccine as well. All symptoms have resolved excepty the eye twitching. Patient went to the emergency room for treatment.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Heart rate increased, Hypoaesthesia
Clinical narrative: Dizziness, numbness and tingling on face and arms, incresed heart rate (132) increased blood pressure (152/85), Shortness of breath, pain at injection site, pain in upper arm. symptoms appeared within 1 hour after injection and continued through the night. The following day the symptoms indcreased at 7am and er visit followed. Four days later arm is still sore, still having dizzy spells and increased heart rate and numbness off and on at left arm.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Dizziness, numbness and tingling on face and arms, incresed heart rate (132) increased blood pressure (152/85), Shortness of breath, pain at injection site, pain in upper arm. symptoms appeared within 1 hour after injection and continued through the night. The following day the symptoms indcreased at 7am and er visit followed. Four days later arm is still sore, still having dizzy spells and increased heart rate and numbness off and on at left arm.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Malaise, Pain, Pruritus, Urticaria
Clinical narrative: Shortly after the vaccination my arm began to hurt, in my opinion, above average for this vaccination which I've had before. Then within a few hours I began to feel sick and got hives on my face, head and chest. I itched alot. No shortness of breath was noted or breathing problems.  Some dizziness the next day (today).
Age: 1.26
Sex: M
Vaccine: HEP, HIBV, MMR, PNC
Symptoms: Antisocial behaviour, Aphasia, Immune system disorder, Mental retardation severity unspecified, Nervous system disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine, manufacturer unk, was received from medical records via an attorney regarding a male pt who experienced global developmental delay and autism spectrum disorder. The pt received a fourth dose on 5/29/02 (age 15 months), along with a fourth dose of Prevnar and a first dose of MMR II. The pts history includes nutritional support (pt followed by an allergist who coordinates diet, free of gluten, casein, soy, corn and starches) past history of having received chelation therapy 2003 for reported elevations of mercury, arsenic and lead despite blood levels reportedly normal. Indication for Hib vaccine was immunization. Product was administered on 5/29/02. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prevnar, Dtap, Ipol, Varicella, Hep B and MMR II. Concomitant medications were not reported. Medical records received from an attorney, alleged that in 6/03, the pt was diagnosed with autism spectrum disorder, described in a separate neurological consult as pervasive developmental disorder. Additional a pediatric development consult performed 6/8/04 described the pt as having global developmental delay. The pts outcome for the events were unk. No additional information was available at the time of this report.
Age: 1.26
Sex: M
Vaccine: HEP, HIBV, MMR, PNC
Symptoms: Neurodevelopmental disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine, manufacturer unk, was received from medical records via an attorney regarding a male pt who experienced global developmental delay and autism spectrum disorder. The pt received a fourth dose on 5/29/02 (age 15 months), along with a fourth dose of Prevnar and a first dose of MMR II. The pts history includes nutritional support (pt followed by an allergist who coordinates diet, free of gluten, casein, soy, corn and starches) past history of having received chelation therapy 2003 for reported elevations of mercury, arsenic and lead despite blood levels reportedly normal. Indication for Hib vaccine was immunization. Product was administered on 5/29/02. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prevnar, Dtap, Ipol, Varicella, Hep B and MMR II. Concomitant medications were not reported. Medical records received from an attorney, alleged that in 6/03, the pt was diagnosed with autism spectrum disorder, described in a separate neurological consult as pervasive developmental disorder. Additional a pediatric development consult performed 6/8/04 described the pt as having global developmental delay. The pts outcome for the events were unk. No additional information was available at the time of this report.
Age: 1.26
Sex: M
Vaccine: HEP, HIBV, MMR, PNC
Symptoms: Autism, Drug toxicity, Neurodevelopmental disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib vaccine, manufacturer unk, was received from medical records via an attorney regarding a male pt who experienced global developmental delay and autism spectrum disorder. The pt received a fourth dose on 5/29/02 (age 15 months), along with a fourth dose of Prevnar and a first dose of MMR II. The pts history includes nutritional support (pt followed by an allergist who coordinates diet, free of gluten, casein, soy, corn and starches) past history of having received chelation therapy 2003 for reported elevations of mercury, arsenic and lead despite blood levels reportedly normal. Indication for Hib vaccine was immunization. Product was administered on 5/29/02. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prevnar, Dtap, Ipol, Varicella, Hep B and MMR II. Concomitant medications were not reported. Medical records received from an attorney, alleged that in 6/03, the pt was diagnosed with autism spectrum disorder, described in a separate neurological consult as pervasive developmental disorder. Additional a pediatric development consult performed 6/8/04 described the pt as having global developmental delay. The pts outcome for the events were unk. No additional information was available at the time of this report.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diarrhoea, Faeces discoloured, Gastrooesophageal reflux disease, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 8/30/06 was vaccinated PO with the first 2.0ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). The physician reported that on 8/31/06, the pt developed diarrhea. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old male who on 8/30/06 was vaccinated PO with the first 2.0ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). The physician reported that on 8/31/06, the pt developed diarrhea. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Medication error, Purpura, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 71 year old female with no known drug allergies who on 9/5/06 was vaccinated SC with a dose of varicella Zoster virus vaccine live. On the evening of vaccination, on 9/5/06, the pt developed dizziness and a headache. The next day she developed large, red bruises like areas over her whole body, also reported as head to toe redness. The areas were itchy and burned. Unspecified medical attention was sought. At the time of report, the pt was recovering. There was no product quality complaint involved. Additional information had been requested. Additional information from the nurse practitioner indicated on 09/07/2006 the patient was seen in the office and reported that she suddenly had a rash develop on the lateral aspect of her thigh, two days ago on 09/05/06. She reported that the rash had improved since 09/06/06. The patient wanted the rash inspected due to previous vaccination. She reported that the rash was pruritic and described no pain at the site or SOR. On examination there was a confluent macular rash with areas of vesiculation noted to the left lateral thigh that extended toward the knee. There was also an area to the right inner groin. The assessment was idiopathic urticaria, pruritis. The plan was to treat with diphenhydramine hydrochloride (BENADRYL) 25 mg to mg PO q 6 hours as needed for the rash and monitor for changes or extension. On 09/08/06 the patient improved. The diphenhydramine hydrochloride (BENADRYL) was causing sedation therefore, cetirizine hydrochloride (ZYRTEC) or loratadine (CLARITIN) was recommended. It was reported that the patient was wary of those medications. On 09/09/06 the rash worsened, extended generalized rash to the entire body. She was started on a 6 day "Pred pack" and cetirizine hydrochloride (ZYRTEC) mg daily. On 09/11/06 the patient returned for a re-check of her rash and did report that she had some improvement since starting the medications at 4pm on 09/10/06. Upon examination she had a generalized macular rash that was generalized to the body, erythematous in color and was pruritic. No petechiae was noted to her nailbeds. An area of bruising to the right AC was noted. The assessment was urticaria and possible vaccine rash. The patient was to continue on the pred pack and cetirizine hydrochloride (ZYRTEC). A CBC with diff was obtained, neutrophils were high and lymphocytes 10 (low). Otherwise all values were within normal limits. No further information was available.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Dizziness, Erythema, Full blood count, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 71 year old female with no known drug allergies who on 9/5/06 was vaccinated SC with a dose of varicella Zoster virus vaccine live. On the evening of vaccination, on 9/5/06, the pt developed dizziness and a headache. The next day she developed large, red bruises like areas over her whole body, also reported as head to toe redness. The areas were itchy and burned. Unspecified medical attention was sought. At the time of report, the pt was recovering. There was no product quality complaint involved. Additional information had been requested. Additional information from the nurse practitioner indicated on 09/07/2006 the patient was seen in the office and reported that she suddenly had a rash develop on the lateral aspect of her thigh, two days ago on 09/05/06. She reported that the rash had improved since 09/06/06. The patient wanted the rash inspected due to previous vaccination. She reported that the rash was pruritic and described no pain at the site or SOR. On examination there was a confluent macular rash with areas of vesiculation noted to the left lateral thigh that extended toward the knee. There was also an area to the right inner groin. The assessment was idiopathic urticaria, pruritis. The plan was to treat with diphenhydramine hydrochloride (BENADRYL) 25 mg to mg PO q 6 hours as needed for the rash and monitor for changes or extension. On 09/08/06 the patient improved. The diphenhydramine hydrochloride (BENADRYL) was causing sedation therefore, cetirizine hydrochloride (ZYRTEC) or loratadine (CLARITIN) was recommended. It was reported that the patient was wary of those medications. On 09/09/06 the rash worsened, extended generalized rash to the entire body. She was started on a 6 day "Pred pack" and cetirizine hydrochloride (ZYRTEC) mg daily. On 09/11/06 the patient returned for a re-check of her rash and did report that she had some improvement since starting the medications at 4pm on 09/10/06. Upon examination she had a generalized macular rash that was generalized to the body, erythematous in color and was pruritic. No petechiae was noted to her nailbeds. An area of bruising to the right AC was noted. The assessment was urticaria and possible vaccine rash. The patient was to continue on the pred pack and cetirizine hydrochloride (ZYRTEC). A CBC with diff was obtained, neutrophils were high and lymphocytes 10 (low). Otherwise all values were within normal limits. No further information was available.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Idiopathic urticaria, Lymphocyte count decreased, Neutrophil count increased, Pruritus
Clinical narrative: Information has been received from a physician concerning a 71 year old female with no known drug allergies who on 9/5/06 was vaccinated SC with a dose of varicella Zoster virus vaccine live. On the evening of vaccination, on 9/5/06, the pt developed dizziness and a headache. The next day she developed large, red bruises like areas over her whole body, also reported as head to toe redness. The areas were itchy and burned. Unspecified medical attention was sought. At the time of report, the pt was recovering. There was no product quality complaint involved. Additional information had been requested. Additional information from the nurse practitioner indicated on 09/07/2006 the patient was seen in the office and reported that she suddenly had a rash develop on the lateral aspect of her thigh, two days ago on 09/05/06. She reported that the rash had improved since 09/06/06. The patient wanted the rash inspected due to previous vaccination. She reported that the rash was pruritic and described no pain at the site or SOR. On examination there was a confluent macular rash with areas of vesiculation noted to the left lateral thigh that extended toward the knee. There was also an area to the right inner groin. The assessment was idiopathic urticaria, pruritis. The plan was to treat with diphenhydramine hydrochloride (BENADRYL) 25 mg to mg PO q 6 hours as needed for the rash and monitor for changes or extension. On 09/08/06 the patient improved. The diphenhydramine hydrochloride (BENADRYL) was causing sedation therefore, cetirizine hydrochloride (ZYRTEC) or loratadine (CLARITIN) was recommended. It was reported that the patient was wary of those medications. On 09/09/06 the rash worsened, extended generalized rash to the entire body. She was started on a 6 day "Pred pack" and cetirizine hydrochloride (ZYRTEC) mg daily. On 09/11/06 the patient returned for a re-check of her rash and did report that she had some improvement since starting the medications at 4pm on 09/10/06. Upon examination she had a generalized macular rash that was generalized to the body, erythematous in color and was pruritic. No petechiae was noted to her nailbeds. An area of bruising to the right AC was noted. The assessment was urticaria and possible vaccine rash. The patient was to continue on the pred pack and cetirizine hydrochloride (ZYRTEC). A CBC with diff was obtained, neutrophils were high and lymphocytes 10 (low). Otherwise all values were within normal limits. No further information was available.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 71 year old female with no known drug allergies who on 9/5/06 was vaccinated SC with a dose of varicella Zoster virus vaccine live. On the evening of vaccination, on 9/5/06, the pt developed dizziness and a headache. The next day she developed large, red bruises like areas over her whole body, also reported as head to toe redness. The areas were itchy and burned. Unspecified medical attention was sought. At the time of report, the pt was recovering. There was no product quality complaint involved. Additional information had been requested. Additional information from the nurse practitioner indicated on 09/07/2006 the patient was seen in the office and reported that she suddenly had a rash develop on the lateral aspect of her thigh, two days ago on 09/05/06. She reported that the rash had improved since 09/06/06. The patient wanted the rash inspected due to previous vaccination. She reported that the rash was pruritic and described no pain at the site or SOR. On examination there was a confluent macular rash with areas of vesiculation noted to the left lateral thigh that extended toward the knee. There was also an area to the right inner groin. The assessment was idiopathic urticaria, pruritis. The plan was to treat with diphenhydramine hydrochloride (BENADRYL) 25 mg to mg PO q 6 hours as needed for the rash and monitor for changes or extension. On 09/08/06 the patient improved. The diphenhydramine hydrochloride (BENADRYL) was causing sedation therefore, cetirizine hydrochloride (ZYRTEC) or loratadine (CLARITIN) was recommended. It was reported that the patient was wary of those medications. On 09/09/06 the rash worsened, extended generalized rash to the entire body. She was started on a 6 day "Pred pack" and cetirizine hydrochloride (ZYRTEC) mg daily. On 09/11/06 the patient returned for a re-check of her rash and did report that she had some improvement since starting the medications at 4pm on 09/10/06. Upon examination she had a generalized macular rash that was generalized to the body, erythematous in color and was pruritic. No petechiae was noted to her nailbeds. An area of bruising to the right AC was noted. The assessment was urticaria and possible vaccine rash. The patient was to continue on the pred pack and cetirizine hydrochloride (ZYRTEC). A CBC with diff was obtained, neutrophils were high and lymphocytes 10 (low). Otherwise all values were within normal limits. No further information was available.  Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Information has been received from a physician concerning a male pt, over 60 years old, who was vaccinated with a 0.65 ml dose of varicella zoster virus vaccine live. Subsequently eight days after vaccination, the pt developed a case of shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.  Follow-up information was received from a physician concerning a 74 year old white male patient with hypertension, diabetes, high cholesterol and ocular pressure who on 8/22/06 at 13:15 was vaccinated in the left deltoid with a 0.65 ml first does of varicella-zoster virus vaccine live (Oka/Merck) (lot # 652965/0622F) (also reported as "0868P"). Concomitant therapy included glyburide, aspirin, rosuvastatin calcium (CRESTOR), niacin (NIASPAN), vitamins (unspecified), omega-3 marine triglycerides, atenolol, nifedipine (NIFEDICAL XL), bimatoprost (LUMIGAN) AND lisinopril-HCTZ (manufacturer unknown). There was no illness at the time of vaccination. Subsequently, eight days after vaccination, the patient developed a case of shingles. Unspecified medical attention was sought. Additional information from the physician indicated that the patient's shingles rash appeared on 8/30/06 at 08:00. Subsequently the patient recovered. There was no product quality complaint involved. No further information is expected.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Herpes zoster, Viral infection
Clinical narrative: Information has been received from a physician concerning a male pt, over 60 years old, who was vaccinated with a 0.65 ml dose of varicella zoster virus vaccine live. Subsequently eight days after vaccination, the pt developed a case of shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.  Follow-up information was received from a physician concerning a 74 year old white male patient with hypertension, diabetes, high cholesterol and ocular pressure who on 8/22/06 at 13:15 was vaccinated in the left deltoid with a 0.65 ml first does of varicella-zoster virus vaccine live (Oka/Merck) (lot # 652965/0622F) (also reported as "0868P"). Concomitant therapy included glyburide, aspirin, rosuvastatin calcium (CRESTOR), niacin (NIASPAN), vitamins (unspecified), omega-3 marine triglycerides, atenolol, nifedipine (NIFEDICAL XL), bimatoprost (LUMIGAN) AND lisinopril-HCTZ (manufacturer unknown). There was no illness at the time of vaccination. Subsequently, eight days after vaccination, the patient developed a case of shingles. Unspecified medical attention was sought. Additional information from the physician indicated that the patient's shingles rash appeared on 8/30/06 at 08:00. Subsequently the patient recovered. There was no product quality complaint involved. No further information is expected.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TD, VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 65 year old female who is a physician with asthma and penicillin and aspirin allergies, who on 9/22/06 was vaccinated SB in the right arm with a 0.65 ml dose of varicella zoster virus vaccine live. Concomitant vaccination (given in the same arm about 3 inches away from the site of varicella zoster) included a dose of influenza virus vaccine (unspecified). Other concomitant medications included Advair, and Allegra. On 9/23/06 the pt experienced a severe localized reaction on her right arm including erythema, pain/tenderness, swelling, pruritis and warmth. It was reported that the reactions appeared within 24 hours after the injection. At the time of the report, 9/25/06, the pt still had the symptoms. NO product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TD, VARZOS, FLUX, VARZOS
Symptoms: Pruritus, Sleep disorder
Clinical narrative: Information has been received from a 65 year old female who is a physician with asthma and penicillin and aspirin allergies, who on 9/22/06 was vaccinated SB in the right arm with a 0.65 ml dose of varicella zoster virus vaccine live. Concomitant vaccination (given in the same arm about 3 inches away from the site of varicella zoster) included a dose of influenza virus vaccine (unspecified). Other concomitant medications included Advair, and Allegra. On 9/23/06 the pt experienced a severe localized reaction on her right arm including erythema, pain/tenderness, swelling, pruritis and warmth. It was reported that the reactions appeared within 24 hours after the injection. At the time of the report, 9/25/06, the pt still had the symptoms. NO product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV, TD, VARZOS, FLUX, VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 65 year old female who is a physician with asthma and penicillin and aspirin allergies, who on 9/22/06 was vaccinated SB in the right arm with a 0.65 ml dose of varicella zoster virus vaccine live. Concomitant vaccination (given in the same arm about 3 inches away from the site of varicella zoster) included a dose of influenza virus vaccine (unspecified). Other concomitant medications included Advair, and Allegra. On 9/23/06 the pt experienced a severe localized reaction on her right arm including erythema, pain/tenderness, swelling, pruritis and warmth. It was reported that the reactions appeared within 24 hours after the injection. At the time of the report, 9/25/06, the pt still had the symptoms. NO product quality complaint was involved. Additional information has been requested.