chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Irritability, Myalgia, Nuclear magnetic resonance imaging normal, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Red blood cells CSF positive, Reflux laryngitis, Rhinitis, Rhinitis, Rhinitis seasonal
Clinical narrative: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.
Age: 43.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Scintillating scotoma, Sleep disorder, Tension headache, Visual disturbance, Vitamin B12 normal
Clinical narrative: 1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Muscle twitching
Clinical narrative: 2 mo shots she started a twitching reaction for a few days, then she had a full blown seizure 4 mo. Patient has been evaluated; & she has to take occupational, developmental, speech , & physical therapy.  She is delayed in all these areas.  60 Day Follow-up Information 03-JUL-2006: Ongoing seizure activity.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Pain, Shoulder pain
Clinical narrative: Severe left arm reaction pain shoulder to elbow lasting 1 week.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: Severe left arm reaction from shoulder to elbow lasting 1 week.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia
Clinical narrative: Child had DTAP #4 & Hib #4 onset 2/1/03 started having high fever on 2/3/06 fever 104t and 103 degrees.
Age: 1.85
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Erythema, Pyrexia, Rash, Rash macular, Swelling
Clinical narrative: Left leg swelling after imm. (2-3/069) T-101.2, blotchy, flat rash, red - 3-4" diameter - per mother's report. Temp 2-3-06 to 2-6-06 with periodic increases to 100.6 degrees.
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site induration, Pain
Clinical narrative: Pt started w/an uncomfortable feeling in right arm on 01/27/06. On 01/28/06 pt started experiencing a hard, painful, red and very warm area in upper right deltoid. The redness started radiating down right deltoid to the elbow and was continuing at her 01/31/06 office visit. Using Benadryl and cold packs to lesser the Sxs.
Age: 0.16
Sex: F
Vaccine: DTAP, PNC
Symptoms: Decreased appetite, Vomiting
Clinical narrative: information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding an 8 week old female patient who experienced vomiting and a decrease in appetite. At 8 weeks of age, the patient received the first dose on 1/12/2006. The patient also received a dose of Diphtheria/tetanus toxoids/acellular pertussis vaccine (manufacturer unknown) on 1/12/2006. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on 01/12/2006. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. On 01/13/2006, the patient experienced vomiting and a decreased in appetite. As of 01/16/2006, it was reported that the vomiting was ongoing. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient had pneumonia shot 2/7/06 - Right arm is red, swollen and firm from shoulder to elbow. Also area is itching. No pain, patient started feeling itchiness in right upper arm last evening. Zyrtec 10mg to take one daily for 7 days given 2/8/06. B/P 108/64-60-20-98
Age: 1.19
Sex: F
Vaccine: DTAP
Symptoms: Cough, Erythema, Pruritus, Tenderness
Clinical narrative: Erythema, tenderness surrounding vaccine site right thigh with itching noted on 4/13/05. Tread with PO Benadryl for itching.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Swollen left shoulder
Age: 17.0
Sex: M
Vaccine: MNQ, TTOX, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: chicken pox lesions over past 5 days.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Myalgia, Neck pain, Pain, Pain
Clinical narrative: Deep aching pain, not swollen or red. Muscles on arm hurting badly since then. Pain comes and goes. Take anti-inflammatory to relief pain, enough to go to sleep. Site of injection still very tender. Pain began 3/4 days after shot (11/20/05), pain was from elbow to shoulder, sometimes up my neck, now. Worse when I'm horizontal [so intense I can't sleep or I wake up] Pain in ranging from dull ache to sharp jabs-sore to the touch, also
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Deep aching pain, not swollen or red. Muscles on arm hurting badly since then. Pain comes and goes. Take anti-inflammatory to relief pain, enough to go to sleep. Site of injection still very tender. Pain began 3/4 days after shot (11/20/05), pain was from elbow to shoulder, sometimes up my neck, now. Worse when I'm horizontal [so intense I can't sleep or I wake up] Pain in ranging from dull ache to sharp jabs-sore to the touch, also
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Feeling hot, Tenderness
Clinical narrative: Redness, warm, tenderness at injection site.  Patient also complained of feeling "woozy" next day. Pt. given Zyrtec.  Redness decreased and better within 2 days after injection.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Myalgia, Tenderness
Clinical narrative: Pt reported soreness night of vaccine, next morning came into clinic, arm red, warm, tender approximately 5x6 area.  Pt will take Benadryl.
Age: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Tenderness
Clinical narrative: Mother reported swelling and soreness at injection site, he was seen on 2/6/06, had swollen lymph node under R arm no erythema or warmth noted. Had 6 inch tender area on anterior and posterior shoulder. Treated with Motrin 800 mg for pain. Mother reported on 2/7/06 he felt worse and he was seen again. Still no erythema or warmth but TTP in R axilla pain 6/10 given Lortab 5/500 for pain and Prednisone taper.
Age: 1.34
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Irritability, Pruritus, Rash, Rash maculo-papular
Clinical narrative: A red itchy rash appeared all over body, child cranky and fussy. Thighs did swell more than with previous shots. Rash has persisted more than a week and worsens if Benadryl is not given. Maculopapular reddish and reticulated palpable rash over face, trunk and proximal extremities. Eczema worsened too.
Age: 1.39
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Oral intake reduced, Pyrexia
Clinical narrative: Had an incredibly high fever of 104 for two days, was incredibly irritable and would not eat.  Motrin would only bring his fever down to 101-102.  The spot where the shot was administered was incredibly swollen and red for almost a week.
Age: 44.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Arthralgia, Back pain, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Approximately 6:30 AM on 2/6/06 the vaccinee developed pain in right arm and observed 6 lesions in a circular pattern at the vaccination site. Later that day, the area within the circle became red and the surrounding area became swollen. She has also had a headache that has not stopped since the day of the vaccinations. On 2/8/06 she developed fever, and pain in her back, knees and ankles. She took Aleve to relieve the pain.
Age: 44.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Pain, Pyrexia, Skin ulcer
Clinical narrative: Approximately 6:30 AM on 2/6/06 the vaccinee developed pain in right arm and observed 6 lesions in a circular pattern at the vaccination site. Later that day, the area within the circle became red and the surrounding area became swollen. She has also had a headache that has not stopped since the day of the vaccinations. On 2/8/06 she developed fever, and pain in her back, knees and ankles. She took Aleve to relieve the pain.
Age: 71.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Medication error
Clinical narrative: Localized redness from inadvertent indradermal administration of Td instead of TST.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Medication error
Clinical narrative: Localized redness from inadvertent intradermal administration of Td instead of TST.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site reaction, Pain, Pyrexia
Clinical narrative: Pt developed fever, achiness & L arm pain with swelling at injection site. I spoke with pt on 2/6/06 and her symptoms had resolved.  She had slight soreness of L arm.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Pt had significant erythema, swelling of upper arm.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: redness site, TYLENOL and ice-developed cellulitis. KEFLEX
Age: 50.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Swelling, Tinnitus
Clinical narrative: Sore throat, swelling within 2 days of Flumist, persisted for weeks,then tinnitus.  Still having URI symptoms 1 month after Flumist.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Bacterial infection, Cellulitis, Chills, Erythema, Injection site induration
Clinical narrative: At day 13, patient developed bacterial super infection of vaccination site on right calf. Patient chose to vaccinate himself on right calf for unclear reasons. He is a medical provider in US Navy.3/2/06Received available medical records which revealed patient experienced calf pain w/edema, induration & erythema; fever, chills, headache; cellulitis & inguinal adenopathy.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: At day 13, patient developed bacterial super infection of vaccination site on right calf. Patient chose to vaccinate himself on right calf for unclear reasons. He is a medical provider in US Navy.3/2/06Received available medical records which revealed patient experienced calf pain w/edema, induration & erythema; fever, chills, headache; cellulitis & inguinal adenopathy.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Acute respiratory distress syndrome, Chest discomfort, Cough
Clinical narrative: Dry cough. " A little chest tightness." states physician.  Friend told him he had Oculo-Respiratory Syndrome-an adverse event found after Canadian flu vaccine.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Tic
Clinical narrative: Patient developed motor tics 2 days after getting the Fluvirin vaccine from her PCP. The tics are not definitively related to the vaccine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Pruritus, Swelling
Clinical narrative: Swollen area left arm 5" diameter. Blisters itching, redness.  No bleeding. Treatment-Z Pack, Medrol dose pack
Sex: U
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis around injection site.
Age: 15.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Headache, Liver function test abnormal
Clinical narrative: Fever and headache within about 24 hours, vasovagal syncope about 40 hours after vaccine seen in ER and got IV. Labs there showed elevated LFT's. days later LFT's were back to normal.
Age: 15.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pyrexia, Syncope vasovagal
Clinical narrative: Fever and headache within about 24 hours, vasovagal syncope about 40 hours after vaccine seen in ER and got IV. Labs there showed elevated LFT's. days later LFT's were back to normal.
Age: 26.0
Sex: M
Vaccine: HEP, MNQ, PPV, YF
Symptoms: Erythema, Myalgia, Palpitations, Pyrexia
Clinical narrative: Initial report received on 09/Jan/2006 from a health care provider. A 25 year old male patient had received and administration (route not reported) of Menactra, lot number U1877AA, in the left deltoids; a subcutaneous injection of YF-VAX, lot number UE664AB, in the right arm; an administration (route not reported) of another manufacturer's Pneumococcal vaccine, lot number 1047P, in the left deltoid and an administration (route not reported) of another manufacturer's Hepatitis B vaccine, lot number 0031P, in the right deltoid on 06/Jan/2006 at 11:32. One day later, the patient developed a temperature of 103 degrees Fahrenheit and palpitations. On 09/Jan/2006 the patient's temperature was 98.4 degrees Fahrenheit and it was noted that the patient had a slightly red left arm that was also slight sore. It was not reported whether the patient had recovered from these events at the time of this report. Follow-up information received on 31/Jan/2006 from a health care provider. The event palpitations was a stress related anxiety syndrome. The size of the erythema is unknown. The reported arm pain occurred in the left arm. There were no relevant diagnostic tests performed. At the time of this report, the patient had recovered.
Age: 50.0
Sex: F
Vaccine: MNQ, TD, YF
Symptoms: Headache, Hypersensitivity, Pyrexia, Rash
Clinical narrative: Initial report received on 30/Jan/2006 from a health care professional. A 50 year old patient with a history of allergy to Codeine, had received her first intramuscular injection of DECAVAC, lot number U1676AA, in the left arm, her first intramuscular injection of Menactra, lot number U1877AA, in the right arm and her first subcutaneous injection of YF-VAX, lot number U8664AB, in the left arm on 25/Jan/2006 at 16:35. One day later on 26/Jan/2006 at 23:00 she experienced a possible allergic reaction to the vaccines. She was seen in the emergency room with a possible rash to her arms and stomach that was accompanied by a fever and headache. She was prescribed Prednisone and Tagamet, but at the time of this report, the prescriptions had not been filled. The patient had recovered from these events at the time of this report.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema peripheral, Pruritus, Rash macular, Swelling face
Clinical narrative: Initial report received on 16/Nov/2005 from a health care professional. A 19 year old male patient with no significant medical history had received his first intra-muscular injection of Menactra, lot number U1860AA, in the left arm on 07/Nov/2005. Seven days later, on 14/Nov/2005, he presented with a generalized macular rash and itching that was treated orally with Benadryl. The next day, the patient contracted the health center complaining of swelling of the lips and hands. The patient denied having any associated respiratory problems or shortness of breath. He saw his primary care physician who determined the patient's diagnosis to be reaction to Menactra vaccine. The patient's recovery status was not reported. Follow-up information received on 26/Jan/2006. Per the reporter, the patient's symptoms resolved during Solumedrol dose pack. No further complaints of any residual symptoms by the patient on 24/Jan/2006 when the reporter spoke with the patient. No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: Red, hot, swollen L Lat aspect of arm
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Dizziness, Erythema, Myalgia, Pyrexia
Clinical narrative: Two days after dt administration. He developed soreness, redness of arm.  Had fever to 103 and felt weak and lightheaded on 2/3/06. Arm still sore on 2/6/06-14x24cm area of erythema on exam of right upper arm.  Treatment-Predinose and Benadryl
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Medication error, Unintended pregnancy
Clinical narrative: Patient discovered to be pregnant on this date, 9 February, 2006.  She received the Anthrax vaccine (2nd shot in series) the 8th February, 2006.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Face oedema, Irritability, Pruritus, Rash
Clinical narrative: From chart documentation: Parents reported--had vaccines yesterday and today has new onset puffy facial rash started 6 hours after vaccine and very fussy today with crying and apparent pruritis.  Exam revealed: erythematous macular papular rash to face , dense with slight plaque to cheeks but no scale includes scalp, trunk rash is more diffuse macular papular rash with an apparance more c/w exanthem rash. No wheezing.  Cleared promptly with Benadryl with some return of symptoms as dose wore off and good response to repeat dose. At re-eval day after above rash was nearly entirely gone except faint residual macules on trunk still similar in appearance to exanthem.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: From chart documentation: Parents reported--had vaccines yesterday and today has new onset puffy facial rash started 6 hours after vaccine and very fussy today with crying and apparent pruritis.  Exam revealed: erythematous macular papular rash to face , dense with slight plaque to cheeks but no scale includes scalp, trunk rash is more diffuse macular papular rash with an apparance more c/w exanthem rash. No wheezing.  Cleared promptly with Benadryl with some return of symptoms as dose wore off and good response to repeat dose. At re-eval day after above rash was nearly entirely gone except faint residual macules on trunk still similar in appearance to exanthem.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Received MMR 2 weeks ago, now has urticaria on entire body.
Age: 1.01
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fever onset on 02/08/06 and still ongoing on 02/09/06. Highest recorded temperature=39C. Onset of maculopapular rash on trunk on 02/09/06. No Koplik Spots, coryza or conjunctivitis observed. Tylenol given for fever.
Age: 49.0
Sex: M
Vaccine: HEPA, MMR, TD
Symptoms: Asthenia, Hypoaesthesia, Injection site pain
Clinical narrative: 12/12/05, C/O of pain at time of injection.  1/20/06 C/O continual pain in left deltoid since time of injection.  He rates pain as 1 which increases to 3 when he lifts or moves his arm.  There is no redness or swelling.  He denies pain in the elbow.  He is always aware of the pain and at times it wakes him at night.  When lying on his left shoulder he does not experience pain.  He believes the strength in his left arm is less then before the injection.  He states he has had slight numbness in his 1st and 2nd fingers but thinks it may be attributed to an injury he sustained to his wrist some time ago.  He was advised to be seen for an evaluation.  Name and number of contact person was provided.  Follow up phone and email contact were made to inquire about his arm.  He stated symptoms are the same but he does not care to seek medical evaluation or treatment at this time.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Viral infection
Clinical narrative: Mom states that "her daughter had a case of Chickenpox, I took her into the family doctor to check-He said it was Chickenpox, and that I should notify the one who gave her the vaccine."
Age: 1.19
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Hypokinesia, Medication error, Pyrexia, Synovitis
Clinical narrative: A report was received from a healthcare professional on 12/19/2005, regarding a 13 month old male vaccinee. No details were provided regarding the vaccinees medical history or concomitant medications. On 10/21/2005, the vaccinee received 0.25 ml of influenza vaccine. On 12/9/2005, the vaccinee received 0.25 ml of Fluvirin intramuscularly in the leg. On 12/11/2005, it was noted that the vaccinee was not bearing any weight on the leg that received the vaccination. No localized redness at injection site was reported. At the time of reporting the adverse event was continuing. Follow up information received on 2/1/2006: the vaccinee had no relevant past medical history and was receiving no concomitant medications. The vaccinee was diagnosed with transient synovitis in the left hip, hip pain and a fever. Onset of symptoms was within twenty four hours of receiving Fluvirin. X ray of the left hip and lower leg were negative and blood cultures and biochemistry were all within normal limits. The vaccinee was treated with Motrin (Ibuprofen). All symptoms were resolved within four weeks of vaccination.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Bacterial infection, Condition aggravated, Cough, Gastrooesophageal reflux disease, Laboratory test abnormal
Clinical narrative: This case was reported by a nurse and described the occurrence of worsening cough in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The subjects medical history was notable for reflux and cough. The cough began on Jan 5 2006. A polymerase chain reaction for pertussis was negative on 1/17/2006. On 1/27/2006 the subject received 1st dose of Pediarix (lot AC21B047AA). On 02/01/2006, 5 days after vaccination with Pediarix, the subject was admitted to the hospital with coughing and reflux. A polymerase chain reaction for pertussis was positive on 2/2/2006. The nurse considered the events to be clinically significant (or requiring intervention) (OMIC). The outcome of the events was not reported.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Autism
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 1 year old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The reporter is an acquaintance of the subject. A physician or other health care professional has not verified this report. On 8/24/2001, the day the subject was born, he received the 1st dose of hepatitis B vaccine, lot number not reported. At one year of age, on an unspecified date in 2002, the subject experienced symptoms of autism. On an unspecified date on or before, 2/3/2006, the subject was diagnosed with autism. The outcome of the autism was not reported. Comment: Autism was assessed as medically serious by manufacturer (OMIC).
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Autism, Drooling, Faecal incontinence, Gaze palsy
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 12 month old male subject who was vaccinated with a hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. There was no concurrent medications. The reporter state that, on 24 August 2001, "the day her son was born," he received the 1st dose of hepatitis B vaccine (lot number not reported). On 24 August 2001, less than one day after vaccination with hepatitis B vaccine, the subject's "eyes became off track and he could not suck." The reporter also stated that, "when he was about 6 to 12 months old, he stopped making sounds. At 12 months (exact date not reported), he started experiencing symptoms of autism." The reporter state that the subject "received the usual childhood vaccines until age 2." The subject was seen at a physician's office. On an unspecified date in 2002, the subject was diagnosed with developmental delay and severe speech problems and slight autism. As of 03 February 2006, the subject is unable to control his bowel, is unable to be potty trained and drools." The events were considered to be disabling and to require clinically significant intervention (OMIC). The subject was treated with physical therapy and speech therapy. The reported stated that, "when the vaccines were stopped at 2 years of age, he improved."
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Mental retardation severity unspecified, Speech disorder, Urinary incontinence
Clinical narrative: This case was reported by a consumer and described the occurrence of autism in a 12 month old male subject who was vaccinated with a hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. There was no concurrent medications. The reporter state that, on 24 August 2001, "the day her son was born," he received the 1st dose of hepatitis B vaccine (lot number not reported). On 24 August 2001, less than one day after vaccination with hepatitis B vaccine, the subject's "eyes became off track and he could not suck." The reporter also stated that, "when he was about 6 to 12 months old, he stopped making sounds. At 12 months (exact date not reported), he started experiencing symptoms of autism." The reporter state that the subject "received the usual childhood vaccines until age 2." The subject was seen at a physician's office. On an unspecified date in 2002, the subject was diagnosed with developmental delay and severe speech problems and slight autism. As of 03 February 2006, the subject is unable to control his bowel, is unable to be potty trained and drools." The events were considered to be disabling and to require clinically significant intervention (OMIC). The subject was treated with physical therapy and speech therapy. The reported stated that, "when the vaccines were stopped at 2 years of age, he improved."
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, HBHEPB, IPV, PNC
Symptoms: Erythema, Pruritus, Rash macular, Skin ulcer, Urticaria
Clinical narrative: On 2/6/06 Mom in clinic c/o child had rash, hives, itching on Saturday. 2/4/06 Mom treated with 2.5 HIC cream ? on 2/4/06. Macular erythematous, lesions on face. Mom reports was on back and legs. ?  temp. Denies new foods cream soups, detergent ?. No urticaria. Will see tomorrow.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Muscular weakness, Pain, Pharyngolaryngeal pain
Clinical narrative: Same day he took vax felt legs weakness. Body ached started the 7th. On the 9th he has strep throat.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Rash papular
Clinical narrative: Diffuse maculopapular rash approx 7" x 4" over left deltoid. Not Arthus rxn.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Shoulder pain
Clinical narrative: Occurred within 24 hrs chronic left arm shoulder pain; left shoulder elevation; very limited ROM of left arm. We have followed pt x 3 wks,N8A-IDS, referred to P.T. and ortho.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: 3 cm erythema, 4 cm induration on left thigh. Warm to touch. Developed over 2 days.
Age: 25.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site hypersensitivity, Injection site vesicles, Pruritus, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female inpatient with obesity, other unspecified conditions, latex allergy, morphine allergy, and multiple other medication allergies, who on 12/28/2005 was vaccinated subcutaneously in the left arm with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown) and influenza virus vaccine (unspecified), prior to discharge from the hospital. Patient was in the hospital for an unspecified reason. Nurse reported that the patient was obese and the vaccination was given subcutaneously because the needle was not long enough. Shortly after vaccination, on 12/28/2005, the patient developed injection site itching, chills, shaking and fever of 39.2 degrees C. After discharge, on 1/3/2006, she was seen at the clinic with a 5cm x 3 cm blister. The blister was opened and now the patient has an open wound and big hole. The wound is being packed daily and the patient has received cephalexin (Keflex) and pain pills (unspecified). The patients present status was reported as not recovered. No product quality complaint was involved. Injection site itching, chills, shaking, fever of 39.2 degree C and blister 5cm x 3cm were considered to be disabling and an other important medical event (OMIC). Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Tremor
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female inpatient with obesity, other unspecified conditions, latex allergy, morphine allergy, and multiple other medication allergies, who on 12/28/2005 was vaccinated subcutaneously in the left arm with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown) and influenza virus vaccine (unspecified), prior to discharge from the hospital. Patient was in the hospital for an unspecified reason. Nurse reported that the patient was obese and the vaccination was given subcutaneously because the needle was not long enough. Shortly after vaccination, on 12/28/2005, the patient developed injection site itching, chills, shaking and fever of 39.2 degrees C. After discharge, on 1/3/2006, she was seen at the clinic with a 5cm x 3 cm blister. The blister was opened and now the patient has an open wound and big hole. The wound is being packed daily and the patient has received cephalexin (Keflex) and pain pills (unspecified). The patients present status was reported as not recovered. No product quality complaint was involved. Injection site itching, chills, shaking, fever of 39.2 degree C and blister 5cm x 3cm were considered to be disabling and an other important medical event (OMIC). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Convulsion, Pain
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The day after vaccination, the patient experienced seizure-like symptoms. Subsequently, the patient also experienced soreness. Unspecified medical attention was sought. At the time of this report. the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, seizure-like symptoms were considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: CSF test abnormal, Condition aggravated, Encephalitis, Injection site erythema, Multiple sclerosis
Clinical narrative: Initial report received on 1/27/2006 from an investigator participating in the above mentioned trial under the reference number FID02. A 61 year old female subject received an intradermal injection of either study article influenza virus vaccine USP trival A and B high dose, Subvirion U or study article influenza virus vaccine USP trival A and B Subvirion U on 9/27/2005. On that day she developed redness at the injection site which resolved over the next nine days. Twenty one days post vaccination, she had no complaints and was administered an intramuscular injection of Fluzone SV 2005-2006, lot number not reported. Approximately ten days following that vaccination, she was hospitalized with neurological complaints and diagnosed with transverse myelitis. A MRI showed subtle findings in the spinal cord. She was treated with steroids and fully recovered. Per the reporter, the subject is now (date not reported) readmitted with an exacerbation of the disease, and the neurologist believes this is a form of acute disseminated encephalomyelitis. The MRI findings are extensive in the posterior cord although her clinical symptoms are not as bad. She also has CSF pleocytosis with 100 cells/cu mm. Per the reporter, the subject may have had subtle neurological symptoms for years that had not been reported for medical attention. With exacerbation and remissions, it may be the start of multiple sclerosis. At the time of this report, the subject had not recovered. The causality of the event is reported as associated. Follow up information received on 2/3/2006. The onset date for the second episode of transverse myelitis is reported as 1/27/2006. At the time of this repot, the subject had not recovered. According to the investigator, the event is related to the study, product.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Myelitis transverse, Neurological symptom, Pleocytosis
Clinical narrative: Initial report received on 1/27/2006 from an investigator participating in the above mentioned trial under the reference number FID02. A 61 year old female subject received an intradermal injection of either study article influenza virus vaccine USP trival A and B high dose, Subvirion U or study article influenza virus vaccine USP trival A and B Subvirion U on 9/27/2005. On that day she developed redness at the injection site which resolved over the next nine days. Twenty one days post vaccination, she had no complaints and was administered an intramuscular injection of Fluzone SV 2005-2006, lot number not reported. Approximately ten days following that vaccination, she was hospitalized with neurological complaints and diagnosed with transverse myelitis. A MRI showed subtle findings in the spinal cord. She was treated with steroids and fully recovered. Per the reporter, the subject is now (date not reported) readmitted with an exacerbation of the disease, and the neurologist believes this is a form of acute disseminated encephalomyelitis. The MRI findings are extensive in the posterior cord although her clinical symptoms are not as bad. She also has CSF pleocytosis with 100 cells/cu mm. Per the reporter, the subject may have had subtle neurological symptoms for years that had not been reported for medical attention. With exacerbation and remissions, it may be the start of multiple sclerosis. At the time of this report, the subject had not recovered. The causality of the event is reported as associated. Follow up information received on 2/3/2006. The onset date for the second episode of transverse myelitis is reported as 1/27/2006. At the time of this repot, the subject had not recovered. According to the investigator, the event is related to the study, product.
Age: 0.53
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apraxia, Autism, Autism spectrum disorder, Blood culture positive, Diarrhoea
Clinical narrative: My son was born on 1/27/02. While in delivery, doctor said I needed penicillin for Strep medicine was given 2 hours before delivery. After he was born 24 hours later, he was put in NICU unit for infection which he never had given medication Gentamycin/Ampicillin. Shortly after his stay at hospital, he was vaccinated at private physician for his routine Hep B; was given on 2/8/02 and according to my notes, might have received another dose at hospital. Shortly after this vaccine was given, we had taken him to health clinic because our insurance did not pay for visit and had his other vaccine given at clinic which at every visit and was told his head was to big, but not told that he might have another condition. My son kept having reaction of being to hot; put on fever next 7 months; was not tolerating formula, diarrhea, was sick. 18 months ear infection, eyes rolled behind his head after vaccination Hep B #3 12/4/02.3/2/06 Discharge summary received which revealed Dx: Sepsis w/elevated WBC & + blood cultures. 3/20/06 Received medical records from Dr. which revealed: maternal infection at birth, 2 wks preemie.  Delayed speech & walking, tongue thrusting, poor oral & feeding skills, failure to thrive, PDD, hypotonia, genu varum, pes planus, ASD, oral motor apraxia, echolalia, hand flapping, head banging, auditory stimulation.  Paternal uncle w/depression & paternal great aunt w/mental retardation. 4/10/06 Medical records received from child development specialist.  No new terms added. Autism speech problems, hyperactive, sensory problems oral motor, mercury in his system and organs  All paper work s/b monited yes, the future of our children deserve better and feel every effort for each child should have careful screening before any combinations of vaccination gets delievered in there little bodies.  Without knowing what the future cause maybe. 60 Day Follow-up Information: Sensory, speech, development, POD NOS, Autism.
Age: 0.53
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dyskinesia, Echolalia, Eye movement disorder, Failure to thrive, Feeding disorder of infancy or early childhood
Clinical narrative: My son was born on 1/27/02. While in delivery, doctor said I needed penicillin for Strep medicine was given 2 hours before delivery. After he was born 24 hours later, he was put in NICU unit for infection which he never had given medication Gentamycin/Ampicillin. Shortly after his stay at hospital, he was vaccinated at private physician for his routine Hep B; was given on 2/8/02 and according to my notes, might have received another dose at hospital. Shortly after this vaccine was given, we had taken him to health clinic because our insurance did not pay for visit and had his other vaccine given at clinic which at every visit and was told his head was to big, but not told that he might have another condition. My son kept having reaction of being to hot; put on fever next 7 months; was not tolerating formula, diarrhea, was sick. 18 months ear infection, eyes rolled behind his head after vaccination Hep B #3 12/4/02.3/2/06 Discharge summary received which revealed Dx: Sepsis w/elevated WBC & + blood cultures. 3/20/06 Received medical records from Dr. which revealed: maternal infection at birth, 2 wks preemie.  Delayed speech & walking, tongue thrusting, poor oral & feeding skills, failure to thrive, PDD, hypotonia, genu varum, pes planus, ASD, oral motor apraxia, echolalia, hand flapping, head banging, auditory stimulation.  Paternal uncle w/depression & paternal great aunt w/mental retardation. 4/10/06 Medical records received from child development specialist.  No new terms added. Autism speech problems, hyperactive, sensory problems oral motor, mercury in his system and organs  All paper work s/b monited yes, the future of our children deserve better and feel every effort for each child should have careful screening before any combinations of vaccination gets delievered in there little bodies.  Without knowing what the future cause maybe. 60 Day Follow-up Information: Sensory, speech, development, POD NOS, Autism.
Age: 0.53
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Foot deformity, Head banging, Hydrocephalus, Hypotonia, Infection
Clinical narrative: My son was born on 1/27/02. While in delivery, doctor said I needed penicillin for Strep medicine was given 2 hours before delivery. After he was born 24 hours later, he was put in NICU unit for infection which he never had given medication Gentamycin/Ampicillin. Shortly after his stay at hospital, he was vaccinated at private physician for his routine Hep B; was given on 2/8/02 and according to my notes, might have received another dose at hospital. Shortly after this vaccine was given, we had taken him to health clinic because our insurance did not pay for visit and had his other vaccine given at clinic which at every visit and was told his head was to big, but not told that he might have another condition. My son kept having reaction of being to hot; put on fever next 7 months; was not tolerating formula, diarrhea, was sick. 18 months ear infection, eyes rolled behind his head after vaccination Hep B #3 12/4/02.3/2/06 Discharge summary received which revealed Dx: Sepsis w/elevated WBC & + blood cultures. 3/20/06 Received medical records from Dr. which revealed: maternal infection at birth, 2 wks preemie.  Delayed speech & walking, tongue thrusting, poor oral & feeding skills, failure to thrive, PDD, hypotonia, genu varum, pes planus, ASD, oral motor apraxia, echolalia, hand flapping, head banging, auditory stimulation.  Paternal uncle w/depression & paternal great aunt w/mental retardation. 4/10/06 Medical records received from child development specialist.  No new terms added. Autism speech problems, hyperactive, sensory problems oral motor, mercury in his system and organs  All paper work s/b monited yes, the future of our children deserve better and feel every effort for each child should have careful screening before any combinations of vaccination gets delievered in there little bodies.  Without knowing what the future cause maybe. 60 Day Follow-up Information: Sensory, speech, development, POD NOS, Autism.
Age: 0.53
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Knee deformity, Laboratory test abnormal, Metal poisoning, Nervous system disorder, Premature labour
Clinical narrative: My son was born on 1/27/02. While in delivery, doctor said I needed penicillin for Strep medicine was given 2 hours before delivery. After he was born 24 hours later, he was put in NICU unit for infection which he never had given medication Gentamycin/Ampicillin. Shortly after his stay at hospital, he was vaccinated at private physician for his routine Hep B; was given on 2/8/02 and according to my notes, might have received another dose at hospital. Shortly after this vaccine was given, we had taken him to health clinic because our insurance did not pay for visit and had his other vaccine given at clinic which at every visit and was told his head was to big, but not told that he might have another condition. My son kept having reaction of being to hot; put on fever next 7 months; was not tolerating formula, diarrhea, was sick. 18 months ear infection, eyes rolled behind his head after vaccination Hep B #3 12/4/02.3/2/06 Discharge summary received which revealed Dx: Sepsis w/elevated WBC & + blood cultures. 3/20/06 Received medical records from Dr. which revealed: maternal infection at birth, 2 wks preemie.  Delayed speech & walking, tongue thrusting, poor oral & feeding skills, failure to thrive, PDD, hypotonia, genu varum, pes planus, ASD, oral motor apraxia, echolalia, hand flapping, head banging, auditory stimulation.  Paternal uncle w/depression & paternal great aunt w/mental retardation. 4/10/06 Medical records received from child development specialist.  No new terms added. Autism speech problems, hyperactive, sensory problems oral motor, mercury in his system and organs  All paper work s/b monited yes, the future of our children deserve better and feel every effort for each child should have careful screening before any combinations of vaccination gets delievered in there little bodies.  Without knowing what the future cause maybe. 60 Day Follow-up Information: Sensory, speech, development, POD NOS, Autism.
Age: 0.53
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Psychomotor hyperactivity, Pyrexia, Sensorimotor disorder, Sepsis, Speech disorder
Clinical narrative: My son was born on 1/27/02. While in delivery, doctor said I needed penicillin for Strep medicine was given 2 hours before delivery. After he was born 24 hours later, he was put in NICU unit for infection which he never had given medication Gentamycin/Ampicillin. Shortly after his stay at hospital, he was vaccinated at private physician for his routine Hep B; was given on 2/8/02 and according to my notes, might have received another dose at hospital. Shortly after this vaccine was given, we had taken him to health clinic because our insurance did not pay for visit and had his other vaccine given at clinic which at every visit and was told his head was to big, but not told that he might have another condition. My son kept having reaction of being to hot; put on fever next 7 months; was not tolerating formula, diarrhea, was sick. 18 months ear infection, eyes rolled behind his head after vaccination Hep B #3 12/4/02.3/2/06 Discharge summary received which revealed Dx: Sepsis w/elevated WBC & + blood cultures. 3/20/06 Received medical records from Dr. which revealed: maternal infection at birth, 2 wks preemie.  Delayed speech & walking, tongue thrusting, poor oral & feeding skills, failure to thrive, PDD, hypotonia, genu varum, pes planus, ASD, oral motor apraxia, echolalia, hand flapping, head banging, auditory stimulation.  Paternal uncle w/depression & paternal great aunt w/mental retardation. 4/10/06 Medical records received from child development specialist.  No new terms added. Autism speech problems, hyperactive, sensory problems oral motor, mercury in his system and organs  All paper work s/b monited yes, the future of our children deserve better and feel every effort for each child should have careful screening before any combinations of vaccination gets delievered in there little bodies.  Without knowing what the future cause maybe. 60 Day Follow-up Information: Sensory, speech, development, POD NOS, Autism.