chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Red blood cell sedimentation rate increased, Tremor, Urticaria chronic
Clinical narrative: Initial case received 19 February 2010 from a physician (is also the patient). A 55 year old male patient with a medical history of hypertension and chronic urticaria with infrequent angioedema, received an injection (route and site not reported) of ADACEL (lot number C2889AA) on 29 January 2010. Immediately following vaccination the patient experienced injection site tenderness. Within a couple of days he experienced injection site swelling, shaking, chills, night sweats, joint tenderness and muscle tenderness. Then over the next week he experienced fatigue, headaches, increased night sweats, increased joint soreness and increased muscle soreness. He had a temperature ranging to "102." On an unspecified date following vaccination, the patient's pre-existing chronic urticaria with infrequent angioedema worsened. Concomitant medications included LIPITOR, ASA, MODURETIC and vitamin B 1000IU. He had no known allergies and had no illness at the time of vaccination. On an unspecified date the patient (physician) was seen by another physician, lab work showed an elevated sed rate of 64 and blood in urine. On an unspecified date, the patient reported that he had stopped taking LIPITOR 2 weeks ago (approximate date 05 February 2010). He was using TYLENOL and ibuprofen. At the time of this report the patient stated he felt the symptoms were improving, but still had body aches, muscle weakness, muscle soreness, decreased energy level, occasional night sweats and headaches. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Varicella
Clinical narrative: pt presented in office with rash on entire body consistent with Varicella starting 1 day prior.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyskinesia, Electroencephalogram, Muscle twitching, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Uncontrollable twitching and jerking per Mom.  Was transported to hospital by EMS. Treated with Xanax and Zofran and released. Multiple ER visits since.  EEG 1/20/10.  Currently under the care of Neuro Dr.   MRI shows back right side of brain abnormalties per Mom. Appointment scheduled for 48 hour EEG on 03/03/10.  Currently taking Tinex 1/2 mg twice a day.  No shaking episodes since 02/16/10 per Mom.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MEN, TDAP
Symptoms: Nausea, Pallor, Presyncope, Tachycardia
Clinical narrative: Severe nausea and patient became pre-syncopal with significant pallor and tachycardia.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: 104 fever for 3 days and rash on chest/belly/neck on 02/25/2010.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Low grade fever
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: 24 hours after vaccine developed swelling, redness and discomfort at injection site.
Age: 49.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Pain, Pain in extremity
Clinical narrative: My arm has progressively gotten painful. And is worse no, 3 months later then the first day of the shot. Certain pulling and twisting movements are too painful to attempt.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Lethargy, Myalgia, Oropharyngeal pain
Clinical narrative: Headache, Sore Throat, Muscle Ache, Lethargic, Dizziness
Age: 42.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Peripheral coldness
Clinical narrative: Left side extremities are constantly cold.  Wrist, calf, shin (especially the shin), ankle, hand, and sometimes foot.  It hasn't stopped yet, I still have the cold extremeties.  I wrap them in ace bandages to make them feel better.  I was hoping this would go away, but it hasn't.
Age: 29.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: No reaction on previous exposure to drug, Urticaria
Clinical narrative: A staff member received the H1N1 vacc in the right deltoid and 45 minutes later developed raised hives down his right arm. He did not react to the seasonal flu vaccine or any previous INFLUENZA vaccines.
Age: 1.67
Sex: F
Vaccine: DTAP, FLU(H1N1), HIBV, PNC
Symptoms: Urticaria
Clinical narrative: 20 month old female in for immunization update, was given DTaP, HIB, PREVNAR and H1N1, on 2/18/10, on 2/19/10 came to clinic with urticaria. Presumed due to H1N1, other vaccines were boosters.
Age: 1.4
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Fatigue, Lethargy, Muscle twitching, Tongue biting, Unresponsive to stimuli
Clinical narrative: Received vaccine - post that - very lethargic on 2/19/10 AM. Per mom had twitches at nite, but no seizure that she knows of. Did have bite on both sides of tongue. Poor response to mom at home, decreased response in the clinic, very tired. In the ER all labs were normal except HCO3 was decreased. Was give IVF and improved lethargy from AM to 4PM. Follow up information - HAVRIX correct vaccine lot number provided.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: Blood alkaline phosphatase increased, Blood culture negative, Blood sodium decreased, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: Culture urine negative, Feeding disorder of infancy or early childhood, Hypokinesia, Lumbar puncture normal, Skin warm
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: Staring, Tremor
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: Basophil percentage increased, CSF culture negative, CSF glucose increased, CSF protein decreased, CSF white blood cell count negative
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: Dyskinesia, Electroencephalogram normal, Encephalopathy, Gram stain, Granulocyte percentage
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: Haematocrit normal, Haemoglobin normal, Hypertonia, Listless, Lymphocyte percentage
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: Platelet count increased, Pyrexia, Red blood cells CSF positive, Staring, Unresponsive to stimuli
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 0.65
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPHEPBIP, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU(H1N1), FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Parents stated that child had slight swelling at injection site L deltoid, stated child had red, itchy rash X 2 wk. on L upper arm, no fever.
Age: 4.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vomiting
Clinical narrative: Left arm site became red, tender, raised. Severe vomiting for 12 hours.
Age: 17.5
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site warmth, Pruritus
Clinical narrative: Within 1-2 minutes complaint of itching at site extending to 2-3 inches below site. Within 10 minutes site became warm. No redness, no rash. No decrease in range of motion. 30 minutes later, slight itching continued.
Age: 16.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Somnolence
Clinical narrative: Complaint of drowsiness & headache. Pulse 100, B/P 104/76. Right arm site no redness or itching.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Syncope
Clinical narrative: Fainting. B/P 120/70. Ammonia Inhalant used. Alerted. Left arm no redness.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Acute lymphocytic leukaemia, Biopsy, Biopsy bone marrow, Computerised tomogram, Full blood count
Clinical narrative: Pain in L arm and shoulder, lasted to the end of the month. Diagnose with acute lymphoblastic leukemia. Some of T-cells had problem and hospitalization was required.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Musculoskeletal pain, Pain in extremity, Smear test
Clinical narrative: Pain in L arm and shoulder, lasted to the end of the month. Diagnose with acute lymphoblastic leukemia. Some of T-cells had problem and hospitalization was required.
Age: 0.6
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever x2D. Tmx 103R. vomiting, lethargy. Tx: Fever measures PO fluids - Pedialyte
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Shortly after receiving vaccine pt began to notice pain in her deltoid region which radiated up into her trapezius muscle and also down her arm slightly.
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: Patient reports fatigue and stomach upset approximately one hour following vaccination. Diarrhea started evening of 2/11/10.  Reports an episode of numbness in left arm and left side of face on 2/13/10. Diarrhea and fatigue continues.  Patient was advised by HD to see primary physician or report to emergency room and he did not seek medical attention for complaints.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site discolouration, Injection site pruritus, Injection site rash, Injection site warmth, Otitis media
Clinical narrative: Woke with pink, warm, raised, rough, itchy rash 6cmX5cm on right thigh.  Coincidental R otitis media discovered on exam.  Treated for OM and possible cellulitis with Augmentin 600 PO BID.
Age: 71.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus
Clinical narrative: patient complaining of itching on head, neck, and ears.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pruritus, Swollen tongue
Clinical narrative: pt given H1N1 vaccine 20min later she felt itchy, arm turning red, felt tongue enlarging. pt given 25mg Benadryl 25mg im, pt improved sent home on prn Benadryl and prednisone burst pack
Age: 26.0
Sex: M
Vaccine: FLUX(H1N1), MMR
Symptoms: Body temperature increased, Dizziness, Fatigue, Headache
Clinical narrative: severe headache, dizziness, elevated temperature, fatigue
Age: 11.0
Sex: F
Vaccine: HEPA, HPVX, TDAP
Symptoms: Dizziness, Eye pain, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt felt faint immediately after injection; pain, soreness at injection site continued for several hours; the following morning pt complains of pain in eyes especially upon looking up  (T-daP and Hep A given at same time of HPV vaccine)
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Blood test abnormal, Fatigue, Headache
Clinical narrative: muscle Aches, headache, general weakness and fatigue. Progresses over next few weeks,by 10/24 swelling in arms, legs feet, hands and neck, difficulty putting on socks and shoes, combing my hair, getting over the lip in the tub to take a shower.Use cane for use with walking and help with getting in and out of car, up from chairs. 11/10  Neck area limits movement of my head, cannot back car. 11/24 Bloodwork shows elevated sed rate - refer to neurologist 12/9  MRI of spine 12/14.Nerve conduction study and EMG 12/17 with neuromuscular doc. muscle biopsy 1/8/2010.  DX Myositis - pregnisone treatment. Ongoing weakness while we experiment with meds and doses.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Mobility decreased, Myalgia, Myositis, Oedema peripheral
Clinical narrative: muscle Aches, headache, general weakness and fatigue. Progresses over next few weeks,by 10/24 swelling in arms, legs feet, hands and neck, difficulty putting on socks and shoes, combing my hair, getting over the lip in the tub to take a shower.Use cane for use with walking and help with getting in and out of car, up from chairs. 11/10  Neck area limits movement of my head, cannot back car. 11/24 Bloodwork shows elevated sed rate - refer to neurologist 12/9  MRI of spine 12/14.Nerve conduction study and EMG 12/17 with neuromuscular doc. muscle biopsy 1/8/2010.  DX Myositis - pregnisone treatment. Ongoing weakness while we experiment with meds and doses.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: muscle Aches, headache, general weakness and fatigue. Progresses over next few weeks,by 10/24 swelling in arms, legs feet, hands and neck, difficulty putting on socks and shoes, combing my hair, getting over the lip in the tub to take a shower.Use cane for use with walking and help with getting in and out of car, up from chairs. 11/10  Neck area limits movement of my head, cannot back car. 11/24 Bloodwork shows elevated sed rate - refer to neurologist 12/9  MRI of spine 12/14.Nerve conduction study and EMG 12/17 with neuromuscular doc. muscle biopsy 1/8/2010.  DX Myositis - pregnisone treatment. Ongoing weakness while we experiment with meds and doses.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Redness and warmth to injection site.  Only painful when pressed on.  Fever of 101.3 noted at that time.  Some diarrhea.
Age: 34.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Vomiting
Clinical narrative: Seizure; including vomiting for an unknown amount of time. Pt also seized while admitted to the hospital. Follow-up information received March 12.  This was not the 4th vaccination.  This is the 1st.  Medical records have been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Headache
Clinical narrative: Sudden onset of severe headache and back pain. Pain increased throughout the evening and patient took Tramadol for the pain. Headache and back pain persisted at a lower level the next day. Fatigue symptoms started next day. Headache and back pain tapered off on Monday. Fatigue tapered on on Wednesday.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Headache, Influenza serology, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Had a headache.  More symptoms occurred Sunday evening to include: SEVERE headache (1-1/2 days), chills, aches, barely move, neck stiffness, sight issues.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain, Visual impairment
Clinical narrative: Had a headache.  More symptoms occurred Sunday evening to include: SEVERE headache (1-1/2 days), chills, aches, barely move, neck stiffness, sight issues.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Myelitis transverse
Clinical narrative: Transversal Myelitis
Age: 32.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Eye irritation, Fatigue, Insomnia, Myalgia
Clinical narrative: Eye irritation, sore throat, muscle pain and fatigue, joint pain, and insomnia.
Age: 32.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Oropharyngeal pain
Clinical narrative: Eye irritation, sore throat, muscle pain and fatigue, joint pain, and insomnia.
Age: 36.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Headache, Hypoaesthesia, Muscle twitching, Nasal congestion
Clinical narrative: Sinus pressure, nasal congestion, frontal headache, dizziness-- initially. Then after 3 days, visual halo/flashes, muscle twitching and numbness/tingling in hands. Muscle twitching stopped 2/24/10 but numbness continues. Still w/ visual symptoms. Has seen a neurologist and an ophthalmologist. No diagnoses made/ no distinct pathology found by them.
Age: 36.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Paraesthesia, Photopsia, Sinus headache, Visual impairment
Clinical narrative: Sinus pressure, nasal congestion, frontal headache, dizziness-- initially. Then after 3 days, visual halo/flashes, muscle twitching and numbness/tingling in hands. Muscle twitching stopped 2/24/10 but numbness continues. Still w/ visual symptoms. Has seen a neurologist and an ophthalmologist. No diagnoses made/ no distinct pathology found by them.
Age: 92.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Burning sensation, Pain in extremity, Toothache
Clinical narrative: "Woke up with pain in teeth, same tooth on both sides of mouth, feels like they are on fire."  Also complained of alternating pain in finger tips.  This pain comes and goes. Both complaints continue to occur periodically.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: body aches, fever like symptoms, tiredness, loss of appetite.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Feeling of body temperature change, Headache, Nausea, Throat tightness
Clinical narrative: Headache, nausea (no vomiting) 7-8 hrs after Hep B 1st shot. Resolved within 24 hrs. (Felt hot/cold at the time and throat felt tight after onset of symptoms.)
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site papule, Injection site rash, Injection site vesicles
Clinical narrative: 6.5x4 cm eruption (erythema, slight induration, vesicles/papules) at site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Induration to left arm 85 x 85 cm, warm to the touch and painful. Tx->Ice packs, TYLENOL and BENADRYL if it worsens pt to return to clinic.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Fontanelle bulging, Skin discolouration
Clinical narrative: At approximately 4:30pm bilateral mid-calves to feet turned purple and left lateral hand turned purple; bulging and pulsating fontanelle. (on 2/17/10) witnessed by parents only.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLUN3, HEPA, IPV, MNQ, TDAP, YF
Symptoms: Chills, Fatigue, Full blood count, Hyperhidrosis, Muscle tightness
Clinical narrative: Day after vaccines administrated, pt had tight back and neck, then had onset sweats, chills, fever. Now better, feels tired & achy.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), FLUN3, HEPA, IPV, MNQ, TDAP, YF
Symptoms: Musculoskeletal discomfort, Pain, Pyrexia
Clinical narrative: Day after vaccines administrated, pt had tight back and neck, then had onset sweats, chills, fever. Now better, feels tired & achy.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Dizziness, Erythema, Headache, Pain
Clinical narrative: 2/25/10 Pt was seen 2/20/10 seen pv. Received immun 2/17/10 in R arm. She c/o R arm pain that evening and next day. Seen by another MD 2/19, did x-rays, nothing found. She describes the pain as burning, esp face. Then also c/o legs hurting and face burning. She also c/o HA and dizziness. No fainting, no cough or URI, no vomiting or diarrhea, appetite normal, T max 100.2. No physical changes noted on exam except winces with pain on palpation and movement of R arm and legs but from pressure. No skin findings except 3 or 4 <1cm maculopapules, pink on L iliac crest area, no bulla, no pus, no wheals. No redness or swelling of R arm or legs. No swelling of face. Cheeks sl. pink. This was temporally related to the immunization.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Rash maculo-papular, X-ray normal
Clinical narrative: 2/25/10 Pt was seen 2/20/10 seen pv. Received immun 2/17/10 in R arm. She c/o R arm pain that evening and next day. Seen by another MD 2/19, did x-rays, nothing found. She describes the pain as burning, esp face. Then also c/o legs hurting and face burning. She also c/o HA and dizziness. No fainting, no cough or URI, no vomiting or diarrhea, appetite normal, T max 100.2. No physical changes noted on exam except winces with pain on palpation and movement of R arm and legs but from pressure. No skin findings except 3 or 4 <1cm maculopapules, pink on L iliac crest area, no bulla, no pus, no wheals. No redness or swelling of R arm or legs. No swelling of face. Cheeks sl. pink. This was temporally related to the immunization.
Age: 1.2
Sex: M
Vaccine: HIBV
Symptoms: Blood immunoglobulin E, Eye discharge, Injection site dermatitis, Injection site pruritus, Laboratory test
Clinical narrative: Information has been received from a consumer concerning consumer's son a 3 year old male who on 08-MAR-2006 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (reported as 0914L). Subsequently the patient experienced itchy Varicella like rash around the injection site ever since. The rash flares up and becomes worse when the child is sick with a cold or other illness. The patient sought medical attention, was referred to a dermatologist, and an unspecified steroid cream (manufacturer unknown) was prescribed, but it did not help. At the time of reporting, the patient had not recovered. Follow up information was received from a pediatrician who reported that the now 3 years old male returned with his parents for localized pruritic dermatitis at site of immunization 31 months ago, in May 2006. the pediatrician stated that the vaccine was OMPC, and the reaction was probably an Arthus reaction. An Arthus reaction began the day of immunization but should not last longer than a few weeks. The pruritis has perpetuated itself by his scratching and eczema. The pediatrician recommended keeping the site under clothes at all times in hopes that he would forget about it. The family had a nice routine for eczema. When the patient bathed, soap was avoided and a EUCERIN product similar to CETAPHIL was substituted. AVENO lotion was applied several times per day. DESONIDE cream was used briefly for flares of skin rash. The trial of ACYCLOVIR did not make a difference. Laboratory test performed in last month (November 2008) were normal except for serum IgE 126 IU/ml. On exam on 16-DEC-2008, the right thigh dermatitis was quiescent. The patient had some nasal and eye drainage. TMs and pharynx were normal. The pediatrician thought that the family was coping rather well with his rashes and recommended that follow up on a PRN basis. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: HIBV
Symptoms: Rash, Rash pruritic, Rash vesicular, Rhinorrhoea, Type III immune complex mediated reaction
Clinical narrative: Information has been received from a consumer concerning consumer's son a 3 year old male who on 08-MAR-2006 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (reported as 0914L). Subsequently the patient experienced itchy Varicella like rash around the injection site ever since. The rash flares up and becomes worse when the child is sick with a cold or other illness. The patient sought medical attention, was referred to a dermatologist, and an unspecified steroid cream (manufacturer unknown) was prescribed, but it did not help. At the time of reporting, the patient had not recovered. Follow up information was received from a pediatrician who reported that the now 3 years old male returned with his parents for localized pruritic dermatitis at site of immunization 31 months ago, in May 2006. the pediatrician stated that the vaccine was OMPC, and the reaction was probably an Arthus reaction. An Arthus reaction began the day of immunization but should not last longer than a few weeks. The pruritis has perpetuated itself by his scratching and eczema. The pediatrician recommended keeping the site under clothes at all times in hopes that he would forget about it. The family had a nice routine for eczema. When the patient bathed, soap was avoided and a EUCERIN product similar to CETAPHIL was substituted. AVENO lotion was applied several times per day. DESONIDE cream was used briefly for flares of skin rash. The trial of ACYCLOVIR did not make a difference. Laboratory test performed in last month (November 2008) were normal except for serum IgE 126 IU/ml. On exam on 16-DEC-2008, the right thigh dermatitis was quiescent. The patient had some nasal and eye drainage. TMs and pharynx were normal. The pediatrician thought that the family was coping rather well with his rashes and recommended that follow up on a PRN basis. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cough, Crying, Head deformity, Insomnia, Rash generalised
Clinical narrative: Information has been received from a physician via medical records concerning a 19-Week-old male with a family history of cancer and diabetes who on 03-DEC-2008 was vaccinated with a 0.5ml single dose of PEDIARIX (lot# AC71B1BAA) and a 0.5 single dose of PREVNAR (lot# G73459). On 29-JAN-2009 the patient was seen by a physician with a rash all over his body; a runny, stuffy,"green" nose; a congested cough; who was reportedly "crying a lot and not sleeping". At this appointment it was also noted that the patient was to be referred to the hospital for a "malshaped head". No outcome were reported. The next visit would be 09-FEB-2009 for the next shots. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rhinorrhoea
Clinical narrative: Information has been received from a physician via medical records concerning a 19-Week-old male with a family history of cancer and diabetes who on 03-DEC-2008 was vaccinated with a 0.5ml single dose of PEDIARIX (lot# AC71B1BAA) and a 0.5 single dose of PREVNAR (lot# G73459). On 29-JAN-2009 the patient was seen by a physician with a rash all over his body; a runny, stuffy,"green" nose; a congested cough; who was reportedly "crying a lot and not sleeping". At this appointment it was also noted that the patient was to be referred to the hospital for a "malshaped head". No outcome were reported. The next visit would be 09-FEB-2009 for the next shots. Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Adverse event
Clinical narrative: Information has been received from a consumer concerning her daughter who at an unknown date, was vaccinated with PEDVAXHIB (lot# not reported). Subsequently the patient experienced an unspecified side effect. It was unspecified if the patient sought medical attention. No further information is available.
Age: 1.13
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a consumer concerning her 14 month old daughter with atopy, lactose intolerance, and allergies to peanuts, eggs and tree mix, who in September 2007, was vaccinated with a dose of PEDVAXHIB. There was no concomitant medication. Within an hour of receiving the PEDVAXHIB the patient experienced redness and rash at the injection site on her left leg. The patient was given BENADRYL, and it took a couple of days for the experience to go away. No laboratory studies performed. The patient sought unspecified medical attention. The patient had recovered a couple of days after received the PEDVAXHIB. Additional information is not expected.
Sex: M
Vaccine: HIBV, PNC
Symptoms: Adverse event
Clinical narrative: Information has been received form a consumer concerning her son who on an unspecified date was vaccinated with PEDVAXHIB (OMPC). Concomitant therapy included PREVNAR. It was reported that the patient had a "similar reaction" like her other son. The consumer reported previously that her other son had adverse experiences while vaccinated with ATTENUVAX (Enders-Edmonston) (MSD) (WAES # 0902USA04542) and VARIVAX (Merck) (MSD) WAES # 0903USA00002). No further information is available.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Lethargy
Clinical narrative: Information has been received from a consumer concerning her now 5 month old son who in approximately December 2008, "when he was 2 months of age", was vaccinated with a dose of PEDVAXHIB. The mother reported that the patient received "an unknown HIB vaccine". The manufacturer of the HIB vaccine was unknown. Concomitant therapy included PREVNAR. In approximately December 2008, "for 4 days after vaccination", the patient was extremely lethargic. On an unspecified date, the patient recovered from lethargic. The patient was seen by the doctor and sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Eczema, Hypersensitivity, Rash
Clinical narrative: Information has been received from a consumer concerning her now 6 year old son with penicillin allergy, egg allergy and certain food allergy and a history of zinc deficiency who in approximately 2004, "when he was between 12 or 24 months old", was vaccinated with a dose of PEDVAXHIB. The mother reported that she was unsure the manufacturer of the vaccine. In approximately 2004, "after receiving the vaccine", the patient developed allergies and rashes. The mother also reported that the patient developed eczema on an unspecified date. "After a few years", the patient had recovered. The patient was seen by the physician and sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her a year old son who was vaccinated with a dose of PEDVAXHIB (name and manufacturer unspecified). The mother was trying to space out vaccines for her son to avoid serious reactions however after getting the vaccine the patient developed a fever. This is one of several reports from the same source. No further information is available.
Sex: U
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her second child who on an unspecified date was vaccinated with PEDVAXHIB (manufacturer unknown). The patient developed high fever after receiving the "HIB vaccine". The outcome of the patient's high fever was not reported. This is one of several reports from the same source. No further information is available.
Age: 0.3
Sex: M
Vaccine: HIBV
Symptoms: Childhood disintegrative disorder
Clinical narrative: Information has been received from a consumer concerning her 4 month old son who was vaccinated with a dose of HIB vaccine (manufacturer unspecified).  Two weeks later for 2 to 3 days his developmental progress stopped (the baby would not smile, roll over, be active like normal children are).  At the time of this report the patient had recovered.  Additional information is not expected.
Age: 0.8
Sex: F
Vaccine: HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter developed a fever of 105 deg F after received "polio and HIB" vaccines (manufacturer unspecified) at 9 months of age.  It's unknown if the patient has sought any medical attention.  The child fully recovered and is currently 2 years old.  Consumer would not provide demographics and disconnected.  No further information is available.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a newborn infant who on 31-AUG-2009 was vaccinated with a dose of PEDVAXHIB (dose, route, and lot # not reported).  The pharmacist reported that the patient was given a dose of PEDVAXHIB instead of a HEPATITIS B vaccine.  No adverse effect reported.  Medical attention was sought through a telephone call to the pharmacy.  Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HIBV
Symptoms: Pericarditis
Clinical narrative: Information has been received from the CDC (reporter unknown) concerning a 5 year old patient who on unspecified dates was vaccinated with full doses of PEDVAXHIB (manufacturer unknown).  Subsequently, on an unspecified date the patient developed HIB pericarditis.  This case was reported by the CDC.  It was unknown if the patient sought medical attention.  The outcome of the event was unknown.  Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Anxiety, Depressed mood, Feeling abnormal, Frustration, Motion sickness
Clinical narrative: The approximately 44 year old female consumer reported that she began CHANTIX starter pack in Apr2007, to stop smoking, ZOLOFT 50 mg daily, for depression, in Aug2007, and received two BIOPORT injections, while overseas, on unknown dates, prior to ZOLOFT and CHANTIX. At an unknown time, the consumer reports that she was depressed and felt like she had morning sickness with the CHANTIX. The consumer feels terrible, and her family and coworkers think she is nuts. On unknown dates, the consumer has had weight gain, and now weighs 148 pounds, anxiety, been frustrated, feels that something is neurologically wrong with her, and feels like a lunatic. The consumer's dose was increased to 100mg daily. In Sep2007, the consumer stopped taking ZOLOFT, because she felt the ZOLOFT was making things worse. The consumer feels the combination of the BIOTHRAX vaccine, CHANTIX and ZOLOFT has caused her events, since she feels that they all stimulate the nervous system. The consumer stopped taking CHANTIX, in May2007, because she was at a military training school and ran out of medication. The consumer smokes a half pack of cigarettes daily and her doctors want her to go for testing for her events, but the consumer refuses to go to the hospital. The consumer has had no relevant laboratory testing. As of 10Oct2007, the consumer is no longer taking ZOLOFT, CHANTIX, or BIOTHRAX vaccine. The consumer continues to be depressed, morning sickness, feels terrible, her family thinks she is nuts, has weight gain, anxiety, frustrated, something is neurologically wrong, feels like a lunatic, still hurts, and has motion sickness. Is unknown if the consumer has resolved from the ZOLOFT making things worse. The consumer works for a civilian company that is trying to go smoke free. She has five children and five grandchildren she used to take care of. The consumer gets her medications locally.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Nervous system disorder, Vomiting in pregnancy, Weight increased
Clinical narrative: The approximately 44 year old female consumer reported that she began CHANTIX starter pack in Apr2007, to stop smoking, ZOLOFT 50 mg daily, for depression, in Aug2007, and received two BIOPORT injections, while overseas, on unknown dates, prior to ZOLOFT and CHANTIX. At an unknown time, the consumer reports that she was depressed and felt like she had morning sickness with the CHANTIX. The consumer feels terrible, and her family and coworkers think she is nuts. On unknown dates, the consumer has had weight gain, and now weighs 148 pounds, anxiety, been frustrated, feels that something is neurologically wrong with her, and feels like a lunatic. The consumer's dose was increased to 100mg daily. In Sep2007, the consumer stopped taking ZOLOFT, because she felt the ZOLOFT was making things worse. The consumer feels the combination of the BIOTHRAX vaccine, CHANTIX and ZOLOFT has caused her events, since she feels that they all stimulate the nervous system. The consumer stopped taking CHANTIX, in May2007, because she was at a military training school and ran out of medication. The consumer smokes a half pack of cigarettes daily and her doctors want her to go for testing for her events, but the consumer refuses to go to the hospital. The consumer has had no relevant laboratory testing. As of 10Oct2007, the consumer is no longer taking ZOLOFT, CHANTIX, or BIOTHRAX vaccine. The consumer continues to be depressed, morning sickness, feels terrible, her family thinks she is nuts, has weight gain, anxiety, frustrated, something is neurologically wrong, feels like a lunatic, still hurts, and has motion sickness. Is unknown if the consumer has resolved from the ZOLOFT making things worse. The consumer works for a civilian company that is trying to go smoke free. She has five children and five grandchildren she used to take care of. The consumer gets her medications locally.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Dysphagia, Eye swelling, Paraesthesia oral, Salivary hypersecretion, Throat irritation
Clinical narrative: A 46-year-old female patient has been using DEPO-PROVERA injections for contraception for several years and she usually sneezed immediately after receiving one of them. She was administered her most recent 150mg intramuscular injection on 05Aug03 and, on this occasion, her eyes became puffy, her tongue and throat was tingling and tight, and she started swallowing frequently with an over production of saliva. The patient also received intramuscular BIOTHARX vaccine. The outcome of the event is unknown. The reported considered the reactions to be serious as life-threatening. Submission of a report does not constitute an admission that the medical personnel, user facility, distributor, manufacturer of product caused or contributed to the event.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Throat tightness
Clinical narrative: A 46-year-old female patient has been using DEPO-PROVERA injections for contraception for several years and she usually sneezed immediately after receiving one of them. She was administered her most recent 150mg intramuscular injection on 05Aug03 and, on this occasion, her eyes became puffy, her tongue and throat was tingling and tight, and she started swallowing frequently with an over production of saliva. The patient also received intramuscular BIOTHARX vaccine. The outcome of the event is unknown. The reported considered the reactions to be serious as life-threatening. Submission of a report does not constitute an admission that the medical personnel, user facility, distributor, manufacturer of product caused or contributed to the event.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain upper, Back injury, Back pain, Dry mouth, Fatigue
Clinical narrative: Injured my back at work lifting a automotive transmission. Doctor determined the swelling of my back was a muscle spasm. Prescribed me a 120 day supply of cyclobenzaprine and naproxen and sent me back to work. For a few weeks I tolerated the pain but eventually had to see a doctor. Saw a doctor but the new policy is not to give pain killers to people with back injuries, I was sent away. Again was late for work 8 times and had to see a doctor. Pain in the middle of my back feels like a knife stabbing in between the vertebrae in the middle of my back. Doctor again said there was nothing he could do. Went on like this for total of 4  months. I have experienced sleeplessness, go 2-3 days without sleep, finally collapsing from exhaustion. Nauseous, dry mouth and stomach ache-ulcer? Still have back pain which is severe enough I can not stand or sir for prolonged periods. Have trouble sleeping. Believe these to be side effects of cyclobenzaprine for taking it for 4 months. 15JUL01-22JUL01 Confined. 28JUL01 Physical therapy - conducted hot-cold pack therapy and electro-shock therapy- 08JUL01, 15JUL01, 22JUL01
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Insomnia, Muscle spasms, Nausea, X-ray
Clinical narrative: Injured my back at work lifting a automotive transmission. Doctor determined the swelling of my back was a muscle spasm. Prescribed me a 120 day supply of cyclobenzaprine and naproxen and sent me back to work. For a few weeks I tolerated the pain but eventually had to see a doctor. Saw a doctor but the new policy is not to give pain killers to people with back injuries, I was sent away. Again was late for work 8 times and had to see a doctor. Pain in the middle of my back feels like a knife stabbing in between the vertebrae in the middle of my back. Doctor again said there was nothing he could do. Went on like this for total of 4  months. I have experienced sleeplessness, go 2-3 days without sleep, finally collapsing from exhaustion. Nauseous, dry mouth and stomach ache-ulcer? Still have back pain which is severe enough I can not stand or sir for prolonged periods. Have trouble sleeping. Believe these to be side effects of cyclobenzaprine for taking it for 4 months. 15JUL01-22JUL01 Confined. 28JUL01 Physical therapy - conducted hot-cold pack therapy and electro-shock therapy- 08JUL01, 15JUL01, 22JUL01
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Oedema peripheral, Rash, Rash macular
Clinical narrative: A poison like rash on hands, feet, and back of neck.  Macular rash hands neck. Sl edema of hands. VS stable (see note).
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Flushing, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: Awoke with sore throat, runny nose, and general ill feeling. Noted muscle aches, face flushed with sensation of warmth. Treated self with Zyrtec and Ibuprofen and OTC decongestant.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Rhinorrhoea
Clinical narrative: Awoke with sore throat, runny nose, and general ill feeling. Noted muscle aches, face flushed with sensation of warmth. Treated self with Zyrtec and Ibuprofen and OTC decongestant.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Blood test normal, Cardiac stress test normal, Chest pain, Electrocardiogram normal
Clinical narrative: As reported by subject: Deployed in Feb 2003. Healthy before and during deployment. In 2004, within months of return from a foreign country, he experienced fatigue, general ill feeling and left sided face pain. Had Anthrax vaccine #4 21FEB04. Seen in clinic, diagnosis of nerve damage in face, possibly related to sinus problems, or dental problems, or dental problems or accidental injury during combat. Had x-ray of sinus which showed deviated septum. Had several office outpatient surgeries since 2004 for deviated septum and sinus problems. Also had significant dental work done. Treatments have not changed left sided face pain. Complained of back pain. MRI in 2008 showed degenerative arthritis. MRI also showed mass in back diagnosed as lipoma. Chest pain in 2008, blood work, EKG and stress test were WNL. Has difficulty sleeping at night and is tired all the time. Sleep study diagnosed sleep apnea. Treatment with CPAP machine has not corrected the tiredness. 2009 diagnosed with gout.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Facial pain, Fatigue, Insomnia, Lipoma, Malaise
Clinical narrative: As reported by subject: Deployed in Feb 2003. Healthy before and during deployment. In 2004, within months of return from a foreign country, he experienced fatigue, general ill feeling and left sided face pain. Had Anthrax vaccine #4 21FEB04. Seen in clinic, diagnosis of nerve damage in face, possibly related to sinus problems, or dental problems, or dental problems or accidental injury during combat. Had x-ray of sinus which showed deviated septum. Had several office outpatient surgeries since 2004 for deviated septum and sinus problems. Also had significant dental work done. Treatments have not changed left sided face pain. Complained of back pain. MRI in 2008 showed degenerative arthritis. MRI also showed mass in back diagnosed as lipoma. Chest pain in 2008, blood work, EKG and stress test were WNL. Has difficulty sleeping at night and is tired all the time. Sleep study diagnosed sleep apnea. Treatment with CPAP machine has not corrected the tiredness. 2009 diagnosed with gout.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Mass, Nerve injury, Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Sleep apnoea syndrome
Clinical narrative: As reported by subject: Deployed in Feb 2003. Healthy before and during deployment. In 2004, within months of return from a foreign country, he experienced fatigue, general ill feeling and left sided face pain. Had Anthrax vaccine #4 21FEB04. Seen in clinic, diagnosis of nerve damage in face, possibly related to sinus problems, or dental problems, or dental problems or accidental injury during combat. Had x-ray of sinus which showed deviated septum. Had several office outpatient surgeries since 2004 for deviated septum and sinus problems. Also had significant dental work done. Treatments have not changed left sided face pain. Complained of back pain. MRI in 2008 showed degenerative arthritis. MRI also showed mass in back diagnosed as lipoma. Chest pain in 2008, blood work, EKG and stress test were WNL. Has difficulty sleeping at night and is tired all the time. Sleep study diagnosed sleep apnea. Treatment with CPAP machine has not corrected the tiredness. 2009 diagnosed with gout.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep study abnormal, X-ray abnormal
Clinical narrative: As reported by subject: Deployed in Feb 2003. Healthy before and during deployment. In 2004, within months of return from a foreign country, he experienced fatigue, general ill feeling and left sided face pain. Had Anthrax vaccine #4 21FEB04. Seen in clinic, diagnosis of nerve damage in face, possibly related to sinus problems, or dental problems, or dental problems or accidental injury during combat. Had x-ray of sinus which showed deviated septum. Had several office outpatient surgeries since 2004 for deviated septum and sinus problems. Also had significant dental work done. Treatments have not changed left sided face pain. Complained of back pain. MRI in 2008 showed degenerative arthritis. MRI also showed mass in back diagnosed as lipoma. Chest pain in 2008, blood work, EKG and stress test were WNL. Has difficulty sleeping at night and is tired all the time. Sleep study diagnosed sleep apnea. Treatment with CPAP machine has not corrected the tiredness. 2009 diagnosed with gout.