chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebral infarction, Cerebrovascular accident, Gastroenteritis, Laboratory test abnormal
Clinical narrative: 7 year old with onset of gastroenteritis symptoms 2/13/05. Subsequently had positive brain scan determined to be cerebral infarction.
Age: 41.0
Sex: M
Vaccine: JEV
Symptoms: Pruritus, Rash papular
Clinical narrative: States developed "palm sized red bumpy" rash on mid abdomen within 24 hours post administration of second JE Vax vaccine, associated with itching. No respiratory involvement. No reaction after first JE Vax. Self treated with aloe vera. Did not see doctor.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Left arm swelling, redness and tenderness.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received 3 immunizations in the left thigh, which is tender to the touch, red, warm and swollen. Patient is afebrile.
Age: 26.0
Sex: M
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Rash pruritic
Clinical narrative: On 02/25/05, after receiving vaccinations and a PPD, client states rash on trunk area (abdomen and back areas). The rash was itchy, pink raised areas, pinpoint in size. Patient was afebrile. History of this rash for 2 years, exacerbated by vaccines on
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Few scattered red bumps with blisters on chest, back and calf.
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Drug ineffective
Clinical narrative: Information regarding Hib-titer Vaccine (haemophilus b conjugate vaccine(diphtheria crm 197 protein conjugate)injection) was received from a physician, the mother of a 7 year old male patient who, experienced decreased immune responsiveness after having completed a primary series of Hib-titer at 15 months of age, in 07/1997. Product Details: Indication for HIb-titer vaccine was immunization. Product series was administered in 06/1996, 08/1996,  10/1996, and completed in 07/1997. Dose regimen was 0.5ml 1 time per day (IM). Concomitant therapy: concomitant therapy included Tri-Immunol Vaccine(diphtheria and tetanus toxoids and pertussis vaccine absorbed injection, and Orimune vaccine (poliovirus live oral trivalent solution). Event Details: On 05/21/2004 a physician the mother of a 7 year old male patient reported that her son received 4 doses of Hib-titer, the first dose at 2 months of age(06/96), second dose at 4 months of age(08/96), the third dose at 6 months of age(10/96) and in 07/1997 at 15 months of age, received his fourth dose completing his primary series. The reporter indicated that because her son has suffered with "chronic sinusitis, treated with various antibiotics" since he was 9 months old and since he "tested positive for Haemophilus B", after a throat culture was performed in 12/2003, she decided to "do a titer to see if he had acquired adequate immunity from Hib-titer". On 04/01/2004, a  titer was performed, which resulted in a titer of 0.35. The reporter stated,  "an optimum level would be 1.0". Since her son had a " sub-optimal response to Hib-titer(decreased immune responsiveness), she was considering re-vaccination to get good immunity. "the reporter also stated that her son's physician, where all the child's vaccines were administered, was not aware of the sub-optimal response to the hib-titer. Test Results: Culture Throat (results "positive for Haemophilus B and Streptococcus) was done in 12/2003. Antibody test(results:"antibody titer showed titer of 0.35.") was done on 04/01/2004. No additional information was available at the time of the report.
Age: 0.15
Sex: M
Vaccine: DTP, HEP, HIBV
Symptoms: Hemihypertrophy
Clinical narrative: Information regarding Haemophilus Influenza B vaccine (manufacturer unknown) was received from mother regarding her 9 year old son, who, as an infant, developed shaking of his one arm and one leg, and was diagnosed with hemi-hypertrophy. At 1 month of age, the patient received his first dose on 01/15/1995.
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Rash maculo-papular
Clinical narrative: Yellow fever vaccination given 02/07/05. Patient called on 02/21/05 stating she had developed a maculo-papular rash, no other symptoms. Viral URI resolved the week before vaccine was given. Follow up call on 02/23/05 indicates rash resolving.
Age: 22.0
Sex: U
Vaccine: LYME
Symptoms: Amnesia, Anxiety, Arthralgia, Arthritis, Asthenia
Clinical narrative: Chronic Lymes, tired, weak, aching bones, osteo arthritis in left shoulder. Fast heart rate memory loss, focus eye problems. Skin lesions Chronic respiratory cough. Additional symptoms noted: cognitive problems, sleeping alot, anxiety, depression. Per follow up report received on 05/16/2005:  Patient still had Lyme's Disease.  Still being treated with antibiotics.  Has vision problems and vertigo on a regular basis.  Short term memory loss.  Left shoulder has arthritis.  Diagnosed with Degenerative Arthiritis in left AC joint. Per follow up report- Patient still suffers from including but not limited to dizziness, eye sight problems, head pressure with head aches, brain fog. Nausea, weakness, trembling. Difficult word finding, heart palpitations. Disorganization with thoughts. Depressed and tired. Muscle twitching, skin rashes. Joint pain in my back, knees, shoulders mostly. Now question of seizures? Just want to feel better. Be able to work out at the gym and not suffer from it. This has been going on for too long. Trouble sleeping.
Age: 22.0
Sex: U
Vaccine: LYME
Symptoms: Asthenia, Cognitive disorder, Cough, Depression, Dizziness
Clinical narrative: Chronic Lymes, tired, weak, aching bones, osteo arthritis in left shoulder. Fast heart rate memory loss, focus eye problems. Skin lesions Chronic respiratory cough. Additional symptoms noted: cognitive problems, sleeping alot, anxiety, depression. Per follow up report received on 05/16/2005:  Patient still had Lyme's Disease.  Still being treated with antibiotics.  Has vision problems and vertigo on a regular basis.  Short term memory loss.  Left shoulder has arthritis.  Diagnosed with Degenerative Arthiritis in left AC joint. Per follow up report- Patient still suffers from including but not limited to dizziness, eye sight problems, head pressure with head aches, brain fog. Nausea, weakness, trembling. Difficult word finding, heart palpitations. Disorganization with thoughts. Depressed and tired. Muscle twitching, skin rashes. Joint pain in my back, knees, shoulders mostly. Now question of seizures? Just want to feel better. Be able to work out at the gym and not suffer from it. This has been going on for too long. Trouble sleeping.
Age: 22.0
Sex: U
Vaccine: LYME
Symptoms: Fatigue, Headache, Laboratory test abnormal, Nausea, Osteoarthritis
Clinical narrative: Chronic Lymes, tired, weak, aching bones, osteo arthritis in left shoulder. Fast heart rate memory loss, focus eye problems. Skin lesions Chronic respiratory cough. Additional symptoms noted: cognitive problems, sleeping alot, anxiety, depression. Per follow up report received on 05/16/2005:  Patient still had Lyme's Disease.  Still being treated with antibiotics.  Has vision problems and vertigo on a regular basis.  Short term memory loss.  Left shoulder has arthritis.  Diagnosed with Degenerative Arthiritis in left AC joint. Per follow up report- Patient still suffers from including but not limited to dizziness, eye sight problems, head pressure with head aches, brain fog. Nausea, weakness, trembling. Difficult word finding, heart palpitations. Disorganization with thoughts. Depressed and tired. Muscle twitching, skin rashes. Joint pain in my back, knees, shoulders mostly. Now question of seizures? Just want to feel better. Be able to work out at the gym and not suffer from it. This has been going on for too long. Trouble sleeping.
Age: 22.0
Sex: U
Vaccine: LYME
Symptoms: Skin lesion, Somnolence, Tachycardia, Tremor, Vertigo
Clinical narrative: Chronic Lymes, tired, weak, aching bones, osteo arthritis in left shoulder. Fast heart rate memory loss, focus eye problems. Skin lesions Chronic respiratory cough. Additional symptoms noted: cognitive problems, sleeping alot, anxiety, depression. Per follow up report received on 05/16/2005:  Patient still had Lyme's Disease.  Still being treated with antibiotics.  Has vision problems and vertigo on a regular basis.  Short term memory loss.  Left shoulder has arthritis.  Diagnosed with Degenerative Arthiritis in left AC joint. Per follow up report- Patient still suffers from including but not limited to dizziness, eye sight problems, head pressure with head aches, brain fog. Nausea, weakness, trembling. Difficult word finding, heart palpitations. Disorganization with thoughts. Depressed and tired. Muscle twitching, skin rashes. Joint pain in my back, knees, shoulders mostly. Now question of seizures? Just want to feel better. Be able to work out at the gym and not suffer from it. This has been going on for too long. Trouble sleeping.
Age: 22.0
Sex: U
Vaccine: LYME
Symptoms: Viral infection, Visual disturbance
Clinical narrative: Chronic Lymes, tired, weak, aching bones, osteo arthritis in left shoulder. Fast heart rate memory loss, focus eye problems. Skin lesions Chronic respiratory cough. Additional symptoms noted: cognitive problems, sleeping alot, anxiety, depression. Per follow up report received on 05/16/2005:  Patient still had Lyme's Disease.  Still being treated with antibiotics.  Has vision problems and vertigo on a regular basis.  Short term memory loss.  Left shoulder has arthritis.  Diagnosed with Degenerative Arthiritis in left AC joint. Per follow up report- Patient still suffers from including but not limited to dizziness, eye sight problems, head pressure with head aches, brain fog. Nausea, weakness, trembling. Difficult word finding, heart palpitations. Disorganization with thoughts. Depressed and tired. Muscle twitching, skin rashes. Joint pain in my back, knees, shoulders mostly. Now question of seizures? Just want to feel better. Be able to work out at the gym and not suffer from it. This has been going on for too long. Trouble sleeping.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Vaccine given at 9:30 AM by 5 PM left arm hard, sore and swollen but no redness. This AM arm much more swollen. Left arm 36cm in circumference and right arm 33cm in circumference. 9'x6' reddened hard area shoulder to elbow.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Demyelination, Hypokinesia, Laboratory test abnormal, Nausea
Clinical narrative: Influenza vaccine given on 12/10/04. 1/24/05: URI symptoms. 1/25: shoveled snow. 1/26: Nausea, vomiting, weakness. 1/27: Lost movement and feeling in lower half of body. Per follow up report received 05/06/2005:  Patient still has paraplegia and bladder control symptoms.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Upper respiratory tract infection, Vomiting, White blood cell disorder
Clinical narrative: Influenza vaccine given on 12/10/04. 1/24/05: URI symptoms. 1/25: shoveled snow. 1/26: Nausea, vomiting, weakness. 1/27: Lost movement and feeling in lower half of body. Per follow up report received 05/06/2005:  Patient still has paraplegia and bladder control symptoms.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Hypertonia, Pain, Parkinsonism
Clinical narrative: Right arm was like a ball of fire, a knot with fingers squeezing constantly. Very Very intense pain. Had physical therapy and massages.
Age: 1.32
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Parent states patient had fever last night. Temperature was 97.6 at 2 PM on 02/24/05. Right thigh was warm, red, swollen superior to injection site. Parent advised to ice area. Alternate Tylenol with ibuprofen. Return to clinic if fever continues.
Age: 16.0
Sex: M
Vaccine: HEPA, TD, VARCEL
Symptoms: Headache, Skin ulcer
Clinical narrative: Lesions over general body area with headache.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Dysphagia, Flushing, Hypotonia, Tremor
Clinical narrative: Felt dizzy following shot. Developed tremors of arms and legs. (BP 166/97, P 117) Bright red flush on face and neck. BP rose to 200/100, throat was dry and she couldn't swallow well. 911 was called. Oxygen applied by 911 EMS personnel, IV started. Arms and legs flaccid, patient was unable to move them. No respiratory distress. In ER for 2 hours given vistaril.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Faeces pale, Fatigue
Clinical narrative: Prescription from Vivotif Berna given to patient on August 3, 2004. After filling prescription, patient called on 08/19/04, stating she took 2nd pill on 08/06/04 and developed yellow/orange stools, fatigue, abdominal cramping but no fever. On 08/31/04, all symptoms resolved, after possible treatment from doctor.
Age: 1.18
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pyrexia
Clinical narrative: Chicken pox, fever and blisters. Treated with Aveeno, Benadryl and fever control.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Skin-left arm, erythema, warmth, redness, down to elbow and circumferentially around arm + excoriation on left arm.
Age: 52.0
Sex: M
Vaccine: PPV, TD
Symptoms: Urticaria
Clinical narrative: Hives
Age: 1.23
Sex: F
Vaccine: DTAPH, MMR, PNC
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Rash diffuse erythematous macules
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching/hives beginning approx. one day after tetanus toxoid injection. Rash subsided somewhat but still present 2 weeks after injection. Donor took prednisone Rx for treatment. Advised to use Aveeno bath and Benadryl, topical or oral.
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Nausea
Clinical narrative: Approx 10 min after tetanus toxoid injection was given donor c/o lightheadedness/dizziness and nausea which lasted approx 20 min. Donor sat in plasma center until sx subsided and then left.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Within 24 hours of receiving IPV and DTaP in Right thigh on 08/4/04, pt had onset of redness, swelling locally.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Feeling hot, Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: Mom states pt c/o right arm pain after immunization. Tylenol given with some relief, pain continued through the night. Pt awoke with a swollen deltoid area, warm to touch and erythema surrounding injection site approx 5" x 2 1/2". Pt also c/o having difficulty breathing x 1 1/2-2 hrs on and off and her throat was sore and clogged. Pt was able to swallow breakfast, ice applied, swelling reduced, no Benadryl given by mom prior to visit in office. At office visit, mild swelling and erythema 5x 2 1/2" tender, warm, difficult ROM in R arm, pain. Tx: Benadryl 96 hrs, ice prn, enc ROM call with increased s/s, SOB prn
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nasal congestion, Pharyngolaryngeal pain, Tenderness
Clinical narrative: Mom states pt c/o right arm pain after immunization. Tylenol given with some relief, pain continued through the night. Pt awoke with a swollen deltoid area, warm to touch and erythema surrounding injection site approx 5" x 2 1/2". Pt also c/o having difficulty breathing x 1 1/2-2 hrs on and off and her throat was sore and clogged. Pt was able to swallow breakfast, ice applied, swelling reduced, no Benadryl given by mom prior to visit in office. At office visit, mild swelling and erythema 5x 2 1/2" tender, warm, difficult ROM in R arm, pain. Tx: Benadryl 96 hrs, ice prn, enc ROM call with increased s/s, SOB prn
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Demyelination, Fatigue, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: 8 days with vaccine lymph nodes developed on both sides neck, 13 days rash demyelination then overwhelming fatigue, intermittent sore throat, joints ache.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 8 days with vaccine lymph nodes developed on both sides neck, 13 days rash demyelination then overwhelming fatigue, intermittent sore throat, joints ache.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Developed flat rash 2/7/05 on neck, face, back, and chest, temp of 102. Resolved 2 days later.
Age: 10.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site mass, Rash erythematous, Rash macular
Clinical narrative: 9 x 10 cm indurated macular erythematous patch.
Age: 16.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site pain
Clinical narrative: Care given state he c/o arm being very sore and stayed in bed for the morning the next day. Was not reported till 02/11/05.
Age: 1.5
Sex: U
Vaccine: DTP
Symptoms: Injection site oedema
Clinical narrative: 16 month old had extremely swollen thigh after receiving the 4th DTaP.
Age: 0.34
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: 2 days after vaccines pt began crying on and off for a period of 10 days. No further problems after that. Mom says she has been crying for 10 days constantly.
Age: 1.66
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Feeling hot, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: 2/15/05 woke up crabby by nap time, fever 103F given bath to decrease temp. Noticed red (PM), hot area on lt thigh, injection site, favored lt leg, vomit AM 2/16/05.
Age: 22.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor, Paraesthesia
Clinical narrative: Post immunization lightheadedness, pale, hot, diaph skin, tingling in his head from watching injection, lasting 5-10 mins, laid pt on bed, legs elevated, 500ml water.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Client was lightheaded, dizzy, and then passed out. She continued to feel dizzy and lightheaded the rest of the day. The next day she was fine. It happened at school, right after lunch.
Age: 26.0
Sex: M
Vaccine: TTOX
Symptoms: Arthralgia, Feeling hot, Headache, Injection site pain, Injection site rash
Clinical narrative: Pt received the tetanus shot on 02/14/05 at 3:45PM. He returned to center on 02/17/05. His arm was red approx 6" in diameter around immunization sight. He stated it was painful. Also rash at sight, hot to touch. Also, complained of joint pain and headache. Donor went to the local emergency room and was told it was a reaction to the tetanus shot.
Age: 1.38
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness, raised skin, temp  24 hrs after vaccination. Benadryl.
Age: 22.0
Sex: F
Vaccine: FLU3, SMALL, TYP
Symptoms: Medication error, Unintended pregnancy
Clinical narrative: Patient was undergoing predeployment processing on 07 Feb 05. The Smallpox vaccination was administered following a urine HcG test. On 28 Feb 2005, the patient notified me that she had a positive home pregnancy test.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pain, Pyrexia, Skin ulcer
Clinical narrative: Patient broke out all over body with water blisters and open sores. Patient had a fever of 99.2. More than 100 sores were present 48 hours after vaccine. Patient was taken to clinic 72 hours after vaccine because of the excrutiating pain. Doctor prescribed anti-viral medication, Acyclovir, to be taken for 5 days.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Hyperhidrosis, Hypoaesthesia, Thermal burn, Throat tightness
Clinical narrative: Dose Administered at 5pm on 02-25-05.  6:15pm on same day employee began symptoms of tightness in throat, bilat hand numbness, face burning, diaphoretic, no dyspnea.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Mild case of chicken pox.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm red and swollen.  Warm to touch without tenderness.  Good movement.  Placed on short course of steroids.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Possible vaccine failure. Varicella lesions erupted 02/23/05. Less than 50 lesions.
Age: 42.0
Sex: M
Vaccine: DT, HEPA, TYP, YF
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Myalgia, Nausea
Clinical narrative: Patient  developed sudden onset of myalgias, nausea, vomiting, abdominal pain, fever, RLQ pain and chills on afternoon of 2/23/05. Yellow fever vaccine was administered on 2/22/05. Patient hospitalized on 2/24/05 and an appendectomy was performed. Patient discharged next day without complications.
Age: 42.0
Sex: M
Vaccine: DT, HEPA, TYP, YF
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient  developed sudden onset of myalgias, nausea, vomiting, abdominal pain, fever, RLQ pain and chills on afternoon of 2/23/05. Yellow fever vaccine was administered on 2/22/05. Patient hospitalized on 2/24/05 and an appendectomy was performed. Patient discharged next day without complications.
Age: 1.57
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site swelling, Skin nodule, Tenderness
Clinical narrative: Patient developed swelling at injection site which is still noted almost one month after vaccination. Parents uncertain which of 2 vaccines the child received at that site. The child is not limping, but the parents state the area seems tender when the child is bathed. On examination there is a subcutaneous nodule, pea sized, on the left lateral thigh. There is no overlying erythema, and there is no apparent tenderness.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Agitation, Screaming
Clinical narrative: Within 1/2 hour, child started acting agitated. Started screaming non-stop for 5 hours per mother.
Age: 0.52
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Temperature of 101 F.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, red skin on left deltoid within 4 to 6 hours after immunization. At time of visit, had grown to approximately 8cm x 4cm. Mother instructed to observe & return to clinic if no improvement.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Influenza like illness, Nausea, Visual disturbance, Vomiting
Clinical narrative: She received her pneumococcal vaccine upon hospital discharge on 2/24/05 at 1030am.  Pt went home and developed flu-like symptoms with nausea/vomiting/diarrhea during the next 24-48 hours.  After experiencing "blackness" in her vision - she reported to a ER.  She was found to have a SCr of 6.9.
Age: 0.53
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Parent reports after first .25cc dose of influenza vaccine on 1/31/05 patient had unconsolable crying for 12 hours and temperature as high as 101.9 not reduced by Tylenol. Parent called hospital advice RN, was told to place patient in cool/lukewarm bath to decrease temperature, Parent stated it worked, fever broke and crying stopped.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen area on Right thigh.  Area 11X6 inches.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Client returned with complaint of pain in left side of neck, right shoulder, and lower left side of arm after receiving flu shot 2 hours prior.
Age: 37.0
Sex: F
Vaccine: ANTH, RAB
Symptoms: Arthralgia, Fibromyalgia, Influenza like illness, Joint swelling, Musculoskeletal stiffness
Clinical narrative: I began feeling joint pain and stiffness all over my body in June of 1997 and in addition to that, I always felt like I was on the verge of getting the flu. I toughed it out until Spring of 1998, when my knees became ver swollen and doubled in size after going up and down a ladder a few times. I went to the doctor on 06/02/98. He prescribed 1000 mg daily of Naproxen and that reduced the swelling in my joints as long as I kept taking it. Over the next month, I felt a little better and the flu like symptoms finally subsided after a year, as long as I kept taking the Naproxen. I was still very stiff and sore so I went to an Osteopathic doctor on 07/20/1998. He diagnosed the severe stiffness, soreness joint pain and flu like symptoms as fibromyalgia. He prescribed physical therapy on 07/29/98 and continued treatment until 09/09/98. I currently have been changed from Naproxen to 20 mg daily of Bextra to relieve the fibromyalgia symptoms. As long as I continue the Bextra I can tolerate most normal activity.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Eye disorder, Laboratory test abnormal, Retinal disorder, Visual acuity reduced
Clinical narrative: One week after receiving second anthrax vaccine dose patient noted decreased vision in her left eye. On initial examination visual activity measured 20/25 in right eye and 20/70 in the left. Intraocular pressures were 12 mmHg bilaterally. Slit lamp examination results were normal. Fundoscopic examination of the right eye eye had normal results. The left fundus showed subretinal fluid within the central macula. Fluorescein angiography revealed a focus hyperfloresence in early transit followed by late leakage and pooling consistent with CSC. The results were review with the patient and vaccinations were halted, and she has been examined monthly. Her visual acuity remained at 20/100 in her left eye for 3 months and slowly improved. Seven months after presentation the vision in her left eye measured 20/30 so a mild visual deficit still remains. This report is may be a duplicated of VAERS case 197330.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Injection site induration, Myalgia
Clinical narrative: Joint pain in both shoulders and elbows (arthralgia) muscle aches (myalgia) 26 year old female described joint pain in both shoulders and both elbows, left greater than right and mucscle aches on left side only. Noted to begin on 01/07/2004. She was seen by a physician on 01/16/2004, Upon exam at Occupational Health Clinic 01/16/2004, chest clear, BP 120/80, Heart RR, ext, no edema, small induration to left arm, 1-2cm in diameter, mild discomfort to bicipital tendons at both shoulder, NL exams of elbows, NL liver and spleen. As of 02/03/2004 all symptoms have resolved. Occupational Health Service on 01/23/2004 recommended Zyrtec or Claritin prior to next Anthrax vaccination. Patient had point tenderness to both shoulders over deltoid bursa-more on the left than the right, NL ROM, NL neuro exam.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema multiforme, Rash
Clinical narrative: Member presented with a pruritic rash that had developed on his face approximately 12 hours after receiving his 5th Anthrax vaccination. The rash had spread to his torso and lower extremities. Findings of  punch biopsy felt to be consistent with an erythema multiform reaction. The patient was treated wtih a 2 week course of prednisone and intramuscular diphenhydramine(Benadryl), and clearing of symptoms was noted within 10 days.
Age: 42.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Anorexia, Arthralgia, Chills, Injection site nodule, Joint stiffness
Clinical narrative: As reported, a 42 year old Caucasian with history of arrhythmia after ASD repair developed stiffness followed by pain of his knees and all proximal interphalangeal (PIP) joints starting day 5 after the first anthrax vaccine dose (lot FAV064). Chills, fever, joint and neck pain with nodule at injection site occurred with Dose 2 (lot FAV066). Dose 3 associated with fever, chills, nausea, vomiting, neck, hand and shoulder pain. Doses 2 and 3 were coupled with Typhoid VI and Yellow Fever respectively with no known prior adverse reaction to either vaccine. Symptoms of pain and stiffness persisted for 9 months with anorexia and 6.8 kg weight loss. Physical exam revealed swelling of bilateral PIP joints with presence of Bouchard's nodules. Vaccination was terminated after the third dose.
Age: 42.0
Sex: M
Vaccine: ANTH, YF
Symptoms: Joint swelling, Neck pain, Pyrexia, Rheumatoid factor, Weight decreased
Clinical narrative: As reported, a 42 year old Caucasian with history of arrhythmia after ASD repair developed stiffness followed by pain of his knees and all proximal interphalangeal (PIP) joints starting day 5 after the first anthrax vaccine dose (lot FAV064). Chills, fever, joint and neck pain with nodule at injection site occurred with Dose 2 (lot FAV066). Dose 3 associated with fever, chills, nausea, vomiting, neck, hand and shoulder pain. Doses 2 and 3 were coupled with Typhoid VI and Yellow Fever respectively with no known prior adverse reaction to either vaccine. Symptoms of pain and stiffness persisted for 9 months with anorexia and 6.8 kg weight loss. Physical exam revealed swelling of bilateral PIP joints with presence of Bouchard's nodules. Vaccination was terminated after the third dose.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Otitis media, Tenderness
Clinical narrative: Received 1st vaccine 3/17/00. That night and over the next few days the injection site went very red and became swollen and tender. Also experienced a couple of transient/short term mild ear infections 3/18/00-3/30/00.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Skin nodule
Clinical narrative: Subject started with Anthrax vaccine Jan-Feb 2000 and has several shots since (latest being 8/16/03). By Oct03, subject had developed six nodules on his body, including his back.
Age: 41.0
Sex: M
Vaccine: ANTH, MMR, TTOX
Symptoms: Pruritus, Rash erythematous, Rash maculo-papular
Clinical narrative: Pt developed generalized, red, raised rash on body from the neck down, not on face. Some itching. Vaccinations (AVA, MMR and Tetanus) given 3/2/04, pt at shrimp that night, also exposed to a ferret that night. Rash developed the following day 3/3/04). 4/8/04, follow up phone call from nurse stating pt is doing fine now, no rash.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymphadenitis
Clinical narrative: Swelling at site of injection 3 inches x 3 inches. Swollen lymph nodes under arm. Area of swelling hot to touch. Sore and tender in area of swelling. Subject seen at clinic 8/3/04 for second dose of AVA. All previous adverse event symptoms from dose # have resolved as of 7/31/04 per subject.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Rash papular
Clinical narrative: Pimple like rash over abdomen at waist, upper back, on right side and over both thighs. Rash is very itchy. No drainage noted. She states she felt itching before rash erupted. She was seen at the occupational health center on 09/20/04 for evaluation. Advised to use Benadryl po and topical for treatment. The rash was completely healed by about the 8ht of October.
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: A short time after receiving the anthrax vaccine, this individual came back to the clinic complaining of shortness of breath/difficulty breathing. His heart rate was high and he was sent to the family practice clinic, where he was given epinephrine and sent to ER. Reporter was later told that this subject had a previously unknown "unusual health condition". Reporter couldn't recall what the condition was. Reporter states that a VAERS report was submitted. Subject recovered.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral, Pain
Clinical narrative: A 27 year old male reported a " negative reaction after injection", a painful and swollen arm. Pt did not want to take any more injections. He was shortly afterwards terminated from employment due to repeatedly positive testing for illicit drug use and has been lost to follow up.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Chest pain, Headache, Nausea
Clinical narrative: Patient developed abdominal cramping and nausea 3 hours after receiving AVA. He was pre-treated with 5 mg of valium for "shot Phobia". Mild headache. Pain 8/10, then dropped to 1-2/10 following antacids. Temperature 99.7 to 97.9, BP 120/80, P83. No vomiting, shortness of breath, diarrhea or diaphoresis. Looked calm, good skin color. Patient has recovered. The cramps lasted approximately 36 hours. Patient also experienced minor chest pain during that time.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Student received second dose of AVA 4/16/04 in the immunization clinic. On 04/19/04, reported back to nurse with the following symptoms: Right arm red, swollen and warm to touch. Clinic nurse sent her to the affiliated urgent care center where she was treated. She returned to the clinic 04/20/04 and the affected arm was much improved.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Laboratory test abnormal, Neck pain, Psoriasis
Clinical narrative: Patient received 1st dose of AVA on 02/10/99 and developed rash within 3 days on stomach and legs. Rash resolved prior to second dose on 02/24/99. Within a few days the rash came back worse and has never resolved. Rash on face, legs, shins abdomen, genital area. Patient also has joint pains, pain in neck, spine and lower back. Patient received 3 more doses of anthrax vaccine: 03/19/99 FAV033, 08/26/99 FAV039, 02/28/00 FAV024 until military ran out of vaccine. Patient was medically discharged December 2003. Was diagnosed with psoriasis.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Patient received 1st dose of AVA on 02/10/99 and developed rash within 3 days on stomach and legs. Rash resolved prior to second dose on 02/24/99. Within a few days the rash came back worse and has never resolved. Rash on face, legs, shins abdomen, genital area. Patient also has joint pains, pain in neck, spine and lower back. Patient received 3 more doses of anthrax vaccine: 03/19/99 FAV033, 08/26/99 FAV039, 02/28/00 FAV024 until military ran out of vaccine. Patient was medically discharged December 2003. Was diagnosed with psoriasis.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Within 3 days of receiving the anthrax vaccine patient noticed a rash on his abdomen and legs. Rash went away before his second anthrax vaccine on 02/24/99.
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Visual disturbance
Clinical narrative: Father reports son had anthrax vaccine and is having vision problems and muscle fatigue.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Diarrhoea, Fatigue, Feeling hot, Headache
Clinical narrative: At 5 hours after immunization subject felt very tired. Over the next 6 hours, he vomited 5-6 times. Experienced body aches, chills, felt warm, small diarrheal stool and headache. By 03/15/04 subject still with symptoms of headache, also neck pain, photophobia and body aches. Subject seen in ER and a spinal tap was done. Doctor told him that he had an inflammation of the spinal cord related to the vaccine, but did not have meningitis due to infectious process.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Laboratory test abnormal, Neck pain, Pain, Photophobia, Vomiting
Clinical narrative: At 5 hours after immunization subject felt very tired. Over the next 6 hours, he vomited 5-6 times. Experienced body aches, chills, felt warm, small diarrheal stool and headache. By 03/15/04 subject still with symptoms of headache, also neck pain, photophobia and body aches. Subject seen in ER and a spinal tap was done. Doctor told him that he had an inflammation of the spinal cord related to the vaccine, but did not have meningitis due to infectious process.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Hypersensitivity, Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient received IPV, DTAP, MMR, Prevnar 02/23/2005.  That night Mom took child to ER with nausea and vomiting, fever 102 degrees, red-swollen arm (DTAP site) baseball sized.  Sent home after treatment.  Symptoms persisted and went to doctor's office next day.  Told it was "allergic reaction to DTAP".  Treated with Benadryl and Tylenol.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, OPV
Symptoms: Erythema
Clinical narrative: Scattered erythemous papular vescular rash thinly on trunk, few on face and scalp.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Patient called approximated 3 hours after injection complained of abdominal rash and hives, then within 15 minutes later noted tightness in chest, taken to ER.  Where she was given Benadryl injection, observed for a short time and given steroid prescription and released from hospital.
Age: 1.44
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Convulsion, Dysphagia, Irritability, Pyrexia
Clinical narrative: Mom laid child down for nap at 5:00PM, noticed that he "might feel a little warm".  Child slept from 5PM to 6:15PM.  Woke up at 6:15PM irritable and fussy.  Had seizure at 6:45PM, temp 101 after seizure.  Tried to give child Tylenol, but was unable to swallow it.  Went to ER temp was 104.  Child was given Tylenol and monitored and released to parents.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received regarding a case in litigation concerning a patient who on 7/19/99 may have been vaccinated with a dose of hepatitis B virus vaccine. Hepatitis B virus vaccine lot numbers 628825/1399H, 62950/1680H, and 631633/0751J were noted. Subsequently, the patient died. The cause of death was not reported. Lot checks have been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. No additional details were provided.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Arthritis, Bacterial infection, Ear pain, Gait disturbance
Clinical narrative: This is a spontaneous case report sent to a private physician that refers to a male aged 8 years. He received FluMist on 1/17/05 at 1:00 in the afternoon. The patient's concomitant medication included cefdinir. On 1/21/05, the patient presented in the reporters office complaining of left ear pain. He received ciprofloxacin and dexamethasone for treatment of the ear pain. On 1/24/05, the patient developed fever, vomiting, pain in his right leg, right foot, pain in his wrist, and elbow. He complained that he could not walk and could only move his toes. On 1/25/05, he presented in the reporter's office and required hospitalization for group A streptococcal bacteremia, osteomyelitis, and arthritis. He was placed on the general floor and was discharged on 2/11/05. As of 2/22/05, the patient is at home on IV antibiotics, out of school, and using a walker and bed pan. He is recovering slowly. The reporter stated the events were not related to FluMist. 04 Aug 05- Several attemps made to obtain patient's recovery status but unable to. Letter requesting this information was sent to the reporter/ physician.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Osteomyelitis, Pain in extremity, Pyrexia, Sepsis, Streptococcal identification test positive
Clinical narrative: This is a spontaneous case report sent to a private physician that refers to a male aged 8 years. He received FluMist on 1/17/05 at 1:00 in the afternoon. The patient's concomitant medication included cefdinir. On 1/21/05, the patient presented in the reporters office complaining of left ear pain. He received ciprofloxacin and dexamethasone for treatment of the ear pain. On 1/24/05, the patient developed fever, vomiting, pain in his right leg, right foot, pain in his wrist, and elbow. He complained that he could not walk and could only move his toes. On 1/25/05, he presented in the reporter's office and required hospitalization for group A streptococcal bacteremia, osteomyelitis, and arthritis. He was placed on the general floor and was discharged on 2/11/05. As of 2/22/05, the patient is at home on IV antibiotics, out of school, and using a walker and bed pan. He is recovering slowly. The reporter stated the events were not related to FluMist. 04 Aug 05- Several attemps made to obtain patient's recovery status but unable to. Letter requesting this information was sent to the reporter/ physician.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: This is a spontaneous case report sent to a private physician that refers to a male aged 8 years. He received FluMist on 1/17/05 at 1:00 in the afternoon. The patient's concomitant medication included cefdinir. On 1/21/05, the patient presented in the reporters office complaining of left ear pain. He received ciprofloxacin and dexamethasone for treatment of the ear pain. On 1/24/05, the patient developed fever, vomiting, pain in his right leg, right foot, pain in his wrist, and elbow. He complained that he could not walk and could only move his toes. On 1/25/05, he presented in the reporter's office and required hospitalization for group A streptococcal bacteremia, osteomyelitis, and arthritis. He was placed on the general floor and was discharged on 2/11/05. As of 2/22/05, the patient is at home on IV antibiotics, out of school, and using a walker and bed pan. He is recovering slowly. The reporter stated the events were not related to FluMist. 04 Aug 05- Several attemps made to obtain patient's recovery status but unable to. Letter requesting this information was sent to the reporter/ physician.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Tenderness
Clinical narrative: Patient receive yellow fever vaccine on 02/17/05. On 02/20/05 noted tenderness in arm from arm pit to elbow. No outward symptoms.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Drug ineffective, Fall, Injury, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old male who on 1/25/05 was vaccinated with what was thought to be pneumococcal 23v polysaccharide vaccine. On 2/2/05, the patient was found laying next to his bed and taken to the emergency room where he was diagnosed and admitted with pneumonia. He had a fever of 101.6 upon hospital admission. He was treated with azithromycin and ceftriaxone sodium and recovered. It was noted that no symptoms were exhibited before the patient was found on the floor, and he had no complaints of any illness. The patient is still hospitalized because he fell while in the hospital and was being observed. A product quality complaint was not involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Abscess, Malaise, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 7 year old male with chromosome abnormality and no allergies who on 28Jan05 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml). Concomitant therapy included mometasone furoate (Nasonex). On 28Jan05, that afternoon, the pt had a fever and felt sick. The pt had vomiting next day, had an abscess with pus, culture was negative. The pt was admitted to the hospital for 5 days and was treated with an unnamed IV antibiotics. It was reported that the pt's condition had improved and partially resolved. It was also reported that two other pt's had an adverse experience (WAES0502USA03081 and 0502USA03082). Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Cognitive disorder, Neurodevelopmental disorder, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a healthcare professional regarding a 4 year old male patient who experienced developmental delay and weakness of all aspects of language based learning. The patient received the fourth dose of Hib-Titer on 6/27/97. Reported stated no medical history or conditions other than developmental delay. Indication for Hib-Titer vaccine was immunization. Product was administered on 6/27/97. Dose regimen was 1 dose. Additional suspect medication included Orimune vaccine, IPOL, Tetramune Vaccine, Acel-Imune vaccine, Infanrix, MMR II, Varivax, Engerix B, and Hepatitis B vaccine. Concomitant medications were not reported. The patient was diagnosed with developmental delay on 2/5/01. On an undisclosed date, the patient additionally was diagnosed with weakness of all aspects of language based learning. No additional information was available at the time of this report. A copy of this report is being forwarded to the manufacturers of the concomitantly administered vaccines.
Sex: F
Vaccine: PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, a relative of a 3 year old female patient who received a fourth dose of Prevnar on 8/24/03. On 3/24/04, the child developed autism. The patient's concurrent illness includes ear infection (reported as ear tubes were inserted for chronic ear infections). Indication for Prevnar was immunization. Product was administered on 8/24/03. Dose regimen was 1 dose (IM). Additional suspect medication included Hib-Titer vaccine, Act-Hib, Infanrix, MMR II, Varivax, Engerix, Recombivax, and Polio vaccine. Concomitant medications were not reported. On 8/24/03, the patient received a fourth dose of Prevnar. On 3/24/04, the patient developed autism. As of 2/17/05, the patient had not recovered. No additional information was available at the time of this report.
Age: 1.53
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Depressed level of consciousness, Hypoxia, Loss of consciousness
Clinical narrative: On the day after vaccines administered, patient had sudden onset of hypoxia and loss of consciousness. All tests have been negative including brain biopsy. Patient is in a semi-comatose state requiring tube feeding and total care.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Chills, Erythema, Injection site induration, Lymphadenopathy, Malaise
Clinical narrative: Malaise, generalized body aches, chills, temp 102, erythema, induration, tenderness left upper arm from shoulder to elbow. Transient left axillary lymphadenopathy.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Malaise, generalized body aches, chills, temp 102, erythema, induration, tenderness left upper arm from shoulder to elbow. Transient left axillary lymphadenopathy.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Muscle spasms, Rhinorrhoea, Sneezing, Throat tightness
Clinical narrative: Approximately 34.5 hours after receiving vaccination, she experienced muscle cramps in her leg, runny nose, sneezing and sensation that her throat was closing. She said she may have been having a panic attack. She used her nebulizer, took benadryl and a steroid. She had her epi pen by side in case she needed it. The episode lasted 5 minutes.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Child received a single vaccine, influenza 0.5 cc at 3:30 p.m. Parent and provider 10 minutes later notice non itchy urticaria, raised clear rash surrounded by erythema on neck and cheeks. Over 10 minutes this faded and progressed to forearms, upper chest and back. No wheezing. All bumps resolved by the time they reached home 15 to 20 minutes later.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Seizure. Follow up: New onset seizure; evaluated at medical center. Had CT and other work up, seen in office 1/21/05.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, PNC, VARCEL
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Had erythematous maculo-papular rash that began 3 days after the injections, on both thighs and arms. The rash worsened over the next 17 days and th macules have coalesced into patches. The maculo-papular rash spread to lower extremities and onto the dorsum of both feet.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Infection transmission via personal contact, Influenza like illness
Clinical narrative: Child's mother, a pediatrician, received FluMist (LAIV) on the specified date. The child, who did not receive FluMist, became ill with "flu like" symptoms 15 days later. It was reported that the "whole family became ill". An influenza virus (wild type, not vaccine strain) was isolated from the child from a sample taken one day after onset of illness.