chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Otitis media, Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning a 15 month old female who was well at the time of vaccination, who on 02/26/2003 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). On 03/02/2003 at 2 AM the child developed a fever of 101 and then the fever went up to 101-102.3. On 03/03/2003 at 4 AM the child's temperature was 104.3 in one ear and 102.3 in the other ear. It is unknown if medical attention was sought. Follow up information from the health care professional reported that the pt developed otitis media which was diagnosed on 08Mar03 and was treated with amoxicillin and she developed a rash on 11Mar03 (was not seen in office). The health care professional reported on follow up information that the pt recovered. No further information is available.
Age: 1.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Mouth ulceration, Pyrexia
Clinical narrative: Information has been received from a consumer concerning an 18 month old female with no medical history and no allergies who on 02/22/2003 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Concomitant therapy included vaccination with a dose of varicella virus vaccine live (manufacturer unknown) which was given on the same day as the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 02/24/2003 the pt experienced a fever of 102-103 degrees and ulcers in the mouth. The pt was to go to the doctor. Additional info has been requested.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 15 month old pt who on 02/10/2003 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). One week later, on 02/17/2003 the mother said that the child had a fever of 103.5 that lasted about a day and then resolved. Unspecified medical attention was sought. Additional info has been requested.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female pt, with no relevant medical history, who in 1996 and 2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There was no concomitant medication. It was reported that the pt "wasn't hospitalized". The pt was undergoing a health evaluation in an outpatient clinic and a recent titer was negative for rubella. No additional info was available. No specified medical attention was sought. Additional info has been requested.
Age: 11.0
Sex: F
Vaccine: HEP, MMR, TTOX
Symptoms: Erythema, Headache
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old child who on 03/07/2003 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Additional suspect therapy was vaccination on the same day with a second dose of hepatitis B vaccine recombitant (yeast) (MSD) (lot # not reported). Concomitant therapy included vaccination on the same day with a first dose of tetanus toxoid (manufacturer unknown) (lot # not reported). Follow up info received from the nurse stated that the pt had a fever on the evening of the vaccines and for the next 2 days. It was initially reported that on 03/10/2003 the mother reported that the pt had developed a fever and a rash. On follow up it was reported that the mother had called the physician's practice to state that the child had developed a rash and a headache. When the child was seen at the physician's practice on 03/10/2003 there was no rash. Additional follow up info received from the nurse indicated that there was evidence of a local reaction and what had been reported as a rash was only red cheeks with dry skin. Additional info has been requested.
Age: 1.3
Sex: F
Vaccine: HBHEPB, MMR
Symptoms: Convulsion, Laboratory test abnormal, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 16 month old female with no relevant medical history, who on 3/11/03 was vaccinated with MMR (second generation) (lot # 644420/1010M). Additional suspect therapy included vaccination on the same day with a dose of HIB conjugate-Hepatitis B vaccine (lot #644950/1129M). On 3/12/03 the day after vaccination with MMR (second generation) and HIB conjugate-hepatitis B vaccine the patient had a seizure at home. Unspecified medical attention was sought. It was reported that treatment was amoxicillin 400mg daily for 6 weeks. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. Follow up on 06/25/04 states: "Follow up information from the nurse reported the mom had stated that the baby's arms and legs were having spasms. The baby's mouth clenched shut and the baby's color was blue. The duration was reported by the mother to have been 3-5 minutes. The baby had a glazed look in the eye after the spasms stopped and did not focus. The baby was unable to hold her head up and her limbs were limp. The nurse noted seizure and this was reported to have begun at approximately 2:30PM on 03/12/03.  The pt went to the ER and the diagnoses reported were "LOM", febrile seizure and viral syndrome. Lab evaluation revealed: urine + culture was negative, WBC count: 10.7, Bands 6; Hemoglobin normal; Hematocrit normal; Chem 8-normal; Bun-Creat 14.3 ratio 4.1. The pt was treated with Rocephin 500mg IM. Follow up information reported that as of 07/03/03 the pt has not had any more seizures. Upon internal review, febrile seizures was determined to be an other important medical event (OMIC). No further information is available."
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated on an unspecified date with a dose of MMR II (lot # not reported). Immediately upon receiving the vaccination, the patient developed a hard knot just above the injection site (also reported as a knot above administration site). On follow up information, the same physician reported that 2 weeks after the dose, on 05Mar03, the pt developed redness, induration, swelling and tenderness at measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) site. The pt recovered from these events. THe physician also reported that a pt was vaccinated with varicella virus vaccine live and experienced a rash. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Otitis media
Clinical narrative: Information has been received from a nurse concerning a 12 month old female patient with a history of hyperbilirubinemia at birth and no concomitant medication who on Feb 26, 2001 was vaccinated with a dose of MMR II (lot # 635922/0015L). Concomitant therapy on Feb 26, 2001 included a dose of varicella virus vaccine live (lot #1342K not valid for this product). It was reported that the patient was well at the time of vaccination. The patient visited the office on March 2001 for right otitis media. It was also reported that the child was back in the office on March 2001 for a visit and the right otitis media was still present. It was reported that the patient was not hospitalized. Additional information has been requested. The reporter indicated that the patient's sibling also had an experience (WAES0302USA00161).
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Lymphadenopathy, Rash maculo-papular
Clinical narrative: Information has been received from a physician via company representative concerning a 12 month old male patient, with no past medical history or allergies, who on March 7, 2003 at 09:00 was vaccinated with a first dose of MMR II (lot # 63963/1201M) SC into the left arm. Concomitant therapy included varicella virus vaccine live (lot #643822/0866M), a third dose of Streptococcus pneumonia vaccine (Prevnar) (lot # 485-985) IM into the left thigh and fourth dose of HIB conjugate vaccine (ActHIB) (lot # UB431AB) IM into the right thigh. There was no reported illness at the time of vaccination. On approximately Mar 07, 2003 the patient broke out in a rash all over his body and was suffering from a fever. Unspecified medical attention was sought. Follow up information has been received from a physician which indicated that the patient developed a macular papular rash on the chest, face, and back and also developed occipital adenopathy. There were no diagnostic teste performed. The reported indicated that the patient recovered on Mar 22, 2003. Additional information is not expected. It was reported that "five other children" had similar experiences.
Sex: U
Vaccine: MMR
Symptoms: Asthma
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR II. On March 21, 2003, it was reported that the patient developed asthma after receiving MMR II. No further information was provided. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Infection transmission via personal contact, Rash
Clinical narrative: Information has been received from a registered nurse concerning a female patient whose child was vaccinated with a dose of MMR II. Subsequently the mother, whose vaccination history is unknown, broke out in a rash. It was noted that the person with the rash was out of state and the person who called the nurse was going to visit them. It was reported that the nurse has no other information. Unspecified medical attention was sought. Additional information is not expected.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 14 month old female who on Aug 2, 2002 was vaccinated in the right thigh with a first dose of MMR II (lot # 640140/1373L) and in the left thigh with a first dose of varicella virus vaccine live (lot # 640556/0258M). On Nov 01, 2002  the patient was seen in the physician's office for a rash on her back which had started the prior evening. The day of the office visit, the rash was in the patient's chest and torso, and it was not itchy. Examination revealed that the patient was pleasant with a " faint erythematous, mac-pap rash on torso-some on extremities-spares." It was noted that the patient was overall much better and had decreased upper respiratory tract infection and rhinosinusitis symptoms. The physician's assessment was "rashing illness," "rash-viral" questionably secondary to amoxicillin. The patient was to continue amoxicillin, take diphenhydramine hydrochloride (Benadryl) 1/2 tsp TID, and call if the rash spread or increased. On Nov 06, 2002, it was noted that the patient stayed on amoxicillin and the rash decreased. Vaccination records indicated that the patient had been vaccinated with hepatitis B vaccine recombinant (lot # not provided) on Aug 06, 2001: hepatitis B vaccine recombinant (lot # 638722/0325L) on Sep 06, 2001: and hepatitis B vaccine recombinant (lot # 641451/1499L) on May 10, 2002. The patient's mother had been exposed to varicella virus vaccine live during pregnancy. Additional information has been requested.  Follow up information from the physician indicated that the pt had no past medical history or allergies and that there was no illness at the time of vaccination. It was reported that the symptoms were related to vaccine and may have been related to food/viral. It was noted that the only report in the pt's chart that pertained  to a rash was recorded on 20Sep2002 and that there was no subsequent mention of a rash (conflicting information). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female registered nurse who on March 27, 2003 was administering MMR II to a patient and the patient's mother bumped the nurse's hand, the needle came out of the patient's arm and some of the vaccine went into the nurse's eye. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a pharmacy tech concerning a pediatric patient who was vaccinated with a dose of MMR II. It was reported that at titer was drawn and the patient failed to seroconvert to mumps. No addition al information was provided. Unspecified medical attention was sought . Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old  female patient, with allergies to penicillin, sulfa and ciprofloxacin hydrochloride, who on March 26, 2003 at 14:15 (previously reported as Mar 27, 2003) was vaccinated SC into the left upper arm with a second dose of MMR II (lot #644644/1080M). It was reported that the patient was not ill at the time of vaccination. No concomitant medications were reported. The patient received the first dose of MMR II on Aug 13, 1984. On March 28, 2003 (previously reported as March 27, 2003), the patient presented with local inflammation to the left upper arm with a red, raised lump on her arm at the injection site. The area was hot to touch and about 1in in diameter. the patient had no other symptoms. The patient denied itching and ice was applied. As of April 02, 2003 the local inflammation had subsided and the patient recovered. Unspecified medical attention was sought. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal, Nonspecific reaction
Clinical narrative: Information has been received from a 25 year old female patient, with diabetes and a negative titer for rubella, who was vaccinated with a dose of MMR II. Post vaccination the patient's titer remained negative. The vaccine was repeated 2 more times at varying intervals after the birth if her three children. The patient's last titer was 5 years ago, in approximately 1997, and remained negative. Unspecified medical attention was sought. Additional information has been requested. The patient also reported a similar experience with MMR.
Age: 1.07
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Skin discolouration, Speech disorder
Clinical narrative: He had MMR, Varicella, Pneumococcal shots at Doctor's office.  That evening he turned noticably yellow. Several friends asked me what was wrong with him. I took him to the doctor the next day.  Dr. ignored the symptoms and blamed on diet, although diet hadn't changed and he had never been yellow before.  He was babbling and completely stopped. His energy level dropped. He continued being yellow for about a year.  We have since changed doctors, and she suggested we fill out the report.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Chest pain, Dyspnoea, Rash, Rash pruritic
Clinical narrative: Patient was administered Havrix brand Hepatitis A vaccine, 1.0 ml in the right deltoid, at approximately noon on Tuesday, June 3, 2003.  At 5 PM, she called the office complaining of a red, blotchy rash on her chest, neck, and upper arms (bilateral) which first appeared around 3 PM.  She took Claritin and later reported to the ER due to the appearance of mild chest pain and shortness of breath.  She was administered Benadryl by injection with mild improvement of symptoms and discharged.  Her symptoms of blotchy, swollen, red, pruritic rash on her face, neck, arms back, and abdomen continued the next morning and she was advised to take oral Benadryl pending resolution.  She reports no rash below the level of the umbilicus.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Loss of consciousness, Throat tightness, Urticaria
Clinical narrative: Day 10 hives developed covering both hands, upper and lower arms, the sid4es and small of the back and in patches on both legs. Hives resolved partially and flared again several times. By day 19 hives returned, given Benedryl by Corpsman. Patient developed shortness of breath and his "throat closed". Patient lost consciousness. Was given epinephrine, , Benedryl and O2. He wa transported to a medical facility by EMS.
Age: 18.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Dyspnoea, Palpitations
Clinical narrative: 10d. s/p vaccination experienced chest pain, palpations, dyspneaè ER è Discharged to home
Age: 18.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest discomfort, Chest pain, Cough, Dizziness, Dyspnoea
Clinical narrative: 10d. s/p vaccination experienced chest pain, palpations, dyspneaè ER è Discharged to home
Age: 18.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Headache, Myalgia, Somnolence, Wheezing
Clinical narrative: 10d. s/p vaccination experienced chest pain, palpations, dyspneaè ER è Discharged to home
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Erythema, Oedema, Pain
Clinical narrative: Received DTaP on 5/28/03. Parent called on 5/30/03 stating left arm is swollen, red, bruised and painful from shoulder to elbow. Instructed parent to call Pediatrician.  Doctor visit on same day.  Treatment prescribed ice packs every 20 minutes and Benadryl every 4-6 hours over weekend.  Follow-up call 6/2/03 revealed condition resolved.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Left arm - sore and stiff, progressing to numbness. Chest and neck - tightening, chest pain. Shortness of breath; dizziness. Smoker; family history of cardiac disease. Referring to cardiologist because of family history.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Left arm - sore and stiff, progressing to numbness. Chest and neck - tightening, chest pain. Shortness of breath; dizziness. Smoker; family history of cardiac disease. Referring to cardiologist because of family history.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Blindness, Optic neuritis, Photosensitivity reaction, Skin ulcer
Clinical narrative: On March 7, 2002, 35 days after my third hepatitis B vaccine, I woke up blind in my left eye.  The near total blindness lasted about 4 months.  The vision has gradually improved, but is far from normal.  I still go blind when I am in sunlight or bright light.  My indoor vision is limited.  I saw my primary physician a few days after the blindness set in.  She immediately sent me to see an emergency opthamologist.  The opthamologist told me I might have a brain tumor or MS and ordered a CAT scan.  Since this doctor was only an emergency doctor, I was told to see another opthamologist a few days later.  This doctor told me I might have MS and he ordered an MRI.  He told me what I had was optic neuritis.  He also referred me to a neurologist. The neurologist found no neurological problems.  The CAT scan was negative for abnormalities.  The MRI showed only the lesion on my optic nerve.  I have been having check-ups every few months with the opthamologist.  I saw a third opthamologist/retinal specialist in April/03.  He said I had idiopathic retro-bulbar neuritis.  I recently became aware through a friend of the connection between hepatitis B vaccines and optic neuritis.  This week I began researching the possibility on the internet.  I believe the vaccine was the cause of my illness, but I have not been to my doctor to discuss this yet.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Developed progressive generalized severe muscular aching throughout body. Onset 2 hrs, duration 3-4 weeks. Required MD visit, Vioxx and Vicodin to cope with pain. Medications alleviated generalized pain but arm remained sore to the point of difficulty in use, for another week.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Myocardial infarction, Shoulder pain
Clinical narrative: Onset of left shoulder pain, increased troponin and CK-MD levels 80 days after vaccination.  EKG showed ST elevation consistent with MI. Pain resolved within 24 hours, ardiac catheterization unremarkable, pt. discharged on 81 mg ASA/day.
Age: 57.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Injection given in long head of right triceps muscle. Site became very painful and swollen from elbow to armpit. Skin was taught and cherry red.  Area itched and I developed headache and general discomfort/uneasiness for about 30 hours. On day two, the swelling migtated to the inside of the right elbow. Redness and headache persisted.
Age: 57.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus
Clinical narrative: Injection given in long head of right triceps muscle. Site became very painful and swollen from elbow to armpit. Skin was taught and cherry red.  Area itched and I developed headache and general discomfort/uneasiness for about 30 hours. On day two, the swelling migtated to the inside of the right elbow. Redness and headache persisted.
Age: 57.0
Sex: F
Vaccine: SMALL
Symptoms: Coordination abnormal, Facial palsy, Headache, Hemiparesis, Nausea
Clinical narrative: Headache, nausea, vomiting, low grade fever on PVD 4.  Persisted on and off but pt. was able to work.  On 05/30/03 (PVD 28) ataxia, R sided weakness, R lower face droop, dropping objects.  Had consultation with neurologist, performed an MRI of brain multiple small ring-enhancing lesions
Age: 57.0
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Headache, nausea, vomiting, low grade fever on PVD 4.  Persisted on and off but pt. was able to work.  On 05/30/03 (PVD 28) ataxia, R sided weakness, R lower face droop, dropping objects.  Had consultation with neurologist, performed an MRI of brain multiple small ring-enhancing lesions
Age: 64.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Chills, Cough, Discomfort, Dyspnoea
Clinical narrative: 5/19/03 6th day of vaccination: C/O Headaches and states had an episode of L upper chest pain. Continuous L arm pain at vaccine site, and L shoulder pain. 5/20/03 7th day: Pt seen in walk in for c/o chest pains.  She had small pox vaccine in 5/13/03, on left upper arm.  Noted acute onset of sharp left upper arm pain radiating up arm to shoulder  left neck and left upper chest, while sitting at work.  Lasted one hour, then diminished.  Has had some dull ache right neck.  Still has some ache both sides neck R>L.  Vaccine site has sore and swollen since yesterday, getting worse.  No substernal chest pain or dyspnea. no change with walking / exertion. 5/28/03 15th day: While at work very tired. C/O chills and sweats, fevers of 102.5 in the evening. Developed cough (productive), 5/29/03 T. 102.2.  Yellow sputum and rhinorhea She was off duty and never reported these C/O's til 6/3/03.  6/3/03: still having mild discomfort R neck. Vaccine site has progressed well and has scab.  T 97.5. Seen in employee health and was placed on ABX for URI.   6/4/03: Seen by her provider. she still has a cough and is tired.
Age: 64.0
Sex: F
Vaccine: SMALL
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site oedema, Injection site pain
Clinical narrative: 5/19/03 6th day of vaccination: C/O Headaches and states had an episode of L upper chest pain. Continuous L arm pain at vaccine site, and L shoulder pain. 5/20/03 7th day: Pt seen in walk in for c/o chest pains.  She had small pox vaccine in 5/13/03, on left upper arm.  Noted acute onset of sharp left upper arm pain radiating up arm to shoulder  left neck and left upper chest, while sitting at work.  Lasted one hour, then diminished.  Has had some dull ache right neck.  Still has some ache both sides neck R>L.  Vaccine site has sore and swollen since yesterday, getting worse.  No substernal chest pain or dyspnea. no change with walking / exertion. 5/28/03 15th day: While at work very tired. C/O chills and sweats, fevers of 102.5 in the evening. Developed cough (productive), 5/29/03 T. 102.2.  Yellow sputum and rhinorhea She was off duty and never reported these C/O's til 6/3/03.  6/3/03: still having mild discomfort R neck. Vaccine site has progressed well and has scab.  T 97.5. Seen in employee health and was placed on ABX for URI.   6/4/03: Seen by her provider. she still has a cough and is tired.
Age: 64.0
Sex: F
Vaccine: SMALL
Symptoms: Pain, Productive cough, Pyrexia, Rhinorrhoea
Clinical narrative: 5/19/03 6th day of vaccination: C/O Headaches and states had an episode of L upper chest pain. Continuous L arm pain at vaccine site, and L shoulder pain. 5/20/03 7th day: Pt seen in walk in for c/o chest pains.  She had small pox vaccine in 5/13/03, on left upper arm.  Noted acute onset of sharp left upper arm pain radiating up arm to shoulder  left neck and left upper chest, while sitting at work.  Lasted one hour, then diminished.  Has had some dull ache right neck.  Still has some ache both sides neck R>L.  Vaccine site has sore and swollen since yesterday, getting worse.  No substernal chest pain or dyspnea. no change with walking / exertion. 5/28/03 15th day: While at work very tired. C/O chills and sweats, fevers of 102.5 in the evening. Developed cough (productive), 5/29/03 T. 102.2.  Yellow sputum and rhinorhea She was off duty and never reported these C/O's til 6/3/03.  6/3/03: still having mild discomfort R neck. Vaccine site has progressed well and has scab.  T 97.5. Seen in employee health and was placed on ABX for URI.   6/4/03: Seen by her provider. she still has a cough and is tired.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Aplastic anaemia, Hepatitis, Laboratory test abnormal, Pancytopenia
Clinical narrative: Hepatitits and pancytopenia, ? early aplastic anemia due to hepatitis B vaccine (occurred following dose #3).
Age: 69.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Feeling hot, Rash vesicular
Clinical narrative: From initial information received on 5/23/03 from a health clinic, regarding an adverse event occurring in the US, it was reported that a 69 year old female patient received her first dose of TD ADS ADULT, lot number U0833AA, given IM in her left arm at 10AM on 5/19/03. The next day, the patient developed warmth and erythema which progressed with the development of vesicular lesions. The following day, the patient was admitted to the hospital and started on antibiotics and systemic antihistamines. The patient was hospitalized for two days. The recovery status was not reported. The patient was taking atorvastatin, calcium, aspirin, multivitamins and estrogen/progestin at the time of vaccination and has an allergy to penicillin.  Follow up on 09/17/2003: "The on-line VAERS E-report number is E-3103.  From additional information received on 09/08/2003 from the responsible physician, the correct spelling of her last name was reported.  The patient's recovery status is still unknown.  No additional relevant information for the adverse experience was obtained.  Case is closed."
Age: 69.0
Sex: F
Vaccine: TD, TD
Symptoms: Blister, Erythema, Feeling hot
Clinical narrative: From initial information received on 5/23/03 from a health clinic, regarding an adverse event occurring in the US, it was reported that a 69 year old female patient received her first dose of TD ADS ADULT, lot number U0833AA, given IM in her left arm at 10AM on 5/19/03. The next day, the patient developed warmth and erythema which progressed with the development of vesicular lesions. The following day, the patient was admitted to the hospital and started on antibiotics and systemic antihistamines. The patient was hospitalized for two days. The recovery status was not reported. The patient was taking atorvastatin, calcium, aspirin, multivitamins and estrogen/progestin at the time of vaccination and has an allergy to penicillin.  Follow up on 09/17/2003: "The on-line VAERS E-report number is E-3103.  From additional information received on 09/08/2003 from the responsible physician, the correct spelling of her last name was reported.  The patient's recovery status is still unknown.  No additional relevant information for the adverse experience was obtained.  Case is closed."
Age: 52.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site erythema, Injection site pustule, Rash pustular
Clinical narrative: Rash - 6 pustules developed over the course of one day.  4 on right epigastrium, 2 on left epigastrium.  Later on PVD 11 developed three flat lesions, one on r groin, on l buttock, and r toe.  Lesions about 3 mm
Age: 52.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash pustular, Skin ulcer
Clinical narrative: Rash - 6 pustules developed over the course of one day.  4 on right epigastrium, 2 on left epigastrium.  Later on PVD 11 developed three flat lesions, one on r groin, on l buttock, and r toe.  Lesions about 3 mm
Age: 42.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Blister, Headache
Clinical narrative: Headache - severe beginning on day 6 and persisting. Some decrease symptoms but continue with headache as of day 12. Saw neurologist - neuro OK . Some improvement.
Age: 42.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Headache
Clinical narrative: Headache - severe beginning on day 6 and persisting. Some decrease symptoms but continue with headache as of day 12. Saw neurologist - neuro OK . Some improvement.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Anaemia, Cough, Myalgia, Pain, Pharyngolaryngeal pain
Clinical narrative: 53 year old adm 12/2. 4 weeks ago, the patient given the flu vaccine (1st time) and developed a productive cough, myalgias, fevers (as high as 100), and a sore throat. Patient given azithro. Symptoms continued so patient we to ED. CXR (+); ? pneumonia. Patient given another course of azithro and felt better. Approximately 1.5 weeks PTA, patient noticed a pruritic area on the back of her right arm and right thigh. The lesions started to swell to approximately 1 cm in size. PMD increased her prednisone. Lesions became purple and patient diagnosed with new anemia. Patient awoke on 12/1 with painful LE lesions. Patient started on stress dose steroids. Morphine given for pain. ESR=76. Systemic vasculitis secondary to the influlenza vaccine suspected. Bx: c/w hemorrhagic skin necrosis. Most likely antiphospholipid precipitated by the flu vaccine.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Pyrexia, Skin necrosis, Skin ulcer, Vasculitis
Clinical narrative: 53 year old adm 12/2. 4 weeks ago, the patient given the flu vaccine (1st time) and developed a productive cough, myalgias, fevers (as high as 100), and a sore throat. Patient given azithro. Symptoms continued so patient we to ED. CXR (+); ? pneumonia. Patient given another course of azithro and felt better. Approximately 1.5 weeks PTA, patient noticed a pruritic area on the back of her right arm and right thigh. The lesions started to swell to approximately 1 cm in size. PMD increased her prednisone. Lesions became purple and patient diagnosed with new anemia. Patient awoke on 12/1 with painful LE lesions. Patient started on stress dose steroids. Morphine given for pain. ESR=76. Systemic vasculitis secondary to the influlenza vaccine suspected. Bx: c/w hemorrhagic skin necrosis. Most likely antiphospholipid precipitated by the flu vaccine.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Lymphadenopathy, Pain, Tenderness
Clinical narrative: Aching in face, fatigue, swollen glands behind ears with tenderness, sore through ears when palpated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: 14 x 10 cm local reaction - red, hot to touch, painful. Taking Motrin every 6 hours. By that evening, pt was better.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pyrexia, Tenderness
Clinical narrative: Temperature 97.5 ax. Pulse 100, Resp 24 - swollen erythematous right testicle, tender to touch, testes descended bilaterally.
Age: 0.4
Sex: F
Vaccine: DTAP
Symptoms: Agitation, Crying, Diarrhoea, Injection site erythema, Injection site warmth
Clinical narrative: Day 1: Odd-sounding, high-pitched cry. Days 1-5: Somnolence (began 15 minutes after vaccination), gradually resolving; irritability, gradually resolving. Days 1-7: Injection site pink and hot, gradually resolving. Days 1-18: Fever - temperature "yo-yo'd" up and down, with lowest temperatures always above normal; gradually returned to normal over a period of about 2.5 weeks; entire head very hot to touch, even when fever at lowest points and rest of body felt much cooler; gradually returned to normal over a period of about 2.5 weeks. Days 2-17: Severe diaper rash (with red swollen areas on Days 5-10). Days 4-6, 19-20: Upper respiratory congestion (runny/stuffy nose, cough). Days 4-13: White rash, whole body (so severe skin became "scaley" with bumps by Day 6). Days 7-19: Diarrhea (foamy, bright yellow stools several times daily; sometimes "explosive"). Days 8-10: Vomiting and projectile vomiting. Days 9-17: Red rash, whole body. Days 11-14: Episodes of severe crying beginning suddenly, usually in conjunction with breastfeedings. Days 15, 20: Odd, repetitive, seizure-like movement of left arm. Days 18-40: Mild diaper rash. Days 21, 25, 28: Hives on trunk, unknown cause. Days 22-23: Fever and green diarrhea. Days 22, 32-34: Sneezing (without other upper respiratory symptoms). Days 31-34: Sleeping much more than usual, normal alertness when awake. Day 35: Painful intestinal gas. Days 33-66: Green, semi-digested, very liquid stools (with occasional days of normal-colored, well-digested stools - Days 48, 49, 55, 58-63); over a period of about 10 days beginning Day 66, stools gradually returned to consistent normal color and consistency. Note: What was striking about this period of illness following the DTaP vaccination was the contrast with the baby's previous good health. In her first 5 months, previous to this vaccination, her health had been good except for (1) an episode of severe diaper rash, along with very infrequent stooling - both apparently due to GI candida related to antibiotics and well resolved by about 2 months with minimal treatment; (2) 2 mild and brief "colds"; (3) an occasional greenish stool, and (4) mild allergy symptoms traced to dairy and soy. Before this vaccination, she had never had an odd-sounding, high-pitched cry; somnolence; significant fever, a "hot head", whole body red rash; severe whole body white rash; foamy yellow diarrhea; odd, repetitive, seizure-like arm movements; or hives; and she hasn't had any of these symptoms since the period immediately following this vaccination.
Age: 0.4
Sex: F
Vaccine: DTAP
Symptoms: Irritability, Pyrexia, Rash, Sneezing, Somnolence
Clinical narrative: Day 1: Odd-sounding, high-pitched cry. Days 1-5: Somnolence (began 15 minutes after vaccination), gradually resolving; irritability, gradually resolving. Days 1-7: Injection site pink and hot, gradually resolving. Days 1-18: Fever - temperature "yo-yo'd" up and down, with lowest temperatures always above normal; gradually returned to normal over a period of about 2.5 weeks; entire head very hot to touch, even when fever at lowest points and rest of body felt much cooler; gradually returned to normal over a period of about 2.5 weeks. Days 2-17: Severe diaper rash (with red swollen areas on Days 5-10). Days 4-6, 19-20: Upper respiratory congestion (runny/stuffy nose, cough). Days 4-13: White rash, whole body (so severe skin became "scaley" with bumps by Day 6). Days 7-19: Diarrhea (foamy, bright yellow stools several times daily; sometimes "explosive"). Days 8-10: Vomiting and projectile vomiting. Days 9-17: Red rash, whole body. Days 11-14: Episodes of severe crying beginning suddenly, usually in conjunction with breastfeedings. Days 15, 20: Odd, repetitive, seizure-like movement of left arm. Days 18-40: Mild diaper rash. Days 21, 25, 28: Hives on trunk, unknown cause. Days 22-23: Fever and green diarrhea. Days 22, 32-34: Sneezing (without other upper respiratory symptoms). Days 31-34: Sleeping much more than usual, normal alertness when awake. Day 35: Painful intestinal gas. Days 33-66: Green, semi-digested, very liquid stools (with occasional days of normal-colored, well-digested stools - Days 48, 49, 55, 58-63); over a period of about 10 days beginning Day 66, stools gradually returned to consistent normal color and consistency. Note: What was striking about this period of illness following the DTaP vaccination was the contrast with the baby's previous good health. In her first 5 months, previous to this vaccination, her health had been good except for (1) an episode of severe diaper rash, along with very infrequent stooling - both apparently due to GI candida related to antibiotics and well resolved by about 2 months with minimal treatment; (2) 2 mild and brief "colds"; (3) an occasional greenish stool, and (4) mild allergy symptoms traced to dairy and soy. Before this vaccination, she had never had an odd-sounding, high-pitched cry; somnolence; significant fever, a "hot head", whole body red rash; severe whole body white rash; foamy yellow diarrhea; odd, repetitive, seizure-like arm movements; or hives; and she hasn't had any of these symptoms since the period immediately following this vaccination.
Age: 0.4
Sex: F
Vaccine: DTAP
Symptoms: Upper respiratory tract congestion, Urticaria, Vomiting
Clinical narrative: Day 1: Odd-sounding, high-pitched cry. Days 1-5: Somnolence (began 15 minutes after vaccination), gradually resolving; irritability, gradually resolving. Days 1-7: Injection site pink and hot, gradually resolving. Days 1-18: Fever - temperature "yo-yo'd" up and down, with lowest temperatures always above normal; gradually returned to normal over a period of about 2.5 weeks; entire head very hot to touch, even when fever at lowest points and rest of body felt much cooler; gradually returned to normal over a period of about 2.5 weeks. Days 2-17: Severe diaper rash (with red swollen areas on Days 5-10). Days 4-6, 19-20: Upper respiratory congestion (runny/stuffy nose, cough). Days 4-13: White rash, whole body (so severe skin became "scaley" with bumps by Day 6). Days 7-19: Diarrhea (foamy, bright yellow stools several times daily; sometimes "explosive"). Days 8-10: Vomiting and projectile vomiting. Days 9-17: Red rash, whole body. Days 11-14: Episodes of severe crying beginning suddenly, usually in conjunction with breastfeedings. Days 15, 20: Odd, repetitive, seizure-like movement of left arm. Days 18-40: Mild diaper rash. Days 21, 25, 28: Hives on trunk, unknown cause. Days 22-23: Fever and green diarrhea. Days 22, 32-34: Sneezing (without other upper respiratory symptoms). Days 31-34: Sleeping much more than usual, normal alertness when awake. Day 35: Painful intestinal gas. Days 33-66: Green, semi-digested, very liquid stools (with occasional days of normal-colored, well-digested stools - Days 48, 49, 55, 58-63); over a period of about 10 days beginning Day 66, stools gradually returned to consistent normal color and consistency. Note: What was striking about this period of illness following the DTaP vaccination was the contrast with the baby's previous good health. In her first 5 months, previous to this vaccination, her health had been good except for (1) an episode of severe diaper rash, along with very infrequent stooling - both apparently due to GI candida related to antibiotics and well resolved by about 2 months with minimal treatment; (2) 2 mild and brief "colds"; (3) an occasional greenish stool, and (4) mild allergy symptoms traced to dairy and soy. Before this vaccination, she had never had an odd-sounding, high-pitched cry; somnolence; significant fever, a "hot head", whole body red rash; severe whole body white rash; foamy yellow diarrhea; odd, repetitive, seizure-like arm movements; or hives; and she hasn't had any of these symptoms since the period immediately following this vaccination.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Dry mouth, Injection site induration, Injection site oedema, Pain, Pyrexia
Clinical narrative: Body rash, aches, fever, localized swelling, cotton mouth, swelling up to right side of neck. 3cm x 4cm area of induration on right upper deltoid area. Pain in area of vaccine.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Rash
Clinical narrative: Body rash, aches, fever, localized swelling, cotton mouth, swelling up to right side of neck. 3cm x 4cm area of induration on right upper deltoid area. Pain in area of vaccine.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Headache, Pain, Pyrexia, Rash
Clinical narrative: Td given 5/13/03. Seen on 5/16/03 after 2 days fever 103, achy, headache and confluent red rash covering 1/2 upper arm.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Eye movement disorder, Febrile convulsion, Pyrexia, Rash
Clinical narrative: 106 degrees temp. Febrile seizure for 5 minutes. Turned blue, eyes rolled back, foaming at the mouth. 102-103 degrees for 5 days following rash on trunk on the 3rd day. Saw neurologist - recommended no further Pertussis vaccinations.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left deltoid intramuscular vaccine site with redness, slight induration, no pain or tenderness to touch. Advised to use cool compress to area, to call if worsens.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Irritability, Pyrexia
Clinical narrative: Immediately following immunizations: low grade fever off/on for 3.5 weeks; also diarrhea, irritability that also lasted over 3 weeks.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia
Clinical narrative: Day after injection, pt felt numbness in right thumb which lasted 2 days and then subsided.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Urticaria
Clinical narrative: Daughter was given MMR 10/21/02. A dose of .5 by Merck 0340M. She had a w/d after the shot. And then on 10/28/02 we noticed a rash all over her body. Then we saw hives forming on her legs and arms which were making them swollen. We rushed our daughter to the hospital that night to find that the hives and swelling had subsided which only left a rash. We're concerned that she had a reaction to the vaccination only because when she was 15 months old she received her first MMR and she had a seizure soon after. The doctors didn't think at the time it was connected to the vaccine and said it was probably a febrile seizure.
Age: 6.0
Sex: M
Vaccine: DTAP, HBPV, MMR
Symptoms: Infection
Clinical narrative: Developed full-blown chicken pox 5 years after receiving vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Large area of erythema and induration 8.5 cm x 13.5 cm (generalized induration-no definite border). Elevated temp to surface of skin. Received DTaP, IPV to left thigh 36 hour prior to reaction.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Asphyxia, Coma, Injury
Clinical narrative: Infant found unresponsive laying on stomach am of 6/3. The autopsy states suffocation.
Age: 0.4
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Culture, Polymerase chain reaction, Secondary transmission
Clinical narrative: 2 hour infection right thigh of breast feeding mom, who's husband was immunized on 5/7/03 with vaccinia vaccine.
Age: 0.4
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Dermatitis, Infection transmission via personal contact, Pyrexia, Vaccination complication
Clinical narrative: 2 hour infection right thigh of breast feeding mom, who's husband was immunized on 5/7/03 with vaccinia vaccine.
Age: 0.4
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Culture, Polymerase chain reaction, Secondary transmission
Clinical narrative: Inadvertant auto-inoculation Patient's father was the one who received the vaccine on 05/04/03. His DOB: 08/18/75. Father/vaccinee, covered site with bandage or long sleeves. Assumed that site leaked drainage on bed linens--> contact with mother's breast (secondary auto-inoculation and separate VAERS report being filed)-->contact with patient's mouth/cheek through breastfeeding(tertiary auto-inoculation) On 5/29/03, parents noted lesion on patient's lip On 5/30/03, parents noted lesion on patient's cheek On 6/2/03, when patient was taken for eval by  local MD, another lesion was noted on her tongue; she also had a low grade fever. Increased concern because patient had history of cradle cap, and now had possible early atopic dermatitis on face. Transferred to Medical Center for further evaluation, observation, and treatment. As of today, no additional lesions; no eye involvement; determined not to have eczema; asymptomatic. Plan to observe in hospital for approximately 1 week. * QUESTION AS TO WHETHER ANOTHER VAERS REPORT WAS FILED BY PEDIATRICIAN*
Age: 0.4
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Dermatitis, Infection transmission via personal contact, Pyrexia, Vaccination complication
Clinical narrative: Inadvertant auto-inoculation Patient's father was the one who received the vaccine on 05/04/03. His DOB: 08/18/75. Father/vaccinee, covered site with bandage or long sleeves. Assumed that site leaked drainage on bed linens--> contact with mother's breast (secondary auto-inoculation and separate VAERS report being filed)-->contact with patient's mouth/cheek through breastfeeding(tertiary auto-inoculation) On 5/29/03, parents noted lesion on patient's lip On 5/30/03, parents noted lesion on patient's cheek On 6/2/03, when patient was taken for eval by  local MD, another lesion was noted on her tongue; she also had a low grade fever. Increased concern because patient had history of cradle cap, and now had possible early atopic dermatitis on face. Transferred to Medical Center for further evaluation, observation, and treatment. As of today, no additional lesions; no eye involvement; determined not to have eczema; asymptomatic. Plan to observe in hospital for approximately 1 week. * QUESTION AS TO WHETHER ANOTHER VAERS REPORT WAS FILED BY PEDIATRICIAN*
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Infection transmission via personal contact
Clinical narrative: SECONDARY TRANSMISSION  Close contact (breast feeding) mother, to husband who was immunized with vaccinia vaccine on 05/07/03.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left upper arm - deltoid to elbow
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Asthma, Diarrhoea, Dyspnoea, Lethargy, Pyrexia
Clinical narrative: High fever-104+, lethargy, rash, diarrhea, vomiting, difficulty breathing. Tx with Motrin, adverse reactions lasted about 48 hours, ended up with asthma as a consequence.
Age: 0.8
Sex: M
Vaccine: HIBV
Symptoms: Rash, Vomiting
Clinical narrative: High fever-104+, lethargy, rash, diarrhea, vomiting, difficulty breathing. Tx with Motrin, adverse reactions lasted about 48 hours, ended up with asthma as a consequence.
Age: 1.3
Sex: M
Vaccine: DTAPH
Symptoms: Injection site erythema
Clinical narrative: Immunization received 6/2/03. Pt experienced area of erythema approx 3" diameter around injection site. Seen in office 6/3/03.
Age: 1.25
Sex: M
Vaccine: DTAPH
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Large raised welt (5.5" x 6") with blistering
Age: 1.2
Sex: U
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: 2 vesicles on left arm.
Sex: U
Vaccine: PNC
Symptoms: Erythema, Feeling hot, Injection site induration, Oedema
Clinical narrative: About size of a silver dollar swollen red warm hard.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Urticaria
Clinical narrative: Patient went to ER on 05/21/2003 with complaints of redness and swelling at the site of tetanus shot.  Patient's symptoms started on 05/30/2003.  On exam, patient was noted to have erythema, warmth and uticaria.  No discharge on the right upper deltoid.  She was told to apply ice, use Benadryl prn and was given keflex 500mg four times daily.  Hold: no fever.