chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Asthma, Back pain, Dyspnoea, Feeling hot, Headache
Clinical narrative: Received stitches 6/20/06 in ER where Td was given. Then 6/21/06 arm red, swollen, warm to touch, trouble breathing fever, headache, back hurts, and a yellow around mouth. Admitted to hospital on 6/21/06 for meningitis work up. 07/03/06-received records from Lexington Pediatric Practice to include ED report for DOS 6/20/06-treated for puncture wound in right thigh. Attempted to seek medical attention on 6/19/06 but declined to wait 6 hours in ED. Current medication Albuterol and Motrin. RX with sutures and tetanus immunization, Keflex 250mg 1 dose in ED. Returned to physician's office on 6/21/06-with c/o SOB, headache, neck pain and some light sensitivity. Skin around mouth yellow in color. Injection site indurated for 1.5 inches around site. Pain when move head and chin to chest. Did not fill RX for Keflex. Follow-up visit to pediatrician's office after hospitalization for suture removal from thigh. Afebrile, referred to allergist. Admitted to hospital to r/o bacterial meningitis. Waiting for records from hospital.  07/17/2006-records received from Lexington Med Ctr DC Summary: DC DX: fever, meningitis ruled out; systemic reaction to tetanus or tetanus diphtheria (Tb) booster; local reaction to a tetanus diphtheria toxoid (Tb) booster; sinusitis; chronic diagnosis of asthma, under control. C/O persistent HA and neck pain, febrile for 2 days.  PE on day 2 revealed continued inflammation around the site of the tetanus booster. RX with Rocephin and Motrin. DC instructions; follow-up in office in 2 days, RX Motrin, Omnicef and Nasonex, loratadine and Albuterol.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Nonspecific reaction, Pyrexia
Clinical narrative: Received stitches 6/20/06 in ER where Td was given. Then 6/21/06 arm red, swollen, warm to touch, trouble breathing fever, headache, back hurts, and a yellow around mouth. Admitted to hospital on 6/21/06 for meningitis work up. 07/03/06-received records from Lexington Pediatric Practice to include ED report for DOS 6/20/06-treated for puncture wound in right thigh. Attempted to seek medical attention on 6/19/06 but declined to wait 6 hours in ED. Current medication Albuterol and Motrin. RX with sutures and tetanus immunization, Keflex 250mg 1 dose in ED. Returned to physician's office on 6/21/06-with c/o SOB, headache, neck pain and some light sensitivity. Skin around mouth yellow in color. Injection site indurated for 1.5 inches around site. Pain when move head and chin to chest. Did not fill RX for Keflex. Follow-up visit to pediatrician's office after hospitalization for suture removal from thigh. Afebrile, referred to allergist. Admitted to hospital to r/o bacterial meningitis. Waiting for records from hospital.  07/17/2006-records received from Lexington Med Ctr DC Summary: DC DX: fever, meningitis ruled out; systemic reaction to tetanus or tetanus diphtheria (Tb) booster; local reaction to a tetanus diphtheria toxoid (Tb) booster; sinusitis; chronic diagnosis of asthma, under control. C/O persistent HA and neck pain, febrile for 2 days.  PE on day 2 revealed continued inflammation around the site of the tetanus booster. RX with Rocephin and Motrin. DC instructions; follow-up in office in 2 days, RX Motrin, Omnicef and Nasonex, loratadine and Albuterol.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Sinusitis, Skin discolouration
Clinical narrative: Received stitches 6/20/06 in ER where Td was given. Then 6/21/06 arm red, swollen, warm to touch, trouble breathing fever, headache, back hurts, and a yellow around mouth. Admitted to hospital on 6/21/06 for meningitis work up. 07/03/06-received records from Lexington Pediatric Practice to include ED report for DOS 6/20/06-treated for puncture wound in right thigh. Attempted to seek medical attention on 6/19/06 but declined to wait 6 hours in ED. Current medication Albuterol and Motrin. RX with sutures and tetanus immunization, Keflex 250mg 1 dose in ED. Returned to physician's office on 6/21/06-with c/o SOB, headache, neck pain and some light sensitivity. Skin around mouth yellow in color. Injection site indurated for 1.5 inches around site. Pain when move head and chin to chest. Did not fill RX for Keflex. Follow-up visit to pediatrician's office after hospitalization for suture removal from thigh. Afebrile, referred to allergist. Admitted to hospital to r/o bacterial meningitis. Waiting for records from hospital.  07/17/2006-records received from Lexington Med Ctr DC Summary: DC DX: fever, meningitis ruled out; systemic reaction to tetanus or tetanus diphtheria (Tb) booster; local reaction to a tetanus diphtheria toxoid (Tb) booster; sinusitis; chronic diagnosis of asthma, under control. C/O persistent HA and neck pain, febrile for 2 days.  PE on day 2 revealed continued inflammation around the site of the tetanus booster. RX with Rocephin and Motrin. DC instructions; follow-up in office in 2 days, RX Motrin, Omnicef and Nasonex, loratadine and Albuterol.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 20x15cm erythemic local rxn to left thigh.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Injection site swelling, Screaming
Clinical narrative: Mom reports pt screaming for 3 hrs straight with approx 5 min breaks from screaming to sleep, right leg with swelling. Tylenol 0.4ml given q 4 hrs since just before vaccine cool compress to legs.
Age: 1.35
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash erythematous, Rash papular, Rash vesicular, Skin ulcer
Clinical narrative: Skin rash noted 6/26/06. PE sparse erythematous, vesiculopapular lesions sparsely scattered on head, trunk and extremities up to 8 lesions.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Arm soreness for one week following TdaP vaccination.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Tenderness
Clinical narrative: Information has been received from a physician concerning a 37 year old male patient with an unknown medical history, who on 10/08/2005, was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine 651329/1047P), one year after his first vaccination, which was in October 2004. It was noted that the patient requested the vaccine even through he had been vaccinated one year earlier. The vaccine was administered by the medical assistant with a physician order. One day after the vaccination, on physician order. One day after the vaccination, on 10/9/2005, the patient developed slight erythema and was tender. There was no illness at the time of vaccination. The patient recovered on 10/10/2005. A product quality complaint was not involved. No additional information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician, via a company representatives, concerning a 65 year old female, with asthma and immunocompromised, who in 1997 was vaccinated 9route unknown) with a first dose of pneumococcal 23v polysaccharide vaccine (lot unknown).  Concomitant therapy included (therapy unspecified) for asthma.  In 1997 the patient developed cellulitis after the vaccination and was hospitalized.  In December 2005, the patient was vaccinated intramuscularly in the right deltoid 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot unknown).  The patient developed cellulitis in vaccinated arm.  Her arm became red, painful, and swollen down to the elbow.  She also had a fever.  She was treated with intravenous antibiotics, ceftriaxone sodium (ROCEPHIN) and moxifloxacin hydrochloride (AVELOX).  It took her 5 weeks to recover completely.  No product quality compliant was involved.  Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: HEPA, TD, TYP, YF, HEPA, TD, TYP, YF
Symptoms: Chills, Headache, Myalgia, Paraesthesia, Pharyngolaryngeal pain
Clinical narrative: Seriousness Criteria: Other Medically Significant (OMIC). Initial report received from a health care professional on 6/15/06. A 39 year old male pt with a medical history of hay fever, had received an injection of Decavac (lot U1707DA), administered in the right deltoid; a SC injection of YF-vax (lot UE630AA), in the "left" (site not specified); an injection of Havrix, (lot AHAVB109AA), in the left deltoid; and a dose of Oral Typhoid vaccine, (lot 3000935), on 5/25/06 at 11:00 AM. Six days later, on 5/31/06, the pt developed a fever, myalgia, headache, chills, sore throat and chest tightness. In addition, be experienced tingling in his hands. The pt was seen in the ER that same day. A CBC, UA and chemistry panel were completed, but no results were provided. The pt recovered from the events an unspecified amount of time later.
Age: 40.0
Sex: M
Vaccine: HEPA, TD, TYP, YF, HEPA, TD, TYP, YF
Symptoms: Pyrexia
Clinical narrative: Seriousness Criteria: Other Medically Significant (OMIC). Initial report received from a health care professional on 6/15/06. A 39 year old male pt with a medical history of hay fever, had received an injection of Decavac (lot U1707DA), administered in the right deltoid; a SC injection of YF-vax (lot UE630AA), in the "left" (site not specified); an injection of Havrix, (lot AHAVB109AA), in the left deltoid; and a dose of Oral Typhoid vaccine, (lot 3000935), on 5/25/06 at 11:00 AM. Six days later, on 5/31/06, the pt developed a fever, myalgia, headache, chills, sore throat and chest tightness. In addition, be experienced tingling in his hands. The pt was seen in the ER that same day. A CBC, UA and chemistry panel were completed, but no results were provided. The pt recovered from the events an unspecified amount of time later.
Age: 40.0
Sex: M
Vaccine: HEPA, TD, TYP, YF, HEPA, TD, TYP, YF
Symptoms: Chest discomfort, Chills, Headache, Myalgia, Paraesthesia
Clinical narrative: Seriousness Criteria: Other Medically Significant (OMIC). Initial report received from a health care professional on 6/15/06. A 39 year old male pt with a medical history of hay fever, had received an injection of Decavac (lot U1707DA), administered in the right deltoid; a SC injection of YF-vax (lot UE630AA), in the "left" (site not specified); an injection of Havrix, (lot AHAVB109AA), in the left deltoid; and a dose of Oral Typhoid vaccine, (lot 3000935), on 5/25/06 at 11:00 AM. Six days later, on 5/31/06, the pt developed a fever, myalgia, headache, chills, sore throat and chest tightness. In addition, be experienced tingling in his hands. The pt was seen in the ER that same day. A CBC, UA and chemistry panel were completed, but no results were provided. The pt recovered from the events an unspecified amount of time later.
Age: 40.0
Sex: M
Vaccine: HEPA, TD, TYP, YF, HEPA, TD, TYP, YF
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Seriousness Criteria: Other Medically Significant (OMIC). Initial report received from a health care professional on 6/15/06. A 39 year old male pt with a medical history of hay fever, had received an injection of Decavac (lot U1707DA), administered in the right deltoid; a SC injection of YF-vax (lot UE630AA), in the "left" (site not specified); an injection of Havrix, (lot AHAVB109AA), in the left deltoid; and a dose of Oral Typhoid vaccine, (lot 3000935), on 5/25/06 at 11:00 AM. Six days later, on 5/31/06, the pt developed a fever, myalgia, headache, chills, sore throat and chest tightness. In addition, be experienced tingling in his hands. The pt was seen in the ER that same day. A CBC, UA and chemistry panel were completed, but no results were provided. The pt recovered from the events an unspecified amount of time later.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypersensitivity, Injection site rash, Pruritus
Clinical narrative: Red itchy rash that appeared 10 days after she received the Tdap. Rash only present at site of injection.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion, Cyanosis, Eye movement disorder, Febrile convulsion, Pyrexia
Clinical narrative: Wed 6/21 and Thurs, 6/22/06, our son wasn't himself. Friday 6/23, he woke up with a fever. his highest fever temp was 101.7. At 4:30 PM, he began convulsing, his eyes went back of his head and lips turned blue. Had been giving liquid and baths to reduce fever with Advil and Tylenol.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Wed 6/21 and Thurs, 6/22/06, our son wasn't himself. Friday 6/23, he woke up with a fever. his highest fever temp was 101.7. At 4:30 PM, he began convulsing, his eyes went back of his head and lips turned blue. Had been giving liquid and baths to reduce fever with Advil and Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Blood pressure decreased, Bradycardia, Convulsion, Cyanosis, Dyskinesia
Clinical narrative: Patient fainted on the way home 5 minutes after immunization. Mom brought her back at once. She seized with arms tonic and clonic movement, lips cyanotic and unconscious. BP was down to 80/50 with bradycardia. She recovered about 5 minutes later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted on the way home 5 minutes after immunization. Mom brought her back at once. She seized with arms tonic and clonic movement, lips cyanotic and unconscious. BP was down to 80/50 with bradycardia. She recovered about 5 minutes later.
Age: 19.0
Sex: M
Vaccine: IPV
Symptoms: Abdominal pain, Bacterial infection, Demyelination, Diarrhoea, Headache
Clinical narrative: Case initially received on 06/20/06. It was reported that a 19 year old man was vaccinated with one dose of inactivated poliomyelitis vaccine on 06/09/06. On 06/13/06 he developed headache, abdominal pain, slight diarrhea, experienced a syncope and was hospitalized. Examination revealed a splenomegaly and a cranial MRI showed a small area of demyelinization in the brain (left). A stool sample was positive for "salmonella". In this context of central demyelination and salmonella infection, it would have been relevant to have results of infectious check-up (Campylobacter pylori or enteroviruses) and medical history of the patient to fully assess the case.
Age: 19.0
Sex: M
Vaccine: IPV
Symptoms: Laboratory test abnormal, Splenomegaly, Syncope
Clinical narrative: Case initially received on 06/20/06. It was reported that a 19 year old man was vaccinated with one dose of inactivated poliomyelitis vaccine on 06/09/06. On 06/13/06 he developed headache, abdominal pain, slight diarrhea, experienced a syncope and was hospitalized. Examination revealed a splenomegaly and a cranial MRI showed a small area of demyelinization in the brain (left). A stool sample was positive for "salmonella". In this context of central demyelination and salmonella infection, it would have been relevant to have results of infectious check-up (Campylobacter pylori or enteroviruses) and medical history of the patient to fully assess the case.
Age: 0.27
Sex: M
Vaccine: DTAP
Symptoms: Crying, Hypotonia, Injection site nodule, Stupor
Clinical narrative: Initial report received on 6/21/2006 from health care professional. A 5 month old male child patient, prematurely born, experienced hypotonic-hyporesponsive episode 30 minutes following the first primary intramuscular diphtheria, tetanus and acellular pertussis vaccine (Pertacel), lot number C1973AB administration in the thigh on 04/10/2006. The above mentioned event persisted until 2 hours after the vaccination. The child cried persistently for 2 hours just after the vaccination and he had also developed nodulus at the site of administration 12 hours following the vaccination. The mother went to an emergency hospital 30 minutes after vaccination and the physician administered Prednisolone liquid-Prelone. The patient received antithermic drug one hour before vaccination, and the nurse declared that it is an usual procedure in her clinic. The patient has already recovered and the mother reported this event to the nurse two months after the vaccination, when the patient went back to the clinic to received the booster. The patient recovered at the time of the report. The cases of hypotonic hyporesponsive response and persistent crying were observed in the clinical trial of CPD15T vaccine. The onset 30 minutes post vaccination is consistent with the definition of HHE in relationship with vaccination (48 hours post immunization). It has to be confirmed that the duration of HHE was less than 48 hours. Nodule is though an unlisted event following CPDT vaccination. Medically important condition (OMIC).
Age: 0.9
Sex: M
Vaccine: DTPPHIB, HEP
Symptoms: Dehydration, Gastrointestinal disorder, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 11 month old male, with no reported medical history, who on 06/12/2006 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (thimerosal free). Concomitant vaccine administered on the same day included a fourth dose of diphtheria toxoid(+) Hib conj vaccine (tet toxoid) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus Toxoid (Pediacel). At the evening after vaccination he developed some fever. The next days the fever increased until 40c during 2 days. The third day the temperature creased and he developed exanthema on his trunk and back. The general practitioner gave antihistamine, but it was noted that it did not help. Five days after vaccination he was admitted to the hospital because of possible dehydration. No further hospital details were known. Locally, a 10 cm large red swelling was visible, which was painful upon touching. After one week he was recovered. It was thought that he might have suffered from a gastrointestinal disorder. The case is closed. Other business partner numbers include: E2006-03104 and 200600562.
Age: 0.9
Sex: M
Vaccine: DTPPHIB, HEP
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning an 11 month old male, with no reported medical history, who on 06/12/2006 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (thimerosal free). Concomitant vaccine administered on the same day included a fourth dose of diphtheria toxoid(+) Hib conj vaccine (tet toxoid) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus Toxoid (Pediacel). At the evening after vaccination he developed some fever. The next days the fever increased until 40c during 2 days. The third day the temperature creased and he developed exanthema on his trunk and back. The general practitioner gave antihistamine, but it was noted that it did not help. Five days after vaccination he was admitted to the hospital because of possible dehydration. No further hospital details were known. Locally, a 10 cm large red swelling was visible, which was painful upon touching. After one week he was recovered. It was thought that he might have suffered from a gastrointestinal disorder. The case is closed. Other business partner numbers include: E2006-03104 and 200600562.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Vasculitis
Clinical narrative: Information has been received from an LPN concerning a 65 year old female patient with a urinary tract infection (UTI), rheumatoid arthritis, hyperlipidemia, GERD, COPD, and no known allergies and a recent history of hospitalization for right flank pain (diagnosed with UTI) who on 05/04/2006 or 05/05/2006 before being discharged from hospital was vaccinated IM in the deltoid with a dos of pneumococcal 23v polysaccharide vaccine Concomitant therapy included atorvastatin calcium (Lipitor) and ciprofloxacin hydrochloride (Cipro). Three to four days post vaccination (approximately 05/07/06), the patient went back to the hospital with rash. The diagnosis at that time was rash and UTI, and the patient was told she had an allergic reaction to the vaccine. The patient was hospitalized for 3 days. She was treated with Iv Steroids. The nurse stated that the patient had vasculitis, and that the rash was painful, all over her body, on palms of hands and her feet which were wrapped. No laboratory studies were performed for rash. As of the reporting date the patient hand not improved. Additional information has been requested. The nurse considered the events to be other important medical events and to be disabling. (OMIC)
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fatigue, Headache, Medication error, Oedema peripheral, Pain
Clinical narrative: Information has been received from a health authority concerning a 36 year old male who on 11/10/2005 was vaccinated intramuscularly in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #648713/1336N, batch #hv24420). Concomitant suspect therapy given intramuscularly in the same arm included a dose of influenza virus split virion 3v vaccine inactivated (Enzira) (batch #02701). That same day the patient experienced a severe systemic reaction. The patient felt unwell (fatigue) and feverish with a very painful, red, and swollen arm. He also had a headache. The symptoms persisted for five days. At the time of report the patient was recovering. It was noted that the patient had previously received an influenza vaccination without any adverse effects. No further information is available. Other business partner numbers include E200600625 and ADROIT IE002280. The reporter felt that fever, fatigue, pain in arm, swollen arm and headache were other important medical events. (OMIC)
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health authority concerning a 36 year old male who on 11/10/2005 was vaccinated intramuscularly in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #648713/1336N, batch #hv24420). Concomitant suspect therapy given intramuscularly in the same arm included a dose of influenza virus split virion 3v vaccine inactivated (Enzira) (batch #02701). That same day the patient experienced a severe systemic reaction. The patient felt unwell (fatigue) and feverish with a very painful, red, and swollen arm. He also had a headache. The symptoms persisted for five days. At the time of report the patient was recovering. It was noted that the patient had previously received an influenza vaccination without any adverse effects. No further information is available. Other business partner numbers include E200600625 and ADROIT IE002280. The reporter felt that fever, fatigue, pain in arm, swollen arm and headache were other important medical events. (OMIC)
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Laboratory test abnormal, Pyrexia, Viral infection, Vomiting
Clinical narrative: 5 hours after vaccine patient had a fever of 100 to 101, with vomiting and loose stools. Probable viral gastro problem. 07/05/06-records requested and received:DC summary DX: Viral Syndrome.  Blood cultures, CXR, UA CSF negative. Prior to admission had 2 episodes of emesis and watery stools. PMH minor reflux, RX with Axid. Temp at
Age: 0.22
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Laboratory test abnormal, Meningitis, Pyrexia, Viral infection
Clinical narrative: Patient came in for well child check and was fine. Immunizations given were Pediarix, HIB and Prevnar. Afterward, patient developed a fever and came to the ED the next day. He was admitted for high fever and viral meningitis. DC Summary for DOS 6/21-6/25/06 DC DX: Viral Meningitis  temperatures and cold sweats 36 hours prior to ED visit. Temp on admission 39.6.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pneumonia, Pyrexia, Respiratory rate increased
Clinical narrative: Patient had vaccines on 6/08/2006 and developed a high fever that night.  Breathing rapidly, he was seen in the ED the next day and admitted for questionable pneumonia.
Age: 1.28
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Child legs red slightly swollen and warm to touch. Instructed to use Benadryl cream and Benadryl liquid around the clock for 24 hrs. Repeat if worsens.
Age: 1.26
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Mother called into office today concerned that pt broke out in widespread chickenpox rash. Pt has chickenpox on her back/face/neck/legs/belly/hands/feet. Started the night of 6/27/06.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Evening of given vaccination 6 hrs later, developed redness, swelling at site. Continued to develop through next 48 hrs and called Dr who suggested to go to the ER where cephalexin given for cellulitis.
Age: 17.0
Sex: U
Vaccine: MNQ, PPV
Symptoms: Asthenia, Dizziness, Heart rate increased, Malaise, Pallor
Clinical narrative: Paleness, weakness, rapid heart rate, dizziness, general malaise
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Asthenia, Headache
Clinical narrative: Father states 1 day of HA, shoulder pain and leg weakness after Menactra shot. Went to doctor and missed 1 day of school, better now on 6/9/06.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Feeling hot, Injection site erythema
Clinical narrative: Local spreading, erythema and warmth x 2 days. Measuring 8 x 10cm. Dx: cellulitis.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Rec'd vaccine 3PM 6/23/06, about 24 hrs later started to get red at injection site enlarging from 24-48hrs after injection.
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Nausea, Oedema, Pruritus, Vomiting
Clinical narrative: Hep B 1 administered 6/28/06. Within 10 minutes began intermittent itching all day. No rash, difficulty breathing, N and V, edema or other symptoms. A 5/6 on a scale of 1-10.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Injection site erythema, Injection site nodule
Clinical narrative: Raised bump 2" in diameter, thick in texture and red in color in the area of injection. The area is warmer in temp than surrounding skin.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: May 18, 2006 called with a compliant states (10:00AM). Son's right arm, red, hot, swollen, no decrease ability to use arm, gave Tylenol/Motrin x 2.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Developed urticaria on face (hand, eyes and mouth) and chest/abdomen within 2 hrs of 6 month immunizations. Had not been given Tylenol. Did have his regular formula.
Age: 0.62
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash, Somnolence
Clinical narrative: 10 min after receiving vaccination mom returned with baby. Rash noted on stomach back and face. None noted on legs or feet. Client does not appear to be in any resp distress. Afebrile. Benadryl 0.5cc PO given. Instructed to give every 4-6 until rash resolved. If not resolved in 24 hrs instructed to go to hosp with shot record. No hives, but rash slightly bumpy. No welts noted. 5/30/06 12:50PM Rash slightly bumpy, no welts or hives noted. Dr stated that client should be given Benadryl prior to next vaccination. Follow up: 4:40PM: called to check up on client, mom states baby doing okay. Rash remains same. States no resp. Problems, playful after waking up after taking Benadryl and Tylenol earlier. Encourage to continue to give Tylenol. Benadryl 0.5cc q 4-6hrs today. Will call back tomorrow to check on cond of rash. 5/31/06 (Wednesday) Follow up:10:15A called this morning to check on client. Mom states rash resolving cont to be afebrile. Only a few spots noted. Mom says baby playful normal behavior. Told her to continue with Benadryl rest of day.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Movement disorder
Clinical narrative: Severe pain in left deltoid causing difficulty with abducting arm (without erythema/swelling/fever) lasting >2 wks.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area left deltoid
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Cyanosis, Dyskinesia, Listless
Clinical narrative: Parent found pt laying on floor. He was blue, jerking, and then listless. 911 called and transported to ER. No resuscitation needed. Dr stated he had a seizure. Discharged to home.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site swelling
Clinical narrative: Right arm warm and swollen 7x 7 1/2 cm
Age: 1.03
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Eye oedema, Hypersensitivity, Rash, Urticaria
Clinical narrative: MMR and Varivax and PCV7 on 6/14/06. Mom noticed eye swelling, rash. Used Benadryl, went to ED on 06/20/06 diagnosed with allergic rxn/hives.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Petechiae
Clinical narrative: Petechial rash, onset 5 days after MMR with worsening over the next 7 days. Still present 20 days after immunization.
Age: 47.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Gastritis, Thyroid neoplasm
Clinical narrative: Patient experienced gastritis and thyroid nodules.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Feeling hot, Oedema peripheral
Clinical narrative: Patient received IPV vaccine 0.5cc intramuscularly in the left deltoid; MMR vaccine 0.5cc subcutaneously in the left outer aspect of the upper arm on 06/26/2006. Grandmother brought in on 06/28/06, left upper arm warm to the touch along with edema. The doctor diagnosed as cellulitis and treated with Keflex 250 mg every eight hours for 10 days. Follow up on 7/3/06.
Age: 21.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Chills, Dizziness, Headache
Clinical narrative: On 06/15/06, the patient experienced dizziness, headaches, chills but no rash. Husband gave her a half of vicoprofen for the headache. Has not seen physician.
Age: 1.01
Sex: M
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Accident, Injection site erythema, Urticaria
Clinical narrative: Child jerked arm during administration of vaccine. Redness was noticed post injection with small wheal located in the center of site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Within 24 hours of vaccination patient experienced erythema, tenderness and warmth at the site. Tenderness and warmth resoved within 72 hours.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt in for complete physical on 06/27/06 and a pnemovax was administered.  Pt called on 6/29/06 & c/o redness, swelling, and discomfort at injection site as well as a fever.  Pt instructed to use tylenol or ibuprofen as needed and to call if symptoms worsened or did not improve.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Both arms had erythema and tenderness at vaccine sites. Mother brought child back to office for examination within 24 hours.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abscess
Clinical narrative: ABSCESS RIGHT THIGH. PARENT TO APPLY WARM COMPRESSES THREE TIMES A DAY AND TO ADMINISTER AUGMENTIN 125MG TWICE A DAY FOR 10 DAYS. TO RETURN TO CLINIC ON FRIDAY 07/07/06 FOR RECHECK.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Colitis, Dehydration, Diarrhoea, Electrolyte imbalance
Clinical narrative: The day after vaccination (6/12), there was redness and warmth at the site of injection.  The nurse marked it to assess swelling.  The patient was afebrile and able to move the arm with no limits.  On 6/13, swelling and warmth was increased, so IV cefazolin was started due to suspected cellulitis.  The patient received 2 days of cefazolin and was discharged from the hospital 6/15.  The reaction was improved. DC Summary: DC DX: recurrent C Difficile colitis; pneumococcal vaccine reaction versus cellulitis; electrolyte abnormality secondary to diarrhea, resolved. HX of HTN, HX hypercholesterolemia; HX of anxiety; HX of bilateral total knee arthroplasty. Enteritis, Dehydration. Present Illness: diarrhea.  Allergies: aspirin, contrast dye and eggs. PE: temp 100.3, temp 37.6, remainder of exam unremarkable with mild tenderness to palpation in left lower quadrant and right lower quadrant. Hospital Course: rash developed that was warm on her right arm, unclear whether this was cellulitis or a vaccine reaction. Received Ancef.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Swelling
Clinical narrative: The day after vaccination (6/12), there was redness and warmth at the site of injection.  The nurse marked it to assess swelling.  The patient was afebrile and able to move the arm with no limits.  On 6/13, swelling and warmth was increased, so IV cefazolin was started due to suspected cellulitis.  The patient received 2 days of cefazolin and was discharged from the hospital 6/15.  The reaction was improved. DC Summary: DC DX: recurrent C Difficile colitis; pneumococcal vaccine reaction versus cellulitis; electrolyte abnormality secondary to diarrhea, resolved. HX of HTN, HX hypercholesterolemia; HX of anxiety; HX of bilateral total knee arthroplasty. Enteritis, Dehydration. Present Illness: diarrhea.  Allergies: aspirin, contrast dye and eggs. PE: temp 100.3, temp 37.6, remainder of exam unremarkable with mild tenderness to palpation in left lower quadrant and right lower quadrant. Hospital Course: rash developed that was warm on her right arm, unclear whether this was cellulitis or a vaccine reaction. Received Ancef.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Bronchospasm, Nausea, Pruritus, Respiratory disorder
Clinical narrative: Patient experienced anaphylaxis, bronchospasm, itchy throat, urticaria, nausea over a 20 minute course. Given Epinephrine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Patient experienced anaphylaxis, bronchospasm, itchy throat, urticaria, nausea over a 20 minute course. Given Epinephrine.
Age: 1.45
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Cellulitis, Erythema, Injection site reaction, Injection site swelling, White blood cell count increased
Clinical narrative: Received vaccinations on 06/29/2006. Developed swelling at injection sites on 06/30/2006. seen in office on 07/01/2006, for possible vaccine reaction. Sent to ER and was admitted to the hospital for cellulitis infection secondary to local vaccine reaction. Received IV antibiotics. Medical records include erythema. msv
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Haematoma, Injection site erythema, Injection site pain, Injection site swelling, Injury
Clinical narrative: Patient received Adacel in the left deltoid and then hit in the same arm by a baseball on 0619/2006. On 06/20/06, area was red, swollen, bruised and painful. Fever of 101 degrees on 06/21/06. Patient instructed to do Advil, ice and heat. If no better come back to physician office.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient received Adacel in the left deltoid and then hit in the same arm by a baseball on 0619/2006. On 06/20/06, area was red, swollen, bruised and painful. Fever of 101 degrees on 06/21/06. Patient instructed to do Advil, ice and heat. If no better come back to physician office.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Angioneurotic oedema
Clinical narrative: Patient experienced Angioedema. Started on Claritin, Kenalog and Prednisone.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Asthenia, Coordination abnormal, Crying, Hypokinesia, Irritability
Clinical narrative: Fever of 102.7F and neurologic symptoms (irritability, inappropriate screaming spells, weakness in legs, trouble walking or sitting erect and lack of coordination). Symptoms began day 1-2 after MMR+Varicella immunizations given in local clinic and progressively resolved over the next week or so.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Neurological symptom, Pyrexia
Clinical narrative: Fever of 102.7F and neurologic symptoms (irritability, inappropriate screaming spells, weakness in legs, trouble walking or sitting erect and lack of coordination). Symptoms began day 1-2 after MMR+Varicella immunizations given in local clinic and progressively resolved over the next week or so.
Age: 1.89
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Red, swollen area approximately the size of an orange on the left deltoid, also tender to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Red swollen area the size of an apple that is warm to the touch.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Injection site abscess, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at site, notified clinic on 05/23/06 and they recommended warm compresses. Began draining on 05/29/06, went to local emergency department on 05/30/06 and was given Bactrim DS. On 06/01/2006, went to another emergency department with drainage, pain and odor at site. I&D was performed of the abscess, packing placed, given Vicodin and Keflex.
Age: 10.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Tetanus vaccine given in the left arm on 06/26/2006. Now the child has a knot the size of a small lime, red, warm to touch, painful. Advised to use warm compresses, give Benadryl and Motrin.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Pain
Clinical narrative: Left shoulder has tenderness, mildly reduced range of motion. Pain increased at night time. Ibuprofen 600 mg three times a day.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Coordination abnormal, Ear pain, Guillain-Barre syndrome, Hypoaesthesia, Malaise
Clinical narrative: Loss of nerve sensation and muscle coordination. Numbness and tingling in hands, feet, and face. Condition ongoing to date. Medical records state atypical GBS, ear pain, malaise, mononucleosis. msv
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Nerve injury, Paraesthesia, Viral infection
Clinical narrative: Loss of nerve sensation and muscle coordination. Numbness and tingling in hands, feet, and face. Condition ongoing to date. Medical records state atypical GBS, ear pain, malaise, mononucleosis. msv
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Loss of nerve sensation and muscle coordination. Numbness and tingling in hands, feet, and face. Condition ongoing to date. Medical records state atypical GBS, ear pain, malaise, mononucleosis. msv
Age: 1.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Depressed level of consciousness, Diarrhoea, Gaze palsy, Retching, Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a 12 month old female with a history of being hospitalized for a positive allergy (source of allergy unk) and no other medical history or concurrent conditions who on 23Jun06 was vaccinated SC in the left thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot653355/0301F). Concomitant therapy included a dose of tuberculin purified protein derivative. There was no other concomitant medication. On 23Jun06, the pt experienced an anaphylactic reaction and went into respiratory distress. The physician reported that within two minutes of administration, the pt began to vomit. She then grew pale and limp with projectile vomiting. She passed out twice. She was given oxygen and continued to be in and out of consciousness. She was transferred and admitted to the hospital on 23Jun06. Blood work including a rotavirus test and CBC was done, the results of which are awaited. While in the hospital she developed diarrhea. The pt was discharged from the hospital on 24Jun06 with a final diagnosis of allergic reaction to vaccine versus allergic reaction to milk. On 26Jun06, she returned to the physician's office and was noted to be recovered. A lot check has been requested. The pt's experiences were considered to be immediately life threatening and other important medical events (OMIC) by the reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Anaphylactic reaction, Diarrhoea, Hypersensitivity, Hypotonia, Hypoxia
Clinical narrative: Information has been received from a physician concerning a 12 month old female with a history of being hospitalized for a positive allergy (source of allergy unk) and no other medical history or concurrent conditions who on 23Jun06 was vaccinated SC in the left thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot653355/0301F). Concomitant therapy included a dose of tuberculin purified protein derivative. There was no other concomitant medication. On 23Jun06, the pt experienced an anaphylactic reaction and went into respiratory distress. The physician reported that within two minutes of administration, the pt began to vomit. She then grew pale and limp with projectile vomiting. She passed out twice. She was given oxygen and continued to be in and out of consciousness. She was transferred and admitted to the hospital on 23Jun06. Blood work including a rotavirus test and CBC was done, the results of which are awaited. While in the hospital she developed diarrhea. The pt was discharged from the hospital on 24Jun06 with a final diagnosis of allergic reaction to vaccine versus allergic reaction to milk. On 26Jun06, she returned to the physician's office and was noted to be recovered. A lot check has been requested. The pt's experiences were considered to be immediately life threatening and other important medical events (OMIC) by the reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Loss of consciousness, Pallor, Respiratory distress, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 month old female with a history of being hospitalized for a positive allergy (source of allergy unk) and no other medical history or concurrent conditions who on 23Jun06 was vaccinated SC in the left thigh with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot653355/0301F). Concomitant therapy included a dose of tuberculin purified protein derivative. There was no other concomitant medication. On 23Jun06, the pt experienced an anaphylactic reaction and went into respiratory distress. The physician reported that within two minutes of administration, the pt began to vomit. She then grew pale and limp with projectile vomiting. She passed out twice. She was given oxygen and continued to be in and out of consciousness. She was transferred and admitted to the hospital on 23Jun06. Blood work including a rotavirus test and CBC was done, the results of which are awaited. While in the hospital she developed diarrhea. The pt was discharged from the hospital on 24Jun06 with a final diagnosis of allergic reaction to vaccine versus allergic reaction to milk. On 26Jun06, she returned to the physician's office and was noted to be recovered. A lot check has been requested. The pt's experiences were considered to be immediately life threatening and other important medical events (OMIC) by the reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Info has been received from a physician concerning an unspecified pt who was vaccinated with a dose of MMRII. The pt was admitted to the hospital after vaccination (details of event not further specified). Through follow-up contact with a nurse, it was learned that the info concerning this pt was obtained per a hospital. She had no other info available to her.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 62 year old male patient with left hemiplegia and a history of stroke several years ago who on 06/07/2006 was vaccinated IM in the the left upper arm with his second dose of pneumococcal 23v polysaccharide vaccine (lot #650835/0966P, batch #nb29850). A few hours post vaccination the patient developed an injection site reaction with redness and warmth. In the evening the symptoms worsened and he developed swelling of the whole arm down to the fingers. Voltaren bandings and cooling were administered. It was noted that the patient's first vaccination in 1999 was well tolerated. At the time of the report his symptoms were ongoing. No product quality complaint was involved. Additional information has been requested. Other business partner numbers included E2006-092996. The reporter considered injection site reaction, redness, sensation of heat, and large arm swelling to be other important medical events. (OMIC)
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia, Skin ulcer, Tenderness
Clinical narrative: 4x4cm red, raised, tender, tingling lesion around site of injection at 48 hrs. No lymphangitis. No regional nodes. Rx: Atarax 50mg q 6 hrs.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Eye oedema, Influenza like illness, Pruritus
Clinical narrative: Flu like symptoms 6 hr after administration Pruritic. Eye swelling 12 hrs after administration.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Hypokinesia, Injection site oedema, Injection site pain
Clinical narrative: Swelling of injection site L deltoid, pain of injection site L deltoid, difficulty moving arm.
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Info has been received from a consumer concerning her daughter who was vaccinated with a dose of MMRII. Subsequently, she experienced a high fever. There was no product quality complaint involved. No further info was available.
Age: 1.03
Sex: F
Vaccine: HEP, HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Info has been received from an RN concerning a 12 month old white female child with no pre-existing allergies, birth defects or medical conditions, who on 3/21/06 at 10:00 AM, was vaccinated, SC, in the left thigh, with a 1st dose of MMRII (lot 651813/0770R). Concomitant vaccinations included the 3rd dose of Hib conj.-hepatitis B vaccine (lot 651838/0359R) given IM, in the right thigh and the 1st dose of Hep-A vaccine (lot 652085/1069R), given IM, in the right thigh. There was no illness at the time of vaccination. On 3/30/06, the pt developed a fever 102.6F and a rash on face and stomach. The rash spread to her entire body including her torso, arms and legs. The pt was seen in the ER. It was reported that they appeared like red mosquito-like bites with positive blanching. The pt was happy and pleasant and did not appear itchy. At the time of this report, the pt still had a rash and was not completely recovered. Additional info has been received from an RN on 5/31/06, indicating that the pt's rash completely cleared and she was free of signs and symptoms and recovered as of 4/5/06. No further info is expected.
Age: 1.1
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Info has been received from a consumer concerning a 13 month old female with no pertinent medical history or allergies who on 4/1/06 was vaccinated with MMRII. There was no concomitant medication. On 4/6/06, the pt developed a fever and cough. The pt's fever and cough persisted. The pt did not seek medical attention. Additional info is not expected.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a nurse practitioner NP concerning a 12 month old male patient who was vaccinated with a dose of measles virus vaccine live (enders Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (upgrade process). Subsequently, on approximately on 4/7/2006, the patient experienced a maculopapular rash from head to toe. It was reported that at the time of rash onset, the patient was also taking amoxicillin. Unspecified medical attention was sought. No outcome was reported there was no product quality complaint. Additional information has been requested.