chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Oedema, Pain, Photophobia
Clinical narrative: Complex regional pain syndrome, condition aggravated, mobility decreased, pain, weakness left or right side, injection site burning. Initial report received from another mfr. on 5/8/06, the reporter to this mfr being a health care professional. A 44 year old female pt, with a history of complex regional pain syndrome, who received an IM, LA, injection of Decavac; a Tuberculin skin test and an IM, RA, first dose injection of Engerix-B on 8/30/05. Immediately post-vax, the pt experienced a burning sensation at an unspecified injection site. Per the reporter, the burning sensation slowly progressed into limited mobility, pain and weakness of the right side of the body. The pt was wheelchair bound. She was examined by a physician who considered the vaccines to have caused pt's worsening complex regional pain syndrome and deemed the event disabling. There was improvement in the pt's mobility, but the right-sided weakness, pain and the overall worsening of complex regional pain syndrome were ongoing. The events were considered probably related to Engerix-B  and the tetanus diphtheria vaccine. At the time of the initial report, the pt had not recovered.
Age: 44.0
Sex: F
Vaccine: HEP, TD, HEP, TD, HEP, TD
Symptoms: Condition aggravated, Hemiparesis, Hypokinesia, Pain, Skin burning sensation
Clinical narrative: Complex regional pain syndrome, condition aggravated, mobility decreased, pain, weakness left or right side, injection site burning. Initial report received from another mfr. on 5/8/06, the reporter to this mfr being a health care professional. A 44 year old female pt, with a history of complex regional pain syndrome, who received an IM, LA, injection of Decavac; a Tuberculin skin test and an IM, RA, first dose injection of Engerix-B on 8/30/05. Immediately post-vax, the pt experienced a burning sensation at an unspecified injection site. Per the reporter, the burning sensation slowly progressed into limited mobility, pain and weakness of the right side of the body. The pt was wheelchair bound. She was examined by a physician who considered the vaccines to have caused pt's worsening complex regional pain syndrome and deemed the event disabling. There was improvement in the pt's mobility, but the right-sided weakness, pain and the overall worsening of complex regional pain syndrome were ongoing. The events were considered probably related to Engerix-B  and the tetanus diphtheria vaccine. At the time of the initial report, the pt had not recovered.
Age: 1.51
Sex: F
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash papular
Clinical narrative: Low-grade fever 100.5 with face/cheek rash spreading to arms/legs. 5/15/06 Pt seen. No conjunctivitis, no cough, no fever, no cough but head covered with pink papular rash.
Age: 14.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 4 X 3cm superficial erythema, warm to touch, non-fluctuating. RX: Benadryl 50mgm po X 1; HC cream.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Hypokinesia, Pain
Clinical narrative: On 5/10/06, pt reported left arm has been hurting every since had Tetanus Diphtheria Booster on 1/06/2006. On 5/10/06, reported sharp pain in left arm. L arm aches when moving it.
Age: 58.0
Sex: M
Vaccine: IPV, MEN, YF
Symptoms: Abnormal behaviour, Insomnia, Mania, Psychomotor hyperactivity, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a health care professional on 5/5/2006. A 58 year old male patient with a medical history of hypertension and hyperlipidemia had received injections of IPOL< Menomune ACYW and YF Vax on 4/24/2006. The lot numbers, routes and sites of administration were not reported. Six days post vaccination the patient developed a fever of 103 degrees F, manic episodes, hyperactivity, insomnia, a racing mind and began talking a lot. The fever lasted for three days, and the other symptoms persisted. The patient was scheduled to follow up with an infectious disease specialist. At the time of this report, the patient had a mild to moderate improvement in his signs and symptoms, but had not recovered.
Age: 58.0
Sex: M
Vaccine: IPV, MEN, YF
Symptoms: Speech disorder
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received from a health care professional on 5/5/2006. A 58 year old male patient with a medical history of hypertension and hyperlipidemia had received injections of IPOL< Menomune ACYW and YF Vax on 4/24/2006. The lot numbers, routes and sites of administration were not reported. Six days post vaccination the patient developed a fever of 103 degrees F, manic episodes, hyperactivity, insomnia, a racing mind and began talking a lot. The fever lasted for three days, and the other symptoms persisted. The patient was scheduled to follow up with an infectious disease specialist. At the time of this report, the patient had a mild to moderate improvement in his signs and symptoms, but had not recovered.
Age: 98.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Info has been received from a physician, via a company representative, concerning a 98 year old male who "two years ago", on 4/26/04, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. "Two weeks ago" on 4/26/06, the pt died due to non-pneumococcal cause. It was reported that the pt was hospitalized or had prolonged hospitalization and that the experience was life threatening. The non-pneumococcal cause of death was considered to be immediately life-threatening. Additional info has been requested.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Bacterial infection, Injection site abscess, Injection site pain, Injection site swelling
Clinical narrative: Father reported pain and swelling of R leg within 48 hours of injection. Began applying an ointment to area. Symptoms worsened and was taken to ER on 4/2/06. Dx of abscess which was I and D'd. Tx included antibiotics and pain medication. Administering RN reports what appeared as fire ant bite on extremity vaccine administered.
Age: 0.69
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Hypoacusis
Clinical narrative: Initial report received on 09May06 from an investigator. A 13 month old female subject developed profound sensorineural hearing loss bilaterally after she had received an IM, right thigh, second dose injection of Fluzone No Preservative Trival A & B Subvirion U, lot number U1743IA, on 07Dec05. At nine to ten months of age, the parent had noticed that the baby was not responding to sound. The SAE was considered by the investigator to be a persistent or significant disability/incapacity. The onset set date of the SAE was reported as 04May06, 148 days following administration of the second dose of the study vaccine. At the time of this report, the subject had not recovered. According to the investigator, the event was related to the study vaccine.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site oedema, Injection site pain, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received via another company from a rheumatologist concerning an approx 84 yr old female with osteoarthritis concerning an approx 84 yr old female with osteoarthritis who in 2006 was vaccinated with pneumococcal 23v polysaccharide vaccine by a general physician. Subsequently, in 2006, the pt presented at emergency dept and was admitted with severe swelling and pain in arm. The pt had high temp of 38C degree. The fluid from the arm was drained and tested. The results showed severe inflammatory response with high white cell count over 17,000 and C reactive protein (CRP), approx 100. At the time of reporting on 10May06, the pt's severe swelling and pain in arm persisted. The reporting rheumatologist believed the vaccine injection might have been administered intraarticularly. The rheumatologist felt that severe swelling and pain in arm were related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received via another company from a rheumatologist concerning an approx 84 yr old female with osteoarthritis concerning an approx 84 yr old female with osteoarthritis who in 2006 was vaccinated with pneumococcal 23v polysaccharide vaccine by a general physician. Subsequently, in 2006, the pt presented at emergency dept and was admitted with severe swelling and pain in arm. The pt had high temp of 38C degree. The fluid from the arm was drained and tested. The results showed severe inflammatory response with high white cell count over 17,000 and C reactive protein (CRP), approx 100. At the time of reporting on 10May06, the pt's severe swelling and pain in arm persisted. The reporting rheumatologist believed the vaccine injection might have been administered intraarticularly. The rheumatologist felt that severe swelling and pain in arm were related to therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Anaphylactic reaction, Flushing, Rash erythematous
Clinical narrative: Information has been received from a nurse concerning a 17 week old male who on 3/9/2006 was vaccinated in the left thigh with the second dose of Hib conj vaccine (OMPC) (lot 651072/0185R). Concomitant suspect vaccinations received on 3/9/2006 included the second dose of Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX) (lot # AC21B034AA) in the left thigh and the second dose of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (Crm197) (Prevnar) (Lot A56117D) in the right thigh. On 3/9/2006, within minutes of vaccination, the patient developed facial redness and a raised, oval patch on his trunk. The patient was seen at physicians office and diagnosed with having an anaphylactic reaction. The patient was treated with diphenhydramine hydrochloride Benadryl. The patient subsequently recovered from the anaphylactic reaction the same day. The anaphylactic reaction was felt to be an other important medical event (OMIC) and was felt to be related to the Hib conj vaccine,  Diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (PEDIARIX), and Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (Crm197) (Prevnar) vaccines. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Emesis; tem 103F, headache, myalgias within 24 hours of administration; symptomatic treatment.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: L shoulder pain adjacent to vaccination site. Partially recovered.
Age: 39.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Acne, Arthralgia, Asthenia, Back pain, Chest pain
Clinical narrative: Joint and muscle aches, skin acne, nocturnal myoclonus, mood swings, difficulty concentration, cramps on legs, low level of energy, frequent headaches, stiffness, decreased libido, numbness of legs, low back pains, sores chest. Adverse events started while performing duties overseas, but due to the limited availability of medical facilities and the mission demands, it was not until I returned to my Home of Record on Jun 04, that medical assistance/treatment was started. Unable to furnish this information, since those vaccines were done by the military personnel while in preparation to ship to overseas.
Age: 39.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Disturbance in attention, Headache, Hypoaesthesia, Libido decreased, Mood swings
Clinical narrative: Joint and muscle aches, skin acne, nocturnal myoclonus, mood swings, difficulty concentration, cramps on legs, low level of energy, frequent headaches, stiffness, decreased libido, numbness of legs, low back pains, sores chest. Adverse events started while performing duties overseas, but due to the limited availability of medical facilities and the mission demands, it was not until I returned to my Home of Record on Jun 04, that medical assistance/treatment was started. Unable to furnish this information, since those vaccines were done by the military personnel while in preparation to ship to overseas.
Age: 39.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Muscle spasms, Musculoskeletal stiffness, Myalgia, Myoclonus
Clinical narrative: Joint and muscle aches, skin acne, nocturnal myoclonus, mood swings, difficulty concentration, cramps on legs, low level of energy, frequent headaches, stiffness, decreased libido, numbness of legs, low back pains, sores chest. Adverse events started while performing duties overseas, but due to the limited availability of medical facilities and the mission demands, it was not until I returned to my Home of Record on Jun 04, that medical assistance/treatment was started. Unable to furnish this information, since those vaccines were done by the military personnel while in preparation to ship to overseas.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varivax outbreak. Dx: 5/13/06.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt received TD vaccine at a Walk in Adult Clinic on 5/5/06. Stated that in AM of 5/6/06, when awoke, noted left deltoid area tender and slight swelling and redness. On 5/7/06, noticed a swelling and redness had gotten worse and under her left arm swollen as well. C/o pain and difficulty lifting arm due to swelling under the arm. On Monday, 5/8/06, pt went to PCP but was not seen. She call HD and she then came and was seen by NP. She was instructed to apply ice 24 hrs then a warm compress to area. Lt deltoid area was hard, reddened and swollen. Lt lymph node under her arm was swollen as well. Pt c/o pain to touch under her arm and pain when lifting left arm. Instructed to take Advil or Motrin as directed on vial. If pain and swelling got worse 24 hrs was to go to ER or PCP ASAP. She verbalized understanding. She stated that on Friday 5/5/06, she had also started taking Adipex 37.5mg 1/2 tab QD x days. Then she was to take 1 tab QD. She stated that she had applied ice and then warm compress to affected area as instructed. She had taken Advil as well and the swelling and pain had resolved.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Lymph node pain
Clinical narrative: Pt received TD vaccine at a Walk in Adult Clinic on 5/5/06. Stated that in AM of 5/6/06, when awoke, noted left deltoid area tender and slight swelling and redness. On 5/7/06, noticed a swelling and redness had gotten worse and under her left arm swollen as well. C/o pain and difficulty lifting arm due to swelling under the arm. On Monday, 5/8/06, pt went to PCP but was not seen. She call HD and she then came and was seen by NP. She was instructed to apply ice 24 hrs then a warm compress to area. Lt deltoid area was hard, reddened and swollen. Lt lymph node under her arm was swollen as well. Pt c/o pain to touch under her arm and pain when lifting left arm. Instructed to take Advil or Motrin as directed on vial. If pain and swelling got worse 24 hrs was to go to ER or PCP ASAP. She verbalized understanding. She stated that on Friday 5/5/06, she had also started taking Adipex 37.5mg 1/2 tab QD x days. Then she was to take 1 tab QD. She stated that she had applied ice and then warm compress to affected area as instructed. She had taken Advil as well and the swelling and pain had resolved.
Age: 7.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Swelling
Clinical narrative: Redness, itching, swelling of entire upper arm. Arm was hot to touch. This lasted 4-5 days.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Lethargy, Nasal congestion, Nausea, Neck pain, Pyrexia
Clinical narrative: 5/9/06 at 19:30 PM Temp 101.2, swelling, nausea, nasal congestion, soreness on R side of the neck and lethargy. No fever at present but other symptoms persist.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: 5/9/06 at 19:30 PM Temp 101.2, swelling, nausea, nasal congestion, soreness on R side of the neck and lethargy. No fever at present but other symptoms persist.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: None reported
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Dizziness, Nasal congestion, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 5/9/06 at 19:30 PM, T 101.3, lightheaded, nasal congestion, sore throat and decreased appetite. Nasal congestion persist today.
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin discolouration
Clinical narrative: 5/11/06 Mom calls to report on 5/10/06 50 cent piece dark swollen area Rt thigh. 5/11/06 5" in diameter, red, hot and swollen. No fevers, Mom declines to have child seen. MD recommends to monitor for fevers, may apply cold pak to site, may give Motrin or Tylenol and see MD if further problems occur.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: L deltoid swollen and red. Per mom, she noted just this PM, 5/11/06 at 16:00 PM, L deltoid hot to touch. Pt denies pain. No fever. MD notified and seen pt. Advised mom to apply ice compresses and give Motrin an needed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Rash erythematous
Clinical narrative: Mother reports 24 hrs after injection right thigh (Dtap). Noted redness and red rash 4-5 inches from site. Noted swelling upper thigh from knee to groin. No warmth c/o itching and soreness. Benadryl and Tylenol. No previous reaction to any vaccine. Not seen by MD 5/10/06 no swelling or redness per mom.
Age: 10.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness of right arm noted by mom 24 hrs after vaccination (at 5cm in diameter), increasing in size during next 48 hrs until 10cm in diameter then resolving slowly. Complete resolution on day 5/12/06
Age: 1.02
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Rash
Clinical narrative: Rash onset 5/12/06
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Client received varicella shot in 1998. Developed sxs (mild) 5/06 NO fever and LSO pox.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Pt reported some redness and itching on 5/12/2006 upon awakening 5/13/06 noted severe swelling, redness, increased heat to touch extending from shoulder to elbow; went to emergency dept. Rec. ibuprofen 600gm a 6 hrs, Oxycodin prn pain, Benadryl 50gm q 6 hrs, seen on 5/15/06 at clinic, condition resolving.
Age: 0.61
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Temp 104R, No local reaction, no complaints
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 5 yr old well child. Vaccines given for school attendance. Reaction in arm where tetanus Dtap and IPV given in right delt. HCM erythematous area developed at injection site.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Ventricular extrasystoles
Clinical narrative: PVC occurred 10 days after vaccination, lasted 5 days, decreasing in severity each day. Joint pain with swollen wrists 14 days after vaccination
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Hypokinesia, Musculoskeletal stiffness, Nausea
Clinical narrative: The evening of the day I rec'd the shot, I became nauseated til next AM. When I awoke in AM I could not move very easily. Every bone in my body was still and painful. This pain and stiffness lasted til following day.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MU
Symptoms: Contusion, Erythema, Injection site warmth, Swelling
Clinical narrative: Right arm swollen, red, hot, and bruised.  Advised to use ice packs on arm.  No fever.  Telephone call to Mom on 5/4 and 5/9 - not at home/left message.  Spoke with Mom by phone on 5/10- problem resolved.  No private MD visit made.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Screaming
Clinical narrative: Parents stated infant screamed x3 days following immunization.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration and reddened area measuring 4cm x 5.5cm--ice packs applied, advised analgesics for discomfort.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: 5/3/06 AM Reports fever last night (temp not taken) upper left lateral arm red, warm, swollen with raised center. Ice and Ibuprofen suggested. 5/5/06 AM Arms much improved. Reports no other s/s 5/8/06 AM Reports with s/s beginning with fever last night (temp not taken) red, raised, itching, fluid filled lesions on abd and neck. Employee tells us he is using Benadryl cream for itching, we advisehim to continue Ibuprofen for fever. 5/10/06 AM New fluid filled lesions on back and groin appeared last night. All areas drying/crusty except groin. 5/11/06 AM No new lesions, no fever, all sites dry and crusty. 5/12/06 AM Returns to work.
Age: 39.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: 5/3/06 AM Reports fever last night (temp not taken) upper left lateral arm red, warm, swollen with raised center. Ice and Ibuprofen suggested. 5/5/06 AM Arms much improved. Reports no other s/s 5/8/06 AM Reports with s/s beginning with fever last night (temp not taken) red, raised, itching, fluid filled lesions on abd and neck. Employee tells us he is using Benadryl cream for itching, we advisehim to continue Ibuprofen for fever. 5/10/06 AM New fluid filled lesions on back and groin appeared last night. All areas drying/crusty except groin. 5/11/06 AM No new lesions, no fever, all sites dry and crusty. 5/12/06 AM Returns to work.
Age: 21.0
Sex: M
Vaccine: FLU3, HEPA, IPV, MEN, TDAP, YF
Symptoms: Asthenia, Pallor, Syncope, Vitreous floaters
Clinical narrative: A FEW MINUTES AFTER OVERSEAS IMMUNIZATIONS COMPLETED HE SAID HE WANTED THE TYPHOID TODAY ALSO. NO TYPHOID GIVEN TODAY.  WRITING UP CHARGE PAPERS-OBSERVED CLIENT BECAME VERY PALE, SAW BLACK SPOTS AND FELT FAINT.  SITTING IN CHAIR-DRINKING OJ, MOIST AND COOL CLOTH TO FOREHEAD & WRISTS-PERFUSE PERSPIRATION-ASSISTED FROM CHAIR AND LAID DOWN, ELEVATED FEET ON PILLOWS-CALLED NURSE TO HELP MONITOR AND INCIDENT REPORT.  BP 118/76 P 73 @2:48 PM ALERT & ORIENTED X3.  ATE CRACKERS AND OJ. DANGLED, BP 106/80, P68.  STOOD WITH ASSISTANCE.  TO CAR WITH FRIEND DRIVER @3:45 PM. AFTER EVENT, STATED HE FELT WEAK WHILE OBSERVING FRIEND GET SHOTS BEFORE HE RECEIVED HIS.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Injection site erythema, Lethargy, Pyrexia, Rash macular
Clinical narrative: Reported by mother to have developed "red blotches on right arm and redness "bullseye" at injection site.  Temp 101.2 and became lethargic evening after receiving shots.  Mother took him to ER where he was given injection of Benedryl.  Mom states that he improved very quickly.  Is sleeping this am and no signs of distress.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Atelectasis, Cough, Lethargy, Nasal congestion, Oral intake reduced
Clinical narrative: Patient received vaccines at 7 weeks of age. That evening patient develop fever and was described by mother as being lethargic and feeding poorly. Admitted to Hospital, septic work-up done and started on antibiotics. History: At time of vaccine patient was diagnosis with URI; Presenting complaint: afebrile, history cough, congestion, sneezing. Phy exam: Normal exam except nasal congestion. Vital signs normal. 7/25/06 Received medical records from hospital which reveal patient experienced right upper lobe pneumonia confirmed by x-ray.  Had cold signs & Symptoms 2-3 days prior to admit.  Had been seen by PCP on day of admission for the immunizations and then developed fever up to 103.6 at home.  Septic w/u was neg.  Rapidly improved on IV antibiotics & d/c home 4/27 on oral antibiotics./ss
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pneumonia, Pyrexia, Sneezing
Clinical narrative: Patient received vaccines at 7 weeks of age. That evening patient develop fever and was described by mother as being lethargic and feeding poorly. Admitted to Hospital, septic work-up done and started on antibiotics. History: At time of vaccine patient was diagnosis with URI; Presenting complaint: afebrile, history cough, congestion, sneezing. Phy exam: Normal exam except nasal congestion. Vital signs normal. 7/25/06 Received medical records from hospital which reveal patient experienced right upper lobe pneumonia confirmed by x-ray.  Had cold signs & Symptoms 2-3 days prior to admit.  Had been seen by PCP on day of admission for the immunizations and then developed fever up to 103.6 at home.  Septic w/u was neg.  Rapidly improved on IV antibiotics & d/c home 4/27 on oral antibiotics./ss
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: 4:00PM-Patient given Hep A. Shortly after receiving stated "My ears are ringing and I have tingling around the mouth". When questioned if had previous history of complications with vaccine stated "no, but in the past have had a reaction to shellfish". Pt.was given 20cc of liquid benadryl and vital signs were taken. VS were stable. Alerted facility physician and monitored pt. for 1 hour. Notified patients physician of incident and private physician  ordered solumedrol for patient.VS were taken and stable before leaving clinic. Followed-up with patient following day and pt denied any further complications.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure increased, Dizziness, Fatigue, Hyperhidrosis, Hypersensitivity
Clinical narrative: Received the first of three Hepatitis B (Engerix B) shot in the left deltoid at 16:10 on 5/17/06. Already read the Hepatitus B info packet and signed the consent form. Also stated that he was not allergic to bakers yeast. After the shot, I asked to have a seat for 20 minutes to make sure he doesn't have an allergic reaction. At 16:17, the employee was standing at the front desk typing into his pager when he said he wasn't feeling well. I caught the employee as he was beginning to go limp. I got the employee back to the exam room and laid him on the exam table. The employee was sweating profusely and signe of pallor. Stated that he was feeling diszzy, nauseaous and might throw up. Also stated the he was very tired and his arms and legs were tingling. Upon observation, the lips began to swell up. Stated that he did not feel any tightening in his throat.  I had the MERT team paged out and EMS system implemented.  I immediately placed him on 15 liters of oxygen via non-rebreather.  The vitals were BP 142/102, pulse 126 and breathing was shallow. Ambulance arrived on scene and transported to hospital.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Hypotonia, Hypoventilation, Malaise, Nausea, Pallor
Clinical narrative: Received the first of three Hepatitis B (Engerix B) shot in the left deltoid at 16:10 on 5/17/06. Already read the Hepatitus B info packet and signed the consent form. Also stated that he was not allergic to bakers yeast. After the shot, I asked to have a seat for 20 minutes to make sure he doesn't have an allergic reaction. At 16:17, the employee was standing at the front desk typing into his pager when he said he wasn't feeling well. I caught the employee as he was beginning to go limp. I got the employee back to the exam room and laid him on the exam table. The employee was sweating profusely and signe of pallor. Stated that he was feeling diszzy, nauseaous and might throw up. Also stated the he was very tired and his arms and legs were tingling. Upon observation, the lips began to swell up. Stated that he did not feel any tightening in his throat.  I had the MERT team paged out and EMS system implemented.  I immediately placed him on 15 liters of oxygen via non-rebreather.  The vitals were BP 142/102, pulse 126 and breathing was shallow. Ambulance arrived on scene and transported to hospital.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Received the first of three Hepatitis B (Engerix B) shot in the left deltoid at 16:10 on 5/17/06. Already read the Hepatitus B info packet and signed the consent form. Also stated that he was not allergic to bakers yeast. After the shot, I asked to have a seat for 20 minutes to make sure he doesn't have an allergic reaction. At 16:17, the employee was standing at the front desk typing into his pager when he said he wasn't feeling well. I caught the employee as he was beginning to go limp. I got the employee back to the exam room and laid him on the exam table. The employee was sweating profusely and signe of pallor. Stated that he was feeling diszzy, nauseaous and might throw up. Also stated the he was very tired and his arms and legs were tingling. Upon observation, the lips began to swell up. Stated that he did not feel any tightening in his throat.  I had the MERT team paged out and EMS system implemented.  I immediately placed him on 15 liters of oxygen via non-rebreather.  The vitals were BP 142/102, pulse 126 and breathing was shallow. Ambulance arrived on scene and transported to hospital.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Eye pain, Fatigue, Headache, Malaise
Clinical narrative: Patient  reported the following: "By the evening of the thirteenth I felt generally sick, sluggish, and very fatigued.  Sunday morning I woke up with a headache and aches in every part of my body. Every part of me hurt beyond an ache, every muscle, every joint.  By noon, I could not move without pain, my eyes hurt to move, I tried to drive, but I felt myself falling asleep at the wheel.  I spent the entire day sleeping and drinking water.  I took the dose of tylenol but it didn't dent the pain.  I ran a fever of 103. I woke Monday feeling better but my head still ached and most of my joints still hurt and I stayed home from work."
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pain, Pyrexia, Sluggishness
Clinical narrative: Patient  reported the following: "By the evening of the thirteenth I felt generally sick, sluggish, and very fatigued.  Sunday morning I woke up with a headache and aches in every part of my body. Every part of me hurt beyond an ache, every muscle, every joint.  By noon, I could not move without pain, my eyes hurt to move, I tried to drive, but I felt myself falling asleep at the wheel.  I spent the entire day sleeping and drinking water.  I took the dose of tylenol but it didn't dent the pain.  I ran a fever of 103. I woke Monday feeling better but my head still ached and most of my joints still hurt and I stayed home from work."
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site induration, Injection site reaction, Leukocytosis, Oedema peripheral
Clinical narrative: Idiosyncratic/probable reaction.  Patient noticed induration at injection site on 4/19/06; over the course of 5 days patient developed cellulitis from shoulder to elbow (swelling, pain, fever, leukocytis) & was admitted for IV antibiotics (cefazolin, vancomycin). Patient improved and was discharged on 4/27/06 with outpatient antibiotics.  12/22/06 Received medical records from hospital which reveal patient admitted 4/23/05-4/27/05 with RUE cellulitis s/p tetanus vax.  Improved on antibiotics & continued on oral antibiotics at home.   Final DX:  RUE cellulitis, improved.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Idiosyncratic/probable reaction.  Patient noticed induration at injection site on 4/19/06; over the course of 5 days patient developed cellulitis from shoulder to elbow (swelling, pain, fever, leukocytis) & was admitted for IV antibiotics (cefazolin, vancomycin). Patient improved and was discharged on 4/27/06 with outpatient antibiotics.  12/22/06 Received medical records from hospital which reveal patient admitted 4/23/05-4/27/05 with RUE cellulitis s/p tetanus vax.  Improved on antibiotics & continued on oral antibiotics at home.   Final DX:  RUE cellulitis, improved.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Chills, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: On the morning following Menactra vaccination, the patient experienced flulike symptoms (chills, fatigue), and swelling, pain at the site of injection (right deltoid). She felt a little tightness of her chest, but no wheezing or severe shortness of breath. As of the time she informed her healthcare provider (3pm later that day, her symptoms had improved, and she only felt fatigue and some soreness of her arm.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling
Clinical narrative: On the morning following Menactra vaccination, the patient experienced flulike symptoms (chills, fatigue), and swelling, pain at the site of injection (right deltoid). She felt a little tightness of her chest, but no wheezing or severe shortness of breath. As of the time she informed her healthcare provider (3pm later that day, her symptoms had improved, and she only felt fatigue and some soreness of her arm.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pain, Paraesthesia
Clinical narrative: Patient described onset of trouble breathing, tactile temperature, bilateral arm pain with tingling in the hands, throat and chest tightness, and dizziness beginning in the evening after she had received her shots in the afternoon.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Pyrexia, Throat tightness
Clinical narrative: Patient described onset of trouble breathing, tactile temperature, bilateral arm pain with tingling in the hands, throat and chest tightness, and dizziness beginning in the evening after she had received her shots in the afternoon.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Gamma-glutamyltransferase increased, Injection site hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated alanine aminotransferase in a 49 yr old female subject who was vaccinated with hep B vaccine recombinant (Engerix B). The reported is the subject. The subject medical history included acid reflex and sinus headache. Concurrent medications included Motrin IB sinus (Motrin sinus) and Pamotidine (Pepcid). On unspecified dates in 1992, the subject received a three dose series of hepatitis B vaccine (unk manf). On an unspecified date before 13Feb06, a hep B surface antibody titer was low. On 13Feb06 the subject received a dose of Engerix B in the left arm as the 4th dose in the hep B vaccination series. On 13Mar06, 29 days after vaccination with Engerix B, the subject experienced lump injection site and injection site pruritis. The subject was seen at a physician's office. Blood tests performed on 13Mar06 revealed an increased level of hep B surface antibody, an elevated immunoglobulin level of 468 and elevated levels of alanine aminotransferase at 102, aspartate aminotransferase at 74, alkaline phosphatase at 276, and gamma glutamyl transferase at 227. The subject reported that the night before the labs were drawn on 12Mar06, she took one Motrin IB sinus. The injection site lump and pruritis resolved after 3 days. On 11May06, a retest blood sample was performed. The results showed an alanine aminotransferase level of 90. The outcome of the elevated levels of immunoglobulin, aspartate aminotransferase, alkaline phosphatase, and gamma glutamyl transferase were not reported. Increased alanine aminotransferase and increased aspartate aminotransferase were assessed as medically serious by manf (OMIC).
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Laboratory test abnormal, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated alanine aminotransferase in a 49 yr old female subject who was vaccinated with hep B vaccine recombinant (Engerix B). The reported is the subject. The subject medical history included acid reflex and sinus headache. Concurrent medications included Motrin IB sinus (Motrin sinus) and Pamotidine (Pepcid). On unspecified dates in 1992, the subject received a three dose series of hepatitis B vaccine (unk manf). On an unspecified date before 13Feb06, a hep B surface antibody titer was low. On 13Feb06 the subject received a dose of Engerix B in the left arm as the 4th dose in the hep B vaccination series. On 13Mar06, 29 days after vaccination with Engerix B, the subject experienced lump injection site and injection site pruritis. The subject was seen at a physician's office. Blood tests performed on 13Mar06 revealed an increased level of hep B surface antibody, an elevated immunoglobulin level of 468 and elevated levels of alanine aminotransferase at 102, aspartate aminotransferase at 74, alkaline phosphatase at 276, and gamma glutamyl transferase at 227. The subject reported that the night before the labs were drawn on 12Mar06, she took one Motrin IB sinus. The injection site lump and pruritis resolved after 3 days. On 11May06, a retest blood sample was performed. The results showed an alanine aminotransferase level of 90. The outcome of the elevated levels of immunoglobulin, aspartate aminotransferase, alkaline phosphatase, and gamma glutamyl transferase were not reported. Increased alanine aminotransferase and increased aspartate aminotransferase were assessed as medically serious by manf (OMIC).
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Reaction to Dtap on right arm, swollen, red, indurated.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site reaction, Oedema
Clinical narrative: Local rxn. Antihistamine taken, 4cm round warm, fine, slight edema.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Diarrhoea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Urticarial rash, fever, vomiting, loose stools, occurred a little over 24 hrs from vaccination. Treatment Benadryl sl supportive.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Vomiting
Clinical narrative: Redness/pain at injection site began 8 hrs after injection, vomiting after 42 hrs.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Pruritus
Clinical narrative: Area of injection became red, lg hard lump and itchy. Lump and redness have increased since day of injection.
Age: 1.05
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Irritability, Lymphadenopathy, Parotitis, Pyrexia
Clinical narrative: Fever starting 4/27/06. Fussiness starting 5/2/06. Lymphadenopathy and Parotitis.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right deltoid, lower injection site 4"x 2 3/4" reaction raised and red area. Earlier that day the pt had her allergy shots.
Age: 69.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Disorientation, Dizziness, Dysarthria, Hallucination, Laboratory test abnormal
Clinical narrative: Client received YF, IPV and oral Ty vax on 5/3/06. Had a dizzy disoriented episode 3 days later that lasted 12 hrs. Went to hospital and had neg head CT scan. Symptoms resolved after 12 hrs. 7/3/06 Received medical records from hospital which reveal patient admitted 5/6/06 w/diagnosis of disorientation, dysarthria & slurred speech.  Admitted to having 3 glasses of wine night before, attended conference following day w/o symptoms until after lunch.  Had hallucinations while in ER & became somnolent.  Had been seen in ER 1 week prior for similar s/s.
Age: 69.0
Sex: F
Vaccine: IPV, TYP, YF
Symptoms: Somnolence
Clinical narrative: Client received YF, IPV and oral Ty vax on 5/3/06. Had a dizzy disoriented episode 3 days later that lasted 12 hrs. Went to hospital and had neg head CT scan. Symptoms resolved after 12 hrs. 7/3/06 Received medical records from hospital which reveal patient admitted 5/6/06 w/diagnosis of disorientation, dysarthria & slurred speech.  Admitted to having 3 glasses of wine night before, attended conference following day w/o symptoms until after lunch.  Had hallucinations while in ER & became somnolent.  Had been seen in ER 1 week prior for similar s/s.
Age: 23.0
Sex: M
Vaccine: FLUX, HEP, SMALL
Symptoms: Aspartate aminotransferase increased, Chest pain, Electrocardiogram abnormal, Hypokinesia, Laboratory test abnormal
Clinical narrative: 23 year old male who presented with chest pain 11 days following his smallpox immunization. EKG and echo are consistent with mild myocarditis. Pt is being transferred to hospital. Per 60 day follow up: After the patient left foreign country to return to the US, I have not heard any further reports about this patient. I am unsure of where he is at this time.
Age: 23.0
Sex: M
Vaccine: FLUX, HEP, SMALL
Symptoms: Myocarditis, Red blood cell sedimentation rate increased
Clinical narrative: 23 year old male who presented with chest pain 11 days following his smallpox immunization. EKG and echo are consistent with mild myocarditis. Pt is being transferred to hospital. Per 60 day follow up: After the patient left foreign country to return to the US, I have not heard any further reports about this patient. I am unsure of where he is at this time.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Computerised tomogram, Hypokinesia, Muscle disorder, Neuritis
Clinical narrative: Heaviness, weakness, muscle loss, loss of motion, severe pain, continues with doctor visits, MRI and Physical therapy. Medical records state osteocondroma, neuritis, edema. msv Follow-up: Still rebuilding/strengthening muscle. Appers to improving, not quite 100%. Just released from physical therapy 30 days ago. Pain appears to be gone since muscle has finally begun to build. Still under doctor's observation. Next appt Aug 2.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Nuclear magnetic resonance imaging, Oedema, Osteochondroma, Pain, Sensation of heaviness
Clinical narrative: Heaviness, weakness, muscle loss, loss of motion, severe pain, continues with doctor visits, MRI and Physical therapy. Medical records state osteocondroma, neuritis, edema. msv Follow-up: Still rebuilding/strengthening muscle. Appers to improving, not quite 100%. Just released from physical therapy 30 days ago. Pain appears to be gone since muscle has finally begun to build. Still under doctor's observation. Next appt Aug 2.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: X-ray
Clinical narrative: Heaviness, weakness, muscle loss, loss of motion, severe pain, continues with doctor visits, MRI and Physical therapy. Medical records state osteocondroma, neuritis, edema. msv Follow-up: Still rebuilding/strengthening muscle. Appers to improving, not quite 100%. Just released from physical therapy 30 days ago. Pain appears to be gone since muscle has finally begun to build. Still under doctor's observation. Next appt Aug 2.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Cerebellar syndrome, Coordination abnormal, Electrocardiogram abnormal, Haematocrit decreased
Clinical narrative: Ataxia possible cerebellitis. Required observation only. Medical records state leg pain. msv
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Ataxia possible cerebellitis. Required observation only. Medical records state leg pain. msv
Age: 1.03
Sex: M
Vaccine: HIBV, MMRV
Symptoms: CSF cell count normal, Cyanosis, Febrile convulsion, Irritability, Lumbar puncture
Clinical narrative: Vaccine given on 5/9/06, MMRV and Hib. Febrile seizures on 5/13/2006. Admit to hospital, spinal tap, IV. Physical exam normal. 5/30/06 Medical records received from hospital which reveal patient admitted overnight w/dx febrile seizures.  Initially brought to ER w/ssizure & cyanosis.  Neg eval & was d/c home.  Later same day, recurrent seizure w/cyanosis & was admitted for observation.  All labs including CSF were WNL & final diagnosis was fever associated w/MMR/ss. 60 day Follow-up Information 02-AUG-2006: This patient has had another febrile seizure since the vaccination event. Working diagnosis common childhood febrile seizure.
Age: 1.03
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Pyrexia
Clinical narrative: Vaccine given on 5/9/06, MMRV and Hib. Febrile seizures on 5/13/2006. Admit to hospital, spinal tap, IV. Physical exam normal. 5/30/06 Medical records received from hospital which reveal patient admitted overnight w/dx febrile seizures.  Initially brought to ER w/ssizure & cyanosis.  Neg eval & was d/c home.  Later same day, recurrent seizure w/cyanosis & was admitted for observation.  All labs including CSF were WNL & final diagnosis was fever associated w/MMR/ss. 60 day Follow-up Information 02-AUG-2006: This patient has had another febrile seizure since the vaccination event. Working diagnosis common childhood febrile seizure.
Age: 1.08
Sex: F
Vaccine: MMRV, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Fine maculopapular rash no vesicles. No keplide pots. "Resembles measles".
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Red spot bigger than a quarter size on L thigh. 5/12/06 17:45 PM, spoke with pt's mother. Doing okay.
Age: 0.58
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Influenza like illness, Pharyngitis, Pyrexia
Clinical narrative: 5/15/06 Physical and immunizations given. On 5/16/06, 01:00 AM, temperature 103.6-104.1. Tylenol every 4 hrs. Seen by doctor. Pharyngitis influenza. Treated with IM/Rocephin.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, hot to touch L deltoid. Rx: Cephalexin; 3 days from immunizations.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt developed cellulitis on L deltoid area measuring 5" X 6 1/2". Tender to touch, red and warm. Started on Cephalexin and Benadryl (5/10/06).
Age: 17.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Nausea, Pruritus
Clinical narrative: Almost 2 weeks after vaccination, client reported that she had itching, nausea and broke out in <50 small, red blisters. The itching started 4/20/06 and one broke out 4/21/06. The rash lasted about 3 days. Client denies any fever. No treatment was needed.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: 5/9/06, runny nose. 5/12/06 elevated temp 103.9. Elevated temp continued on 5/13/06 and 5/14/06 Woke up with rash on 5/15/06. Saw physician. Was given antibiotics.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Flushing
Clinical narrative: Hours after vaccine face and trunk became red/flushed. Next day became ataxic. Redness resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Localized urticaria at injection site.
Age: 54.0
Sex: F
Vaccine: MU
Symptoms: Blood pressure increased, Flushing, Headache
Clinical narrative: Headaches, flushing of cheeks, had daily since getting vaccine. Has been taking Migraine Strength Excedrin. HX of migraines on Inderal. Last migraine 6-7 years ago. Gets headaches a lot before this but they were always relieved by
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain, induration, erythema at injection site pain with elevation of arm on 5/12/06. Better now.
Age: 1.06
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Decreased appetite, Lethargy, Rash macular
Clinical narrative: PT CAME TO HEALTH DEPT ON 5/18/2006 WITH DECREASED APPETITE, MACULAR FACIAL RASH, AND LETHARGY.  PT'S RAPID STREP TEST WAS NEGATIVE.  THE PATIENT WAS REFERRED TO DOCTOR BY FNP.  THE PATIENT WAS SEEN BY DR THE SAME DAY.