chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives, Cluster of 2 patients (sisters - no individual patient identification provided) developed hives the next day after receiving Menactra (lot number U1932AB, route and site administration not reported) on 09 April 2007, received from a health care professional in the USA on 27 April 2007. Case1: A female patient (one of 2 sisters) developed hives on the arms only, the next day after she received Menactra (lot number U1932AB, route and site of administration not reported) on 09 April 2007. It was unknown if any other vaccines were administered within 4 weeks. The patient was treated by her father, who is a dermatologist, with an unknown medication and the event resolved. The second sister's case is detailed in case 2007-01439.
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives, Cluster of 2 patients (sisters - no individual patient identification provided) developed hives the next day after receiving Menactra (lot number U1932AB, route and site administration not reported) on 09 April 2007, received from a health care professional in the USA on 27 April 2007. Case 2:  A female patient (one of 2 sisters) developed hives on the arms and legs, the next day after she received Menactra (lot number U1932AB, route and site of administration not reported) on 09 April 2007. It was unknown if any other vaccines were administered within 4 weeks. The patient was treated by her father, who is a dermatologist, with an unknown medication and the event resolved. The first sister's case is detailed in case 2007-01458.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Cataract, Depression, Diabetes mellitus, Dizziness
Clinical narrative: This case was reported by a consumer and described the occurrence of Bell's palsy in a 40-year-old male subject who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. The reporter was the subject's mother. In 2001, the subject received the "complete series" of Lymerix (injection). In 2001, within months of vaccination with Lymerix, the subject developed Bell's palsy, depression, and dizziness. In approximately 2004 he developed diabetes, and in 2006 developed glaucoma and cataract. On an unknown date, he developed neuropathy. The reporting consumer stated that the subject "may have actually developed Lyme disease", noting that his health had deteriorated since. The consumer further reported that the subject had "not been able to work due to the toxicity caused by this vaccine..." This case was assessed as medically serious by manufacturer. At the time of reporting the events were unresolved.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Drug toxicity, Facial palsy, General physical health deterioration, Glaucoma, Lyme disease
Clinical narrative: This case was reported by a consumer and described the occurrence of Bell's palsy in a 40-year-old male subject who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. The reporter was the subject's mother. In 2001, the subject received the "complete series" of Lymerix (injection). In 2001, within months of vaccination with Lymerix, the subject developed Bell's palsy, depression, and dizziness. In approximately 2004 he developed diabetes, and in 2006 developed glaucoma and cataract. On an unknown date, he developed neuropathy. The reporting consumer stated that the subject "may have actually developed Lyme disease", noting that his health had deteriorated since. The consumer further reported that the subject had "not been able to work due to the toxicity caused by this vaccine..." This case was assessed as medically serious by manufacturer. At the time of reporting the events were unresolved.
Age: 40.0
Sex: M
Vaccine: LYME
Symptoms: Neuropathy
Clinical narrative: This case was reported by a consumer and described the occurrence of Bell's palsy in a 40-year-old male subject who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. The reporter was the subject's mother. In 2001, the subject received the "complete series" of Lymerix (injection). In 2001, within months of vaccination with Lymerix, the subject developed Bell's palsy, depression, and dizziness. In approximately 2004 he developed diabetes, and in 2006 developed glaucoma and cataract. On an unknown date, he developed neuropathy. The reporting consumer stated that the subject "may have actually developed Lyme disease", noting that his health had deteriorated since. The consumer further reported that the subject had "not been able to work due to the toxicity caused by this vaccine..." This case was assessed as medically serious by manufacturer. At the time of reporting the events were unresolved.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, RV5
Symptoms: Dehydration, Erythema multiforme, Inappropriate schedule of drug administration, Medication error, Pyrexia
Clinical narrative: Developed erythema multiforme, dehydration, fever. 05/14/2007 MR received for 3 night admit (5/3-6/07) for petechial rash and fever x 5 days. Dehydration noted.  Vomiting began on day 3 and was intermittant.  No diarrhea.   PE: Mildly ill appearing.  TMs bulging and erythematous with cloudy yellow fluid posteriorly. Ulcers on buccal mucosa.  Inguinal lymphadenopathy. Erythematous cheeks in a scattered morbilliform rash. Central violaceous coloring. Does blanch. Child is actively scratching.  Petechiae on arms, erythematous confluent macules on extremities.  Perivaginal erythema. Developed watery diarrhea and thrush during admission.  Petechiae and rash resolving during admission.  Discharge DX: Viral syndrome, Fever-resolved, Viral exanthem-resolving, Diarrhea-resolving.
Age: 20.0
Sex: M
Vaccine: TYP
Symptoms: Cardiomyopathy, Echocardiogram abnormal
Clinical narrative: briefly: cardiomyopathy, confirmed with echocardiogram.  05/09/2007  Additional records received from reporter. ID consult reveals pt reported for military duty with c/o fever x 2.  Typhoid vax given at that time.  That pm c/o worsening H/A and fatigue.  ER visit that night (03/03/2007) where pt. was febrile (101.7-102'F).  Pt. developed worsening dyspnea and fatigue. Pt was hospitalized again on 4/6/07 for new onset heart failure, cardioverted and worked up for a heart transplant. Otherwise txd medically. PMH: None. Flu shot x 2 this year. Allergies: NKDA.  Assessment:  New onset cardiomyopathy.  06/18/2007 MR received for hospitalization 4/6-19/2007 as above.  No new codes.
Age: 6.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMRV
Symptoms: Injection site erythema, Injection site rash, Local reaction
Clinical narrative: Red blotching rash around IPV injection site small area of redness around Dapt injection site. Local erythematous reaction to IPV
Age: 1.2
Sex: U
Vaccine: MMRV
Symptoms: Erythema, Erythema multiforme, Pyrexia, Rash papular, Skin lesion
Clinical narrative: Pink generalized papular rash started 5/4/07; developed fever to 101.5 - 102 on 5/5/07 with generalized urticariall rash w/ some target lesions consistent with erythema multiforme
Age: 1.2
Sex: U
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: Pink generalized papular rash started 5/4/07; developed fever to 101.5 - 102 on 5/5/07 with generalized urticariall rash w/ some target lesions consistent with erythema multiforme
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 25.0
Sex: F
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Injection site erythema, Pain, Pyrexia, Skin discolouration, Swelling
Clinical narrative: PT c/o soreness, swelling, discoloration. Initially  @ 24 hr had fever when Sx started - Rt arm 2 cm diameter, red, gl taken, Resolving after 2nd day.  Still Symptomatic States getting better
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Ear pain, Injection site erythema, Neck pain
Clinical narrative: Pt has redness on L arm (deltoid) 100m x 95m No induration present. Pt states this starts Sunday. First felt "pain" under Lt ear and Rt side of neck. Then that went away and she noticed the red Lt arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection of MCV4 and Tdap in (L) deltoid 5/3/07. Erythema swelling, pain in area of injection site 5/3/07 Area measured 8 x 6 cm
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Basophil count normal, Blood culture negative, Culture urine negative, Eosinophil count, Haematocrit normal
Clinical narrative: On 4/26 and 4/27 pt received a total of 5 vaccines (MGC, Hep A, Hep B, in left upper arm IM on 4/26) and Pneumococcal subq in left triceps area and Tdap IM in left upper arm on 4/27/07. Early on a.m. of 4/28/07, pt experienced fever, headache, body-aches, nausea and a reaction surrounding vaccine site in left triceps. Site was painful, hot to the touch, pruritic, red and edematous. There was a knot at the site the size of a goose egg and the redness, pain and swelling went from his left upper triceps area to his elbow. Systemic symptoms resolved over next 24 hours with round the clock administration of Tylenol. No adenopathy. No paresthesias in LUE. Pt has no history of previous vaccine adverse reactions. The reaction surrounding the vaccine site diminished significantly by 2 May. Fever workup was done and reveled no evidence of infection.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Haemoglobin normal, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: On 4/26 and 4/27 pt received a total of 5 vaccines (MGC, Hep A, Hep B, in left upper arm IM on 4/26) and Pneumococcal subq in left triceps area and Tdap IM in left upper arm on 4/27/07. Early on a.m. of 4/28/07, pt experienced fever, headache, body-aches, nausea and a reaction surrounding vaccine site in left triceps. Site was painful, hot to the touch, pruritic, red and edematous. There was a knot at the site the size of a goose egg and the redness, pain and swelling went from his left upper triceps area to his elbow. Systemic symptoms resolved over next 24 hours with round the clock administration of Tylenol. No adenopathy. No paresthesias in LUE. Pt has no history of previous vaccine adverse reactions. The reaction surrounding the vaccine site diminished significantly by 2 May. Fever workup was done and reveled no evidence of infection.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Lymphocyte count decreased, Monocyte count increased
Clinical narrative: On 4/26 and 4/27 pt received a total of 5 vaccines (MGC, Hep A, Hep B, in left upper arm IM on 4/26) and Pneumococcal subq in left triceps area and Tdap IM in left upper arm on 4/27/07. Early on a.m. of 4/28/07, pt experienced fever, headache, body-aches, nausea and a reaction surrounding vaccine site in left triceps. Site was painful, hot to the touch, pruritic, red and edematous. There was a knot at the site the size of a goose egg and the redness, pain and swelling went from his left upper triceps area to his elbow. Systemic symptoms resolved over next 24 hours with round the clock administration of Tylenol. No adenopathy. No paresthesias in LUE. Pt has no history of previous vaccine adverse reactions. The reaction surrounding the vaccine site diminished significantly by 2 May. Fever workup was done and reveled no evidence of infection.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Neutrophil count increased, Pain, Platelet count normal, Pyrexia
Clinical narrative: On 4/26 and 4/27 pt received a total of 5 vaccines (MGC, Hep A, Hep B, in left upper arm IM on 4/26) and Pneumococcal subq in left triceps area and Tdap IM in left upper arm on 4/27/07. Early on a.m. of 4/28/07, pt experienced fever, headache, body-aches, nausea and a reaction surrounding vaccine site in left triceps. Site was painful, hot to the touch, pruritic, red and edematous. There was a knot at the site the size of a goose egg and the redness, pain and swelling went from his left upper triceps area to his elbow. Systemic symptoms resolved over next 24 hours with round the clock administration of Tylenol. No adenopathy. No paresthesias in LUE. Pt has no history of previous vaccine adverse reactions. The reaction surrounding the vaccine site diminished significantly by 2 May. Fever workup was done and reveled no evidence of infection.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Red blood cell count normal, White blood cell count increased
Clinical narrative: On 4/26 and 4/27 pt received a total of 5 vaccines (MGC, Hep A, Hep B, in left upper arm IM on 4/26) and Pneumococcal subq in left triceps area and Tdap IM in left upper arm on 4/27/07. Early on a.m. of 4/28/07, pt experienced fever, headache, body-aches, nausea and a reaction surrounding vaccine site in left triceps. Site was painful, hot to the touch, pruritic, red and edematous. There was a knot at the site the size of a goose egg and the redness, pain and swelling went from his left upper triceps area to his elbow. Systemic symptoms resolved over next 24 hours with round the clock administration of Tylenol. No adenopathy. No paresthesias in LUE. Pt has no history of previous vaccine adverse reactions. The reaction surrounding the vaccine site diminished significantly by 2 May. Fever workup was done and reveled no evidence of infection.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red bumps apx 1 1/2 in x 2 in Hot to touch
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Erythema, Pallor, Rash macular, Unresponsive to stimuli
Clinical narrative: Left leg erythematous, face pale, appeared unresponsive, within seconds the child responded, multiple macular eruptions present. Sent to the ED-WNL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patients mom called 5/7/7 - Patient had DTAP given on 5/4/7 and on Sat 5/5/7 mom noticed swelling, redness and painful - I advised pt to be seen - Appt to see Dr 5/7/7 was advised to use Benadryl for localized reaction.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Infrequent bowel movements, Injection site erythema, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Immunizations given on 4/26/07. Pt sleepy that day. Next day Friday 4/27/07 pt was given Tylenol and Motrin alternating. Pt according to her mother had fever as high as 103. Pt would only breastfeed and refused pedialyte. Pt had Pt had no BM's, Left thigh had 7-8 red bumps around injection site was red and warm. Seen ER 4/29 and Dr office 4/30.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Somnolence
Clinical narrative: Immunizations given on 4/26/07. Pt sleepy that day. Next day Friday 4/27/07 pt was given Tylenol and Motrin alternating. Pt according to her mother had fever as high as 103. Pt would only breastfeed and refused pedialyte. Pt had Pt had no BM's, Left thigh had 7-8 red bumps around injection site was red and warm. Seen ER 4/29 and Dr office 4/30.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Noted red warm area to left upper arm area onset 5/6/07, area slightly raised. Mother gave child Tylenol and Benadryl child complained of mild pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Significant local reaction L deltoid 6 x 6 cm induration, red, tender, warm, started Keflex/Heat/Motrin. 48 hrs after injection.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Conjunctivitis, Eye infection, Periorbital oedema
Clinical narrative: Within one hour of Varicella vaccine administration patient developed injected eyes and periorbital edema. Presumed to clinic with bilateral conjunctivitis infected, periorbital area puffy. Vital signs WNL. Benadryl 1 tsp PO given.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Drug hypersensitivity, Eye oedema
Clinical narrative: Within one hour of Varicella vaccine administration patient developed injected eyes and periorbital edema. Presumed to clinic with bilateral conjunctivitis infected, periorbital area puffy. Vital signs WNL. Benadryl 1 tsp PO given.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Eye swelling
Clinical narrative: Within one hour of Varicella vaccine administration patient developed injected eyes and periorbital edema. Presumed to clinic with bilateral conjunctivitis infected, periorbital area puffy. Vital signs WNL. Benadryl 1 tsp PO given.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Eyelid oedema, Lip swelling, Pruritus, Swelling face
Clinical narrative: Itching swelling of face, including lip, eyelids, swelling of hands and feet, hives at body.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site discolouration, Injection site pustule, Injection site swelling, Nodule
Clinical narrative: Knot started forming within first 24hrs.  Continued to swell and discolor.  Day 6 sought medical attention large egg shap and dark discoloration at vaccination site. Day 7 mutliple pustules started forming.  Day 8 pustules started to burst.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMRV
Symptoms: Crying, Pallor, Pyrexia, Restlessness, Sleep disorder
Clinical narrative: High Fever of 101.9 (AX) for 2 days. patient was very pale with a glazed over look to her eyes and restless for those 2-3 days. Called Dr.s office they said pale meant was only worriesome if it occured immediately after shots .the Dr.s office also said to give her tylenol for fever and that I should call back if the symptoms continued longer than 48 hours. I Gave her Tylenol evey 4 hours for the next 48 hours and then as needed for the next day.(Only 2x on day 3) She continues to wake up at night and cry for no apparent reason and this did not occur before he vaccinations.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Back pain, Dizziness, Fatigue, Gait disturbance, Muscle spasms
Clinical narrative: Father of client reports onset of fever 100 degrees, fatigue and low back pain onseta at 10am 2-27-07. Reports client was sitting in chair and had lower back muscle spasms.  Back pain was severa enough that he had a hard time walking.  Father gave cleint tylenol which he said relieved the efever and helped relieve the back pain. 2-28-07 client was dizzy but pain and fever had improved.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Father of client reports onset of fever 100 degrees, fatigue and low back pain onseta at 10am 2-27-07. Reports client was sitting in chair and had lower back muscle spasms.  Back pain was severa enough that he had a hard time walking.  Father gave cleint tylenol which he said relieved the efever and helped relieve the back pain. 2-28-07 client was dizzy but pain and fever had improved.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Respiratory distress, Swollen tongue
Clinical narrative: per mother of child, respiratory distress, eye and tongue swelling. They stopped on way home and called 911 - taken by ambulance to medical center. epinephrine and beadryl in ER, d/c 4 hours later on predisone and benedryl.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 4 hours of administration of the DTap injection, patient's arm became swollen at the injection site.  It was swollen to about 5 inches in diameter.  It was hot, red and hard to the touch.  Dr. was contacted that evening by phone.  He suggested waiting overnight to see what happened.  The arm was exactly the same, if not more swollen the next morning.  Dr. saw patient in the office the morning following administration.  He said patient should take Benadryl and Loratadine q 4 hours for the next 48 hours.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Vaccination complication
Clinical narrative: MOTHER CALLED AFTER HOURS SERVICE ON 5-4-07--STATES INFANT CONSTANLY CRYING HALF OF DAY AND LOOKS VERY SICK TO HER. SHE WAS ADVISED TO TAKE THE INFANT TO THE ED FOR EVALUATION.  MOTHER STATES ED ADVISED INFANT IS MOST LIKELY HAVING A REACTION TO THE VACCINES.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Erythema, Palpitations, Tremor
Clinical narrative: Difficulty swallowing, palpitations, reddish skin, trembling.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Gene mutation identification test positive, Homocystinaemia, Hyperlipidaemia, Pain in extremity
Clinical narrative: Traveled from 3/3/07-3/10/07. On 3/6/07 had calf pain that traveled to the thigh. On 3/19/07, went to Medical Center ER for severe pain in lower back. Two large clots found in lung (pulmonary embolus). Admitted for heparin treatment for a few days. Discharged on Coumadin for 6 months. Has lingering pain in lower back and damage to the lung. Had started taking BCP's for the first time in approx. Feb. 0f 2007. Had genetic testing done after the pulmonary embolus which showed that she has a prothrombin genetic mutation, elevated lipoprotein and hemocystine line.  05/21/2007 MR received form treating hospital.  Initially presented to ED on 3/19/2007 with c/o Right back pain which was worse upon lying down, as well as pain in chest which was worse with deep breathing.  The pain radiated to the Right shoulder.  Had been having some Right leg discomfort while traveling prior to ED visit PMH: Recent travel with 2 flights x 3hrs. On BCP.  Admitted with the following DX: LBP, R Flank pain, Pulmonary Embolism, Pulmonary Infarct.  Pulmonary Critical Care consult with DX; Pulmonary Embolism and Infarct. Pt. returned to ER on 3/25/07 with c/o calf pain since that morning. Still c/o SOB x 1 week. DX: Calf pain.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulmonary embolism
Clinical narrative: Traveled from 3/3/07-3/10/07. On 3/6/07 had calf pain that traveled to the thigh. On 3/19/07, went to Medical Center ER for severe pain in lower back. Two large clots found in lung (pulmonary embolus). Admitted for heparin treatment for a few days. Discharged on Coumadin for 6 months. Has lingering pain in lower back and damage to the lung. Had started taking BCP's for the first time in approx. Feb. 0f 2007. Had genetic testing done after the pulmonary embolus which showed that she has a prothrombin genetic mutation, elevated lipoprotein and hemocystine line.  05/21/2007 MR received form treating hospital.  Initially presented to ED on 3/19/2007 with c/o Right back pain which was worse upon lying down, as well as pain in chest which was worse with deep breathing.  The pain radiated to the Right shoulder.  Had been having some Right leg discomfort while traveling prior to ED visit PMH: Recent travel with 2 flights x 3hrs. On BCP.  Admitted with the following DX: LBP, R Flank pain, Pulmonary Embolism, Pulmonary Infarct.  Pulmonary Critical Care consult with DX; Pulmonary Embolism and Infarct. Pt. returned to ER on 3/25/07 with c/o calf pain since that morning. Still c/o SOB x 1 week. DX: Calf pain.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Back pain, Chest X-ray abnormal, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: Traveled from 3/3/07-3/10/07. On 3/6/07 had calf pain that traveled to the thigh. On 3/19/07, went to Medical Center ER for severe pain in lower back. Two large clots found in lung (pulmonary embolus). Admitted for heparin treatment for a few days. Discharged on Coumadin for 6 months. Has lingering pain in lower back and damage to the lung. Had started taking BCP's for the first time in approx. Feb. 0f 2007. Had genetic testing done after the pulmonary embolus which showed that she has a prothrombin genetic mutation, elevated lipoprotein and hemocystine line.  05/21/2007 MR received form treating hospital.  Initially presented to ED on 3/19/2007 with c/o Right back pain which was worse upon lying down, as well as pain in chest which was worse with deep breathing.  The pain radiated to the Right shoulder.  Had been having some Right leg discomfort while traveling prior to ED visit PMH: Recent travel with 2 flights x 3hrs. On BCP.  Admitted with the following DX: LBP, R Flank pain, Pulmonary Embolism, Pulmonary Infarct.  Pulmonary Critical Care consult with DX; Pulmonary Embolism and Infarct. Pt. returned to ER on 3/25/07 with c/o calf pain since that morning. Still c/o SOB x 1 week. DX: Calf pain.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Flank pain, Full blood count, International normalised ratio decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Traveled from 3/3/07-3/10/07. On 3/6/07 had calf pain that traveled to the thigh. On 3/19/07, went to Medical Center ER for severe pain in lower back. Two large clots found in lung (pulmonary embolus). Admitted for heparin treatment for a few days. Discharged on Coumadin for 6 months. Has lingering pain in lower back and damage to the lung. Had started taking BCP's for the first time in approx. Feb. 0f 2007. Had genetic testing done after the pulmonary embolus which showed that she has a prothrombin genetic mutation, elevated lipoprotein and hemocystine line.  05/21/2007 MR received form treating hospital.  Initially presented to ED on 3/19/2007 with c/o Right back pain which was worse upon lying down, as well as pain in chest which was worse with deep breathing.  The pain radiated to the Right shoulder.  Had been having some Right leg discomfort while traveling prior to ED visit PMH: Recent travel with 2 flights x 3hrs. On BCP.  Admitted with the following DX: LBP, R Flank pain, Pulmonary Embolism, Pulmonary Infarct.  Pulmonary Critical Care consult with DX; Pulmonary Embolism and Infarct. Pt. returned to ER on 3/25/07 with c/o calf pain since that morning. Still c/o SOB x 1 week. DX: Calf pain.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulmonary embolism, Pulmonary infarction, White blood cell count increased
Clinical narrative: Traveled from 3/3/07-3/10/07. On 3/6/07 had calf pain that traveled to the thigh. On 3/19/07, went to Medical Center ER for severe pain in lower back. Two large clots found in lung (pulmonary embolus). Admitted for heparin treatment for a few days. Discharged on Coumadin for 6 months. Has lingering pain in lower back and damage to the lung. Had started taking BCP's for the first time in approx. Feb. 0f 2007. Had genetic testing done after the pulmonary embolus which showed that she has a prothrombin genetic mutation, elevated lipoprotein and hemocystine line.  05/21/2007 MR received form treating hospital.  Initially presented to ED on 3/19/2007 with c/o Right back pain which was worse upon lying down, as well as pain in chest which was worse with deep breathing.  The pain radiated to the Right shoulder.  Had been having some Right leg discomfort while traveling prior to ED visit PMH: Recent travel with 2 flights x 3hrs. On BCP.  Admitted with the following DX: LBP, R Flank pain, Pulmonary Embolism, Pulmonary Infarct.  Pulmonary Critical Care consult with DX; Pulmonary Embolism and Infarct. Pt. returned to ER on 3/25/07 with c/o calf pain since that morning. Still c/o SOB x 1 week. DX: Calf pain.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Swelling, Tenderness
Clinical narrative: Local tenderness swelling Temp 103 x 24 hr
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right anterior thigh swelling, redness, warmth, itching about 5 cm in diameter
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Pt states she started itching Friday on the buttocks and itching has now spread to abdomen and thighs. Pt took Benadryl and was instructed to continue with Benadryl today and call me tomorrow unless it becomes worse and was then told to seek medical attention after discussing this with Dr.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Positive pregnancy test on 4/24/07; HPV4 #2 given 04/02/07.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and Rash
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Computerised tomogram, Dysphonia, Dysstasia, Head injury, Headache
Clinical narrative: Received Typhoid injection and fainted approximately 5-8 minutes after injection.  Stated she had never had such a reaction to a shot before.  After the injection she complained of pain at the injection site but otherwise said she felt, "fine".  Witnesses stated she passed out in waiting area of clinic and hit the back of her head on the floor.  Client was found unconscious by a nurse.  Client regained consciousness after 25-30 seconds.  After waking up she stated that she could only whisper, she was unable to get up, and she complained of headache.  Her pulse was 62 and strong, BP was 122/66.  An ambulance was called as client was still not able to get up.  Client was transported to hospital by ambulance.  A follow-up call to the client revealed that she stayed overnight in the hospital for tests and found out she had a 1 to 1.5 inch skull fracture.  5/15/07 Received medical records from hospital which reveal patient experienced a fall onto concrete after having fainting or syncopal episode s/p vax.  Admitted for overnight observation 4/23-4/24/07.  Patient was neurologically intact.  Progressed well w/no neuro deficits & was d/c to home w/continued family observation. FINAL DX: concussion mild, skull fracture.
Age: 18.0
Sex: F
Vaccine: TYP
Symptoms: Injection site pain, Loss of consciousness, Skull fracture, Syncope, X-ray
Clinical narrative: Received Typhoid injection and fainted approximately 5-8 minutes after injection.  Stated she had never had such a reaction to a shot before.  After the injection she complained of pain at the injection site but otherwise said she felt, "fine".  Witnesses stated she passed out in waiting area of clinic and hit the back of her head on the floor.  Client was found unconscious by a nurse.  Client regained consciousness after 25-30 seconds.  After waking up she stated that she could only whisper, she was unable to get up, and she complained of headache.  Her pulse was 62 and strong, BP was 122/66.  An ambulance was called as client was still not able to get up.  Client was transported to hospital by ambulance.  A follow-up call to the client revealed that she stayed overnight in the hospital for tests and found out she had a 1 to 1.5 inch skull fracture.  5/15/07 Received medical records from hospital which reveal patient experienced a fall onto concrete after having fainting or syncopal episode s/p vax.  Admitted for overnight observation 4/23-4/24/07.  Patient was neurologically intact.  Progressed well w/no neuro deficits & was d/c to home w/continued family observation. FINAL DX: concussion mild, skull fracture.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse effect
Clinical narrative: None as of yet when I contacted the parent
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Hypersensitivity, Injection site erythema, Injection site mass, Rash, Rash generalised
Clinical narrative: Vaccines were given on 4/30/2007.  Yesterday 05/06/2007, in the morning Mother noticed small slightly raised rash on upper abdominal area.  Throughout the day she noted it getting worse and by this morning he had the rash all over his trunk, legs, arms and head. She said she wouldn't have given the vaccines he received a week ago any thought, but there was a distinct redness and lump aroud the injection site of his right leg.  Prior to this rash, he did not seem to have any problems following the vaccinations.  Mom took him to an Immediate Care Facility. this morning where the Dr. told her it was an allergic reation but to what is still in question. He advised her to give Benadryl and report the reaction to our facility, although it is doubtful that this episode was due to the vaccination received on the 30th of April.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Dizziness, Fatigue, Headache, Pallor
Clinical narrative: Hives, one degree fever, headache, chills, fatigue,paleness, dizziness
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives, one degree fever, headache, chills, fatigue,paleness, dizziness
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: 5/7/07. 0500 CST PT AWOKE WITH NUMB L HAND AND CRAMPED TRICEP MUSCLE. TINGLING AND NUMBNESS IN HIS HAND HAVE CONTINUED THROUGHT THE DAY AND SEEM TO FLUCTUATE OR "MOVE" AREAS OF HIS HAND. CERTAIN POSITIONS OF HIS ARM AND HAND DO NOT SEEM TO HAVE ANY EFFECT, POSITVE OR NEGATIVE, ON THE TINGLING AND NUMBNESS. APPROX 1600 CST PT C/O FEELING SHARP PAIN BETWEEN HIS RING AND MIDDLE FINGER.  "IT FELT LIKE A SPIKE BEING DRIVEN BTWN MY MIDDLE AND RING FINGERS ALL THE WAY DOWN TO MY WRIST." PAIN LASTED 30-45 MIN.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema (approx. 7 cm), hardness @ site of injection
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt presents at clinic 5/4/2007 with redness and warmth to right upper arm outer aspect, and c/o pain and tenderness since evening of 5/2/2007.  Was assessed to be cellulitis by provider and treated with Keflex 500mg, one capsule by mouth three times per day for 10 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Anorexia, Fatigue, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Local pain at site(R Shoulder), developed several hours later, then fever and fatigue present the next day with loss of appetite.  This continued into day 2 post vac at which time developed rash over injection site had nausea and vomited one time.  At this time (day 3 post vac) seems better with non-tender erythema over injection site.  Now affebrile and otherwise asymptomatic.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Local pain at site(R Shoulder), developed several hours later, then fever and fatigue present the next day with loss of appetite.  This continued into day 2 post vac at which time developed rash over injection site had nausea and vomited one time.  At this time (day 3 post vac) seems better with non-tender erythema over injection site.  Now affebrile and otherwise asymptomatic.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: L deltoid swollen and hot to the touch
Age: 1.0
Sex: M
Vaccine: HBHEPB, HEPA, PNC, VARCEL
Symptoms: Erythema, Induration, Inflammation, Rash papular
Clinical narrative: 2 weeks after inoculation left thigh patient developed superficial papules nodular induration with superficial soft tissue redness inflamed.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt upper arm red, warm to touch, swollen (erythema > 10cm)
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: 4/25/07 Rash ? chickenpox on face, trunk, back and feet.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Erythema, Oedema peripheral
Clinical narrative: Received Varicella vaccine 4/26/07. On 4/27/07 left arm red and swollen. Seen on 5/1/07 swelling and redness subsiding. Received Benadryl was seen 4/26/07 for nausea and abd. pain and diarrhea. 5/1/07 No more diarrhea, still c/o nausea and stomach pain.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site pruritus, Skin warm
Clinical narrative: Itching and redness at immunization site starting 48 hrs after immunization. Exam - large patch of warm, red, slightly, indurated round patch, nontender treatment with Benadryl. Safety net script given for Keflex if worsened.
Age: 8.0
Sex: M
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Scabbed Varicella on upper body.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 6.5 x 6.0 cm area of erythema with small area of induration
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 12 x 9.75 cm, light red area with moderate induration L upper arm
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Injection site pain
Clinical narrative: L Deltoid ache and mild weakness not resolved since 11/29/2006. Ache is at injection site. No visible atrophy. Normal strength, full ROM on exam.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 2 days after vaccine - Red - swell at site of Varivax. Overnight increased red, induration, has been a febrile 2-3 cm diameter - Cx : Cellulitis. TX : Keflex 500mg x 10 days.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Headache, Influenza like illness, Pain in extremity, Swelling
Clinical narrative: Pt called 04-19-07 "sore arm," "Headache". Pt seen by Dr 04-20-07 per progress notes. " Flu like symptoms, round goose egg size swelling," related to TD admin on 04-18-07. Pt received td in 2004.
Age: 14.0
Sex: M
Vaccine: HEPA, MEN, VARCEL
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Swelling and redness that night he had the vaccine on 4/24/07. 11x9 cm Erythema induration. Ice pack to right arm. May give Motrin PRN for Pain.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injected limb mobility decreased, Injection site haematoma, Nausea
Clinical narrative: Intital report received from a patient in the USA on 04 January 2007. A 35 year old, female patient experienced fatigue, nausea and couldn't lift her arm 4 days after she received Decavac (lot number U1786DA, route of administration not reported) in the left deltoid on 14 December 2006. She had a haematoma at the site of injection. She called the doctor and was told to use an ice pack and heat alternately and use an antiinflamatory. In the morning (AM) and night, she can't lift her left arm - it is sore. At the time of the report, she had not recovered. She did not have any illness at the time of injection. Her last Decavac injection was in 1995.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial report received on 09/Mar/2006 form a health care provider. A 43-year-old female patient with no significant past medical history, had received an intra-muscular injection of DECAVAC, lot number U16176A, in the left deltoid. Fifteen days later, the patient developed muscle aches and stiffness with limited range of motion in the left arm. At the time of this report, the patient had not recovered form these events. Follow-up received on 07/Apr/2006 from the responsible physician. The patient was seen by a physician for the event on 08/Mar/2006 and has recovered. No further information expected. The reporter for this case is the same as for case 2006-00580. A corrective version for this case was created on 13/sep/2006 to correct the lot number in the narrative section to U1617GA. No new information was received.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Bursitis, Injected limb mobility decreased, Musculoskeletal stiffness, Myalgia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report received on 09/Mar/2006 from a health care provider. A 46 year old female patient with a history of hypertension, had received an intramuscular injection of Decavac, lot number U1617GA (corrected), in the left deltoid on 17/Jan/2006. Thirty-one days later, she developed muscle aches, stiffness and limited range of motion in the left arm that lasted five weeks. An MRI was completed (results not reported). At the time of this report the patient had not recovered from these events. Follow-up information received on 07/Apr/2006 from responsible physician. The patient had no illness at the time of vaccination. It was confirmed by the reporter that the injection was administered in the left deltoid. The patient had an MRI (date performed not reported) which showed tendonosis, tendonpathy, bursitis and residual red marrow infiltration. Per responsible physician, the patient was 70% better on 10/Mar/2006. Follow-up information received on 15/May/2006 from responsible physician. Per reporter the patient had no past history of tendonpathy or tendonitis. Decavac was received as a booster. The MRI was performed on 10/Mar/2006 and showed 1. Mild supraspinatus tendinopathy with some mild subdeltoid bursitis. 2. Mild hypertrophic changes of the AC joint. 3. Probably residual red marrow in the proximal humerus. Per reporter the presumed mechanisms are unclear. The physician did not consider the bursitis to be caused by vaccine misadministration into the bursa. Recovery status of the patient was not reported. No further information expected. Additional documents available with source files: MRI result.
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Rotator cuff syndrome
Clinical narrative: Initial report received on 09/Mar/2006 from a health care provider. A 46 year old female patient with a history of hypertension, had received an intramuscular injection of Decavac, lot number U1617GA (corrected), in the left deltoid on 17/Jan/2006. Thirty-one days later, she developed muscle aches, stiffness and limited range of motion in the left arm that lasted five weeks. An MRI was completed (results not reported). At the time of this report the patient had not recovered from these events. Follow-up information received on 07/Apr/2006 from responsible physician. The patient had no illness at the time of vaccination. It was confirmed by the reporter that the injection was administered in the left deltoid. The patient had an MRI (date performed not reported) which showed tendonosis, tendonpathy, bursitis and residual red marrow infiltration. Per responsible physician, the patient was 70% better on 10/Mar/2006. Follow-up information received on 15/May/2006 from responsible physician. Per reporter the patient had no past history of tendonpathy or tendonitis. Decavac was received as a booster. The MRI was performed on 10/Mar/2006 and showed 1. Mild supraspinatus tendinopathy with some mild subdeltoid bursitis. 2. Mild hypertrophic changes of the AC joint. 3. Probably residual red marrow in the proximal humerus. Per reporter the presumed mechanisms are unclear. The physician did not consider the bursitis to be caused by vaccine misadministration into the bursa. Recovery status of the patient was not reported. No further information expected. Additional documents available with source files: MRI result.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site rash, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Initial report received from a consumer in the USA on 15/Mar/2006. A 35 year old female patient with an allergy to latex developed a rash on her right shoulder of the injection site to the mid humerus, redness and itchy under her arm, pain to the top of her shoulder and swelling of her right hand the day after receiving the injection of Decavac, lot number U1597CA (expiry date 20/May/2007) in the right deltoid on 14/Mar/2006.  The patient, who is the reporter had no illness at the time of vaccination and has received "many" previous doses. Treatment included the use of Flexall, over the counter Motrin and heat to the site. It was not reported if the patient was seen by a physician. Recovery status was not reported. Follow-up information received on 31/Mar/2006 from a physician. Per the reporter, the patient did not report this adverse event to him but she did recover from these adverse events eight days post-vaccination. No further information is expected. A corrective version was created on 02 April 2007 with the LRD of the previous version(31 March 2006) in order to document "yes" to medically confirmed in the record.
Age: 75.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial report received on 22/Mar/2006 from a health care provider. A 75-year-old female patient with no illnesses at the time of the vaccination had received an intramuscular injection of DECAVAC, manufacturer sanofi pasteur, Inc. , lot number U1636CA, in the right deltoid on 15/Mar/2006. A few hours later, she developed 4cm induration, redness and warmth at the injection site spreading down to the elbow. It is unknown when her last tetanus booster was received. At the time of this report, the patient had not recovered from these events. Follow-up information received on 15/May/2006 from reporter. Per reporter, the patient's symptoms began three hours post vaccination, however was not reported until one week later. The patient recovered. No further information expected.
Age: 29.0
Sex: M
Vaccine: PPV, TD
Symptoms: Axillary pain, Hyperhidrosis, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Initial report received from a registered nurse at a health center on 21/Apr/2006. A 29-year-old male patient developed bouts of diaphoresis lasting a short time, a fever, heat and swelling at the injection site with pain in the right axillary node area the day after receiving the injection (route not reported) of TD, lot number U1703DA in the left deltoid and the intramuscular injection of Pneumococcal vaccine (manufacturer Merck), lot number L048P in the right deltoid on 19/Apr/2006. Per reporter the patient had no illness at the time of vaccination. The patient's symptoms began the day after vaccination, on the 20/Apr/2006 in the evening. On 21/Apr/2006 the patient's temperature was 98.6 degrees Fahrenheit. He was seen by a physician. No treatment was reported. The patient's recovery status was unknown at the time of this report. He is scheduled for a recheck on 24/Apr/2006. A new version was created, on 06/Jun/2006, to amend the product screen to Decavac. Decavac was the product administered, not TD ADS Adult as previously recorded.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Local swelling, Mobility decreased, Neck pain
Clinical narrative: Initial report received from a Registered Nurse in the USA on 16/May/2006. A 37-year-old female patient with an allergy to latex developed pain and swelling at the injection site and the left side of her neck the day she received the intramuscular injection of Decavac, lot number U1618CA (expiry date 23/May/2007) in the left deltoid on 09/May/ 2006. She also received a TB skin test, lot number reported as 26902, manufacturer not reported in the right forearm on 08/May/2006. Per reporter the patient had no illness at the time of vaccination. The patient had difficulty raising her left arm and had pain down her arm to the 4th and 5th digits. On 10/May/2006 the patient was seen in the emergency department and given Lyrtacl and Toradol. Per reporter, the patient recovered.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a Registered Nurse in the USA on 16/May/2006. A 37-year-old female patient with an allergy to latex developed pain and swelling at the injection site and the left side of her neck the day she received the intramuscular injection of Decavac, lot number U1618CA (expiry date 23/May/2007) in the left deltoid on 09/May/ 2006. She also received a TB skin test, lot number reported as 26902, manufacturer not reported in the right forearm on 08/May/2006. Per reporter the patient had no illness at the time of vaccination. The patient had difficulty raising her left arm and had pain down her arm to the 4th and 5th digits. On 10/May/2006 the patient was seen in the emergency department and given Lyrtacl and Toradol. Per reporter, the patient recovered.