chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Injection site erythema, Joint range of motion decreased, Nausea
Clinical narrative: Pain in right deltoid, decreased mobility of right shoulder, nausea, chills and fatigue all on 10/31/03 Above symptoms continued and redness approx 8 inches surrounding injection site noted on 11/01/03 Treatment: Ice to injection site and tylenol for the pain
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Muscular weakness, Nausea
Clinical narrative: Became nauseated, dizzy and had muscle weakness.  Next morning 10/30 continued to have severe muscle weakness, greater on L side of body.  Went to ER.  All tests WNL.  Went home prior to recommended overnight stay for stress test.  No diagnosis made at ER.  Muscle weakness continues to date.  Personal physician retired and has appt. with new doctor on 11/17.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL, TYP
Symptoms: Aphthous stomatitis, Injection site erythema, Injection site swelling, Lymphadenopathy, Lymphangitis
Clinical narrative: 23 Oct 2003 Received vaccinations on this date.  Reports he attended the briefings on smallpox and anthrax vaccinations and received the brochures.No complaints on this date except he had "cold symptoms-runny nose, stuffy head." 28 Oct 2003 Noticed approximately 4 bumps like "zits" on his right thigh.  No itching, no pain.  Went away on their own after a couple of days. 01 Nov 2003 Noticed red streaking from smallpox vaccination site to approximately 2 inches medial to left axillary area.  Also noted tender knot on neck.  No headache, no dizziness.  Neck pain only localized to swollen lymph node.  Had a fever of 102 that normalized after Motrin.  Feels a little more tired than usual.Also noted a canker sore on tip of tongue.Denies any chest pain or palpitations.  Shortness of breath noted only after a long run but not with normal activities or at rest.  No cough. 02 Nov 2003 Continued symptoms as above.  Fever of 99.7 that normalized after Motrin. 03 Nov 2003 Referred to the VHC.  No fever today.  Continued erythematous streaking from SPV to approximately 2 inches medial to left axillary area.  Continued tender, swollen lymph node in posterior cervical neck area and axillary area.  Continued oral canker sore.  No other oral lesions.  No lesions on palms or soles.  Few discrete "bumps" noted on left upper arm and one on chest.  Lesions non-pruritic.  However, patient does complain of itching at SPV site.No complaints of pain, numbness, tingling, or edema at location of anthrax or other vaccinations.  ASSESSMENT:  1. Lymphadenopathy-Left posterior cervical and axillary- Normal side effect associated with smallpox vaccination 2. Lymphangitis-Normal variant associated with smallpox vaccination 3. Robust smallpox vaccination with erythema and edema surrounding vaccination site. 4. Non-viral pustulosis  5. Aphthous ulcer  Treatment Plan: 1. Motrin 800 mg po tid #30 with no refills for comfort. 2. Allegra 180 mg po qd #30 with no refills to relieve itching. 3. Provided patient education and reassurance regarding expected side effects and normal variants of the smallpox vaccination.  Reinforced education on care of the SPV vaccination to prevent transfer of the Vaccinia virus. 4. In a pre-event setting, he should be exempt from all future smallpox vaccinations unless direct exposure occurs. 5. Return visit x 2 days to reassess lymphangitis and lesions. 6. Discussed other symptoms to watch for: instructed patient if he has any chest pain, palpitations, increased shortness of breath, he should go to the emergency room immediately.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL, TYP
Symptoms: Neck pain, Pharyngitis, Pyrexia, Rhinitis, Rhinorrhoea
Clinical narrative: 23 Oct 2003 Received vaccinations on this date.  Reports he attended the briefings on smallpox and anthrax vaccinations and received the brochures.No complaints on this date except he had "cold symptoms-runny nose, stuffy head." 28 Oct 2003 Noticed approximately 4 bumps like "zits" on his right thigh.  No itching, no pain.  Went away on their own after a couple of days. 01 Nov 2003 Noticed red streaking from smallpox vaccination site to approximately 2 inches medial to left axillary area.  Also noted tender knot on neck.  No headache, no dizziness.  Neck pain only localized to swollen lymph node.  Had a fever of 102 that normalized after Motrin.  Feels a little more tired than usual.Also noted a canker sore on tip of tongue.Denies any chest pain or palpitations.  Shortness of breath noted only after a long run but not with normal activities or at rest.  No cough. 02 Nov 2003 Continued symptoms as above.  Fever of 99.7 that normalized after Motrin. 03 Nov 2003 Referred to the VHC.  No fever today.  Continued erythematous streaking from SPV to approximately 2 inches medial to left axillary area.  Continued tender, swollen lymph node in posterior cervical neck area and axillary area.  Continued oral canker sore.  No other oral lesions.  No lesions on palms or soles.  Few discrete "bumps" noted on left upper arm and one on chest.  Lesions non-pruritic.  However, patient does complain of itching at SPV site.No complaints of pain, numbness, tingling, or edema at location of anthrax or other vaccinations.  ASSESSMENT:  1. Lymphadenopathy-Left posterior cervical and axillary- Normal side effect associated with smallpox vaccination 2. Lymphangitis-Normal variant associated with smallpox vaccination 3. Robust smallpox vaccination with erythema and edema surrounding vaccination site. 4. Non-viral pustulosis  5. Aphthous ulcer  Treatment Plan: 1. Motrin 800 mg po tid #30 with no refills for comfort. 2. Allegra 180 mg po qd #30 with no refills to relieve itching. 3. Provided patient education and reassurance regarding expected side effects and normal variants of the smallpox vaccination.  Reinforced education on care of the SPV vaccination to prevent transfer of the Vaccinia virus. 4. In a pre-event setting, he should be exempt from all future smallpox vaccinations unless direct exposure occurs. 5. Return visit x 2 days to reassess lymphangitis and lesions. 6. Discussed other symptoms to watch for: instructed patient if he has any chest pain, palpitations, increased shortness of breath, he should go to the emergency room immediately.
Age: 31.0
Sex: M
Vaccine: ANTH, FLUX, HEP, SMALL, TYP
Symptoms: Skin ulcer
Clinical narrative: 23 Oct 2003 Received vaccinations on this date.  Reports he attended the briefings on smallpox and anthrax vaccinations and received the brochures.No complaints on this date except he had "cold symptoms-runny nose, stuffy head." 28 Oct 2003 Noticed approximately 4 bumps like "zits" on his right thigh.  No itching, no pain.  Went away on their own after a couple of days. 01 Nov 2003 Noticed red streaking from smallpox vaccination site to approximately 2 inches medial to left axillary area.  Also noted tender knot on neck.  No headache, no dizziness.  Neck pain only localized to swollen lymph node.  Had a fever of 102 that normalized after Motrin.  Feels a little more tired than usual.Also noted a canker sore on tip of tongue.Denies any chest pain or palpitations.  Shortness of breath noted only after a long run but not with normal activities or at rest.  No cough. 02 Nov 2003 Continued symptoms as above.  Fever of 99.7 that normalized after Motrin. 03 Nov 2003 Referred to the VHC.  No fever today.  Continued erythematous streaking from SPV to approximately 2 inches medial to left axillary area.  Continued tender, swollen lymph node in posterior cervical neck area and axillary area.  Continued oral canker sore.  No other oral lesions.  No lesions on palms or soles.  Few discrete "bumps" noted on left upper arm and one on chest.  Lesions non-pruritic.  However, patient does complain of itching at SPV site.No complaints of pain, numbness, tingling, or edema at location of anthrax or other vaccinations.  ASSESSMENT:  1. Lymphadenopathy-Left posterior cervical and axillary- Normal side effect associated with smallpox vaccination 2. Lymphangitis-Normal variant associated with smallpox vaccination 3. Robust smallpox vaccination with erythema and edema surrounding vaccination site. 4. Non-viral pustulosis  5. Aphthous ulcer  Treatment Plan: 1. Motrin 800 mg po tid #30 with no refills for comfort. 2. Allegra 180 mg po qd #30 with no refills to relieve itching. 3. Provided patient education and reassurance regarding expected side effects and normal variants of the smallpox vaccination.  Reinforced education on care of the SPV vaccination to prevent transfer of the Vaccinia virus. 4. In a pre-event setting, he should be exempt from all future smallpox vaccinations unless direct exposure occurs. 5. Return visit x 2 days to reassess lymphangitis and lesions. 6. Discussed other symptoms to watch for: instructed patient if he has any chest pain, palpitations, increased shortness of breath, he should go to the emergency room immediately.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Depersonalisation, Guillain-Barre syndrome, Hypoaesthesia, Influenza like illness
Clinical narrative: Anthrax #3 on 2-4-03, smallpox on 2-19-13. Dev flu like symptoms late April/early May with inc weakness and numbness in hands. Seen at clinic and hospitalized. Dx with sx of early Guillain Barre Syndrome. Symptoms inc, pt developed paralysis and required intubation, and electrophoresis. Released from hospital on May 28 and treated with outpt physical therapy. Currently has improved but is not fully recovered. Continues to experience weakness and reports dec stamina. Spoke to pt in mid Dec. He has retuned to regular duty and states he still tries easily. "Not quite back to his old self".
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Paralysis
Clinical narrative: Anthrax #3 on 2-4-03, smallpox on 2-19-13. Dev flu like symptoms late April/early May with inc weakness and numbness in hands. Seen at clinic and hospitalized. Dx with sx of early Guillain Barre Syndrome. Symptoms inc, pt developed paralysis and required intubation, and electrophoresis. Released from hospital on May 28 and treated with outpt physical therapy. Currently has improved but is not fully recovered. Continues to experience weakness and reports dec stamina. Spoke to pt in mid Dec. He has retuned to regular duty and states he still tries easily. "Not quite back to his old self".
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site hypersensitivity, Malaise, Pruritus, Rash
Clinical narrative: ABOUT 10 MIN POST INJECTION A HALF DOLLAR SIZE RASH APPEARED OVER INJECTION SITE. WAS ITCHY SO EMPLOYEE APPLIED BENADRYL CREAM AND RETURNED TO EMPLOYEE HEALTH OFFICE. I HAD HER SIT FOR ANOTHER 10 MIN. NO FURTHER ENLARGING OF RASH OR COMPLAINTS OF OTHER SYMPTOMS. EMPLOYEE RETURNED TO HER JOB. SUDDENLY FELT "VERY ODD" AND BEGAN HAVING SOME BREATHING DIFFICULTY. COWORKER TOOK HER TO EMERGENCY ROOM WHERE EMPLOYEE RECEIVED A BREATHING TREATMENT AND STEROID MEDICATIONS AND A NEBULIZER. EMPLOYE RETURNED TO WORK.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Oedema, Rash, Rash maculo-papular
Clinical narrative: Patient developed lower extremity rash 4 days 10/26 after vaccine administered on 10/22.  Presents to clinic now on 11/03 with confluent lower extremity rash and mac/papular on trunk and upper extremities. Lower extremities with non-pitting edema and bullae forming and pt c/o lower ext. joint pain.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Gastrointestinal disorder, Headache, Meningitis, Myocarditis
Clinical narrative: 6 days s/p vaccination - developed a severe headache, low grade fever, and nausea without other GI symptoms, as well as chest pain without shortness of breath. The discharge summary and consult reports received on 3/11/04 state myopericarditis and aseptic meningitis. At this point he seems to have recovered. However, we cannot be complete sure until after his 2 yr follow-up.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Nausea, Pyrexia
Clinical narrative: 6 days s/p vaccination - developed a severe headache, low grade fever, and nausea without other GI symptoms, as well as chest pain without shortness of breath. The discharge summary and consult reports received on 3/11/04 state myopericarditis and aseptic meningitis. At this point he seems to have recovered. However, we cannot be complete sure until after his 2 yr follow-up.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: Lump developed under axilla of left arm where vaccination was given.  Seen by physician.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: 102.7 fever, severe body aches, nausea, began 24 hours after shot.  Saw Doctor, was told I had flu like sickness but had not gotten it from the shot.  Treated with pain medication and nausea medication.  Symptoms subsided at approx 84 hours later.  Shot Thurs afternoon, sick friday afternoon, sick saturday and Sunday, began recovery Monday morning.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site rash, Pruritus
Clinical narrative: Patient complained of itching @ injection site(Right Deltoid), approximately 15 minutes after administration of Fluvirin Vaccine.  Noted mild redness & rash at injection site.  Patient denied shortness of breath. Diphenhydramine 25mg(2 tabs) given P.O. with good results. Rash and redness resolving in 15 minutes. Patient dismissed to home at 9:35am
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Hyperaesthesia, Skin burning sensation, Skin exfoliation
Clinical narrative: Injection rec'd 10/26/2003 administered by nurse as part of group immunization. After one week, the skin on the palms of my hands and the soles of my feet is extremely sensitive and red.  I rec'd the Swine flu vaccine 10/1976 and three wks later all the skin on my palms and soles peeled off in sheets, making these areas very sensitive--like a burning sensation.  Now this is happening again!  I have not rec'd a flu shot since 1976 because of what happened.  This year I tried again because I thought maybe things have changed.
Age: 0.1
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: localized reaction to injection site.  Swelling and redness to area while still in office approx. 5 minutes after given. Waited 10 minutes and seemed to have stopped. We drew a circle around area, gave benadryl and told mom to return tommorrow to recheck.  Also told mom to call with ant changes
Age: 15.0
Sex: F
Vaccine: DT, FLU3
Symptoms: Convulsion, Loss of consciousness, Syncope
Clinical narrative: Loss of consciousness, convulsive syncope or seizure (2 episodes) immediately following the administration of the flu and diptheria-tetanus booster vaccinations.  The patient was transported by ambulance to the hospital.  She is seeing a neurologist for further tests.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Flushing, Heart rate increased
Clinical narrative: immediately following administration of Pneumovax, patient became flushed and reported a racing heart and chest tightness.  She described it as "like receiving an aminophylline shot".  The patient was given 25mg of liquid Benadryl.  She was observed for 30 minutes until her symptoms resolved completely.  The patient was told to follow up with her physician and to report to the ER if symptoms recur.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV, DTAP, IPV
Symptoms: Erythema multiforme, Pruritus, Pyrexia, Rash maculo-papular, Serum sickness
Clinical narrative: This report was received from a physician and described the occurrence of erythema multiforme in an 18 month old male pt who received Infanrix for prophylaxis. This pt had no known allergies, no concurrent medications, and no adverse experiences following receipt of the first three doses of Daptacel. The pt was described by the physicians as "otherwise healthy." The pt received Infanrix on 9/13/03 for the fourth dose in the immunization series. On that date, the pt also received an injection of IPOL. On 9/17/03, 4 days post-immunization, the pt developed a fever of less than 100 deg F, an itchy maculopapular rash that was confluent on the thigh where Infanrix had been administered, and "a lot of other urticarial, target-like lesions on the whole body." The target-like lesions ranged in size from greater than 3mm to 1.5 inches in diameter. The pt was seen by the physician, who made a diagnosis of "typical erythema multiforme." She also stated htat "his whole set of symptoms" were "like a serum-sickness type reaction." The physician prescribed diphenhydramine, which "helps with the itchy rash." The pt continued to have a fever and to get new lesions as of 9/18/03. Additional info was received from the reporting physician on 10/21/03. The physician reported that the events resolved on 9/21/03. The physician considered the events to be serious (OMIC) because they jeopardized the pt or required intervention to prevent a serious outcome. The physician considered the events to be possibly related to vaccination with Infanrix.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV, DTAP, IPV
Symptoms: Skin ulcer
Clinical narrative: This report was received from a physician and described the occurrence of erythema multiforme in an 18 month old male pt who received Infanrix for prophylaxis. This pt had no known allergies, no concurrent medications, and no adverse experiences following receipt of the first three doses of Daptacel. The pt was described by the physicians as "otherwise healthy." The pt received Infanrix on 9/13/03 for the fourth dose in the immunization series. On that date, the pt also received an injection of IPOL. On 9/17/03, 4 days post-immunization, the pt developed a fever of less than 100 deg F, an itchy maculopapular rash that was confluent on the thigh where Infanrix had been administered, and "a lot of other urticarial, target-like lesions on the whole body." The target-like lesions ranged in size from greater than 3mm to 1.5 inches in diameter. The pt was seen by the physician, who made a diagnosis of "typical erythema multiforme." She also stated htat "his whole set of symptoms" were "like a serum-sickness type reaction." The physician prescribed diphenhydramine, which "helps with the itchy rash." The pt continued to have a fever and to get new lesions as of 9/18/03. Additional info was received from the reporting physician on 10/21/03. The physician reported that the events resolved on 9/21/03. The physician considered the events to be serious (OMIC) because they jeopardized the pt or required intervention to prevent a serious outcome. The physician considered the events to be possibly related to vaccination with Infanrix.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV, DTAP, IPV
Symptoms: Urticaria
Clinical narrative: This report was received from a physician and described the occurrence of erythema multiforme in an 18 month old male pt who received Infanrix for prophylaxis. This pt had no known allergies, no concurrent medications, and no adverse experiences following receipt of the first three doses of Daptacel. The pt was described by the physicians as "otherwise healthy." The pt received Infanrix on 9/13/03 for the fourth dose in the immunization series. On that date, the pt also received an injection of IPOL. On 9/17/03, 4 days post-immunization, the pt developed a fever of less than 100 deg F, an itchy maculopapular rash that was confluent on the thigh where Infanrix had been administered, and "a lot of other urticarial, target-like lesions on the whole body." The target-like lesions ranged in size from greater than 3mm to 1.5 inches in diameter. The pt was seen by the physician, who made a diagnosis of "typical erythema multiforme." She also stated htat "his whole set of symptoms" were "like a serum-sickness type reaction." The physician prescribed diphenhydramine, which "helps with the itchy rash." The pt continued to have a fever and to get new lesions as of 9/18/03. Additional info was received from the reporting physician on 10/21/03. The physician reported that the events resolved on 9/21/03. The physician considered the events to be serious (OMIC) because they jeopardized the pt or required intervention to prevent a serious outcome. The physician considered the events to be possibly related to vaccination with Infanrix.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Cardiomyopathy, Dyspnoea, Fatigue, Liver function test abnormal, Nausea
Clinical narrative: Admit to hospital with new onset CHF. Receive smallpox vaccine 3/6/03 along with "many other vaccines." Also received Anthrax vaccine #3 mid GI-2 wks later had GI symptoms -s (nausea), SOB, and fatigue. Dx with non-ischemic dialateral cardioamyopathy 8/14/03.
Age: 42.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Cardiomyopathy, Dyspnoea, Fatigue, Gastrointestinal disorder, Nausea
Clinical narrative: Admit to hospital with new onset CHF. Receive smallpox vaccine 3/6/03 along with "many other vaccines." Also received Anthrax vaccine #3 mid GI-2 wks later had GI symptoms -s (nausea), SOB, and fatigue. Dx with non-ischemic dialateral cardioamyopathy 8/14/03.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Oedema, Pruritus
Clinical narrative: Injection received 10/14/2003. Site became edematous, erythemic. Mother reports edema to below deltoid area. Recommended eval by MD. Mother reports another child had similar Rx to DTaP around the 4th, 5th immunization. Child not c/o pain but itching at site by child. Recommended ice to site also. No further DTaP's to be administered. VAERS report done per office.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Injection received 10/14/2003. Site became edematous, erythemic. Mother reports edema to below deltoid area. Recommended eval by MD. Mother reports another child had similar Rx to DTaP around the 4th, 5th immunization. Child not c/o pain but itching at site by child. Recommended ice to site also. No further DTaP's to be administered. VAERS report done per office.
Age: 67.0
Sex: M
Vaccine: FLU3, HEPA, PPV, YF
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: (10/29) S: received yellow fever L post. tricep on 10/21. Next day noticed more redness 6 in from inj site. site warm. On 10/22 area increased in size and began to feel painful. No N/V, slight itchiness, no rash. (10/24) - present to clinic with of pain (3-4/10), red, warm area. O: 4x8cm erythmic, high temp plague (L) bicep ending 2-3 on above antecubital. No tx wanted to phone call to client. Arm all clear be seen by PCP.
Age: 67.0
Sex: M
Vaccine: FLU3, HEPA, PPV, YF
Symptoms: Pyrexia
Clinical narrative: (10/29) S: received yellow fever L post. tricep on 10/21. Next day noticed more redness 6 in from inj site. site warm. On 10/22 area increased in size and began to feel painful. No N/V, slight itchiness, no rash. (10/24) - present to clinic with of pain (3-4/10), red, warm area. O: 4x8cm erythmic, high temp plague (L) bicep ending 2-3 on above antecubital. No tx wanted to phone call to client. Arm all clear be seen by PCP.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV, TD
Symptoms: Cardio-respiratory arrest, Coronary artery disease
Clinical narrative: Death approx 6 to 7 hrs after vaccine administration. The death certificate state cardiopulmonary arrest and CAD.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: From initial information received on 10/27/03 from a hospital clinic regarding an adverse event occurring in the USA, it was reported that a female patient received FLUZONE, lot number U1081AA, administered IM in the left arm on 10/10/03. The patient also received an unspecified allergy injection that same day. The next day, the patient experienced general malaise, fatigue, nausea, and vomiting and weakness. She also experienced fever, but the reporter was unsure of the exact reading. The patient was hospitalized on an unspecified date. The recovery status was reported as unknown and it was noted that the patient was still in the hospital at the time of this report. Follow up on 11/13/2003: "From additional information received through a telephone call on 11/06/2003 from a health care professional, the patient's date of birth was provided.  The patient was an 84 year old female, who received the influenza vaccine on 10/10/2003.  On 10/13/2003, the patient was seen in the ER, released, and saw her primary physician.  She was hospitalized from 10/20/2003 to 10/23/2003 for a diagnosis of pneumonia.  The primary physician's information was provided.  Reportedly, the patient recovered from this event.  A phone call was made to the patient's primary physician requesting a discharge summary, which was to be faxed if available.  No further information was provided.  From additional information received through a telephone call on 11/07/2003 from a health care professional, the patient's gender was clarified.  The patient is a male.  No further information was provided." Follow up on 05/17/04 states: "No additional information was obtained. No further information is anticipated, this case is considered closed." Follow up 01/06/05: Medical Assessment: The amount of availabe data is not sufficient to assess this case.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: From initial information received on 10/27/03 from a hospital clinic regarding an adverse event occurring in the USA, it was reported that a female patient received FLUZONE, lot number U1081AA, administered IM in the left arm on 10/10/03. The patient also received an unspecified allergy injection that same day. The next day, the patient experienced general malaise, fatigue, nausea, and vomiting and weakness. She also experienced fever, but the reporter was unsure of the exact reading. The patient was hospitalized on an unspecified date. The recovery status was reported as unknown and it was noted that the patient was still in the hospital at the time of this report. Follow up on 11/13/2003: "From additional information received through a telephone call on 11/06/2003 from a health care professional, the patient's date of birth was provided.  The patient was an 84 year old female, who received the influenza vaccine on 10/10/2003.  On 10/13/2003, the patient was seen in the ER, released, and saw her primary physician.  She was hospitalized from 10/20/2003 to 10/23/2003 for a diagnosis of pneumonia.  The primary physician's information was provided.  Reportedly, the patient recovered from this event.  A phone call was made to the patient's primary physician requesting a discharge summary, which was to be faxed if available.  No further information was provided.  From additional information received through a telephone call on 11/07/2003 from a health care professional, the patient's gender was clarified.  The patient is a male.  No further information was provided." Follow up on 05/17/04 states: "No additional information was obtained. No further information is anticipated, this case is considered closed." Follow up 01/06/05: Medical Assessment: The amount of availabe data is not sufficient to assess this case.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Lung neoplasm malignant
Clinical narrative: This subject is a 74 year old female who was diagnosed with right lung carcinoma while enrolled in RSV11 study. The subject received RSV vaccine or Placebo and influenza vaccine on 10/15/02. The subject's start date for the lung cancer was 4/18/03, 185 days post immunization. He was diagnosed 4/03 (specific date not reported). Treatment included chemotherapy and radiation. The subject is not recovered and will not continue in the study as of 10/28/03. The event was reported by the investigator as not related to the study vaccine.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Herpes zoster
Clinical narrative: This subject is a 72 year old male who died while enrolled in the RSV11 study. Subject received RSV vaccine or Placebo and influenza vaccine on 10/15/2003. The subject developed shingles 10/19/03, 4 days post immunization and 7 days later, on 10/26/03 he had increasing shortness of breath and died while on the way to the hospital. The death was reported by the investigator as possibly related to the study vaccine.  Follow up on 12/10/03: "Additional info received 12/01/03.  Death cert received with the date of death being 10/28/03 not 10/26/03 as stated in the initial report . Cause of death was CHF w/approximate interval of 2 weeks between onset and death.  Due to or as a consequence of CAD w/appropriate interval of years between onset and death.  Due to or as a consequence of Idiopathic Pulmonary Fibrosis w/approximate interval of months between onset and death." Follow up on 02/09/04: "The causality has been changed by the investigator from possible relationship to "unrelated"."
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: CP received with sl NTG. Required admit r/o MI. NI cardiolyte study. All one hr post vaccine. Back to nl by next am. Discharge summary states chest pain. msv
Age: 1.6
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Cerebrovascular accident, Hemiparesis, Hypokinesia, Muscular weakness, Pyrexia
Clinical narrative: Vaccines were given on 10/7/03 pm child developed fever next day and increased sleepiness. Mother called PMD's office at night of 10/8/03 and was given fever monitoring, testing instructions. Next time parent called on 10/12/03. Mother was informing us that pt was not moving a lot and had weakness of his L arm. Pt was taken to hospital ER and diagnosed with L hemiparesis. MRI of the head revealed R middle cerebral arthey ischemic stroke. He was admitted to the hospital inpatient floor. Extensive blood work up was done including coagulation studies, protein C, S, factor V Leida was negative. Etiology of this event is unclear. Child was started on anticoagulants during hospital stay. Currently is on no medications. The hospital records received on 3/23/04 states stroke.
Age: 1.6
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Somnolence
Clinical narrative: Vaccines were given on 10/7/03 pm child developed fever next day and increased sleepiness. Mother called PMD's office at night of 10/8/03 and was given fever monitoring, testing instructions. Next time parent called on 10/12/03. Mother was informing us that pt was not moving a lot and had weakness of his L arm. Pt was taken to hospital ER and diagnosed with L hemiparesis. MRI of the head revealed R middle cerebral arthey ischemic stroke. He was admitted to the hospital inpatient floor. Extensive blood work up was done including coagulation studies, protein C, S, factor V Leida was negative. Etiology of this event is unclear. Child was started on anticoagulants during hospital stay. Currently is on no medications. The hospital records received on 3/23/04 states stroke.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Hypokinesia, Muscle twitching, Pyrexia
Clinical narrative: Admitted to hospital on 10/22/03 for fever with abnormal movements. Work up was unremarkable. NL CT, EEG, MRI. The medical records state hand jerking and facial twitching.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Developed swollen left arm, fever 12 hrs post vaccination. Hospitalized, on high doses antibiotics recovered in 2 days.
Age: 43.0
Sex: F
Vaccine: MMR, TD
Symptoms: Dysphagia, Dyspnoea, Hypersensitivity, Respiratory distress
Clinical narrative: Approx. 7-10 min post injection pt called husband on cell phone from vehicle. Experienced respiratory distress, difficulty swallowing/breathing stopped at local fire station and was assisted by EMT to hospital by ambulance. R arm induration 14cm x 14cm. Discharge summary states allergic reaction. msv
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site oedema, Rash pruritic
Clinical narrative: Localized swelling and rash on left bicep 4 x 3.5 inch rash.  Excessive itching.  Flu-like symptoms.
Age: 44.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site swelling, Lipoma
Clinical narrative: 6 months after the vaccine was given, patient still has a "lipoma".  Said to be a raised hard protruding 1.5 inches on right deltoid.  Patient saw general surgeon and was told they wouldn't remove or do an incision to drain.
Sex: F
Vaccine: HEP
Symptoms: Muscle spasms, Myalgia, Restless legs syndrome
Clinical narrative: Several hours after receiving vaccine got very restless legs (that she couldn't hold still) followed by muscle cramping that spread from legs up through trunk, arms and neck.  Resolved during sleep at night.  Muscles tender to touch in legs and various parts of body the next day.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Pruritus, Rash papular
Clinical narrative: At 13:45, 15 minutes after vaccination developed tingling and numbness of sore with itching at ear itching.  No shortness of breath or wheeze.  Benadryl, Prednisone.  At 15:15, developed several papules of arms, otherwise no new symptoms.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Malaise, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: On 10/25/2003 became ill.  Body aches, severe pain of right arm where fluvirin was given down the arm.  Fever of 101.  10/28/2003: Still feels ill and have sore throat.  Referred to MD.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site oedema, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Woke up next morning: pain and swelling where injection was given.  Numbness in arm.  Mild to moderate swelling in under arm. Lymph nodes in axillary area very swollen and painful  Fevers 99-100.7 degrees.  Pain, numbness and swelling in left axilla radiates to hand and into left breast.  Advil 800mg every 6-8 hours.  Trying Z-pack 2 per mouth for 5 days.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site oedema, Rash pruritic
Clinical narrative: Local swelling at injection site about 50 cent piece size 10/06/2003.  Next day 10/07/2003, about 13:00 complained of shortness of breath, generalized itching and rash bilateral arm, chest, neck.  Prescribed: Benadryl at employee health.  Complained of 2nd shortness of breath.  Required albuterol rehab, 5 day prednisone 40mg.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue, Influenza like illness
Clinical narrative: Flu-like symptoms, coughing (like if out of breath), exhausted, tired.  Cough could be worsened by fire.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Inside of arm (elbow to armpit) and left side of body with hives and itching.  Have been using medicated powder to stop itching.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysphonia, Throat tightness, Urticaria
Clinical narrative: 15:15: Voice became hoarse.  Went home.  She noticed welts above left hip.  Felt throat was closing.  She called clinic at about 16:30, nurse called back.  Recommended to come in, took 4 t. childrens Benadryl.  Saw MD.  She was given Benadryl and a white pill.  She developed more welts was slightly lightheaded.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Arm swollen and red
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: 3 x 3.5 inch red induration, warm, covering both DTAP and IPV injection sites.  Appeared next AM.  Not painful.  Given Benadryl and Ibuprofen and resolved with further medication.
Age: 3.6
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever 102-103 for 2 days.  Hives on post vaccine day #3.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema, Pain, Pyrexia
Clinical narrative: Swelling, redness, pain and fever 12 hours after DTAP, measure 17x11 cm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Oedema
Clinical narrative: Cellulitis right thigh 5 days.  Augmentin oral.  Redness, swelling.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Developed itching of trunk the same evening after receiving vaccine. Developed rash overnight--awoke the following morning with severe hives.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Conjunctivitis, Decreased appetite, Erythema, Pharyngitis, Pyrexia
Clinical narrative: Received MMR on 10/23/2003.  Developed increased temperature (max 103 F), conjunctivitis, pharyngitis and erythematous maculo-papular multiple ? eruptions difficulty and generalized accompanied with poor appetite.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Rash macular, Rash papular
Clinical narrative: Received MMR on 10/23/2003.  Developed increased temperature (max 103 F), conjunctivitis, pharyngitis and erythematous maculo-papular multiple ? eruptions difficulty and generalized accompanied with poor appetite.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Oedema, Pain, Pyrexia
Clinical narrative: Patient given pneumovax vaccine on 10/20/2003.  (Merck Lot # 0287N).  The next day patient experienced pain, swelling, fever to 101.4.  Came to office today and has 8-10 cm area erythema, induration below injection site.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Patient developed erythematous rash on left deltoid after receiving pneumovax.  She also reported subjection fever last evening.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash macular, Rash papular
Clinical narrative: Diffuse punotate papular macular erythematous rash.  12 days after MMR/Varicella.
Sex: F
Vaccine: TD
Symptoms: Gait disturbance, Syncope
Clinical narrative: Patient start hypo ventilating prior to shot.  Stated she felt ok after shot.  Left to go to car and fainted 5 minutes after shot.  Gait unstable required staff to carry her back inside of building out of car.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Flushing, Rash erythematous, Urticaria
Clinical narrative: Patient and brother came in 09/25/2003, stated shot he got yesterday was causing him problems.  Patient's face was flushed, he had raised red rash on face, neck right shoulder; hives noted on right flank.  Reports no difficulty breathing. Instructed to go to ER immediately because he had no PCP.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Flushing, Hypersensitivity, Pruritus, Sneezing, Throat tightness
Clinical narrative: Child sneezed a few times as they were leaving but mother not concerned.  Within 5-10 minutes, he was flushed with hives breaking out on hands, feet and extremities that itched.  Also started with a dry cough and throat tightness.  Mother immediately went to local ER for evaluation and treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Child sneezed a few times as they were leaving but mother not concerned.  Within 5-10 minutes, he was flushed with hives breaking out on hands, feet and extremities that itched.  Also started with a dry cough and throat tightness.  Mother immediately went to local ER for evaluation and treatment.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Patient reported severe redness, swelling and itching at the site by evening to ER at 22:00.  Got Benadryl and ATB from MD 9/02/2003.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: 3 inch red reaction: red, swollen, hot, feverish, tired.  Used ice packs, Benadryl as needed.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: After receiving my third Hep B ? I experienced flu-like symptoms, headache, chills, fever and overall fatigue and body aches.  It has persisted for two days.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rhinorrhoea
Clinical narrative: 1) Immunizations given 09/24/2003; 2) 10/03/2003: Fever for 2 days 103 right (Tylenol/Motrin given alternately every 4 hours). 3) 10/05/2003: Rash developed-tiny red bumps all over body; 4) 10/05/2003- Runny nose; 5) Child will have ER check physical symptoms as reported.  No other untoward symptoms reported.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: 4x6 cm redness and warmth to left leg.  Treated with heat/ice.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Left arm with 5x2cm area of warmth and redness.  Treated with ice/heat.
Age: 1.2
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Since administration on 07/31/2003; child has had 3 chickenpox outbreaks approximately 2-3 weeks apart.  Only cutaneous symptoms-no systemic symptoms.
Age: 4.4
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Local reaction: red, swollen, painful.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Warm, edematous and red area around injection site 4.5 inches by 3.5 inches.  No fever, pain in arm.  Seen 2 days after injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema
Clinical narrative: Local swelling erythematous reaction.
Age: 1.6
Sex: M
Vaccine: DTP, HIBV, IPV
Symptoms: Feeling hot, Injection site induration, Oedema
Clinical narrative: 10x9cm area local hyperedema, warmth.  Slight central induration.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Chest pain, Dyspnoea, Myalgia, Oedema
Clinical narrative: 08/26/2003: Right arm started to swell and muscles became patient was unable to use arm.  Chest muscles became sore, unable to stand and breathe properly.  Taken to MD on 08/27/2003 and Echo gram and MA on patient waiting for results.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Within 24 hours, the child's grandmother noticed that his left arm became red and swollen.  The child did not complain of any other symptoms.  His MD recommended Benadryl 1 25mg three times a day.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Skin ulcer
Clinical narrative: DTAP about 09:00: Warm shoulder and slightly red that same 1 day later.  8x9 cm red, hot, tender lesion right shoulder.  Right rash gone 08/29/2003.
Age: 2.0
Sex: F
Vaccine: HIBV, IPV
Symptoms: Erythema
Clinical narrative: 6x6cm annular erythema patch.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red, indurated dime-size spot on LAT.  Treatment with cool compresses.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Stat after IM DTAP and Hib in left leg, red mark developed medial to site. Fever 102, fine next day. Today 3 1/2 x 2 1/2 inch red raised over hive, not indurated about 1 1/2 hours away from DTaP. Surgical consult, observe thigh.
Age: 0.17
Sex: F
Vaccine: PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Irritability and temp of 102 degrees (R) noticed at 6:20 PM per mom. Seen in ER.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Right arm red/swollen. Warm to touch. Local reaction.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left thigh very red, warm, swollen approx 24 hours after shot. Child refusing to stand or walk. At office visit still red and swollen but showing signs of improvement with less warmth and swelling.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Erythema, Injection site warmth, Rash erythematous, Swelling
Clinical narrative: 2.5 hours after 2 month shots given (DTaP, HIB, Hep B, IPV) child reported back to office with red, raised rash to entire face with the erythema and swelling greatest around perioral area. Right thigh at site of DTaP and HIB was swollen, erythematous and warm.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Somnolence
Clinical narrative: Extreme chills, drowsy, fatigue. All lasted about 5 hours but still some fatigue 10/5/03.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pain, Pruritus
Clinical narrative: Right thigh where she receive DPaT/IPV has been turning red and swollen some itching(?). Tenderness noted.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Cough, Pain
Clinical narrative: Sudden onset right deltoid pain, worse with cough overhead movements of RUE occurred 8 days after shot. Exam showed no evidence abscess, no redness, no warmth. Do not believe this pain related to dt, but am reporting it just in case.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Contusion
Clinical narrative: Fine hair in 2 cm oval pattern on each thigh where vaccine was administered 3 months previous. By history both areas had bruises after the vaccine.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site inflammation, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Pt states shot was painful when injected (hurt "a lot"). Has rotator cuff problems with shoulder, but this is different. Has had significant swelling, inflammation, is hot to the touch and has been headachey last night. Doesn't feel good today, but thinks swelling is down some. On Vioxx for arthritis. Hurts to back shoulder blade and down arm to elbow.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Headache, Injection site oedema, Pain
Clinical narrative: Very sick Fri night pain, swelling. Received PPV on 10/24/03 around 10:00 AM. Severe posterior arm pain and headache by PM with swelling. Swelling and pain included upper and lower arm muscle (severe). Joint pain started on 10/26/03. Arm still very swollen 10/28/03. Pt states some better.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Vomiting
Clinical narrative: Sat. 1/2 dollar size red area at injection site. By Sunday, four finger size wrapped around arm. Severe headache Sunday with vomiting.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus, Rash
Clinical narrative: Pt presented with itchy rash. Red base with clear vesicles increasing in number. No fever. The follow up received on 11/14/03 states, "pt received the vaccine in a foreign country. We have no information on it."
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: 0.5 ml flu vaccine Aventis Pasteur U1093AA IM left deltoid given approx 12 noon 10/22/03. Rash/itching began 6 PM 10/22/03. Rx'd with antihistamine topical/oral.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Insomnia
Clinical narrative: Seven hours after the flu vaccine was administered I experienced extreme dizziness. I was forced to hold to furniture and walls to get to bed. I slept very little and when I awakened I was still somewhat dizzy. The dizziness gradually subsided and was gone by 2:30 PM.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Cellulitis/erythema skin of entire upper arm.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Came into clinic hives on face, upper chest and knee area. Benadryl PO given.
Age: 38.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Asthenia, Dizziness, Dyspnoea, Rash
Clinical narrative: Weakness, dizziness, rash on shoulders, shortness of breath for 4 weeks after injections.