chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: ANTH, MMR, YF, ANTH, MMR, YF, SMALL
Symptoms: Convulsion, Epididymitis, Hernia, Migraine, Oedema
Clinical narrative: This case was considered medically important (OMIC). Information was received from a published literature article against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive the vaccine. A child of one of the vaccinated health care workers developed skin lesions suggestive of secondary vaccinia. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A child developed skin lesions suggestive of secondary vaccinia following exposure to the parent, who was a healthcare worker who received the smallpox vaccination through the vaccination program. The child was kept isolated from a daycare center for five days. The authors noted that the healthcare worker did not miss any time from work, and insurance covered all diagnostic testing. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit and aggressive preliminary education campaign for the compliance in their smallpox vaccination program. Polymerase chain reaction (results: testing for herpes and vaccinia virus was negative) was done on an unspecified date. This is one of three siblings who developed skin lesions suggestive of secondary vaccinia following exposure to a parent who had received the smallpox vaccination.No additional information was available at the date of this report.
Sex: U
Vaccine: ANTH, MMR, YF, ANTH, MMR, YF, SMALL
Symptoms: Pain, Sleep disorder
Clinical narrative: This case was considered medically important (OMIC). Information was received from a published literature article against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive the vaccine. A child of one of the vaccinated health care workers developed skin lesions suggestive of secondary vaccinia. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A child developed skin lesions suggestive of secondary vaccinia following exposure to the parent, who was a healthcare worker who received the smallpox vaccination through the vaccination program. The child was kept isolated from a daycare center for five days. The authors noted that the healthcare worker did not miss any time from work, and insurance covered all diagnostic testing. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit and aggressive preliminary education campaign for the compliance in their smallpox vaccination program. Polymerase chain reaction (results: testing for herpes and vaccinia virus was negative) was done on an unspecified date. This is one of three siblings who developed skin lesions suggestive of secondary vaccinia following exposure to a parent who had received the smallpox vaccination.No additional information was available at the date of this report.
Sex: U
Vaccine: ANTH, MMR, YF, ANTH, MMR, YF, SMALL
Symptoms: Infection transmission via personal contact, Skin ulcer
Clinical narrative: This case was considered medically important (OMIC). Information was received from a published literature article against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive the vaccine. A child of one of the vaccinated health care workers developed skin lesions suggestive of secondary vaccinia. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A child developed skin lesions suggestive of secondary vaccinia following exposure to the parent, who was a healthcare worker who received the smallpox vaccination through the vaccination program. The child was kept isolated from a daycare center for five days. The authors noted that the healthcare worker did not miss any time from work, and insurance covered all diagnostic testing. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit and aggressive preliminary education campaign for the compliance in their smallpox vaccination program. Polymerase chain reaction (results: testing for herpes and vaccinia virus was negative) was done on an unspecified date. This is one of three siblings who developed skin lesions suggestive of secondary vaccinia following exposure to a parent who had received the smallpox vaccination.No additional information was available at the date of this report.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Anorexia, Asthenia, Headache, Laboratory test abnormal
Clinical narrative: Reported to ER on Sat. 11/22 with symptoms of dizziness and unable to stand. School reported that on Fri. 11/21 the pt c/o feeling dizzy and c/o pain from a rash on her wrist. The hospital sent pt to another hospital.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain, Pharyngolaryngeal pain, Rash
Clinical narrative: Reported to ER on Sat. 11/22 with symptoms of dizziness and unable to stand. School reported that on Fri. 11/21 the pt c/o feeling dizzy and c/o pain from a rash on her wrist. The hospital sent pt to another hospital.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Dizziness, Rash
Clinical narrative: Reported to ER on Sat. 11/22 with symptoms of dizziness and unable to stand. School reported that on Fri. 11/21 the pt c/o feeling dizzy and c/o pain from a rash on her wrist. The hospital sent pt to another hospital.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL, UNK
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Was seen by clinic and diagnosed with varicella on 12/22/2003.  Excluded from school until 01/02/2004.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL, UNK
Symptoms: Viral infection
Clinical narrative: Was seen by clinic and diagnosed with varicella on 12/22/2003.  Excluded from school until 01/02/2004.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Skin discolouration
Clinical narrative: Information has been received from a hospital nurse concerning an elderly female pt who was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. The nurse reported that the pt at a hospital became very ill and turned gray after being administered pneumococcal 23v polysaccharide vaccine. It was noted the therapy was discontinued and no treatment was required for the adverse event. It was noted the supervising physician info was not known and no other info was available. There was no product quality complaint reported. Unspecified medical attention was sought. Upon internal review became very ill and turned gray were determined to be other important medical events (OMIC). Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Cardiac disorder, Diarrhoea, Immune system disorder, Renal failure
Clinical narrative: Information has been received from a female consumer who is a certified medical assistant and paramedic with a mitral valve problem, migraines, and allergies to yeast, sulfa, Metrogel, Imitrex, and Daypro, who on an unspecified date in 1995 was vaccinated with an initial dose of hep B virus vaccine. The consumer stated, she had a severe anaphylactic reaction. The consumer reported that this happened in another state, and post vaccination she experienced kidney shut down, hives all over her body, damaged heart muscle, and diarrhea for a week. She reported that her immunologist sent him to "sauna and physical therapy treatments to sweat out the vaccine." The consumer stated that her immune system was "shot" after that. It was noted that a prescription drug was required. Additionally the consumer reported the nurse who administered the vaccine "knew she was allergic to yeast and gave her the injection anyway." There was no product quality complaint reported. Unspecified medical attention was sought. Upon internal review severe anaphylactic reaction, kidney shut down, hives all over her body, damaged heart muscle, and immune system was "shot" were determined to be other important medical events (OMIC). Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a female consumer who is a certified medical assistant and paramedic with a mitral valve problem, migraines, and allergies to yeast, sulfa, Metrogel, Imitrex, and Daypro, who on an unspecified date in 1995 was vaccinated with an initial dose of hep B virus vaccine. The consumer stated, she had a severe anaphylactic reaction. The consumer reported that this happened in another state, and post vaccination she experienced kidney shut down, hives all over her body, damaged heart muscle, and diarrhea for a week. She reported that her immunologist sent him to "sauna and physical therapy treatments to sweat out the vaccine." The consumer stated that her immune system was "shot" after that. It was noted that a prescription drug was required. Additionally the consumer reported the nurse who administered the vaccine "knew she was allergic to yeast and gave her the injection anyway." There was no product quality complaint reported. Unspecified medical attention was sought. Upon internal review severe anaphylactic reaction, kidney shut down, hives all over her body, damaged heart muscle, and immune system was "shot" were determined to be other important medical events (OMIC). Additional info has been requested.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Rash, Rhinorrhoea
Clinical narrative: Pt reacted to FluMist after it was given to him on 12/08/03. His mom said he started with runny nose and red rash all over his body. Pt came back into the office and treated with Zyrtec and Oraped.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Itching in area of injection in left arm. Area also red, swollen and hot to the touch. Sx began in AM of 12/9/03 continuing today. No relief with Tylenol, Benadryl or cold packs to area. Seen by PMD. Dx: cellulitis. Being treated with Keflex.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Chills, Dizziness, Dry mouth, Dyspnoea
Clinical narrative: Approx 2 hours after receiving vaccine, experienced dizziness, difficulty breathing, arm swelling, dry mouth, fever. Approx 5 hours after, chills, nausea, fever, tiredness. Approx 6 hours after, went to hospital ER. There for 4-5 hours, symptoms resolved. 24 hours after, continues feeling tired, no appetite. ER said they think it was a viral event.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Oedema peripheral, Pyrexia, Viral infection
Clinical narrative: Approx 2 hours after receiving vaccine, experienced dizziness, difficulty breathing, arm swelling, dry mouth, fever. Approx 5 hours after, chills, nausea, fever, tiredness. Approx 6 hours after, went to hospital ER. There for 4-5 hours, symptoms resolved. 24 hours after, continues feeling tired, no appetite. ER said they think it was a viral event.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasal congestion, Pyrexia, Sinusitis, Vomiting
Clinical narrative: After receiving Fluzone first time, that afternoon started having fever, continued with fever for a day then got congested and 2 days later started coughing, also vomited. Required Albuterol treatments. Diagnosed with sinusitis and given Augmentin. Second, Fluzone, started vomiting and fever the following day, cough 3 days later. Congested since the following day, came into office diagnosed with cough and sinusitis.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Urticaria, relieved by antihistamine.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: Red rash 24 hours after immunization. Swelling upper left arm after immunization.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Dizziness, Dyspnoea, Hypertension, Palpitations
Clinical narrative: Approx 2 minutes after injection, pt c/o dizziness, shortness of breath and palpitations. BP 230/88. HR 123, R 22, POx=98%. Pt became anxious, was transferred to hospital after 20 minutes. At ER pt given Benadryl, Lopressor, Ativan, Pepcid. Released 5-6 hours later.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Throat tightness, Tongue disorder
Clinical narrative: Vaccine given at 6:30 PM, by 7:55 PM tight feeling in throat, tongue felt thick. Benadryl given with no progression of symptoms. Medical records confirm allergic reaction. msv
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: No treatment, but I got really sick (flu). Got hives on neck, fever (103), arm was swollen for 7 days (hives for 2 days).
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Agitation, Crying, Injection site erythema, Injection site oedema
Clinical narrative: Pt received first DTaP immunization. Began crying inconsolably 30 minutes after appt. Continued until 4:00 PM. Also injection site of the left leg became red and swollen. Advised Tylenol every 4 hours and cool compress to site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Pruritus, Rash, Somnolence
Clinical narrative: Child started with rash around mouth. It then spread to face and trunk with itching. Child is breathing fine. He then started feeling very sleepy all within 15 minutes. Was taken by paramedics. The mother of the child contacted our office on 12/12/03. She described the event as a "serious allergic reaction" and informed me that EMS had administered a shot of epinephrine. The child was transported to the ER and later released. He is fully recovered and doing fine.
Age: 7.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, VARCEL
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: No fever. Vesicles on erythematous covering face, trunk, extremities. Pruritic. Supportive.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Generalized urticaria 3 minutes after vaccine. Treated with Benadryl 125mg/ml, Decadron 4mg/ml. Rx: Predisone 3ml every 12 hours. Zyrtec 2.5ml QD.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Feeling cold, Hyperventilation, Lethargy, Nausea
Clinical narrative: Telephone call to Mom 12/3/03. 12/2: felt cold at 7:30 PM. At 9:30 PM felt hot/cold, dizzy, nauseated, lethargic. 12/3: at 2:45 AM woke up, right arm very sore, shallow rapid breathing, collapsed. At 3 AM Mom took to the ER.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Pain, Syncope
Clinical narrative: Telephone call to Mom 12/3/03. 12/2: felt cold at 7:30 PM. At 9:30 PM felt hot/cold, dizzy, nauseated, lethargic. 12/3: at 2:45 AM woke up, right arm very sore, shallow rapid breathing, collapsed. At 3 AM Mom took to the ER.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Left upper arm red and swollen and warm - approximately 6" area.
Age: 63.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Feeling hot, Rash, Rash pruritic
Clinical narrative: Red rash, puffy-warm and itching about the size of a half dollar, put ice on it and used Hydrocortisone.  After a week almost gone.
Age: 33.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest pain, Cough, Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: FluMist given 12/15, developed fever to 102 with headache, sore throat, cough on 12/16-12/19.  Chest pain-pleuritic 12/20.  Physical exam: HR: 121; Temperature 98; Lungs clear.
Age: 34.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Oedema
Clinical narrative: Significant edema and warmth to elbow circumferentially by 24 hours.  Extended to wrist by 48 hours, receeded and almost resolved by clinic visit on 12/16/03.  No systemic symptoms.  Treatment with PO antihistamines.
Age: 34.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Injection site erythema, Oedema, Pain, Pyrexia
Clinical narrative: Significant edema and warmth to elbow circumferentially by 24 hours.  Extended to wrist by 48 hours, receeded and almost resolved by clinic visit on 12/16/03.  No systemic symptoms.  Treatment with PO antihistamines.
Age: 35.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Oedema
Clinical narrative: 1 day after the immunization significant swelling and warmth.  Pain into the arm to the hand.  Swelling in fingers, low grade fever.  Red and swollen from injection site to 3.5 inches from hand.
Age: 35.0
Sex: U
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Injection site erythema, Oedema, Pain, Pyrexia
Clinical narrative: 1 day after the immunization significant swelling and warmth.  Pain into the arm to the hand.  Swelling in fingers, low grade fever.  Red and swollen from injection site to 3.5 inches from hand.
Age: 56.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Oedema peripheral, Pain, Paraesthesia
Clinical narrative: Woke up next morning with throbbing arm pain.  Pain got worse over next month moving into anterior chest shoulder blade, elbow and tingling and swelling into hand/fingers.  Has started physical therapy 11/25/2003.  Pain now in upper arm with occasional hand/finger numbness.  Is recovering with physical therapy.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Dyspnoea, Oedema, Pallor, Pyrexia
Clinical narrative: Edema increased right arm, shortness of breath, fever (100 T), no tenderness, "looked pale".
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Cutaneous erythema/warmth extending from injection site to elbow circumferentially about 60% or arm.  Treatment: HC cream and Allegra 180mg per mouth for 2 days.  Motrin as needed for pain.  Diagnosis: large local reaction.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Febrile convulsion, Otitis media, Pyrexia
Clinical narrative: Fever 3 or 4 hours after immunization, then 4 hours later febrile seizures when to ER otitis was diagnosed.
Age: 0.2
Sex: F
Vaccine: HIBV, IPV
Symptoms: Rash macular
Clinical narrative: Diffuse macular rash over trunk and extremities. Occurred one day after first immunization with HIB and IVP.  Pt seen 2 days after and rash persisted unknown if r/t immunizations or not.
Age: 1.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Delayed erythema, warm to touch, induration surrounding injection sites.  On right upper anterior thigh.  Treated as cellulitis with cephalexin for 7 days.  Redness resolved.
Age: 5.0
Sex: M
Vaccine: HIBV, MMR, TD, VARCEL
Symptoms: Viral infection
Clinical narrative: (+) clinical varicella, face, head, trunk.
Age: 7.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Rash vesicular
Clinical narrative: Rash consistant with mild chicken pox (trunk, back, eyebrow).
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Pharyngeal oedema
Clinical narrative: After receiving the Hepatitis B vaccine, within the hour, her throat and glands started swelling. Unable to swallow for 48 hours.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Systemic rash.
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Pyrexia
Clinical narrative: Cough, fever of 104 within 24 hours of vaccine.
Sex: U
Vaccine: SMALL
Symptoms: Secondary transmission, Skin ulcer
Clinical narrative: This case was considered medically important (OMIC). Information was received from a published literature article. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive vaccine. A child of one of the vaccinated healthcare workers developed skin lesions suggestive of secondary vaccinia. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A child developed skin lesions suggestive of secondary vaccinia following exposure to the parent, who was a healthcare worker who received the smallpox vaccination through the vaccination program. The child was kept isolated from a daycare center for five days. The authors noted that the healthcare worker did not miss any time from work, and insurance covered all diagnostic testing. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit an aggressive preliminary education campaign for the compliance in their smallpox vaccination program. Polymerase chain reaction (results: testing for herpes and vaccinia virus was negative) was done on an unspecified date. This is one of three siblings who developed skin lesions suggestive of secondary vaccinia following exposure to a parent who had received the smallpox vaccination. No additional information was available at the date of this report.
Sex: U
Vaccine: SMALL
Symptoms: Drug ineffective
Clinical narrative: This case was considered medically important (OMIC). Information was received from a published literature article concerning vaccinating health care workers against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effects on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive vaccine. A patient described in this article had a lack of the skin reaction indicating vaccine activity. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A patient had what the authors described as a non-take, or a lack of the skin reaction indicating vaccine activity. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit an aggressive preliminary education campaign for the compliance in their smallpox vaccination program. The reporter indicated that five patients experienced this event; however, they are not presently identifiable. Additional reports will be generated if identifying information is provided.
Sex: U
Vaccine: SMALL
Symptoms: Myocarditis
Clinical narrative: This case was considered medically important (OMIC). Information was received from a published literature article concerning vaccinating health care workers against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive vaccine. The program was then extended to include non-healthcare workers. One of the vaccinated non-healthcare workers developed perimyocarditis. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. One of the non-healthcare workers who received vaccine developed perimyocarditis. The authors noted that this was the only serious reaction out of approximately 2200 vaccinated non-healthcare workers. The authors concluded that is is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit an aggressive preliminary education campaign for the compliance in their smallpox vaccination program. No further information was available at the date of this report.
Sex: U
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Skin ulcer
Clinical narrative: This case was considered medically important (OMIC). Information was received from a published literature article concerning vaccinating health care workers against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive vaccine. A child of one of the vaccinated healthcare workers developed skin lesions suggestive of secondary vaccinia. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. A child developed skin lesions suggestive of secondary vaccinia following exposure to the parent, who was a healthcare worker who received the smallpox vaccination through the vaccination program. The child was kept isolated from a daycare center for five days. The authors noted that the healthcare worker did not miss any time from work, and insurance covered all diagnostic testing. The authors concluded that it is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit an aggressive preliminary education campaign for the compliance in their smallpox vaccination program. Polymerase chain reaction (results: testing for herpes and vaccinia virus was negative) was done on an unspecified date. This is one of three siblings who developed skin lesions suggestive of secondary vaccinia following exposure to a parent who had received the smallpox vaccination. No additional information was available at the date of this report.
Age: 24.0
Sex: F
Vaccine: ANTH, FLUX
Symptoms: Unintended pregnancy
Clinical narrative: PATIENT ATTEMPTING TO CONCEIVE AT TIME OF VACCINE, NOTIFIED ADMINISTERING STAFF, VACCINE GIVEN REGARDLESS.  PATIENT DID CONCEIVE AND IS NOW 12 2/7 WEEKS PREGNANT.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Cyanosis, Hyperhidrosis, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: 3:30 arm sore, took ibuprofen, 5:00 arm red hot swollen, hard knot, used cold packs, 8:45 rash across nose, cheeks and sweating, lips bluish, benedryly given per dr. phone consult, benedryl given again at 3:30 am, symptoms becan to subside. No further information received
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: 3:30 arm sore, took ibuprofen, 5:00 arm red hot swollen, hard knot, used cold packs, 8:45 rash across nose, cheeks and sweating, lips bluish, benedryly given per dr. phone consult, benedryl given again at 3:30 am, symptoms becan to subside. No further information received
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: On 9/17/03 @ 1pm administered Hepatitis B Vaccine(2nd series dose #2). On 10/1/03 the patient reported experiencing flu like symptoms approx 4-5 hours after receiving the vaccine on 9/17/03. His symptoms consisted of body aches, fever 101.0, & fatigue. Symptoms lasted approx 2 days. Symptoms treated with advil and rest. However, not sure how long his fever lasted because he only checked it at the onset of his symptoms. Please note: The Hepatitis B Vaccine Series was being repeated because the patient had an equivocal titer 3 months after completing the first series. Patient states his symptoms were severe and therefore has declined to complete the vaccine series at this time.  Vaccination Record:  1st Series  Hepatitis B Vaccine dose #1 given 8/21/02 Hepatitis B Vaccine dose #2 given 10/8/02 Hepatitis B Vaccine dose #3 given 3/31/03  HBSAB titer 7/2/03 Equivocal  2nd series  Hepatitis B Vaccine dose #1 given 8/13/03 Hepatitis B Vaccine dose #2 given 9/17/03
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Bacterial infection, Jaundice, Vomiting
Clinical narrative: Patient was given the Hep B vaccine on the day of his birth and again on the next day, April 8th and 9th.  He was hospitalized a week later due to mustard colored thick vomiting and a blockage was suspected at the time.  He was given his third Hep B vaccine at his four month check up and that is when I found out about his two in two day immunizations. The discharge summary received on 3/23/04 indicates previously coded intestinal obstruction was ruled out. Please add jaundice, bacterial eye infection, and tender, hard abdomen.  Per annual report-I don't know because facility says now that the shot was never given.  Funny, since I have a record of it.  Facility needs to stand up for their mistakes and they are just making excuses.  I'm not happy and I am glad you are following up on the case!
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Pyrexia, Rash, Swelling
Clinical narrative: Vaccine administered 12/24/03. 12/25/03, patient developed skin rash and swelling. ER gave IM Benadryl. Patient returned to this provided 12/26/03 with low grade temp at 100.4 and cellulitis. Patient required IV antibiotics on 21 occasions and oral antibiotics currently. No overnight hospitalization.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Developed cellulitis at site of injection following flu vaccine.
Age: 10.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Right shoulder red and swollen about 12 cm area.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Paraesthesia, Thermal burn
Clinical narrative: Patient informed our flu nurse while she was conducting a clinic this year that she had had a severe reaction to last years flu shot. Here is her report: Received flu shot on 11/1/02 in her left arm. Monday, 11/4/02, started experiencing tingling and burning around where she received the shot; this moved down her entire arm. Within the next 2-4 days the tingling moved to her left leg. Had no motor deficits in either the arm or the leg. At this point, she saw her private GP and was eventually referred to a neurologist. The neurologist initially didn't feel it was due to the flu shot, but after attending a conference changed her mind and told her that several other neurologists had noted similar post-flu shot reactions with almost immediate neurological manifestations. Underwent testing; was told there was no nerve damage and the tingling was probably indicative of damage to the myelin sheath and would eventually get better. In March was placed on steroids (10 day course); by April was better, although she was told the episodes might recur. Has since had 2 recurrences, although not as bad as the initial episode--these were focused in her left shoulder and upper arm (not her leg), and consisted of a cold feeling and some tingling. The most recent of these was just several weeks ago (late November 2003). Both of these episodes resolved without treatment after several weeks.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports large, red area at site with a lot of swelling. Hot to touch.
Age: 1.6
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Mom's description: left arm swollen, red, hot to touch. Large swollen area to left shoulder.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Patient received immunizations on 12/27/03. On 12/28/03 in PM, right thigh with 4 inch red raised swollen area at injections ite; area itches at times and slightly painful. Seen in PCP's office on 12/29/03.
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Infection transmission via personal contact, Rash vesicular
Clinical narrative: While student teaching, exposed to chicken pox; broke out 20 spots across chest and belly 12/18/03.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash erythematous, Skin ulcer
Clinical narrative: Right deltoid 6cmx3cm raised, erythematous undular lesion.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache
Clinical narrative: Headache and dizziness approximately 2 hours after administration.
Age: 37.0
Sex: F
Vaccine: TTOX
Symptoms: Back pain, Hyperacusis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: After cutting my finger slicing vegetables, I went to the ER for stitches.  I was given a tetanus shot at 7:00 PM on Dec. 31, 2003. The following day, around 5:00 PM, I started to feel slightly nauseous, with tingling and a 'zinging' sensation throughout my body. I was sensitive to loud noises and sudden movements, which caused more of the 'zinging' (adreniline-like) sensations and an overall nervous feeling.  I felt feverish, but did not feel warm to the touch.  My husband put me to bed and tended to our toddler's bedtime needs.  Every noise they made was amplified and nerve-wracking. I felt like screaming. The vaccine site on my right arm was painful, with the pain radiating down to my hand. My muscles in my right arm, back and neck were tight and tingly. After a while, my husband felt my forehead and I was hot (although I did not take my temperature, I would estimate that it had been slightly elevated). I experienced terrible back pain throughout the night.  In the morning (1/2/04) I felt slightly nauseous, but after drinking some hot tea felt better. As of 1/2/04, the vaccination site is still extremely painful and slightly red and swollen. I am achy all over, particularly in my neck and lower back.  The zinging is still present, but much less frequent and less intense.
Age: 37.0
Sex: F
Vaccine: TTOX
Symptoms: Myalgia, Nausea, Paraesthesia, Pyrexia
Clinical narrative: After cutting my finger slicing vegetables, I went to the ER for stitches.  I was given a tetanus shot at 7:00 PM on Dec. 31, 2003. The following day, around 5:00 PM, I started to feel slightly nauseous, with tingling and a 'zinging' sensation throughout my body. I was sensitive to loud noises and sudden movements, which caused more of the 'zinging' (adreniline-like) sensations and an overall nervous feeling.  I felt feverish, but did not feel warm to the touch.  My husband put me to bed and tended to our toddler's bedtime needs.  Every noise they made was amplified and nerve-wracking. I felt like screaming. The vaccine site on my right arm was painful, with the pain radiating down to my hand. My muscles in my right arm, back and neck were tight and tingly. After a while, my husband felt my forehead and I was hot (although I did not take my temperature, I would estimate that it had been slightly elevated). I experienced terrible back pain throughout the night.  In the morning (1/2/04) I felt slightly nauseous, but after drinking some hot tea felt better. As of 1/2/04, the vaccination site is still extremely painful and slightly red and swollen. I am achy all over, particularly in my neck and lower back.  The zinging is still present, but much less frequent and less intense.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Dizziness, difficulty breathing, increase in pulse, increase in blood pressure.  Within 5 minutes of shot.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Cardiac failure congestive, Diarrhoea, Dizziness, Dyspnoea, Dysuria
Clinical narrative: From initial info received on 12/21/03 through an enhanced surveillance program conducted by the CDC and Prevention (VAERS reference number 194210) regarding an adverse event occurring in an unknown country, it was reported that a 33 year old male pt received his second dose of Yellow Fever on 10/16/02. On 11/16/02, the pt was seen in a clinic with diarrhea, fever, jaundice and elevation of liver enzymes. The pt was hospitalized on 11/19/2002 with a four day history of high grade fever of up to 104 deg F and dyspnea associaged with yellow sputum production, followed by the development of a diffuse "fiery" maculopapular rash. One day prior to admission, the pt developed watery, non-bloody diarrhea, emesis, dysuria, and dizziness, which brought him into the ER. There was no remarkable recent exposure history. On exam, the pt was markedly tachycardiac, with a BP of 98/67. Initial available labs were consistent with a cholestatic picture (AST 191 and TB 5.7). On echo, the pt had an LVEF of 25% and global hypokinesis, and was started on a CHF regimen. A chest x-ray showed bilateral interstitial infiltrates and a BAL was performed Shortly thereafter, the pt developed respiratory distress and was intubated. The pt was evaluated for Denque and Hantaviruses and although he had positive IgM levels for both (2.25 and 1.16 respectively), repeat serology in February of 2003 for Hantavirus was negative at less than 0.90. A CAT scan of the abdomen was remarkable for a splenic tear. The pt was managed symptomatically and improved clinically. He was successfully extubated and his symptoms resolved with the exception of his acute congestive heart failure, for which he was to be followed up with a cardiologist as an outpatient. The final decision for this case was that it was not related to the yellow fever vaccine. 3/8/04: Administrative case closure (no additional information anticipated). From additional information received on 4/20/04, it was reported that this case is US case report. The lot number was reported as UB171AB, manufactured 11/15/2001 with an expiration date of 4/22/03.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Hypokinesia, Jaundice, Liver function test abnormal, Productive cough, Pyrexia
Clinical narrative: From initial info received on 12/21/03 through an enhanced surveillance program conducted by the CDC and Prevention (VAERS reference number 194210) regarding an adverse event occurring in an unknown country, it was reported that a 33 year old male pt received his second dose of Yellow Fever on 10/16/02. On 11/16/02, the pt was seen in a clinic with diarrhea, fever, jaundice and elevation of liver enzymes. The pt was hospitalized on 11/19/2002 with a four day history of high grade fever of up to 104 deg F and dyspnea associaged with yellow sputum production, followed by the development of a diffuse "fiery" maculopapular rash. One day prior to admission, the pt developed watery, non-bloody diarrhea, emesis, dysuria, and dizziness, which brought him into the ER. There was no remarkable recent exposure history. On exam, the pt was markedly tachycardiac, with a BP of 98/67. Initial available labs were consistent with a cholestatic picture (AST 191 and TB 5.7). On echo, the pt had an LVEF of 25% and global hypokinesis, and was started on a CHF regimen. A chest x-ray showed bilateral interstitial infiltrates and a BAL was performed Shortly thereafter, the pt developed respiratory distress and was intubated. The pt was evaluated for Denque and Hantaviruses and although he had positive IgM levels for both (2.25 and 1.16 respectively), repeat serology in February of 2003 for Hantavirus was negative at less than 0.90. A CAT scan of the abdomen was remarkable for a splenic tear. The pt was managed symptomatically and improved clinically. He was successfully extubated and his symptoms resolved with the exception of his acute congestive heart failure, for which he was to be followed up with a cardiologist as an outpatient. The final decision for this case was that it was not related to the yellow fever vaccine. 3/8/04: Administrative case closure (no additional information anticipated). From additional information received on 4/20/04, it was reported that this case is US case report. The lot number was reported as UB171AB, manufactured 11/15/2001 with an expiration date of 4/22/03.
Age: 33.0
Sex: M
Vaccine: YF
Symptoms: Rash maculo-papular, Respiratory distress, Tachycardia, Vomiting
Clinical narrative: From initial info received on 12/21/03 through an enhanced surveillance program conducted by the CDC and Prevention (VAERS reference number 194210) regarding an adverse event occurring in an unknown country, it was reported that a 33 year old male pt received his second dose of Yellow Fever on 10/16/02. On 11/16/02, the pt was seen in a clinic with diarrhea, fever, jaundice and elevation of liver enzymes. The pt was hospitalized on 11/19/2002 with a four day history of high grade fever of up to 104 deg F and dyspnea associaged with yellow sputum production, followed by the development of a diffuse "fiery" maculopapular rash. One day prior to admission, the pt developed watery, non-bloody diarrhea, emesis, dysuria, and dizziness, which brought him into the ER. There was no remarkable recent exposure history. On exam, the pt was markedly tachycardiac, with a BP of 98/67. Initial available labs were consistent with a cholestatic picture (AST 191 and TB 5.7). On echo, the pt had an LVEF of 25% and global hypokinesis, and was started on a CHF regimen. A chest x-ray showed bilateral interstitial infiltrates and a BAL was performed Shortly thereafter, the pt developed respiratory distress and was intubated. The pt was evaluated for Denque and Hantaviruses and although he had positive IgM levels for both (2.25 and 1.16 respectively), repeat serology in February of 2003 for Hantavirus was negative at less than 0.90. A CAT scan of the abdomen was remarkable for a splenic tear. The pt was managed symptomatically and improved clinically. He was successfully extubated and his symptoms resolved with the exception of his acute congestive heart failure, for which he was to be followed up with a cardiologist as an outpatient. The final decision for this case was that it was not related to the yellow fever vaccine. 3/8/04: Administrative case closure (no additional information anticipated). From additional information received on 4/20/04, it was reported that this case is US case report. The lot number was reported as UB171AB, manufactured 11/15/2001 with an expiration date of 4/22/03.
Age: 0.61
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Crying, Electrocardiogram abnormal, Electroencephalogram abnormal, Hypotonia
Clinical narrative: Information has been received from another manufacturer concerning a 7 month old female who on 10/14/03 was vaccinated with a third dose of hepatitis B virus vaccine. Concomitant therapy that day included HIB conjugate vaccine. Other concomitant therapy that day included poliovirus vaccine inactivated (IPOL), third dose of INFANRIX (0.5ml) (lot # DTPA582AS) (in the left thigh) and Prevnar. Approximately four hours later, the patient had prolonged crying. The patient's parents contacted the physician and took the patient to an emergency room, but the patient was not admitted. Within 48 hours of immunization, on 10/15/03, the patient had seizures and hypotonic episodes between crying. The physician reported that the patient had a total of three physician office visits and four visits to an emergency room. During one of the emergency visits, a physician witnessed the patient having a seizure lasting less than 10 minutes, and again, the patient was not admitted to the hospital. The patient's EEG results were abnormal. Her CAT scan results were normal. The prolonged crying resolved on 10/16/03. The seizures and hypotonic were unresolved as of 11/17/03. The reporting physician considered the events to be probably related to vaccination with INFANRIX. The physician noted that she was trying to get the patient admitted for further testing and diagnosis as well as to be placed on anti-seizure medication. This was originally reported by a physician. The reporter considered seizures, hypotonic episodes, and abnormal EEG to be other important medical events (OMIC). No further information is available.
Age: 0.61
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal, Hypotonia, Screaming
Clinical narrative: Information has been received from another manufacturer concerning a 7 month old female who on 10/14/03 was vaccinated with a third dose of hepatitis B virus vaccine. Concomitant therapy that day included HIB conjugate vaccine. Other concomitant therapy that day included poliovirus vaccine inactivated (IPOL), third dose of INFANRIX (0.5ml) (lot # DTPA582AS) (in the left thigh) and Prevnar. Approximately four hours later, the patient had prolonged crying. The patient's parents contacted the physician and took the patient to an emergency room, but the patient was not admitted. Within 48 hours of immunization, on 10/15/03, the patient had seizures and hypotonic episodes between crying. The physician reported that the patient had a total of three physician office visits and four visits to an emergency room. During one of the emergency visits, a physician witnessed the patient having a seizure lasting less than 10 minutes, and again, the patient was not admitted to the hospital. The patient's EEG results were abnormal. Her CAT scan results were normal. The prolonged crying resolved on 10/16/03. The seizures and hypotonic were unresolved as of 11/17/03. The reporting physician considered the events to be probably related to vaccination with INFANRIX. The physician noted that she was trying to get the patient admitted for further testing and diagnosis as well as to be placed on anti-seizure medication. This was originally reported by a physician. The reporter considered seizures, hypotonic episodes, and abnormal EEG to be other important medical events (OMIC). No further information is available.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness, Wheezing
Clinical narrative: Telephone call received 11/14/03, pt states that within 12 hours of receiving flu shot on 10/22/03 she awoke "feeling like her throat was closing". Seen in the ER. Stated the feeling lasted 4 hours during which she was given epinephrine, Benadryl and Tagamet. Stated she stayed on Benadryl for 24 hours past discharge. Stated symptoms of feeling her throat was closing off starting again when she stopped taking Benadryl. Pt remains on Chlortrimetron and Albuterol inhaler and states she continues to experience slight throat closure, wheezing and SOB to date. Pt asked PHN if neomycin was in the vaccine and PHN informed her it is "prepared with neomycin" as stated by telephone call to manufacturer Evans.
Sex: U
Vaccine: HEP
Symptoms: Injury
Clinical narrative: Information has been received from an attorney on behalf of representatives of the estate of a patient who, on 10/19/1998, was vaccinated with a dose of hepatitis B virus vaccine. Subsequently, the patient experienced an unspecified injury. Additional information was received concerning hep b vaccine. It was not indicated if the pt received lot 626311/043H or lot 4949H. Additional information was received regarding Hib conj vaccine. It was not indicated if the pt received Hib conj vaccine.  Upon internal review the unspecified injury was considered an other important medical event. (OMIC) Additional information will be provided when it becomes available.