chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Cardiac imaging procedure abnormal, Cardiac pacemaker insertion, Cardiac telemetry abnormal, Computerised tomogram normal, Echocardiogram normal
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Electrocardiogram P wave abnormal, Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Heart rate irregular, Lymphadenopathy mediastinal
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 57.0
Sex: M
Vaccine: FLU3, TDAP, FLUC3, TDAP
Symptoms: Myocardial oedema, Myocarditis
Clinical narrative: 57 year-old male retiree with 5-year history of HTN, history of OSA, allergic rhinitis, and 1st degree heart block noted in 2010 who was in his usual state of health on 5 FEB 2014 when he received Tdap and Influenza vaccines on 5 FEB following a routine physical. When patient returned for a blood pressure check on 7 FEB, an irregular heart rate was noted. At the time, patient was asymptomatic and an ECG completed did not show significant changes from a 2010 ECG. Patient was referred for a 24-hour Holter which was completed on 19 FEB. During the course of the Holter, cessation of ventricular activity up to 6 seconds was noted and tracings were consistent with high degree AV block/Type 2 Mobitz. During these episodes of ventricular cessation, patient continued to be asymptomatic. After interpretation of Holter monitor recordings, patient was contacted and admitted to hospital. He was placed on telemetry where several non-conducted p-waves with ventricular pauses were observed, but patient remained asymptomatic. During his 6-day hospitalization, patient had normal echocardiogram and CT, Cardiac Angiography (except for dilation of the ascending aorta and minimal bilateral hilar and mediastinal lymphadenopathy), but had positive cardiac enzymes and cardiac MRI (see results below). During hospitalization, Infectious Disease was consulted for recommendations for viral myocarditis and recommended numerous viral serologies (see results below). Patient reported vague history of URI symptoms during the previous month). On 24 FEB, a pacemaker was implanted. When patient was discharged on 25 FEB, his discharge diagnosis included Arrhythmia likely related to myocarditis of unknown etiology. Patient has a history of vertigo during the past 3 years thought to be consistent with BPV. He denies history of syncope or loss of consciousness. He reports a history of lightheadedness and fogginess with standing up too quickly or after eating.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Hypoaesthesia, Hyporeflexia, Laboratory test normal, Mobility decreased
Clinical narrative: Within 5 minutes of getting HPV lower back, lower legs and left arm/wrist were numb and tingling. Seen at ER on 4/17/2014; sent home. Seen in the office on 4/18/2014 with decreased reflexes x 4 extremities, (L) wrist limp and unable to raise hand. Referred to ER -> was there for 3 hr; within last 30 min. symptoms reversed.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Urine analysis normal
Clinical narrative: Within 5 minutes of getting HPV lower back, lower legs and left arm/wrist were numb and tingling. Seen at ER on 4/17/2014; sent home. Seen in the office on 4/18/2014 with decreased reflexes x 4 extremities, (L) wrist limp and unable to raise hand. Referred to ER -> was there for 3 hr; within last 30 min. symptoms reversed.
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients. Ages, genders and other patients' identifiers were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23, subcutaneously in the abdomen. Doses, lot#, expiration dates were not provided. No adverse effects were reported. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 66 year old female patient. On 10-APR-2014, the patient was vaccinated with ZOSTAVAX Lot # K000726 (dose, route and frequency were not reported). On 11-APR-2014 (also reported as a day after receiving ZOSTAVAX), the patient experienced injection site reaction. The pharmacist stated that there was a large area that was bruised and looks red around the injection site. There was a hard bump and was warm to touch. The pharmacist also stated that he will be contacting the patient on 15-APR-2014 to see how the reaction was doing. The patient did not sought any medical attention and did not received any treatment for the event. The outcome of the event was unknown. The reporter did not assessed the causality between the event and the suspect drug. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Vaccine given on 4/7. 4/8 in the evening patient developed a rash. She did not tell mom until 4/9. Seen 4/10 no new exposures. BENADRYL helped some (+) pruritis. No angioedema. No SOB. No dysphagia.Lesions do not look like hives when I saw them.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Exposure to communicable disease, Measles antibody positive, Rash, Rash erythematous
Clinical narrative: Patient was exposed to a measles outbreak at ER. MMR was given on 4/11/14. On 4/12/14 she had a small cluster of red marks on her chin, cheeks and forehead. The next day more appeared on jaw and chest, she c/o burning at rash site and denied cold s/s or fever. Rash resolved.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 75 year old male patient. Pertinent medical history, concomitant medication, drug reactions and allergies were unspecified by the reporter. On 24-MAR-2014 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J006831, expiration date 14-SEP-2014), subcutaneously. On unknown date in 2014 (reported as recently), the patient was diagnosed with shingles. The outcome of shingles was reported as not recovered. The patient sought medical attention via office visit to unspecified physician. The relatedness between shingles and ZOSTAVAX was not provided. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever on and off, site of injection red and tender - swollen to the size of a tennis ball and warm to touch. Sore throat, fatigue, rhinitis. Swelling almost resolved by 4/17/14.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pyrexia, Rhinitis
Clinical narrative: Fever on and off, site of injection red and tender - swollen to the size of a tennis ball and warm to touch. Sore throat, fatigue, rhinitis. Swelling almost resolved by 4/17/14.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Large local swelling; redness at injection site (measures 14 cm round). Recommended ibuprofen, BENADRYL and cool compress.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 2.5 x 2.5 redness and swelling with warmth to (L) deltoid injection site.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Angioedema, Pallor, Rash generalised, Rash macular, Rash pruritic
Clinical narrative: Diffuse pruritic hot urticarial and angioedema like rash.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Diffuse pruritic hot urticarial and angioedema like rash.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Clinical failure of vaccine. Pt received ZOSTAVAX on 08/29/2008 and presented today with uncomplicated truncal Herpes zoster.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a registered nurse refers to 8 patients between the ages of 18 to 21 years which was heard on an unspecified television program. On unspecified dates, these patients received vaccination with M-M-R II (dose and route were not reported). These patients developed mumps after being previously vaccinated with M-M-R II (dose and route were not reported). The outcome and causality were not reported. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Complement factor C4 increased, Complement factor decreased, Cutaneous vasculitis, Cyanosis, Dizziness
Clinical narrative: Case reference number B0986716A was reported in a literature article and refers to a 46-year-old male subject who started developing symptoms of Raynaud's syndrome one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. No other information on the subject's medical, family history or concurrent medication is available. A 46-year-old male subject presented to his primary care physician complaining of bilateral throbbing finger pain that was worse in the cold, at rest and at night, purplish discoloration, finger numbness and lightheadedness one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). No information has been provided regarding any clinical examination or investigations performed on the subject during this visit. The subject presented to an emergency department one week later with concerns of digital ischemia. Once again, no information has been provided regarding any clinical examination or investigations performed on him; but the authors report that he was advised to take ibuprofen that was discontinued after three days due to lack of relief. The subject was admitted one week later (three weeks after vaccination) to hospital with the same symptoms and a 3-day history of black tarry stools. On clinical examination he was noted to have bilateral tender and edematous fingertips, splinter hemorrhages under all the fingernails and some duskiness to the fingertips of the thumb and index finger on the right hand. Laboratory findings were relevant for mild anemia, ESR 39, CRP 2.0, Normal C3 156, elevated C4 46 and CH 50 higher than 63. ANA was 1:100 nucleolar patterns. Rh factor, scleroderma and hepatitis and ANCA panel were negative. Anti histone Ab, Anti-IgG and Anti C3d were negative. Urinalysis revealed a trace of albuminuria and few RBCs. Occult blood was positive. Bilateral upper extremity CT angiogram revealed narrowing of the radial arteries and distal phalangeal arteries consistent with small vessel vasculitis. Chest X-ray and echography were normal. Abdomen scan revealed signs of small intestinal vasculitis. Diagnosis was Raynaud's syndrome with vaccine-induced vasculitis most likely immune-mediated. Treatment consisted of aspirin and calcium channel blockers. Outcome was improvement. Author's conclusion: In spite of its widespread use, hepatitis B vaccination is uncommonly associated with adverse events. However, physicians should be aware of rare instances of small and medium vessel vasculitis. Patients should be informed of this rare potential side effect of Hepatitis B vaccination prior to administration. Physicians should be aware of Vaccination induced Raynaud's vasculitis in the differential diagnosis of a patient presenting with vasculitic symptoms.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Faeces discoloured, Hepatitis viral test negative, Histone antibody negative, Hypoaesthesia, Melaena
Clinical narrative: Case reference number B0986716A was reported in a literature article and refers to a 46-year-old male subject who started developing symptoms of Raynaud's syndrome one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. No other information on the subject's medical, family history or concurrent medication is available. A 46-year-old male subject presented to his primary care physician complaining of bilateral throbbing finger pain that was worse in the cold, at rest and at night, purplish discoloration, finger numbness and lightheadedness one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). No information has been provided regarding any clinical examination or investigations performed on the subject during this visit. The subject presented to an emergency department one week later with concerns of digital ischemia. Once again, no information has been provided regarding any clinical examination or investigations performed on him; but the authors report that he was advised to take ibuprofen that was discontinued after three days due to lack of relief. The subject was admitted one week later (three weeks after vaccination) to hospital with the same symptoms and a 3-day history of black tarry stools. On clinical examination he was noted to have bilateral tender and edematous fingertips, splinter hemorrhages under all the fingernails and some duskiness to the fingertips of the thumb and index finger on the right hand. Laboratory findings were relevant for mild anemia, ESR 39, CRP 2.0, Normal C3 156, elevated C4 46 and CH 50 higher than 63. ANA was 1:100 nucleolar patterns. Rh factor, scleroderma and hepatitis and ANCA panel were negative. Anti histone Ab, Anti-IgG and Anti C3d were negative. Urinalysis revealed a trace of albuminuria and few RBCs. Occult blood was positive. Bilateral upper extremity CT angiogram revealed narrowing of the radial arteries and distal phalangeal arteries consistent with small vessel vasculitis. Chest X-ray and echography were normal. Abdomen scan revealed signs of small intestinal vasculitis. Diagnosis was Raynaud's syndrome with vaccine-induced vasculitis most likely immune-mediated. Treatment consisted of aspirin and calcium channel blockers. Outcome was improvement. Author's conclusion: In spite of its widespread use, hepatitis B vaccination is uncommonly associated with adverse events. However, physicians should be aware of rare instances of small and medium vessel vasculitis. Patients should be informed of this rare potential side effect of Hepatitis B vaccination prior to administration. Physicians should be aware of Vaccination induced Raynaud's vasculitis in the differential diagnosis of a patient presenting with vasculitic symptoms.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Occult blood positive, Oedema peripheral, Pain, Pain in extremity, Pallor
Clinical narrative: Case reference number B0986716A was reported in a literature article and refers to a 46-year-old male subject who started developing symptoms of Raynaud's syndrome one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. No other information on the subject's medical, family history or concurrent medication is available. A 46-year-old male subject presented to his primary care physician complaining of bilateral throbbing finger pain that was worse in the cold, at rest and at night, purplish discoloration, finger numbness and lightheadedness one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). No information has been provided regarding any clinical examination or investigations performed on the subject during this visit. The subject presented to an emergency department one week later with concerns of digital ischemia. Once again, no information has been provided regarding any clinical examination or investigations performed on him; but the authors report that he was advised to take ibuprofen that was discontinued after three days due to lack of relief. The subject was admitted one week later (three weeks after vaccination) to hospital with the same symptoms and a 3-day history of black tarry stools. On clinical examination he was noted to have bilateral tender and edematous fingertips, splinter hemorrhages under all the fingernails and some duskiness to the fingertips of the thumb and index finger on the right hand. Laboratory findings were relevant for mild anemia, ESR 39, CRP 2.0, Normal C3 156, elevated C4 46 and CH 50 higher than 63. ANA was 1:100 nucleolar patterns. Rh factor, scleroderma and hepatitis and ANCA panel were negative. Anti histone Ab, Anti-IgG and Anti C3d were negative. Urinalysis revealed a trace of albuminuria and few RBCs. Occult blood was positive. Bilateral upper extremity CT angiogram revealed narrowing of the radial arteries and distal phalangeal arteries consistent with small vessel vasculitis. Chest X-ray and echography were normal. Abdomen scan revealed signs of small intestinal vasculitis. Diagnosis was Raynaud's syndrome with vaccine-induced vasculitis most likely immune-mediated. Treatment consisted of aspirin and calcium channel blockers. Outcome was improvement. Author's conclusion: In spite of its widespread use, hepatitis B vaccination is uncommonly associated with adverse events. However, physicians should be aware of rare instances of small and medium vessel vasculitis. Patients should be informed of this rare potential side effect of Hepatitis B vaccination prior to administration. Physicians should be aware of Vaccination induced Raynaud's vasculitis in the differential diagnosis of a patient presenting with vasculitic symptoms.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Scan abdomen abnormal, Skin discolouration, Splinter haemorrhages, Tenderness, Ultrasound scan normal
Clinical narrative: Case reference number B0986716A was reported in a literature article and refers to a 46-year-old male subject who started developing symptoms of Raynaud's syndrome one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. No other information on the subject's medical, family history or concurrent medication is available. A 46-year-old male subject presented to his primary care physician complaining of bilateral throbbing finger pain that was worse in the cold, at rest and at night, purplish discoloration, finger numbness and lightheadedness one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). No information has been provided regarding any clinical examination or investigations performed on the subject during this visit. The subject presented to an emergency department one week later with concerns of digital ischemia. Once again, no information has been provided regarding any clinical examination or investigations performed on him; but the authors report that he was advised to take ibuprofen that was discontinued after three days due to lack of relief. The subject was admitted one week later (three weeks after vaccination) to hospital with the same symptoms and a 3-day history of black tarry stools. On clinical examination he was noted to have bilateral tender and edematous fingertips, splinter hemorrhages under all the fingernails and some duskiness to the fingertips of the thumb and index finger on the right hand. Laboratory findings were relevant for mild anemia, ESR 39, CRP 2.0, Normal C3 156, elevated C4 46 and CH 50 higher than 63. ANA was 1:100 nucleolar patterns. Rh factor, scleroderma and hepatitis and ANCA panel were negative. Anti histone Ab, Anti-IgG and Anti C3d were negative. Urinalysis revealed a trace of albuminuria and few RBCs. Occult blood was positive. Bilateral upper extremity CT angiogram revealed narrowing of the radial arteries and distal phalangeal arteries consistent with small vessel vasculitis. Chest X-ray and echography were normal. Abdomen scan revealed signs of small intestinal vasculitis. Diagnosis was Raynaud's syndrome with vaccine-induced vasculitis most likely immune-mediated. Treatment consisted of aspirin and calcium channel blockers. Outcome was improvement. Author's conclusion: In spite of its widespread use, hepatitis B vaccination is uncommonly associated with adverse events. However, physicians should be aware of rare instances of small and medium vessel vasculitis. Patients should be informed of this rare potential side effect of Hepatitis B vaccination prior to administration. Physicians should be aware of Vaccination induced Raynaud's vasculitis in the differential diagnosis of a patient presenting with vasculitic symptoms.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Urine analysis abnormal, Vasculitis gastrointestinal
Clinical narrative: Case reference number B0986716A was reported in a literature article and refers to a 46-year-old male subject who started developing symptoms of Raynaud's syndrome one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. No other information on the subject's medical, family history or concurrent medication is available. A 46-year-old male subject presented to his primary care physician complaining of bilateral throbbing finger pain that was worse in the cold, at rest and at night, purplish discoloration, finger numbness and lightheadedness one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). No information has been provided regarding any clinical examination or investigations performed on the subject during this visit. The subject presented to an emergency department one week later with concerns of digital ischemia. Once again, no information has been provided regarding any clinical examination or investigations performed on him; but the authors report that he was advised to take ibuprofen that was discontinued after three days due to lack of relief. The subject was admitted one week later (three weeks after vaccination) to hospital with the same symptoms and a 3-day history of black tarry stools. On clinical examination he was noted to have bilateral tender and edematous fingertips, splinter hemorrhages under all the fingernails and some duskiness to the fingertips of the thumb and index finger on the right hand. Laboratory findings were relevant for mild anemia, ESR 39, CRP 2.0, Normal C3 156, elevated C4 46 and CH 50 higher than 63. ANA was 1:100 nucleolar patterns. Rh factor, scleroderma and hepatitis and ANCA panel were negative. Anti histone Ab, Anti-IgG and Anti C3d were negative. Urinalysis revealed a trace of albuminuria and few RBCs. Occult blood was positive. Bilateral upper extremity CT angiogram revealed narrowing of the radial arteries and distal phalangeal arteries consistent with small vessel vasculitis. Chest X-ray and echography were normal. Abdomen scan revealed signs of small intestinal vasculitis. Diagnosis was Raynaud's syndrome with vaccine-induced vasculitis most likely immune-mediated. Treatment consisted of aspirin and calcium channel blockers. Outcome was improvement. Author's conclusion: In spite of its widespread use, hepatitis B vaccination is uncommonly associated with adverse events. However, physicians should be aware of rare instances of small and medium vessel vasculitis. Patients should be informed of this rare potential side effect of Hepatitis B vaccination prior to administration. Physicians should be aware of Vaccination induced Raynaud's vasculitis in the differential diagnosis of a patient presenting with vasculitic symptoms.
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Abdominal tenderness, Blood triglycerides normal, Condition aggravated, Diarrhoea
Clinical narrative: Case reference number B0986685A was reported in a literature article and refers to 84-year-old female subject that developed pancreatitis 10 hours after receiving an unspecified low dose influenza vaccine (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. She had no history of prior gastrointestinal symptoms, gall stones, fatty food intolerance or alcoholic intake. She had been diagnosed with acute pancreatitis seven years before and 12 hours after having an influenza vaccine. She had been on hydrochlorothiazide which was thought to have been the precipitant at the time. No other information on the subject's medical, family history or concurrent medication has been provided. An 84-year-old female subject presented to an emergency department on an unspecified date with complaints of severe abdominal pain, nausea, vomiting and one episode of diarrhea, but she denied fever or chills. She had received an unspecified low dose influenza vaccine 10 hours before during a routine follow up visit at her primary care physician's office (manufacturer, batch number, dose and injection site unknown). On clinical examination she was afebrile with a pulse rate of 95 bpm and a blood pressure of 100/68. She had significant epigastric tenderness but without guarding or rebound. Her liver and renal function tests were normal, her lipase level was 1081 and the triglyceride level was normal at 54 mg/dl. Diagnosis was pancreatitis following influenza vaccination. Treatment was conservative and consisted of bowel rest, intravenous fluids and analgesia. Outcome was recovery with discharge after three days. Author's conclusion: "The two episodes of pancreatitis in our patient followed the vaccinations too closely to be explained by chance alone. In view of the absence of predisposing factors, pancreatitis was almost certainly precipitated by the influenza vaccination, although underlying pathophysiological mechanism is unexplained."
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Lipase increased, Liver function test normal, Nausea, Pancreatitis acute, Renal function test normal
Clinical narrative: Case reference number B0986685A was reported in a literature article and refers to 84-year-old female subject that developed pancreatitis 10 hours after receiving an unspecified low dose influenza vaccine (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. She had no history of prior gastrointestinal symptoms, gall stones, fatty food intolerance or alcoholic intake. She had been diagnosed with acute pancreatitis seven years before and 12 hours after having an influenza vaccine. She had been on hydrochlorothiazide which was thought to have been the precipitant at the time. No other information on the subject's medical, family history or concurrent medication has been provided. An 84-year-old female subject presented to an emergency department on an unspecified date with complaints of severe abdominal pain, nausea, vomiting and one episode of diarrhea, but she denied fever or chills. She had received an unspecified low dose influenza vaccine 10 hours before during a routine follow up visit at her primary care physician's office (manufacturer, batch number, dose and injection site unknown). On clinical examination she was afebrile with a pulse rate of 95 bpm and a blood pressure of 100/68. She had significant epigastric tenderness but without guarding or rebound. Her liver and renal function tests were normal, her lipase level was 1081 and the triglyceride level was normal at 54 mg/dl. Diagnosis was pancreatitis following influenza vaccination. Treatment was conservative and consisted of bowel rest, intravenous fluids and analgesia. Outcome was recovery with discharge after three days. Author's conclusion: "The two episodes of pancreatitis in our patient followed the vaccinations too closely to be explained by chance alone. In view of the absence of predisposing factors, pancreatitis was almost certainly precipitated by the influenza vaccination, although underlying pathophysiological mechanism is unexplained."
Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case reference number B0986685A was reported in a literature article and refers to 84-year-old female subject that developed pancreatitis 10 hours after receiving an unspecified low dose influenza vaccine (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. She had no history of prior gastrointestinal symptoms, gall stones, fatty food intolerance or alcoholic intake. She had been diagnosed with acute pancreatitis seven years before and 12 hours after having an influenza vaccine. She had been on hydrochlorothiazide which was thought to have been the precipitant at the time. No other information on the subject's medical, family history or concurrent medication has been provided. An 84-year-old female subject presented to an emergency department on an unspecified date with complaints of severe abdominal pain, nausea, vomiting and one episode of diarrhea, but she denied fever or chills. She had received an unspecified low dose influenza vaccine 10 hours before during a routine follow up visit at her primary care physician's office (manufacturer, batch number, dose and injection site unknown). On clinical examination she was afebrile with a pulse rate of 95 bpm and a blood pressure of 100/68. She had significant epigastric tenderness but without guarding or rebound. Her liver and renal function tests were normal, her lipase level was 1081 and the triglyceride level was normal at 54 mg/dl. Diagnosis was pancreatitis following influenza vaccination. Treatment was conservative and consisted of bowel rest, intravenous fluids and analgesia. Outcome was recovery with discharge after three days. Author's conclusion: "The two episodes of pancreatitis in our patient followed the vaccinations too closely to be explained by chance alone. In view of the absence of predisposing factors, pancreatitis was almost certainly precipitated by the influenza vaccination, although underlying pathophysiological mechanism is unexplained."
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine, Syncope, Vomiting
Clinical narrative: My daughter had an adverse effect to the HPV vaccine. She fainted, vomited several hours later and had dibilitating migraine headache with light sensitivity, (never had more than a very mild headache previously). Has since had 2 more migraines which I believe are related.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Herpes zoster
Clinical narrative: Shingles virus first appears on body.  Received treatment with antiviral medication and pain patches.  Not sure if this is related to the Tdap vaccination, but thought I would still report it.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 24 hrs of vaccine pt developed redness, pain and swelling at injection sties (L thigh). 48 hrs after vaccine pt was seen in ER and treated with cephalexin and BENADRYL and ibuprofen.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with a history of depression, anxiety and behavioral disorder. Concomitant medication included LEXAPRO and ACZONE. On 31MAR2014 the patient was vaccinated with GARDASIL (lot # J013324, expiration date 12FEB2016), intramuscular, in the left arm for "Going to College". The patient also received a dose of MENACTRA in the left arm that same day. On 03APR2014, 4 days after onset of therapy, the patient experienced leg pain and complained of injection site pain and redness where she received MENACTRA. The outcome of leg pain and injection site pain and redness was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Had DTAP on 4/7 and developed redness and swelling the same evening and it spread to side was over 5" diameter. Better in 4 days.
Age: 70.0
Sex: M
Vaccine: DTAP
Symptoms: Burning sensation, Chills, Erythema, Feeling abnormal, Injection site rash
Clinical narrative: Initially developed left arm erythema and rash at the site of the vaccine and subsequently developed feeling of being unwell, low grade fever, chills and viral resp symptoms.
Age: 70.0
Sex: M
Vaccine: DTAP
Symptoms: Malaise, Papule, Pyrexia, Vaccination site erythema
Clinical narrative: Initially developed left arm erythema and rash at the site of the vaccine and subsequently developed feeling of being unwell, low grade fever, chills and viral resp symptoms.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash on (L) arm 24 hrs after injection 14 x 6 cm distal to TDAP.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Sensation of foreign body, Wheezing
Clinical narrative: Flu vaccine at approximately 1 PM on 9/16/13. At 4:30 PM patient complained of chest tightness, feeling lump in throat and wheezing. States she took a decongestant and it resolved. Full recovery noted.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Impaired driving ability, Pyrexia, Vomiting
Clinical narrative: Patient reports becoming "dizzy, unstable" 10 minutes after vaccine. Within 1 hour, started vomiting and had fever. (Self-reported fever 101.7 degrees F). States he was dizzy for days, couldn't drive for a week. Vomiting lasted several days.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Local reaction, Syncope
Clinical narrative: Pt experienced syncope in waiting room and recovered without complication on 9/24/13. Returned on 9/26/13 with local reaction to (R) upper arm. Assessed and advised to see MD; referral given.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a currently 88 years old female consumer reporting on herself with hypertension and without any pertinent drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot number and expiration date were not reported). Secondary therapies were not reported. Concomitant therapies included pravastatin sodium, metoprolol, benazepril hydrochloride and Warfarin. The consumer stated that "a few weeks ago", she developed a rash underneath her breast that was "red blood". The consumer stated that she saw an unspecified pharmacist on an unspecified date, in regards to the reaction and they instructed her to use an antibacterial ointment (manufacturer unknown) on the rash. The consumer stated that the antibacterial ointment "did not do anything". At the time of the report, the rash was still present. No labs diagnostics were performed. Additional information is not expected.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Gave child PEDIARIX (DTAP, IPV, HEP B) and Hep B instead of HIB.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Hives all over body EXCEPT feet, legs, and hands.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling developed around injection site, measuring 3.5 inches x 2.5 inches.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site irritation, Vaccination complication
Clinical narrative: Local irritation at site of occlusive dressing, satellite lesions appears consistent with vaccine site.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Burning sensation, Local reaction, Pruritus
Clinical narrative: PT HAD A LOCAL REACTION ON HIS OUTER LEFT ARM. PT COMPLAINED OF BURNING AND ITCHING. THERE WAS NO AIRWAY COMPROMISE. PT WAS MONITORED FOR 45 MIN AND WAS SENT HOME WITH COLD COMPRESS AND TYLENOL. PT RETURNED TO CLINIC A WEEK LATER WITH A SLIGHT REACTION STILL ON OUTER LEFT ARM AND WAS GIVEN BENADRYL.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Chest X-ray normal, Chills, Hypotension, Influenza virus test negative
Clinical narrative: Patient received 2 vaccinations in our clinic on 2-26-14. Both vaccines were administered in the same arm about 1 inch apart. Patient reported onset of fever and chills approximately 3 hours after injections. Temp up to 101 degrees. On 2/28 patient seen in emergency for evaluation and admitted for hypotension, cellulitis vs pyomyositis.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Metabolic function test normal, Pyomyositis, Pyrexia, Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: Patient received 2 vaccinations in our clinic on 2-26-14. Both vaccines were administered in the same arm about 1 inch apart. Patient reported onset of fever and chills approximately 3 hours after injections. Temp up to 101 degrees. On 2/28 patient seen in emergency for evaluation and admitted for hypotension, cellulitis vs pyomyositis.
Age: 55.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Patient received 2 vaccinations in our clinic on 2-26-14. Both vaccines were administered in the same arm about 1 inch apart. Patient reported onset of fever and chills approximately 3 hours after injections. Temp up to 101 degrees. On 2/28 patient seen in emergency for evaluation and admitted for hypotension, cellulitis vs pyomyositis.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apparent life threatening event, Crying, Echocardiogram, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: Immediately after receiving vaccines child was fussy and crying took a nap and woke up - had an episode of ALTE. Infant was taken to ED then transferred to another hospital admitted x2 1/2 days.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Vaccination complication
Clinical narrative: Immediately after receiving vaccines child was fussy and crying took a nap and woke up - had an episode of ALTE. Infant was taken to ED then transferred to another hospital admitted x2 1/2 days.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Autonomic nervous system imbalance, Blood aldosterone increased, Blood potassium normal, Blood sodium decreased
Clinical narrative: Case number PHHY2014US046564 is an initial literature report received on 15 Apr 2014. In this article the author presented a case of severe rapid renal salt-wasting in patient with presumed influenza vaccine induced Guillain-Barre Syndrome. The report refers to a 56 year old female patient. She was vaccinated with an influenza vaccine (manufacturer and batch number: not reported). On an unknown date after vaccination, she presented with two weeks of vomiting, progressive weakness and tingling that began in bilateral lower followed by upper extremities. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre syndrome. She was hospitalized and within two days of admission, her condition rapidly deteriorated requiring mechanical ventilation. On an unknown date by day three, her serum sodium level decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium level ranged 3.2 to 3.7 mEq/L, uric acid was 1.5 mg/dL. She was presumed "hypo-to euvolemic" based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. The liquid input and output over 26 hours was 1.2 L 5% dextrose, half normal saline and urine volume was 2.2 L, urine sodium was 235 mEq/L, urine potassium was 41 mEq/L. Net volume was 1.0 L, net sodium potassium was 526 mEq. On an unknown date, brain natriuretic peptide level was 964 pg/mL, plasma renin activity was 2.2 ng/mL/h and serum aldosterone was 12 ng/dL. She was given 3% saline at a rate of 80 to 100 mL/hour with poor response until fludrocortisone 0.1 mg daily was added for three days. On an unknown date, urine sodium level promptly reduced to less than 10 mEq/L. Plasmapheresis was initiated with neurological and serum sodium improvement (6 to 8 mEq/day). Renal salt-wasting had been hypothesized to be due to GBS autonomic dysfunction, resultant sympathoadrenal dysregulation and inappropriate BNP secretion. In conclusion author stated that it was vital to recognize this rare GBS associated renal salt-wasting complication and differentiate the entity from SIADH due to differences in treatment plans.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Blood uric acid decreased, Brain natriuretic peptide increased, General physical health deterioration, Guillain-Barre syndrome, Hypophagia
Clinical narrative: Case number PHHY2014US046564 is an initial literature report received on 15 Apr 2014. In this article the author presented a case of severe rapid renal salt-wasting in patient with presumed influenza vaccine induced Guillain-Barre Syndrome. The report refers to a 56 year old female patient. She was vaccinated with an influenza vaccine (manufacturer and batch number: not reported). On an unknown date after vaccination, she presented with two weeks of vomiting, progressive weakness and tingling that began in bilateral lower followed by upper extremities. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre syndrome. She was hospitalized and within two days of admission, her condition rapidly deteriorated requiring mechanical ventilation. On an unknown date by day three, her serum sodium level decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium level ranged 3.2 to 3.7 mEq/L, uric acid was 1.5 mg/dL. She was presumed "hypo-to euvolemic" based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. The liquid input and output over 26 hours was 1.2 L 5% dextrose, half normal saline and urine volume was 2.2 L, urine sodium was 235 mEq/L, urine potassium was 41 mEq/L. Net volume was 1.0 L, net sodium potassium was 526 mEq. On an unknown date, brain natriuretic peptide level was 964 pg/mL, plasma renin activity was 2.2 ng/mL/h and serum aldosterone was 12 ng/dL. She was given 3% saline at a rate of 80 to 100 mL/hour with poor response until fludrocortisone 0.1 mg daily was added for three days. On an unknown date, urine sodium level promptly reduced to less than 10 mEq/L. Plasmapheresis was initiated with neurological and serum sodium improvement (6 to 8 mEq/day). Renal salt-wasting had been hypothesized to be due to GBS autonomic dysfunction, resultant sympathoadrenal dysregulation and inappropriate BNP secretion. In conclusion author stated that it was vital to recognize this rare GBS associated renal salt-wasting complication and differentiate the entity from SIADH due to differences in treatment plans.