chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Cardiac imaging procedure normal, Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: On 1 DEC [post-vaccination day (PVD) 9] patient reports onset of chest pain. He describes chest pain as a "sharp pressure"-type pain located in a "horseshoe" pattern along his left sternal border. He rates the pain intensity as about 4/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). The pain did not radiate. He denies accompanying nausea/vomiting, diaphoresis, palpitations, or peripheral edema. He reports difficulty breathing in that it was "hard to take deep breaths" (due to pain). He carried out his usual duties between 1 and 3 DEC at which time the chest pain waxed and waned in intensity, ranging between 4-7/10. He did not note increased pain with activity or exertion, and did not note changes in pain with positional changes. On the evening of 3 DEC, chest pain was consistently 8/10, keeping patient from sleeping through the night - "nothing I could do to get comfortable". Patient sought evaluation at local facility on a.m. of 4 DEC. Patient's PE was normal. Because his ECG was abnormal, patient was transferred to the local ER, and after his initial cardiac enzymes were abnormal, patient was transferred to another ER, and then admitted to the hospital. He received aspirin while in the local clinic and he reports by the time he was evaluated at the ER, his chest pain had decreased (2/10). By 5 DEC, patient's chest pain had completely resolved and has not returned. Patient was hospitalized between 4 and 8 DEC 2013. While hospitalized, per notation in patient discharge instructions, coronary angiography, cardiac MRI, and transthoracic echocardiogram were completed - results were reported as normal by the patient. At time of discharge, patient was asymptomatic and his cardiac enzymes were trending down (per notation in admission H&P). Patient has a pending outpatient cardiology appointment for later this month. He is on ASA 325 mg daily and colchicine 0.6 mg twice daily. He was placed on a profile limiting his duty for 8 weeks. He is due deploy on 22 JAN. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for minimal history of tobacco use (1-2 cigarettes per week x2 years). Denies history of previous adverse events following immunizations.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Echocardiogram, Echocardiogram normal, Electrocardiogram PR interval, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: On 1 DEC [post-vaccination day (PVD) 9] patient reports onset of chest pain. He describes chest pain as a "sharp pressure"-type pain located in a "horseshoe" pattern along his left sternal border. He rates the pain intensity as about 4/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). The pain did not radiate. He denies accompanying nausea/vomiting, diaphoresis, palpitations, or peripheral edema. He reports difficulty breathing in that it was "hard to take deep breaths" (due to pain). He carried out his usual duties between 1 and 3 DEC at which time the chest pain waxed and waned in intensity, ranging between 4-7/10. He did not note increased pain with activity or exertion, and did not note changes in pain with positional changes. On the evening of 3 DEC, chest pain was consistently 8/10, keeping patient from sleeping through the night - "nothing I could do to get comfortable". Patient sought evaluation at local facility on a.m. of 4 DEC. Patient's PE was normal. Because his ECG was abnormal, patient was transferred to the local ER, and after his initial cardiac enzymes were abnormal, patient was transferred to another ER, and then admitted to the hospital. He received aspirin while in the local clinic and he reports by the time he was evaluated at the ER, his chest pain had decreased (2/10). By 5 DEC, patient's chest pain had completely resolved and has not returned. Patient was hospitalized between 4 and 8 DEC 2013. While hospitalized, per notation in patient discharge instructions, coronary angiography, cardiac MRI, and transthoracic echocardiogram were completed - results were reported as normal by the patient. At time of discharge, patient was asymptomatic and his cardiac enzymes were trending down (per notation in admission H&P). Patient has a pending outpatient cardiology appointment for later this month. He is on ASA 325 mg daily and colchicine 0.6 mg twice daily. He was placed on a profile limiting his duty for 8 weeks. He is due deploy on 22 JAN. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for minimal history of tobacco use (1-2 cigarettes per week x2 years). Denies history of previous adverse events following immunizations.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Haematocrit decreased, Haemoglobin normal, Insomnia, Platelet count decreased, Troponin I increased
Clinical narrative: On 1 DEC [post-vaccination day (PVD) 9] patient reports onset of chest pain. He describes chest pain as a "sharp pressure"-type pain located in a "horseshoe" pattern along his left sternal border. He rates the pain intensity as about 4/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). The pain did not radiate. He denies accompanying nausea/vomiting, diaphoresis, palpitations, or peripheral edema. He reports difficulty breathing in that it was "hard to take deep breaths" (due to pain). He carried out his usual duties between 1 and 3 DEC at which time the chest pain waxed and waned in intensity, ranging between 4-7/10. He did not note increased pain with activity or exertion, and did not note changes in pain with positional changes. On the evening of 3 DEC, chest pain was consistently 8/10, keeping patient from sleeping through the night - "nothing I could do to get comfortable". Patient sought evaluation at local facility on a.m. of 4 DEC. Patient's PE was normal. Because his ECG was abnormal, patient was transferred to the local ER, and after his initial cardiac enzymes were abnormal, patient was transferred to another ER, and then admitted to the hospital. He received aspirin while in the local clinic and he reports by the time he was evaluated at the ER, his chest pain had decreased (2/10). By 5 DEC, patient's chest pain had completely resolved and has not returned. Patient was hospitalized between 4 and 8 DEC 2013. While hospitalized, per notation in patient discharge instructions, coronary angiography, cardiac MRI, and transthoracic echocardiogram were completed - results were reported as normal by the patient. At time of discharge, patient was asymptomatic and his cardiac enzymes were trending down (per notation in admission H&P). Patient has a pending outpatient cardiology appointment for later this month. He is on ASA 325 mg daily and colchicine 0.6 mg twice daily. He was placed on a profile limiting his duty for 8 weeks. He is due deploy on 22 JAN. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for minimal history of tobacco use (1-2 cigarettes per week x2 years). Denies history of previous adverse events following immunizations.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: White blood cell count normal
Clinical narrative: On 1 DEC [post-vaccination day (PVD) 9] patient reports onset of chest pain. He describes chest pain as a "sharp pressure"-type pain located in a "horseshoe" pattern along his left sternal border. He rates the pain intensity as about 4/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). The pain did not radiate. He denies accompanying nausea/vomiting, diaphoresis, palpitations, or peripheral edema. He reports difficulty breathing in that it was "hard to take deep breaths" (due to pain). He carried out his usual duties between 1 and 3 DEC at which time the chest pain waxed and waned in intensity, ranging between 4-7/10. He did not note increased pain with activity or exertion, and did not note changes in pain with positional changes. On the evening of 3 DEC, chest pain was consistently 8/10, keeping patient from sleeping through the night - "nothing I could do to get comfortable". Patient sought evaluation at local facility on a.m. of 4 DEC. Patient's PE was normal. Because his ECG was abnormal, patient was transferred to the local ER, and after his initial cardiac enzymes were abnormal, patient was transferred to another ER, and then admitted to the hospital. He received aspirin while in the local clinic and he reports by the time he was evaluated at the ER, his chest pain had decreased (2/10). By 5 DEC, patient's chest pain had completely resolved and has not returned. Patient was hospitalized between 4 and 8 DEC 2013. While hospitalized, per notation in patient discharge instructions, coronary angiography, cardiac MRI, and transthoracic echocardiogram were completed - results were reported as normal by the patient. At time of discharge, patient was asymptomatic and his cardiac enzymes were trending down (per notation in admission H&P). Patient has a pending outpatient cardiology appointment for later this month. He is on ASA 325 mg daily and colchicine 0.6 mg twice daily. He was placed on a profile limiting his duty for 8 weeks. He is due deploy on 22 JAN. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for minimal history of tobacco use (1-2 cigarettes per week x2 years). Denies history of previous adverse events following immunizations.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Cardiac imaging procedure, Echocardiogram, Electrocardiogram abnormal, Nuclear magnetic resonance imaging, Pericarditis
Clinical narrative: On 1 DEC [post-vaccination day (PVD) 9] patient reports onset of chest pain. He describes chest pain as a "sharp pressure"-type pain located in a "horseshoe" pattern along his left sternal border. He rates the pain intensity as about 4/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). The pain did not radiate. He denies accompanying nausea/vomiting, diaphoresis, palpitations, or peripheral edema. He reports difficulty breathing in that it was "hard to take deep breaths" (due to pain). He carried out his usual duties between 1 and 3 DEC at which time the chest pain waxed and waned in intensity, ranging between 4-7/10. He did not note increased pain with activity or exertion, and did not note changes in pain with positional changes. On the evening of 3 DEC, chest pain was consistently 8/10, keeping patient from sleeping through the night - "nothing I could do to get comfortable". Patient sought evaluation at local facility on a.m. of 4 DEC. Patient's PE was normal. Because his ECG was abnormal, patient was transferred to the local ER, and after his initial cardiac enzymes were abnormal, patient was transferred to another ER, and then admitted to the hospital. He received aspirin while in the local clinic and he reports by the time he was evaluated at the ER, his chest pain had decreased (2/10). By 5 DEC, patient's chest pain had completely resolved and has not returned. Patient was hospitalized between 4 and 8 DEC 2013. While hospitalized, per notation in patient discharge instructions, coronary angiography, cardiac MRI, and transthoracic echocardiogram were completed - results were reported as normal by the patient. At time of discharge, patient was asymptomatic and his cardiac enzymes were trending down (per notation in admission H&P). Patient has a pending outpatient cardiology appointment for later this month. He is on ASA 325 mg daily and colchicine 0.6 mg twice daily. He was placed on a profile limiting his duty for 8 weeks. He is due deploy on 22 JAN. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for minimal history of tobacco use (1-2 cigarettes per week x2 years). Denies history of previous adverse events following immunizations.
Age: 21.0
Sex: M
Vaccine: ANTH, PPV, SMALL, TYP, ANTH, PPV, SMALL
Symptoms: Troponin I increased
Clinical narrative: On 1 DEC [post-vaccination day (PVD) 9] patient reports onset of chest pain. He describes chest pain as a "sharp pressure"-type pain located in a "horseshoe" pattern along his left sternal border. He rates the pain intensity as about 4/10 using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). The pain did not radiate. He denies accompanying nausea/vomiting, diaphoresis, palpitations, or peripheral edema. He reports difficulty breathing in that it was "hard to take deep breaths" (due to pain). He carried out his usual duties between 1 and 3 DEC at which time the chest pain waxed and waned in intensity, ranging between 4-7/10. He did not note increased pain with activity or exertion, and did not note changes in pain with positional changes. On the evening of 3 DEC, chest pain was consistently 8/10, keeping patient from sleeping through the night - "nothing I could do to get comfortable". Patient sought evaluation at local facility on a.m. of 4 DEC. Patient's PE was normal. Because his ECG was abnormal, patient was transferred to the local ER, and after his initial cardiac enzymes were abnormal, patient was transferred to another ER, and then admitted to the hospital. He received aspirin while in the local clinic and he reports by the time he was evaluated at the ER, his chest pain had decreased (2/10). By 5 DEC, patient's chest pain had completely resolved and has not returned. Patient was hospitalized between 4 and 8 DEC 2013. While hospitalized, per notation in patient discharge instructions, coronary angiography, cardiac MRI, and transthoracic echocardiogram were completed - results were reported as normal by the patient. At time of discharge, patient was asymptomatic and his cardiac enzymes were trending down (per notation in admission H&P). Patient has a pending outpatient cardiology appointment for later this month. He is on ASA 325 mg daily and colchicine 0.6 mg twice daily. He was placed on a profile limiting his duty for 8 weeks. He is due deploy on 22 JAN. Patient has a negative health history, specifically no history of cardiac disease. CAD RFs: Negative except for minimal history of tobacco use (1-2 cigarettes per week x2 years). Denies history of previous adverse events following immunizations.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Pain, Rash
Clinical narrative: This spontaneous report as received from an approximately 64 year old female nurse with osteoporosis, mitral valve prolapse and allergy to nitrofurantoin and contrast dye regarding herself. On 26-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) subcutaneous. Concomitant therapies included calcium (unspecified) (manufacturer unknown), omega-3 marine triglycerides (manufacturer unknown), ascorbic acid (manufacturer unknown), vitamin D (unspecified) (manufacturer unknown), baby aspirin (manufacturer unknown) and turmeric (manufacturer unknown). On the morning of 28-DEC-2013 the patient developed a headache that lasted all day and was unrelieved by taking TYLENOL (manufacturer unknown). On 29-DEC-2013 the patient developed a rash on her breast and the rash spread to her axilla and her back. The patient reported that the rash is very painful, itches and contains blisters. The patient also had unspecified flu-like symptoms and extreme fatigue which developed on an unspecified date. The patient had been taking 800mg of MOTRIN (manufacturer unknown) every 8 hours to treat the pain. On 31-DEC-2013 the patient began taking 1 gram of VALTREX (manufacturer unknown) 3 times daily, which she is prescribed to take for 7 days. The patient reported that the rash on her chest has begun to crust over, however, the rash on her axilla and back have not begun to crust over. It was reported that the patient sought medical attention and called a physician. The outcome of headache, rash on chest began to crust, extreme fatigue, flu like symptoms, rash on her breast and the rash spread to her axilla and her back the rash was painful itches and contains blisters and rash on her breast and the rash spread to her axilla and her back was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular, Scab
Clinical narrative: This spontaneous report as received from an approximately 64 year old female nurse with osteoporosis, mitral valve prolapse and allergy to nitrofurantoin and contrast dye regarding herself. On 26-DEC-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) subcutaneous. Concomitant therapies included calcium (unspecified) (manufacturer unknown), omega-3 marine triglycerides (manufacturer unknown), ascorbic acid (manufacturer unknown), vitamin D (unspecified) (manufacturer unknown), baby aspirin (manufacturer unknown) and turmeric (manufacturer unknown). On the morning of 28-DEC-2013 the patient developed a headache that lasted all day and was unrelieved by taking TYLENOL (manufacturer unknown). On 29-DEC-2013 the patient developed a rash on her breast and the rash spread to her axilla and her back. The patient reported that the rash is very painful, itches and contains blisters. The patient also had unspecified flu-like symptoms and extreme fatigue which developed on an unspecified date. The patient had been taking 800mg of MOTRIN (manufacturer unknown) every 8 hours to treat the pain. On 31-DEC-2013 the patient began taking 1 gram of VALTREX (manufacturer unknown) 3 times daily, which she is prescribed to take for 7 days. The patient reported that the rash on her chest has begun to crust over, however, the rash on her axilla and back have not begun to crust over. It was reported that the patient sought medical attention and called a physician. The outcome of headache, rash on chest began to crust, extreme fatigue, flu like symptoms, rash on her breast and the rash spread to her axilla and her back the rash was painful itches and contains blisters and rash on her breast and the rash spread to her axilla and her back was reported as recovering. The relatedness of the events to the therapy with ZOSTAVAX was unknown. No product quality issue was reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Extensive swelling of vaccinated limb, Irritability, Pain, Skin warm
Clinical narrative: Left leg (lateral leg-hip to just above the knee) with redness, warmth, and itching-oral anti-histamines.
Age: 4.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Left leg (lateral leg-hip to just above the knee) with redness, warmth, and itching-oral anti-histamines.
Age: 45.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Sharp, stabbing pain in the arm that lasted for months, still hurts in injection spot. For months, could not lift arm at all! Terrible, stabbing pain, some redness at site. Merck contacted and Dr. - Merck said oh well. Good luck basically, no care or apologies.
Age: 45.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Sharp, stabbing pain in the arm that lasted for months, still hurts in injection spot. For months, could not lift arm at all! Terrible, stabbing pain, some redness at site. Merck contacted and Dr. - Merck said oh well. Good luck basically, no care or apologies.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Diagnosed with Bell's Palsy at emergency department.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot #J003539, expiration date 25-MAR-2015), (dose, location and route unspecified). The outcome of the event was not provided. Follow up information has been received from a registered nurse who called and stated the patient (who received VARIVAX (Merck) exposed to unknown temperatures for 5 hours during interoffice transport) have been revaccinated. No symptoms reported. This is one of several reports received from the same source (Linked MARRS#: 1309USA011086, 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897, 1401USA000205). Additional information is not expected.
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient. The pharmacist reported that the patient was vaccinated with LIQUID PEDVAXHIB at ages of 2 months, 4 months, 6 months and 15 months. Dosing information, route of administration and lot numbers were not provided. No adverse effect reported. No other information was provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Erythema, Local swelling, Neutrophil count increased
Clinical narrative: This spontaneous report as received from a pharmacist and hospital safety officer (nurse) refers to a 68 year old male patient. The patient's current conditions included hyperglycemia, hypercholesterolemia, GERD (gastroesophageal reflux disease) and sleep apnea. Patient had no known drug reactions/allergies. On 19-DEC-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as J005071, expiry date 19-JAN-2015, intramuscular). No other concomitant medications were reported. In December 2013 (approximately) after receipt of the vaccination, the patient experienced red, hot, swollen, tautness of skin which was painful and sore. Patient also experienced fever and chills. Patient sought medical attention-he visited an unspecified emergency room in which he was treated with unspecified intravenous antibiotics for cellulitis (disability and hospitalization). Laboratory tests included an unspecified blood test that showed elevated neutrophils. Hospital physician requested patient to come back to the hospital the following day to receive additional intravenous antibiotics, but patient denied due to lack of transportation. Hospital physician wrote patient script for unspecified oral antibiotics. The event caused temporary disability to the patient. The event was not life-threatening and no intervention was required to prevent any other serious criteria. The outcome of cellulitis was reported as not recovered. The causality for the cellulitis was not reported. Reporters have requested a lot check to be conducted on this lot (J005071). Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain of skin, Pyrexia, Skin tightness, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist and hospital safety officer (nurse) refers to a 68 year old male patient. The patient's current conditions included hyperglycemia, hypercholesterolemia, GERD (gastroesophageal reflux disease) and sleep apnea. Patient had no known drug reactions/allergies. On 19-DEC-2013 the patient was vaccinated with PNEUMOVAX23 (lot number reported as J005071, expiry date 19-JAN-2015, intramuscular). No other concomitant medications were reported. In December 2013 (approximately) after receipt of the vaccination, the patient experienced red, hot, swollen, tautness of skin which was painful and sore. Patient also experienced fever and chills. Patient sought medical attention-he visited an unspecified emergency room in which he was treated with unspecified intravenous antibiotics for cellulitis (disability and hospitalization). Laboratory tests included an unspecified blood test that showed elevated neutrophils. Hospital physician requested patient to come back to the hospital the following day to receive additional intravenous antibiotics, but patient denied due to lack of transportation. Hospital physician wrote patient script for unspecified oral antibiotics. The event caused temporary disability to the patient. The event was not life-threatening and no intervention was required to prevent any other serious criteria. The outcome of cellulitis was reported as not recovered. The causality for the cellulitis was not reported. Reporters have requested a lot check to be conducted on this lot (J005071). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of incorrecct storage VARIVAX (Merck) (lot # J003539, expiration date 25-MAR-2015), (dose, location and route unspecified). The outcome of the event was not provided. Follow up information has been received from the registered nurse who called and stated all patients (who received VARIVAX (Merck) exposed to unknown temperatures for 5 hours during interoffice transport) have been revaccinated. No symptoms reported. This is one of several reports received from the same source (Linked MARRS#: 1309USA011086, 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897, 1401USA000205). Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the dose of GARDASIL, injection in gluteus muscle, intramuscularly (strength, dose, lot number and expiration date not provided). No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: CSF white blood cell count increased, Herpes simplex serology negative, Herpes zoster, Laboratory test normal, Malaise
Clinical narrative: This spontaneous report as received from a physician refers to approximately 8 years old male patient. The patient's medical history included sensitive skin. The patient had no drug allergies/reactions. On an unspecified date in 2006 approximately (when the patient was 1 year old) patient was vaccinated with VARIVAX (merck) dose one, dose (unspecified), frequency (unspecified), and route (unspecified). Second dose of VARIVAX (merck) was administered on an unspecified date when the patient was between 4 years and 6 years of age. No concomitant medication was reported. On 09-DEC-2013 the patient broke out with zoster. Patient sought medical attention at an unspecified physician's office on 09-DEC-2013 and was treated with a 7 day course of oral acyclovir. On 26-DEC-2013, patient presented himself to an unspecified physician with complaint of not feeling well and was hospitalized on same day (26-DEC-2013). On 26-DEC-2013 the patient was diagnosed with meningitis (hospitalization and medically significant). Treatment included an additional 2 weeks of IV acyclovir which was begun on 26-DEC-2013. Lumbar Puncture performed on 26-DEC-2013, resulted in 1,932 white cells. The results HSV (Herpes simplex virus) and PCR (polymerase chain reaction) obtained on 27-DEC-2013 were negative and the result of VZV (Varicella zoster virus) obtained on 30-DEC-2013 was negative. Patient was scheduled for discharge from hospital on 31-DEC-2013. The patient had no drug reactions/allergies. No product quality complaint was involved. Causality assessment was not provided. The outcome of events was reported as recovered (28-DEC-2013). No further information was provided. Upon internal review, the event of meningitis was considered to be medically significant. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLUN4
Symptoms: Meningitis, Polymerase chain reaction, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to approximately 8 years old male patient. The patient's medical history included sensitive skin. The patient had no drug allergies/reactions. On an unspecified date in 2006 approximately (when the patient was 1 year old) patient was vaccinated with VARIVAX (merck) dose one, dose (unspecified), frequency (unspecified), and route (unspecified). Second dose of VARIVAX (merck) was administered on an unspecified date when the patient was between 4 years and 6 years of age. No concomitant medication was reported. On 09-DEC-2013 the patient broke out with zoster. Patient sought medical attention at an unspecified physician's office on 09-DEC-2013 and was treated with a 7 day course of oral acyclovir. On 26-DEC-2013, patient presented himself to an unspecified physician with complaint of not feeling well and was hospitalized on same day (26-DEC-2013). On 26-DEC-2013 the patient was diagnosed with meningitis (hospitalization and medically significant). Treatment included an additional 2 weeks of IV acyclovir which was begun on 26-DEC-2013. Lumbar Puncture performed on 26-DEC-2013, resulted in 1,932 white cells. The results HSV (Herpes simplex virus) and PCR (polymerase chain reaction) obtained on 27-DEC-2013 were negative and the result of VZV (Varicella zoster virus) obtained on 30-DEC-2013 was negative. Patient was scheduled for discharge from hospital on 31-DEC-2013. The patient had no drug reactions/allergies. No product quality complaint was involved. Causality assessment was not provided. The outcome of events was reported as recovered (28-DEC-2013). No further information was provided. Upon internal review, the event of meningitis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot #J003221, expiration date 15-MAR-2015), (dose, location and route unspecified). The outcome of the event was not provided. Follow up information has been received from a registered nurse who called and stated the patient (who received VARIVAX (Merck) exposed to unknown temperatures for 5 hours during interoffice transport) have been revaccinated. No symptoms reported. This is one of several reports received from the same source (Linked MARRS#: 1309USA011086, 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA014866, 1310USA014868, 1310USA015422, 1310USA015165, 1311USA000069, 1310USA015424, 1311USA000058, 1311USA000042, 1311USA000013, 1310USA015170, 1311USA000014, 1310USA015153, 1310USA015090, 1311USA000067, 1311USA000064, 1311USA000021, 1311USA000020, 1311USA000022, 1310USA015101, 1310USA014853, 1311USA000075, 1310USA014895, 1310USA015119, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065, 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637, 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000032, 1311USA000002, 1310USA014897, 1401USA000205). Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Left arm is red, swollen, hot and hard. Pt was told by another health care worker to report it to the place where she had it done. Provider talked to pt, pt was advised to put warm, moist compresses, pt went and saw her local md and was told to take Motrin and continue with the compresses. Allergy listed in pt's medical chart.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Bursa injury, Local swelling, Movement disorder, Musculoskeletal pain, Nerve injury
Clinical narrative: Extreme swelling and pain left shoulder next day. Applied ice took Advil, after several days call Dr. Nurse said is normal continue with ice and Tylenol. After 2 weeks my shoulder began to have extreme throbbing, pain swelling and loss of motion in left arm. It continued to travel down arm and left leg and into center of back and neck. I called my Dr. Went in for evaluaton. Dr decided the shots H1N1 and pnuemonia possibly from needle hit nerve and caused extreme bursa injury. Wanted to prescribe pain meds and phys therapy. I decided no pain med instead using ice and Tylenol and started Phys Therapy that same week. Still now after 3 mo, I am suffering from extreme pain. I now have a Tens Unit to help manage pain and continuing with Phys therapy which is helping slowly. I wake up wit throbbing pain many times at night almost like a bad toothache in my arm and shoulder and neck on left side.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Extreme swelling and pain left shoulder next day. Applied ice took Advil, after several days call Dr. Nurse said is normal continue with ice and Tylenol. After 2 weeks my shoulder began to have extreme throbbing, pain swelling and loss of motion in left arm. It continued to travel down arm and left leg and into center of back and neck. I called my Dr. Went in for evaluaton. Dr decided the shots H1N1 and pnuemonia possibly from needle hit nerve and caused extreme bursa injury. Wanted to prescribe pain meds and phys therapy. I decided no pain med instead using ice and Tylenol and started Phys Therapy that same week. Still now after 3 mo, I am suffering from extreme pain. I now have a Tens Unit to help manage pain and continuing with Phys therapy which is helping slowly. I wake up wit throbbing pain many times at night almost like a bad toothache in my arm and shoulder and neck on left side.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blister, Infection, Pyrexia, Varicella
Clinical narrative: PER PARENTS, PATIENT RAN A FEVER FOR TWO DAYS AFTER RECEIVING 1 YR OLD SHOTS.  TMAX UNKNOWN BY PARENT. ON 01/01/2014 THE PARENTS NOTICED BLISTERS ON CHILD AND CHILD WAS FEBRILE.  ON 1/2/14 PATIENT CAME IN TO THE OFFICE.  PHYSICIAN DIAGNOSED THE PATIENT WITH VARICELLA.  DUE TO A SECONDARY SKIN INFECTION TEH PATIENT HAD TO BE HOSPITALIZED.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Started as small bumps on hands and then developed into a rash on both hands.  Rash is also located on right upper arms and both thighs with itching.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from Community Nursing Services Home Health & Hospice refers to a patient of unknown age and gender. Medical history was not provided. On an unknown date the patient was vaccinated with PROQUAD lot # J004322 with expiration date 17-OCT-2014, which was improperly stored (dose and route unknown). Concomitant medication was not provided. Follow up information was received from a registered nurse concerning the patient who was vaccinated with the improperly stored PROQUAD. No symptoms were reported. The patient had been revaccinated. This is one of several reported received from the same source. Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: This spontaneous report as received from a 80 year old male patient regarding himself. The patient had Allergy to ZETIA. On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX dose (unspecified), frequency (unspecified), route (unspecified), for prevention of shingles. Concomitant therapies included medication for heart issue (manufacturer unspecified). on 20-DEC-2013, he felt a burning sensation on his back left by the shoulder blade which was running around to the front of his chest. Patient also felt that vaccine gave him the shingles instead of protecting him from it. The outcome of events was unknown. Patient sought unspecified medical attention. No product quality complaint was involved. Causality was unknown. This is one of the two reports received from the same patient (#1401USA001174). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information was received from an unspecified health professional regarding a patient (demographics unknown), who on an unknown date, was vaccinated with VARIVAX (Merck), lot # J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination is unknown. Follow up information has been received from the nurse who called and stated the patient (who received VARIVAX (Merck) that was exposed to unknown temperatures for 5 hours) have been revaccinated. No symptoms reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. On 02-JAN-2014 the patient was vaccinated with expired dose of ZOSTAVAX (lot # H016765; expiration date: 10-DEC-2013) (dose, route and frequency unspecified) for an unknown indication. No medical history and concomitant medications were reported. The patient has not reported or demonstrated any side effects. Outcome and causality were not reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient who had received PNEUMOVAX 23 every year beginning 2009 and last in 2012, at an unspecified healthcare provider. No adverse effect was reported. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Anaemia, Asthenia, Fatigue, Guillain-Barre syndrome, Occult blood negative
Clinical narrative: 56 male in his usual state of health abruptly developed generalized body rash and easy fatigue, weakness approximately 4 weeks after receiving his seasonal flu vaccination through Employee Health. He presented to Dermatology for evaluation of his rash. Patient was admitted to the Hospital on November 11, 2013 for further work up and evaluation. "HOSPITAL COURSE (focused): Pt presented with B/L LE weakness and had suspicion of GBS, pt was evaluated by Neurology and they R/O GBS. Pt found to have anemia and AKI, hemoccult stool test negative. Pt was transfused, Hb stable post transfusion. Nephrology consulted they want to follow as out pt. Pt wanted to go home. Discharged in stable condition with close F/U."
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Renal failure acute, Transfusion
Clinical narrative: 56 male in his usual state of health abruptly developed generalized body rash and easy fatigue, weakness approximately 4 weeks after receiving his seasonal flu vaccination through Employee Health. He presented to Dermatology for evaluation of his rash. Patient was admitted to the Hospital on November 11, 2013 for further work up and evaluation. "HOSPITAL COURSE (focused): Pt presented with B/L LE weakness and had suspicion of GBS, pt was evaluated by Neurology and they R/O GBS. Pt found to have anemia and AKI, hemoccult stool test negative. Pt was transfused, Hb stable post transfusion. Nephrology consulted they want to follow as out pt. Pt wanted to go home. Discharged in stable condition with close F/U."
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 30-DEC-2013 the patient was vaccinated with a dose of MMR II Injection (lot # H01894, expired date: 18-OCT-2014) 0.5 ml subcutaneous. It was reported that the dose of MMR II injection was exposed to 86 degrees Fahrenheit for 72 hours which was not supported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician (healthcare worker) refers to a patient of unknown age and gender. The healthcare worker reported that on 30-DEC-2013, the patient was vaccinated with a dose of GARDASIL (lot # 1073AA, expiry 11-OCT-2013). No adverse event reported. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Axillary adenopathy 1 day after HPV occurred after HPV #1 and HPV #2 (Large tender axillary node) on side of injection.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Malaise, Palpitations, Sensation of heaviness
Clinical narrative: SOB, racing heart rate, heaviness in B/L legs, feeling of malaise and unwell x 2 days, not flu like sx, not cold sx.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram, Contusion, Lymphadenopathy
Clinical narrative: Pt reports 3 - 4 days after High Dose flu lymph nodes enlarged. Did not seek medical care until 12/16/13 at primary care. Was referred to surgeon and scheduled surgery for 1/6. After asking did report a bruise also. Pt states it's from the flu shot given in the joint way high.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's medical history was not reported. On unspecified date in 2006, the patient was vaccinated with the first dose of GARDASIL, .5 ml, intramuscular for "CDC guideline recommendations". No concomitant medications were reported. The reporter reported that the year GARDASIL come out in 2006 the patient had broken out in a rash all over her body after being given GARDASIL. The patient sought medical attention contacted the physician. On unknown date, the patient received treatment with BENADRYL. Lab diagnostic studies were not reported. The outcome of the patient had broken out in a rash all over her body was reported as recovered/resolved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date, reported as about 6 years ago, the patient was vaccinated with GARDASIL dose 1 and 2. Route was not reported. No concomitant medication was reported. On 18-DEC-2013 the patient was in the office to possibly get her third dose. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 90 year old female patient. It was reported that the patient had no drug allergies. On 05-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J007210 via subcutaneous injection. No co-suspected or concomitant medications were reported. The reporter stated that the patient is currently (calculated as December 2013) being prescribed 20 mg prednisone (manufacturer unknown) daily for five days. The indication (unspecified adverse event) was not reported. The outcome of the unspecified event was reported as not recovered. The reporter could not provide any additional information and a causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 18-DEC-2013, the patient was vaccinated with ZOSTAVAX subcutaneous. (lot # J011212, expiration date: 29-AUG-2014). Dose was not reported. No co-suspect and concomitant therapies were reported. The reporter stated that on 18-DEC-2013, the patient received improperly stored ZOSTAVAX that was exposed to 75F for 24 hours. No known adverse effects. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a patient's mother refers to her 15 year old male son. On an unknown date in August 2012, the patient was vaccinated with GARDASIL (dose 1, route and frequency unspecified) as preventive vaccine. No medical history and concomitant medications were reported. No adverse events were reported for the 1st dose of GARDASIL. On an unknown date in June 2013, the patient received dose 2 of GARDASIL as preventive vaccine and fainted. The patient recovered before leaving the hospital the same day. Causality of the event was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 12 year 7 month old male patient. She reported that the male patient was scheduled to receive the third dose of GARDASIL dose 3, 0.5 ml, intramuscular and also an unspecified flu vaccine (Manufacturer unknown) on 23-DEC-2013. She reported that the patient inadvertently received two doses of GARDASIL, 0.5 ml intramuscularly in two different anatomic sites. The physician stated that no adverse effects were reported. Additional information has been requested.