chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: FLUN4, SMALL, FLUN4, SMALL
Symptoms: Hypoxia, Leukocytosis, Myocarditis, Nuclear magnetic resonance imaging normal, Pericardial disease
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 23 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 12 days after the subject had received the following vaccines on 24 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Influenza, live, intranasal quadrivalent vaccine (manufacturer and lot number not reported). On 06 October 2013, Troponin I result was abnormal with highest record value of 20.00ng/mL with a normal echocardiogram and normal MRI of heart. ECG result was not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLUN4, SMALL, FLUN4, SMALL
Symptoms: Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 23 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 12 days after the subject had received the following vaccines on 24 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Influenza, live, intranasal quadrivalent vaccine (manufacturer and lot number not reported). On 06 October 2013, Troponin I result was abnormal with highest record value of 20.00ng/mL with a normal echocardiogram and normal MRI of heart. ECG result was not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLUN4, SMALL, FLUN4, SMALL
Symptoms: Cardiac imaging procedure normal, Echocardiogram normal, Electrocardiogram, Pericardial disease, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 23 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 12 days after the subject had received the following vaccines on 24 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Influenza, live, intranasal quadrivalent vaccine (manufacturer and lot number not reported). On 06 October 2013, Troponin I result was abnormal with highest record value of 20.00ng/mL with a normal echocardiogram and normal MRI of heart. ECG result was not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Presyncope
Clinical narrative: Case number PHHY2013US147789 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510239) website on 16 Dec 2013 and a follow-up information was received from Quality Assurance Department (reference number: 271884) on 23 Dec 2013 another follow up was received from QA department on 23 Jan 2014. This report refers to a 21-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13453P, expiry date: 31 May 2014) in right arm on 22 Oct 2013. On the same day approximately five minutes after vaccination she experienced vasovagal episode. The event lasted for about five seconds. It was reported that she was rested and her vitals were monitored and observed for 30 minutes. When she was discharged she was stable. The final outcome of the event was complete recovery. The seriousness and causality of the events were not reported. No additional information was available. Batch review report (reference number: 271884) received from quality assurance department on 23 Jan 2014. Based on the batch review performed, it was concluded that FLUVIRIN (batch number: 13453P, expiry date: 31 May 2014) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 271884) on 23 Dec 2013: Updated QA reference number only. Follow up received from Quality Assurance Department on 23 Jan 2014: Updated batch review report.
Age: 1.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-JAN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous. The reporter stated that the patient was inadvertently administered a dose of ZOSTAVAX instead of the intended first dose of VARIVAX. No adverse effects reported. No product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-JAN-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous. The reporter stated that the patient was inadvertently administered a dose of ZOSTAVAX instead of the intended first dose of VARIVAX. No adverse effects reported. No product quality complaint involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Pt reports swelling in left arm where vaccine administered which just appeared this morning (2 days after vaccine administration). Pt reports not bothersome/itchy. Has not tried any treatment other than occasional ice.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: Edema and induration, 10x15x3cm on left upper arm.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a currently 21 year old female patient. On an unknown date when the patient was 13 or 14 years old she was vaccinated with the full series of GARDASIL (dose, frequency, lot number and expiration date not reported) for immunization. There was no concomitant medication reported. The reporting nurse from a physician's office stated that someone she knew personally, stated that the patient after completing the series of GARDASIL tested positive for HPV. The nurse could not specify which strain she tested positive for. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 15-OCT-2012, the patient was administered an incorrectly stored dose of ZOSTAVAX, lot# 0468AE, expiration date: 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 26-NOV-2012, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-OCT-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-AUG-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 1.06
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Red welt/hive on lateral left thigh.
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On 10-JAN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (dosage and lot# unspecified). On 16-JAN-2014, the patient experienced long list of adverse events. The outcome of the event was unknown. No further information provided as the pharmacist was too busy to answer questions for the report. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Hypotension
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to her 19 years daughter. In June 2008 (specified date unknown) the patient was vaccinated with the third dose of GARDASIL (lot# unspecified) (dose, route and location unspecified). The first dose of GARDASIL (lot# unspecified) (dose, route and location unspecified) was vaccinated in 2007 (specified date unknown). The reporter did not have any information about the second dose of GARDASIL (lot# unspecified) (dose, route and location unspecified), but the reporter did confirm that the patient did receive the second dose of GARDASIL. On an unspecified date, the patient experienced "low blood pressure and abdominal pain" after receiving the third dose of GARDASIL. The patient has sought medical attention via saw the doctor. The outcome of the events was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 26-DEC-2012, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 28-FEB-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-DEC-2012, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-FEB-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 28-DEC-2012, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 20-FEB-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On 24-AUG-2011 the patient was vaccinated with GARDASIL first dose. No concomitant medications were reported. On 24-JAN-2014, the patient visited the clinic to receive her second dose of GARDASIL. No adverse effects reported. No PQC involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient. No pertinent medical history and drug reactions were reported. On 18-JAN-2014, the patient was vaccinated with ZOSTAVAX lot # J011218, single dose, subcutaneous. No concomitant medication was administered. On 20-JAN-2014, the patient developed a red welt at the injection site. On 21-JAN-2014, the area of reaction became very painful. The symptoms were now improving without requiring medical treatment. No lab diagnostic tests were performed. Patient's present status was reported as recovering. The patient sought medical attention, called pharmacy. No product quality complaint (PQC) was reported. This is case 1 of 3. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 20-FEB-2013, the patient was administered with a dose VARIVAX (Lot # 19099AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a unknown multiple patient of unknown age and sex. On an unknown unspecified date an unspecified number of other patients have received second dose or third dose of GARDASIL (lot #, expiration date, dose, frequency, route of administration were not reported) for unknown indication late because they go to college and do not return to the office on time. No symptoms were reported. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a 54 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (lot number, dose and route not specified). The use of this vaccine is not recommended for a 54 year old. Hence there was an inappropriate schedule of the vaccine administration. No adverse events were noted. No product quality issue was noted. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-MAR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-MAR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-FEB-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-APR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 06-MAR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 05-APR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-JAN-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-DEC-2013 the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 injection 25/0.5 Y (lot # J005068 expiry 18-JAN-2015). No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 31-JAN-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 28-SEP-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 19-SEP-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-NOV-2012, the patient was administered with a dose VARIVAX (Lot # 0435AE, expiry 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 11-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-SEP-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0435AA, expiry date 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a male patient of unknown age. On December 2013, reported as a month ago from date of report, the patient was vaccinated with ZOSTAVAX. Dose, lot and expiry date were unspecified. On an unknown date approximately in January 2014, reported as recently, the patient was seen by the pharmacist, and that time he had an active case of shingles. The outcome of active case of shingles was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 07-SEP-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0435AE, expiry date 28-FEB-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 15-OCT-2012, the patient was administered an incorrectly stored dose of ZOSTAVAX, lot # 0468AE, expiration date: 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 05-APR-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0869AA expiry date, 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: C/O of (RD) redness and swelling x 1 day. Denies pain/discomfort/fever T: 97.8 (Axill). NP provider Rx BENADRYL (child) 1/2 tsp Q 6 H PRN, TYLENOL 1 tsp Q 6-8 H PRN. F/U tomorrow; if worse ER hospital. 12/18/13 pt came in for F/U much better color lighter.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Blister, Decreased activity, Fatigue, Immune system disorder
Clinical narrative: This spontaneous report was received from a consumer refers to himself as 84 year old male patient. The patient pertinent medical history included he was very active his whole life. On an unknown date in October 2011, the patient was vaccinated with ZOSTAVAX standard dose. Concomitant medication included MINOCYCLINE. On an unknown date in the year 2011 (also reported that 2 to 3 weeks after vaccination), the patient experienced water bubbles on his left leg below the knee. The water bubbles appeared intermittently and leave a scab when they disappear and often times reappear in the same location. The patient treated the water bubbles with a hot salt bath. On an unknown date in January 2012, the patient had the water bubbles biopsied and the patient was told that they were related to an unspecified issue with his immune system. On an unknown date, the patient developed rash and he was not sure about the dates and severity related to that symptom. On an unknown date, the patient felt tired and has no ambition to be active anymore after having the vaccine. The patient was treated with prednisone since on an unknown date in April 2013. The outcome of the events was reported as not recovered. The physician did not provide any causality between the events and the suspect product. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: This spontaneous report was received from a consumer refers to himself as 84 year old male patient. The patient pertinent medical history included he was very active his whole life. On an unknown date in October 2011, the patient was vaccinated with ZOSTAVAX standard dose. Concomitant medication included MINOCYCLINE. On an unknown date in the year 2011 (also reported that 2 to 3 weeks after vaccination), the patient experienced water bubbles on his left leg below the knee. The water bubbles appeared intermittently and leave a scab when they disappear and often times reappear in the same location. The patient treated the water bubbles with a hot salt bath. On an unknown date in January 2012, the patient had the water bubbles biopsied and the patient was told that they were related to an unspecified issue with his immune system. On an unknown date, the patient developed rash and he was not sure about the dates and severity related to that symptom. On an unknown date, the patient felt tired and has no ambition to be active anymore after having the vaccine. The patient was treated with prednisone since on an unknown date in April 2013. The outcome of the events was reported as not recovered. The physician did not provide any causality between the events and the suspect product. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage
Clinical narrative: Case number PHEH2014US001723, is a combined initial and follow up spontaneous report received from the nurse on 20 Jan 2014 and 21 Jan 2014. This report refers to a 21-year-old pregnant female. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 29 Oct 2013. It was reported that she did not know that she was 5 weeks pregnant at the time of vaccination. It was reported that the hospital threatened her job if she did not get vaccinated. On an unspecified date one week after vaccination, she started bleeding. The doctor at the emergency room could not determine the cause of bleeding. The baby had a heart rate of 152 beats/min on 12 Nov 2013. She had a miscarriage on 13 Nov 2013. She was 5.5 weeks pregnant at the time of miscarriage. The seriousness and causality was not reported.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage
Clinical narrative: Case number PHEH2014US001518 is an initial spontaneous report from a nurse received on 20 Jan 2014. This report refers to a 21-year-old pregnant female patient. The patient received FLUVIRIN (batch number unknown) intramuscularly on 29 Oct 2013 and she did not know that she was 5 weeks pregnant at that time. It was reported that the patient was pregnant on 05 Nov 2013. A week later she started bleeding. The doctor at the emergency room could not determine the bleeding source. On 12 Nov 2013, the heart rate of fetus was 152 beats per minute. On 13 Nov 2013, the patient had a miscarriage. It was reported that she was 5.5 weeks gestation at the time of miscarriage. The seriousness and causality assessment of the events was unknown.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen at injection site (R) thigh size of a softball. Pt got generic BACTRIM on 1-24-14. Script for KEFLEX on 1-25-14. D/C BACTRIM and con't KEFLEX. informed on 1-27-14.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: 2 inch x 1.5 inch erythematous, mildly tender papule, (L) anterior thigh. BENADRYL given in office. No urticaria. No anaphylactoid rxn. Mom reports area worsened 1/25/14, taken to urgent care center, given 3 day supply KEFLEX -> much improved. Mom still giving BENADRYL.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Haematochezia, Haemorrhage, Intestinal resection, Intussusception, Lethargy
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 month old female patient with no drug reactions/allergies. No medical history was provided. On 07-JAN-2014, the patient was vaccinated with the first dose of ROTATEQ (lot # J002785; expiration date 02-AUG-2013), 0.5 ml, orally. No co-suspect or concomitant therapies were reported. The registered nurse reported that the mother of the patient stated that on 15-JAN-2014, the patient was lethargic and began vomiting. On 16-JAN-2014, the patient had a bloody diaper and was taken to the emergency room of hospital. On the same day, the patient was transported from the emergency room to another hospital where she was diagnosed with intussusception and received surgery for a bowel resection. On 21-JAN-2014, the patient was discharged from the hospital. At the time of the report, the outcome was recovered on an unspecified date in January 2014. The causality was not provided. The events of intussusception and surgery for bowel resection were considered to be immediately life-threatening by the primary reporter. Upon internal review, the event of surgery for a bowel resection was considered to be another important medical event. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 month old female patient with no drug reactions/allergies. No medical history was provided. On 07-JAN-2014, the patient was vaccinated with the first dose of ROTATEQ (lot # J002785; expiration date 02-AUG-2013), 0.5 ml, orally. No co-suspect or concomitant therapies were reported. The registered nurse reported that the mother of the patient stated that on 15-JAN-2014, the patient was lethargic and began vomiting. On 16-JAN-2014, the patient had a bloody diaper and was taken to the emergency room of hospital. On the same day, the patient was transported from the emergency room to another hospital where she was diagnosed with intussusception and received surgery for a bowel resection. On 21-JAN-2014, the patient was discharged from the hospital. At the time of the report, the outcome was recovered on an unspecified date in January 2014. The causality was not provided. The events of intussusception and surgery for bowel resection were considered to be immediately life-threatening by the primary reporter. Upon internal review, the event of surgery for a bowel resection was considered to be another important medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date, the patient was (route not provided) vaccinated with ZOSTAVAX (lot number and expiry date not provided). On an unknown date, the patient had a "horrible reaction" involving redness and swelling at the injection site. The outcome of "horrible reaction" involving redness and swelling at the injection site was unknown. The action taken with ZOSTAVAX was not provided. The reporter did not assess the relationship between the events and the ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Patient had hard bump at injection site, which was itchy, red and warm to the touch.  Her arm was red and puffy for a couple of days afterward and she had a headache.  All symptoms cleared up within 7 days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Patient had hard bump at injection site, which was itchy, red and warm to the touch.  Her arm was red and puffy for a couple of days afterward and she had a headache.  All symptoms cleared up within 7 days.
Age: 20.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Back pain, Bacterial test negative, Blood culture negative, Blood test normal, Chills
Clinical narrative: Sore arms: All day, 7:48am felt lightheaded and had the chills, arm pain began to worsen. Took Ibuprofen, 1:46pm: getting worse, struggling to get through work day, still felt fevered, on way home from work approx 2:30pm, had to pull over and urinate, and it burned, felt hot.  3:30pm collapsed, ambulance was called, fever of 106 degrees, extreme back and neck pain, as well as head pain. Rushed to hospital.  Stayed in hospital until Sunday 1/19/2014 at 5pm.  Between 1/16/204 - 1/18/2014, patient suffered febrile seizures, his temperature ranged between 101-104.
Age: 20.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Dizziness, Dysuria, Epstein-Barr virus test negative, Febrile convulsion, Feeling hot
Clinical narrative: Sore arms: All day, 7:48am felt lightheaded and had the chills, arm pain began to worsen. Took Ibuprofen, 1:46pm: getting worse, struggling to get through work day, still felt fevered, on way home from work approx 2:30pm, had to pull over and urinate, and it burned, felt hot.  3:30pm collapsed, ambulance was called, fever of 106 degrees, extreme back and neck pain, as well as head pain. Rushed to hospital.  Stayed in hospital until Sunday 1/19/2014 at 5pm.  Between 1/16/204 - 1/18/2014, patient suffered febrile seizures, his temperature ranged between 101-104.
Age: 20.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Headache, Herpes simplex serology negative, Influenza virus test negative, Lumbar puncture normal, Neck pain
Clinical narrative: Sore arms: All day, 7:48am felt lightheaded and had the chills, arm pain began to worsen. Took Ibuprofen, 1:46pm: getting worse, struggling to get through work day, still felt fevered, on way home from work approx 2:30pm, had to pull over and urinate, and it burned, felt hot.  3:30pm collapsed, ambulance was called, fever of 106 degrees, extreme back and neck pain, as well as head pain. Rushed to hospital.  Stayed in hospital until Sunday 1/19/2014 at 5pm.  Between 1/16/204 - 1/18/2014, patient suffered febrile seizures, his temperature ranged between 101-104.
Age: 20.0
Sex: M
Vaccine: FLU3, MNQ, PPV
Symptoms: Pain in extremity, Pyrexia, Syncope
Clinical narrative: Sore arms: All day, 7:48am felt lightheaded and had the chills, arm pain began to worsen. Took Ibuprofen, 1:46pm: getting worse, struggling to get through work day, still felt fevered, on way home from work approx 2:30pm, had to pull over and urinate, and it burned, felt hot.  3:30pm collapsed, ambulance was called, fever of 106 degrees, extreme back and neck pain, as well as head pain. Rushed to hospital.  Stayed in hospital until Sunday 1/19/2014 at 5pm.  Between 1/16/204 - 1/18/2014, patient suffered febrile seizures, his temperature ranged between 101-104.
Age: 50.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Joint stiffness, Myalgia
Clinical narrative: C/o stiffness in joints, achy back muscles, tired, has been going on for 2 weeks. Advised to see provider.
Age: 0.55
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Hives, face swelling-redness.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Injection site reaction, Muscular weakness, Musculoskeletal pain, Sensory disturbance
Clinical narrative: Unusual sensation in my upper left arm region (the same shoulder where the vaccination was administrated) associated with weakness in the triceps and pectoral muscles during my workout. First started about a day before with some diffuse pain in the same shoulder blade area, which continued by now, when lately diminished.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Bell's palsy on 2013-12-30, clinician comment: diagnosed with Bell's palsy within 4 weeks of vaccine.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Hypersensitivity, Rash erythematous, Rash generalised
Clinical narrative: Student's mother refers she had a allergic reaction to the first Flu Mist, she had red dots in all her body the same day she had the Flu Mist. No breathing difficulties reported.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea, Hypersensitivity, Lip swelling, Local swelling
Clinical narrative: Student's father refers the day after Flu Mist was given, she developed a severe allergic reaction (Lips and hands were swollen and had breathing difficulties). Parents took student to a Clinic to get treatment.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Pyrexia, Serum sickness, Urticaria
Clinical narrative: Onset following day with 101 degree fever. Taken to ER on day 6 for IV fluids. Day 8 hives, swollen/painful joints, fever. Admitted for 4 days in hospital. F/U Rheumatologist diagnosed "serum sickness".
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac monitoring normal, Dizziness, Echocardiogram normal, Fall, Hypoaesthesia
Clinical narrative: Numbness on left side of body. From foot up to face. Dizziness, fell to floor. Had symptoms for 3 days while hospitalized. Was treated as if I was having mini strokes. MRI on head, Doppler on carotid arteries, wore heart monitor, echocardiogram.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Transient ischaemic attack, Ultrasound Doppler, Ultrasound Doppler normal
Clinical narrative: Numbness on left side of body. From foot up to face. Dizziness, fell to floor. Had symptoms for 3 days while hospitalized. Was treated as if I was having mini strokes. MRI on head, Doppler on carotid arteries, wore heart monitor, echocardiogram.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Attention deficit/hyperactivity disorder, Bipolar disorder, Educational problem, Inappropriate schedule of drug administration
Clinical narrative: Patient received her 1st dose of GARDASIL in Jan of 2008, 2nd dose in May of 2008 and I believe her 3rd in June of 2008. She declined severely in school and in illness since. She cannot pass a driver's license exam or keep a job. If I knew about this vaccine I would have refused. Patient has been diagnosed with ADHD, schizophrenic and bipolar since.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Schizophrenia
Clinical narrative: Patient received her 1st dose of GARDASIL in Jan of 2008, 2nd dose in May of 2008 and I believe her 3rd in June of 2008. She declined severely in school and in illness since. She cannot pass a driver's license exam or keep a job. If I knew about this vaccine I would have refused. Patient has been diagnosed with ADHD, schizophrenic and bipolar since.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abasia, Bacterial infection, Chills, Decreased appetite, Fall
Clinical narrative: Very bad headache 48 hrs. after vaccination; fever; chills; headache was all day, all night; no appetite; both legs were weak and walking was unsteady; fell once; could not walk at all need physical therapy and occupational therapy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Headache, Muscular weakness, Pyrexia, Viral infection
Clinical narrative: Very bad headache 48 hrs. after vaccination; fever; chills; headache was all day, all night; no appetite; both legs were weak and walking was unsteady; fell once; could not walk at all need physical therapy and occupational therapy.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: Very bad headache 48 hrs. after vaccination; fever; chills; headache was all day, all night; no appetite; both legs were weak and walking was unsteady; fell once; could not walk at all need physical therapy and occupational therapy.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Amnesia, Disturbance in attention, Feeling hot, Pyrexia
Clinical narrative: Pt received flu shot (FLULAVAL Quadrivalent) NDC# 19515-0895-11 on 1/13/14. Pt came to pharmacy on 1/21/14 to report ill effects 1 day following including loss of short term memory, loss of attention, feeling warm sensation in the head region, somewhat of a fever. To date, symptoms have not abated. Pt will f/u with her PCP.
Age: 15.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Seizure like phenomena, Syncope
Clinical narrative: Pt fainted while sitting in a chair (after getting shot). Slight seizure-like hand cramping while fainted (about 30 sec - 1 min total time fainted). Woke up fine and oriented.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given the adult flu vaccine instead of the pediatric dose. No problems per dad.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Large red area from inj site down inside of arm, red warm to touch. Treated for cellulitis vs med reaction.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Culture, Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: Patient's mother reports a trip to the ER within 24 hours of vaccination due to soft ball like bump at the injection site. This bump is swollen, red, and hot to the touch. Pt also had fever. She was given antibiotics, and MD said it was infection secondary to the immunization. Culture still pending. What type of infection not known.