chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Case number PHEH2016US025358, is an initial spontaneous report received from a nurse on 29 Sep 2016. This report refers to a 34 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX Quadrivalent (lot number: 185888) at a dose of 0.5 ml intramuscular in left deltoid on 27 Sep 2016 at 04:10. Nurse reported that the patient experienced nausea and vomiting on 28 Sep 2016. The patient thought it might be a smell in the environment. The patient also experienced difficultly in focusing on 28 Sep 2016. On the same day (28 Sep 2016), the patient reported smells strange, then began to get achy, dizzy, nausea, and throw (vomited) 5 times. She felt tired, decreased appetite, achy, slight nasal drainage, for 2 days but continued with poor appetite and felt foggy until 01 Oct 2016. No cause of odor was found in the work environment. She felt fine. Nausea subsided but not completely resolved as stomach was still in knots. The outcome of the events strange smell sensation, achy, dizziness, nausea, vomiting, decreased appetite, nasal discharge, foggy and difficulty in focusing was reported as complete recovery on an unknown date and of abdominal mass was unknown.  The seriousness of the events was reported as non serious. The causality of the events abdominal mass, nausea, vomiting and disturbance in attention was reported as suspected with FLUCELVAX and of other events was not reported. Follow up report received from a nurse on 02 Nov 2016: Added events (strange smell sensation, achy, dizziness, decreased appetite, nasal drainage and foggy). Updated suspect drug information (vaccine administration time and anatomical location).
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea, Pain, Parosmia, Rhinorrhoea, Vision blurred
Clinical narrative: Case number PHEH2016US025358, is an initial spontaneous report received from a nurse on 29 Sep 2016. This report refers to a 34 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX Quadrivalent (lot number: 185888) at a dose of 0.5 ml intramuscular in left deltoid on 27 Sep 2016 at 04:10. Nurse reported that the patient experienced nausea and vomiting on 28 Sep 2016. The patient thought it might be a smell in the environment. The patient also experienced difficultly in focusing on 28 Sep 2016. On the same day (28 Sep 2016), the patient reported smells strange, then began to get achy, dizzy, nausea, and throw (vomited) 5 times. She felt tired, decreased appetite, achy, slight nasal drainage, for 2 days but continued with poor appetite and felt foggy until 01 Oct 2016. No cause of odor was found in the work environment. She felt fine. Nausea subsided but not completely resolved as stomach was still in knots. The outcome of the events strange smell sensation, achy, dizziness, nausea, vomiting, decreased appetite, nasal discharge, foggy and difficulty in focusing was reported as complete recovery on an unknown date and of abdominal mass was unknown.  The seriousness of the events was reported as non serious. The causality of the events abdominal mass, nausea, vomiting and disturbance in attention was reported as suspected with FLUCELVAX and of other events was not reported. Follow up report received from a nurse on 02 Nov 2016: Added events (strange smell sensation, achy, dizziness, decreased appetite, nasal drainage and foggy). Updated suspect drug information (vaccine administration time and anatomical location).
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Case number PHEH2016US025358, is an initial spontaneous report received from a nurse on 29 Sep 2016. This report refers to a 34 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX Quadrivalent (lot number: 185888) at a dose of 0.5 ml intramuscular in left deltoid on 27 Sep 2016 at 04:10. Nurse reported that the patient experienced nausea and vomiting on 28 Sep 2016. The patient thought it might be a smell in the environment. The patient also experienced difficultly in focusing on 28 Sep 2016. On the same day (28 Sep 2016), the patient reported smells strange, then began to get achy, dizzy, nausea, and throw (vomited) 5 times. She felt tired, decreased appetite, achy, slight nasal drainage, for 2 days but continued with poor appetite and felt foggy until 01 Oct 2016. No cause of odor was found in the work environment. She felt fine. Nausea subsided but not completely resolved as stomach was still in knots. The outcome of the events strange smell sensation, achy, dizziness, nausea, vomiting, decreased appetite, nasal discharge, foggy and difficulty in focusing was reported as complete recovery on an unknown date and of abdominal mass was unknown.  The seriousness of the events was reported as non serious. The causality of the events abdominal mass, nausea, vomiting and disturbance in attention was reported as suspected with FLUCELVAX and of other events was not reported. Follow up report received from a nurse on 02 Nov 2016: Added events (strange smell sensation, achy, dizziness, decreased appetite, nasal drainage and foggy). Updated suspect drug information (vaccine administration time and anatomical location).
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Case PHEH2016US025424 is an initial spontaneous report received from nurse on 29 Sep 2016. This report refers to 51 year old female patient. Medical history was not reported. Concomitant medication included DIOVAN. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888, expiry date not reported) at a dose of 0.5 ml in left deltoid intramuscular on 20 Sep 2016. On the same day, patient experienced warmth and erythema at site for 3 days afterward. It was reported that, the patient had increased redness, warmth, soreness and slight edema that started the day after injection and lasted for two days. The patient was applied ice on site and refused to take BENADRYL. By the evening of 22 Sep 2016 the patient symptoms were subsided. The outcome of events was resolved on 22 Sep 2016. The seriousness of events was reported as non serious. The causality of events was not reported. Follow up report received from nurse on 02 Nov 2016: Concomitant medication added, vaccination anatomical location added, event (increased redness, warmth, soreness and slight edema) added, event recovery date updated, and update narrative accordingly.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US025680, is a spontaneous report initially received from a nurse on 03 Oct 2016. This report refers to 03 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619301) at a dose of 0.5 ml intramuscularly in left thigh on 03 Oct 2016 at 03 PM when she was at age of 03 year an 09 months old. The vaccine was meant for 04 years old and older patients. It was reported that vaccine was well tolerated by the patient. The patient had no adverse reaction or local swelling. No adverse event was reported following this medication error. The nurse assesses the seriousness of the case as non serious. Follow up report received from a nurse on 07 Nov 2016: Added patients age (03 year and 09 months old), suspect drug information (site of application, dose time and vaccine tolerated) and seriousness.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Local swelling, Pyrexia, Skin warm
Clinical narrative: Weekend of 11/12/2016 felt feverish; 11/15/2016 noticed a bump on my right arm below my shoulder, warm and as days go by the bump got more intense, bigger (4 inches long & 3 1/2 wide) and hot.
Sex: F
Vaccine: FLUX
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Death, Differential white blood cell count abnormal, Dyspnoea
Clinical narrative: Case number PHHY2017US009651, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 672116) on 23 Jan 2017. This report refers to an adult female patient. Historical condition was not reported and no information on patient's family history was reported. The patient was a nursing home resident, the current conditions included breast cancer (in remission), pericarditis requiring a pericardial window, mediastinitis, hypertension and diabetes mellitus. Concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine INN (unknown whether pandemic or seasonal (manufacturer unknown), batch number: not reported) on an unknown date. On an unknown date, after vaccination, the patient experienced shortness of breath and clinical evidence of pneumonia. Lab tests were performed on an unspecified date and it revealed that, the patient's white cell count was elevated with a left shift in differential count (range and normal value not provided) and for chest X-ray, there was a confirmatory evidence in the form of infiltrates. It was reported that, the patient had evidence of pneumonia with evidence of respiratory failure and a rapid respiratory viral panel that confirmed metapneumovirus infection (MPV). The patient's family refused intubation and prolonged non-invasive ventilation which caused pneumothorax and acute respiratory distress syndrome (ARDS) resulted in the patient's demise. It was unknown if the autopsy was performed. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (fatal, hospitalization and medically significant) and the causality was not reported. It was reported that, the reporter did not comment on the relationship between metapneumovirus infection and unspecified influenza vaccine. The reporter concluded that, the disease spectrum of metapneumovirus could vary widely and the outcomes vary largely based on comorbidities. The infection could frequently lead to severe respiratory failure, progressing to acute respiratory distress syndrome and death in the elderly or debilitated patients.
Sex: F
Vaccine: FLUX
Symptoms: Human metapneumovirus test positive, Lung infiltration, Mechanical ventilation, Metapneumovirus infection, Pneumonia
Clinical narrative: Case number PHHY2017US009651, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 672116) on 23 Jan 2017. This report refers to an adult female patient. Historical condition was not reported and no information on patient's family history was reported. The patient was a nursing home resident, the current conditions included breast cancer (in remission), pericarditis requiring a pericardial window, mediastinitis, hypertension and diabetes mellitus. Concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine INN (unknown whether pandemic or seasonal (manufacturer unknown), batch number: not reported) on an unknown date. On an unknown date, after vaccination, the patient experienced shortness of breath and clinical evidence of pneumonia. Lab tests were performed on an unspecified date and it revealed that, the patient's white cell count was elevated with a left shift in differential count (range and normal value not provided) and for chest X-ray, there was a confirmatory evidence in the form of infiltrates. It was reported that, the patient had evidence of pneumonia with evidence of respiratory failure and a rapid respiratory viral panel that confirmed metapneumovirus infection (MPV). The patient's family refused intubation and prolonged non-invasive ventilation which caused pneumothorax and acute respiratory distress syndrome (ARDS) resulted in the patient's demise. It was unknown if the autopsy was performed. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (fatal, hospitalization and medically significant) and the causality was not reported. It was reported that, the reporter did not comment on the relationship between metapneumovirus infection and unspecified influenza vaccine. The reporter concluded that, the disease spectrum of metapneumovirus could vary widely and the outcomes vary largely based on comorbidities. The infection could frequently lead to severe respiratory failure, progressing to acute respiratory distress syndrome and death in the elderly or debilitated patients.
Sex: F
Vaccine: FLUX
Symptoms: Pneumothorax, Respiratory failure, Respiratory viral panel, Shift to the left, White blood cell count abnormal
Clinical narrative: Case number PHHY2017US009651, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 672116) on 23 Jan 2017. This report refers to an adult female patient. Historical condition was not reported and no information on patient's family history was reported. The patient was a nursing home resident, the current conditions included breast cancer (in remission), pericarditis requiring a pericardial window, mediastinitis, hypertension and diabetes mellitus. Concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine INN (unknown whether pandemic or seasonal (manufacturer unknown), batch number: not reported) on an unknown date. On an unknown date, after vaccination, the patient experienced shortness of breath and clinical evidence of pneumonia. Lab tests were performed on an unspecified date and it revealed that, the patient's white cell count was elevated with a left shift in differential count (range and normal value not provided) and for chest X-ray, there was a confirmatory evidence in the form of infiltrates. It was reported that, the patient had evidence of pneumonia with evidence of respiratory failure and a rapid respiratory viral panel that confirmed metapneumovirus infection (MPV). The patient's family refused intubation and prolonged non-invasive ventilation which caused pneumothorax and acute respiratory distress syndrome (ARDS) resulted in the patient's demise. It was unknown if the autopsy was performed. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (fatal, hospitalization and medically significant) and the causality was not reported. It was reported that, the reporter did not comment on the relationship between metapneumovirus infection and unspecified influenza vaccine. The reporter concluded that, the disease spectrum of metapneumovirus could vary widely and the outcomes vary largely based on comorbidities. The infection could frequently lead to severe respiratory failure, progressing to acute respiratory distress syndrome and death in the elderly or debilitated patients.
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: Case number PHHY2017US009651, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 672116) on 23 Jan 2017. This report refers to an adult female patient. Historical condition was not reported and no information on patient's family history was reported. The patient was a nursing home resident, the current conditions included breast cancer (in remission), pericarditis requiring a pericardial window, mediastinitis, hypertension and diabetes mellitus. Concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine INN (unknown whether pandemic or seasonal (manufacturer unknown), batch number: not reported) on an unknown date. On an unknown date, after vaccination, the patient experienced shortness of breath and clinical evidence of pneumonia. Lab tests were performed on an unspecified date and it revealed that, the patient's white cell count was elevated with a left shift in differential count (range and normal value not provided) and for chest X-ray, there was a confirmatory evidence in the form of infiltrates. It was reported that, the patient had evidence of pneumonia with evidence of respiratory failure and a rapid respiratory viral panel that confirmed metapneumovirus infection (MPV). The patient's family refused intubation and prolonged non-invasive ventilation which caused pneumothorax and acute respiratory distress syndrome (ARDS) resulted in the patient's demise. It was unknown if the autopsy was performed. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious (fatal, hospitalization and medically significant) and the causality was not reported. It was reported that, the reporter did not comment on the relationship between metapneumovirus infection and unspecified influenza vaccine. The reporter concluded that, the disease spectrum of metapneumovirus could vary widely and the outcomes vary largely based on comorbidities. The infection could frequently lead to severe respiratory failure, progressing to acute respiratory distress syndrome and death in the elderly or debilitated patients.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Abnormal behaviour, Blood glucose normal, Computerised tomogram head normal, Electrocardiogram normal
Clinical narrative: Paralyzed from the waist down. Unable to walk. Vomiting. Eyes going sporadic. We took patient to the ER where numerous test were ran (blood work, CT scan, EKG).  All tests came back normal. ER doctor suggested he experienced a seizure. After 24 hours, patient was able to walk again.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Eye movement disorder, Full blood count normal, Hypotonia, Metabolic function test normal, Somnolence
Clinical narrative: Paralyzed from the waist down. Unable to walk. Vomiting. Eyes going sporadic. We took patient to the ER where numerous test were ran (blood work, CT scan, EKG).  All tests came back normal. ER doctor suggested he experienced a seizure. After 24 hours, patient was able to walk again.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Syncope, Vomiting, Weight bearing difficulty
Clinical narrative: Paralyzed from the waist down. Unable to walk. Vomiting. Eyes going sporadic. We took patient to the ER where numerous test were ran (blood work, CT scan, EKG).  All tests came back normal. ER doctor suggested he experienced a seizure. After 24 hours, patient was able to walk again.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Eye disorder
Clinical narrative: Paralyzed from the waist down. Unable to walk. Vomiting. Eyes going sporadic. We took patient to the ER where numerous test were ran (blood work, CT scan, EKG).  All tests came back normal. ER doctor suggested he experienced a seizure. After 24 hours, patient was able to walk again.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Paralysis, Seizure, Vomiting
Clinical narrative: Paralyzed from the waist down. Unable to walk. Vomiting. Eyes going sporadic. We took patient to the ER where numerous test were ran (blood work, CT scan, EKG).  All tests came back normal. ER doctor suggested he experienced a seizure. After 24 hours, patient was able to walk again.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Rash
Clinical narrative: Patient reports two dots on lower extremity with redness surrounding and bruising.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative, referring to a female patient in her thirties. The patient's pertinent medical history, concomitant therapies and drug/allergies reactions were not reported. Concurrent conditions included diabetes mellitus. On an unknown date, the patient in her thirties was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved in this report. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PROQUAD injection (dose, route of administration, lot # and expiration date were not reported) rather than a dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received on 12-JAN-2017 from an office manager at a physician's office. On 10-JAN-2017, a dose of PREVNAR 13 (lot not reported) was administered to an unspecified patient rather than a dose of PNEUMOVAX 23 (lot not reported). No patient details, medical history or concomitant medications were reported. No adverse effects were reported. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of an unknown age and gender. There was information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates in January 2017, reported as between 04-JAN-2017 and 13-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L040054 with an expiration date 26-DEC-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). Administered doses of GARDASIL 9 experienced temperature excursion of 32.5 degrees Fahrenheit for 3 hours and 23 minutes, on 12-JAN-2017. There were previous temperature excursions which took 5 hours with the temperature of 30.3 degrees Fahrenheit on 04-JAN-2017, 3 hours and 58 minutes with the temperature 31.4 degrees Fahrenheit on 05-JAN-2017, 1 hour with the temperature 32.9 degrees Fahrenheit on 06-JAN-2017, 21 minutes with the temperature 34.7 degrees Fahrenheit on 09-JAN-2017, 4 hours with the temperature 31.8 degrees Fahrenheit on 10-JAN-2016, one hour and 45 minutes with the temperature 32.9 degrees Fahrenheit on 11-JAN-2017. The cumulative time of the temperature excursions was 19 hours and 27 minutes with the lowest temperature 30.3 degrees Fahrenheit. No adverse effects were reported. Data logger was involved (new data logger system in place). Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012018.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was receive from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot numbers K011562, expiration date 08-APR-2017; M030380, expiration date 01-FEB-2019, dose, route and anatomical location were not reported) for prophylaxis. The temperature was between 0 Centigrade degrees and 2 Centigrade degrees, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions: 1. between 0 Centigrade degrees and 2 Centigrade degrees for 32 hours; 2. between 0 Centigrade degrees and 2 Centigrade degrees for 30 hours; 3. between 0 Centigrade degrees and 2 Centigrade degrees for 29 hours; 4. between 0 Centigrade degrees and 2 Centigrade degrees for 36 hours. These temperature excursions were detected with digital data logger. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same reporter. Lot number K011562  is not valid for GARDASIL 9. However, it was valid for GARDASIL. Sender's Comments: US-009507513-1701USA008611:Original Case: 1701USA008041; US-009507513-1701USA008041:Original Case : 1701USA008041; US-009507513-1701USA008608:Original Case : 1701USA008041; US-009507513-1701USA008609:Original Case : 1701USA008041.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). Administered doses of GARDASIL 9 experienced an unknown temperature (out of range temperatures) for an unknown time, on an unknown date. There were multiple previous temperature excursions (dates, times and temperatures of the excursions were not reported). It was unknown if the digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012036: US-009507513-1701USA012038: US-009507513-1701USA012035: US-009507513-1701USA012037.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a patient's relative, referring to a 82 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included unspecified pain medicines. It was reported, that 35 to 40 years ago the patient had the first round of unspecified shingles vaccine (in approximately 1977). On 03-JUN-2009, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. On January 2017 (reported as "now in 2017"), the patient experienced a case of shingles (herpes zoster) and a vaccination failure (reported as "I wanted to submit a report for an ineffective vaccination"). The reporter's grandmother also mentioned that she was aware of another person who was vaccinated and still broke out with shingles (MARRS # 1701USA010282). The outcome of the events was not reported. The causality between the vaccination with ZOSTAVAX and the events was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010282:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 29-NOV-2016, the patient was inadvertently vaccinated with a dose VARIVAX intramuscularly (product use issue) in the deltoid (unspecified arm) instead of subcutaneously, ( lot # M033211 with an expiration date in 13-JUL-2018), (dose, dose number and frequency were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patients started GARDASIL series with GARDASIL (strength, dose, route, lot # and expiration date were not reported) for prophylaxis and completed the series with GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (Interchange of vaccine products). No adverse symptoms reported. Additional information has been requested.
Age: 38.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practicioner and a reporter (role unspecified) from the nurse's healthcare facility and refers to a 38 year old patient of unknown gender. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 22-NOV-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml, subcutaneously in right upper arm (lot # K024825, expitarion date: 02-DEC-2016). The dose of M-M-R II was reported to be stored on unknown dates at 8.6 degrees Fahrenheit (F) for 1 minute, 6.5 F for 1 minute and 47 F for 1 hour and 40 minutes. The temperature excursion was detected with a data logger. No previous excursions were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information is not expected, as the reporter has no further data.; Sender's Comments: US-009507513-1610USA013766:
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner and from a reporter (role unspecified) from the nurse's healthcare facility and refers to a 10 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 28-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection, 0.5 ml, subcutaneously in left arm (lot # M005972, expiration date: 02-FEB-2016). There were no concomitant therapies reported. The administered dose of VARIVAX was reported to be stored on unknown dates at 8.6 degrees Fahrenheit (F) for 1 minute, 6.5 F for 1 minute and 47 F for 1 hour and 40 minutes. No previous excursions were involved. The temperature excursion was detected with a data logger. No product quality complain was involved. This is one of several reports from the same reporter. Additional information is not expected as the reporter has no further information.; Sender's Comments: US-009507513-1610USA014546:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 24-JAN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L024129, expiry date: 17-JAN-2017 (route of administration, anatomical location and dose were not reported). No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  currently 61 year old non-pregnant female patient. The patient's concurrent condition included allergy to penicillin. The patient had no medical history and no concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiry date were not reported) for vaccination. On an unknown date in January 2017, reported as "a day or so after administration", the patient experienced swelling and redness at the injection site as well as slight headache, slight dizziness, weak and fatigued. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient seek medical attention by calling a pharmacy. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  currently 61 year old non-pregnant female patient. The patient's concurrent condition included allergy to penicillin. The patient had no medical history and no concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiry date were not reported) for vaccination. On an unknown date in January 2017, reported as "a day or so after administration", the patient experienced swelling and redness at the injection site as well as slight headache, slight dizziness, weak and fatigued. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient seek medical attention by calling a pharmacy. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  currently 61 year old non-pregnant female patient. The patient's concurrent condition included allergy to penicillin. The patient had no medical history and no concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiry date were not reported) for vaccination. On an unknown date in January 2017, reported as "a day or so after administration", the patient experienced swelling and redness at the injection site as well as slight headache, slight dizziness, weak and fatigued. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient seek medical attention by calling a pharmacy. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat irritation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a  currently 61 year old non-pregnant female patient. The patient's concurrent condition included allergy to penicillin. The patient had no medical history and no concomitant medications. On 17-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiry date were not reported) for vaccination. On an unknown date in January 2017, reported as "a day or so after administration", the patient experienced swelling and redness at the injection site as well as slight headache, slight dizziness, weak and fatigued. No treatment was given for the events. No lab diagnostic studies were performed. At the time of the report, the patient did not recover from the events. The patient seek medical attention by calling a pharmacy. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner and from a reporter (role unspecified) from the nurse's healthcare facility and refers to a 15 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-OCT-2016 the patient was vaccinated with an improperly stored dose of VARIVAX injection, 0.5 ml, subcutaneously in right upper arm (lot # M005972, expiration date: 02-FEB-2016) for prophylaxis. The VARIVAX was reported to be stored on unknown dates at 8.6 degrees Fahrenheit (F) for 1 minute, 6.5 F for 1 minute and 47 F for 1 hour and 40 minutes. No previous excursions were involved. The temperature excursion was detected with a data logger. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter has no further information.; Sender's Comments: US-009507513-1610USA014546:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 23-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, lot number L036823, expiration date 24-DEC-2016, (dose, route and anatomical location were not reported) for prophylaxis. No adverse events were reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative, and refers to an approximately 70 year old female patient. The patient has no medical history or concurrent conditions. On 11-JAN-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection (route of administration, anatomical location, lot number and expiration date were not reported)  for "vaccination".  Concomitant therapies included bupropion hydrochloride(WELLBUTRIN). On an unspecified date in January 2017, after receiving the vaccine, the injection site was very swollen. On an unspecified date in January 2017, the patient called to the pharmacy for medical attention, however no treatment was given for the adverse event. There were no laboratory diagnostic studies performed. On 14-JAN-2017, the patient had recovered from the event. Causality assessment was not provided. Additional information is not expected because there was no consent for follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown age and gender. There was information about the patients' concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates in January 2017, reported as between 04-JAN-2017 and 13-JAN-2017, the patients were vaccinated with LIQUID PEDVAXHIB lot # M032148 with an expiration date 18-APR-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). Administered doses of LIQUID PEDVAXHIB experienced temperature excursion of 32.5 degrees Fahrenheit for 3 hours and 23 minutes, on 12-JAN-2017. There were previous temperature excursions which took 5 hours with the temperature of 30.3 degrees Fahrenheit on 04-JAN-2017, 3 hours and 58 minutes with the temperature 31.4 degrees Fahrenheit on 05-JAN-2017, 1 hour with the temperature 32.9 degrees Fahrenheit on 06-JAN-2017, 21 minutes with the temperature 34.7 degrees Fahrenheit on 09-JAN-2017, 4 hours with the temperature 31.8 degrees Fahrenheit on 10-JAN-2016, one hour and 45 minutes with the temperature 32.9 degree Fahrenheit on 11-JAN-2017. The cumulative time of the temperature excursions was 19 hours and 27 minutes with the lowest temperature 30.3 degrees Fahrenheit. No adverse effects were reported. Data logger was involved (new data logger system in place). Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA006576:
Age: 66.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Went to hospital on 19th. Reported bilateral lower ext. weakness. Diagnosed at hospital with Guillain-Barre like syndrome.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Lymphadenopathy, Pyrexia, Urticaria
Clinical narrative: Fever and chills. lymphadenopathy to right axilla. Hives.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Cyst, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Tendonitis
Clinical narrative: Ongoing constant shoulder ache and severe/sharp shoulder pains when moving shoulder.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Frozen L shoulder on 03NOV2016 at 1400. Given CELEBREX and is now doing physical therapy. Physical therapy has improved symptoms.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Autoimmune disorder, Immunology test abnormal, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: At first just had small red itchy bumps on arms  that would come and go but over the next few weeks the bumps got bigger and would spread throughout her body. Doctor said they were hives and advised us to use Zyrtec and get blood work to see if it was an allergy. Blood work said she was having an autoimmune response to something she had the first GARDASIL 9 shot on 07/13/2016 and the second shot on 09/15/2016  she noticed the hives on 10/10/16 while she was in class and her arms were itching bad. We treated it with Benadryl but Over the next few weeks it got worse and worse and was covering her whole body and the Benadryl wasn't enough. We went to her primary doctor who send us to an allergist who ordered blood work and found out it wasn't an allergic reaction it was an autoimmune response. She has been healthy besides the hives so we can't figure out what triggered her immune system except for one of these immunization shots.  Now she has to take an antihistamine two times a day and is always worried she will have a breakout.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Autoimmune disorder, Immunology test abnormal, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: At first just had small red itchy bumps on arms  that would come and go but over the next few weeks the bumps got bigger and would spread throughout her body. Doctor said they were hives and advised us to use Zyrtec and get blood work to see if it was an allergy. Blood work said she was having an autoimmune response to something she had the first GARDASIL 9 shot on 07/13/2016 and the second shot on 09/15/2016  she noticed the hives on 10/10/16 while she was in class and her arms were itching bad. We treated it with Benadryl but Over the next few weeks it got worse and worse and was covering her whole body and the Benadryl wasn't enough. We went to her primary doctor who send us to an allergist who ordered blood work and found out it wasn't an allergic reaction it was an autoimmune response. She has been healthy besides the hives so we can't figure out what triggered her immune system except for one of these immunization shots.  Now she has to take an antihistamine two times a day and is always worried she will have a breakout.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Rash pruritic, Urticaria
Clinical narrative: At first just had small red itchy bumps on arms  that would come and go but over the next few weeks the bumps got bigger and would spread throughout her body. Doctor said they were hives and advised us to use Zyrtec and get blood work to see if it was an allergy. Blood work said she was having an autoimmune response to something she had the first GARDASIL 9 shot on 07/13/2016 and the second shot on 09/15/2016  she noticed the hives on 10/10/16 while she was in class and her arms were itching bad. We treated it with Benadryl but Over the next few weeks it got worse and worse and was covering her whole body and the Benadryl wasn't enough. We went to her primary doctor who send us to an allergist who ordered blood work and found out it wasn't an allergic reaction it was an autoimmune response. She has been healthy besides the hives so we can't figure out what triggered her immune system except for one of these immunization shots.  Now she has to take an antihistamine two times a day and is always worried she will have a breakout.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Started as a band of rash across abdomin, then spread to both arms and back of neck .Extremely itchy. Went to an urgent care who gave her prednisone and Benadryl.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Delirium, Dizziness, Hemiparesis, Inappropriate affect
Clinical narrative: Approx 10 minutes after receiving immunization, patient was feeling faint and nauseous, couldn't feel left arm or leg.  Patient confused, delirious, laughing for no reason, lethargic.  Neuro exam revealed left side weakness.  Was sent to ER via car.  Parents did not take to ER stating patient improved.  Behavior lasted approximately an hour.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Lethargy, Nausea, Sensory loss
Clinical narrative: Approx 10 minutes after receiving immunization, patient was feeling faint and nauseous, couldn't feel left arm or leg.  Patient confused, delirious, laughing for no reason, lethargic.  Neuro exam revealed left side weakness.  Was sent to ER via car.  Parents did not take to ER stating patient improved.  Behavior lasted approximately an hour.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On 01/20/17, 4 yo F was brought to clinic for well child check. During this visit, pt was ordered to receive DTaP IPV combined vaccine IM vaccine (KINRIX) (Order #299585402). At 1345, pt received 0.5 mL injection in right quadriceps (NDC #58160-812-43, Mfg: GlaxoSmithKline; Lot:  JD797, Exp: 11/13/2017). On 01/22, pt developed erythema, warmth and tenderness over her right anteromedial thigh surrounding the site of the injection. Pt was taken to Urgent Care clinic where MD  notified mother that the symptoms were suggestive of an inflammatory response to the recent inoculation. Based on the size of the involved area and concern for cellulitis, MD prescribed sulfamethoxazole-trimethoprim (SEPTRA) suspension with instructions to take 13.6 mLs (108.8 mg of trimethoprim total) by mouth 2 (two) times daily for 10 days. On 01/25, mother notified the primary care clinic of the reaction. By that time, pt's symptoms had improved with only some residual discomfort at the site. No report of adverse sequela.
Age: 47.0
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer Inc. and refers to a 59 year old patient of unknown gender. The patient was immunocompromised. No information about the patient's medical history and concomitant medications was provided. On unknown date in approximately 2005 (reported as at age 47), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (route, site of vaccination, dose, lot number and expiration date were not reported). On unknown date in approximately 2008 (reported as at age 50), the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (route, site of vaccination, dose, lot number and expiration date were not reported). The reporter wanted to know if the immunocompromised patient can be vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) before reaching 65 years of age. On an unknown date, the patient developed unspecified side effects. The outcome of the event was unknown at the time of the report. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Additional information has been requested.