chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Full blood count, Laboratory test
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 65 year old male patient with hypertension, degenerative joint disease (DJD), gastrooesophageal reflux disease (GERD), and elevated cholesterol. It was reported that the patient had no drug reactions or allergies. On 14-FEB-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 lot # M026317, expiration date 01-NOV-2018 (route of administration and strength were not reported), and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid both in the left shoulder for prophylaxis. On an unspecified date in 2017, the patient reported that she had experienced shortness of breath and weakness within 3 hours of injection. On 27-FEB-2017, the patient returned to the nurse's office complaining of low blood pressure (hypotension), fatigue, and shortness of breath. On 28-FEB-2017, the patient went to the emergency room, and was subsequently admitted at the hospital on the same day with a diagnosis of hemolytic anemia. Reportedly, while hospitalization, the patient received an unspecified number of blood transfusions due to his hemoglobin level of 7.5 (units not provided). It was unknown what the patient's hemoglobin level was prior to receiving PNEUMOVAX 23. On an unspecified date, the patient was treated with corticosteroids (unspecified) for an unspecified reason. At the time of this report, the subject had not recovered from the events of haemolytic anaemia and hypotension, and was still hospitalized. The outcome of the unspecified adverse event was not reported. The relationship between the events and PNEUMOVAX 23 was not provided. The events of haemolytic anaemia and hypotension were considered to be medically significant and life threatening by the reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Full blood count, Haemoglobin
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 65 year old male patient with hypertension, degenerative joint disease (DJD), gastrooesophageal reflux disease (GERD), and elevated cholesterol. It was reported that the patient had no drug reactions or allergies. On 14-FEB-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 lot # M026317, expiration date 01-NOV-2018 (route of administration and strength were not reported), and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid both in the left shoulder for prophylaxis. On an unspecified date in 2017, the patient reported that she had experienced shortness of breath and weakness within 3 hours of injection. On 27-FEB-2017, the patient returned to the nurse's office complaining of low blood pressure (hypotension), fatigue, and shortness of breath. On 28-FEB-2017, the patient went to the emergency room, and was subsequently admitted at the hospital on the same day with a diagnosis of hemolytic anemia. Reportedly, while hospitalization, the patient received an unspecified number of blood transfusions due to his hemoglobin level of 7.5 (units not provided). It was unknown what the patient's hemoglobin level was prior to receiving PNEUMOVAX 23. On an unspecified date, the patient was treated with corticosteroids (unspecified) for an unspecified reason. At the time of this report, the subject had not recovered from the events of haemolytic anaemia and hypotension, and was still hospitalized. The outcome of the unspecified adverse event was not reported. The relationship between the events and PNEUMOVAX 23 was not provided. The events of haemolytic anaemia and hypotension were considered to be medically significant and life threatening by the reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Haemoglobin decreased, Haemolytic anaemia, Laboratory test, Transfusion
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 65 year old male patient with hypertension, degenerative joint disease (DJD), gastrooesophageal reflux disease (GERD), and elevated cholesterol. It was reported that the patient had no drug reactions or allergies. On 14-FEB-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 lot # M026317, expiration date 01-NOV-2018 (route of administration and strength were not reported), and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid both in the left shoulder for prophylaxis. On an unspecified date in 2017, the patient reported that she had experienced shortness of breath and weakness within 3 hours of injection. On 27-FEB-2017, the patient returned to the nurse's office complaining of low blood pressure (hypotension), fatigue, and shortness of breath. On 28-FEB-2017, the patient went to the emergency room, and was subsequently admitted at the hospital on the same day with a diagnosis of hemolytic anemia. Reportedly, while hospitalization, the patient received an unspecified number of blood transfusions due to his hemoglobin level of 7.5 (units not provided). It was unknown what the patient's hemoglobin level was prior to receiving PNEUMOVAX 23. On an unspecified date, the patient was treated with corticosteroids (unspecified) for an unspecified reason. At the time of this report, the subject had not recovered from the events of haemolytic anaemia and hypotension, and was still hospitalized. The outcome of the unspecified adverse event was not reported. The relationship between the events and PNEUMOVAX 23 was not provided. The events of haemolytic anaemia and hypotension were considered to be medically significant and life threatening by the reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Asthenia, Dyspnoea, Fatigue, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 65 year old male patient with hypertension, degenerative joint disease (DJD), gastrooesophageal reflux disease (GERD), and elevated cholesterol. It was reported that the patient had no drug reactions or allergies. On 14-FEB-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 lot # M026317, expiration date 01-NOV-2018 (route of administration and strength were not reported), and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid both in the left shoulder for prophylaxis. On an unspecified date in 2017, the patient reported that she had experienced shortness of breath and weakness within 3 hours of injection. On 27-FEB-2017, the patient returned to the nurse's office complaining of low blood pressure (hypotension), fatigue, and shortness of breath. On 28-FEB-2017, the patient went to the emergency room, and was subsequently admitted at the hospital on the same day with a diagnosis of hemolytic anemia. Reportedly, while hospitalization, the patient received an unspecified number of blood transfusions due to his hemoglobin level of 7.5 (units not provided). It was unknown what the patient's hemoglobin level was prior to receiving PNEUMOVAX 23. On an unspecified date, the patient was treated with corticosteroids (unspecified) for an unspecified reason. At the time of this report, the subject had not recovered from the events of haemolytic anaemia and hypotension, and was still hospitalized. The outcome of the unspecified adverse event was not reported. The relationship between the events and PNEUMOVAX 23 was not provided. The events of haemolytic anaemia and hypotension were considered to be medically significant and life threatening by the reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, PPV, TDAP, PPV, TDAP
Symptoms: Hypotension, Transfusion
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 65 year old male patient with hypertension, degenerative joint disease (DJD), gastrooesophageal reflux disease (GERD), and elevated cholesterol. It was reported that the patient had no drug reactions or allergies. On 14-FEB-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 lot # M026317, expiration date 01-NOV-2018 (route of administration and strength were not reported), and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid both in the left shoulder for prophylaxis. On an unspecified date in 2017, the patient reported that she had experienced shortness of breath and weakness within 3 hours of injection. On 27-FEB-2017, the patient returned to the nurse's office complaining of low blood pressure (hypotension), fatigue, and shortness of breath. On 28-FEB-2017, the patient went to the emergency room, and was subsequently admitted at the hospital on the same day with a diagnosis of hemolytic anemia. Reportedly, while hospitalization, the patient received an unspecified number of blood transfusions due to his hemoglobin level of 7.5 (units not provided). It was unknown what the patient's hemoglobin level was prior to receiving PNEUMOVAX 23. On an unspecified date, the patient was treated with corticosteroids (unspecified) for an unspecified reason. At the time of this report, the subject had not recovered from the events of haemolytic anaemia and hypotension, and was still hospitalized. The outcome of the unspecified adverse event was not reported. The relationship between the events and PNEUMOVAX 23 was not provided. The events of haemolytic anaemia and hypotension were considered to be medically significant and life threatening by the reporter. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: 2 hours after hepatitis b vaccination 1st dose developed hives  on her left cheek, mid abdomen , right hand and left wrist.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Secondary transmission
Clinical narrative: This spontaneous report has been received from a nurse practitioner (N.P) who was also the consumer reporting on her partner, a female patient of an unknown age. The patient's pertinent medical history, drug allergies/reactions, or concomitant therapies were not reported. On 29-DEC-2016, the patient's partner was vaccinated with ZOSTAVAX for the prevention of Herpez zoster (lot #, expiration date, dose, and route of administration were not reported). The patient's partner reported that on 03-JAN-2017, the patient developed shingles (Herpes zoster). It was reported that on that day, the patient started with pain. On 05-JAN-2017, the patient went to an emergency room (ER) due to her pain. On 08-JAN-2017, she developed a rash and then sought medical attention from her primary care physician on an unknown date. The physician prescribed valacyclovir hydrochloride (VALTREX) and gabapentin (also reported as no treatment was given). The patient's partner was thinking she might have transmitted the Herpes zoster to the patient. On an unknown date, the reporter accepted the varicella Zoster virus (VZV) packet. No product quality complaint was involved. The outcome of Herpes zoster was not reported. The causality assessment between Herpes zoster and vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates in 2017, the patients were vaccinated with improperly stored doses of VARIVAX, subcutaneous, lot# L027288 with an expiration date 21-JUL-2017 for prophylaxis (dose was not reported). No adverse event was reported. Administered doses of VARIVAX experienced the temperature excursion of -13.3 degrees Celsius for 30 minutes on 30-JAN-2017, -14 degrees Celsius for 30 minutes on 31-JAN-2017, -13.1 degrees Celsius for 45 minutes on 01-FEB-2017, -13.8 degrees Celsius for 30 minutes on 02-FEB-2017, -13.3 degrees Celsius for 60 minutes on 03-FEB-2017, -13.1 degrees Celsius for 75 minutes on 04-FEB-2017, -13.8 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 06-FEB-2017,-13.3 degrees Celsius for 75 minutes on 10-FEB-2017, -14.9 degrees Celsius for 15 minutes on 10-FEB-2017, -13.3 degrees Celsius for 60 minutes on 10-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -14.9 degrees Celsius for 15 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017. There was no previous temperature excursions. Data logger was involved. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information is not expected because no consent to contact with the reporter was provided. Sender's Comments: US-009507513-1703USA000327.
Age: 14.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a currently 14 year-old patient of unknown gender. Information regarding no concurrent conditions, medical history, drug reactions or allergies or concomitant medications was unknown by the reporter. On 25-FEB-2002, 16-MAY-2002 and 18-SEP-2002, the patient received a doses of Hepatitis B vaccine (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not reported) for Hepatitis B prophylaxis; and on an unspecified date, the patient had insufficient titers for Hepatitis B (hepatitis B antibody negative). On 18-JUL-2016, the patient received a dose of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were not reported), and on 04-JAN-2017, the patient received another dose of RECOMBIVAX HB (dose, frequency and route were not reported) lot # M000442 with expiration date of 31-MAR-2018; both for hepatitis B prophylaxis, which had been exposed to temperature 32 F, for a time frame of 24 hours. No previous temperature incursion was reported. The outcome of the event, and their relationship with suspect therapy was not reported. No product quality complaint was involved (PQC). Data logger was involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30 year old female patient. The patient had no relevant medical history, past drug history, or concomitant medications. On 16-FEB-2017, the patient was vaccinated with expired VARIVAX (lot # J012327, expiration date reported as 20-OCT-2015, 0.5 ml, subcutaneous) for vaccination. The vaccine was administered by the pharmacist at the pharmacy. At the time of reporting (16-FEB-2017), the patient was doing fine and had no adverse effects from receiving the expired vaccine. The patient had not received any treatment. There was no relevant laboratory data. It was unknown if the patient would continue VARIVAX. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Dysgeusia, Injection site erythema
Clinical narrative: Information has been received from a female patient of unknown age concerning herself. The patient had no concomitant medication or drug reactions/allergies. Medical history was not reported. On 20-FEB-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot# and expiration date were unknown) for prevention of infection from pneumococcus bacteria. The injection site did turn red after being vaccination on the same day. On next day 21-FEB-2017, the patient had chills, no appetite and a bad taste in her mouth. After returning home from work, she tried to regurgitate but could not. The patient then took EX-LAX (OLD FORMULA) to clean herself out and felt much better afterwards. The patient did contact her physician. There was no treatment given for the events. The outcome of the events was reported as recovered (unknown date in February 2017). No product quality complaint involved. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old female patient. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 17-OCT-2016 the patient received her first dose of LIQUID PEDVAXHIB(strength, dose and route unknown, lot# M025193, expiration date 21-MAY-2019) at age 2 months, then received her second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB)(strength, dose and route unknown, lot#M027883, expiration date 15-APR-2019) on 19-DEC-2016 for prophylaxis. On 23-FEB-2017, at age 6 months, the patient then inadvertently received a third dose of LIQUID PEDVAXHIB (strength, dose and route unknown, lot # M036612, expiration date 19-MAY-2019) for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Lethargy, Postural orthostatic tachycardia syndrome
Clinical narrative: Information has been received from a neurologist via a company representative concerning a currently 16 years old female patient. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. The patient received three doses of GARDASIL (strength, dose, frequency, route, lot# and expiration date were unknown) on 02-JUL-2013, 06-SEP-2013 and 09-JAN-2014 respectively for prevention of human papillomavirus by an anonymous physician. In May 2016, the patient developed lethargy and had three episodes of dizziness. The patient was evaluated by a neurologist in July 2016. On an unknown date, the patient was diagnosed with postural orthostatic tachycardia syndrome (POTS). The outcome of the event was reported as not recovered. The causality between the event and GARDASIL was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Information was received from a nurse, referring to a 22 year old non-pregnant female patient. The patient did not have concomitant medication, medical history and drug reactions/allergies. On 15-FEB-2017, the patient was vaccinated with her first dose of GARDASIL 9 (lot# was reported as L012190 with expiration date 13-APR-2017; concentration, frequency and route were unknown) for vaccination. Since 15-FEB-2017 to 27-FEB-2017, the patient experienced headache. No lab diagnostics study was performed, and no treatment was given for the event. At the time of reporting, the patient was not recovered from the event. The causality between headache and GARDASIL 9 was not provided. No product quality complaint was involved. Lot number L012190 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a 21 year old female patient. She was allergic to penicillin (manufacturer, date, and reaction unknown). Patient had no concomitant medication nor medical history. The patient became pregnant with last menstrual period (LMP) of 13-SEP-2016 and estimated due date (EDD) of 20-JUN-2017. On 16-FEB-2017, the patient was vaccinated with VARIVAX (dose and frequency unknown; lot # M023383, expiry date: 11-MAY-2018; route: subcutaneous) in error to prevent chickenpox. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: DTAP, FLUX, MMR, VARCEL, DTAP, FLUX, MMR, VARCEL
Symptoms: Cough, Fatigue, Feeling hot
Clinical narrative: Information has been received from nurse via a field representative referring to herself/himself of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates within the last few weeks, the patient was vaccinated with VARIVAX (dose, route, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included M-M-R II (dose, route, lot # and expiration date were not reported), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and influenza virus vaccine (unspecified) (it was not specified if the vaccines listed previously were administered concomitantly or on separate dates). At unspecified time after the patient received vaccines, the patient developed a sporadic cough, fatigue, and feel hot without having a fever. The outcome of the events was unknown. The causality assessment was unknown. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 40 year old patient of unknown gender. There was no information about concurrent condition, concomitant medication and medical history. On 24-FEB-2017, the patient was vaccinated with a dose of PROQUAD (lot# L040411, expiration date 13-APR-2017, dose, frequency and route unknown) for prophylaxis (Inappropriate age at vaccine administration). No adverse effect was reported. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information had been received on 02-MAR-2017 from a nurse who reported that two male patients (age unknown) were inadvertently administered expired doses of MMR II (lot# L004658, expiration 11-FEB-2017). The patient was administered a dose on 15-FEB-2017 and the other patient (see MARRS# 1703USA001814) was administered a dose on 24-FEB-2017. No adverse effect reported for either patient. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001814:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 03-MAR-2017 from a registered nurse regarding multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on  03-FEB-2017, 10-FEB-2017, and 16-FEB-2017 unspecified patients were administered an expired VAQTA vaccine (lot # L027735, expiration date 21-JAN-2017)(dose not specified). No adverse effects were reported. No further information was provided. The action taken with VAQTA was not applicable and the outcome of administered an expired VAQTA was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 06-MAR-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 06-MAR-2017 the patient was vaccinated with a dose of VARIVAX lot # L001329 expiration 13-JAN-2017, subcutaneous for prophylaxis which was expired. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Gastrointestinal tube insertion, Haematochezia, Parenteral nutrition, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative via Poison & Drng Center (RMPDC) (US17-009665) referring to a 6 month and 5 days old patient of unknown gender. The patient's past medical history, concomitant medications, and past drug history were unknown. On 15-OCT-2016 the patient was vaccinated with the first dose of ROTATEQ (lot# M018957, one time dose) orally for prevention of rotavirus gastroenteritis. On 06-DEC-2016 the patient was vaccinated with the second dose of ROTATEQ (lot# M031805, one time dose) orally for prevention of rotavirus gastroenteritis. On 14-FEB-2017, the patient presented to the pediatrician office with a rash on the bottom, severe diarrhea, and bloody stools. On 14-FEB-2017 the Adena/ Rota Antigen Rapid Test was performed in the pediatrician office and the results were negative. The patient continued to worsen. On 15-FEB-2017 the patient was admitted to hospital. On an unknown date, while admitted to the hospital, the patient tested positive for the rotavirus and received Total Parenteral Nutrition (TPN) via a nasogastric (NG) tube trickle feed. The patient improved to formula feedings on an unknown date and on 27-FEB-2017 the patient was released from the hospital. As of 08-MAR-2017 the physician recommends against giving the patient the third dose of ROTATEQ. On an unknown date, patient's rash, severe diarrhea and bloody stools had recovered but the patient was still on a modified diet. The causality between the event and ROTATEQ was not reported. Upon internal review, bloody stools was considered as medically significant event. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: This spontaneous report was received from a physician via a company representative via Poison & Drng Center (RMPDC) (US17-009665) referring to a 6 month and 5 days old patient of unknown gender. The patient's past medical history, concomitant medications, and past drug history were unknown. On 15-OCT-2016 the patient was vaccinated with the first dose of ROTATEQ (lot# M018957, one time dose) orally for prevention of rotavirus gastroenteritis. On 06-DEC-2016 the patient was vaccinated with the second dose of ROTATEQ (lot# M031805, one time dose) orally for prevention of rotavirus gastroenteritis. On 14-FEB-2017, the patient presented to the pediatrician office with a rash on the bottom, severe diarrhea, and bloody stools. On 14-FEB-2017 the Adena/ Rota Antigen Rapid Test was performed in the pediatrician office and the results were negative. The patient continued to worsen. On 15-FEB-2017 the patient was admitted to hospital. On an unknown date, while admitted to the hospital, the patient tested positive for the rotavirus and received Total Parenteral Nutrition (TPN) via a nasogastric (NG) tube trickle feed. The patient improved to formula feedings on an unknown date and on 27-FEB-2017 the patient was released from the hospital. As of 08-MAR-2017 the physician recommends against giving the patient the third dose of ROTATEQ. On an unknown date, patient's rash, severe diarrhea and bloody stools had recovered but the patient was still on a modified diet. The causality between the event and ROTATEQ was not reported. Upon internal review, bloody stools was considered as medically significant event. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 12 yeas old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number M024261 with expiration date of 30-JUL-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008111: original case : 1701USA008111.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 12 yeas old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 16-JAN-2017, the patient was vaccinated with improperly stored doses of GARDASIL 9 lot number M024261 with expiration date of 30-JUL-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008111: Original case: 1701USA008111.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 4 years old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 11-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot number M035688 with expiration date of 10-AUG-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose with lot number M035688 was exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours measured with digital data logger and the lot had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 11 yeas old patient of unknown gender. There was no information about the patients' medical history, concurrent conditions and concomitant therapies. On 10-JAN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number M017983 with expiration date of 30-MAY-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 12 years old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number M024261 with expiration date of 30-JUL-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008111: Original Case: 1701USA008111.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 13 months old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 12-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX from lot number M028551 with expiration date of 07-JUN-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose with lot number M028551 was exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours measured with digital data logger. The lot also had previous temperature excursion higher than -10°C but lower than 8°C for 20 hours 16 minutes and -2.8°C for 1 hour 32 minutes. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 4 months old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 09-JAN-2017, the patient was vaccinated with improperly stored doses of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (strength, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 4 months old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 09-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (strenght, dosage schedule, anatomical location and route of administration were not provided) for prophylaxis. The administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning an 8 weeks old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 16-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (strength, dosage schedule, anatomical location not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 7 months old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (strength, dosage schedule, anatomical location not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning an 8 weeks old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 16-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (dose and anatomical location not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111:
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site reaction, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist via the patient's wife referring to a 55 year old male patient with diabetes mellitus. On 07-MAR-2017, the patient was vaccinated with the 2nd dose of PNEUMOVAX23 (lot # M040804, expiry date 20-MAY-2018) 0.5 ml, intramuscular for vaccination because the patient is diabetic. Other co-suspect or concomitant medications were not reported. On 08-MAR-2017, the patient was experiencing low-grade fever (pyrexia) and injection site reaction. The patient's wife told to the pharmacist that the patient has already received a 1st dose of PNEUMOVAX23 sometime in the fall of 2016 (unspecified date) but the patient had forgotten he had received that previous dose (inappropriate schedule of drug administration). The pharmacist recommended that the patient should take ibuprofen for his symptoms but it was not known if he had taken any yet. At the time of reporting the outcome of inappropriate schedule of drug administration, injection site reaction and pyrexia was unknown. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse concerning a 5 years old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 12-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot number M035688 with expiration date of 10-AUG-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose with lot number M035688 was exposed to a temperature higher than -10°C but lower than 8°C for 9.7 hours measured with digital data logger and the lot had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009503: US-009507513-1701USA009504:
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient reports constant sharp burning pain up and down arm, especially at injection site and worse when stretching.
Age: 1.33
Sex: F
Vaccine: DTAP, FLU4, HEP
Symptoms: Injection site urticaria, Rash generalised, Vomiting
Clinical narrative: Rash + Vomiting reported to provider. Provider indicated urticarial reaction at injection site with no other symptoms. mother stated aprox 2 hours after receiving vaccines the child broke out in rash (entire body) with vomiting.
Age: 35.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt has very swollen arm with redness spreading down several inches from injection site. Pt arm is warm to touch. Pt was seen by physician on 03/13/2017 at 8:40 AM and given medication to help with swelling and told to come back if it does not get better in a couple days.
Age: 44.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Asthma, Condition aggravated, Erythema, Fatigue, Injection site warmth
Clinical narrative: Localized Pain, redness, swelling, fever at sight. Asthma attack. Fever of 102.1. Fatigue.
Age: 44.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Localized Pain, redness, swelling, fever at sight. Asthma attack. Fever of 102.1. Fatigue.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. Information on medical history, concomitant medications and drug allergies was not provided. On known dates, multiple unspecified patients were vaccinated with a dose of improperly stored PROQUAD (lot# M039448, expire date: 20-MAR-2018; dose unknown) for prophylaxis. The temperature of storage for PROQUAD was above -10 Celsius and below 8 Celsius for 1hour and 2 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA002284.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates in approximately 2017, the patients were vaccinated with PROQUAD lot # M006106 with an expiration date 01-AUG-2017 for prophylaxis (dose and route of administration were not reported). No adverse event was reported. Administered doses of PROQUAD experienced the temperature excursion of -13.3 degrees Celsius for 30 minutes on 30-JAN-2017, -14 degrees Celsius for 30 minutes on 31-JAN-2017, -13.1 degrees Celsius for 45 minutes on 01-FEB-2017, -13.8 degrees Celsius for 30 minutes on 02-FEB-2017, -13.3 degrees Celsius for 60 minutes on 03-FEB-2017, -13.1 degrees Celsius for 75 minutes on 04-FEB-2017, -13.8 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 05-FEB-2017, -13.6 degrees Celsius for 30 minutes on 06-FEB-2017,-13.3 degrees Celsius for 75 minutes on 10-FEB-2017, -14.9 degrees Celsius for 15 minutes on 10-FEB-2017, -13.3 degrees Celsius for 60 minutes on 10-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017, -13.2 degrees Celsius for 75 minutes on 11-FEB-2017, -14.9 degrees Celsius for 15 minutes on 11-FEB-2017, -13.2 degrees Celsius for 45 minutes on 12-FEB-2017. There was no previous temperature excursions. Data logger was involved. 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-009507513-1702USA006196:
Age: 26.0
Sex: M
Vaccine: HPVX
Symptoms: Injection site rash, Myalgia
Clinical narrative: This spontaneous report was received from a 27-year-old male patient, who was reporting on himself. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On an unknown date (when the patient was 26 years old), he was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of GARDASIL, intramuscularly (dose, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced injection site rash and muscle pain after receiving GARDASIL. The outcome of the events was reported as recovered.  The relatedness between the events and GARDASIL or GARDASIL 9 was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 24-FEB-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # L004658, expiration date 11-FEB-2017 (dose number, dosage and route of administration not provided). No adverse effect reported. No further information was provided. Additional information has been requested. Sender's Comments: US-009507513-1703USA001778.