chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.58
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 7 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Private pay/ Insurance. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 22-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 24-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Public fund. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 24-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with (public fund). The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 26-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Private pay/ Insurance. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 27-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Private pay/ Insurance. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.25
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 03-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 08-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB(dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 09-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 10-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 10-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 16-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: no adverse effects; patients received improperly stored doses, exposed to a temperature of 34.5 Fahrenheit for 100 minutes; This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring unspecified number of patients of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored M-M-R II (dosage regimen were not reported) lot # M006544, expiry date 03-FEB-2018 for prophylaxis (incorrect product storage). Other suspect therapies included water, sterile (DILUENT FOR INTRON A) (dosage regimen were not reported) lot # M004118, expiry date 05-AUG-2018 for prophylaxis. Temperature excursion: 47.3F, Cumulative time frame: 50.5 hours data logger was used. No adverse effects (no adverse event) reported. The outcome of incorrect product storage and no adverse event were unknown. This is one of two reports MARRS # 1612USA008885. Additional information has been requested. Sender's Comments: 1612USA008885: Original Case : 1612USA008885.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Information has been received from a clinical practice manager concerning a female patient of unknown age. There was no information about concurrent condition, concomitant medication and medical history. On 29-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # reported as M040804, expiration date 20-MAY-2018) (dose, frequency and route unknown) for prophylaxis. On an unspecified date in 2016 after vaccinated with PNEUMOVAX23, the patient developed cellulitis, which extended beyond the injection sites. Treatment with unspecified antibiotics was given to the patient. The outcome of the event was unknown. The causality between the event and PNEUMOVAX23 was not provided. Upon internal review, cellulitis was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow-up. Sender's Comments: US-009507513-1612USA012870: US-009507513-1612USA009590.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Information has been received from a clinical practice manager concerning a female patient of unknown age. There was no information about concurrent condition, concomitant medication and medical history. On 13-DEC-2016, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # reported as M041811, expiration date 25-MAY-2018) (dose, frequency and route unknown) for prophylaxis. On an unspecified date in December 2016 after vaccinated with PNEUMOVAX23, the patient developed cellulitis, which extended beyond the injection sites. Treatment with unspecified antibiotics was given to the patient. The outcome of the event was unknown. The causality between the event and PNEUMOVAX23 was not provided. Upon internal review, cellulitis was determined to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for follow-up.  Sender's Comments: US-009507513-1612USA009590: US-009507513-1612USA012869.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist student regarding a 66 year of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-DEC-2016 the patient was vaccinated with an expired dose of PNEUMOVAX23 from lot # L021367 with expiry: 05-NOV-2016 (route and dose not reported), for prophylaxis. No adverse effects reported. No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of ROTATEQ lot# M029252 with expiry date: 04-MAR-2018 and lot# M018957 with expiry date: 22-NOV-2017 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of M-M-R II  lot# M027637 with expiry date: 02-JUN-2018, lot# L040960 with expiry date: 16-OCT-2017 and lot# L003855 with expiry date: 05-FEB-2017 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved.  This is one of the several reports due to the same reporter.  Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of VAQTA lot# M018644 with expiry date: 20-SEP-2017 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients received unknown number of doses of RECOMBIVAX HB lot# M020926 with expiry date: 11-AUG-2018, lot# L048848 with expiry date: 09-AUG-2018 following temperature excursions to -1 C for 30 minutes and 9C for 13 minutes for prophylaxis (dosing details not reported). There was no previous temperature excursion. The call was due to data logger. No adverse effects were reported in any patients. No product quality complaint was involved. This is one of the several reports due to the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number patient of unknown age and gender. Since 02-DEC-2016, the patients were vaccinated with doses of improperly-stored VARIVAX (lot# reported as M032495, expiration date: 06-JUL-2018; strength, dosage, frequency and route unspecified) for prophylaxis.  No adverse effects were reported. Temperature and time frame was reported as 40.7 F for 16 hours and 34 minutes and there was no previous temperature excursion. This case is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA005014:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On unknown dates these patients were vaccinated with improperly stored doses of GARDASIL 9 (lot#M027344, expiry date 30-JUN-2018, lot#M028233, expiry date 30-SEP-2018 and lot#M033212, expiry date 31-JUL-2018) for prophylaxis. No adverse effects were reported. The vaccines were exposed to the temperature of 33.8 degree Fahrenheit for 8 hours 11 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. This is one of the two reports reported from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004255.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthma, Atrial fibrillation, Back pain, Bacterial infection
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016552021) on 13-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of Influenza high dose seasonal (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 31-Oct-2011. Patient's medical history included back surgery in 2010, joint replacement of left rotator cuff in 2005, hysterectomy complete/total in 1980 and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced atrial fibrillation, Malignant hypertensive chronic kidney disease renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled, neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg, excluding foot, osteoarthritis of knee, gastroesophageal reflux disease, chest pain, dyspnea, allergic rhinitis due to pollen, nausea, bacterial infection disease, chronic bronchitis, diarrhea, dyslipidemia, shoulder joint pain, low back pain and headache. Patient received influenza, seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 09 November 2015, influenza seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 05 October 2012. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. The reporter had considered the case serious for the important medical event for: atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled with symptoms of neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg. List of documents held by sender: none. Sender's Comments: Patient with history of multiple surgeries and was on multiple medication received INFLUENZA HIGH DOSE SEASONAL (manufacturer unknown) and experienced atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, Type 2 diabetes mellitus uncontrolled, Organic sleep apnea, Status asthmaticus, Urinary tract infection, Cellulitis of leg, excluding foot and multiple events. Time of onset was unknown. This is poorly documented case. More details regarding concurrent condition, concomitant medication, exact time to onset, investigation reports to rule out the alternative cause are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchial hyperreactivity, Bronchitis chronic, Cellulitis, Chest pain, Chronic kidney disease
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016552021) on 13-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of Influenza high dose seasonal (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 31-Oct-2011. Patient's medical history included back surgery in 2010, joint replacement of left rotator cuff in 2005, hysterectomy complete/total in 1980 and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced atrial fibrillation, Malignant hypertensive chronic kidney disease renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled, neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg, excluding foot, osteoarthritis of knee, gastroesophageal reflux disease, chest pain, dyspnea, allergic rhinitis due to pollen, nausea, bacterial infection disease, chronic bronchitis, diarrhea, dyslipidemia, shoulder joint pain, low back pain and headache. Patient received influenza, seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 09 November 2015, influenza seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 05 October 2012. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. The reporter had considered the case serious for the important medical event for: atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled with symptoms of neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg. List of documents held by sender: none. Sender's Comments: Patient with history of multiple surgeries and was on multiple medication received INFLUENZA HIGH DOSE SEASONAL (manufacturer unknown) and experienced atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, Type 2 diabetes mellitus uncontrolled, Organic sleep apnea, Status asthmaticus, Urinary tract infection, Cellulitis of leg, excluding foot and multiple events. Time of onset was unknown. This is poorly documented case. More details regarding concurrent condition, concomitant medication, exact time to onset, investigation reports to rule out the alternative cause are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyslipidaemia, Dyspnoea, Essential hypertension, Gastrooesophageal reflux disease
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016552021) on 13-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of Influenza high dose seasonal (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 31-Oct-2011. Patient's medical history included back surgery in 2010, joint replacement of left rotator cuff in 2005, hysterectomy complete/total in 1980 and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced atrial fibrillation, Malignant hypertensive chronic kidney disease renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled, neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg, excluding foot, osteoarthritis of knee, gastroesophageal reflux disease, chest pain, dyspnea, allergic rhinitis due to pollen, nausea, bacterial infection disease, chronic bronchitis, diarrhea, dyslipidemia, shoulder joint pain, low back pain and headache. Patient received influenza, seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 09 November 2015, influenza seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 05 October 2012. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. The reporter had considered the case serious for the important medical event for: atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled with symptoms of neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg. List of documents held by sender: none. Sender's Comments: Patient with history of multiple surgeries and was on multiple medication received INFLUENZA HIGH DOSE SEASONAL (manufacturer unknown) and experienced atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, Type 2 diabetes mellitus uncontrolled, Organic sleep apnea, Status asthmaticus, Urinary tract infection, Cellulitis of leg, excluding foot and multiple events. Time of onset was unknown. This is poorly documented case. More details regarding concurrent condition, concomitant medication, exact time to onset, investigation reports to rule out the alternative cause are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malignant renal hypertension, Nausea, Neuropathy peripheral, Osteoarthritis
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016552021) on 13-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of Influenza high dose seasonal (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 31-Oct-2011. Patient's medical history included back surgery in 2010, joint replacement of left rotator cuff in 2005, hysterectomy complete/total in 1980 and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced atrial fibrillation, Malignant hypertensive chronic kidney disease renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled, neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg, excluding foot, osteoarthritis of knee, gastroesophageal reflux disease, chest pain, dyspnea, allergic rhinitis due to pollen, nausea, bacterial infection disease, chronic bronchitis, diarrhea, dyslipidemia, shoulder joint pain, low back pain and headache. Patient received influenza, seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 09 November 2015, influenza seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 05 October 2012. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. The reporter had considered the case serious for the important medical event for: atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled with symptoms of neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg. List of documents held by sender: none. Sender's Comments: Patient with history of multiple surgeries and was on multiple medication received INFLUENZA HIGH DOSE SEASONAL (manufacturer unknown) and experienced atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, Type 2 diabetes mellitus uncontrolled, Organic sleep apnea, Status asthmaticus, Urinary tract infection, Cellulitis of leg, excluding foot and multiple events. Time of onset was unknown. This is poorly documented case. More details regarding concurrent condition, concomitant medication, exact time to onset, investigation reports to rule out the alternative cause are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Renal failure, Seasonal allergy, Sleep apnoea syndrome, Status asthmaticus, Type 2 diabetes mellitus
Clinical narrative: Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016552021) on 13-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of Influenza high dose seasonal (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 31-Oct-2011. Patient's medical history included back surgery in 2010, joint replacement of left rotator cuff in 2005, hysterectomy complete/total in 1980 and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced atrial fibrillation, Malignant hypertensive chronic kidney disease renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled, neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg, excluding foot, osteoarthritis of knee, gastroesophageal reflux disease, chest pain, dyspnea, allergic rhinitis due to pollen, nausea, bacterial infection disease, chronic bronchitis, diarrhea, dyslipidemia, shoulder joint pain, low back pain and headache. Patient received influenza, seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 09 November 2015, influenza seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 05 October 2012. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. The reporter had considered the case serious for the important medical event for: atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled with symptoms of neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg. List of documents held by sender: none. Sender's Comments: Patient with history of multiple surgeries and was on multiple medication received INFLUENZA HIGH DOSE SEASONAL (manufacturer unknown) and experienced atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, Type 2 diabetes mellitus uncontrolled, Organic sleep apnea, Status asthmaticus, Urinary tract infection, Cellulitis of leg, excluding foot and multiple events. Time of onset was unknown. This is poorly documented case. More details regarding concurrent condition, concomitant medication, exact time to onset, investigation reports to rule out the alternative cause are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.