chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified administrator refers to a patient of unknown demographics. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 21-OCT-2016, the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (lot # K018964, expiry date 15-OCT-2016 (strength, dosing details and anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of 5 years old. No information regarding the patient pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-AUG-2016, the patient was inadvertently vaccinated with improperly stored doses of VARIVAX (lot # M005971 and expiration date: 02-FEB-2018) (dose and route of administration were not reported). No adverse event reported. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a male patient of 4 years old. No information regarding the patient pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-AUG-2016, the patient was inadvertently vaccinated with improperly stored doses of VARIVAX (lot # M005971 and expiration date: 02-FEB-2018 (dose and route of administration were not reported). No adverse event reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VARIVAX (lot # M000760, expiration date 01-JUN-2018, lot # M003441, expiration date 19-JAN-2018, lot # M019643, expiration date 20-APR-2018; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R; 24, 33, 0.555555556 and R; 320, 31, -0.555555556 and R; 224, 32, 0, and R. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a 59-year-old female patient refers to herself. The patient's medical history and concurrent conditions were not provided, because she did not wish to participate in answering the questions within this report. On 17-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, dose, frequency and route of administration were not provided). No concomitant medications were provided. On 18-OCT-2016, she experienced severe pain at the injection site. On the next day, the patient experienced more pain and swelling at the injection site as well as headaches and fatigue. The adverse events did not improve. There was a treatment given for the events but the patient did not recovered from them at the time of this report. The patient sought medical attention via contacting with a physician. The relatedness between the events and PNEUMOVAX23 was not reported. 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 pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored RECOMBIVAX HB injection (lot # L048208, expiry date 15-SEP-2017 and dose not reported) intramuscularly. The administered dose experienced a temperature excursion of 50 Fahrenheit for a cumulative of 16 Hours and 45 Minutes and 33 Fahrenheit for a cumulative of 24 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were unknown. On an unknown date, the patient was vaccinated with M-M-R II injection (dosing details, lot# and expiry date unknown). The patient experienced "stinging" at the injection site during the time that the M-M-R II was being administered. The patient recovered as soon as the M-M-R II was finished being administered. Causality assessment was not provided. There was no Product Quality Complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were unknown. On multiple unspecified dates, the patients were administered improperly stored VARIVAX (dose and route unknown, lot #M010485, expiration date: 01-MAR-2018). The vaccines were exposed to 7.5 Fahrenheit degree for 15 hours. No previous excursions. There were no data logger. There was no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were administered improperly stored PROQUAD (dose and route unknown, lot # M029598, expiration date: 10-DEC-2017). The vaccines were exposed to 7.5 Fahrenheit degree for 15 hours. There were no previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 16-NOV-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 1992 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a certificated medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored PROQUAD (lot # M004894, expiration date 26-JUL-2017, lot # M011661, expiration date 08-SEP-2017, lot # M017334, expiration date 05-OCT-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-APR-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 408 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 248 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L038917, expiration date 20-FEB-2018 and lot # M009378 expiration date 23-APR-2018 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a male patient of unknown age. No information about the patient's medical history and concurrent conditions was reported. In approximately April 2016 (reported as 'about 6 months ago') the patient was vaccinated with a dose of unspecified pneumococcal vaccine (manufacturer unknown) in his arm (dose, route of administration, lot# and expiry date were not reported)-the reporter stated that it could not be determined if it was PNEUMOVAX 23 or PREVENAR 13. Concomitant therapies were not reported. On an unknown date, the patient experienced redness and swelling around injection site. The patient's entire arm in which vaccine was administered was red. The outcome of adverse events was not reported. The relatedness between the unspecified pneumococcal vaccine (manufacturer unknown) and events was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple unspecified patients of an unknown age and gender. The patient's pertinent medical history and concomitant therapies were not reported. On multiple unspecified dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, indication, lot # and expiration date were not reported) in an unspecified arm. On an unknown dates, at an unspecified time after administration, the patients experienced pain, redness and red streaks on the arm of administration. The outcome of pain, redness and red streaks on the arm of administration was unknown. The relatedness between pain, redness, red streaks and PNEUMOVAX 23 was not reported. Additional information has been requested
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-MAY-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 32 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the second time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 584 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the fourth time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were administered improperly stored VAQTA (dose and route unknown, lot # M018644, expiration date: 20-SEP-2017). The vaccines were exposed to temperature excursions in 3 different refrigerators, but not exposed to multiple excursions. The three refrigerators are described as "A: temperature: max 48 Fahrenheit degree for 15 hours, B: temperature: max 49.3 Fahrenheit degree for 15 hours, a C: temperature max 51.4 Fahrenheit degree for 15 hours". There were no previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were administered improperly stored RECOMBIVAX HB (dose and route unknown, lot # L033343, expiration date: 13-SEP-2017). The vaccines were exposed to temperature excursions in 3 different refrigerators, but not exposed to multiple excursions. The three refrigerators are described as "A: temperature: max 48 Fahrenheit degree for 15 hours, B: temperature: max 49.3 Fahrenheit degree for 15 hours, and C temperature max 51.4 Fahrenheit degree for 15 hours". There were no previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 23 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date in 2010, after possibly receiving a dose of GARDASIL (dosing details, lot# and expiry date unknown), the patient came back into clinic to request a dose GARDASIL 9 (dosing details, lot# and expiry date unknown) on 21-OCT-2016. No adverse effects were reported. Additional information is not expected as the reporter denied consent to be contacted for further information.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-MAR-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 408 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 248 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-JUN-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 32 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the second time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 584 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the fourth time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were administered improperly stored M-M-R II (dose and route unknown, lot # L047133, expiration date: 24-NOV-2017). The vaccines were exposed to temperature excursions in 3 different refrigerators, but not exposed to multiple excursions. The three refrigerators were described as "A: temperature: max 48 Fahrenheit degree for 15 hours, B: temperature: max 49.3 Fahrenheit degree for 15 hours, and C: temperature max 51.4 Fahrenheit degree for 15 hours. No previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 04-OCT-2016, the patient was inadvertently vaccinated with an expired dose of M-M-R II, subcutaneously (lot number M001200 with an expiration date on 28-AUG-2016, albumin status was rHA). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 26-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 1.1 Celsius degrees for 920 hours and for 0 Celsius degrees for 168 hours with lowest temperature recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via an unspecified reporter thought the company representative, concerning a patient of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 25-NOV-2014, the patient was vaccinated with an unspecified improperly stored dose of RECOMBIVAX HB 10microgram/ 1ml "10x1 DS/VTF" (lot number J008227 with an expiration date of 07-FEB-2016) (route, dose and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. The dose of the vaccine experienced a lowest temperature excursion of 28 Fahrenheit (F) for 72 hours, and a highest recorded temperature during the temperature excursion of 47 F for 40 hours. The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 23-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 16-JAN-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # K018525 and expiration date: 28-APR-2017 (Route was not provided). It was stated that the excursion duration was 12 hours and the highest temperature recorded was 46.6 degrees F (8.1111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from 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 physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of inactivated VAQTA, "10pk 25U/0.5ml SD LLok wCap Ped" which had a lot number of L013324 and expiration date 24-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the inactivated VAQTA vaccine had one temperature excursion of 24 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R). This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VAQTA that were exposed to a fridge excursion on 21-JUL-2017 (lot # M003011, expiration date 15-NOV-2017, lot # L009445 expiration date 01-JUN-2017, L009521 expiration date28-APR-2017, lot # K012456 expiration date 28-APR-2017, lot# L023936 expiration date 15-MAR-2017, lot# L045713 expiration date 14-JAN-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 06-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 0 Celsius degrees for 168 hours and 1.1 Celsius degrees for 840 hours with lowest temperature recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 24-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 296 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 40 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degree for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from an unspecified healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored ROTATEQ that were exposed to a fridge excursion on 21-JUL-2017 (lot # L044476, expiration date 07-JUL-2017, lot: L020865, expiration date 09-FEB-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 14-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 20-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report was received from a medical assistant via company representative and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date, the patient experienced the "worst case of shingles the facility has ever seen". The patient thought that the rash that developed was caused by yard work he was doing (on an unspecified date) and treated himself with a heating pad. On an unknown date, when the patient fell asleep with the heating pad the blisters worsened. A week after the symptoms initiated, the patient went to see his physician who referred him to see a specialist. Within the last ten days, the unspecified specialist confirmed the patient had a case of shingles and treated him with an unspecified antiviral medication. The patient was also offered unspecified pain medication but he refused to use it due to having no pain. The outcome of shingles was unknown. The relatedness between the shingles and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to contact the physician.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to the three patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M021428 with expiry date on 19-OCT-2017, albumin status: recombinant human albumin (rHA); dose was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 10-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml,  lot # L007720 with expiration date of 08-JUL-2016, (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1 F (also reported as -1 Celsius degree) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. On 15-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date 08-JUL-2016, (strength, route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on unknown dates which lasted 96 and 24 hours with lowest recorded temperatures of -1 F (also reported as -1 Celsius degree) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Oedema peripheral
Clinical narrative: Erythema and edema of arm that received injection. Bruising and pooling of blood in tricep region.
Sex: F
Vaccine: PPV
Symptoms: Confusional state
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's historical vaccine included PREVNAR 13 administered approximately in October 2015 (reported as 1 year ago). On 18-OCT-2016, the patient was vaccinated in an unspecified clinic with a dose of PNEUMOVAX 23 (dose, frequency, route and site of administration, lot #, expiration date not reported). On the same day, the patient was confused and did not remember that she had received PNEUMOVAX 23 earlier that day and was vaccinated with a dose of PREVNAR 13 in a pharmacy. The outcome of the events was unknown. The reporter did not assess the causal relationship between PNEUMOVAX 23 and the events. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mL VIs 10SDV, (lot number L035882, with expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMVOAX 23 vaccine had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from 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 vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of VAQTA lot # M003618, expiration date 18-NOV-2017, lot # L031196, expiration date 05-FEB-2017 and lot # M021124, expiration date 02-FEB-2018 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. There were no data logger and no prior excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Received pneumonia booster - (23 valent) 10/26/2016. A large "bulge" developed on the lower inside of my (R) arm, 6-8 inches from injection site. It is painful and this morning is many times larger than when I went to bed last night. It is hard and tight. I alternated hot and cold packs until bedtime but no relief. What next?
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 06-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", 0.5 ml, lot # L007720 with expiration date of 08-JUL-2016 (strength, route of administration were not reported) No concomitant medications were reported. No adverse effect and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours, with a lowest recorded temperature of 1 F (also reported as 1 Celsius degree). There were also another excursions on an unknown dates which lasted 100, 96, 24 and 24 hours with lowest recorded temperatures of 34 F (reported as 1.111111111 Celsius degrees), -1 F (also reported as -1 Celsius degree), 32 F (report as 0 Celsius degrees) and 0 F (also reported as 0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.