chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly storred doses of RECOMBIVAX HB (lot # L038018, expiry date: 13-SEP-2017) (dose and route of administration not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. There was previous temperature excursion for RECOMBIVAX HB: 47 degree of Fahrenheit to 77 degree of Fahrenheit for 3 hours. Data logger was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA012563: US-009507513-1705USA012564: US-009507513-1705USA012562:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-NOV-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L043702 with expiration date 03-NOV-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA010816: US-009507513-1705USA010817: US-009507513-1705USA010818: US-009507513-1705USA010819: US-009507513-1705USA010820: US-009507513-1705USA010821: US-009507513-1705USA010822: US-009507513-1705USA010823: US-009507513-1705USA010824: US-009507513-1705USA010825: US-009507513-1705USA010826: US-009507513-1705USA010827: US-009507513-1705USA010828: US-009507513-1705USA010829: US-009507513-1705USA010830: US-009507513-1705USA010831: US-009507513-1705USA010832: US-009507513-1705USA010833: US-009507513-1705USA010834: US-009507513-1705USA010835: US-009507513-1705USA010836: US-009507513-1705USA010837: US-009507513-1705USA010838: US-009507513-1705USA010839: US-009507513-1705USA010840: US-009507513-1705USA010841: US-009507513-1705USA010842: US-009507513-1705USA010843: US-009507513-1705USA010844: US-009507513-1705USA010845: US-009507513-1705USA010846: US-009507513-1705USA010847: US-009507513-1705USA010848: US-009507513-1705USA010849: US-009507513-1705USA010850: US-009507513-1705USA010851: US-009507513-1705USA010852: US-009507513-1705USA010853: US-009507513-1705USA010854: US-009507513-1705USA010855: US-009507513-1705USA010856: US-009507513-1705USA010857: US-009507513-1705USA010858: US-009507513-1705USA010859: US-009507513-1705USA010860: US-009507513-1705USA010861: US-009507513-1705USA010862: US-009507513-1705USA010863: US-009507513-1705USA010864: US-009507513-1705USA010865: US-009507513-1705USA010866: US-009507513-1705USA010867: US-009507513-1705USA010868: US-009507513-1705USA010869: US-009507513-1705USA010870: US-009507513-1705USA010871: US-009507513-1705USA010872: US-009507513-1705USA010873: US-009507513-1705USA010874: US-009507513-1705USA010875: US-009507513-1705USA010876: US-009507513-1705USA010877: US-009507513-1705USA010878: US-009507513-1705USA010879: US-009507513-1705USA010880: US-009507513-1705USA010881: US-009507513-1705USA010882.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided.  On 14-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L043702 with expiration date 03-NOV-2017 status albumin: RHA) . Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 23-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot #L043702 with expiration date 03-NOV-2017, status albumin: RHA) . Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-NOV-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L043702 with expiration date 03-NOV-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 21-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L043702 with expiration date 03-NOV-2017, status albumin: RHA) . Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 18-NOV-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L043702 with expiration date 03-NOV-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-DEC-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 13-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017, status albumin: recombinant human albumin (rHA)). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II  lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-FEB-2017, the patient was vaccinated with improprerly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved.  This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-FEB-2017, the patient was vaccinated with improprerly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-FEB-2017, the patient was vaccinated with improperly stored dose of M-M-R II  lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-FEB-2017, the patient was vaccinated with improprerly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Paralysis
Clinical narrative: This initial spontaneous report was received from a Registered Nurse referring to a 13 year old female patient. The patient had no pertinent medical history and was taking no concomitant medications. Drug reactions/allergies were unknown. On an unspecified date, the patient was vaccinated with GARDASIL 9 at the age of 13 (lot number and route not provided). On an unspecified date, she became paralyzed and was hospitalized. She was given unspecified treatment. The nurse reported that the patient, whose mother is a nurse, had filed a lawsuit regarding the adverse effects experienced after receiving GARDASIL 9.  The outcome of the event was unknown. Causality was not provided. Upon internal review, paralysis was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients; medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot number: M019690, expiry date: 02-NOV-2017 and lot number: M038724 and expiry date: 24-APR-2018) (dose not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. There was previous temperature excursion for ROTATEQ: 47 degree of Fahrenheit to 77 degree of Fahrenheit for 3 hours. Data logger was involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA012563: US-009507513-1705USA012564: US-009507513-1705USA008387:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients was vaccinated with improperly stored dose of GARDASIL 9 lot number: M034780 and expiry date: 14-APR-2019) (dose and route of administration not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. There was previous temperature excursion for GARDASIL 9: 47 degree of Fahrenheit to 77 degree of Fahrenheit for 3 hours. Data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008387: US-009507513-1705USA012564: US-009507513-1705USA012562.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA lot number reported as M043731 and expiry date: 22-MAY-2019 and lot number: N005274 with expiry date: 03-APR-2018) (dose and route of administration not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. It was not reported if there was any previous temperature excursion for VAQTA. Data logger was involved.  This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:   US-009507513-1705USA012563: US-009507513-1705USA008387: US-009507513-1705USA012562:
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous case, initially received on 12-Aug-2016, was reported by a health professional and concerns a male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On an unknown date "years ago", the patient received an unspecified flu vaccine. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Guillain Barre syndrome after receiving the vaccine (Medically Significant). The patient did not die. The outcome was reported as recovered. No additional information available. Reporter comments: The reporter could not rule out AFLURIA was given. Case correction 30-Nov-2016: company suspect drug corrected to influenza vaccine (INN).
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Allodynia, Anxiety, Arthralgia, Bone pain, Bundle branch block left
Clinical narrative: Flu like symptoms 2 days after vaccine muscle, joint pain, nausea/vomiting. Aug. 4 - Dx with cellulitis. Adverse reaction to TDaP (antibiotics, swollen, tender, red arm/numbness). Sept. - Dx with post vaccination syndrome - allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan. diagnosed with fibromyalgia. Off work x 3 months short term disability. Symptoms still persist. Also diagnosed with (L) bundle branch block.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Disability, Erythema, Fibromyalgia, Headache
Clinical narrative: Flu like symptoms 2 days after vaccine muscle, joint pain, nausea/vomiting. Aug. 4 - Dx with cellulitis. Adverse reaction to TDaP (antibiotics, swollen, tender, red arm/numbness). Sept. - Dx with post vaccination syndrome - allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan. diagnosed with fibromyalgia. Off work x 3 months short term disability. Symptoms still persist. Also diagnosed with (L) bundle branch block.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Impaired work ability, Influenza like illness, Muscle spasms, Muscle twitching
Clinical narrative: Flu like symptoms 2 days after vaccine muscle, joint pain, nausea/vomiting. Aug. 4 - Dx with cellulitis. Adverse reaction to TDaP (antibiotics, swollen, tender, red arm/numbness). Sept. - Dx with post vaccination syndrome - allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan. diagnosed with fibromyalgia. Off work x 3 months short term disability. Symptoms still persist. Also diagnosed with (L) bundle branch block.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Neuralgia, Oropharyngeal pain, Paraesthesia
Clinical narrative: Flu like symptoms 2 days after vaccine muscle, joint pain, nausea/vomiting. Aug. 4 - Dx with cellulitis. Adverse reaction to TDaP (antibiotics, swollen, tender, red arm/numbness). Sept. - Dx with post vaccination syndrome - allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan. diagnosed with fibromyalgia. Off work x 3 months short term disability. Symptoms still persist. Also diagnosed with (L) bundle branch block.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Post vaccination syndrome, Swelling, Tenderness, Vomiting
Clinical narrative: Flu like symptoms 2 days after vaccine muscle, joint pain, nausea/vomiting. Aug. 4 - Dx with cellulitis. Adverse reaction to TDaP (antibiotics, swollen, tender, red arm/numbness). Sept. - Dx with post vaccination syndrome - allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan. diagnosed with fibromyalgia. Off work x 3 months short term disability. Symptoms still persist. Also diagnosed with (L) bundle branch block.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Urticaria
Clinical narrative: Mom stated child was fine until 5:30 PM when she noticed infant had broken out in hives all over body and was running a temperature of 102.3. She then immediately called the infant's PCP, who prescribed over the phone TYLENOL and Amoxicillin x 5 days. Mom stated infant's hives cleared in 3 days. No other symptoms reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unspecified date, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot # L024129, expiration date 21-JAN-2017, dose and route of administration was not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report has been received from a a physician via a company representative, referring to a 59 years old male patient. The patient's medical history, drug and allergy history and current conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose number, route, anatomical location, lot number and expiration date were not reported) for prevention of pneumococcal disease.  The patient's concomitant therapies were not provided. It was reported that on an unknown date, the patient developed an itchy rash in an unknown location for an unknown amount of time after receiving PNEUMOVAX23, and as a treatment, the physician prescribed cetirizine hydrochloride (ZYRTEC). The patient's outcome was unknown at the time of reporting. The causality assessment between the event and PNEUMOVAX23 was unknown. Additional information is not expected because there was not consent to contact the reporter.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a female adult patient of an unknown age. The patient's medical history, drug and allergy and current condionts were not reported. It was reported that on 15-MAY-2017 the patient was vaccinated with a properly stored dose of PNEUMOVAX23 with a lot number: M006139 and an expiration date on 13-MAY-2017. The patient's concomitant therapies were not provided. No adverse effects were reported. 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 and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 28-DEC-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 12-DEC-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 07-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017,. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.  Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 24-JAN-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 07-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 07-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. ; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 28-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L049314, expiration date 03-DEC-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 05-DEC-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 14-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. ; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 09-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # M000768, expiration date 05-JAN-2018. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. ; Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 28-NOV-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 28-DEC-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 30-NOV-2016, the patient received an improperly stored dose of M-M-R II (therapy type: recombinant human albumin, RHA) injection (lot # M015931 with expiration date at 30-MAR-2018; dose, route of administration and anatomical location were not reported). The administered dose of vaccine was exposed to a temperature of -14.4 degrees Celsius (C) for 54 minutes. Digital data logger was used to track the temperature. There was no previous temperature excursion reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 03-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 02-DEC-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 21-NOV-2016, the patient was vaccinated with improperly stored dose of PROQUAD lot # M021731 with expiration date 29-OCT-2017 (dose and route of administration were not reported). The reason of the call was temperature alarm received via a Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 degrees Celsius for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.