chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: Welt on upper arm; Rash on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Welt on upper arm) and VACCINATION SITE RASH (Rash on upper arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (Welt on upper arm) and VACCINATION SITE RASH (Rash on upper arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE URTICARIA (Welt on upper arm) and VACCINATION SITE RASH (Rash on upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Neck pain
Clinical narrative: Hand was hurting really bad; neck hurting; feet hurting; knee hurting; Nausea; Severe joint pain; slight headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand was hurting really bad), NECK PAIN (neck hurting), PAIN IN EXTREMITY (feet hurting), HEADACHE (slight headache) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) from 2006 to an unknown date.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (slight headache) and FATIGUE (tired). On 19-Jan-2021, the patient experienced ARTHRALGIA (Severe joint pain). On 12-Feb-2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Hand was hurting really bad), NECK PAIN (neck hurting), PAIN IN EXTREMITY (feet hurting) and ARTHRALGIA (knee hurting). The patient was treated with DICLOFENAC SODIUM (VOLTARENE [DICLOFENAC SODIUM]) at an unspecified dose and frequency and Surgery ( right shoulder surgery over 10 years ago without any known sequelae) for Arthralgia. On 26-Jan-2021, ARTHRALGIA (Severe joint pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Hand was hurting really bad), NECK PAIN (neck hurting), PAIN IN EXTREMITY (feet hurting), HEADACHE (slight headache), FATIGUE (tired) and ARTHRALGIA (knee hurting) outcome was unknown and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Evista concomitant drug used for indication of bone health.   This case was linked to MOD-2021-089653, MOD-2021-089653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow up received on 04-FEB-2021 included new events, concomitant medication.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hand was hurting really bad; neck hurting; feet hurting; knee hurting; Nausea; Severe joint pain; slight headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand was hurting really bad), NECK PAIN (neck hurting), PAIN IN EXTREMITY (feet hurting), HEADACHE (slight headache) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) from 2006 to an unknown date.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (slight headache) and FATIGUE (tired). On 19-Jan-2021, the patient experienced ARTHRALGIA (Severe joint pain). On 12-Feb-2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (Hand was hurting really bad), NECK PAIN (neck hurting), PAIN IN EXTREMITY (feet hurting) and ARTHRALGIA (knee hurting). The patient was treated with DICLOFENAC SODIUM (VOLTARENE [DICLOFENAC SODIUM]) at an unspecified dose and frequency and Surgery ( right shoulder surgery over 10 years ago without any known sequelae) for Arthralgia. On 26-Jan-2021, ARTHRALGIA (Severe joint pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Hand was hurting really bad), NECK PAIN (neck hurting), PAIN IN EXTREMITY (feet hurting), HEADACHE (slight headache), FATIGUE (tired) and ARTHRALGIA (knee hurting) outcome was unknown and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Evista concomitant drug used for indication of bone health.   This case was linked to MOD-2021-089653, MOD-2021-089653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow up received on 04-FEB-2021 included new events, concomitant medication.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bowel movement irregularity, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Upset stomach; Bowel movement; Headache; Fatigue; A spontaneous report was received from a type concerning a 64-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-like symptoms/influenza like illness, headache, fatigue, upset stomach/abdominal discomfort, bowel movement/bowel movement irregularity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events flu-like symptoms, headache, fatigue, upset stomach, bowel movement.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu-like symptoms, headache, fatigue, upset stomach, bowel movement was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Nodule
Clinical narrative: Terrible pain in her neck; Tiny lump; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Terrible pain in her neck) and NODULE (Tiny lump) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Terrible pain in her neck) and NODULE (Tiny lump). At the time of the report, NECK PAIN (Terrible pain in her neck) and NODULE (Tiny lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She received her second injection 5Feb21 and the lump did not change in size but is a little firmer. No relevant concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (muscle aches) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Anticoagulant therapy, ATORVASTATIN for Cholesterol, ATENOLOL for Hypertension, ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS] and ZINC for Supplementation therapy.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (fever) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-026699 (E2B Linked Report).; Sender's Comments:  MOD-2021-026699:different patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Appetite disorder, Decreased appetite, Headache, Pain
Clinical narrative: Could not eat; Needed to eat bland foods; Stomach feels wonky; Body aches; Threw up; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Could not eat), APPETITE DISORDER (Needed to eat bland foods), ABDOMINAL DISCOMFORT (Stomach feels wonky), PAIN (Body aches) and VOMITING (Threw up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Could not eat), APPETITE DISORDER (Needed to eat bland foods), ABDOMINAL DISCOMFORT (Stomach feels wonky), PAIN (Body aches), VOMITING (Threw up) and HEADACHE (Headaches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Could not eat), APPETITE DISORDER (Needed to eat bland foods), ABDOMINAL DISCOMFORT (Stomach feels wonky), PAIN (Body aches), VOMITING (Threw up) and HEADACHE (Headaches) outcome was unknown.            No Concomitant medications were provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Could not eat; Needed to eat bland foods; Stomach feels wonky; Body aches; Threw up; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Could not eat), APPETITE DISORDER (Needed to eat bland foods), ABDOMINAL DISCOMFORT (Stomach feels wonky), PAIN (Body aches) and VOMITING (Threw up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history was not reported .    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Could not eat), APPETITE DISORDER (Needed to eat bland foods), ABDOMINAL DISCOMFORT (Stomach feels wonky), PAIN (Body aches), VOMITING (Threw up) and HEADACHE (Headaches). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Could not eat), APPETITE DISORDER (Needed to eat bland foods), ABDOMINAL DISCOMFORT (Stomach feels wonky), PAIN (Body aches), VOMITING (Threw up) and HEADACHE (Headaches) outcome was unknown.            No Concomitant medications were provided
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Dizziness, Feeling cold, Gastric disorder
Clinical narrative: SPITTING BLOOD FOR PAST 4 MONTHS; BLURRY VISION; DIZZINESS; STOMACH INFLAMMATION; LONGER MENSTRUAL CYCLE; BURNING SENSATION THAT FLOWS AROUND HER HEAD; FEELS LIKE IT IS POPPING ON HER BRAIN; STOMACH ISSUES; TINGLING OF FACE; NUMBNESS OF FACE; COLD SENSATION THAT FLOWS AROUND HER HEAD; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: intrauterine contraceptive device, and concurrent conditions included: nonsmoker, non-alcoholic, and menstrual irregularity, and other pre-existing medical conditions included: The patient does not have any allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced spitting blood for past 4 months. On 12-APR-2021, the patient experienced blurry vision. On 12-APR-2021, the patient experienced dizziness. On 12-APR-2021, the patient experienced stomach inflammation. On 12-APR-2021, the patient experienced longer menstrual cycle. On 12-APR-2021, the patient experienced burning sensation that flows around her head. On 12-APR-2021, the patient experienced feels like it is popping on her brain. On 12-APR-2021, the patient experienced stomach issues. On 12-APR-2021, the patient experienced tingling of face. On 12-APR-2021, the patient experienced numbness of face. On 12-APR-2021, the patient experienced cold sensation that flows around her head. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spitting blood for past 4 months, blurry vision, dizziness, stomach inflammation, numbness of face, tingling of face, longer menstrual cycle, cold sensation that flows around her head, burning sensation that flows around her head, and stomach issues, and the outcome of feels like it is popping on her brain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Gastritis, Haemoptysis, Head discomfort, Hypoaesthesia, Oligomenorrhoea
Clinical narrative: SPITTING BLOOD FOR PAST 4 MONTHS; BLURRY VISION; DIZZINESS; STOMACH INFLAMMATION; LONGER MENSTRUAL CYCLE; BURNING SENSATION THAT FLOWS AROUND HER HEAD; FEELS LIKE IT IS POPPING ON HER BRAIN; STOMACH ISSUES; TINGLING OF FACE; NUMBNESS OF FACE; COLD SENSATION THAT FLOWS AROUND HER HEAD; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: intrauterine contraceptive device, and concurrent conditions included: nonsmoker, non-alcoholic, and menstrual irregularity, and other pre-existing medical conditions included: The patient does not have any allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced spitting blood for past 4 months. On 12-APR-2021, the patient experienced blurry vision. On 12-APR-2021, the patient experienced dizziness. On 12-APR-2021, the patient experienced stomach inflammation. On 12-APR-2021, the patient experienced longer menstrual cycle. On 12-APR-2021, the patient experienced burning sensation that flows around her head. On 12-APR-2021, the patient experienced feels like it is popping on her brain. On 12-APR-2021, the patient experienced stomach issues. On 12-APR-2021, the patient experienced tingling of face. On 12-APR-2021, the patient experienced numbness of face. On 12-APR-2021, the patient experienced cold sensation that flows around her head. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spitting blood for past 4 months, blurry vision, dizziness, stomach inflammation, numbness of face, tingling of face, longer menstrual cycle, cold sensation that flows around her head, burning sensation that flows around her head, and stomach issues, and the outcome of feels like it is popping on her brain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: SPITTING BLOOD FOR PAST 4 MONTHS; BLURRY VISION; DIZZINESS; STOMACH INFLAMMATION; LONGER MENSTRUAL CYCLE; BURNING SENSATION THAT FLOWS AROUND HER HEAD; FEELS LIKE IT IS POPPING ON HER BRAIN; STOMACH ISSUES; TINGLING OF FACE; NUMBNESS OF FACE; COLD SENSATION THAT FLOWS AROUND HER HEAD; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: intrauterine contraceptive device, and concurrent conditions included: nonsmoker, non-alcoholic, and menstrual irregularity, and other pre-existing medical conditions included: The patient does not have any allergies. The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced spitting blood for past 4 months. On 12-APR-2021, the patient experienced blurry vision. On 12-APR-2021, the patient experienced dizziness. On 12-APR-2021, the patient experienced stomach inflammation. On 12-APR-2021, the patient experienced longer menstrual cycle. On 12-APR-2021, the patient experienced burning sensation that flows around her head. On 12-APR-2021, the patient experienced feels like it is popping on her brain. On 12-APR-2021, the patient experienced stomach issues. On 12-APR-2021, the patient experienced tingling of face. On 12-APR-2021, the patient experienced numbness of face. On 12-APR-2021, the patient experienced cold sensation that flows around her head. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from spitting blood for past 4 months, blurry vision, dizziness, stomach inflammation, numbness of face, tingling of face, longer menstrual cycle, cold sensation that flows around her head, burning sensation that flows around her head, and stomach issues, and the outcome of feels like it is popping on her brain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; ROTATEQ that underwent a temperature excursion was administered.; This spontaneous report was received from a study coordinator referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On 16-JUL-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally as prophylaxis, (lot number:1741375 and expiration date: 5-MAR-2022) (dose, vaccination scheme and frequency, were not reported) which experienced a temperature excursion of 10.3 degrees Celsius for 16 minutes, as recorded by a data logger. There was no adverse effect reported or a previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion that occurred on PROQUAD were administered.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history, concomitant therapies and drug and/or allergies reactions was not provided.   On 16-JUL-2021, the patient was inadvertently administered with improperly stored  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, vaccination scheme, route and anatomical location of administration were not provided, with lot number T019422 verified as valid and upon internal review expiration date established as 02-DEC-2021) for prophylaxis.  Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was improperly stored at a temperature of 15.6 degrees Fahrenheit of a reported range from minus 58 degrees Fahrenheit to 5 degrees Fahrenheit for a time frame 32 minutes. Another temperature excursion was called at a temperature of 8.4 degrees Fahrenheit for a time frame of 9 minutes. It was reported previous temperature excursion of 15.6 degrees Fahrenheit, and this was called because of a data logger. No additional adverse event was reported   This is one of two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion that occurred on VARlVAX.  that underwent temperature excursions was administered.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, pertinent medical history, concomitant therapies and drug and/or allergies reactions was not provided.   On 16-JUL-2021, the patient was inadvertently administered with improperly stored  varicella virus vaccine live (oka/merck)(VARIVAX)  (strength, dose, vaccination scheme, route and anatomical location of administration were not provided, with lot number S038698 verified as valid and upon internal review expiration date established as 01-DEC-2021) for prophylaxis. varicella virus vaccine live (oka/merck) (VARIVAX) was improperly stored at a temperature of 15.6 degrees Fahrenheit of a recommended range from minus 58 degrees Fahrenheit to 5 degrees Fahrenheit for a time frame 32 minutes. Another temperature excursion was called at a temperature of 8.4 degrees Fahrenheit for a time frame of 9 minutes. It was reported previous temperature excursion of 15.6 degrees Fahrenheit, and this was called because of a data logger. No additional adverse event was reported   This is one of two reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a dose of GARDASIL 9 was administered following a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent condition, medical history or concomitant therapies provided.  On 19-JUL-2021, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T026954, expiration date 13-APR-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event was reported.  Administered dose of vaccine experienced the temperature excursion of 49.35 degrees Fahrenheit for 1 hour 24 minutes. Data logger was involved. There were no previous excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T026954; expirationdate: 13-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEP, HEPA, HPV9, MMR, RV5
Symptoms: Product storage error
Clinical narrative: excursion was just found and happened about 2 weeks ago and was unsure whether or not were administered to patients but that some probably were; This non valid spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages or genders. The patients' concurrent conditions. Medical history or concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T028929, expiration date reported as 08-MAR-2023; rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1707591, expiration date reported as 11-MAR-2022; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) lot # T013725, expiration date reported on 21-APR-2022; hepatitis a vaccine, inactivated(VAQTA) lot # T035721, expiration date reported on 15-APR-2022; or hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # T028933, expiration date on 03-NOV-2022. The nurse reported a temperature excursion; temperature of 9.6 C, time frame of 1 hour and 25 minutes, with no previous temperature excursion, and a data logger was involved. The nurse stated that the excursion was just found and happened about 2 weeks ago and was unsure whether were administered to patients or not, but that some probably were. No product quality complaint reported.  This is a non valid report since no patient identifiers were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 29-JUN-2021, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number T013727, expiration date 21-APR-2022, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 15-SEP-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number R028526, expiration date 04-OCT-2020, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 22-SEP-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number R028526, expiration date 04-OCT-2020, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 12-FEB-2021, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 12-AUG-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number R028526, expiration date 04-OCT-2020, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 12-OCT-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 17-JUL-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 18-AUG-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 28-OCT-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 19-OCT-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 17-SEP-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916 which was determined to be valid; expiration date reported as 16-SEP, and determined to be valid as 16-SEP-2021) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 28-JUL-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number R028526, expiration date 04-OCT-2020, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 22-FEB-2021, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number S028916, expiration date 16-SEP-2021, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269: US-009507513-2108USA000270: US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: