chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ underwent a temperature excursion was administered to a patient; No adverse event; This spontaneous report has been received from a physician concerning a patient of unknown gender and age. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 16-MAY-2022, the patient was administered an Improper storage of product in use of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 milliliters (mL), orally (PO) (formulation, strength, vaccination scheme, and anatomical site of vaccination were not reported, lot number 1742420, which has been verified to be valid, expiration date reported and validated as 31-JAN-2023), as prophylaxis. The vaccine administered was stored at temperature of 53.2 degrees Fahrenheit (F) for a time frame of 3 hours. There was no previous temperature excursion. It was unknown if a data logger was used. No additional adverse event was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: administration of improperly stored vaccines to unknown patients after the temperature; no adverse event; This spontaneous report has been received from an office manager (vaccine coordinator) concerning a patient of unknown gender and age. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 20-JAN-2022, varicella virus vaccine live (Oka/Merck) (VARIVAX), first dose (formulation, strength, dose vaccination scheme, route of administration, and anatomical site of vaccination were not reported, lot Number U020244, which has been verified to be valid, expiration date reported and validated as 28-JUN-2023), for prophylaxis; underwent a temperature excursion. The vaccine administered was stored at temperature of -14 degrees Celsius (C) during a time frame of 7 hours. It was unknown if a previous temperature excursion occurred or if a data logger was used.  On an unspecified date in 2022, an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (Improper storage of product in use) was administrated to the patient. No additional adverse event was provided.   This was one of eight reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997: US-009507513-2205USA005067:02167774 US-009507513-2205USA005084:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE or PQC reported; PROQUAD was administered after the expiry date; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 18-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) 0.5 mL, lot # T037955, expiration date 09-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis (expired product administered). There was no temperature excursions to report. No additional events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller reports that an improperly stored dose of PROAQUAD was administered to the patient on 19 MAY 2022.; This spontaneous report was received from a physician and refer to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 19-MAY-2022, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 ml, lot # U029148, expiration date 16-MAR-2023 (dose number and route of administration were not provided) for prophylaxis (product storage error). The administered dose of the vaccine underwent temperature excursion of 74.01 Fahrenheit degrees for 15 hours. There were no previous temperature excursion. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Just fount out they had another TE  / Varivax has been administered; This spontaneous report was received from an unspecified reporter (customer, reported as "Other") referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The reporter informed about a temperature excursion (TE) "1 week ago" for vaccines of varicella virus vaccine live (Oka/Merck) (VARIVAX), as follows: temperature -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; -10 Celsius degrees up to 8 Celsius degrees (-0.4C) for 1 hour 25 minutes 0 seconds; previous temperature excursion: -14 Celsius degrees up to -10 Celsius degrees (-12C) for 0 hours 50 minutes 0 seconds.   On an unknown date between 11-MAY-2022 and 24-MAY-2022, the patient was administered a dose of these varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (lot # U039949 has been verified to be a valid lot number, expiration date: 16-DEC-2023; dose and route of administration not reported) administered for prophylaxis (Product storage error); additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK"). There were no additional adverse event (AE) details provided (No adverse event). There was no product quality complaint (PQC).
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Just found out they had another TE / Varivax has been administered; This spontaneous report was received from an unspecified reporter (customer, reported as "Other") referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The reporter informed about a temperature excursion (TE) "1 week ago" for vaccines of varicella virus vaccine live (Oka/Merck) (VARIVAX), as follows: temperature -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; -10 Celsius degrees up to 8 Celsius degrees (-0.4C) for 1 hour 25 minutes 0 seconds; previous temperature excursion: -14 Celsius degrees up to -10 Celsius degrees (-12C) for 0 hours 50 minutes 0 seconds.   On an unknown date between 11-MAY-2022 and 24-MAY-2022, the patient was administered a dose of these varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (lot # U039949 has been verified to be a valid lot number, expiration date: 16-DEC-2023; dose and route of administration not reported) administered for prophylaxis (Product storage error); additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK"). There were no additional adverse event (AE) details provided (No adverse event). There was no product quality complaint (PQC).
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Product storage error; This spontaneous report has been received from the medical assistant referring a 1-year-old male patient.  The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not provided.  On 04-APR-2022, the patient was vaccinated  with  an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, administered subcutaneously as prophylaxis (strength was not provided) following a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours and -10 degrees C up to 8 degrees C for 1 hour 30 minutes, it was stated that a data logger was involved (product storage error). There was no previous temperature excursion reported. It was stated that the event was attributable to the device component malfunction, however there is no device involved. No additional adverse event was reported.; Sender's Comments:  US-009507513-2205USA008004:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; Temperature excusion occurred on 23-MAR-2022; This spontaneous report has been received from a medical assistant, concerning a 5-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 30-MAR-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) first dose, subcutaneously (valid lot number U025790 [expiration date 19-AUG-2023]) for prophylaxis, after a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec. The time frame of 3 h, 0 min, 0 sec; 1 h, 30, min 0 sec (product storage error) and a device component malfunction was reported (dose, vaccination scheme frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008105: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008066: US-009507513-2205USA008069: US-009507513-2205USA008100: US-009507513-2205USA008189: US-009507513-2205USA008064: US-009507513-2205USA008795: US-009507513-2205USA008800: US-009507513-2205USA008830: US-009507513-2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007739: US-009507513-2205USA007748: US-009507513-2205USA007749: US-009507513-2205USA007861:
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Product storage error; This spontaneous report has been received from a nurse referring a 5-year-old female patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 24-MAR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, administered subcutaneously as prophylaxis (strength, dose and anatomical location were not provided) (product storage error). The temperature excursion occurred between -14 degrees Celsius up to -10 degrees Celsius for 3 hours and between -10 degrees Celsius up to 8 degrees Celsius for 1 hour and 30 minutes. It was reported that a data logger was involved. No previous temperature excursion were reported. It was stated that the event was attributable to a device or device component malfunction, however there was no device involved.  No additional adverse events were reported; Sender's Comments:  US-009507513-2205USA008004:
Sex: F
Vaccine: HPV9
Symptoms: Facial discomfort, Pharyngeal swelling, Sensation of foreign body, Sensory disturbance, Throat tightness
Clinical narrative: Her throat felt like it was swollen and bumpy; The patient also felt as if there was a rash on her face, however a rash was not present; Her throat felt like it was swollen and bumpy; Her throat felt like it was swollen and bumpy; This spontaneous report has been received from a physician referring a 30-year-old female patient.  The patient's medical history included papanicolaou smear abnormal. The patient's drugs reaction or allergies includes problem with diphenhydramine hydrochloride (BENADRYL) in the past. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  administered as prophylaxis (strength, dose description, vaccination scheme, lot number, expiration date, anatomical location and route of administration were not provided).  On an unknown date, at an unspecified time after the vaccination, the patient felt like her throat was closing off (throat tightness). The patient also felt as if there was a rash on her face, however a rash was not present (sensory disturbance). Her throat felt like it was swollen and bumpy (sensation of foreign body and pharyngeal swelling). Due the events, the patient went to the emergency department to seek care, however the wait was too long to see a provider, the staff at the emergency department advised her to take diphenhydramine hydrochloride (BENADRYL), which she did. The patients physician was not convinced that the patients symptoms were from the vaccine, the provider was assessing if it perhaps environmental conditions (such as something in the air) could have caused the patients symptoms however the patient reported that she did nothing unusual the day of the symptoms other than going to the park and eating lunch with her mother. The outcome of the events was not reported.  The causality assessment between the events and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE details are available; Caller states they had a patient who was inadvertently administered PROQUAD and VARIVAX today. No additional AE details are available. No PQC reported.  VARIVAX T032932 9/28/2022 0.5ml PROQUAD U009262 9/19/2022 0.5ml; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 31-MAY-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot number T032932, expiration date reported as  28-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 ml, lot #number 009262, expiration date: reported as 19-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of vaccine administered). No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Healthcare Business Professional who was in charge of vaccine storage and stability.; No additional AE reported; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot# U022320 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 15-JUL-2023) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were -11.45° Celsius (C) for 1 hour respectively.  If a digital data logger was involved was not reported.  The vaccines experience a previous temperature excursion of -14°C up to -10°C for 30 minutes.  No adverse event reported.; Sender's Comments:  US-009507513-2205USA007031: US-009507513-2205USA007284:
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse calling to report that a mom wanted her daughters vaccine schedule "split up"/VARIVAX was administered less than 28 days after the MMRII; This spontaneous report was received from a Registered Nurse and refers to a 1-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions and allergies. Concomitant medications included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II), hepatitis a vaccine (manufacturer unknown) and pneumococcal vaccine (manufacturer unknown).  On 02-JUN-2022, 3 weeks after administration of measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) (Also reported as "less than 28 days after the MMRII"), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). It was stated that the patient's mom wanted her daughters vaccine schedule "split up", so that she would only receive 2 vaccines at a time. The Nurse stated that she thought it had been the full 28 days since the last visit and the varicella virus vaccine live (oka/merck) (VARIVAX) was administered less than 28 days after the measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R ). She was requesting information on weather she will need to repeat the varicella virus vaccine live (oka/merck) (VARIVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant reporting that a patient was administered PROQUAD after a temperature excursion. No additional information provided. Additional AE cases: 02177149, 02177160, 02177161, 02177162, 02177163, 02177164, 02177165, 02177166, 02177167. No a; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 31-MAY-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #U024508, expiration date: 02-FEB-2023, administered subcutaneously for prophylaxis (strength and exact dose were not provided).  The measles, mumps, rubella and varicella (Oka Merck) virus vaccine live (PROQUAD) was administered after a temperature excursion (8.3F) in a time frame of 15 Minutes. No additional adverse event (AE) and no PQC were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported PROQUAD was administered after a temperature excursion to patient. Product was administered on Jun 2, 2022. No further information provided. This is patient one of two. Cross reference AE case: 02178242. No additional AE reported. No PQC; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 02-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number U039957, expiration date reported and validated as 14-JUN-2023) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse event reported.  The vaccine experienced a temperature excursion of minus (-) 4.5 degrees Celsius (C) for 3 hours and 58 minutes. There was no previous temperature excursion.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001554:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reported PROQUAD was administered after a temperature excursion to patient; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, historical drugs, and concomitant therapies were not reported.  On an unknown date, a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) vaccine (lot number U039957 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported and confirmed as 14-JUN-2023) suffered a temperature excursion of -4.5 Celsius degrees during a time frame of 3 hours 58 minutes. The vaccine had not suffered a previous temperature excursion.  On 02-JUN-2022, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) (lot number U039957, expiration date 14-JUN-2023) (dose, route of administration, and anatomical location were not provided) once, as prophylaxis (Product storage error). The temperature excursion that had suffered the vaccine administered was first identified on 03-JUN-2022.  No additional adverse events were reported, no further information provided.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2206USA001552:
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 13-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 09-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 06-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 05-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 09-weeks-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 09-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 06-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 13-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 09-weeks-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 13-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 04-months-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 16-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 07-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 13-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 06-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 16-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 11-weeks-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 17-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: used two vials from the freezer after 30 days to administer them; used two vials from the freezer after 30 days to administer them; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used two vials from the freezer after 30 days to administer them) and PRODUCT STORAGE ERROR (used two vials from the freezer after 30 days to administer them) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (used two vials from the freezer after 30 days to administer them) and PRODUCT STORAGE ERROR (used two vials from the freezer after 30 days to administer them). At the time of the report, EXPIRED PRODUCT ADMINISTERED (used two vials from the freezer after 30 days to administer them) and PRODUCT STORAGE ERROR (used two vials from the freezer after 30 days to administer them) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported  On 17-MAY-2022 the vial was initially stored in the refrigerator.  Treatment information was not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage; Used two vials from the freezer after 30 days to administer them; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) and EXPIRED PRODUCT ADMINISTERED (Used two vials from the freezer after 30 days to administer them) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used two vials from the freezer after 30 days to administer them). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage). At the time of the report, PRODUCT STORAGE ERROR (Inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) and EXPIRED PRODUCT ADMINISTERED (Used two vials from the freezer after 30 days to administer them) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reporter stated that it was notified to them that their upright freezer (two separate doors for freezer and fridge) was not good to use after 30 days. They normally pull the vials out before the 30 days to thaw. Reporter further stated that they wanted to have a standalone freezer because of an automatic defrost cycle on some two door freezer/fridge combinations. The vial was initially stored in the refrigerator on 17-May-2022 (1 vial) and 19-May-2022 (1 vial). The temperature had not gone out of range at all, no temperature excursion happened. The patient received booster dose. Reporter further stated that the patients had not contacted them about any problems.  Treatment information was not reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage; They used two vials from the freezer after 30 days to administer them to 4 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They used two vials from the freezer after 30 days to administer them to 4 patients) and PRODUCT STORAGE ERROR (Moderna shot and inadvertently had the Moderna in the freezer and the freezer was not approved for over 30 days of storage) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter stated that it was notified to them that their upright freezer (two separate doors for freezer and fridge) was not good to use after 30 days. They normally pull the vials out before the 30 days to thaw. Reporter further stated that they wanted to have a stand alone freezer because of an automatic defrost cycle on some two door freezer/fridge combinations.  The vial was initially stored in the refrigerator on 17-May-2022 (1 vial) and 19-May-2022 (1 vial). The temperature had not gone out of range at all, and the vial did not undergo any temperature excursions  Reporter further stated that the patients had not contacted them about any problems.  No treatment medication were provided.