chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; Patient vaccinated with product incorrectly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknow age or gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAR-2022, the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U021995, expiration date: 13-JAN-2023) was stored incorrectly for a time frame of 24 hours at a temperature of 0.4°C. There was also a previous temperature excursion.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose regimen details not provided, lot #U021995, and expiration date: 13-JAN-2023) administered for prophylaxis. No adverse event was provided. ; Sender's Comments:  US-009507513-2206USA006587: US-009507513-2206USA006770: US-009507513-2206USA007068:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no adverse effects or symptoms from this dose; Caller is a medical assistant who reports six expired doses of VAQTA were administered; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported.  On 15-JUN-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) once (lot number: T031201, which was determined to be valid, with an expiration date on 14-JUN-2022) as prophylaxis (route and anatomical location of administration were not reported) (expired product administered). The hepatitis A vaccine inactivated (VAQTA) mentioned did not have any prior temperature excursion and the patient had no adverse effects or symptoms from this dose.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23. During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured. Additional AE filed in  02190216, 02190130, 02190106, 02190106, 02; This spontaneous report has been received from a nurse referring a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies.  On 03-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number U021995, expiration date on 13-JAN-2023 for prophylaxis (strength, formulation, dose, frequency, and route of administration were not reported) that underwent a temperature excursion of 0.3 Celsius grades in 24 hours (product storage error). No additional adverse events were reported.  The outcome of the event was not reported. ; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA006587: US-009507513-2206USA007098: US-009507513-2206USA007068:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23. During the evaluation the customer reported that the PNEUMOVAX 23 was administered to the patient after the excursion occured. Additional AE filed in 02190216, 02190130, 02190106, 02190106, 021; This spontaneous report has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent) lot number U022819 with expiration date on 14-JAN-2023 for prophylaxis (dose, route of administration, strength and anatomical location not reported). The pneumococcal vaccine, polyvalent (23-valent) was stored at a temperature of 1.4 degrees Celsius (°C) for the time frame of 24 hours. No additional adverse effects reported. ; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA007068: US-009507513-2206USA007098:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no adverse effects or symptoms; medical assistant who reports six expired doses of VAQTA were administered; This spontaneous report has been received from a medical assistant referring a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On 17-JUN-2022, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliter once, lot number T031201, expiration date: 14-JUN-2022, as prophylaxis (strength, vaccination scheme, anatomical location of administration and route of administration were not provided) (expired product administered). It was stated that the patient had no adverse effects or symptoms from this dose. It was also mentioned that hepatitis a vaccine, inactivated (VAQTA) did not have any prior temperature excursions.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23.; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 11-APR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U021995 has been verified to be a valid lot number, expiration date: 13-JAN-2023) (strength, dose, frequency, and vaccination scheme were not provided) (product storage error) administered for prophylaxis.   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 0.7 Celsius (C) for a time frame of 24 hours. There was a previous temperature excursion.   No additional adverse events were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA007094: US-009507513-2206USA006587: US-009507513-2206USA006674: US-009507513-2206USA006670: US-009507513-2206USA006731: US-009507513-2206USA007090: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA006852: US-009507513-2206USA007070: US-009507513-2206USA007098: US-009507513-2206USA006952: US-009507513-2206USA007059:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured; This spontaneous report was received from a registered nurse referring to an unknown age and gender patient, whose medical history, concurrent conditions, previous adverse drug reaction, allergies, and concomitant medications were not provided.  On 15-MAR-2022, after an excursion took place, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection, administered for prophylaxis (lot number: U021995 with an expiration date: 13-JAN-2023 was verified to be a valid lot number; strength, dose, frequency, anatomical injection site, and vaccination scheme were not provided) (product storage error).  The dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored in a temperature of 0 degrees Celsius (C) for 24 hours. It was reported that there was a previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA006770: US-009507513-2206USA006587:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: PNEUMOVAX 23 was administered to the patient after the excursion occured; No additional Adverse Event reported; This spontaneous report has been received from a registered nurse, concerning to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 18-MAR-2022,  the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U022819 which was determined to be valid with expiration date 14-JAN-2023, for prophylaxis, after a temperature excursion of 0 degrees Celsius (C) for a time frame of 24 hours (product storage error) (dose, vaccination scheme, and frequency were not provided). Additionally, a 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-009507513-2206USA006770: US-009507513-2206USA006587: US-009507513-2206USA007068: US-009507513-2206USA007098:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PNEUMOVAX 23 was administered to the patient after the excursion occured.; This spontaneous report has been received from a registered nurse, concerning to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 02-MAR-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U021995 which was determined to be valid with expiration date 13-JAN-2023, for prophylaxis, after a temperature excursion of 0 degrees Celsius (C) for a time frame of 168 hours (product storage error) (dose, vaccination scheme, and frequency were not provided). Additionally, 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-009507513-2206USA006587: US-009507513-2206USA007090: US-009507513-2206USA007070: US-009507513-2206USA007059: US-009507513-2206USA007045: US-009507513-2206USA006981: US-009507513-2206USA006952: US-009507513-2206USA006852: US-009507513-2206USA006731: US-009507513-2206USA006674: US-009507513-2206USA007068: US-009507513-2206USA007098: US-009507513-2206USA006770: US-009507513-2206USA006432: US-009507513-2206USA006670:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a HCP calling to report a TE for PNEUMOVAX 23; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.  On 14-MAR-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot number U021995 has been verified to be a valid lot number, expiration date 13-JAN-2023) (strength, dose, frequency, and vaccination scheme were not provided) (product storage error) administered for prophylaxis.   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 0 degree Celsius (C) for a time frame of 24 hours. There was a previous temperature excursion.   No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007094: US-009507513-2206USA006587: US-009507513-2206USA006674: US-009507513-2206USA006670: US-009507513-2206USA006770: US-009507513-2206USA006731: US-009507513-2206USA007090: US-009507513-2206USA007068: US-009507513-2206USA006981: US-009507513-2206USA007045: US-009507513-2206USA006852: US-009507513-2206USA007070: US-009507513-2206USA006952: US-009507513-2206USA007059:
Age: 40.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Product use issue
Clinical narrative: Physician is calling in to report an AE on a patient that was administered MMR-II and VARIVAX while undergoing treatment for Lupus on immunosuppressive therapies BENLYSTA and prednisone; This spontaneous report was received from a physician and refers to a 40-year-old female patient. The patient's concurrent conditions included lupus. Concomitant therapies included belimumab (BENLYSTA) and prednisone. There was no information about the patient's drug reactions, allergies or medical history provided.   On 20-JUN-2022, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) one injection intramuscularly for prophylaxis (indication also reported as "MMR-II PRE-EMPLOYEMENT AT MEDICAL CENTER") (exact dose, anatomical site, lot # and expiration date were not provided), and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) one injection intramuscularly for prophylaxis (exact dose, anatomical site, lot # and expiration date were not provided). The patient was administered the suspect products while undergoing treatment for lupus on immunosuppressive therapies of belimumab (BENLYSTA) and prednisone (Product use issue). It was unknown if the patient was treated for this event.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired dose of M-M-R II was administered; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 23-JUN-2022, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type rHA) subcutaneous injection (lot # T018669 has been verified to be a valid lot number, expiration date: 29-MAY-2022; dose and route of administration not reported) administered for prophylaxis (Expired product administered). Additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK") (lot # W009117, expiration date 16-JUL-2024). Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the diluent used to reconstitute the vaccine were stored according to prescribing information through the date of administration. There were no additional adverse event (AE) details provided, there was no additional AE (No adverse event). There was no product quality complaint (PQC).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details; Adult patient was administered a dose of PROQUAD inadvertently; This spontaneous report was received from a nurse and refers to a 27-year-old patient of unspecified gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 20-JUN-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type rHA) subcutaneous injection (lot # U002530 has been verified to be a valid lot number, expiration date: 24-JUL-2022; dose and route of administration not reported) inadvertently, administered for prophylaxis (Product administered to patient of inappropriate age). 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: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered to the patient after the excursion occured; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 23-JUN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U029496, expiration date: 21-SEP-2023, administered (strength and route of administration were not provided) for prophylaxis (Product storage error).   On an unknown date, before the administration, the vaccine underwent temperature excursion at 7.7 Fahrenheit degrees (F) for 30 minutes. No previous temperature excursions were reported. No adverse events were reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; administered doses of vaccines to 5 patients following temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding patient's medical history, concurrent conditions or concomitant therapies was provided.  On 20-JUN-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, lot #U007505, expiration date: 04-SEP-2022, albumin status verified to be rHA (strength and route of administration were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot # U029496, expiration date: 21-SEP-2023, administered for prophylaxis (strength, dose number and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 7.7 degrees Fahrenheit for 30 minutes.; Sender's Comments:  US-009507513-2206USA007839:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; administered to the patient after the excursion occured; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 26-MAY-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot #U039262, expiration date: 09-JUN-2023 (strength and route of administration were not provided) for prophylaxis (Product storage error).   On an unknown date, before the administration, the vaccine underwent temperature excursion at 6.0 Fahrenheit degrees (F) for 30 minutes. Previous temperature excursions were reported. No adverse events were reported (No adverse event).  This is one of several reports from the same reporter.
Sex: F
Vaccine: HPV9
Symptoms: Palpitations, Syncope
Clinical narrative: became faint; racing heart; This spontaneous report was received from a consumer, referring to a 26-year-old female patient. Her medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in June 2022, the patient received first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot #, expiration date, dosage and exact anatomical location were not provided) for prophylaxis.  On an unknown date in June 2022, after receiving the vaccination, the patient became faint. Moreover, a week later, she had a racing heart and was taken to the emergency room. The outcome of the events was not reported.  The relatedness between the suspect vaccine and the events was not provided.  Upon internal review, the event of syncope was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; dose of PROQUAD that experienced a temperautre excursion was administered to the patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 20-MAY-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, 0.5 ml, lot # U039262, expiration date 09-JUN-2023, for prophylaxis (anatomical site was not provided) (Product storage issue). The vaccine was improperly stored for 30 minutes in temperature of 7.3 F. Data logger was not used to capture temperature excursion. There was no previous temperature excursion. No additional adverse event was reported (No adverse event).; Sender's Comments:  US-009507513-2206USA007845: US-009507513-2206USA007839:
Sex: M
Vaccine: PPV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; PNEUMOVAX 23 syringes experienced a temperature excursion on March 21, 2022; This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringes (lot #T033369, expiration date: 26-MAY-2022; lot #T039322, expiration date: 09-SEP-2022) that experienced a temperature excursion on 21-MAR-2022 may have been administered (strength, dose and route were not provided) to patients for prophylaxis after that date (product storage error).  The aforementioned doses of vaccine experienced a temperature excursion in 30.2 degrees Fahrenheit (F) for 7 hours 45 minutes. There was no previous temperature excursion. The reporter was not able to provide any additional details at this time. No additional adverse event (AE) information provided.   Follow up information has been received from the medical assistant on 23-JUN-2022. The patient was 63-year-old male. The vaccine was administered by medical assistant in the left deltoid. The patient was vaccinated at private doctor's office/ hospital and the vaccine was purchased with private funds. Temperature excursion occurred as a result of a reading from a Digital Data Logger. On 21-MAR-2022, current temperature was 30.2 degrees (min 37.9-max 41.8) at 4:30 pm and 41.5 degrees (min 37.7-max 42.4) at 7:45 am. The pm read appeared to be written wrong, possible 38.2 degrees vs 30.2, but to be safe it was removed from inverting. It was not available for return as it was destroyed. ; Sender's Comments:  US-009507513-2205USA003408:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; Caller reports that a dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured.; This spontaneous report has been received from a medical assitant, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 01-JUN-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml), subcutaneous injection (valid lot number U029496 [expiration date 21-SEP-2023]) for prophylaxis, after a temperature excursion of 7.7 degrees Fahrenheits (F) for 30 minutes (product storage error) (vaccination scheme, and frequency were not provided). Additionally, a 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-009507513-2206USA007717: US-009507513-2206USA007710: US-009507513-2206USA007693: US-009507513-2206USA007675: US-009507513-2206USA007547: US-009507513-2206USA007910: US-009507513-2206USA007894: US-009507513-2206USA007855: US-009507513-2206USA007845: US-009507513-2206USA007706: US-009507513-2206USA007527:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Caller is a medical assistant calling to report an adverse event for PROQUAD. Caller reports that a dose of PROQUAD that experienced a temperautre excursion was administered to the patient after the excursion occured. Additional AE's filed in 021923; This spontaneous report was received from a medical assistant 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 an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 ml, lot number U039262, expiration date reported as 09-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided) after it was exposure to a temperature excursion (product storage error). The temperature excursion was of 7.7 Fahrenheit degrees for 30 minutes. It was reported that there was a previous temperature exclusion. No additional adverse event was reported.; Sender's Comments:  US-009507513-2206USA007839: US-009507513-2206USA007717: US-009507513-2206USA007675: US-009507513-2206USA007710: US-009507513-2206USA007855: US-009507513-2206USA007547: US-009507513-2206USA007894: US-009507513-2206USA007527: US-009507513-2206USA007706: US-009507513-2206USA007910: US-009507513-2206USA007693:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Caller is medical assistant who reports administered doses of vaccines to 5 patients following temperature excursion.; This spontaneous report has been received from a medical assistant, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 16-MAY-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose (valid lot number U007478 [expiration date 08-MAR-2023]) for prophylaxis, after a temperature excursion (product storage error) (dose, vaccination scheme, and frequency were not provided).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007701: US-009507513-2206USA007852: US-009507513-2206USA007854: US-009507513-2206USA007865:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Caller is medical assistant who reports administered doses of vaccines to 5 patients following temperature excursion. No additional adverse events/No Product quality complaints. See AE cases for other patients:   Patient 1: 02192565  Patient 2: 02192; This spontaneous report was received from a medical assistant and refers to a patient of unknown age an gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 25-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 1 dose, lot number U007505, expiration date: reported as 04-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) after temperature exposure (product storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2206USA007849:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events; Caller is medical assistant who reports administered doses of vaccines to 5 patients following temperature excursion.; This spontaneous report has been received from a medical assistant, concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 15-JUN-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose (valid lot number U007478 [expiration date 08-MAR-2023]) for prophylaxis, after a temperature excursion (product storage error) (dose, vaccination scheme, and frequency were not provided).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA007849: US-009507513-2206USA007701: US-009507513-2206USA007852: US-009507513-2206USA007865:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller reports that a dose of VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 01-JUN-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection 0,5 milliliters (ml) as prophylaxis (lot number: U029496, which was determined to be valid, with an expiration date on 21-SEP-2022) (scheme, route and anatomical location of administration were not reported) (product storage error). Administered dose underwent a temperature excursion of 7.7 degrees Fahrenheit (F) for 30 minutes. It was reported that there was a previous temperature excursion. No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2206USA007693: US-009507513-2206USA007710: US-009507513-2206USA007717: US-009507513-2206USA007675: US-009507513-2206USA007839: US-009507513-2206USA007845: US-009507513-2206USA007547: US-009507513-2206USA007894: US-009507513-2206USA007527: US-009507513-2206USA007706: US-009507513-2206USA007910:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Caller is medical assistant who reports administered doses of vaccines to 5 patients following temperature excursion. No additional adverse events/No Product quality complaints. See AE cases for other patients:   Patient 1: 02192565  Patient 2: 02192; This spontaneous report was received from a medical assistant 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 25-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 1 dose, lot number U007505, expiration date: reported as 04-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) after temperature exposure (product storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2206USA007849: US-009507513-2206USA007854: US-009507513-2206USA007852: US-009507513-2206USA007701:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pharmacist reporting an AE. Per caller, an adult employee received pediatric PROQUAD instead of MMRII. Caller did not have any details of administration, stating that information was not in the report he got. No additional AE. No PQC.  Caller stated; an adult employee received pediatric PROQUAD instead of MMRII.; No additional AE; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a pediatric measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml, administered for prophylaxis (strength, lot number, expiry date, and route of administration were not provided) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, dose description, lot number, expiry date, and route of administration were not provided) (wrong vaccine administered and product administered to patient of inappropriate age). No additional adverse events was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event (No additional AE reported); VARIVAX that experienced a temperautre excursion was administered to the patient after the excursion occured; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 14-JUN-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection 0,5 milliliters (ml) as prophylaxis (lot number: U029496, which was determined to be valid, with an expiration date on 21-SEP-2023) (scheme, route and anatomical location of administration were not reported) (product storage error). Administered dose underwent a temperature excursion of 7.7 degrees Fahrenheit (F) for 30 minutes. It was reported that there was a previous temperature excursion. No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2206USA007839: US-009507513-2206USA007845:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details available.; Nurse calling to report expired MMR II was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent. The patient's concurrent conditions, medical history, allergies and drug reactions were not reported.   On 27-FEB-2022, the patient was vaccinated with an expired recombinant human albumin (rHA) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot #T007235, expiration date: 27-FEB-2022, (strength, dose, dose number, formulation, route and site of administration were not provided) for prophylaxis (expired product administered). Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent had been stored according to prescribing information through the date of administration. No additional adverse events was provided (no adverse event).
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; Medical assistant reporting AE improperly stored for VARIVAX.  See temperature excursion case 02193291. No additional AE information or PQC reported. Names of vaccines involved (including lot/expiration) VARIVAX: W002599 01/24/2024Temperature: 4C; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unspecified gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported  On 27-JUN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one dose, lot #W002599, expiration date: 24-JAN-2024 (exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis, after the vaccine underwent temperature excursion in 4 Celsius degrees, in a timeframe of 108 hours. No additional adverse event was reported.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event reported; HCP reports a 15 year old patient, weighting 126 pounds was accidently administered an adult dose of VAQTA instead of a pediatric dose on Jun 27, 2022.; This spontaneous report was received from a medical assistant concerning a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.    On 27-JUN-2022, the patient was accidently vaccinated with an adult dose of Hepatitis A Vaccine, inactivated (VAQTA) (dosage regimen, lot#, expiration date, route of administration and anatomical location were not provided) as prophylaxis, instead of a pediatric dose (product administered to patient of inappropriate age).  No further information or adverse event were reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; at least one dose of PNEUMOVAX 23 was administered following a temperature excursion.; This spontaneous report has been received from a nurse referring a patient of a 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 27-JUN-2022, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 syringes, lot number U034712, expiration date: 30-JUL-2023, as prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) following a temperature excursion of 58.3 degrees Fahrenheit (F) for 8 hours (product storage error), there was stated that no previous temperature excursion occurred. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details or PQC; Patient was administered an expired dose of MMR-II.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding medical history, previous drug reactions or allergies was provided. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).   On 25-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number T018892 has been verified to be valid, expiration date reported and established as 02-JUN-2022) (expired product administered).   No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; HCP reports patient received the second dose of VAQTA ten days before six months after the first dose. Patient received first dose of VAQTA on Jun 15, 2012. Patient received second dose of VAQTA on Dec 7, 2012. No further information provided. This i; This spontaneous report has been received from a medical assistant, regarding an identifiable patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies were unknown.  On 15-JUN-2012, the patient was vaccinated with the first one dose of Hepatitis A Vaccine, Inactivated (VAQTA) vial (lot number reported as 1647AA which was confirmed as valid, expiration date not provided but stablished as 23-SEP-2014), and on 07-DEC-2012 with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) vial (lot number reported as 0273AE which was confirmed as valid, expiration date not provided but stablished as 06-DEC-2014), both administered as prophylaxis (strength, exact dose, route of administration and anatomical location, lot number and expiration date were not provided); the second dose was administered ten days before six months after the first dose (inappropriate schedule of product administration). No adverse events reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA009121:Case number: 02195271
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif every day instead of the schedule recommended in the PI; A spontaneous report was received from the assistant nursing director on 14JUN2022. It described a patient (unknown age and gender) who "took Vivotif every day instead of the schedule recommended in the PI" (PT: Inappropriate schedule of product administration). The patient took the Vivotif capsule (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took their Vivotif capsules every day instead of every other day as recommended in the product information (PI).  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient took Vivotif every day instead of the schedule recommended in the PI (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took Vivotif every day instead of the schedule recommended in the PI (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: sore; Slightly warm; A little red; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain, feeling of warmth and erythema. On an unknown date, the outcome of the pain, feeling of warmth and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pain, feeling of warmth and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-June-2022 Reporter's Comment: The patient reported this case via interactive digital media. The patient after receiving the Shingrix vaccine experienced slightly warm and little red and it was still sore. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Hypersomnia, Illness, Pain in extremity, Peripheral swelling
Clinical narrative: Very swollen; Arm is still sore, really hurts; Arm is red; Sick; oversleeping/  I have slept like a total of 14 or more hours; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of underdose (For tolerance to the Flu shot refer case US2022AMR095672).   On 16th June 2022, the patient received the 1st dose of Shingles vaccine. On 16th June 2022, less than a day after receiving Shingles vaccine, the patient experienced swelling arm, pain in arm, erythema of extremities, sickness and hypersomnia. On an unknown date, the outcome of the swelling arm, pain in arm, erythema of extremities, sickness and hypersomnia were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, pain in arm, erythema of extremities, sickness and hypersomnia to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR095672   Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The case was reported by the consumer for himself/herself. The patient stated that when he/she got the shot on Thursday morning (at the time of reporting). His/her arm was still sore, red, really hurts and very swollen. The patient stated that he/she had slept like a total of 14 or more hours. The reporter said he/she never nap during the day unless he/she was sick. The reporter said he/she went to bed at 1:00-4:30 then went to bed at 7:00 that night did not got up until 7:45 next morning.  The patient heard there was a 2nd shot. The patient was sure doctor must had told him/her, but he/she chose not to hear it.  Additional supportive information: Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095672:Same reporter
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Incorrect dose administered, Malaise, Underdose
Clinical narrative: Flu shot in 2 parts, half this week, half next week; Flu shot in 2 parts, half this week, half next week; Flu shot in 2 parts, half this week, half next week; This case was reported by a consumer via interactive digital media and described the occurrence of underdose in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Flu vaccine and the 1st dose of Flu vaccine. On an unknown date, not applicable after receiving Flu vaccine and unknown after receiving Flu vaccine, the patient experienced underdose, underdose and inappropriate dose of vaccine administered. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the underdose, underdose and inappropriate dose of vaccine administered were unknown.   Linked case(s) involving the same patient:  US2022AMR095671   Additional Information: GSK Receipt Date: 20-JUN-2022 Reporter's Comments: Reporter's Comments: This case reported by patient via interactive digital media. When the patient got a flu shot he/she had to took it in 2 parts.  The patient received half vaccine for one week and half vaccine for next week or he/she get so sick. Additional Supportive Information: The patient received Flu vaccine in 2 parts, which led to underdose and inappropriate dose of vaccine administration. Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095671:Same reporter