chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No treatment and concomitant medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-711736.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711736:Master case
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215H22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu vaccine on 19-Jan-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No concomitant medications were reported.  The BUD was reported as 08-Feb-2023.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-711736.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711736:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023).    It was unknown patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    Vaccines were thawed on 13-JAN-2023 and 4 doses were administered on 17-FEB-2023. Bivalent vaccine administered and no symptoms have been reported at that time. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712038, US-MODERNATX, INC.-MOD-2023-712309, US-MODERNATX, INC.-MOD-2023-712328 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712038:Master case US-MODERNATX, INC.-MOD-2023-712309:Patient 2 of 4 US-MODERNATX, INC.-MOD-2023-712328:Patient 3 of 4
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023).    No concomitant medications was reported.  Vaccines were thawed on 13-JAN-2023 and 4 doses were administered on 17-FEB-2023. No symptoms have been reported.  No treatment medications was reported.  This case contains information about patient-2 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-712275, US-MODERNATX, INC.-MOD-2023-712328, US-MODERNATX, INC.-MOD-2023-712038 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712275: US-MODERNATX, INC.-MOD-2023-712328: US-MODERNATX, INC.-MOD-2023-712038:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was thawed on 13-JAN-2023 and dose was administered on 17-FEB-2023).    Concomitant drugs were not reported. It was reported that the vaccines were thawed on 13-Jan-2023.  It was also reported that no symptoms were reported at that time. Treatment medications were not provided. This case was reported for patient 3 of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-712038, US-MODERNATX, INC.-MOD-2023-712309, US-MODERNATX, INC.-MOD-2023-712275 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712038:Master case US-MODERNATX, INC.-MOD-2023-712275:Patient 2of 4 US-MODERNATX, INC.-MOD-2023-712309:
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue
Clinical narrative: patient got COVID-19; patient is tired all the time; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (patient got COVID-19) and FATIGUE (patient is tired all the time) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Hypertension and Overweight. Concomitant products included LOSARTAN, CHARCOAL, ACTIVATED (CARBOTURAL), HYDROCHLOROTHIAZIDE, AMLODIPINE and POTASSIUM for an unknown indication.    On 09-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced COVID-19 (patient got COVID-19) and FATIGUE (patient is tired all the time). In December 2022, COVID-19 (patient got COVID-19) had resolved with sequelae. At the time of the report, FATIGUE (patient is tired all the time) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received first dose of Moderna COVID-19 Vaccine on 22-Feb-2021 batch number 001A21A, second dose on 22-Mar-2021 batch number 047A21A, first booster on 25-Oct-2021 batch number 012521D  and second booster on 30-Mar-2022 batch number 0B6L21A. It was reported that patient experienced headache and nausea during 24 hours after dose 2. On 25-Nov-2022 patient got COVID-19 even after getting the Moderna shots, and it lasted approximately for 16 days till Dec 2022 and patient was currently tired all the time. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712228 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712228:Bivalent case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 doses of the vaccine were given today after they expired on 13FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023).    No concomitant medications was reported.  Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had no reported symptoms.   No additional medications, doses, or treatments medications was reported.  This case contains information for the 1st out of 2 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712225:2nd child
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours; fever; chills; sweats; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), FATIGUE (patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours), PYREXIA (fever) and CHILLS (chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A, 037A21B, 071F21A and 027L21A) for COVID-19 prophylaxis.             No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours). At the time of the report, HYPERHIDROSIS (sweats), FATIGUE (patient was so fatigued that he could not get to the bathroom without holding the wall/Patient slept for nearly 24 hours), PYREXIA (fever) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 103.5 Degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. The patient reports that he did well after all of his Moderna Covid-19 vaccinations however after his second Moderna Primary Series Dose the patient had several Adverse events. Patient reported adverse reactions of fatigue on the next day March 14, 2021.  After 26 hours the symptoms went away for patient. Patient reported adverse reactions of low level fatigue for a day with first Moderna Covid 19 vaccine booster dose and second Moderna Covid 19 vaccine booster dose.    No treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712256 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712256:Monovalent case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose administered after the 30 day BUD).
Age: 1.83
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Doses were administered after the 30 day BUD; No adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD), PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 22-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD), PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and PRODUCT STORAGE ERROR (Doses were administered after the 30 day BUD).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The BUD was reported as 8-Feb-2023.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712259, US-MODERNATX, INC.-MOD-2023-712263 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712263:3rd patient (J-Y) US-MODERNATX, INC.-MOD-2023-712259:2nd patient (A-P)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines were thawed on 13JAN2023 and 4 doses were administered on 17FEB2023).    It was unknown patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.    Vaccines were thawed on 13-JAN-2023 and 4 doses were administered on 17-FEB-2023. Bivalent vaccine administered and no symptoms have been reported at that time. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712275, US-MODERNATX, INC.-MOD-2023-712328, US-MODERNATX, INC.-MOD-2023-712309 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712275:Patient 1 of 4 US-MODERNATX, INC.-MOD-2023-712328:Patient 3 of 4 US-MODERNATX, INC.-MOD-2023-712309:Patient 2 of 4
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 patient received monovalent vaccine past the 30 day use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 patient received monovalent vaccine past the 30 day use by date.).    Concomitant medication was not provided.   Treatment information was not provided.  This case contains information for the 1st out of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712108:Same reporter(2 patient invalid case)
Age: 0.42
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In February 2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A dose of the Moderna COVID-19 after the published expiration date on 17FEB2023. No symptoms. Monovalent).    No concomitant medication were reported. Patient had no symptoms. No treatment information was provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and administered vaccine on 16-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date,      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Dec-2022 and administered vaccine on 16-Feb-2023).     No treatment drug details was reported.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.     On 16-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (On 29Dec2022. the vial was initially stored in the refrigerator and administered on 16Feb2023).    No concomitant medications were reported.  Dosage text was reported as Additional Booster.   This was their 5th Moderna vaccine.  Clinic Manager reported that 4 doses of the Moderna Bivalent 6yrs and older vaccine was administered after 30-day Use by Date. Dose administered after 30-day Use by Date or after manufacturer date of expiry. Patient received Bivalent 6yrs and older vaccine was administered. individual vials stored in carton. Vial size was reported as 2.5 mL. On 29Dec2022. the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated on 17Feb2023 they accidentally administered 1 dose of the primary series of Moderna COVID-19 Vaccine after the manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Patient had no allergies. Patient had no relevant medical history.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated on 17Feb2023 they accidentally administered 1 dose of the primary series of Moderna COVID-19 Vaccine after the manufacturing expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated on 17Feb2023 they accidentally administered 1 dose of the primary series of Moderna COVID-19 Vaccine after the manufacturing expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant medication details was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated no Adverse events were reported. No treatment medication details was reported.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; No adverse event; They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They inadvertently administered dose of the Moderna Monovalent primary series to patient after date of expiry of 13-Feb-2023) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No allergy, concomitant diseases and risk factor were reported. No known Allergies were reported.  No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 20-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712280 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712280:Patient 1
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Jan-2023 and administered the vaccine on 14-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     It was reported that patient does not had any allergies.     On 14-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Jan-2023 and administered the vaccine on 14-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-Jan-2023 and administered the vaccine on 14-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023; No adverse event; Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 16-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Bivalent 6yrs and older vaccine was administered after 30 day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 29-Dec-2022 and was administered on 16-Feb-2023).    Concomitant drugs were not reported. It was reported that it was patient's fifth Moderna vaccine. It was also reported that the bivalent individual vials stored in carton was of 2.5 ml size. The vial was initially stored in the refrigerator on 29-dec-2022. The vial did not underwent any temperature excursion.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (On 29-Dec-2022 the vial was initially stored in the refrigerator and administered on 16-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     It was unknown whether patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.          For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (On 29-Dec-2022 the vial was initially stored in the refrigerator and administered on 16-Feb-2023).    No concomitant medications was reported. This was 5th Moderna Bivalent 6years and older vaccine.  The vial did not undergo any temperature excursions. No treatment medication was provided.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AZ7166B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 21-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.).    Concomitant medications details were not reported by the reporter. Dosage text was reported as Additional booster. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neck mass, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (she had a lump on the neck, near to the clavicle, the second day it got bigger), PAIN IN EXTREMITY (she felt sore on top of her neck and upper arms), NECK PAIN (she felt sore on top of her neck) and PERIPHERAL SWELLING (Her upper arms and armpits had gotten swollen) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.      Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 09-Feb-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced NECK MASS (she had a lump on the neck, near to the clavicle, the second day it got bigger). In February 2023, the patient experienced PAIN IN EXTREMITY (she felt sore on top of her neck and upper arms), NECK PAIN (she felt sore on top of her neck) and PERIPHERAL SWELLING (Her upper arms and armpits had gotten swollen).      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (At the beginning of the call that patient was trying to deal with something that was a side effect of Moderna) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (At the beginning of the call that patient was trying to deal with something that was a side effect of Moderna). At the time of the report, IMMUNISATION REACTION (At the beginning of the call that patient was trying to deal with something that was a side effect of Moderna) outcome was unknown.         No concomitant information was reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; On 21-FEB-2023, this serious, initial non-interventional study safety report from Regulatory Authority was received from a consumer via Regulatory Authority and was received by Novavax on 21-FEB-2023.  An individual of an unspecified race, age, and sex was vaccinated with intramuscular Novavax Covid-19 Vaccine (Recombinant and Adjuvanted) 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced pain at the injection site (PT: Vaccination site pain) (Serious: Hospitalization) and was hospitalized for an unknown number of nights.  At the time of reporting, the event outcome of Vaccination site pain was unknown.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination site pain after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Vaccination site pain was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Vaccination site pain was assessed as unknown.