chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient felt horrible; Patient could barely turn over; Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient wasn't very sick but lost sense of taste and had terrible sore throat,also  felt funny electric shocks in body.) in March 2020. Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened). In March 2021, BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) had resolved. At the time of the report, FEELING ABNORMAL (Patient felt horrible) and MOBILITY DECREASED (Patient could barely turn over) outcome was unknown.            No concomitant medications were reported. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-660536, MOD-2022-660509 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blindness, Blood pressure measurement, Blood test, Carpal tunnel syndrome
Clinical narrative: Patient felt horrible; Patient could barely turn over; Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient wasn't very sick but lost sense of taste and had terrible sore throat,also  felt funny electric shocks in body.) in March 2020. Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened). In March 2021, BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) had resolved. At the time of the report, FEELING ABNORMAL (Patient felt horrible) and MOBILITY DECREASED (Patient could barely turn over) outcome was unknown.            No concomitant medications were reported. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-660536, MOD-2022-660509 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypertension, Hypoaesthesia, Neck pain, Night sweats
Clinical narrative: Patient felt horrible; Patient could barely turn over; Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient wasn't very sick but lost sense of taste and had terrible sore throat,also  felt funny electric shocks in body.) in March 2020. Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened). In March 2021, BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) had resolved. At the time of the report, FEELING ABNORMAL (Patient felt horrible) and MOBILITY DECREASED (Patient could barely turn over) outcome was unknown.            No concomitant medications were reported. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-660536, MOD-2022-660509 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Papilloedema, Paraesthesia, Peripheral swelling, Rash, Urinary tract infection
Clinical narrative: Patient felt horrible; Patient could barely turn over; Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient wasn't very sick but lost sense of taste and had terrible sore throat,also  felt funny electric shocks in body.) in March 2020. Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened). In March 2021, BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) had resolved. At the time of the report, FEELING ABNORMAL (Patient felt horrible) and MOBILITY DECREASED (Patient could barely turn over) outcome was unknown.            No concomitant medications were reported. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-660536, MOD-2022-660509 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Patient felt horrible; Patient could barely turn over; Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient wasn't very sick but lost sense of taste and had terrible sore throat,also  felt funny electric shocks in body.) in March 2020. Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened). In March 2021, BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) had resolved. At the time of the report, FEELING ABNORMAL (Patient felt horrible) and MOBILITY DECREASED (Patient could barely turn over) outcome was unknown.            No concomitant medications were reported. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-660536, MOD-2022-660509 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bedridden, Feeling abnormal, Mobility decreased
Clinical narrative: Patient felt horrible; Patient could barely turn over; Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient wasn't very sick but lost sense of taste and had terrible sore throat,also  felt funny electric shocks in body.) in March 2020. Concurrent medical conditions included Perfume sensitivity and Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Patient felt horrible), MOBILITY DECREASED (Patient could barely turn over) and BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened). In March 2021, BEDRIDDEN (Patient had to be in bed for 36 hours after the 2nd dose/Patient was flattened) had resolved. At the time of the report, FEELING ABNORMAL (Patient felt horrible) and MOBILITY DECREASED (Patient could barely turn over) outcome was unknown.            No concomitant medications were reported. No other vaccines was given within 1 month prior to Moderna COVID-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-660536, MOD-2022-660509 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pain in extremity
Clinical narrative: arm was very sore; felt under the weather; Feel sort of crappy day after booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), MALAISE (felt under the weather) and FEELING ABNORMAL (Feel sort of crappy day after booster) in a male patient of an unknown age 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was very sore), MALAISE (felt under the weather) and FEELING ABNORMAL (Feel sort of crappy day after booster). At the time of the report, PAIN IN EXTREMITY (arm was very sore), MALAISE (felt under the weather) and FEELING ABNORMAL (Feel sort of crappy day after booster) outcome was unknown.            No concomitant medications were reported.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660538.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660538:case for another patient-
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: had a reaction twice; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a reaction twice) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 10-Oct-2022, 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. In October 2022, the patient experienced IMMUNISATION REACTION (had a reaction twice). At the time of the report, IMMUNISATION REACTION (had a reaction twice) outcome was unknown.     No concomitant drug was reported. No treatment drug was reported.   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Malaise
Clinical narrative: dry retching; Slept for about 18 hours; continue to felt ill; Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches; Headache; Profoundly fatigued; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of RETCHING (dry retching), HYPERSOMNIA (Slept for about 18 hours), MALAISE (continue to felt ill), MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for Flu prophylaxis.    No Medical History information was reported.   On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced RETCHING (dry retching), HYPERSOMNIA (Slept for about 18 hours), MALAISE (continue to felt ill), MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches), HEADACHE (Headache), FATIGUE (Profoundly fatigued) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN for Headache, at a dose of 1000 milligram. At the time of the report, RETCHING (dry retching) had not resolved, HYPERSOMNIA (Slept for about 18 hours) and CHILLS (Chills) outcome was unknown, MALAISE (continue to felt ill), HEADACHE (Headache) and FATIGUE (Profoundly fatigued) was resolving and MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches) had resolved.        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.   Concomitant medication was not reported.  Patient received bivalent Moderna booster shot on the afternoon. This shot was given approximately 1 minute after the seasonal flu shot was administered.  Approximately 2 hours after vaccine administration patient experienced adverse events. Patient continue to felt ill, but am well enough now to get up and self-report.  While the fatigue was ongoing, it has improved significantly. The muscle aches have subsided. The headache was ongoing but responds to 1000mg acetaminophen.   This case was linked to MOD-2021-375334 (Patient Link).   Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Myalgia, Retching
Clinical narrative: dry retching; Slept for about 18 hours; continue to felt ill; Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches; Headache; Profoundly fatigued; Chills; This spontaneous case was reported by a pharmacist and describes the occurrence of RETCHING (dry retching), HYPERSOMNIA (Slept for about 18 hours), MALAISE (continue to felt ill), MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for Flu prophylaxis.    No Medical History information was reported.   On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced RETCHING (dry retching), HYPERSOMNIA (Slept for about 18 hours), MALAISE (continue to felt ill), MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches), HEADACHE (Headache), FATIGUE (Profoundly fatigued) and CHILLS (Chills). The patient was treated with ACETAMINOPHEN for Headache, at a dose of 1000 milligram. At the time of the report, RETCHING (dry retching) had not resolved, HYPERSOMNIA (Slept for about 18 hours) and CHILLS (Chills) outcome was unknown, MALAISE (continue to felt ill), HEADACHE (Headache) and FATIGUE (Profoundly fatigued) was resolving and MYALGIA (Only waking up intermittently awaking up intermittently due to muscle achesdue to muscle aches) had resolved.        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.   Concomitant medication was not reported.  Patient received bivalent Moderna booster shot on the afternoon. This shot was given approximately 1 minute after the seasonal flu shot was administered.  Approximately 2 hours after vaccine administration patient experienced adverse events. Patient continue to felt ill, but am well enough now to get up and self-report.  While the fatigue was ongoing, it has improved significantly. The muscle aches have subsided. The headache was ongoing but responds to 1000mg acetaminophen.   This case was linked to MOD-2021-375334 (Patient Link).   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Tremor, Vaccination site erythema
Clinical narrative: shakes; sore left arm; chills; redness at injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TREMOR (shakes), PAIN IN EXTREMITY (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (redness at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20AH) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced TREMOR (shakes), PAIN IN EXTREMITY (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, TREMOR (shakes), PAIN IN EXTREMITY (sore left arm), CHILLS (chills) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-660555, MOD-2022-660557, MOD-2022-660560, MOD-2022-660563 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: right arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (right arm soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 939904, 015M20A and 030L20AH) for COVID-19 prophylaxis.     No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (right arm soreness). At the time of the report, PAIN IN EXTREMITY (right arm soreness) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-660549, MOD-2022-660555, MOD-2022-660557, MOD-2022-660563 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: My first booster also made my armpit swell but not as severe as this; Tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19) and LYMPHADENOPATHY (My first booster also made my armpit swell but not as severe as this) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 011J20A and 011J20A) for COVID-19 prophylaxis.     Patient had no chronic or long-standing health conditions.  Concurrent medical conditions included Allergy to animal.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced LYMPHADENOPATHY (My first booster also made my armpit swell but not as severe as this). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and LYMPHADENOPATHY (My first booster also made my armpit swell but not as severe as this) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         Patient had an Moderna distributed COVID-19 test on 05-Jan-2022.  No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-658670 (Patient Link).
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis. No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine) 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 WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine instead of receiving Moderna Covid-19 Vaccine, Bivalent, they got Moderna Covid-19 vaccine). Concomitant product use was not provided by the reporter. The patients were administered Moderna COVID-19 vaccine with blue capped purple-bordered (Ages 6-11 MONOVALENT) instead of receiving Moderna COVID-19 vaccine, bivalent.  Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Soreness and redness at the injection site; Soreness and redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Soreness and redness at the injection site) and VACCINATION SITE ERYTHEMA (Soreness and redness at the injection site) in an 80-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.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness and redness at the injection site) and VACCINATION SITE ERYTHEMA (Soreness and redness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and redness at the injection site) and VACCINATION SITE ERYTHEMA (Soreness and redness at the injection site) outcome was unknown.        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.   No concomitant medications were reported. On 21-Jan-2021, the patient received 1st dose of Moderna COVID-19 vaccine (Lot number 030L20AH; expiration date: not known; left arm). On 18-Feb-2021, the patient received 2nd dose of Moderna COVID-19 vaccine (Lot number: 015M20A; expiration date: not known; left arm). On 09-Nov-2021, the patient received 1st booster dose of Moderna COVID-19 vaccine (Lot number: 939904; expiration date: not known; left arm). On 18-Apr-2022, the patient received 2nd booster dose of Moderna COVID-19 vaccine (Lot number: 066K21A; expiration date: not known; right arm). On an unknown date, patient received the booster dose of Moderna COVID-19 vaccine, Bivalent. No treatment medications were reported.   This case was linked to MOD-2022-660549, MOD-2022-660555, MOD-2022-660557, MOD-2022-660560 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection) 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. AS7164B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Dose 1), Pfizer COVID-19 vaccine (Dose 3) and Pfizer COVID-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 17-Oct-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 17-Oct-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection) 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 INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The dose was administered using a 5/8ths inch needle and was suspected to have been given not by intramuscular injection).    No concomitant medications were provided. The patient received 4th dose of the Moderna COVID-19 vaccine on 16-Apr-2022.  No symptoms were reported. No additional doses, medications, or treatments taken at this time.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose on 22-JAN-2021 and second dose on 1-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-JAN-2021 and second dose on 1-MAR-2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Obesity. Concurrent medical conditions included Drug allergy (Name of Drug as Reported-No).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-JAN-2021 and second dose on 1-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 22-JAN-2021 and second dose on 1-MAR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medication was reported.  Patient received third dose as Moderna vaccine on 29-OCT-2021, and anatomical location was reported as right arm.  Patient received fourth dose as Moderna vaccine on 05-May-2022,  anatomical location was reported as right arm and vaccine administration time was 02:00 PM.  Patient started Pfizer Paxlovid drug on 6-SEP-2022 and stopped at 10-SEP-2022, indication used as treatment of COVID-19.  On 13-Oct-2022 Patient had Rebound COVID positive and outcome for this was reported as recovering/resolving.  No treatment medication were provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: No adverse event; First dose on 06-Feb-2021 and second dose on 02-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-Feb-2021 and second dose on 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13A21A and 024M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Overweight and Borderline diabetes.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-Feb-2021 and second dose on 02-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 06-Feb-2021 and second dose on 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, SARS-CoV-2 test: (Positive) Positive. On 11-Oct-2022, SARS-CoV-2 test: (Negative) tested negative at night. On 14-Oct-2022, SARS-CoV-2 test: (Positive) tested positive at night. No concomitant medications were reported.   The patient received Moderna dose 3 (Batch/Lot No: 033F21A) on 02-Nov-2021 and dose 4 (Batch/Lot No: 054A22A) on 06-Jun-2022.  On 05-Oct-2022, the patient experience symptoms and was tested positive on 06-Oct-2022. He received unspecified steroid shot and started Paxlovid treatment on the same day. The patient did not have major symptoms aside from slight cough and phlegm and was tested negative on 11-Oct-2022 at night. He continued to have slight cough and phlegm, tested positive on 11-Oct-2022 at night. The patient was not taking any medications/products within 2 weeks of starting COVID-19 treatment.   No treatment details were reported for event inappropriate schedule of vaccine administration.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine/monovalent received instead of bivalent; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose 1), COVID-19 VACCINE (Booster dose) and Pfizer COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    Concomitant medications details were not reported by the reporter.  The reporter was trying to find out if her children were given the monovalent or bivalent. She thought patient was given the wrong vaccine at the pharmacy. The pharmacy told that they gave the children the monovalent, but they were scheduled for the bivalent vaccine. The reporter stated her child received two Pfizer doses and a booster. She stated patient had no adverse reaction.  Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-660593, US-MODERNATX, INC.-MOD-2022-660597 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660593:Patient 2 US-MODERNATX, INC.-MOD-2022-660597:Patient 3
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine/monovalent received instead of bivalent; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (booster), Pfizer vaccine (Dose 2) and Pfizer vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Pfizer vaccine and Pfizer vaccine.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      No concomitant medication information provided. The reporter was trying to find out if her children were given the monovalent or bivalent. She thought patient was given the wrong vaccine at the pharmacy. The pharmacy told that they gave the children the monovalent, but they were scheduled for the bivalent vaccine. The reporter stated her child received two Pfizer doses and a booster. She stated patient did not experience any adverse reaction. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660584, US-MODERNATX, INC.-MOD-2022-660597 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660584:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-660597:Patient 3 (same reporter)
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) and NO ADVERSE EVENT (No adverse event) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered) 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 WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine / instead of receiving Moderna COVID-19 Vaccine, Bivalent, they got Moderna COVID-19 vaccine with Blue Capped Purple-Bordered).    No concomitant product reported by reporter.  Seven patient received Moderna COVID-19 vaccine with Blue Capped Purple-Bordered (Ages 6-11 years Monovalent) instead of receiving Moderna COVID-19 Vaccine Bivalent.  No treatment medication reported by reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Irritability
Clinical narrative: Erythema (getting red); Irritability (Irritated); This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Erythema (getting red)) and IRRITABILITY (Irritability (Irritated)) in a female patient of an unknown age 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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Erythema (getting red)) and IRRITABILITY (Irritability (Irritated)). At the time of the report, ERYTHEMA (Erythema (getting red)) and IRRITABILITY (Irritability (Irritated)) 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.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Peripheral swelling
Clinical narrative: limbs are swelling; suffering since she got the booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (limbs are swelling) and IMMUNISATION REACTION (suffering since she got the booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (limbs are swelling) and IMMUNISATION REACTION (suffering since she got the booster). At the time of the report, PERIPHERAL SWELLING (limbs are swelling) and IMMUNISATION REACTION (suffering since she got the booster) had not resolved.            No concomitant medications were reported. Patient had been suffering since she got the booster. It's been over a year. Her limbs were swelling. No treatment medications were reported.  The patient wants to see the toxicity data on the vaccine. The patient wants to know the inactive ingredients and the pharmacology.   This case was linked to MOD-2021-029577, MOD-2021-029584 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) 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)) 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients) 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 ACCIDENTAL UNDERDOSE (Moderna Covid-19 Vaccine, Bivalent 0.25mL, instead of 0.5mL to given adult patients).    No concomitant medication information provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient was administered bivalent vaccine beyond the 30 day use; No adverse event; Patient was administered bivalent vaccine beyond the 30 day use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine beyond the 30 day use), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2022, 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 14-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine beyond the 30 day use), PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use) 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 (Patient was administered bivalent vaccine beyond the 30 day use) and PRODUCT STORAGE ERROR (Patient was administered bivalent vaccine beyond the 30 day use).    No concomitant medications were reported. Vial size was reported as 2.5 ml. The vial was initially stored in the refrigerator on 13-Sep-2022 at 2:20pm. Use by date was reported as 13-Oct-2022. The vial did not undergo any temperature excursions. The patient was administered the vaccine before noon time. No treatment medications were reported. This case contains information for the 1st of 2 patients described by the reporter.