chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Prostatic specific antigen, Prostatic specific antigen decreased
Clinical narrative: PSA level had fallen; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN DECREASED (PSA level had fallen) 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)) for COVID-19 prophylaxis.     The patient's past medical history included TURP on 26-Jul-2019. Concurrent medical conditions included Enlarged prostate and Prostate cancer (non-aggressive mild form of Prostate Cancer).    On 12-Sep-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 20-Oct-2022, the patient experienced PROSTATIC SPECIFIC ANTIGEN DECREASED (PSA level had fallen). At the time of the report, PROSTATIC SPECIFIC ANTIGEN DECREASED (PSA level had fallen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2022, Prostatic specific antigen: 2.83 ng/mL.         Patient received a TURP procedure to reduce an enlarged Prostate. Unfortunately cancerous tissue was identified incidentally to that procedure [Gleason 3+3]. Patient's PSA has slowly increased suggested a non-aggressive mild form of Prostate Cancer.  PSA results included: On 22-Jan-2020:1.4 Aug 2020: 2.3 April 2021: 2.3 Oct2021: 2.8 April 22: 3.49ng/ml.  Patient was expecting PSA level to have increased gradually after vaccine administration. Patient not receiving medication (such as Finasteride or Dutasteride) just periodic 6 monthly checks of PSA levels. Treatment drug was not reported.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) 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 WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    Concomitant medications were not reported.  Patient received Moderna original 0.5ml doses instead of the bivalent booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Live follow up received is significant. Patient details were added.
Age: 64.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) 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 WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    Concomitant medications were not reported.  Patient received Moderna original 0.5ml doses instead of the bivalent booster.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-664520, US-MODERNATX, INC.-MOD-2022-664527, US-MODERNATX, INC.-MOD-2022-664529, US-MODERNATX, INC.-MOD-2022-664532 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Live follow up received is significant. Patient details were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664520:Patient 1 Same reporter US-MODERNATX, INC.-MOD-2022-664527:Patient-2 Same reporter US-MODERNATX, INC.-MOD-2022-664529:Patient-3 Same reporter US-MODERNATX, INC.-MOD-2022-664532:Patient-5 Same reporter
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Have a sore arm; Swelling in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Have a sore arm) and PERIPHERAL SWELLING (Swelling in the arm) in an 86-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.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer booster) and Pfizer (Pfizer vaccination). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    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 (Have a sore arm) and PERIPHERAL SWELLING (Swelling in the arm). At the time of the report, PAIN IN EXTREMITY (Have a sore arm) had not resolved and PERIPHERAL SWELLING (Swelling in the arm) was resolving.            Concomitant medications were not reported.  Treatment information was not provided.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) 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 WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    Concomitant medications were not reported.  Patient received Moderna original 0.5ml doses instead of the bivalent booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Live follow up received was contains Patient details were added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: She also had the same symptoms that he did; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (She also had the same symptoms that he did) in a 78-year-old female patient 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 IMMUNISATION REACTION (She also had the same symptoms that he did). At the time of the report, IMMUNISATION REACTION (She also had the same symptoms that he did) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medication use information was not reported.  Patient stated that his wife tested negative, but she also had the same symptoms that he did.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-664772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-664772: (Husband case)
Sex: U
Vaccine: COVID19
Symptoms: Stress fracture
Clinical narrative: Stress fracture at their back; This spontaneous case was reported by a consumer and describes the occurrence of STRESS FRACTURE (Stress fracture at their back) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced STRESS FRACTURE (Stress fracture at their back). At the time of the report, STRESS FRACTURE (Stress fracture at their back) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product label confusion
Clinical narrative: He reported that the vial label is confusing; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) 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 assessments were provided for INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing).    Concomitant Medication use information was not provided by reporter.  It was a Dark blue Cap and a label with purple border. On the vial label it stated, Booster dose only.  It was reported that received a shipment of NDC 80777-275--05 after receiving the Bivalent vials.  Treatment Medication use information was not provided by reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Vaccination site pain
Clinical narrative: muscle spasms; muscle pain; sore left arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle spasms), VACCINATION SITE PAIN (sore left arm) and MYALGIA (muscle pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 032M20A and 024M20A) for COVID-19 prophylaxis.     The patient's past medical history included Ear drum perforation. Concomitant products included TIMOLOL MALEATE and TESTOSTERONE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasms) and MYALGIA (muscle pain). At the time of the report, MUSCLE SPASMS (muscle spasms) and MYALGIA (muscle pain) had resolved and VACCINATION SITE PAIN (sore left arm) outcome was unknown.            The patient reported muscle spasms and muscle pain which started 2 weeks after the booster dose. Patient had a perforation in his left ear drum at the time that he received the Moderna Covid-19 vaccine.  Treatment drug was not reported.   This case was linked to MOD-2022-664794 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2022, the patient experienced COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in October 2022 for COVID-19 treatment, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2022, SARS-CoV-2 test: Positive. On 12-Oct-2022, SARS-CoV-2 test: Negative. On 14-Oct-2022, SARS-CoV-2 test: Positive. In October 2022, SARS-CoV-2 test: (Negative) tested negative again multiple times. On 24-Oct-2022, SARS-CoV-2 test: Negative.   No concomitant medications were provided. Patient had a negative test on 12-Oct-2022, took Paxlovid, and tested positive for COVID-19 on 14-Oct-2022. Then tested negative again on 24-Oct-2022 and had tested negative again multiple times since then.  Patient had taken Tylenol for his symptoms.   This case was linked to MOD-2022-665337 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2022, the patient experienced COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in October 2022 for COVID-19 treatment, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19 and experienced symptoms like a bad head cold and aches all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2022, SARS-CoV-2 test: Positive. On 12-Oct-2022, SARS-CoV-2 test: Negative. On 14-Oct-2022, SARS-CoV-2 test: Positive. In October 2022, SARS-CoV-2 test: (Negative) tested negative again multiple times. On 24-Oct-2022, SARS-CoV-2 test: Negative.   No concomitant medications were provided. Patient had a negative test on 12-Oct-2022, took Paxlovid, and tested positive for COVID-19 on 14-Oct-2022. Then tested negative again on 24-Oct-2022 and had tested negative again multiple times since then.  Patient had taken Tylenol for his symptoms.   This case was linked to MOD-2022-665337 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: No Adverse Event; Patient received first dose on 12-FEB-2021, second dose received on 2-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-FEB-2021, second dose received on 2-MAR-2021) and NO ADVERSE EVENT (No Adverse Event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 (Patient received first dose on 12-FEB-2021, second dose received on 2-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 (Patient received first dose on 12-FEB-2021, second dose received on 2-MAR-2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-665333 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Patient received first dose on 12-FEB-2021, second dose received on 2-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 12-FEB-2021, second dose received on 2-MAR-2021) and NO ADVERSE EVENT (No Adverse Event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 012M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 (Patient received first dose on 12-FEB-2021, second dose received on 2-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 (Patient received first dose on 12-FEB-2021, second dose received on 2-MAR-2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-665333 (Patient Link).
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a monovalent vaccine instead of a bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a monovalent vaccine instead of a bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     Patient does not have any allergies.  The patient's past medical history included Cat scratch fever. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, lot number-FK5127, Dose as 0.2 ml, route of administration as : Left deltoid.) on 08-Nov-2021, Pfizer (Dose 2, lot number-FL0007, Dose as 0.2 ml and route of administration as Right deltoid.) on 30-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Alpha thalassemia trait. Concomitant products included AZITHROMYCIN and INFLUENZA VACCINE for an unknown indication.    On 26-Oct-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a monovalent vaccine instead of a bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a monovalent vaccine instead of a bivalent 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 (Patient received a monovalent vaccine instead of a bivalent vaccine).    It was reported that patient had received the vaccine for 6 to 11 year monovalent vaccine at 0.5ml dose. The patient was supposed to receive a bivalent dose. The dose patient received on 26-Oct-2022 was first booster.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: given bivalent as 1st dose in the primary series; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (given bivalent as 1st dose in the primary series) and NO ADVERSE EVENT (No adverse event) 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 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first 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 INCORRECT DOSE ADMINISTERED (given bivalent as 1st dose in the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (given bivalent as 1st dose in the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 INCORRECT DOSE ADMINISTERED (given bivalent as 1st dose in the primary series).    No concomitant medication was reported. No treatment medication was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Muscle spasms, Musculoskeletal discomfort, Vaccination site pain
Clinical narrative: had spasm in feet; could not get comfortable in any position; spasms in his left shoulder where he had the injection, They continued all night; soreness in arms at vaccine site; This spontaneous case was reported by an other caregiver and describes the occurrence of MUSCLE SPASMS (had spasm in feet), DISCOMFORT (could not get comfortable in any position), MUSCULOSKELETAL DISCOMFORT (spasms in his left shoulder where he had the injection, They continued all night) and VACCINATION SITE PAIN (soreness in arms at vaccine site) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, 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 26-Oct-2022, the patient experienced MUSCLE SPASMS (had spasm in feet), DISCOMFORT (could not get comfortable in any position), MUSCULOSKELETAL DISCOMFORT (spasms in his left shoulder where he had the injection, They continued all night) and VACCINATION SITE PAIN (soreness in arms at vaccine site). At the time of the report, MUSCLE SPASMS (had spasm in feet), DISCOMFORT (could not get comfortable in any position), MUSCULOSKELETAL DISCOMFORT (spasms in his left shoulder where he had the injection, They continued all night) and VACCINATION SITE PAIN (soreness in arms at vaccine site) had not resolved.            No concomitant medication were reported.  Patient experienced the symptoms and they continued all night. No treatment was provided but reporter mentioned that she would give the patient Gatorade and Tylenol.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial at room temperature 2 hours 18 minutes prior to first puncture; No adverse event; COVID-19 vaccine given after 33 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator), PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022 at 3:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022 at 3:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator), PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (COVID-19 vaccine given after 33 days in the refrigerator) and PRODUCT STORAGE ERROR (Vial at room temperature 2 hours 18 minutes prior to first puncture).    Concomitant product use was not provided by the reporter.  The patient's age was reported as 2 years, 8 months.  The vial initially stored in refrigerator on 23-Sep-2022 at 12:31.  The vial stored at room temperature on 26-Oct-2022 at 13:32.  The vial at room temperature 2 hours 18 minutes prior to first puncture and on 26-Oct-2022 at 15:50 the vial first punctured.  The patient received vaccine from vial with blue cap/magenta border for 6 months-5 years.  Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient was administered vaccine after the 30 day beyond use date; No adverse event; patient was administered vaccine after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male 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 vaccination.     No Medical History information was reported.    On 21-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 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient was administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered vaccine after the 30 day beyond use date), PRODUCT STORAGE ERROR (patient was administered vaccine after the 30 day beyond use date) 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 vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (patient was administered vaccine after the 30 day beyond use date).    No concomitant medications were reported.  Individual vial was opened.  Vial size was reported as 2.5 ml.  The vial was initially stored in the refrigerator on 20-Sep-2022.  The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male 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 vaccination.     No Medical History information was reported.    On 21-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 21-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 30 day beyond use date) 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 (Vaccine administered after the 30 day beyond use date).    No concomitant medications were reported.  It was reported that patient received vaccine from opened individual vials of vial size 2.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo any temperature excursions. Patient was administered the vaccine as Second booster dose.  No treatment details were reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster) 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 (Patient received a 0.5ml dose of the monovalent Moderna COVID19 vaccine as a booster).    No concomitant medications were reported.  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; First primary dose received as Bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (First primary dose received as Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (First primary dose received as Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (First primary dose received as Bivalent booster) 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 WRONG PRODUCT ADMINISTERED (First primary dose received as Bivalent booster).    Concomitant drugs were not reported. It was reported that patient received bivalent booster and after administering reporter realized that patient never had a primary dose. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) 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 vaccination.     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 (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml) 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 (Patients received 0.25ml of Bivalent Moderna COVID-19 vaccine instead of 0.5 ml).    No concomitant medications were reported. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment drug details were reported. This case is reported for 19th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-665494 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665494:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 vaccination.     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 (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant medication was reported.    Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022. No treatment information was reported. This case was reported for 20th patient out of 20 patients.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 vaccination.     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 (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 (Received 0.25ml of Bivalent booster instead of 0.5 ml).    No concomitant medication was reported.     Vaccination date was reported as 01-SEP-2022 to 26-OCT-2022.  No treatment information was reported.  This case was reported for 9th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-665435, US-MODERNATX, INC.-MOD-2022-665399, US-MODERNATX, INC.-MOD-2022-665436, US-MODERNATX, INC.-MOD-2022-665437, US-MODERNATX, INC.-MOD-2022-665466, US-MODERNATX, INC.-MOD-2022-665472, US-MODERNATX, INC.-MOD-2022-665480, US-MODERNATX, INC.-MOD-2022-665491, US-MODERNATX, INC.-MOD-2022-665504, US-MODERNATX, INC.-MOD-2022-665519, US-MODERNATX, INC.-MOD-2022-665541, US-MODERNATX, INC.-MOD-2022-665611, US-MODERNATX, INC.-MOD-2022-665613, US-MODERNATX, INC.-MOD-2022-665659, US-MODERNATX, INC.-MOD-2022-665669, US-MODERNATX, INC.-MOD-2022-665686, US-MODERNATX, INC.-MOD-2022-665696, US-MODERNATX, INC.-MOD-2022-665704, US-MODERNATX, INC.-MOD-2022-665705 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665435: US-MODERNATX, INC.-MOD-2022-665399: US-MODERNATX, INC.-MOD-2022-665436: US-MODERNATX, INC.-MOD-2022-665437: US-MODERNATX, INC.-MOD-2022-665466: US-MODERNATX, INC.-MOD-2022-665472: US-MODERNATX, INC.-MOD-2022-665480: US-MODERNATX, INC.-MOD-2022-665491: US-MODERNATX, INC.-MOD-2022-665504: US-MODERNATX, INC.-MOD-2022-665519: US-MODERNATX, INC.-MOD-2022-665541: US-MODERNATX, INC.-MOD-2022-665611: US-MODERNATX, INC.-MOD-2022-665613: US-MODERNATX, INC.-MOD-2022-665659: US-MODERNATX, INC.-MOD-2022-665669: US-MODERNATX, INC.-MOD-2022-665686: US-MODERNATX, INC.-MOD-2022-665696: US-MODERNATX, INC.-MOD-2022-665704: US-MODERNATX, INC.-MOD-2022-665705:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 vaccination.     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 (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) 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 (Received 0.25ml of Bivalent booster instead of 0.5 ml).    Concomitant medication was not provided. It was reported that none of the patients were pregnant. Vaccination date was reported as 01-Sep-2022 to 26-Oct-2022. Treatment information was not provided. This case is reported for 10th patient out of 20 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-665494, US-MODERNATX, INC.-MOD-2022-665704 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665704:Same reporter US-MODERNATX, INC.-MOD-2022-665494: