chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Underdose
Clinical narrative: No Adverse event; 9 individuals that received Moderna Bivalent Booster 0.25mL dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) and NO ADVERSE EVENT (No Adverse event) in a 35-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-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) .25 milliliter. On 13-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (9 individuals that received Moderna Bivalent Booster 0.25mL dose) 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 (9 individuals that received Moderna Bivalent Booster 0.25mL dose).    Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2022: Live follow-up received is significant. Batch/lot number was added.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: feverish; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Patient had no history of COVID-19. Patient had no history of Pericarditis or myocarditis.  The patient's past medical history included Shortness of breath (not diagnosed with Myocarditis or Pericarditis).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 ( Linked Report). This case was linked to MOD-2022-659965, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:crosslink case - MOD22-026769
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: feverish; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Patient had no history of COVID-19. Patient had no history of Pericarditis or myocarditis.  The patient's past medical history included Shortness of breath (not diagnosed with Myocarditis or Pericarditis).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 ( Linked Report). This case was linked to MOD-2022-659965, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:crosslink case - MOD22-026769
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Myalgia, Oropharyngeal pain, Productive cough
Clinical narrative: feverish; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Patient had no history of COVID-19. Patient had no history of Pericarditis or myocarditis.  The patient's past medical history included Shortness of breath (not diagnosed with Myocarditis or Pericarditis).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 ( Linked Report). This case was linked to MOD-2022-659965, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:crosslink case - MOD22-026769
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Sputum discoloured
Clinical narrative: feverish; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Patient had no history of COVID-19. Patient had no history of Pericarditis or myocarditis.  The patient's past medical history included Shortness of breath (not diagnosed with Myocarditis or Pericarditis).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (feverish). At the time of the report, PYREXIA (feverish) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 ( Linked Report). This case was linked to MOD-2022-659965, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:crosslink case - MOD22-026769
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: feverish; fatigue; sore muscles; First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath (It was not diagnosed with Myocarditis or Pericarditis).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (feverish), FATIGUE (fatigue) and MYALGIA (sore muscles). 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021). At the time of the report, PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient did not had a history of Covid-19 Patient did not had a history of Pericarditis or myocarditis   This case was linked to MOD-2022-659965, MOD-2022-659956 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: feverish; fatigue; sore muscles; First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath (It was not diagnosed with Myocarditis or Pericarditis).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (feverish), FATIGUE (fatigue) and MYALGIA (sore muscles). 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021). At the time of the report, PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient did not had a history of Covid-19 Patient did not had a history of Pericarditis or myocarditis   This case was linked to MOD-2022-659965, MOD-2022-659956 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Myalgia, Oropharyngeal pain, Productive cough
Clinical narrative: feverish; fatigue; sore muscles; First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath (It was not diagnosed with Myocarditis or Pericarditis).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (feverish), FATIGUE (fatigue) and MYALGIA (sore muscles). 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021). At the time of the report, PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient did not had a history of Covid-19 Patient did not had a history of Pericarditis or myocarditis   This case was linked to MOD-2022-659965, MOD-2022-659956 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Sputum discoloured
Clinical narrative: feverish; fatigue; sore muscles; First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Shortness of breath (It was not diagnosed with Myocarditis or Pericarditis).   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (feverish), FATIGUE (fatigue) and MYALGIA (sore muscles). 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021). At the time of the report, PYREXIA (feverish), FATIGUE (fatigue), MYALGIA (sore muscles) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of the primary series is 29MAR2021, Second dose of the Primary series received 6APR2021) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. Patient did not had a history of Covid-19 Patient did not had a history of Pericarditis or myocarditis   This case was linked to MOD-2022-659965, MOD-2022-659956 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Patient had a sore throat; Patient had a chronic cough; The patient had shortness of breath; excessive flem; the patient has been coughing up green flem; fever; soreness of muscle for 4 to 5 days; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 001C21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not had a history of COVID-19. Patient did not had a history or diagnosis of Pericarditis or myocarditis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced PYREXIA (fever) and MYALGIA (soreness of muscle for 4 to 5 days). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem). In April 2022, MYALGIA (soreness of muscle for 4 to 5 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem), SPUTUM DISCOLOURED (the patient has been coughing up green flem) and PYREXIA (fever) outcome was unknown.            Concomitant drugs were not reported.  Expiration date was not known for suspect drug. It was reported that patient had soreness of muscle for 4 to 5 days. Patient had shortness of breath however was not diagnosed with Myocarditis or Pericarditis.  Treatment medications were not provided..   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 (Linked Report). This case was linked to MOD-2022-659956, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:MOD22-026769 crosslink case
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Patient had a sore throat; Patient had a chronic cough; The patient had shortness of breath; excessive flem; the patient has been coughing up green flem; fever; soreness of muscle for 4 to 5 days; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 001C21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not had a history of COVID-19. Patient did not had a history or diagnosis of Pericarditis or myocarditis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced PYREXIA (fever) and MYALGIA (soreness of muscle for 4 to 5 days). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem). In April 2022, MYALGIA (soreness of muscle for 4 to 5 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem), SPUTUM DISCOLOURED (the patient has been coughing up green flem) and PYREXIA (fever) outcome was unknown.            Concomitant drugs were not reported.  Expiration date was not known for suspect drug. It was reported that patient had soreness of muscle for 4 to 5 days. Patient had shortness of breath however was not diagnosed with Myocarditis or Pericarditis.  Treatment medications were not provided..   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 (Linked Report). This case was linked to MOD-2022-659956, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:MOD22-026769 crosslink case
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Myalgia, Oropharyngeal pain, Productive cough
Clinical narrative: Patient had a sore throat; Patient had a chronic cough; The patient had shortness of breath; excessive flem; the patient has been coughing up green flem; fever; soreness of muscle for 4 to 5 days; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 001C21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not had a history of COVID-19. Patient did not had a history or diagnosis of Pericarditis or myocarditis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced PYREXIA (fever) and MYALGIA (soreness of muscle for 4 to 5 days). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem). In April 2022, MYALGIA (soreness of muscle for 4 to 5 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem), SPUTUM DISCOLOURED (the patient has been coughing up green flem) and PYREXIA (fever) outcome was unknown.            Concomitant drugs were not reported.  Expiration date was not known for suspect drug. It was reported that patient had soreness of muscle for 4 to 5 days. Patient had shortness of breath however was not diagnosed with Myocarditis or Pericarditis.  Treatment medications were not provided..   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 (Linked Report). This case was linked to MOD-2022-659956, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:MOD22-026769 crosslink case
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Sputum discoloured
Clinical narrative: Patient had a sore throat; Patient had a chronic cough; The patient had shortness of breath; excessive flem; the patient has been coughing up green flem; fever; soreness of muscle for 4 to 5 days; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 001C21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that patient did not had a history of COVID-19. Patient did not had a history or diagnosis of Pericarditis or myocarditis.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced PYREXIA (fever) and MYALGIA (soreness of muscle for 4 to 5 days). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem) and SPUTUM DISCOLOURED (the patient has been coughing up green flem). In April 2022, MYALGIA (soreness of muscle for 4 to 5 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Patient had a sore throat), COUGH (Patient had a chronic cough), DYSPNOEA (The patient had shortness of breath), PRODUCTIVE COUGH (excessive flem), SPUTUM DISCOLOURED (the patient has been coughing up green flem) and PYREXIA (fever) outcome was unknown.            Concomitant drugs were not reported.  Expiration date was not known for suspect drug. It was reported that patient had soreness of muscle for 4 to 5 days. Patient had shortness of breath however was not diagnosed with Myocarditis or Pericarditis.  Treatment medications were not provided..   This case was linked to US-MODERNATX, INC.-MOD-2022-659232 (Linked Report). This case was linked to MOD-2022-659956, MOD-2022-659964 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659232:MOD22-026769 crosslink case
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: patient wanted to receive second dose of primary series 6 months after first dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (patient wanted to receive second dose of primary series 6 months after first dose) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (patient wanted to receive second dose of primary series 6 months after first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (patient wanted to receive second dose of primary series 6 months after first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (patient wanted to receive second dose of primary series 6 months after first dose).    Concomitant medications details were not reported by the reporter.  Reportedly, Healthcare professional was not aware of any symptoms reported by patient after first dose.  Treatment details were not reported by the reporter.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received first dose of vaccine after 30 days by used date in the refrigerator/ stored in refrigerator on 15-Sep-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first dose of vaccine after 30 days by used date in the refrigerator/ stored in refrigerator on 15-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Spikevax) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first dose of vaccine after 30 days by used date in the refrigerator/ stored in refrigerator on 15-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received first dose of vaccine after 30 days by used date in the refrigerator/ stored in refrigerator on 15-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received first dose of vaccine after 30 days by used date in the refrigerator/ stored in refrigerator on 15-Sep-2022).    Concomitant medications details were not reported by the reporter.  Vial size was reported as 2.5mL.  Reportedly, the dose was given after the 30 day by used date in the refrigerator after being thawed on 15-Sep-2022. No reported symptoms. No additional doses were reported. No temperature excursions were noted.  Treatment details and medication details were not reported by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin, Urticaria
Clinical narrative: Felt like skin was hypersensitive; Hive like rash; This spontaneous case was reported by a patient and describes the occurrence of SENSITIVE SKIN (Felt like skin was hypersensitive) and URTICARIA (Hive like rash) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical history was reported.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced SENSITIVE SKIN (Felt like skin was hypersensitive) and URTICARIA (Hive like rash). In 2022, URTICARIA (Hive like rash) had resolved. At the time of the report, SENSITIVE SKIN (Felt like skin was hypersensitive) outcome was unknown.            Patient received the first two Moderna shot and then got the first booster Covid shot and about 3 weeks after receiving the booster shot, patient got a hive like rash, felt like skin was hypersensitive. The rash lasted about 4 and 1/2 months and then around 5 1/2 month it went away. Patient  dealt with it topically and put skin cream on it and it would go away with that.  It was reported that patient was thinking about getting the new booster shot but wanted to know if the new booster shot has the same make up as the older booster.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dyspnoea
Clinical narrative: she couldn't breathe, shortness of breath; sugar went up to 400-something; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (she couldn't breathe, shortness of breath) and BLOOD GLUCOSE INCREASED (sugar went up to 400-something) 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 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 DYSPNOEA (she couldn't breathe, shortness of breath) and BLOOD GLUCOSE INCREASED (sugar went up to 400-something). At the time of the report, DYSPNOEA (she couldn't breathe, shortness of breath) had not resolved and BLOOD GLUCOSE INCREASED (sugar went up to 400-something) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, Blood glucose: up to 400 something.         Concomitant medication was not reported.  Patient had a spell. Patient thought it was probably due to the shot. She hadn't been feeling good since vaccination day. She was still having shortness of breath. She doesn't felt well. She felt tired. She asked how long this will last.  Treatment drug was not reported.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Get a little itchy; Little red mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Get a little itchy) and VACCINATION SITE ERYTHEMA (Little red mark at the injection site) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 939906, 040B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration and Glaucoma. Concomitant products included BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), DORZOLAMIDE and LATANOPROST for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Get a little itchy) and VACCINATION SITE ERYTHEMA (Little red mark at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Get a little itchy) and VACCINATION SITE ERYTHEMA (Little red mark at the injection site) outcome was unknown.      No treatment information mentioned.  Patient got a little red mark at the injection site and would get itchy. The mark is still there and itches from time to time.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore right arm/right arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore right arm/right arm soreness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 015M20A, 013F21A and 066K21A) 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 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore right arm/right arm soreness). At the time of the report, PAIN IN EXTREMITY (sore right arm/right arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient took first booster dose and experienced right arm soreness. After second booster patient also experienced right arm soreness on 16-Apr-2022 outcome of those were unknown.  Treatment medications were not reported.   This case was linked to MOD-2022-660005 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore right arm/right arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore right arm/right arm soreness) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 015M20A, 013F21A and 066K21A) 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 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore right arm/right arm soreness). At the time of the report, PAIN IN EXTREMITY (sore right arm/right arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient took first booster dose and experienced right arm soreness. After second booster patient also experienced right arm soreness on 16-Apr-2022 outcome of those were unknown.  Treatment medications were not reported.   This case was linked to MOD-2022-660005 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: mild right arm soreness; feeling fatigued; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (mild right arm soreness) and FATIGUE (feeling fatigued) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030L20A) 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 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (mild right arm soreness) and FATIGUE (feeling fatigued). At the time of the report, PAIN IN EXTREMITY (mild right arm soreness) and FATIGUE (feeling fatigued) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-660002 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: mild right arm soreness; feeling fatigued; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (mild right arm soreness) and FATIGUE (feeling fatigued) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030L20A) 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 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (mild right arm soreness) and FATIGUE (feeling fatigued). At the time of the report, PAIN IN EXTREMITY (mild right arm soreness) and FATIGUE (feeling fatigued) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-660002 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004A21A, 002A21A and 030L20A) for COVID-19 vaccination.     The patient did not had known allergies to medications, food and other products.  Concurrent medical conditions included High cholesterol (Started 5 years ago, recent status: Stable). Concomitant products included PITAVASTATIN CALCIUM (LIVALO) for Cholesterol.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            The patient never had COVID positive test or diagnosed.  The patient received 4 doses of the Moderna COVID-19 vaccine and not experienced any severe reactions except may be a sore arm.  The patient received flu shot on 03-Oct-2022 and Bivalent booster on 14-oct-2022.  No treatment information was provided.   This case was linked to MOD-2022-659961 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2022, the patient experienced COVID-19 (tested positive for Covid). On 30-Sep-2022, COVID-19 (tested positive for Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2022, SARS-CoV-2 test: (Positive) positive. On 30-Sep-2022, SARS-CoV-2 test: (Negative) negative.         Concomitant medications were not reported.  It was reported that patient seeking location to receive his moderna bivalent booster, and was having hard time finding a location in their area. During the conversion, patient stated that he would have to wait 90 days as he was tested positive for Covid.  Lot numbers to moderna primary and boosters were unknown.  Patient not seeked medical care (office visit, Urgent care, ER, hospitalized).  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660202 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660202:MOD22-026797(Wife Case)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient is Immunocompramised and Received 1st booster instead of 3rd dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is Immunocompramised and Received 1st booster instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066021A, 026L20A and 013M20A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included Transplant (2 transplants). Concurrent medical conditions included Immunocompromised, Diabetes and Gastroparesis (Stomach Gastroparesis).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is Immunocompramised and Received 1st booster instead of 3rd dose). 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 is Immunocompramised and Received 1st booster instead of 3rd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that patient had received antibodies to protect her against COVID 19.   The dose patient received  on 15-Aug-2021 was first booster dose.  No concomitant drug was reported.  No treatment drug was reported.   This case was linked to MOD-2022-660003.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: After verifying 3 times (on the form, with the pharmacist and with the nurse administering the vaccine) the wrong dose was still given to me by this pharmacy. I requested 3 times, the 2nd dose of the Covid-19 vaccine. Instead, I was given the Bivalent booster. As I was told by the 2nd pharmacist when I returned later that day to get the Vaccination Record Card, because they had failed to give it to me when I was there for the vaccine earlier that morning.  **Section below will not allow the entry of the previous/1st dose date: 9/26/22.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Maternal exposure during pregnancy
Clinical narrative: Muscle soreness at the injection; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (Muscle soreness at the injection) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 049D22A, 031H21A, 028A21A and 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 13-Oct-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Oct-2022, the patient experienced INJECTION SITE PAIN (Muscle soreness at the injection) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 13-Oct-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, INJECTION SITE PAIN (Muscle soreness at the injection) outcome was unknown.            Concomitant and treatment medications were not provided.  Company Comment: This is a spontaneous case concerning a 33-year-old female patient with no reported medical history, who experienced the unexpected, non-serious event of Maternal exposure during pregnancy, after receiving the fourth dose of mRNA-1273 vaccine (mRNA-1273.222). The patient also reported to have injection site pain. Gestational age during exposure was not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 33-year-old female patient with no reported medical history, who experienced the unexpected, non-serious event of Maternal exposure during pregnancy, after receiving the fourth dose of mRNA-1273 vaccine (mRNA-1273.222). The patient also reported to have injection site pain. Gestational age during exposure was not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.