chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Glomerular filtration rate decreased, Glucose urine absent, Haematocrit decreased, Haemoglobin decreased, International normalised ratio increased
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Lung disorder, Lymphocyte count, Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Metabolic acidosis, Metabolic function test
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Mitral valve calcification, Monocyte count decreased, Monocyte percentage, Neutrophil count, Neutrophil percentage increased
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nitrite urine absent, PCO2 decreased, PO2, Platelet count decreased, Pneumonia bacterial
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Procalcitonin, Protein total decreased, Protein urine present, Prothrombin time prolonged, Red blood cell count decreased
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cells urine positive, Red cell distribution width increased, SARS-CoV-2 test positive, Specific gravity urine normal, Troponin I increased
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Urinary sediment present, Urine analysis, Urine ketone body, Urine leukocyte esterase
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Urobilinogen urine, Ventilation/perfusion scan, White blood cell count normal, White blood cells urine positive, pH urine normal
Clinical narrative: 90 y.o.    Admit Date:  7/1/2022   Discharge Date:   7/2/2022   Discharge Diagnosis:  Principal Problem:   NSTEMI (non-ST elevated myocardial infarction) Active Problems:   Pneumonia, bacterial   Acute respiratory failure with hypoxia   Alzheimer's dementia   Hospice care patient   Elevated d-dimer   Metabolic acidosis   AKI (acute kidney injury)   CHF, acute   COVID-19 virus infection     Hospital Course:  90 year old female with hospice care was transferred here for NSTEMI. Family decidde to take her back home with hospice today. She is unresponsive.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.7 °F (36.5 °C) Heart Rate (Monitor): 102 Pulse: 99 BP: 111/51 Respirations: 16 SpO2: 90 % O2 Flow Rate (l/min): 2 l/min General Appearance: unconscious  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema   Consults:  IP CONSULT TO SUPPORTIVE CARE SERVICES   Significant Diagnostic Studies:   VQ scan, CXR   Operations: none   Disposition:  Home with hospice   Discharge Condition:  Poor
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) 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 (Received expired 2nd dose, after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022). Concomitant drugs were not reported. It was reported that a 3 year of age patient received expired second dose on 22-Aug-2022 around 9AM which was initially stored in refrigerator on 18-Jul-2022 at 1:30PM.The 2 doses were given from 1 vial and the vial did not undergo any temperature excursions. Treatment medications were not provided. This case was linked to MODERNATX, INC.-MOD-2022-631763 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-631763:Patient-1 case.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Decreased appetite, Joint swelling, Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of JOINT SWELLING (Ankles were swollen), DECREASED APPETITE (Lost appetite), ABDOMINAL PAIN (Some pain in the abdominal area), ARTHRALGIA (Knee pain/Up until now when the patient walks, slight has ankle and knee pain) and PAIN IN EXTREMITY (Sharp pain in both arms/Still slight pain in arms and hands) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 031H21A, 002B21A and 011M20A) for COVID-19 prophylaxis.  Allergies: none and the patient medical history was provided as none.  On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form On 25-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced DECREASED APPETITE (Lost appetite). On 25-Jun-2022, the patient experienced JOINT SWELLING (Ankles were swollen), ABDOMINAL PAIN (Some pain in the abdominal area), ARTHRALGIA (Knee pain/Up until now when the patient walks, slight has ankle and knee pain) and PAIN IN EXTREMITY (Sharp pain in both arms/Still slight pain in arms and hands). At the time of the report, JOINT SWELLING (Ankles were swollen), ARTHRALGIA (Knee pain/Up until now when the patient walks, slight has ankle and knee pain) and PAIN IN EXTREMITY (Sharp pain in both arms/Still slight pain in arms and hands) was resolving, DECREASED APPETITE (Lost appetite) outcome was unknown and ABDOMINAL PAIN (Some pain in the abdominal area) had not resolved. The patient never had COVID positive test or diagnosis. It was reported that no other vaccines were given within one month prior to Moderna COVID-19 vaccine. No concomitant medications were reported. It was reported by the patient that everything had went well after two Moderna doses and first booster. On 22-Jun-2022, the patient went to see doctor, who told to get the patient a second booster. As the patient was leaving the pharmacy, the patient noticed that ankles were swollen, and had knee pain. It was getting worse than better, so the patient went back to the doctor that took well over a month for the swelling to go down. It was further reported that for the first day or two, there was a sharp pain in both arms, but it disappeared. The patient had pain in the abdominal area, which the patient never had in the past. The patient never had difficulty with legs at all. It was also reported that for the pain (knee, arm, hand, abdominal area), the patient had to seek medical care and had a doctor call on 25-Jun-2022 and these symptoms had improved but still going. No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 058H21A, 008C21A and 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, the patient experienced COVID-19 (tested positive for Covid). On 16-Aug-2022, COVID-19 (tested positive for Covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported. It was reported that, sometime after 30-Jul-2022 patient tested positive for COVID, and it lasted 16 days. Patient felt like he had strep throat. Further patient stated that it could have been 01-Aug-2022 when he tested positive. No treatment medications were reported. Company Comment: This is a spontaneous case concerning a 65-year-old male patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result approximately 4 months after receiving the fourth dose of the mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event has resolved. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with no reported medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19. SARS-CoV-2 test yielded a positive result approximately 4 months after receiving the fourth dose of the mRNA-1273 vaccine, no further information on risk factors, co morbidities, clinical course and management of the events was available in the report. It was reported that the outcome of the event has resolved. The current COVID-19 pandemic of remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 1.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 1-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2022 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022) 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 (Received expired 2nd dose, after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial initially stored on 18-Jul-2022 and then administered on 22-Aug-2022). Concomitant drugs were not reported. It was reported that a 1.5 year of age patient received expired second dose on 22-Aug-2022 around 9AM which was initially stored in refrigerator on 18-Jul-2022 at 1:30PM. The 2 doses were given from 1 vial and the vial did not undergo any temperature excursions. Treatment medications were not provided. This case was linked to MODERNATX, INC.-MOD-2022-631757 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-631757:Patient-1 case.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Drug ineffective
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication. 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING). At the time of the report, CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) outcome was unknown. No concomitant medication were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of Humira was not working and flare up with Humira for co suspect Humira was not provided. No treatment details were provided. Company Comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, with reported Co-suspect product included non-company product ADALIMUMAB (Humira), who experienced non-serious, unexpected events of CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) with vaccination with the dose 1 and dose 2 of mRNA-1273 vaccine. No other details regarding the events were reported. Event of Condition aggravated was reported as related by the reporter.  Outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, with reported Co-suspect product included non-company product ADALIMUMAB (Humira), who experienced non-serious, unexpected events of CONDITION AGGRAVATED (FLARE UP with HUMIRA) and DRUG INEFFECTIVE (HUMIRA WAS NOT WORKING) with vaccination with the dose 1 and dose 2 of mRNA-1273 vaccine. No other details regarding the events were reported. Event of Condition aggravated was reported as related by the reporter. Outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On 13-Aug-2022, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) was resolving.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported.  The reporter causality for the event of COVID with HUMIRA was not provided.  No treatment information was reported.  CC: This spontaneous case concerns a 35 year old female patient, with a relevant history of adalimumab use for rheumatoid arthritis, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the second dose of mRNA-1273 vaccine administration.  No treatment medications were reported. The ongoing COVID-19 pandemic and history of history of adalimumab use (immunosuppressant) could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 35 year old female patient, with a relevant history of adalimumab use for rheumatoid arthritis, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after the second dose of mRNA-1273 vaccine administration.  No treatment medications were reported. The ongoing COVID-19 pandemic and history of history of adalimumab use (immunosuppressant) could be confounders for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022; No adverse event; Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022) 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 (Nursing staff administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-JUL-2022 and administered on 15-Aug-2022).    No concomitant information was reported. The reporter was unsure of which injection in the series was this for the patient.  The vial was initially stored in the refrigerator on 15-JUL-2022. The vial did not underwent any temperature excursions. No other adverse reactions reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-632600 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-632600:same reporter
Sex: F
Vaccine: COVID19, UNK
Symptoms: Epistaxis, Injection site pain, Temperature intolerance
Clinical narrative: Heat sensitivity; Nose bleeds in dry heat; Sore arm at injection site with Humira; This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (Heat sensitivity), EPISTAXIS (Nose bleeds in dry heat) and INJECTION SITE PAIN (Sore arm at injection site with Humira) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced TEMPERATURE INTOLERANCE (Heat sensitivity), EPISTAXIS (Nose bleeds in dry heat) and INJECTION SITE PAIN (Sore arm at injection site with Humira). At the time of the report, TEMPERATURE INTOLERANCE (Heat sensitivity) and INJECTION SITE PAIN (Sore arm at injection site with Humira) outcome was unknown and EPISTAXIS (Nose bleeds in dry heat) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of nose bleeds in dry heat with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of sore arm at injection site and nose bleeds in dry heat was not provided. Treatment medications were not reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This vial had spent more than 30 days in the refrigerator; No adverse event; This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022), PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination. It was reported that patient had no allergies to medications, food, and other products. It was unknown if patient had been ever diagnosed with/ tested positive for COVID-19. Patient had no acute illnesses, chronic or long-standing health conditions at the time of vaccination and up to one month before. On 11-Jul-2022 at 11:47 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 15-Aug-2022 at 9:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 25 microgram. On 15-Aug-2022 at 9:35 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022), PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022) and PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator). Patient was not taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies  at time of vaccination and/or at the time of the adverse event. Patient race was reported. Vial was initially stored in the refrigerator on 14JUL 2022 and vial did not undergo any temperature excursions. That vial had spent more than 30 days in the refrigerator and the 30 day BUD was 14 AUG 2022.  No reported symptoms. No additional doses, medications, or treatments had been administered at that time.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse reaction) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. On 19-Aug-2022 at 9:18 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022 at 9:18 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator after puncture).  No concomitant medications were reported. Number of doses/vials includes 2 doses from 1 vial. Date the vial was initially stored in the refrigerator was reported as 04-Aug-2022. Date and time vial was first punctured was reported as 18-Aug-2022 at 10:30 AM. Vial was stored in fridge post puncture. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8degree to 25 degree Celsius which was 46degree to 77degree Fahrenheit) was total of 30 minutes. Vial was not exposed to room temperature for more than 24 hours. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2022: Live follow up received contains significant information: Added patient demographics, suspect product dose details and narrative updated.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30-day BUD was 14-Aug-2022), PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination. Patient did not have allergies to medications, food and other products. Unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health condition. On 11-Jul-2022 at 11:46 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 15-Aug-2022 at 9:33 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 25 microgram. On 15-Aug-2022 at 9:33 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30-day BUD was 14-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30-day BUD was 14-Aug-2022), PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30-day BUD was 14-Aug-2022) and PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator). Patient was not taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination and/or at the time of the adverse event. Patient race was reported as "private". Vial was initially stored in the refrigerator on 14-Jul-2022 and vial did not undergo any temperature excursions. That vial had spent more than 30 days in the refrigerator and the 30-day BUD was 14-Aug-2022. No reported symptoms. No additional doses, medications, or treatments had been administered at that time. This case was linked to US-MODERNATX, INC.-MOD-2022-629582 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-629582: Master case.
Sex: U
Vaccine: COVID19
Symptoms: Blood electrolytes, Blood electrolytes decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLOOD ELECTROLYTES DECREASED (Electrolytes were drained from body) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD ELECTROLYTES DECREASED (Electrolytes were drained from body). At the time of the report, BLOOD ELECTROLYTES DECREASED (Electrolytes were drained from body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood electrolytes: Drained from body. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. It was reported that on an unspecified date patient received MODERNA COVID-19 VACCINE  at an unspecified dose or frequency. It was reported that the patient stated 24 hours after receiving first dose of Moderna vaccine, patient electrolytes were drained from body. HCP advised against second dose of Moderna covid vaccine series because of potential for heart attack. No treatment information was reported. Reporter did not allow further contact.
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: More than 30 days in the refrigerator; No adverse event; Moderna COVID-19 more than 30 days in the refrigerator and administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered), PRODUCT STORAGE ERROR (More than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No medical history reported by reporter. Patient did not have allergies to medications, food and other products. Unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health condition.  No prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.     On 15-Aug-2022 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 15-Aug-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (More than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered), PRODUCT STORAGE ERROR (More than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 more than 30 days in the refrigerator and administered) and PRODUCT STORAGE ERROR (More than 30 days in the refrigerator).    No Concomitant medications were provided. Patient age was reported as 1 year 10months. Patient race was reported. Vial was initially stored in the refrigerator on 14JUL 2022 and vial did not undergo any temperature excursions. That vial had spent more than 30 days in the refrigerator and the 30 day BUD was 14AUG2022.  No reported symptoms. No additional doses, medications, or treatments had been administered at that time.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     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 ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  On 05-AUG-2022, it was reported that a patient started treatment on an unspecified date with Moderna COVID-19 vaccine at unspecified 1 dose/frequency for unknown indication. It was reported that the patient had an anaphylactic reaction to the Moderna Covid-19 vaccine.  No treatment medication information was reported.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction which occurred unknown number of minutes/days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the expected serious (medically significant) event of Anaphylactic reaction which occurred unknown number of minutes/days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Upset stomach; Headache; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 032M20A and 024M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX) for Migraine, ATORVASTATIN, VITAMIN D3, BUTALBITAL, CAFFEINE, PARACETAMOL (BUTALBITAL, ACETAMINOPHEN AND CAFFEINE) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, 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 experienced ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) and HEADACHE (Headache) outcome was unknown.        Concomitant medication included OTC women complete multivitamin. No treatment medication were provided.   This case was linked to MOD-2022-623883 (Patient Link).