chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy menstrual cycle) in a female patient of an unknown age 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 an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy menstrual cycle). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm is still itching at the injection site; Arm is still red at the injection site; Arm is still swollen at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm is still itching at the injection site), VACCINATION SITE ERYTHEMA (Arm is still red at the injection site) and VACCINATION SITE SWELLING (Arm is still swollen at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm is still itching at the injection site), VACCINATION SITE ERYTHEMA (Arm is still red at the injection site) and VACCINATION SITE SWELLING (Arm is still swollen at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Arm is still itching at the injection site), VACCINATION SITE ERYTHEMA (Arm is still red at the injection site) and VACCINATION SITE SWELLING (Arm is still swollen at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a patient of an unknown age and gender 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 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. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye infection, Eye pruritus, Lacrimation increased
Clinical narrative: Every since the shot my eyes are infected itchy watering; Itchy eyes; Watering eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Every since the shot my eyes are infected itchy watering), EYE PRURITUS (Itchy eyes) and LACRIMATION INCREASED (Watering eyes) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE INFECTION (Every since the shot my eyes are infected itchy watering), EYE PRURITUS (Itchy eyes) and LACRIMATION INCREASED (Watering eyes). At the time of the report, EYE INFECTION (Every since the shot my eyes are infected itchy watering), EYE PRURITUS (Itchy eyes) and LACRIMATION INCREASED (Watering eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Headache; Tired; Chilly; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Chilly) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Asthma since December 2007, Hypogammaglobulinemia since December 2018, Hypertension since 2005, High cholesterol, Herpes simplex type I (before 2000), Anxiety depression since 1995, Hypothyroidism (Before 2000), Trigeminal neuralgia since 2005 and GERD (before 2000). Concomitant products included SERTRALINE HCL for Anxiety depression, BUDESONIDE, ALBUTEROL SULFATE, SALBUTAMOL SULFATE (VENTOLIN HFA) and MONTELUKAST for Asthma, ATORVASTATIN for Cholesterol, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) for Eye disorder NOS, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, ACYCLOVIR [ACICLOVIR] for Herpes simplex type I, LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE for Hypertension, LEVOTHYROXINE for Hypothyroidism, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Seasonal allergy, MELATONIN for Sleep disorder, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and CALCIUM PHOSPHATE, TOCOPHERYL ACETATE (ENDUR VM) for Supplementation therapy, GABAPENTIN for Trigeminal neuralgia, UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Chilly). On 12-Mar-2021, PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Tired) and CHILLS (Chilly) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 100.9 (High) 100.9.         Other concomitant medication include Gamma Globulin with Prednisone for Hypogammaglobulinemia, Every three Weeks Infusion.  No Treatment medication information was reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received 28-JUL-2021 contain significant information and Patient information, Medical history ,Dose details, Concomitant medication and outcome of events updated from unknown to recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Angina pectoris, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Heart pain; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), ANGINA PECTORIS (Heart pain) and CHEST PAIN (Chest pain) in a 56-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) for Rheumatoid arthritis.    No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced CHEST PAIN (Chest pain). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and ANGINA PECTORIS (Heart pain). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), ANGINA PECTORIS (Heart pain) and CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 89.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Non serious diarrhea; Arm swelling; Arm turned red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Non serious diarrhea), VACCINATION SITE SWELLING (Arm swelling) and VACCINATION SITE ERYTHEMA (Arm turned red) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Waldenstrom's macroglobulinaemia.    No Medical History information was reported.   On an unknown date, the patient received first 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 IBRUTINIB (IMBRUVICA) (unknown route) 420 mg. On an unknown date, the patient experienced DIARRHOEA (Non serious diarrhea), VACCINATION SITE SWELLING (Arm swelling) and VACCINATION SITE ERYTHEMA (Arm turned red). At the time of the report, DIARRHOEA (Non serious diarrhea) and VACCINATION SITE ERYTHEMA (Arm turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Feeling abnormal; Tiredness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling abnormal) and FATIGUE (Tiredness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    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, the patient experienced FEELING ABNORMAL (Feeling abnormal) and FATIGUE (Tiredness). At the time of the report, FEELING ABNORMAL (Feeling abnormal) and FATIGUE (Tiredness) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Why am I vomiting?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Why am I vomiting?) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Why am I vomiting?). At the time of the report, VOMITING (Why am I vomiting?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Antibody test negative
Clinical narrative: Antibody test negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Antibody test negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Myelofibrosis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Antibody test negative). At the time of the report, ANTIBODY TEST NEGATIVE (Antibody test negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Productive cough
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (coughing up mucus), COUGH (coughing all through the night), FEELING ABNORMAL (this is not a good feeling) and HEADACHE (been sick with headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 27-Apr-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (coughing up mucus), COUGH (coughing all through the night), FEELING ABNORMAL (this is not a good feeling) and HEADACHE (been sick with headache). At the time of the report, PRODUCTIVE COUGH (coughing up mucus), COUGH (coughing all through the night), FEELING ABNORMAL (this is not a good feeling) and HEADACHE (been sick with headache) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Skin burning sensation
Clinical narrative: developed a cough; under both arms I have burning feeling on skin; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (developed a cough) and SKIN BURNING SENSATION (under both arms I have burning feeling on skin) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   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. On an unknown date, the patient experienced COUGH (developed a cough) and SKIN BURNING SENSATION (under both arms I have burning feeling on skin). At the time of the report, COUGH (developed a cough) and SKIN BURNING SENSATION (under both arms I have burning feeling on skin) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: left arm hurt with blood on second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (left arm hurt with blood on second shot) in a 62-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) injection for Panuveitis.    No medical history reported by reporter.    On an unknown date, the patient received first 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 ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (left arm hurt with blood on second shot). At the time of the report, VACCINATION SITE HAEMORRHAGE (left arm hurt with blood on second shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.   This case was linked to MOD-2021-165707 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient's arm is incredibly sore after receiving 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient's arm is incredibly sore after receiving 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient's arm is incredibly sore after receiving 1st dose). At the time of the report, VACCINATION SITE PAIN (Patient's arm is incredibly sore after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.   Patient wanted to know take pill for event.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects). At the time of the report, ADVERSE DRUG REACTION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. No treatment information provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Bad cough; Runny Nose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough) and RHINORRHOEA (Runny Nose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COUGH (Bad cough) and RHINORRHOEA (Runny Nose). At the time of the report, COUGH (Bad cough) and RHINORRHOEA (Runny Nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: no covid antibodies; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (no covid antibodies) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On an unknown date, the patient received first 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. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (no covid antibodies). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (no covid antibodies) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported  No treatment information was provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (She got Moderna's covid vaccine first shot and for her second dose she got Pfizer covid vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment information was provided.  Reporter's comment: She states that she can not fill out 3-4 pages of the form. She would like for someone from safety to call her and  for safety to fill out the form while on the call with her.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant follow up appended On 05-Aug-2021: Non significant follow up. Reporter's comment added. Corresponding fields and narrative were amended accordingly. On 05-Aug-2021: Non-significant follow- up . no new information received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching; swelling; tenderness at injection site; generalize malaise; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (generalize malaise), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (generalize malaise). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (generalize malaise), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swelling) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported    This case was linked to MOD-2021-018567 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like Symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U31620A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like Symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like Symptoms) outcome was unknown.            No concomitant medication reported  No treatment information was provided  COVID-19 Vaccination
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic aspiration, Dysphagia, Thyroid mass, Ultrasound thyroid
Clinical narrative: dysphagia; thyroid nodules; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (dysphagia) and THYROID MASS (thyroid nodules) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jan-2021, the patient experienced THYROID MASS (thyroid nodules). On 22-Jan-2021, the patient experienced DYSPHAGIA (dysphagia). On 18-Jan-2021, THYROID MASS (thyroid nodules) had resolved with sequelae. On 24-Jan-2021, DYSPHAGIA (dysphagia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Ultrasound thyroid: abnormal (abnormal) bilateral thyroid nodules most of which are below 1 cm.complex cystic nodule of right thyroid measures upto 3 cm. On 19-Jan-2021, Diagnostic aspiration: negative (Negative) NEGATIVE FOR MALIGNANT CELLS.         No Concomitant medications were reported No treatment medications were reported. Upon internal review on 4-Aug-21, the age was corrected to 38 years.   This case was linked to MOD-2021-023596 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Pain in arm; Tiredness; Fever; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain in arm), FATIGUE (Tiredness), PYREXIA (Fever) and HEADACHE (Headache) in a 65-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) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In February 2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), FATIGUE (Tiredness), PYREXIA (Fever) and HEADACHE (Headache). In February 2021, VACCINATION SITE PAIN (Pain in arm), FATIGUE (Tiredness), PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered VACCINATION SITE PAIN (Pain in arm), FATIGUE (Tiredness), PYREXIA (Fever) and HEADACHE (Headache) to be possibly related.    No concomitant medication reported  No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Chest is red; I am itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Chest is red) and PRURITUS (I am itching) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Chest is red) and PRURITUS (I am itching). At the time of the report, ERYTHEMA (Chest is red) and PRURITUS (I am itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.   Reporter did not allow further contact
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pruritus
Clinical narrative: Little itching; Headache; Knee pain/Elbow pain; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Little itching), HEADACHE (Headache) and ARTHRALGIA (Knee pain/Elbow pain) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM for an unknown indication.   On 28-Feb-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Little itching), HEADACHE (Headache) and ARTHRALGIA (Knee pain/Elbow pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PRURITUS (Little itching), HEADACHE (Headache) and ARTHRALGIA (Knee pain/Elbow pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-167283 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up accepted on 27-05-21
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Fatigue, Flatulence, Pruritus
Clinical narrative: little Itching; Belly ache; Lot of gas; Joint pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little Itching), ABDOMINAL PAIN (Belly ache), FLATULENCE (Lot of gas), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALPRAZOLAM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PRURITUS (little Itching), ABDOMINAL PAIN (Belly ache), FLATULENCE (Lot of gas), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PRURITUS (little Itching), ABDOMINAL PAIN (Belly ache), FLATULENCE (Lot of gas), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-167261 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Sharp pain in the back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sharp pain in the back) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Sharp pain in the back). At the time of the report, BACK PAIN (Sharp pain in the back) outcome was unknown.            Patient had a sharp pain in back about 8 hours after the second dose of Moderna on 2/24.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Muscle spasms, Pyrexia
Clinical narrative: I feel bad; cramps in legs; Like a fever; tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel bad), MUSCLE SPASMS (cramps in legs), PYREXIA (Like a fever) and FATIGUE (tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On an unknown date, the patient received first 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. On an unknown date, the patient experienced FEELING ABNORMAL (I feel bad), MUSCLE SPASMS (cramps in legs), PYREXIA (Like a fever) and FATIGUE (tired). At the time of the report, FEELING ABNORMAL (I feel bad), MUSCLE SPASMS (cramps in legs), PYREXIA (Like a fever) and FATIGUE (tired) outcome was unknown.            No treatment product information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: arm pain; body ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain), MYALGIA (body ache) and PYREXIA (Fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm pain), MYALGIA (body ache) and PYREXIA (Fever). The patient was treated with EMU OIL, TROLAMINE SALICYLATE (BLUE EMU CONTINUOUS PAIN RELIEF) for Pain, at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Pain, at an unspecified dose and frequency and LIDOCAINE for Pain, at an unspecified dose and frequency. On 20-Mar-2021, VACCINATION SITE PAIN (arm pain), MYALGIA (body ache) and PYREXIA (Fever) had resolved.            No concomitant medications reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-167601 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Neck pain, Tenderness, Vaccination site pain
Clinical narrative: severe arm pain after second dose; pain in back and neck; pain in back and neck; Tenderness in back and arm; muscle pain and soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (severe arm pain after second dose), NECK PAIN (pain in back and neck), BACK PAIN (pain in back and neck), TENDERNESS (Tenderness in back and arm) and MYALGIA (muscle pain and soreness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE PAIN (severe arm pain after second dose), NECK PAIN (pain in back and neck), BACK PAIN (pain in back and neck), TENDERNESS (Tenderness in back and arm) and MYALGIA (muscle pain and soreness). The patient was treated with EMU OIL, TROLAMINE SALICYLATE (BLUE EMU CONTINUOUS PAIN RELIEF) at an unspecified dose and frequency; CAMPHOR, MENTHOL, METHYL SALICYLATE (BENGAY [CAMPHOR;MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (severe arm pain after second dose), NECK PAIN (pain in back and neck), BACK PAIN (pain in back and neck), TENDERNESS (Tenderness in back and arm) and MYALGIA (muscle pain and soreness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant drug was not reported. Treatment information also include area cream.   This case was linked to MOD-2021-167548 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: full body rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (full body rash) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (full body rash). At the time of the report, RASH (full body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Computerised tomogram, Dehydration, Erythema, Feeling abnormal
Clinical narrative: acute parotitis; hurts to chew; Brain fog; brain issues; left side of jaw area is completely swollen/facial swelling; face turned red like sunburn; my body got dehydrated completely, same night was super dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (my body got dehydrated completely, same night was super dehydrated), ERYTHEMA (face turned red like sunburn), PAROTITIS (acute parotitis), SWELLING FACE (left side of jaw area is completely swollen/facial swelling) and MASTICATION DISORDER (hurts to chew) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DEHYDRATION (my body got dehydrated completely, same night was super dehydrated). On 21-May-2021, the patient experienced ERYTHEMA (face turned red like sunburn). On 24-May-2021, the patient experienced SWELLING FACE (left side of jaw area is completely swollen/facial swelling). On an unknown date, the patient experienced PAROTITIS (acute parotitis), MASTICATION DISORDER (hurts to chew), FEELING ABNORMAL (Brain fog) and CEREBRAL DISORDER (brain issues). At the time of the report, DEHYDRATION (my body got dehydrated completely, same night was super dehydrated), ERYTHEMA (face turned red like sunburn), PAROTITIS (acute parotitis), MASTICATION DISORDER (hurts to chew) and CEREBRAL DISORDER (brain issues) outcome was unknown, SWELLING FACE (left side of jaw area is completely swollen/facial swelling) had resolved and FEELING ABNORMAL (Brain fog) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: acute parotitis (abnormal) acute parotitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication included antibiotic, anti-inflammatory for acute parotitis   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received on 30-Jun-2021 included new event
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Mastication disorder, Parotitis, Swelling face
Clinical narrative: acute parotitis; hurts to chew; Brain fog; brain issues; left side of jaw area is completely swollen/facial swelling; face turned red like sunburn; my body got dehydrated completely, same night was super dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (my body got dehydrated completely, same night was super dehydrated), ERYTHEMA (face turned red like sunburn), PAROTITIS (acute parotitis), SWELLING FACE (left side of jaw area is completely swollen/facial swelling) and MASTICATION DISORDER (hurts to chew) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DEHYDRATION (my body got dehydrated completely, same night was super dehydrated). On 21-May-2021, the patient experienced ERYTHEMA (face turned red like sunburn). On 24-May-2021, the patient experienced SWELLING FACE (left side of jaw area is completely swollen/facial swelling). On an unknown date, the patient experienced PAROTITIS (acute parotitis), MASTICATION DISORDER (hurts to chew), FEELING ABNORMAL (Brain fog) and CEREBRAL DISORDER (brain issues). At the time of the report, DEHYDRATION (my body got dehydrated completely, same night was super dehydrated), ERYTHEMA (face turned red like sunburn), PAROTITIS (acute parotitis), MASTICATION DISORDER (hurts to chew) and CEREBRAL DISORDER (brain issues) outcome was unknown, SWELLING FACE (left side of jaw area is completely swollen/facial swelling) had resolved and FEELING ABNORMAL (Brain fog) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: acute parotitis (abnormal) acute parotitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication included antibiotic, anti-inflammatory for acute parotitis   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received on 30-Jun-2021 included new event
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: All over body rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (All over body rash) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (All over body rash). At the time of the report, RASH (All over body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Feeling abnormal, Headache, Paraesthesia, Vaccination site reaction
Clinical narrative: tingling in hands and feet that lasted for weeks; had brain fog; had a lot of reactions; covid arm; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PARAESTHESIA (tingling in hands and feet that lasted for weeks), FEELING ABNORMAL (had brain fog), ADVERSE REACTION (had a lot of reactions), VACCINATION SITE REACTION (covid arm) and HEADACHE (Headache) in a 26-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in hands and feet that lasted for weeks), FEELING ABNORMAL (had brain fog), ADVERSE REACTION (had a lot of reactions), VACCINATION SITE REACTION (covid arm) and HEADACHE (Headache). At the time of the report, PARAESTHESIA (tingling in hands and feet that lasted for weeks), FEELING ABNORMAL (had brain fog), ADVERSE REACTION (had a lot of reactions), VACCINATION SITE REACTION (covid arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not administered with 35 days interval; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not administered with 35 days interval) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history provided by the reporter. .     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered with 35 days interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not administered with 35 days interval) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No other concomitant medical  provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up received on 25-MAY-2021 and contain no new information
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Nausea
Clinical narrative: sick; severe fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), FATIGUE (severe fatigue) and NAUSEA (nausea) in a male patient of an unknown age 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 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. On an unknown date, the patient experienced ILLNESS (sick), FATIGUE (severe fatigue) and NAUSEA (nausea). At the time of the report, ILLNESS (sick), FATIGUE (severe fatigue) and NAUSEA (nausea) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non- significant followup