chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: has sore arm; husband has chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (has sore arm) and CHILLS (husband has chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (has sore arm) and CHILLS (husband has chills). At the time of the report, PAIN IN EXTREMITY (has sore arm) and CHILLS (husband has chills) outcome was unknown.            No concomitant medications was reported Treatment information was not provided. Patient was not for safety to follow up with doctor   This case was linked to MOD-2021-039222 (E2B Linked Report).; Sender's Comments:  MOD-2021-039222:This MOD-2021-039222 case is cross linked with this MOD-2021-040693 case.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate increased
Clinical narrative: Intermittent rapid heart rate; internal chills with normal temperature; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Intermittent rapid heart rate) and CHILLS (internal chills with normal temperature) 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 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced HEART RATE INCREASED (Intermittent rapid heart rate) and CHILLS (internal chills with normal temperature). At the time of the report, HEART RATE INCREASED (Intermittent rapid heart rate) and CHILLS (internal chills with normal temperature) had not resolved.            No concomitant medications were provided.  No treatment was reported for the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Therapeutic response unexpected
Clinical narrative: Lump in her arm; after having the 1st vaccine, for 2 days, her eczema went away; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Lump in her arm) and THERAPEUTIC RESPONSE UNEXPECTED (after having the 1st vaccine, for 2 days, her eczema went away) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12A21A) for COVID-19 vaccination.     The patient's past medical history included Eczema.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (Lump in her arm) and THERAPEUTIC RESPONSE UNEXPECTED (after having the 1st vaccine, for 2 days, her eczema went away). At the time of the report, PERIPHERAL SWELLING (Lump in her arm) and THERAPEUTIC RESPONSE UNEXPECTED (after having the 1st vaccine, for 2 days, her eczema went away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reports that after taking the vaccine she no longer has eczema, and has no more stuffy sinuses. Concomitant and treatment information not provided   This case was linked to MOD-2021-104857 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Significant information includes: 2nd dose details given
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PAIN IN EXTREMITY (arm is sore). At the time of the report, PAIN IN EXTREMITY (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fall, Gait inability, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), FALL (He fell Friday), GAIT INABILITY (Could not ambulate for 2 weeks) and PYREXIA (Had a fever for 12 hours) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. Concurrent medical conditions included Cold agglutinin disease. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset). On 19-Feb-2021, the patient experienced FALL (He fell Friday). On 22-Feb-2021, the patient experienced GAIT INABILITY (Could not ambulate for 2 weeks) and PYREXIA (Had a fever for 12 hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. On 19-Feb-2021, FALL (He fell Friday) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), GAIT INABILITY (Could not ambulate for 2 weeks) and PYREXIA (Had a fever for 12 hours) had resolved. Concomitant product used was not provided by the reporter. On 23-Feb-2021, the patient ended up in the ER (Emergency Room) where a CAT scan, urine analysis, blood work and ECG were performed. All with normal results. He is now able to walk with a walker. This case was linked to MOD-2021-211092. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Updated medical history, lot number and location of vaccination, outcome for events of stomach upset and could not ambulate were updated to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Wanting to pick up baby but brain would not allow her; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Wanting to pick up baby but brain would not allow her) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CONFUSIONAL STATE (Wanting to pick up baby but brain would not allow her). At the time of the report, CONFUSIONAL STATE (Wanting to pick up baby but brain would not allow her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Very rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Very rapid heart beat) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEART RATE INCREASED (Very rapid heart beat). At the time of the report, HEART RATE INCREASED (Very rapid heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Illness, Nasopharyngitis
Clinical narrative: having to walk with a cane; are really cold; feeling really sick; are really dizzy; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (feeling really sick), DIZZINESS (are really dizzy), GAIT DISTURBANCE (having to walk with a cane) and NASOPHARYNGITIS (are really cold) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 10-Mar-2021, the patient experienced ILLNESS (feeling really sick), DIZZINESS (are really dizzy) and NASOPHARYNGITIS (are really cold). On an unknown date, the patient experienced GAIT DISTURBANCE (having to walk with a cane). At the time of the report, ILLNESS (feeling really sick), DIZZINESS (are really dizzy), GAIT DISTURBANCE (having to walk with a cane) and NASOPHARYNGITIS (are really cold) had not resolved.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; Tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE PAIN (Tenderness at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE PAIN (Tenderness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) had resolved and VACCINATION SITE PAIN (Tenderness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Sleep disorder
Clinical narrative: The ticking is like when you are falling asleep and suddenly starts the tickling feeling; Really sore arm; Nausea; Hours after the 2nd dose, the ticking has come back, stronger and sooner than the 1st time ( with the 1st dose) / the ticking is stronger on the opposite side of the vaccine administration , but it is on both hands; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Hours after the 2nd dose, the ticking has come back, stronger and sooner than the 1st time ( with the 1st dose) / the ticking is stronger on the opposite side of the vaccine administration , but it is on both hands), SLEEP DISORDER (The ticking is like when you are falling asleep and suddenly starts the tickling feeling), PAIN IN EXTREMITY (Really sore arm) and NAUSEA (Nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. does not have the card) for COVID-19 vaccination.     Concomitant products included CALCIUM LEVOMEFOLATE (METHYL FOLATE) and ETHINYLESTRADIOL, NORETHISTERONE ACETATE (MICROGESTIN) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PARAESTHESIA (Hours after the 2nd dose, the ticking has come back, stronger and sooner than the 1st time ( with the 1st dose) / the ticking is stronger on the opposite side of the vaccine administration , but it is on both hands), PAIN IN EXTREMITY (Really sore arm) and NAUSEA (Nausea). On an unknown date, the patient experienced SLEEP DISORDER (The ticking is like when you are falling asleep and suddenly starts the tickling feeling). At the time of the report, PARAESTHESIA (Hours after the 2nd dose, the ticking has come back, stronger and sooner than the 1st time ( with the 1st dose) / the ticking is stronger on the opposite side of the vaccine administration , but it is on both hands), SLEEP DISORDER (The ticking is like when you are falling asleep and suddenly starts the tickling feeling), PAIN IN EXTREMITY (Really sore arm) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication reported was acetaminophen (Tylenol) on 11-Mar-2021.   This case was linked to MOD-2021-040678 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: my arthritis has gotten much better; my arthritis has gotten much better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (my arthritis has gotten much better) and PRE-EXISTING CONDITION IMPROVED (my arthritis has gotten much better) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis and Arthritis. Concomitant products included GABAPENTIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, IBUPROFEN and PARACETAMOL (TYLENOL) for an unknown indication.   On 03-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 03-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (my arthritis has gotten much better) and PRE-EXISTING CONDITION IMPROVED (my arthritis has gotten much better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (my arthritis has gotten much better) and PRE-EXISTING CONDITION IMPROVED (my arthritis has gotten much better) outcome was unknown.            The patient reported that after her second dose of mRNA-1273 her arthritis has gotten much better. Consent given for Safety follow-up with patient. Consent given for Safety follow-up with HCP.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: a lot of body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a lot of body aches) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE, AMLODIPINE, CITALOPRAM, LEVOTHYROXINE, VALACICLOVIR HYDROCHLORIDE (VALTREX), PREGABALIN, ATORVASTATIN CALCIUM (LIPITOR), ROPINIROLE, LOSARTAN and TIZANIDINE for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (a lot of body aches) and NAUSEA (nausea). On 12-Mar-2021, MYALGIA (a lot of body aches) and NAUSEA (nausea) had resolved.            No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Initial additional
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: temp of 100; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temp of 100), FATIGUE (tired) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (temp of 100), FATIGUE (tired) and HEADACHE (headache). At the time of the report, PYREXIA (temp of 100), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 100 Temp of 100.         No concomitant medication use was provided by the reporter.  Treatment of events was not reported though patient inquired if taking acetaminophen (Tylenol) was okay.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included QUINAPRIL, BISOPROLOL FUMARATE, FUROSEMIDE, LEVOTHYROXINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication reported was Green Girl B supplement (curcumin, black pepper, resveratrol and enzymes).  Patient has not received any treatment for her symptom.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Disorientation, Fatigue, Headache
Clinical narrative: Dry heaves; Loss of appetite; Difficulty sleeping; Muscle aches; Joint aches; Fatigue; Headache; Nausea; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain fog), RETCHING (Dry heaves), DECREASED APPETITE (Loss of appetite), INSOMNIA (Difficulty sleeping) and MYALGIA (Muscle aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastroesophageal reflux disease.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DISORIENTATION (Brain fog), INSOMNIA (Difficulty sleeping), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 07-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite). On 11-Mar-2021, the patient experienced RETCHING (Dry heaves). On 14-Feb-2021, MYALGIA (Muscle aches) and ARTHRALGIA (Joint aches) had resolved. At the time of the report, DISORIENTATION (Brain fog), RETCHING (Dry heaves), DECREASED APPETITE (Loss of appetite), INSOMNIA (Difficulty sleeping), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nausea, Retching
Clinical narrative: Dry heaves; Loss of appetite; Difficulty sleeping; Muscle aches; Joint aches; Fatigue; Headache; Nausea; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain fog), RETCHING (Dry heaves), DECREASED APPETITE (Loss of appetite), INSOMNIA (Difficulty sleeping) and MYALGIA (Muscle aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastroesophageal reflux disease.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DISORIENTATION (Brain fog), INSOMNIA (Difficulty sleeping), MYALGIA (Muscle aches), ARTHRALGIA (Joint aches), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 07-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite). On 11-Mar-2021, the patient experienced RETCHING (Dry heaves). On 14-Feb-2021, MYALGIA (Muscle aches) and ARTHRALGIA (Joint aches) had resolved. At the time of the report, DISORIENTATION (Brain fog), RETCHING (Dry heaves), DECREASED APPETITE (Loss of appetite), INSOMNIA (Difficulty sleeping), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Condition aggravated, Dyspnoea, Gait inability, Hypoacusis
Clinical narrative: felt like pass out; he couldn't walk; difficulty hearing and breathing; difficulty hearing and breathing; worse symptoms; something is going on from the vaccine; A spontaneous report was received from a nurse concerning a 44-year-old, male patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced difficulty in walking(gait disturbances), felt like pass out( loss of consciousness), difficulty in hearing and breathing (hypoacusis and dyspnea), something is going on from the vaccine (vaccine complication), worse symptoms (condition aggravated).   The patient's medical history included psoriasis and arthritis. Relevant concomitant medications included duloxetine 60mg daily, baby aspirin daily, Tylenol as needed, beloxepin 50mg daily, vitamin c, turmeric 100mg, sildenafil, cortisone cream as needed.  On 25 Feb 2021, four days prior to the onset of events, the patient received  the second of two planned doses of mRNA-1273 (Batch number:012A21A)  intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Four days after the second dose, the patient experienced difficulty in walking.  He said something was going on from the vaccine.  He needed recourses regarding the medication he needed.  He went to his primary doctor and received a steroid injection.  After that, he felt like he was going to pass out, had difficulty in hearing and breathing, and worse symptoms.  His doctor suggested to immediately start with ustekinumab.  Treatment medication included a steroid medication and ustekinumab.  Action taken with mRNA-1273 in response to the event was not applicable.  Outcome of the events, difficulty in walking, felt like he was going to pass out, difficulty in hearing and breathing, vaccine complication and worse symptoms, was unknown.; Reporter'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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: felt like pass out; he couldn't walk; difficulty hearing and breathing; difficulty hearing and breathing; worse symptoms; something is going on from the vaccine; A spontaneous report was received from a nurse concerning a 44-year-old, male patient, who received Moderna's covid-19 vaccine(mRNA-1273) and experienced difficulty in walking(gait disturbances), felt like pass out( loss of consciousness), difficulty in hearing and breathing (hypoacusis and dyspnea), something is going on from the vaccine (vaccine complication), worse symptoms (condition aggravated).   The patient's medical history included psoriasis and arthritis. Relevant concomitant medications included duloxetine 60mg daily, baby aspirin daily, Tylenol as needed, beloxepin 50mg daily, vitamin c, turmeric 100mg, sildenafil, cortisone cream as needed.  On 25 Feb 2021, four days prior to the onset of events, the patient received  the second of two planned doses of mRNA-1273 (Batch number:012A21A)  intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Four days after the second dose, the patient experienced difficulty in walking.  He said something was going on from the vaccine.  He needed recourses regarding the medication he needed.  He went to his primary doctor and received a steroid injection.  After that, he felt like he was going to pass out, had difficulty in hearing and breathing, and worse symptoms.  His doctor suggested to immediately start with ustekinumab.  Treatment medication included a steroid medication and ustekinumab.  Action taken with mRNA-1273 in response to the event was not applicable.  Outcome of the events, difficulty in walking, felt like he was going to pass out, difficulty in hearing and breathing, vaccine complication and worse symptoms, was unknown.; Reporter'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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired feeling) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired feeling). On 10-Mar-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired feeling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of events was reported with acetaminophen (Tylenol).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Influenza like illness, Pain, Pyrexia
Clinical narrative: Loss her taste buds; Real achy; Running fever of 100.6; Like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like she had the flu), AGEUSIA (Loss her taste buds), PAIN (Real achy) and PYREXIA (Running fever of 100.6) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included ROPINIROLE HYDROCHLORIDE (REQUIP), CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), TIZANIDINE, OXYCODONE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced AGEUSIA (Loss her taste buds). In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Like she had the flu), PAIN (Real achy) and PYREXIA (Running fever of 100.6). At the time of the report, INFLUENZA LIKE ILLNESS (Like she had the flu), AGEUSIA (Loss her taste buds), PAIN (Real achy) and PYREXIA (Running fever of 100.6) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100.6 (High) 100.6.         No treatment information was provided. No medical history was provided by the reporter.   This case was linked to MOD-2021-051703, MOD-2021-051703 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: itchy; swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PERIPHERAL SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D25A21A) for COVID-19 vaccination.     Concomitant products included CIMETIDINE (TAGAMET [CIMETIDINE]) for Acid reflux (oesophageal), VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRURITUS (itchy), PERIPHERAL SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red). The patient was treated with HYDROCORTISONE (topical) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), PERIPHERAL SWELLING (swollen) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history information was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Paraesthesia
Clinical narrative: Lump on the palm of her right hand; Tingling; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Lump on the palm of her right hand) and PARAESTHESIA (Tingling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (Lump on the palm of her right hand) and PARAESTHESIA (Tingling). At the time of the report, NODULE (Lump on the palm of her right hand) and PARAESTHESIA (Tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy Injection Site; Sore Injection Site; Tender Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE PAIN (Tender Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Laziness, Malaise, Pain
Clinical narrative: Body aches; Not doing well; Difficulty getting out of bed; Difficulty doing anything; Headache; Fatigue; 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 PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication included muscle relaxers. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Body aches; Not doing well; Difficulty getting out of bed; Difficulty doing anything; Headache; Fatigue; 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 PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches), MALAISE (Not doing well), SOMNOLENCE (Difficulty getting out of bed), LAZINESS (Difficulty doing anything), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication included muscle relaxers. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered) 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered). On 11-Mar-2021, INCORRECT DOSE ADMINISTERED (Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable The physician was concerned that the patient might have received invalid dose. The reporter also stated that there was a possible invalid dose, however the reporter was not sure if the patient had less than 0.5 ml administered.   Concomitant medications were not provided.  Treatment information was not provided..   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: No new information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Impaired work ability
Clinical narrative: No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (Very Sick), HYPERSOMNIA (Slept all day), IMPAIRED WORK ABILITY (Could not go to work), HEADACHE (Very Bad Headache), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), VACCINATION SITE PAIN (Sore Arm (Injection Site)) and FATIGUE (Could not go to work). At the time of the report, MALAISE (Very Sick), HYPERSOMNIA (Slept all day), IMPAIRED WORK ABILITY (Could not go to work), HEADACHE (Very Bad Headache), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), VACCINATION SITE PAIN (Sore Arm (Injection Site)) and FATIGUE (Could not go to work) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient stated she did not want to receive second dose of vaccine.  No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (Very Sick), HYPERSOMNIA (Slept all day), IMPAIRED WORK ABILITY (Could not go to work), HEADACHE (Very Bad Headache), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), VACCINATION SITE PAIN (Sore Arm (Injection Site)) and FATIGUE (Could not go to work). At the time of the report, MALAISE (Very Sick), HYPERSOMNIA (Slept all day), IMPAIRED WORK ABILITY (Could not go to work), HEADACHE (Very Bad Headache), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), VACCINATION SITE PAIN (Sore Arm (Injection Site)) and FATIGUE (Could not go to work) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient stated she did not want to receive second dose of vaccine.  No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination. The patient's past medical history included Heartbeats irregular (When she was little). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Husband of patient reported that the patient continued to have a fast heartbeat and reported that personnel at the vaccine site did not show any concern. No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Delayed reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of SKIN REACTION (Delayed reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN REACTION (Delayed reaction). At the time of the report, SKIN REACTION (Delayed reaction) had not resolved.        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.   Treatment and concomitant medicines were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received, no new was updated. On 15-Jul-2021: Follow-up received, no new information was updated.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 27-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 immunisation.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Reflux esophagitis, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Nov-2020 and the estimated date of delivery was 03-Aug-2021. On 11-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Pain in extremity
Clinical narrative: A little bit of pain in the arm; Rash itches; Rash on the abdomen, chest and lower back; Chills; Headache; Fever; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of pain in the arm), RASH PRURITIC (Rash itches), DIZZINESS (Dizziness), ASTHENIA (Weakness) and RASH (Rash on the abdomen, chest and lower back) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 11-Mar-2021, the patient experienced RASH PRURITIC (Rash itches) and RASH (Rash on the abdomen, chest and lower back). On an unknown date, the patient experienced PAIN IN EXTREMITY (A little bit of pain in the arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 10-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit of pain in the arm), RASH PRURITIC (Rash itches), DIZZINESS (Dizziness), ASTHENIA (Weakness), RASH (Rash on the abdomen, chest and lower back), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a rash on the abdomen, chest and lower back, it's not that strong, is slight but it's red. Rash itches. Had a little bit of pain in the arm. The patient had experienced dizziness and weakness.  The concomitant medications were not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: A little bit of pain in the arm; Rash itches; Rash on the abdomen, chest and lower back; Chills; Headache; Fever; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of pain in the arm), RASH PRURITIC (Rash itches), DIZZINESS (Dizziness), ASTHENIA (Weakness) and RASH (Rash on the abdomen, chest and lower back) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 11-Mar-2021, the patient experienced RASH PRURITIC (Rash itches) and RASH (Rash on the abdomen, chest and lower back). On an unknown date, the patient experienced PAIN IN EXTREMITY (A little bit of pain in the arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 10-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit of pain in the arm), RASH PRURITIC (Rash itches), DIZZINESS (Dizziness), ASTHENIA (Weakness), RASH (Rash on the abdomen, chest and lower back), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a rash on the abdomen, chest and lower back, it's not that strong, is slight but it's red. Rash itches. Had a little bit of pain in the arm. The patient had experienced dizziness and weakness.  The concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Miserable; Sleeping a lot; headache; fatigue; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Miserable), HYPERSOMNIA (Sleeping a lot), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Miserable), HYPERSOMNIA (Sleeping a lot), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Miserable), HYPERSOMNIA (Sleeping a lot), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact