chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), SWELLING FACE (face swollen) and FATIGUE (fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergic reaction to antibiotics (Augmentin), Asthma and Irritable bowel syndrome. Concomitant products included TIMOLOL, VITAMIN D [VITAMIN D NOS] and VITAMIN B [VITAMIN B NOS] for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (fatigue). On 30-Jan-2021, the patient experienced SWELLING FACE (face swollen). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), SWELLING FACE (face swollen) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the events included Allegra and Benadryl for the swelling of the face. This case was linked to US-MODERNATX, INC.-MOD-2021-075052 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient race, ethnicity, height, weight, allergy, medical history added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075052:Second dose vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Influenza like illness, Vaccination site erythema
Clinical narrative: Flu-like symptoms after 1st dose; sick; Severe diarrhea since 1st dose; Very weak after 1st dose; Injection site itchy more than a week after 1st dose; Injection site red more than a week after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose) and VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red more than a week after the 1st dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red more than a week after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication provided by reporter. No concomitant medication provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Flu-like symptoms after 1st dose; sick; Severe diarrhea since 1st dose; Very weak after 1st dose; Injection site itchy more than a week after 1st dose; Injection site red more than a week after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose) and VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021821a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red more than a week after the 1st dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms after 1st dose), ILLNESS (sick), DIARRHOEA (Severe diarrhea since 1st dose), ASTHENIA (Very weak after 1st dose), VACCINATION SITE PRURITUS (Injection site itchy more than a week after 1st dose) and VACCINATION SITE ERYTHEMA (Injection site red more than a week after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication provided by reporter. No concomitant medication provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: General body pain; Chills; Coldness; Tiredness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included NAPROXEN SODIUM (ALEVE), BIMATOPROST (LUMIGAN), LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Aleve.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: General body pain; Chills; Coldness; Tiredness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included NAPROXEN SODIUM (ALEVE), BIMATOPROST (LUMIGAN), LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN (General body pain), CHILLS (Chills), FEELING COLD (Coldness), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Aleve.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysgeusia, Dyspepsia, Feeling hot
Clinical narrative: Burning in heart-chest area; Bitter taste in mouth; Chills; Nausea; Fever; feeling under the weather; bit of sore throat; feels warm; little bit of a headache; little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizzy), MALAISE (feeling under the weather), OROPHARYNGEAL PAIN (bit of sore throat), FEELING HOT (feels warm) and DYSPEPSIA (Burning in heart-chest area) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Bipolar disorder since 1993. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), FLUPHENAZINE DECANOATE (PROLIXIN [FLUPHENAZINE DECANOATE]) and BENZATROPINE MESILATE (COGENTIN) for Bipolar disorder, VITAMIN D3 for an unknown indication.   On 15-Mar-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (little dizzy) and HEADACHE (little bit of a headache). On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (feeling under the weather), OROPHARYNGEAL PAIN (bit of sore throat) and FEELING HOT (feels warm). On an unknown date, the patient experienced DYSPEPSIA (Burning in heart-chest area), DYSGEUSIA (Bitter taste in mouth), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with FAMOTIDINE (PEPCID AC) at a dose of 1 dosage form; OMEPRAZOLE at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Mar-2021, DIZZINESS (little dizzy) and HEADACHE (little bit of a headache) had resolved. At the time of the report, MALAISE (feeling under the weather), OROPHARYNGEAL PAIN (bit of sore throat) and FEELING HOT (feels warm) outcome was unknown, DYSPEPSIA (Burning in heart-chest area) was resolving, DYSGEUSIA (Bitter taste in mouth) and CHILLS (Chills) had not resolved and NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10 May 2021 and contains updated Vaccine information, patient demographics, medical history, concomitant medication, treatment drugs, new events, and outcome of the events
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Burning in heart-chest area; Bitter taste in mouth; Chills; Nausea; Fever; feeling under the weather; bit of sore throat; feels warm; little bit of a headache; little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little dizzy), MALAISE (feeling under the weather), OROPHARYNGEAL PAIN (bit of sore throat), FEELING HOT (feels warm) and DYSPEPSIA (Burning in heart-chest area) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Bipolar disorder since 1993. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), FLUPHENAZINE DECANOATE (PROLIXIN [FLUPHENAZINE DECANOATE]) and BENZATROPINE MESILATE (COGENTIN) for Bipolar disorder, VITAMIN D3 for an unknown indication.   On 15-Mar-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (little dizzy) and HEADACHE (little bit of a headache). On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (feeling under the weather), OROPHARYNGEAL PAIN (bit of sore throat) and FEELING HOT (feels warm). On an unknown date, the patient experienced DYSPEPSIA (Burning in heart-chest area), DYSGEUSIA (Bitter taste in mouth), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with FAMOTIDINE (PEPCID AC) at a dose of 1 dosage form; OMEPRAZOLE at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Mar-2021, DIZZINESS (little dizzy) and HEADACHE (little bit of a headache) had resolved. At the time of the report, MALAISE (feeling under the weather), OROPHARYNGEAL PAIN (bit of sore throat) and FEELING HOT (feels warm) outcome was unknown, DYSPEPSIA (Burning in heart-chest area) was resolving, DYSGEUSIA (Bitter taste in mouth) and CHILLS (Chills) had not resolved and NAUSEA (Nausea) and PYREXIA (Fever) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10 May 2021 and contains updated Vaccine information, patient demographics, medical history, concomitant medication, treatment drugs, new events, and outcome of the events
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dry mouth, Fatigue, Headache, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA) and THINKING ABNORMAL (IRRATIONAL THOUGHTS) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA), THINKING ABNORMAL (IRRATIONAL THOUGHTS), FATIGUE (FATIGUE), PYREXIA (FEVER) and HEADACHE (MILD HEADACHES). At the time of the report, DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA), THINKING ABNORMAL (IRRATIONAL THOUGHTS), FATIGUE (FATIGUE), PYREXIA (FEVER) and HEADACHE (MILD HEADACHES) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Consent given to Safety *Case Crosslinked to MOD21-072559 (Argus # MOD-2021-072801)*** Consumer returning call; from Safety. Consumer left voicemail by Safety referencing Argus # MOD-2021-072801. Consumer asked to provide additional contact information. Consumer does NOT have email or fax. Consumer provided physical mailing address. Consumer prefers Safety contact him via physical mail. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Non-significant Follow-up Appended on 3-jun-2021 as No new information provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Thinking abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA) and THINKING ABNORMAL (IRRATIONAL THOUGHTS) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA), THINKING ABNORMAL (IRRATIONAL THOUGHTS), FATIGUE (FATIGUE), PYREXIA (FEVER) and HEADACHE (MILD HEADACHES). At the time of the report, DECREASED APPETITE (LOSS OF APPETITE), DRY MOUTH (DRY MOUTH), PAIN (GENERAL BODY ACHES), INSOMNIA (INSOMNIA), THINKING ABNORMAL (IRRATIONAL THOUGHTS), FATIGUE (FATIGUE), PYREXIA (FEVER) and HEADACHE (MILD HEADACHES) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Consent given to Safety *Case Crosslinked to MOD21-072559 (Argus # MOD-2021-072801)*** Consumer returning call; from Safety. Consumer left voicemail by Safety referencing Argus # MOD-2021-072801. Consumer asked to provide additional contact information. Consumer does NOT have email or fax. Consumer provided physical mailing address. Consumer prefers Safety contact him via physical mail. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Non-significant Follow-up Appended on 3-jun-2021 as No new information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension
Clinical narrative: Blood pressure was high; On the 2nd dose; Patient reported having a headaches that came and went for about a week; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure was high) and HEADACHE (On the 2nd dose; Patient reported having a headaches that came and went for about a week) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Tremor (pre-exciting condition of tremors.), Hypothyroidism and Osteoporosis NOS. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, PROPRANOLOL for Tremor.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced HYPERTENSION (Blood pressure was high). On an unknown date, the patient experienced HEADACHE (On the 2nd dose; Patient reported having a headaches that came and went for about a week). At the time of the report, HYPERTENSION (Blood pressure was high) had not resolved and HEADACHE (On the 2nd dose; Patient reported having a headaches that came and went for about a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Blood pressure measurement: 140/90 (High) 140/90 to 130/100 blood pressure was high. The bottom number was very high.         Treatment activities for event was done  with increased the dosage of propranolol to help with blood pressure.  The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-072785 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up information was received  and the reporter information, patient demographic, past medical history, vaccine dosage information, route of administration of the vaccine,concomitant medication , outcome of the events were updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and PRURITUS (Itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones. Concurrent medical conditions included Allergy to insect sting (Allergy to bees.). Concomitant products included GABAPENTIN, AMLODIPINE and FLUOXETINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced URTICARIA (Hives) and PRURITUS (Itchy). On 08-Apr-2021, URTICARIA (Hives) and PRURITUS (Itchy) had resolved. Not Provided      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.   Concomitant medication includes sulfur containing antibiotics for kidney stones.  Treatment: Took 1 cap of Benedryl and had liberal amount of Cortisone cream on the infected area.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Eye swelling, Peripheral swelling, Rash, Swelling
Clinical narrative: lesion on chest; face and eyes swollen; face and eyes swollen; neck and arm swelled up; neck and arm swelled up; rash on arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (lesion on chest), EYE SWELLING (face and eyes swollen), SWELLING FACE (face and eyes swollen), SWELLING (neck and arm swelled up) and PERIPHERAL SWELLING (neck and arm swelled up) 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.     The patient's past medical history included No adverse event (No medical history provided.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (lesion on chest), EYE SWELLING (face and eyes swollen), SWELLING FACE (face and eyes swollen), SWELLING (neck and arm swelled up), PERIPHERAL SWELLING (neck and arm swelled up) and RASH (rash on arm). At the time of the report, CHEST DISCOMFORT (lesion on chest), EYE SWELLING (face and eyes swollen), SWELLING FACE (face and eyes swollen), SWELLING (neck and arm swelled up), PERIPHERAL SWELLING (neck and arm swelled up) and RASH (rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter states that the symptoms manifested 10 days after receiving the vaccine and was advised not to get the second vaccine.   Treatment for the event included methylprednisolone 4 mg (Cadista).
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: lesion on chest; face and eyes swollen; face and eyes swollen; neck and arm swelled up; neck and arm swelled up; rash on arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (lesion on chest), EYE SWELLING (face and eyes swollen), SWELLING FACE (face and eyes swollen), SWELLING (neck and arm swelled up) and PERIPHERAL SWELLING (neck and arm swelled up) 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.     The patient's past medical history included No adverse event (No medical history provided.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (lesion on chest), EYE SWELLING (face and eyes swollen), SWELLING FACE (face and eyes swollen), SWELLING (neck and arm swelled up), PERIPHERAL SWELLING (neck and arm swelled up) and RASH (rash on arm). At the time of the report, CHEST DISCOMFORT (lesion on chest), EYE SWELLING (face and eyes swollen), SWELLING FACE (face and eyes swollen), SWELLING (neck and arm swelled up), PERIPHERAL SWELLING (neck and arm swelled up) and RASH (rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter states that the symptoms manifested 10 days after receiving the vaccine and was advised not to get the second vaccine.   Treatment for the event included methylprednisolone 4 mg (Cadista).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Feeling miserable; aches; chills; dizziness; fever of 101.4 Degrees F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable), MYALGIA (aches), CHILLS (chills), DIZZINESS (dizziness) and PYREXIA (fever of 101.4 Degrees F) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling miserable), MYALGIA (aches), CHILLS (chills), DIZZINESS (dizziness) and PYREXIA (fever of 101.4 Degrees F). At the time of the report, FEELING ABNORMAL (Feeling miserable), MYALGIA (aches), CHILLS (chills), DIZZINESS (dizziness) and PYREXIA (fever of 101.4 Degrees F) outcome was unknown.       The patient received treatment information includes ice and Tylenol.     This case was linked to US-MODERNATX, INC.-MOD-2021-072781 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-072781:Dose 1
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Oropharyngeal discomfort
Clinical narrative: Problems with voice; Problem with throat; Has lost her voice; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Problems with voice), OROPHARYNGEAL DISCOMFORT (Problem with throat) and APHONIA (Has lost her voice) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included TRAZODONE, LEVOTHYROXINE, SIMVASTATIN, METHOCARBAMOL, METFORMIN, LISINOPRIL, LAMOTRIGINE, GLIMEPIRIDE, FLUOXETINE, DILTIAZEM and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) 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 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DYSPHONIA (Problems with voice), OROPHARYNGEAL DISCOMFORT (Problem with throat) and APHONIA (Has lost her voice). At the time of the report, DYSPHONIA (Problems with voice), OROPHARYNGEAL DISCOMFORT (Problem with throat) and APHONIA (Has lost her voice) outcome was unknown.            Other concomitant medications included Novolin.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nodule, Pain in extremity, Pruritus, Rash
Clinical narrative: Sore arm; Rash on the Forearms, Groin area (Both inner sides), and Upper left arm. Feels that the Rash is spreading; feels very Tired; Rash area is Bumpy and itching; Rash area is Bumpy and itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Rash area is Bumpy and itching), NODULE (Rash area is Bumpy and itching), PAIN IN EXTREMITY (Sore arm), RASH (Rash on the Forearms, Groin area (Both inner sides), and Upper left arm. Feels that the Rash is spreading) and FATIGUE (feels very Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PRURITUS (Rash area is Bumpy and itching), NODULE (Rash area is Bumpy and itching), RASH (Rash on the Forearms, Groin area (Both inner sides), and Upper left arm. Feels that the Rash is spreading) and FATIGUE (feels very Tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PRURITUS (Rash area is Bumpy and itching), NODULE (Rash area is Bumpy and itching), PAIN IN EXTREMITY (Sore arm), RASH (Rash on the Forearms, Groin area (Both inner sides), and Upper left arm. Feels that the Rash is spreading) and FATIGUE (feels very Tired) had resolved.            No relevant concomitant medications were reported. Patient reported that she had some sort of bug infestation in her home which affected her and the rash had coincided  with the night she received the shot. Treatment information was not provided.  The action taken for mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received and new event,  the outcome of the events were updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Crazy metal taste in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Crazy metal taste in my mouth) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Crazy metal taste in my mouth). At the time of the report, DYSGEUSIA (Crazy metal taste in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information includes antibiotic (Unspecified antibiotic)Treatment information includes Ibuprofen
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Tinnitus
Clinical narrative: He couldn't sleep; Dizziness; severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), TINNITUS (severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head) and INSOMNIA (He couldn't sleep) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] from 29-Mar-2021 to an unknown date for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head). On 29-Mar-2021, the patient experienced DIZZINESS (Dizziness). On an unknown date, the patient experienced INSOMNIA (He couldn't sleep). At the time of the report, DIZZINESS (Dizziness) and TINNITUS (severe ringing in his ear , possible tinnitus, tinnitus in ears, tinitus in head) had not resolved and INSOMNIA (He couldn't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were provided.    No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up information was received and the reporter information,  patient demographics, concomitant medications, new event, outcome of events were updated.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pruritus
Clinical narrative: headache behind his left eye; back itching; nausea; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (headache behind his left eye), PRURITUS (back itching) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ENCORAFENIB (BRAFTOVI) and BINIMETINIB (MEKTOVI) 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, the patient experienced MIGRAINE (headache behind his left eye), PRURITUS (back itching) and NAUSEA (nausea). At the time of the report, MIGRAINE (headache behind his left eye), PRURITUS (back itching) and NAUSEA (nausea) 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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Paraesthesia oral, Throat irritation, Urticaria
Clinical narrative: her throat started to bother her; Anxiety; lips got tingly; hives on her face and arms; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (her throat started to bother her), ANXIETY (Anxiety), PARAESTHESIA ORAL (lips got tingly), URTICARIA (hives on her face and arms) and RASH (rash is just now fading) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included BENZOYL PEROXIDE (ACNE MEDICATION-10) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced THROAT IRRITATION (her throat started to bother her), ANXIETY (Anxiety), PARAESTHESIA ORAL (lips got tingly) and URTICARIA (hives on her face and arms). On an unknown date, the patient experienced RASH (rash is just now fading). On 09-Apr-2021, RASH (rash is just now fading) was resolving. At the time of the report, THROAT IRRITATION (her throat started to bother her), ANXIETY (Anxiety), PARAESTHESIA ORAL (lips got tingly) and URTICARIA (hives on her face and arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Bladder infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    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 CYSTITIS (Bladder infection). At the time of the report, CYSTITIS (Bladder infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller got her first vaccine and is getting the second vaccine today at noon. She does not have a fever, but she has a bladder infection and is it ok to get vaccine today? Consent for Safety follow up
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Had a bad reaction to Moderna vaccine, patient was in bed for 24 hours after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Had a bad reaction to Moderna vaccine, patient was in bed for 24 hours after getting vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Had a bad reaction to Moderna vaccine, patient was in bed for 24 hours after getting vaccine). At the time of the report, ADVERSE REACTION (Had a bad reaction to Moderna vaccine, patient was in bed for 24 hours after getting vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No relevant patient history was provided No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain). On 21-Apr-2021, ARTHRALGIA (joint pains (both hips and knees)/her hips hurt/her knees hurt/such bad joint pain) had resolved. Not Provided          Treatment information was provided by the patient who stated that she used Mobid and Alleve. She stated that the pain began to decrease starting on 09-APR-2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Followup received on 21-Apr-2021, patient race and ethnicity updated, event outcome updated to recovered.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Injection site pain, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (45 minutes after injection developed nausea), DIZZINESS (45 minutes after injection developed dizziness), PAIN IN EXTREMITY (Bad aches in both arms), INJECTION SITE PAIN (Arm of injection really hurts) and PALPITATIONS (Palpitations in chest) in an 83-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. The patient's past medical history included No adverse event. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (45 minutes after injection developed nausea) and DIZZINESS (45 minutes after injection developed dizziness). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Bad aches in both arms), INJECTION SITE PAIN (Arm of injection really hurts) and PALPITATIONS (Palpitations in chest). On 09-Apr-2021, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and DIARRHOEA (Diarrhea). At the time of the report, NAUSEA (45 minutes after injection developed nausea), DIZZINESS (45 minutes after injection developed dizziness), PAIN IN EXTREMITY (Bad aches in both arms), INJECTION SITE PAIN (Arm of injection really hurts), PALPITATIONS (Palpitations in chest), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-072826 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-072826:Second dose case.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (45 minutes after injection developed nausea), DIZZINESS (45 minutes after injection developed dizziness), PAIN IN EXTREMITY (Bad aches in both arms), INJECTION SITE PAIN (Arm of injection really hurts) and PALPITATIONS (Palpitations in chest) in an 83-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. The patient's past medical history included No adverse event. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced NAUSEA (45 minutes after injection developed nausea) and DIZZINESS (45 minutes after injection developed dizziness). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Bad aches in both arms), INJECTION SITE PAIN (Arm of injection really hurts) and PALPITATIONS (Palpitations in chest). On 09-Apr-2021, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and DIARRHOEA (Diarrhea). At the time of the report, NAUSEA (45 minutes after injection developed nausea), DIZZINESS (45 minutes after injection developed dizziness), PAIN IN EXTREMITY (Bad aches in both arms), INJECTION SITE PAIN (Arm of injection really hurts), PALPITATIONS (Palpitations in chest), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-072826 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-072826:Second dose case.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Feeling abnormal
Clinical narrative: hollering/ screaming/bouncing off the walls/threatening "to kill someone" /"is going to eat the car"; threatening "to kill someone"; "is going to eat the car"; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL, ABNORMAL BEHAVIOUR, and ABNORMAL BEHAVIOUR in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL, ABNORMAL BEHAVIOUR, and ABNORMAL BEHAVIOUR outcome was unknown. Not Provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Sinus congestion, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of SINUS CONGESTION (sinus congestion), VACCINATION SITE PRURITUS (injection site reaction with itching, redness, and swelling about walnut size), FATIGUE (felt tired), MYALGIA (achy all over) and VACCINATION SITE ERYTHEMA (injection site reaction with itching, redness, and swelling about walnut size) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fatigue (fatigued and depressed as her mother had passed away on 21DEC2020), Depressed state and Surgery on 07-Dec-2020. Concurrent medical conditions included UTI and Blood pressure high. Concomitant products included VALSARTAN for Blood pressure high, LEVOTHYROXINE and SIMVASTATIN. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PRURITUS (injection site reaction with itching, redness, and swelling about walnut size), FATIGUE (felt tired), MYALGIA (achy all over), VACCINATION SITE ERYTHEMA (injection site reaction with itching, redness, and swelling about walnut size) and VACCINATION SITE SWELLING (injection site reaction with itching, redness, and swelling about walnut size). On an unknown date, the patient experienced SINUS CONGESTION (sinus congestion). On 02-Jan-2021, VACCINATION SITE PRURITUS (injection site reaction with itching, redness, and swelling about walnut size), FATIGUE (felt tired), MYALGIA (achy all over), VACCINATION SITE ERYTHEMA (injection site reaction with itching, redness, and swelling about walnut size) and VACCINATION SITE SWELLING (injection site reaction with itching, redness, and swelling about walnut size) had resolved. At the time of the report, SINUS CONGESTION (sinus congestion) 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.   Treatment medications were not provided as such but the patient stopped taking Simvastatin and Antibiotics.   This case was linked to MOD-2021-020998 (Patient Link).