chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Vaccination site discolouration, Vaccination site pain, Vaccination site rash
Clinical narrative: could not sleep; itching; pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color; Rash around the injection site and it was pink in color; Pain at injection site; Arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), PRURITUS (itching), VACCINATION SITE DISCOLOURATION (pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color), VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE PAIN (Pain at injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FENOFIBRATE and FISH OIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm swollen). On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 26-Mar-2021, the patient experienced INSOMNIA (could not sleep), PRURITUS (itching), VACCINATION SITE DISCOLOURATION (pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color) and VACCINATION SITE RASH (Rash around the injection site and it was pink in color). At the time of the report, INSOMNIA (could not sleep), PRURITUS (itching), VACCINATION SITE DISCOLOURATION (pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE RASH (Rash around the injection site and it was pink in color) 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.   It was reported that the patient also took one a day multivitamin and hand skin and nails gummies as concomitant medications. No treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: could not sleep; itching; pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color; Rash around the injection site and it was pink in color; Pain at injection site; Arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), PRURITUS (itching), VACCINATION SITE DISCOLOURATION (pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color), VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE PAIN (Pain at injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FENOFIBRATE and FISH OIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm swollen). On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 26-Mar-2021, the patient experienced INSOMNIA (could not sleep), PRURITUS (itching), VACCINATION SITE DISCOLOURATION (pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color) and VACCINATION SITE RASH (Rash around the injection site and it was pink in color). At the time of the report, INSOMNIA (could not sleep), PRURITUS (itching), VACCINATION SITE DISCOLOURATION (pain at injection site which went away but came back on Friday night 26Mar2021 and was green in color), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE RASH (Rash around the injection site and it was pink in color) 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.   It was reported that the patient also took one a day multivitamin and hand skin and nails gummies as concomitant medications. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Swollen tongue
Clinical narrative: Tingling lips and tongue; Swollen lips and tongue; Swollen lips and tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling lips and tongue), LIP SWELLING (Swollen lips and tongue) and SWOLLEN TONGUE (Swollen lips and tongue) 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 26-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tingling lips and tongue), LIP SWELLING (Swollen lips and tongue) and SWOLLEN TONGUE (Swollen lips and tongue). At the time of the report, PARAESTHESIA ORAL (Tingling lips and tongue), LIP SWELLING (Swollen lips and tongue) and SWOLLEN TONGUE (Swollen lips and tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Limb discomfort, Myalgia, Pyrexia
Clinical narrative: felt muscular tension in her arms down to her hands; feels like a muscle has been used too much and sore; this morning she had a fever and for the rest of the day; a strange symptom or a heat going down her arm, and same for her legs, that went away after 12; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt muscular tension in her arms down to her hands), FEELING HOT (a strange symptom or a heat going down her arm, and same for her legs, that went away after 12), PYREXIA (this morning she had a fever and for the rest of the day) and MYALGIA (feels like a muscle has been used too much and sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Joint disorder NOS, Diabetic, Heart disorder and Kidney disorder.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING HOT (a strange symptom or a heat going down her arm, and same for her legs, that went away after 12). On 26-Mar-2021, the patient experienced PYREXIA (this morning she had a fever and for the rest of the day). On an unknown date, the patient experienced LIMB DISCOMFORT (felt muscular tension in her arms down to her hands) and MYALGIA (feels like a muscle has been used too much and sore). At the time of the report, LIMB DISCOMFORT (felt muscular tension in her arms down to her hands), FEELING HOT (a strange symptom or a heat going down her arm, and same for her legs, that went away after 12), PYREXIA (this morning she had a fever and for the rest of the day) and MYALGIA (feels like a muscle has been used too much and sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 99.6 99.6 F, 98.5 98.5 F and 98.0 98.0 F.     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 not provided.  Treatment medication was not provided.  Based on the current available information and temporal association between the use of the product and the date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the date of the events a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: Felt cold; Vomiting; Felt freezing; Body aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt freezing), FEELING COLD (Felt cold), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced FEELING COLD (Felt freezing), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Mar-2021, the patient experienced FEELING COLD (Felt cold) and VOMITING (Vomiting). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 25-Mar-2021 for Myalgia, Feeling cold and Headache, at a dose of UNK dosage form. At the time of the report, FEELING COLD (Felt freezing), FEELING COLD (Felt cold), MYALGIA (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: redness and hardness at the injection site, warm to touch, larger than it was yesterday; redness and hardness at the injection site, warm to touch, larger than it was yesterday; redness and hardness at the injection site, warm to touch, larger than it was yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (redness and hardness at the injection site, warm to touch, larger than it was yesterday), VACCINATION SITE ERYTHEMA (redness and hardness at the injection site, warm to touch, larger than it was yesterday) and VACCINATION SITE INDURATION (redness and hardness at the injection site, warm to touch, larger than it was yesterday) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE WARMTH (redness and hardness at the injection site, warm to touch, larger than it was yesterday), VACCINATION SITE ERYTHEMA (redness and hardness at the injection site, warm to touch, larger than it was yesterday) and VACCINATION SITE INDURATION (redness and hardness at the injection site, warm to touch, larger than it was yesterday). At the time of the report, VACCINATION SITE WARMTH (redness and hardness at the injection site, warm to touch, larger than it was yesterday), VACCINATION SITE ERYTHEMA (redness and hardness at the injection site, warm to touch, larger than it was yesterday) and VACCINATION SITE INDURATION (redness and hardness at the injection site, warm to touch, larger than it was yesterday) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.Patient had the first dose of the Moderna vaccine a month ago and going for the second dose tomorrow. Caller does not think the headache is related to the vaccine as it was a month ago and does not provide additional information. Does not consent to safety follow up.  On 26 Mar 2021, the patient experienced the event headache.  Treatment details included Unknown.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, headache was unknown.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Erythema, Fatigue, Injection site pain
Clinical narrative: Systemic arthritis; Fatigue; Redness; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Systemic arthritis), ERYTHEMA (Redness), INJECTION SITE PAIN (pain at the injection site) and FATIGUE (Fatigue) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced ERYTHEMA (Redness) and INJECTION SITE PAIN (pain at the injection site). On 18-Mar-2021, the patient experienced ARTHRITIS (Systemic arthritis) and FATIGUE (Fatigue). At the time of the report, ARTHRITIS (Systemic arthritis), ERYTHEMA (Redness), INJECTION SITE PAIN (pain at the injection site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort
Clinical narrative: feels weak the bone that connect the arm with the body; shoulder aches; pain in the knee; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (feels weak the bone that connect the arm with the body), ARTHRALGIA (shoulder aches) and ARTHRALGIA (pain in the knee) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20K) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 27-Feb-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 MUSCULOSKELETAL DISCOMFORT (feels weak the bone that connect the arm with the body), ARTHRALGIA (shoulder aches) and ARTHRALGIA (pain in the knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (feels weak the bone that connect the arm with the body), ARTHRALGIA (shoulder aches) and ARTHRALGIA (pain in the knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Inability to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Inability to sleep) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Sulfa drug) and Allergy to antibiotic (Allergic to Penicillin). Concomitant products included METFORMIN, TRAMADOL, TRAZODONE and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). At the time of the report, INSOMNIA (Inability to sleep) had not resolved.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm pain near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm pain near injection site) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 VACCINATION SITE PAIN (left arm pain near injection site). At the time of the report, VACCINATION SITE PAIN (left arm pain near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm of injection hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm of injection hurts) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm of injection hurts). At the time of the report, VACCINATION SITE PAIN (arm of injection hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dyspepsia, Fatigue, Headache
Clinical narrative: Joints started to hurt; Extreme fatigue, sleeping 14 hours a day; Diarrhea; Pain at the injection site; Extreme fatigue, sleeping 14 hours a day; Nausea and vomiting; Nausea and vomiting; Headache; sour stomach; Congestion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 27-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), DYSPEPSIA (sour stomach), SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day) and NAUSEA (Nausea and vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced NASAL CONGESTION (Congestion), DYSPEPSIA (sour stomach) and HEADACHE (Headache). On 06-Mar-2021, the patient experienced NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting). On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Extreme fatigue, sleeping 14 hours a day). On 11-Mar-2021, the patient experienced ARTHRALGIA (Joints started to hurt). On 22-Mar-2021, SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day) and FATIGUE (Extreme fatigue, sleeping 14 hours a day) had resolved. At the time of the report, NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), DYSPEPSIA (sour stomach), NAUSEA (Nausea and vomiting), VOMITING (Nausea and vomiting), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) was resolving and ARTHRALGIA (Joints started to hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Laboratory investigations included blood test, lung test, pressure test and heart test were normal.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Somnolence, Vaccination site pain, Vomiting
Clinical narrative: Joints started to hurt; Extreme fatigue, sleeping 14 hours a day; Diarrhea; Pain at the injection site; Extreme fatigue, sleeping 14 hours a day; Nausea and vomiting; Nausea and vomiting; Headache; sour stomach; Congestion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 27-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), DYSPEPSIA (sour stomach), SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day) and NAUSEA (Nausea and vomiting) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced NASAL CONGESTION (Congestion), DYSPEPSIA (sour stomach) and HEADACHE (Headache). On 06-Mar-2021, the patient experienced NAUSEA (Nausea and vomiting) and VOMITING (Nausea and vomiting). On 08-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day), VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (Extreme fatigue, sleeping 14 hours a day). On 11-Mar-2021, the patient experienced ARTHRALGIA (Joints started to hurt). On 22-Mar-2021, SOMNOLENCE (Extreme fatigue, sleeping 14 hours a day) and FATIGUE (Extreme fatigue, sleeping 14 hours a day) had resolved. At the time of the report, NASAL CONGESTION (Congestion), DIARRHOEA (Diarrhea), DYSPEPSIA (sour stomach), NAUSEA (Nausea and vomiting), VOMITING (Nausea and vomiting), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) was resolving and ARTHRALGIA (Joints started to hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Laboratory investigations included blood test, lung test, pressure test and heart test were normal.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: positive covid-19 test; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (positive covid-19 test) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Allergic reaction to drug (Patient is allergic to Penicillin and a second drug which the agent did not understand.).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (positive covid-19 test). The patient was treated with Blood pressure medication for Blood pressure, at an unspecified dose and frequency and Thyroid medication at an unspecified dose and frequency. At the time of the report, COVID-19 (positive covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, COVID-19: positive.     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.   The patient was tested positive covid-19 test on 08-MAR-2021 and had started monoclonal treatment on 10-MAR-2021.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness) 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 11-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 DIZZINESS (Light headedness). At the time of the report, DIZZINESS (Light headedness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and Treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Updated Reporter' Address and E-Mail ID.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm soreness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and HEADACHE (headaches) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and HEADACHE (headaches). On 25-Mar-2021, HEADACHE (headaches) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had Influenza vaccine on 26 Mar 2021.  The patient did not take any medications for her symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: my arm was swollen up; red; extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm was swollen up), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (extremely itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (my arm was swollen up), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (extremely itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTICOSTEROID NOS for Adverse event, at an unspecified dose and frequency. On 18-Mar-2021, PERIPHERAL SWELLING (my arm was swollen up), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (extremely itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concominant medications were not reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Headache, Oropharyngeal pain, SARS-CoV-2 test, Swelling
Clinical narrative: Positive COVID-19 test; Sore throat; Swelling on armpits; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19 test), OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling on armpits) and HEADACHE (Headache) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included COLCHICINE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling on armpits) and HEADACHE (Headache). On an unknown date, the patient experienced COVID-19 (Positive COVID-19 test). At the time of the report, COVID-19 (Positive COVID-19 test), OROPHARYNGEAL PAIN (Sore throat), SWELLING (Swelling on armpits) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included over-the-counter oral medication containing paracetamol, caffeine and phenylephrine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity
Clinical narrative: arm pain; hurts when lift; pain in the muscle at the back of the armpit; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN (hurts when lift), MYALGIA (pain in the muscle at the back of the armpit) and ARTHRALGIA (shoulder pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal), Seizure and Cholesterol. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), ZOLPIDEM TARTRATE (ZOLPIDEM TARTATE) for Cholesterol, LEVETIRACETAM for Seizure.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain), PAIN (hurts when lift), MYALGIA (pain in the muscle at the back of the armpit) and ARTHRALGIA (shoulder pain). At the time of the report, PAIN IN EXTREMITY (arm pain), PAIN (hurts when lift), MYALGIA (pain in the muscle at the back of the armpit) and ARTHRALGIA (shoulder pain) outcome was unknown.            Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: did not feel right; did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel right) and MALAISE (did not feel well) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE HYCLATE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL (did not feel right) and MALAISE (did not feel well). At the time of the report, FEELING ABNORMAL (did not feel right) and MALAISE (did not feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Pain, Vaccination site pain
Clinical narrative: cough; whole body ache; dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), PAIN (whole body ache), DIZZINESS (dizziness) and VACCINATION SITE PAIN (sore arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced COUGH (cough), PAIN (whole body ache), DIZZINESS (dizziness) and VACCINATION SITE PAIN (sore arm). On 15-Feb-2021, COUGH (cough), PAIN (whole body ache) and VACCINATION SITE PAIN (sore arm) had resolved. On 18-Feb-2021, DIZZINESS (dizziness) had resolved.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain, Vaccination site pain
Clinical narrative: whole body ache; dizziness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body ache), DIZZINESS (dizziness) and VACCINATION SITE PAIN (sore arm) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (whole body ache), DIZZINESS (dizziness) and VACCINATION SITE PAIN (sore arm). On 16-Mar-2021, PAIN (whole body ache) and VACCINATION SITE PAIN (sore arm) had resolved. On 18-Mar-2021, DIZZINESS (dizziness) had resolved.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Discharge, Pruritus, Rash macular
Clinical narrative: my face broke with red blotches here and there; there may be 12 on both sides of the face and 3 or 4 are actively weeping; little itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (my face broke with red blotches here and there), DISCHARGE (there may be 12 on both sides of the face and 3 or 4 are actively weeping) and PRURITUS (little itchy) in an 80-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 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced RASH MACULAR (my face broke with red blotches here and there), DISCHARGE (there may be 12 on both sides of the face and 3 or 4 are actively weeping) and PRURITUS (little itchy). At the time of the report, RASH MACULAR (my face broke with red blotches here and there), DISCHARGE (there may be 12 on both sides of the face and 3 or 4 are actively weeping) and PRURITUS (little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Myalgia
Clinical narrative: flu for 2 1/2 weeks; very ill; extreme muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu for 2 1/2 weeks), ILLNESS (very ill) and MYALGIA (extreme muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu for 2 1/2 weeks), ILLNESS (very ill) and MYALGIA (extreme muscle ache). At the time of the report, INFLUENZA (flu for 2 1/2 weeks), ILLNESS (very ill) and MYALGIA (extreme muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: A little weak; Feeling weird; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (A little weak), MALAISE (Feeling weird) and FATIGUE (Tired) in a 73-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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (A little weak), MALAISE (Feeling weird) and FATIGUE (Tired). At the time of the report, ASTHENIA (A little weak), MALAISE (Feeling weird) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: He got arm soreness from the day he got the shot; he feels nauseous and terrible headache; he feels nauseous and terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He got arm soreness from the day he got the shot), NAUSEA (he feels nauseous and terrible headache) and HEADACHE (he feels nauseous and terrible headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-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 PAIN IN EXTREMITY (He got arm soreness from the day he got the shot), NAUSEA (he feels nauseous and terrible headache) and HEADACHE (he feels nauseous and terrible headache). At the time of the report, PAIN IN EXTREMITY (He got arm soreness from the day he got the shot), NAUSEA (he feels nauseous and terrible headache) and HEADACHE (he feels nauseous and terrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Tender to touch Injection Site; Very Sore Injection Site; Big Red Circle Injection Site; Itchy Injection Site; Sore Arm Injection Site (A Little); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)), VACCINATION SITE PAIN (Tender to touch Injection Site), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tender to touch Injection Site), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 18-Mar-2021, VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (Tender to touch Injection Site), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Headache; Swelling on armpits; Pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), LYMPHADENOPATHY (Swelling on armpits) and VACCINATION SITE PAIN (Pain on injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache), LYMPHADENOPATHY (Swelling on armpits) and VACCINATION SITE PAIN (Pain on injection site). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, Headache, Vaccination site pain and Lymphadenopathy axillary, at a dose of UNK dosage form. At the time of the report, PYREXIA (Fever), HEADACHE (Headache), LYMPHADENOPATHY (Swelling on armpits) and VACCINATION SITE PAIN (Pain on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: The follow-up  received on 11-May 2021 was significant and included 2 appended SD's. Follow-up additional I was a picture of the adverse event. Additional 2 was the reporting of the new event in a language.  On 20-May-2021: Follow-up additional 3 was the appended translation for the follow-up additional 2 SD.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042722) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hyperaesthesia, Muscle spasms, Myalgia
Clinical narrative: body aches and pains; cramps to her earlobes; inability to touch her head due to sensitivity; "it was bad!"; headache; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!") and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!"), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Mar-2021, PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!"), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included used an icepack for her head.   This case was linked to MOD-2021-131999, MOD-2021-131999 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Batch number Updated, Concomitant medications added.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body aches and pains; cramps to her earlobes; inability to touch her head due to sensitivity; "it was bad!"; headache; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!") and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!"), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Mar-2021, PAIN (body aches and pains), MUSCLE SPASMS (cramps to her earlobes), HYPERAESTHESIA (inability to touch her head due to sensitivity), FEELING ABNORMAL ("it was bad!"), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included used an icepack for her head.   This case was linked to MOD-2021-131999, MOD-2021-131999 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Batch number Updated, Concomitant medications added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Fatigue
Clinical narrative: she feels like there's a fluid on her ear; dizziness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (she feels like there's a fluid on her ear), DIZZINESS (dizziness) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included NAPROXEN (MIRAMAX) for Constipation, MULTI VITAMIN & MINERAL for Supplementation therapy.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced EAR DISCOMFORT (she feels like there's a fluid on her ear), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, EAR DISCOMFORT (she feels like there's a fluid on her ear), DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.