chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: tender; Fatigue; dry mouth; injection site extremely painful/injection site was sore/injection site was tender; body ache; low grade fever; injection site warm to touch; headache; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (dry mouth), TENDERNESS (tender), VACCINATION SITE WARMTH (injection site warm to touch), HEADACHE (headache) and VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to touch) and HEADACHE (headache). On 09-Mar-2021, the patient experienced DRY MOUTH (dry mouth), VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender), MYALGIA (body ache) and PYREXIA (low grade fever). On 10-Mar-2021, the patient experienced FATIGUE (Fatigue). On 11-Mar-2021, the patient experienced TENDERNESS (tender). At the time of the report, DRY MOUTH (dry mouth), TENDERNESS (tender), VACCINATION SITE WARMTH (injection site warm to touch), HEADACHE (headache), VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender), MYALGIA (body ache), PYREXIA (low grade fever) and FATIGUE (Fatigue) had resolved.      No concomitant medications were reported. Treatment information was not provided.    This case was linked to MOD-2021-047942 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Updated event outcome from unknown to recovered/resolved.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain, Vaccination site warmth
Clinical narrative: tender; Fatigue; dry mouth; injection site extremely painful/injection site was sore/injection site was tender; body ache; low grade fever; injection site warm to touch; headache; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (dry mouth), TENDERNESS (tender), VACCINATION SITE WARMTH (injection site warm to touch), HEADACHE (headache) and VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm to touch) and HEADACHE (headache). On 09-Mar-2021, the patient experienced DRY MOUTH (dry mouth), VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender), MYALGIA (body ache) and PYREXIA (low grade fever). On 10-Mar-2021, the patient experienced FATIGUE (Fatigue). On 11-Mar-2021, the patient experienced TENDERNESS (tender). At the time of the report, DRY MOUTH (dry mouth), TENDERNESS (tender), VACCINATION SITE WARMTH (injection site warm to touch), HEADACHE (headache), VACCINATION SITE PAIN (injection site extremely painful/injection site was sore/injection site was tender), MYALGIA (body ache), PYREXIA (low grade fever) and FATIGUE (Fatigue) had resolved.      No concomitant medications were reported. Treatment information was not provided.    This case was linked to MOD-2021-047942 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Updated event outcome from unknown to recovered/resolved.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Injection site pain, Nasal congestion, Nasopharyngitis
Clinical narrative: smell and taste sensation is lost; smell and taste sensation is lost; cold; little cold and congestion; No side effects from vaccine, just soreness on injection area.; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (smell and taste sensation is lost), AGEUSIA (smell and taste sensation is lost), NASOPHARYNGITIS (cold), NASAL CONGESTION (little cold and congestion) and INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.). On 13-Mar-2021, the patient experienced NASOPHARYNGITIS (cold). 13-Mar-2021, the patient experienced NASAL CONGESTION (little cold and congestion). On 14-Mar-2021, the patient experienced ANOSMIA (smell and taste sensation is lost) and AGEUSIA (smell and taste sensation is lost). At the time of the report, ANOSMIA (smell and taste sensation is lost), AGEUSIA (smell and taste sensation is lost), NASOPHARYNGITIS (cold), NASAL CONGESTION (little cold and congestion) and INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: smell and taste sensation is lost; smell and taste sensation is lost; cold; little cold and congestion; No side effects from vaccine, just soreness on injection area.; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (smell and taste sensation is lost), AGEUSIA (smell and taste sensation is lost), NASOPHARYNGITIS (cold), NASAL CONGESTION (little cold and congestion) and INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.). On 13-Mar-2021, the patient experienced NASOPHARYNGITIS (cold). 13-Mar-2021, the patient experienced NASAL CONGESTION (little cold and congestion). On 14-Mar-2021, the patient experienced ANOSMIA (smell and taste sensation is lost) and AGEUSIA (smell and taste sensation is lost). At the time of the report, ANOSMIA (smell and taste sensation is lost), AGEUSIA (smell and taste sensation is lost), NASOPHARYNGITIS (cold), NASAL CONGESTION (little cold and congestion) and INJECTION SITE PAIN (No side effects from vaccine, just soreness on injection area.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dizziness, Fatigue, Headache
Clinical narrative: Headache; Nausea; Fatigue; Dehydration; Light headed; Fever; Pain in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DEHYDRATION (Dehydration), DIZZINESS (Light headed), PYREXIA (Fever) and HEADACHE (Headache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced DEHYDRATION (Dehydration), DIZZINESS (Light headed), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in arm), DEHYDRATION (Dehydration), DIZZINESS (Light headed), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Headache; Nausea; Fatigue; Dehydration; Light headed; Fever; Pain in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DEHYDRATION (Dehydration), DIZZINESS (Light headed), PYREXIA (Fever) and HEADACHE (Headache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced DEHYDRATION (Dehydration), DIZZINESS (Light headed), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in arm), DEHYDRATION (Dehydration), DIZZINESS (Light headed), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Nausea, Rash macular, Vaccination site pain
Clinical narrative: Arm soreness at injection site after second dose; Vomiting (four sessions of vomiting after midnight); Felt nauseous; Red blotches on my face; My face got red; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches on my face), ERYTHEMA (My face got red), VACCINATION SITE PAIN (Arm soreness at injection site after second dose), VOMITING (Vomiting (four sessions of vomiting after midnight)) and NAUSEA (Felt nauseous) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, 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 FATIGUE (Extreme fatigue). On 16-Mar-2021, the patient experienced RASH MACULAR (Red blotches on my face), ERYTHEMA (My face got red), VOMITING (Vomiting (four sessions of vomiting after midnight)) and NAUSEA (Felt nauseous). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness at injection site after second dose). On 16-Mar-2021, ERYTHEMA (My face got red) had resolved. At the time of the report, RASH MACULAR (Red blotches on my face), VACCINATION SITE PAIN (Arm soreness at injection site after second dose), VOMITING (Vomiting (four sessions of vomiting after midnight)), NAUSEA (Felt nauseous) and FATIGUE (Extreme fatigue) outcome was unknown.            No treatment information was reported.   This case was linked to MOD-2021-047947 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Arm soreness at injection site after second dose; Vomiting (four sessions of vomiting after midnight); Felt nauseous; Red blotches on my face; My face got red; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches on my face), ERYTHEMA (My face got red), VACCINATION SITE PAIN (Arm soreness at injection site after second dose), VOMITING (Vomiting (four sessions of vomiting after midnight)) and NAUSEA (Felt nauseous) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, 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 FATIGUE (Extreme fatigue). On 16-Mar-2021, the patient experienced RASH MACULAR (Red blotches on my face), ERYTHEMA (My face got red), VOMITING (Vomiting (four sessions of vomiting after midnight)) and NAUSEA (Felt nauseous). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness at injection site after second dose). On 16-Mar-2021, ERYTHEMA (My face got red) had resolved. At the time of the report, RASH MACULAR (Red blotches on my face), VACCINATION SITE PAIN (Arm soreness at injection site after second dose), VOMITING (Vomiting (four sessions of vomiting after midnight)), NAUSEA (Felt nauseous) and FATIGUE (Extreme fatigue) outcome was unknown.            No treatment information was reported.   This case was linked to MOD-2021-047947 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Tenderness, Vaccination site warmth
Clinical narrative: upper forearm was tender like a sunburn,  area moves around,area is tender; area is warm to the touch; fingers on left hand are swollen; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (upper forearm was tender like a sunburn,  area moves around,area is tender), VACCINATION SITE WARMTH (area is warm to the touch) and PERIPHERAL SWELLING (fingers on left hand are swollen) 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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TENDERNESS (upper forearm was tender like a sunburn,  area moves around,area is tender), VACCINATION SITE WARMTH (area is warm to the touch) and PERIPHERAL SWELLING (fingers on left hand are swollen). At the time of the report, TENDERNESS (upper forearm was tender like a sunburn,  area moves around,area is tender), VACCINATION SITE WARMTH (area is warm to the touch) and PERIPHERAL SWELLING (fingers on left hand are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment information was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hand deformity, Hypoaesthesia, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: pain in left arm; hands went numb; tingling in arm/"feels like a tingle"; Both hands are hard to open; very stiff; body aches/pain in muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open) and MUSCULOSKELETAL STIFFNESS (very stiff) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open), MUSCULOSKELETAL STIFFNESS (very stiff) and MYALGIA (body aches/pain in muscle). At the time of the report, PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open), MUSCULOSKELETAL STIFFNESS (very stiff) and MYALGIA (body aches/pain in muscle) outcome was unknown. Not Provided          No concomitant or treatment information was reported.   This case was linked to MOD-2021-047811 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: AE Contact Information Updated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: pain in left arm; hands went numb; tingling in arm/"feels like a tingle"; Both hands are hard to open; very stiff; body aches/pain in muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open) and MUSCULOSKELETAL STIFFNESS (very stiff) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open), MUSCULOSKELETAL STIFFNESS (very stiff) and MYALGIA (body aches/pain in muscle). At the time of the report, PAIN IN EXTREMITY (pain in left arm), HYPOAESTHESIA (hands went numb), PARAESTHESIA (tingling in arm/"feels like a tingle"), HAND DEFORMITY (Both hands are hard to open), MUSCULOSKELETAL STIFFNESS (very stiff) and MYALGIA (body aches/pain in muscle) outcome was unknown. Not Provided          No concomitant or treatment information was reported.   This case was linked to MOD-2021-047811 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: AE Contact Information Updated
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild Swelling of right arm; Mild Chills; Pain in right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in right arm), VACCINATION SITE SWELLING (Mild Swelling of right arm) and CHILLS (Mild Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Pollen allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for COPD.    On 12-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 VACCINATION SITE PAIN (Pain in right arm), VACCINATION SITE SWELLING (Mild Swelling of right arm) and CHILLS (Mild Chills). At the time of the report, VACCINATION SITE PAIN (Pain in right arm), VACCINATION SITE SWELLING (Mild Swelling of right arm) and CHILLS (Mild Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included nasal spray with antihistaminic for pollen allergy No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: sore throat; coughing; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing). The patient was treated with DEXTROMETHORPHAN POLISTIREX (ROBITUSSIN 12 HOUR COUGH RELIEF) for Sore throat and Cough, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: by mistake injected 1 ml of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION ERROR (by mistake injected 1 ml of Moderna COVID-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 ERROR (by mistake injected 1 ml of Moderna COVID-19 vaccine). At the time of the report, VACCINATION ERROR (by mistake injected 1 ml of Moderna COVID-19 vaccine) 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.   No concomitant medication was provided. no treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received his first MODERNA COVID-19 vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received his first MODERNA COVID-19 vaccination) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received his first MODERNA COVID-19 vaccination). On 17-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received his first MODERNA COVID-19 vaccination) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: fatigue; Body ache/aches; injection site was very painful/tenderness at injection site; low grade fever; soreness on day of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness on day of injection), MYALGIA (Body ache/aches), VACCINATION SITE PAIN (injection site was very painful/tenderness at injection site), PYREXIA (low grade fever) and FATIGUE (fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN (soreness on day of injection). On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site was very painful/tenderness at injection site) and PYREXIA (low grade fever). On 10-Feb-2021, the patient experienced MYALGIA (Body ache/aches). On 11-Feb-2021, the patient experienced FATIGUE (fatigue). At the time of the report, PAIN (soreness on day of injection), MYALGIA (Body ache/aches), VACCINATION SITE PAIN (injection site was very painful/tenderness at injection site), PYREXIA (low grade fever) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-047928 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event duration updated. Further follow-up denied.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: appetite loss; diarrhea; shoulder hurts; nausea; cold and not able to warm up; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite loss), DIARRHOEA (diarrhea), ARTHRALGIA (shoulder hurts), NAUSEA (nausea) and CHILLS (cold and not able to warm up) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure), Arthritis and Allergy to chemicals (Sulphur). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, AMLODIPINE for Hypertension.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DECREASED APPETITE (appetite loss), DIARRHOEA (diarrhea), ARTHRALGIA (shoulder hurts), NAUSEA (nausea) and CHILLS (cold and not able to warm up). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (appetite loss), DIARRHOEA (diarrhea), ARTHRALGIA (shoulder hurts), NAUSEA (nausea) and CHILLS (cold and not able to warm up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included eye drops.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-017817, US-MODERNATX, INC.-MOD-2021-010482, US-MODERNATX, INC.-MOD-2021-017800, US-MODERNATX, INC.-MOD-2021-017750, US-MODERNATX, INC.-MOD-2021-010477, US-MODERNATX, INC.-MOD-2021-017674, US-MODERNATX, INC.-MOD-2021-019767, US-MODERNATX, INC.-MOD-2021-019740, US-MODERNATX, INC.-MOD-2021-019718, US-MODERNATX, INC.-MOD-2021-017795, US-MODERNATX, INC.-MOD-2021-028790 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018132) US-MODERNATX, INC.-MOD-2021-017817:Crosslinked (MOD21-018034) US-MODERNATX, INC.-MOD-2021-010482:Crosslinked (MOD21-018048) US-MODERNATX, INC.-MOD-2021-017800:Crosslinked (MOD21-018071) US-MODERNATX, INC.-MOD-2021-017750:Crosslinked (MOD21-018080) US-MODERNATX, INC.-MOD-2021-010477:Crosslinked (MOD21-018089) US-MODERNATX, INC.-MOD-2021-017674:Crosslinked (MOD21-018092) US-MODERNATX, INC.-MOD-2021-019767:Crosslinked (MOD21-018097) US-MODERNATX, INC.-MOD-2021-019740:Crosslinked (MOD21-018102) US-MODERNATX, INC.-MOD-2021-019718:Crosslinked (MOD21-018111) US-MODERNATX, INC.-MOD-2021-017795:Crosslinked (MOD21-018119) US-MODERNATX, INC.-MOD-2021-028790:Crosslinked (MOD21-018124)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: itchy/It is a pretty big area; tender, sore at the injection site; redness and tender, sore at the injection site; warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy/It is a pretty big area), VACCINATION SITE PAIN (tender, sore at the injection site) and VACCINATION SITE ERYTHEMA (redness and tender, sore at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Gout and Hypertension. Concomitant products included ALLOPURINOL for Gout, PARACETAMOL (TYLENOL), INSULIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (tender, sore at the injection site) and VACCINATION SITE ERYTHEMA (redness and tender, sore at the injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy/It is a pretty big area). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy/It is a pretty big area), VACCINATION SITE PAIN (tender, sore at the injection site) and VACCINATION SITE ERYTHEMA (redness and tender, sore at the injection site) had not resolved.            Concomitant medications included blood pressure pill and diabetic medication. No treatment information was reported. The action taken for mRNA-1273 was not applicable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (tested positive for COVID) and anosmia (loss of smell) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030L20A) for COVID-19 vaccination. No medical history reported. On Feb 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 15, 2021, patient experienced COVID-19 (tested positive for COVID). On an unknown date, patient experienced anosmia (loss of smell). At the time of the report, COVID-19 (tested positive for COVID) and anosmia (loss of smell) outcome: unknown. Diagnostic results: On Mar 15, 2021, SARS-CoV-2 test: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant information or treatment information reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of back pain (back ache), pain (achiness), headache, chills and pyrexia (fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 16, 2021, patient experienced back pain (back ache), pain (achiness), headache, chills and pyrexia (fever). At the time of the report, back pain (back ache), pain (achiness), headache, chills and pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), unknown was unknown. No concomitant information or treatment information reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Loss of personal independence in daily activities, Mastication disorder, Musculoskeletal stiffness
Clinical narrative: right jaw pain; stiff right jaw; difficulty in chewing; difficulty in brushing her teeth; difficulty sleeping at night; felt achy; felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (felt achy) and FATIGUE (felt tired). On 12-Mar-2021, the patient experienced PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night). On 12-Mar-2021, MYALGIA (felt achy) and FATIGUE (felt tired) had resolved. At the time of the report, PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced difficulty in brushing her teeth. No concomitant information was reported. No treatment information was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in jaw
Clinical narrative: right jaw pain; stiff right jaw; difficulty in chewing; difficulty in brushing her teeth; difficulty sleeping at night; felt achy; felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (felt achy) and FATIGUE (felt tired). On 12-Mar-2021, the patient experienced PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night). On 12-Mar-2021, MYALGIA (felt achy) and FATIGUE (felt tired) had resolved. At the time of the report, PAIN IN JAW (right jaw pain), MUSCULOSKELETAL STIFFNESS (stiff right jaw), MASTICATION DISORDER (difficulty in chewing), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty in brushing her teeth) and INSOMNIA (difficulty sleeping at night) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced difficulty in brushing her teeth. No concomitant information was reported. No treatment information was reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received an accidental third dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received an accidental third dose of the Moderna COVID-19 vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 024M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ziprasidone) and Schizophrenia. Concomitant products included DOCUSATE from 15-Mar-2021 to an unknown date for Constipation, HALOPERIDOL from 15-Mar-2021 to an unknown date and CLOZAPINE from 15-Mar-2021 to an unknown date for Psychosis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received an accidental third dose of the Moderna COVID-19 vaccine). On 17-Mar-2021, EXTRA DOSE ADMINISTERED (Received an accidental third dose of the Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was  inadvertently administered 3rd dose of Moderna COVID vaccine and had  no ill effects. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up information was received and  patient demographics, current illness, allergy, concomitant medication , the start date, frequency, route of administration and indication for use of concomitant medications were updated.; Sender's Comments: This report refers to a case of Extra Dose Administered for mRNA-1273 (Lot number: 024M20A) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Nausea, Pain in extremity, Vaccination site erythema
Clinical narrative: Lump moved to arm pit of injected arm; Lump moved to left breast; Redness at the site of injection; baseball size lump at site of injection; pain in arm; Developed nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE MASS (baseball size lump at site of injection), AXILLARY MASS (Lump moved to arm pit of injected arm), BREAST MASS (Lump moved to left breast) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and NAUSEA (Developed nausea). On 21-Feb-2021, the patient experienced VACCINATION SITE MASS (baseball size lump at site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). On 22-Feb-2021, the patient experienced BREAST MASS (Lump moved to left breast). On 24-Feb-2021, the patient experienced AXILLARY MASS (Lump moved to arm pit of injected arm). At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE MASS (baseball size lump at site of injection), AXILLARY MASS (Lump moved to arm pit of injected arm), BREAST MASS (Lump moved to left breast), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and NAUSEA (Developed nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included Body oil, massage and Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Lump moved to arm pit of injected arm; Lump moved to left breast; Redness at the site of injection; baseball size lump at site of injection; pain in arm; Developed nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE MASS (baseball size lump at site of injection), AXILLARY MASS (Lump moved to arm pit of injected arm), BREAST MASS (Lump moved to left breast) and VACCINATION SITE ERYTHEMA (Redness at the site of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included IBUPROFEN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and NAUSEA (Developed nausea). On 21-Feb-2021, the patient experienced VACCINATION SITE MASS (baseball size lump at site of injection) and VACCINATION SITE ERYTHEMA (Redness at the site of injection). On 22-Feb-2021, the patient experienced BREAST MASS (Lump moved to left breast). On 24-Feb-2021, the patient experienced AXILLARY MASS (Lump moved to arm pit of injected arm). At the time of the report, PAIN IN EXTREMITY (pain in arm), VACCINATION SITE MASS (baseball size lump at site of injection), AXILLARY MASS (Lump moved to arm pit of injected arm), BREAST MASS (Lump moved to left breast), VACCINATION SITE ERYTHEMA (Redness at the site of injection) and NAUSEA (Developed nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included Body oil, massage and Ibuprofen.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Raised area at the site, larger than a silver dollar; Itching at the site; Large soft swollen area at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Raised area at the site, larger than a silver dollar), VACCINATION SITE PRURITUS (Itching at the site) and VACCINATION SITE SWELLING (Large soft swollen area at the site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 MASS (Raised area at the site, larger than a silver dollar), VACCINATION SITE PRURITUS (Itching at the site) and VACCINATION SITE SWELLING (Large soft swollen area at the site). At the time of the report, VACCINATION SITE MASS (Raised area at the site, larger than a silver dollar), VACCINATION SITE PRURITUS (Itching at the site) and VACCINATION SITE SWELLING (Large soft swollen area at the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported Treatment medication were not provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Myalgia, Periorbital swelling
Clinical narrative: bags under eyes; flu like symptoms; swelling of the lymph nodes in the neck; feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (bags under eyes), INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPHADENOPATHY (swelling of the lymph nodes in the neck) and MYALGIA (feeling achy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PERIORBITAL SWELLING (bags under eyes), INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPHADENOPATHY (swelling of the lymph nodes in the neck) and MYALGIA (feeling achy). At the time of the report, PERIORBITAL SWELLING (bags under eyes), INFLUENZA LIKE ILLNESS (flu like symptoms), LYMPHADENOPATHY (swelling of the lymph nodes in the neck) and MYALGIA (feeling achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. Treatment medications were not provided by the reporter.