chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Feeling hot, Paraesthesia, Rash, Urticaria
Clinical narrative: Hot Sensation in Core of Body; Tingling Sensation in Feet; Rash Under Eyes; Blisters on opposite Side of the same Shoulder the Vaccine was Administered in; Hives on Chin/Hives on Both arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot Sensation in Core of Body), PARAESTHESIA (Tingling Sensation in Feet), RASH (Rash Under Eyes), BLISTER (Blisters on opposite Side of the same Shoulder the Vaccine was Administered in) and URTICARIA (Hives on Chin/Hives on Both arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING HOT (Hot Sensation in Core of Body), PARAESTHESIA (Tingling Sensation in Feet), RASH (Rash Under Eyes), BLISTER (Blisters on opposite Side of the same Shoulder the Vaccine was Administered in) and URTICARIA (Hives on Chin/Hives on Both arms). On 17-Feb-2021, FEELING HOT (Hot Sensation in Core of Body), PARAESTHESIA (Tingling Sensation in Feet), RASH (Rash Under Eyes), BLISTER (Blisters on opposite Side of the same Shoulder the Vaccine was Administered in) and URTICARIA (Hives on Chin/Hives on Both arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Pain to the touch of her arm, armpit all the way to her collar bone area; Injection site pain; Redness widespread from site of injection to her arm, arm pit and collar bone; Injection site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness) 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 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, PAIN (Pain to the touch of her arm, armpit all the way to her collar bone area), INJECTION SITE PAIN (Injection site pain), INJECTION SITE ERYTHEMA (Redness widespread from site of injection to her arm, arm pit and collar bone) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-017087 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: No specific follow-up information recorded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Pain in extremity, Tachycardia
Clinical narrative: arm hurt a little bit - left arm; heart rate was 192; blood pressure down to 92-99/70; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate was 192), BLOOD PRESSURE DECREASED (blood pressure down to 92-99/70) and PAIN IN EXTREMITY (arm hurt a little bit - left arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), ROSUVASTATIN and LOSARTAN.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 10-Feb-2021, the patient experienced TACHYCARDIA (heart rate was 192) and BLOOD PRESSURE DECREASED (blood pressure down to 92-99/70). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit - left arm). On 11-Feb-2021, TACHYCARDIA (heart rate was 192) and BLOOD PRESSURE DECREASED (blood pressure down to 92-99/70) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit - left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Vomiting
Clinical narrative: Muscle pain; Chills; 101 degree fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting) in a 75-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 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 18-Feb-2021, the patient experienced MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, Chills, Vomiting and Fever, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (101 degree fever) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101 degree fever.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not Applicable.; Sender's Comments: Based on the current available information which includes a  temporal association between the use of the product and the start date of the reported event, and the known safety profile of mRNA-1273 , a causal relationship with the event cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: red rash on injection site arm; red rash on injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm). The patient was treated with CORTISONE for Rash, at a dose of UNK UNK, qd. At the time of the report, VACCINATION SITE ERYTHEMA (red rash on injection site arm) and VACCINATION SITE RASH (red rash on injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: PAIN IN SHOULDER; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (PAIN IN SHOULDER) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (The patient is scheduled PET scan 13 days later of  1st dose vaccine. The doctors found another spot of his lung.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (PAIN IN SHOULDER). At the time of the report, ARTHRALGIA (PAIN IN SHOULDER) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       His second dose of the Moderna vaccine was scheduled for 25-Feb-2021,13 days later he was scheduled for a was due for petscan.  He had no reaction to the second dose   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Event outcome and narrative was updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LORATADINE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (little soreness). At the time of the report, PAIN IN EXTREMITY (little soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Injection site is warm to touch; Big red patch in the area surrounding the injection site; Knot at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE MASS (Knot at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot at injection site) and VACCINATION SITE PAIN (Soreness at injection site). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to touch) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE MASS (Knot at injection site), VACCINATION SITE PAIN (Soreness at injection site) and VACCINATION SITE ERYTHEMA (Big red patch in the area surrounding the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included massaging.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Hot to the touch; Itchy rash; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SKIN WARM (Hot to the touch), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-JUN-2021 contains No New information.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling at the injection site from arm down to elbow; Redness at the injection site from arm down to elbow; A spontaneous report  was received from a consumer concerning a 82-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling at the injection site from arm down to elbow/vaccination site swelling and redness at the injection site from arm down to elbow/vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, approximately two weeks prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced swelling and redness at the injection site from arm down to elbow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, swelling at the injection site from arm down to elbow and redness at the injection site from arm down to elbow was unknown.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and the known safety profile of mRNA-1273, a causal relationship with the event cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Nausea
Clinical narrative: Migraine like feeling; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine like feeling), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache). On 17-Feb-2021, the patient experienced FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced MIGRAINE (Migraine like feeling) and NAUSEA (Nausea). At the time of the report, MIGRAINE (Migraine like feeling), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-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 (No reported medical history.).    On 13-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 COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test positive: COVID-19 Positive..     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 medications were provided.  No treatment details were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment details were provided.    This case was linked to MOD-2021-016959 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Had redness; Itches a little at injection; 4x2 oblong oval adjacent to the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Had redness), VACCINATION SITE PRURITUS (Itches a little at injection) and VACCINATION SITE RASH (4x2 oblong oval adjacent to the site of injection) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Had redness), VACCINATION SITE PRURITUS (Itches a little at injection) and VACCINATION SITE RASH (4x2 oblong oval adjacent to the site of injection). At the time of the report, ERYTHEMA (Had redness), VACCINATION SITE PRURITUS (Itches a little at injection) and VACCINATION SITE RASH (4x2 oblong oval adjacent to the site of injection) outcome was unknown.            concomitant medications  were not reported  Treatment was not specified
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Feeling hot, Injection site erythema
Clinical narrative: Throat is scratchy and sore; Throat is scratchy and sore; injection site feels hot touch; Injection site reactions developing: red circle (like a red rash with a 2in diameter),; Startting to swell; Injection site is itchy; Injection site aches; Feels freezing; Chills; Eyes feel hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills) and FEELING HOT (Eyes feel hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to sting (wasp sting). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), GARLIC [ALLIUM SATIVUM] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING COLD (Feels freezing), CHILLS (Chills), FEELING HOT (Eyes feel hot) and INJECTION SITE PAIN (Injection site aches). On 25-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell) and INJECTION SITE PRURITUS (Injection site is itchy). At the time of the report, FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills), FEELING HOT (Eyes feel hot), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell), INJECTION SITE PRURITUS (Injection site is itchy) and INJECTION SITE PAIN (Injection site aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101.9 (High) fever-101.9 F.         Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Treatment medications were added, events were updated, allergy was added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Oropharyngeal discomfort
Clinical narrative: Throat is scratchy and sore; Throat is scratchy and sore; injection site feels hot touch; Injection site reactions developing: red circle (like a red rash with a 2in diameter),; Startting to swell; Injection site is itchy; Injection site aches; Feels freezing; Chills; Eyes feel hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills) and FEELING HOT (Eyes feel hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to sting (wasp sting). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), GARLIC [ALLIUM SATIVUM] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING COLD (Feels freezing), CHILLS (Chills), FEELING HOT (Eyes feel hot) and INJECTION SITE PAIN (Injection site aches). On 25-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell) and INJECTION SITE PRURITUS (Injection site is itchy). At the time of the report, FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills), FEELING HOT (Eyes feel hot), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell), INJECTION SITE PRURITUS (Injection site is itchy) and INJECTION SITE PAIN (Injection site aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101.9 (High) fever-101.9 F.         Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Treatment medications were added, events were updated, allergy was added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Throat is scratchy and sore; Throat is scratchy and sore; injection site feels hot touch; Injection site reactions developing: red circle (like a red rash with a 2in diameter),; Startting to swell; Injection site is itchy; Injection site aches; Feels freezing; Chills; Eyes feel hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills) and FEELING HOT (Eyes feel hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to sting (wasp sting). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE, CALCIUM, COLECALCIFEROL (CALCIUM + VITAMIN D3), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), GARLIC [ALLIUM SATIVUM] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING COLD (Feels freezing), CHILLS (Chills), FEELING HOT (Eyes feel hot) and INJECTION SITE PAIN (Injection site aches). On 25-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell) and INJECTION SITE PRURITUS (Injection site is itchy). At the time of the report, FEELING COLD (Feels freezing), OROPHARYNGEAL PAIN (Throat is scratchy and sore), OROPHARYNGEAL DISCOMFORT (Throat is scratchy and sore), CHILLS (Chills), FEELING HOT (Eyes feel hot), INJECTION SITE WARMTH (injection site feels hot touch), INJECTION SITE ERYTHEMA (Injection site reactions developing: red circle (like a red rash with a 2in diameter),), INJECTION SITE SWELLING (Startting to swell), INJECTION SITE PRURITUS (Injection site is itchy) and INJECTION SITE PAIN (Injection site aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101.9 (High) fever-101.9 F.         Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Treatment medications were added, events were updated, allergy was added
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Decreased appetite, Headache, Malaise
Clinical narrative: i got sick; headache; no appetite; joint pain; temperature of 102.8 F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F). At the time of the report, MALAISE (i got sick), HEADACHE (headache), DECREASED APPETITE (no appetite), ARTHRALGIA (joint pain) and BODY TEMPERATURE INCREASED (temperature of 102.8 F) outcome was unknown. Not Provided          No concomitant medication was provided.  Treatment details included acetaminophen.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     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 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     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 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: developed COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed COVID19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 05-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 COVID-19 (developed COVID19). At the time of the report, COVID-19 (developed COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed COVID19) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 05-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 COVID-19 (developed COVID19). At the time of the report, COVID-19 (developed COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, SARS-CoV-2 test positive: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Feeling abnormal, Headache
Clinical narrative: Doesn't feel good; Temperature of 99.2; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Doesn't feel good), BODY TEMPERATURE INCREASED (Temperature of 99.2) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99.2 (Inconclusive) temperature of 99.2.         Concomitant products used included blood pressure and cholesterol medications.  No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: TCR-follow-up received on 15-Jun-2021 contains no new information. Consumer reported everything was fine and declined further follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M207) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter states that she wasn't undergone any treatment but may take naproxen if it keeps bothering her.  No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen in the site of the shot again; Redness in the site of the shot /again; Itchiness in the site of the shot /again; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness in the site of the shot /again), INJECTION SITE PRURITUS (Itchiness in the site of the shot /again) and INJECTION SITE SWELLING (Swollen in the site of the shot again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness in the site of the shot /again) and INJECTION SITE PRURITUS (Itchiness in the site of the shot /again). On 18-Feb-2021, the patient experienced INJECTION SITE SWELLING (Swollen in the site of the shot again). At the time of the report, INJECTION SITE ERYTHEMA (Redness in the site of the shot /again), INJECTION SITE PRURITUS (Itchiness in the site of the shot /again) and INJECTION SITE SWELLING (Swollen in the site of the shot again) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat
Clinical narrative: Experienced bad cold sweats; A spontaneous report was received from a consumer concerning herself, a female patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad cold sweats.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 010m20a) via unknown route for prophylaxis of COVID-19 infection.  On 15 Feb 2021 at night, the patient experienced bad cold sweats. The patient felt fine in the morning.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.    The outcome of event, bad cold sweats, was considered as resolved on 16 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain, Pain in extremity, Rash macular
Clinical narrative: pains in neck; Pain in arm; spots on chin/side of face; Pains from neck to her head; pains in head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pains in neck), PAIN IN EXTREMITY (Pain in arm), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy (Full thyroidectomy). Concurrent medical conditions included Hypertension, High cholesterol, Penicillin allergy and Nickel sensitivity. Concomitant products included OMEPRAZOLE, LEVOTHYROXINE, CLONIDINE and AMLODIPINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced NECK PAIN (pains in neck), PAIN IN EXTREMITY (Pain in arm), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head). On 09-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, NECK PAIN (pains in neck), RASH MACULAR (spots on chin/side of face), PAIN (Pains from neck to her head) and HEADACHE (pains in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Patient went to the emergency room where all tests were negative.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up document was received. It contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sinusitis, Vaccination site pain
Clinical narrative: sore arm, just a little; a little tired and the arm a little bit more sore; sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), VACCINATION SITE PAIN (sore arm, just a little) and FATIGUE (a little tired and the arm a little bit more sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced SINUSITIS (sinus infection). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm, just a little) and FATIGUE (a little tired and the arm a little bit more sore). The patient was treated with DOXYCYCLINE HYDROCHLORIDE (DOXICYCLINE [DOXYCYCLINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and METRONIDAZOLE BENZOATE (METRODOL [METRONIDAZOLE BENZOATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection), VACCINATION SITE PAIN (sore arm, just a little) and FATIGUE (a little tired and the arm a little bit more sore) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Shoulder to elbow are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Shoulder to elbow are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rotator cuff injury (The patient reports that she had injury at rotator cuff in 2015. and re-injured while shoveling or doing any hard work.).    On 15-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 PERIPHERAL SWELLING (Shoulder to elbow are swollen). At the time of the report, PERIPHERAL SWELLING (Shoulder to elbow are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Sore throat; Cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenopia, Pyrexia
Clinical narrative: Eyes feel a little heavy; Felt warm, his temperature was 99F; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F). At the time of the report, ASTHENOPIA (Eyes feel a little heavy) and PYREXIA (Felt warm, his temperature was 99F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pain
Clinical narrative: aches; getting a little itching feeling around the injection site; red - around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-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 PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site). At the time of the report, PAIN (aches), INJECTION SITE PRURITUS (getting a little itching feeling around the injection site) and INJECTION SITE ERYTHEMA (red - around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.