chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Sleepiness; Could not eat or drink for 4 days; Nausea; Vomiting; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SOMNOLENCE (Sleepiness), DECREASED APPETITE (Could not eat or drink for 4 days), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-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.     The patient's past medical history included No adverse event (No Historical condition reported.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIZZINESS (Dizziness), SOMNOLENCE (Sleepiness), DECREASED APPETITE (Could not eat or drink for 4 days), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), SOMNOLENCE (Sleepiness), DECREASED APPETITE (Could not eat or drink for 4 days), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Dizziness; Sleepiness; Could not eat or drink for 4 days; Nausea; Vomiting; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SOMNOLENCE (Sleepiness), DECREASED APPETITE (Could not eat or drink for 4 days), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-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.     The patient's past medical history included No adverse event (No Historical condition reported.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DIZZINESS (Dizziness), SOMNOLENCE (Sleepiness), DECREASED APPETITE (Could not eat or drink for 4 days), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), SOMNOLENCE (Sleepiness), DECREASED APPETITE (Could not eat or drink for 4 days), NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Heart rate increased
Clinical narrative: Increased heart rate; Pain in back; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Increased heart rate), BACK PAIN (Pain in back) and CHILLS (Chills) 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced HEART RATE INCREASED (Increased heart rate), BACK PAIN (Pain in back) and CHILLS (Chills). At the time of the report, HEART RATE INCREASED (Increased heart rate), BACK PAIN (Pain in back) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: Diarrhea for 2 days; Chilled to the bone for 3 hrs; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea for 2 days) and CHILLS (Chilled to the bone for 3 hrs) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diverticulitis.   On 08-Mar-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 08-Mar-2021, the patient experienced CHILLS (Chilled to the bone for 3 hrs). On 10-Mar-2021, the patient experienced DIARRHOEA (Diarrhea for 2 days). On 08-Mar-2021, CHILLS (Chilled to the bone for 3 hrs) had resolved. On 12-Mar-2021, DIARRHOEA (Diarrhea for 2 days) had resolved.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). In January 2021, PAIN IN EXTREMITY (My arm was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient had first shot on a Friday, and patient's arm was sore Saturday and Sunday. The patient was equating it to a flu shot. No treatment information was provided.   This case was linked to MOD-2021-052596 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Influenza like illness, Pain, Vision blurred
Clinical narrative: Blurred vision; Feels like the flu; Aching bones; Very sore; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), INFLUENZA LIKE ILLNESS (Feels like the flu), BONE PAIN (Aching bones), PAIN (Very sore) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included AMLODIPINE and ROSUVASTATIN for an unknown indication.    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 VISION BLURRED (Blurred vision), INFLUENZA LIKE ILLNESS (Feels like the flu), BONE PAIN (Aching bones), PAIN (Very sore) and CHILLS (Chills). At the time of the report, VISION BLURRED (Blurred vision), INFLUENZA LIKE ILLNESS (Feels like the flu), BONE PAIN (Aching bones), PAIN (Very sore) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZIA) for COVID-19 vaccination.     Concomitant products included PROGESTERONE (ENDOMETRIN) and ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Sep-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 12-Mar-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain in extremity, Rash
Clinical narrative: after the 2nd dose, her arm was sore for about a day.; Rash; Lips are swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Lips are swollen), PAIN IN EXTREMITY (after the 2nd dose, her arm was sore for about a day.) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced LIP SWELLING (Lips are swollen) and RASH (Rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (after the 2nd dose, her arm was sore for about a day.). On 12-Mar-2021, RASH (Rash) had resolved. At the time of the report, LIP SWELLING (Lips are swollen) and PAIN IN EXTREMITY (after the 2nd dose, her arm was sore for about a day.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 added new event.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site warmth, Pruritus
Clinical narrative: Itching really bad; Warm at injection site; Knot at injection site/ knot has gotten bigger; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm at injection site), INJECTION SITE NODULE (Knot at injection site/ knot has gotten bigger) and PRURITUS (Itching really bad) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warm at injection site) and INJECTION SITE NODULE (Knot at injection site/ knot has gotten bigger). On 10-Mar-2021, the patient experienced PRURITUS (Itching really bad). At the time of the report, INJECTION SITE WARMTH (Warm at injection site) and PRURITUS (Itching really bad) outcome was unknown and INJECTION SITE NODULE (Knot at injection site/ knot has gotten bigger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood pressure medications. The patient stated that the next day it was warm at injection site and had a knot. The patient also stated that on 10-Mar-2021, it was itching really and on the day of reporting her knot had gotten bigger. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old male 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.).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient had a little sore arm after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient had a little sore arm after receiving 2nd dose) 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 12-Mar-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient had a little sore arm after receiving 2nd dose). At the time of the report, PAIN IN EXTREMITY (Patient had a little sore arm after receiving 2nd dose) outcome was unknown. Not Provided          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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slugged in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slugged in the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PANTOPRAZOLE and ZOLPIDEM for an unknown indication.    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 PAIN IN EXTREMITY (Slugged in the arm). At the time of the report, PAIN IN EXTREMITY (Slugged in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.   This case was linked to MOD-2021-245523, MOD-2021-245523 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant FU: Second dose details and Outcome provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: hard for her to walk; fell; legs gave out; chills; fever of 102.4; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (hard for her to walk), FALL (fell), PAIN IN EXTREMITY (legs gave out), CHILLS (chills) and PYREXIA (fever of 102.4) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 031A21A) 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 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 10-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (fever of 102.4). On 11-Feb-2021, the patient experienced GAIT DISTURBANCE (hard for her to walk), FALL (fell) and PAIN IN EXTREMITY (legs gave out). On 13-Feb-2021, GAIT DISTURBANCE (hard for her to walk), FALL (fell), PAIN IN EXTREMITY (legs gave out), CHILLS (chills) and PYREXIA (fever of 102.4) had resolved.            No relevant concomitant medications were reported.  Treatment information was  not  reported.   This case was linked to MOD-2021-214337 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR added included NNI
Sex: F
Vaccine: COVID19
Symptoms: Rash, Temperature intolerance
Clinical narrative: rash on face; face heating up; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on face) and TEMPERATURE INTOLERANCE (face heating up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced RASH (rash on face) and TEMPERATURE INTOLERANCE (face heating up). At the time of the report, RASH (rash on face) and TEMPERATURE INTOLERANCE (face heating up) outcome was unknown.            No concomitant medications were provided.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 50 doses administered after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (50 doses administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (50 doses administered after temperature excursion). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (50 doses administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported    This case was linked to MOD-2021-042570 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, COVID-19, Dizziness, Headache
Clinical narrative: high fever up to 103F; very bad headache; felt dizzy; has nauseas; back pain ¨like if it is going to explode; bone pain; feels the same way as when she had Covid; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever up to 103F), HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas) and BACK PAIN (back pain ¨like if it is going to explode) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (high fever up to 103F), HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas), BACK PAIN (back pain ¨like if it is going to explode), BONE PAIN (bone pain) and COVID-19 (feels the same way as when she had Covid). At the time of the report, PYREXIA (high fever up to 103F) had not resolved and HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas), BACK PAIN (back pain ¨like if it is going to explode), BONE PAIN (bone pain) and COVID-19 (feels the same way as when she had Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment was reported as 3 pills of ibuprofen 200mg since 11-Mar-2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: high fever up to 103F; very bad headache; felt dizzy; has nauseas; back pain ¨like if it is going to explode; bone pain; feels the same way as when she had Covid; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever up to 103F), HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas) and BACK PAIN (back pain ¨like if it is going to explode) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (high fever up to 103F), HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas), BACK PAIN (back pain ¨like if it is going to explode), BONE PAIN (bone pain) and COVID-19 (feels the same way as when she had Covid). At the time of the report, PYREXIA (high fever up to 103F) had not resolved and HEADACHE (very bad headache), DIZZINESS (felt dizzy), NAUSEA (has nauseas), BACK PAIN (back pain ¨like if it is going to explode), BONE PAIN (bone pain) and COVID-19 (feels the same way as when she had Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment was reported as 3 pills of ibuprofen 200mg since 11-Mar-2021.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood pressure measurement, Somnolence
Clinical narrative: she has been very sleepy more than normal; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she has been very sleepy more than normal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SOMNOLENCE (she has been very sleepy more than normal). At the time of the report, SOMNOLENCE (she has been very sleepy more than normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Blood glucose increased: high (High) increase. On 25-Feb-2021, Blood pressure measurement: high (High) increase.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The Treatment information includes Blood pressure medications and Diabetes type-2 medications.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph node) 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 10-Mar-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 an unknown date, the patient experienced LYMPHADENOPATHY (Swelling of lymph node). At the time of the report, LYMPHADENOPATHY (Swelling of lymph node) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 contains no new information
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Limb discomfort, Pain, Vaccination site pain
Clinical narrative: Extreme pain; Cant lift her right arm; Could not move her right arm from her side; Extreme pain in the arm at injection site/ extreme pain when trying to take off a shirt/extreme pain while trying to change positions in bed/ can't raise her arm over her head; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain), AXILLARY PAIN (Cant lift her right arm), LIMB DISCOMFORT (Could not move her right arm from her side) and VACCINATION SITE PAIN (Extreme pain in the arm at injection site/ extreme pain when trying to take off a shirt/extreme pain while trying to change positions in bed/ can't raise her arm over her head) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-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 11-Mar-2021, the patient experienced PAIN (Extreme pain), AXILLARY PAIN (Cant lift her right arm), LIMB DISCOMFORT (Could not move her right arm from her side) and VACCINATION SITE PAIN (Extreme pain in the arm at injection site/ extreme pain when trying to take off a shirt/extreme pain while trying to change positions in bed/ can't raise her arm over her head). On 14-Mar-2021, PAIN (Extreme pain) and LIMB DISCOMFORT (Could not move her right arm from her side) had resolved. At the time of the report, AXILLARY PAIN (Cant lift her right arm) and VACCINATION SITE PAIN (Extreme pain in the arm at injection site/ extreme pain when trying to take off a shirt/extreme pain while trying to change positions in bed/ can't raise her arm over her head) had not resolved.            Concomitant details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Reporter information updated and outcome of the event from unknown to recovering updated. On 06-May-2021: Follow-up information received  contains non-significant information On 11-May-2021: Follow-up information received  contains non-significant information
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Coffee doesn't taste right; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Coffee doesn't taste right) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (Coffee doesn't taste right). At the time of the report, TASTE DISORDER (Coffee doesn't taste right) 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 and treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Hypersomnia, Nausea, Night sweats
Clinical narrative: sleeping the first night and then started to sweat; sleeping 24hrs; swollen arm; swollen arm and it was red; Fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (sleeping the first night and then started to sweat), HYPERSOMNIA (sleeping 24hrs), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 028Az1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient confirmed testing positive for COVID-19 and mentioned it lasted for 6 weeks and she has lost taste and smell.) in March 2020. Concurrent medical conditions included Blood pressure abnormal.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced NIGHT SWEATS (sleeping the first night and then started to sweat), HYPERSOMNIA (sleeping 24hrs), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red), PYREXIA (Fever), CHILLS (chills) and NAUSEA (nausea). On 10-Mar-2021, HYPERSOMNIA (sleeping 24hrs) had resolved. On 13-Mar-2021, PYREXIA (Fever) outcome was unknown, NAUSEA (nausea) had resolved. At the time of the report, NIGHT SWEATS (sleeping the first night and then started to sweat), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After the first vaccination patient experienced a fever and was sleeping the first night, then started to sweat, chills, and had some nausea. She also had a swollen arm and it was red. She wants to know if these symptoms are normal, is she still contagious after the first dose only, and are the symptoms she is experiencing have any correlation with the fact that she had COVID-19 this past March2020.  Treatment information was not reported.   This case was linked to MOD-2021-136663 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 17-May-2021 and included significant information such as suspect vaccine Lot Number and start date was added, New event was added, medical history was updated, Outcome of the events nausea and fever were updated.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: sleeping the first night and then started to sweat; sleeping 24hrs; swollen arm; swollen arm and it was red; Fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (sleeping the first night and then started to sweat), HYPERSOMNIA (sleeping 24hrs), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 028Az1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient confirmed testing positive for COVID-19 and mentioned it lasted for 6 weeks and she has lost taste and smell.) in March 2020. Concurrent medical conditions included Blood pressure abnormal.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced NIGHT SWEATS (sleeping the first night and then started to sweat), HYPERSOMNIA (sleeping 24hrs), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red), PYREXIA (Fever), CHILLS (chills) and NAUSEA (nausea). On 10-Mar-2021, HYPERSOMNIA (sleeping 24hrs) had resolved. On 13-Mar-2021, PYREXIA (Fever) outcome was unknown, NAUSEA (nausea) had resolved. At the time of the report, NIGHT SWEATS (sleeping the first night and then started to sweat), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (swollen arm and it was red) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       After the first vaccination patient experienced a fever and was sleeping the first night, then started to sweat, chills, and had some nausea. She also had a swollen arm and it was red. She wants to know if these symptoms are normal, is she still contagious after the first dose only, and are the symptoms she is experiencing have any correlation with the fact that she had COVID-19 this past March2020.  Treatment information was not reported.   This case was linked to MOD-2021-136663 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up received on 17-May-2021 and included significant information such as suspect vaccine Lot Number and start date was added, New event was added, medical history was updated, Outcome of the events nausea and fever were updated.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Patient's legs started itching 3 days later; Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later; Patient's left arm was sore after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient's left arm was sore after receiving 2nd dose), PRURITUS (Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later) and PRURITUS (Patient's legs started itching 3 days later) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Patient's left arm was sore after receiving 2nd dose). On 28-Feb-2021, the patient experienced PRURITUS (Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later). On 01-Mar-2021, the patient experienced PRURITUS (Patient's legs started itching 3 days later). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Patient's left arm was sore after receiving 2nd dose), PRURITUS (Patient developed itching on both arms, chest, and her scalp 2 days later,Patient's legs started itching 3 days later) and PRURITUS (Patient's legs started itching 3 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication also included Cholesterol Medications. Treatment details included Benadryl.   This case was linked to MOD-2021-136997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: TCR document received on 05-MAY-2021 contains significant information. Dose 2 details updated, Action taken, De-challenge and re-challenge updated. No further follow-up requested by the consumer. On 23-Jun-2021: Follow up received on 23-JUN-2021 contains Non-significant information. Reporters contact details updated.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck mass, Somnolence
Clinical narrative: Knot on her neck; Felt sleepy; Nauseous; This spontaneous case was reported by a health care professional and describes the occurrence of NECK MASS (Knot on her neck), SOMNOLENCE (Felt sleepy) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced NECK MASS (Knot on her neck), SOMNOLENCE (Felt sleepy) and NAUSEA (Nauseous). At the time of the report, NECK MASS (Knot on her neck), SOMNOLENCE (Felt sleepy) and NAUSEA (Nauseous) outcome 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 medications were provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: arm hurt; fever; lots of chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and CHILLS (lots of chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension and Cholesterol. Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for Cholesterol, VITAMIN D NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and CHILLS (lots of chills). At the time of the report, PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and CHILLS (lots of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include medications for diabetes, for high blood pressure No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness
Clinical narrative: feeling dizzy on my feet; feeling wabbly on my feet; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy on my feet) and MUSCULAR WEAKNESS (feeling wabbly on my feet) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (feeling dizzy on my feet) and MUSCULAR WEAKNESS (feeling wabbly on my feet). At the time of the report, DIZZINESS (feeling dizzy on my feet) and MUSCULAR WEAKNESS (feeling wabbly on my feet) outcome was unknown.            No concomitant medications were provided. No treatment medications are provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pruritus, Sinusitis
Clinical narrative: Sore Throat; Bad Sinus Problems; Itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (Bad Sinus Problems) and PRURITUS (Itching) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (Bad Sinus Problems) and PRURITUS (Itching). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (Bad Sinus Problems) and PRURITUS (Itching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications include Z-Pack and Zyrtec.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: Tightness in chest; Difficulty breathing; Flu like symptoms; 2 hours of sleep last night; Joint pain; Nausea; Muscle aches/ Achiness; headache; Very tired/ Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Difficulty breathing), INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (2 hours of sleep last night) and ARTHRALGIA (Joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetes. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD, GABAPENTIN, LEVOTHYROXINE, INSULIN, APIXABAN (ELIQUIS), VARENICLINE TARTRATE (CHANTIX), MIRABEGRON (MYRBETRIQ), MONTELUKAST, ALBUTEROL [SALBUTAMOL], ALBUTEROL [SALBUTAMOL] and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    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 CHEST DISCOMFORT (Tightness in chest) and DYSPNOEA (Difficulty breathing). 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (2 hours of sleep last night), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle aches/ Achiness), HEADACHE (headache) and FATIGUE (Very tired/ Fatigued). The patient was treated with OXYGEN for Dyspnoea, at a dose of breathing; PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Headache, at a dose of 10/325mg. On 11-Mar-2021, CHEST DISCOMFORT (Tightness in chest) and DYSPNOEA (Difficulty breathing) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle aches/ Achiness), HEADACHE (headache) and FATIGUE (Very tired/ Fatigued) had not resolved and INSOMNIA (2 hours of sleep last night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Myalgia, Nausea
Clinical narrative: Tightness in chest; Difficulty breathing; Flu like symptoms; 2 hours of sleep last night; Joint pain; Nausea; Muscle aches/ Achiness; headache; Very tired/ Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Difficulty breathing), INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (2 hours of sleep last night) and ARTHRALGIA (Joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Diabetes. Concomitant products included UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO ELLIPTA) and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD, GABAPENTIN, LEVOTHYROXINE, INSULIN, APIXABAN (ELIQUIS), VARENICLINE TARTRATE (CHANTIX), MIRABEGRON (MYRBETRIQ), MONTELUKAST, ALBUTEROL [SALBUTAMOL], ALBUTEROL [SALBUTAMOL] and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    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 CHEST DISCOMFORT (Tightness in chest) and DYSPNOEA (Difficulty breathing). 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), INSOMNIA (2 hours of sleep last night), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle aches/ Achiness), HEADACHE (headache) and FATIGUE (Very tired/ Fatigued). The patient was treated with OXYGEN for Dyspnoea, at a dose of breathing; PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Headache, at a dose of 10/325mg. On 11-Mar-2021, CHEST DISCOMFORT (Tightness in chest) and DYSPNOEA (Difficulty breathing) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Joint pain), NAUSEA (Nausea), MYALGIA (Muscle aches/ Achiness), HEADACHE (headache) and FATIGUE (Very tired/ Fatigued) had not resolved and INSOMNIA (2 hours of sleep last night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.