chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Huge rash on left arm a little below injection site; felt fatigued; up all night; could not control her body temperature; freezing cold, yet sweating at the same time; freezing cold, yet sweating at the same time; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE ABNORMAL (could not control her body temperature), FEELING COLD (freezing cold, yet sweating at the same time), HYPERHIDROSIS (freezing cold, yet sweating at the same time), INSOMNIA (up all night) and RASH (Huge rash on left arm a little below injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2020 and COVID-19 from 11-Apr-2021 to 25-Apr-2021.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced BODY TEMPERATURE ABNORMAL (could not control her body temperature), FEELING COLD (freezing cold, yet sweating at the same time) and HYPERHIDROSIS (freezing cold, yet sweating at the same time). On 29-Apr-2021, the patient experienced INSOMNIA (up all night). On 30-Apr-2021, the patient experienced RASH (Huge rash on left arm a little below injection site) and FATIGUE (felt fatigued). On 28-Apr-2021, BODY TEMPERATURE ABNORMAL (could not control her body temperature), FEELING COLD (freezing cold, yet sweating at the same time) and HYPERHIDROSIS (freezing cold, yet sweating at the same time) had resolved. At the time of the report, INSOMNIA (up all night), RASH (Huge rash on left arm a little below injection site) and FATIGUE (felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator .No treatment medications provided by the reporter.  Caller stated she would  ask HCP about putting some cortisone cream.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Mild Itchy around the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Mild Itchy around the site of the injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00ZC ZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Mild Itchy around the site of the injection). At the time of the report, INJECTION SITE PRURITUS (Mild Itchy around the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Redness on injection arm; Hardness about the size of a quarter at the injection site; Pain in injection arm; Feverish skin near injection site; Limit mobility in injection arm due to pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on injection arm), VACCINATION SITE INDURATION (Hardness about the size of a quarter at the injection site), VACCINATION SITE PAIN (Pain in injection arm), VACCINATION SITE WARMTH (Feverish skin near injection site) and VACCINATION SITE DISCOMFORT (Limit mobility in injection arm due to pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on injection arm), VACCINATION SITE INDURATION (Hardness about the size of a quarter at the injection site), VACCINATION SITE PAIN (Pain in injection arm), VACCINATION SITE WARMTH (Feverish skin near injection site) and VACCINATION SITE DISCOMFORT (Limit mobility in injection arm due to pain). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on injection arm), VACCINATION SITE INDURATION (Hardness about the size of a quarter at the injection site), VACCINATION SITE PAIN (Pain in injection arm), VACCINATION SITE WARMTH (Feverish skin near injection site) and VACCINATION SITE DISCOMFORT (Limit mobility in injection arm due to pain) outcome was unknown.            Concomitant medications were provided was Unknown, lost in crash. Treatment medication were not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: 2x2 itching size/the itching size is; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (2x2 itching size/the itching size is) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046bz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (2x2 itching size/the itching size is). At the time of the report, VACCINATION SITE PRURITUS (2x2 itching size/the itching size is) had not resolved.        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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching; Handsswelling; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and PERIPHERAL SWELLING (Handsswelling) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, 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 experienced PRURITUS (Itching) and PERIPHERAL SWELLING (Handsswelling). At the time of the report, PRURITUS (Itching) and PERIPHERAL SWELLING (Handsswelling) outcome was unknown.            Patient stated that he is taking Benadryl.  Action taken with mRNA-1273 Moderna vaccine was Not Applicable
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine in refrigerator was refrozen for 12 hours then put in refrigerator again and later administered; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine in refrigerator was refrozen for 12 hours then put in refrigerator again and later administered) 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 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine in refrigerator was refrozen for 12 hours then put in refrigerator again and later administered). At the time of the report, PRODUCT STORAGE ERROR (Vaccine in refrigerator was refrozen for 12 hours then put in refrigerator again and later administered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: COVID test result after full vaccination series; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID test result after full vaccination series) in a 36-year-old female patient who received mRNA-1273 (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (COVID test result after full vaccination series). At the time of the report, COVID-19 (COVID test result after full vaccination series) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, SARS-CoV-2 antibody test positive: unknown (Positive) positive.     For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications include  berry syrup. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-100431 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100431:Husband's case crosslinked
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Injection site muscle weakness, Mobility decreased, Pain
Clinical narrative: had a blood vessel burst in his leg; felt he did not have any strength; pain in arm/shoulder; maybe arthritis which he never felt in shoulder; Could not raise his arm over his head; Pain then travelled to the other arm; It became so bad that he could not use his arm without pain; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (had a blood vessel burst in his leg), INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), PAIN IN EXTREMITY (pain in arm/shoulder), ARTHRITIS (maybe arthritis which he never felt in shoulder) and PAIN (It became so bad that he could not use his arm without pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 027C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included ACYCLOVIR SODIUM, MELOXICAM, TERAZOSIN and ATORVASTATIN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (It became so bad that he could not use his arm without pain). On 20-Feb-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), PAIN IN EXTREMITY (pain in arm/shoulder), ARTHRITIS (maybe arthritis which he never felt in shoulder), MOBILITY DECREASED (Could not raise his arm over his head) and ARTHRALGIA (Pain then travelled to the other arm). On 27-Apr-2021, the patient experienced VASCULAR INJURY (had a blood vessel burst in his leg). The patient was treated with NAPROXEN for Adverse event, at a dose of 1 dosage form; ACETAMINOPHEN at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VASCULAR INJURY (had a blood vessel burst in his leg), INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), ARTHRITIS (maybe arthritis which he never felt in shoulder), PAIN (It became so bad that he could not use his arm without pain), MOBILITY DECREASED (Could not raise his arm over his head) and ARTHRALGIA (Pain then travelled to the other arm) outcome was unknown and PAIN IN EXTREMITY (pain in arm/shoulder) had not resolved.            This case was linked to MOD-2021-100500 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant Follow-up :- patient confirmed regarding events that his arm is still hurting.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vascular injury
Clinical narrative: had a blood vessel burst in his leg; felt he did not have any strength; pain in arm/shoulder; maybe arthritis which he never felt in shoulder; Could not raise his arm over his head; Pain then travelled to the other arm; It became so bad that he could not use his arm without pain; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (had a blood vessel burst in his leg), INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), PAIN IN EXTREMITY (pain in arm/shoulder), ARTHRITIS (maybe arthritis which he never felt in shoulder) and PAIN (It became so bad that he could not use his arm without pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 027C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included ACYCLOVIR SODIUM, MELOXICAM, TERAZOSIN and ATORVASTATIN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (It became so bad that he could not use his arm without pain). On 20-Feb-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), PAIN IN EXTREMITY (pain in arm/shoulder), ARTHRITIS (maybe arthritis which he never felt in shoulder), MOBILITY DECREASED (Could not raise his arm over his head) and ARTHRALGIA (Pain then travelled to the other arm). On 27-Apr-2021, the patient experienced VASCULAR INJURY (had a blood vessel burst in his leg). The patient was treated with NAPROXEN for Adverse event, at a dose of 1 dosage form; ACETAMINOPHEN at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VASCULAR INJURY (had a blood vessel burst in his leg), INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), ARTHRITIS (maybe arthritis which he never felt in shoulder), PAIN (It became so bad that he could not use his arm without pain), MOBILITY DECREASED (Could not raise his arm over his head) and ARTHRALGIA (Pain then travelled to the other arm) outcome was unknown and PAIN IN EXTREMITY (pain in arm/shoulder) had not resolved.            This case was linked to MOD-2021-100500 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant Follow-up :- patient confirmed regarding events that his arm is still hurting.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hot flush, Nausea, Pain in extremity, Rash
Clinical narrative: Colo:Pinkish Purplish; Warmth; Arm soreness; Rash; nausea; Feeling anxious; Hot flushes; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes), VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth) and PAIN IN EXTREMITY (Arm soreness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B2 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes) and NAUSEA (nausea). On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth), PAIN IN EXTREMITY (Arm soreness) and RASH (Rash). At the time of the report, ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes), VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth), PAIN IN EXTREMITY (Arm soreness), RASH (Rash) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site warmth
Clinical narrative: Colo:Pinkish Purplish; Warmth; Arm soreness; Rash; nausea; Feeling anxious; Hot flushes; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes), VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth) and PAIN IN EXTREMITY (Arm soreness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B2 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes) and NAUSEA (nausea). On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth), PAIN IN EXTREMITY (Arm soreness) and RASH (Rash). At the time of the report, ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes), VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth), PAIN IN EXTREMITY (Arm soreness), RASH (Rash) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness
Clinical narrative: Tightness in the back of both knees; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Tightness in the back of both knees) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020-821A) for COVID-19 vaccination.     Concurrent medical conditions included Varicose veins. Concomitant products included ATENOLOL for Blood pressure abnormal, OMEPRAZOLE for Gastric acid increased, Albuterol and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 29-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced JOINT STIFFNESS (Tightness in the back of both knees). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, JOINT STIFFNESS (Tightness in the back of both knees) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Pain in extremity, Underdose
Clinical narrative: sore arm; some vaccine leaked out; Syringe snapped; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), UNDERDOSE (some vaccine leaked out) and DEVICE CONNECTION ISSUE (Syringe snapped) in a 44-year-old female patient who received mRNA-1273 (batch nos. 016C21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event nor concomitant medications were reported.).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), UNDERDOSE (some vaccine leaked out) and DEVICE CONNECTION ISSUE (Syringe snapped). On 01-May-2021, UNDERDOSE (some vaccine leaked out) and DEVICE CONNECTION ISSUE (Syringe snapped) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was not applicable.       Patient reports that while receiving her second dose of Moderna COVID-19 vaccine the syringe snapped and some vaccine leaked out.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of vaccine 18Mar2021.  Has not received second dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose of vaccine 18Mar2021.  Has not received second dose.) in a 66-year-old male patient who received mRNA-1273 (batch no. 031a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose of vaccine 18Mar2021.  Has not received second dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose of vaccine 18Mar2021.  Has not received second dose.) had resolved.        The action taken with mRNA-1273 (Unknown) was unknown.   For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   Pharmacist is calling for her patient who received his first dose of the Moderna vaccine 43 days ago. His 1st dose was on 18Mar2021 Lot number 031a21a.  No concomitant medication and treatment provided
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost taste after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste after 2nd dose) in a 53-year-old female patient who received mRNA-1273 for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost taste after 2nd dose). At the time of the report, AGEUSIA (Lost taste after 2nd dose) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Presyncope, Pyrexia
Clinical narrative: he was dizzy; he almost passed out; He was sore; he got a fever; Very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (he was dizzy), PRESYNCOPE (he almost passed out), MYALGIA (He was sore), PYREXIA (he got a fever) and FATIGUE (Very tired) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (he was dizzy), PRESYNCOPE (he almost passed out), MYALGIA (He was sore), PYREXIA (he got a fever) and FATIGUE (Very tired). At the time of the report, DIZZINESS (he was dizzy), PRESYNCOPE (he almost passed out), MYALGIA (He was sore), PYREXIA (he got a fever) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by reporter.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received Vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Vaccine) in a 31-year-old female patient who received mRNA-1273 (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. The patient's last menstrual period was in November 2020 and the estimated date of delivery was date. On 30-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Vaccine). The patient received mRNA-1273 during pregnancy.  On 30-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Vaccine) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  The patient was 27 weeks pregnant at the time of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age received the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age received the vaccine) in a 16-year-old male patient who received mRNA-1273 (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication  were not provided. Concomitant medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at the injection site; Swelling at the injection site; Redness at the injection site; slight arthralgia; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), ARTHRALGIA (slight arthralgia) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ARTHRALGIA (slight arthralgia) and FATIGUE (tiredness). On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 07-Apr-2021, ARTHRALGIA (slight arthralgia) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient concerned about a blood clot.  Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment : Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Injection site pain, injection site redness,  injection site swelling, fatigue and arthralgia are consistent with the product known safety profile   This case was linked to MOD-2021-101007 (Patient Link).; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Injection site pain, injection site redness,  injection site swelling, fatigue and arthralgia are consistent with the product known safety profile
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever for one day.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for one day.) in an adult male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever for one day.). At the time of the report, PYREXIA (fever for one day.) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment medication was not reported.   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: lost her sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost her sense of taste) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included AMOXICILLIN for an unknown indication.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced AGEUSIA (lost her sense of taste). At the time of the report, AGEUSIA (lost her sense of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional information was received from initial reporter and no new information
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Peripheral swelling, Rash
Clinical narrative: Fingers on Right Hand are Swollen; Peripheral Edema; severe skin rash, most severe on left leg, migrated to right arm; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Fingers on Right Hand are Swollen), OEDEMA PERIPHERAL (Peripheral Edema) and RASH (severe skin rash, most severe on left leg, migrated to right arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No medical history reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced RASH (severe skin rash, most severe on left leg, migrated to right arm). On 30-Apr-2021, the patient experienced PERIPHERAL SWELLING (Fingers on Right Hand are Swollen) and OEDEMA PERIPHERAL (Peripheral Edema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Apr-2021 at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Fingers on Right Hand are Swollen), OEDEMA PERIPHERAL (Peripheral Edema) and RASH (severe skin rash, most severe on left leg, migrated to right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Action taken withmRNA-1273 in response to the events were not applicable
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: dry mouth 3 days after second dose; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth 3 days after second dose) in a male patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. In February 2021, the patient experienced DRY MOUTH (dry mouth 3 days after second dose). At the time of the report, DRY MOUTH (dry mouth 3 days after second dose) outcome was unknown.            Concomitant medications and treatment information was not provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise, Pain in extremity, Vaccination site pain
Clinical narrative: ice pick had gone thru her arm; arm was sore; very tired/exhausted; arm was killing her; sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick), FEELING ABNORMAL (ice pick had gone thru her arm), PAIN IN EXTREMITY (arm was sore), FATIGUE (very tired/exhausted) and VACCINATION SITE PAIN (arm was killing her) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 021C21A) for COVID-19 vaccination.     No Medical History Information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MALAISE (sick), PAIN IN EXTREMITY (arm was sore), FATIGUE (very tired/exhausted) and VACCINATION SITE PAIN (arm was killing her). On 04-Apr-2021, the patient experienced FEELING ABNORMAL (ice pick had gone thru her arm). On 04-Apr-2021, MALAISE (sick) had resolved. At the time of the report, FEELING ABNORMAL (ice pick had gone thru her arm), PAIN IN EXTREMITY (arm was sore), FATIGUE (very tired/exhausted) and VACCINATION SITE PAIN (arm was killing her) outcome was unknown.            Concomitant medication include Progesterone and estrogen patch. Treatment includes soaked in Epsom salt and Aspirin.   This case was linked to MOD-2021-100460 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm felt hot at the injection site; Redness moved down her arm; Injection site got red; Injection site was raised a tiny bit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Arm felt hot at the injection site), ERYTHEMA (Redness moved down her arm), INJECTION SITE ERYTHEMA (Injection site got red) and INJECTION SITE SWELLING (Injection site was raised a tiny bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced INJECTION SITE WARMTH (Arm felt hot at the injection site), ERYTHEMA (Redness moved down her arm), INJECTION SITE ERYTHEMA (Injection site got red) and INJECTION SITE SWELLING (Injection site was raised a tiny bit). At the time of the report, INJECTION SITE WARMTH (Arm felt hot at the injection site), ERYTHEMA (Redness moved down her arm), INJECTION SITE ERYTHEMA (Injection site got red) and INJECTION SITE SWELLING (Injection site was raised a tiny bit) outcome was unknown. Not Provided          No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient was already fully vaccinated with Covid Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient was already fully vaccinated with Covid Vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient was already fully vaccinated with Covid Vaccine). On 30-Apr-2021, EXTRA DOSE ADMINISTERED (patient was already fully vaccinated with Covid Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided by the reporter. Reporter stated patient told the reporter that he was already fully vaccinated with a COVID vaccine (unknown manufacture) prior to receiving the dose on 30-Apr-2021.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Off label use
Clinical narrative: patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window; Blood pressure elevated; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure elevated) and OFF LABEL USE (patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038-K20A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, 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 experienced BLOOD PRESSURE INCREASED (Blood pressure elevated) and OFF LABEL USE (patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window). At the time of the report, BLOOD PRESSURE INCREASED (Blood pressure elevated) and OFF LABEL USE (patient receiving the 2nd dose of the Moderna Covid-19 vaccine outside of the dosing window) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications: Taken but not listed Patient was told by her primary care provider not to get second dose as scheduled due to her blood pressure being elevated but has given the patient permission to receive it now.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (scheduled to receive her 2nd dose on 02apr2021) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history were provided by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (scheduled to receive her 2nd dose on 02apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (scheduled to receive her 2nd dose on 02apr2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter. No lab data has been provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: warmth over the left arm injection site; redness over the left arm injection site; pain over the left arm injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmth over the left arm injection site), VACCINATION SITE ERYTHEMA (redness over the left arm injection site) and VACCINATION SITE PAIN (pain over the left arm injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warmth over the left arm injection site), VACCINATION SITE ERYTHEMA (redness over the left arm injection site) and VACCINATION SITE PAIN (pain over the left arm injection site). At the time of the report, VACCINATION SITE WARMTH (warmth over the left arm injection site), VACCINATION SITE ERYTHEMA (redness over the left arm injection site) and VACCINATION SITE PAIN (pain over the left arm injection site) outcome was unknown.            The patient went to her doctor and got treated with an antibiotic (unspecified). No concomitant medications were reported   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site bruising
Clinical narrative: Left Arm throbbing; Little bruise at injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Left Arm throbbing) and VACCINATION SITE BRUISING (Little bruise at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID -19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding (Patient has reported to be a breast feeding mom.).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID -19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Left Arm throbbing) and VACCINATION SITE BRUISING (Little bruise at injection site). At the time of the report, PAIN (Left Arm throbbing) and VACCINATION SITE BRUISING (Little bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID -19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-101422 (Parent-Child Link).   See case MOD-2021-101422 for details regarding the child case.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration
Clinical narrative: Allergic attack; Missed her 2nd dose and its been 3months she had her 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Allergic attack) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    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 HYPERSENSITIVITY (Allergic attack) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose). At the time of the report, HYPERSENSITIVITY (Allergic attack) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose) 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.   Concomitant medications were not reported. The patient received steroid shot  several days after receiving the first dose of the Moderna COVID-19 vaccine for allergic attack. The patient missed her second dose and looking for second dose. First shot was administered 3 months ago.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Patient just felt tired; Missed dose; 46 days after the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days after the first dose of the Moderna Covid-19 vaccine), FATIGUE (Patient just felt tired) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days after the first dose of the Moderna Covid-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed dose). On 19-Apr-2021, the patient experienced FATIGUE (Patient just felt tired). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fatigue, at a dose of 500 mg. On 18-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days after the first dose of the Moderna Covid-19 vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. On 20-Apr-2021, FATIGUE (Patient just felt tired) had resolved.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.