chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dysarthria, Fear, Feeling abnormal
Clinical narrative: shaking; felt drunk; scared; vestibular issues; dizzy; spinning; stumble; slur words; brain fog; confused; forget what I'm talking about; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble) and DYSARTHRIA (slur words) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Post concussion syndrome, Ear ringing, Immunocompromised and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriatic arthritis.    On 12-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 VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble), DYSARTHRIA (slur words), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), MEMORY IMPAIRMENT (forget what I'm talking about), FEELING DRUNK (felt drunk) and FEAR (scared). On 17-Mar-2021, the patient experienced TREMOR (shaking). At the time of the report, VESTIBULAR DISORDER (vestibular issues), VERTIGO (spinning), DYSARTHRIA (slur words), MEMORY IMPAIRMENT (forget what I'm talking about) and TREMOR (shaking) outcome was unknown and DIZZINESS (dizzy), GAIT DISTURBANCE (stumble), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), FEELING DRUNK (felt drunk) and FEAR (scared) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported doctor was called. Doctor wanted the patient to wait an extra 4 weeks to receive the second dose. Treatment information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18-MAR-2021, Additional events reported include, stumble, brain fog.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling drunk, Gait disturbance, Memory impairment, Tremor, Vertigo
Clinical narrative: shaking; felt drunk; scared; vestibular issues; dizzy; spinning; stumble; slur words; brain fog; confused; forget what I'm talking about; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble) and DYSARTHRIA (slur words) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Post concussion syndrome, Ear ringing, Immunocompromised and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriatic arthritis.    On 12-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 VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble), DYSARTHRIA (slur words), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), MEMORY IMPAIRMENT (forget what I'm talking about), FEELING DRUNK (felt drunk) and FEAR (scared). On 17-Mar-2021, the patient experienced TREMOR (shaking). At the time of the report, VESTIBULAR DISORDER (vestibular issues), VERTIGO (spinning), DYSARTHRIA (slur words), MEMORY IMPAIRMENT (forget what I'm talking about) and TREMOR (shaking) outcome was unknown and DIZZINESS (dizzy), GAIT DISTURBANCE (stumble), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), FEELING DRUNK (felt drunk) and FEAR (scared) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported doctor was called. Doctor wanted the patient to wait an extra 4 weeks to receive the second dose. Treatment information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18-MAR-2021, Additional events reported include, stumble, brain fog.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibular disorder
Clinical narrative: shaking; felt drunk; scared; vestibular issues; dizzy; spinning; stumble; slur words; brain fog; confused; forget what I'm talking about; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble) and DYSARTHRIA (slur words) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Post concussion syndrome, Ear ringing, Immunocompromised and Psoriatic arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriatic arthritis.    On 12-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 VESTIBULAR DISORDER (vestibular issues), DIZZINESS (dizzy), VERTIGO (spinning), GAIT DISTURBANCE (stumble), DYSARTHRIA (slur words), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), MEMORY IMPAIRMENT (forget what I'm talking about), FEELING DRUNK (felt drunk) and FEAR (scared). On 17-Mar-2021, the patient experienced TREMOR (shaking). At the time of the report, VESTIBULAR DISORDER (vestibular issues), VERTIGO (spinning), DYSARTHRIA (slur words), MEMORY IMPAIRMENT (forget what I'm talking about) and TREMOR (shaking) outcome was unknown and DIZZINESS (dizzy), GAIT DISTURBANCE (stumble), FEELING ABNORMAL (brain fog), CONFUSIONAL STATE (confused), FEELING DRUNK (felt drunk) and FEAR (scared) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported doctor was called. Doctor wanted the patient to wait an extra 4 weeks to receive the second dose. Treatment information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18-MAR-2021, Additional events reported include, stumble, brain fog.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: She feels like she was working all night when she exerts herself; body pain; very thirsty; headache; arm pain; cold; weakness/very week; fever; ver tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), THIRST (very thirsty) and FEELING ABNORMAL (She feels like she was working all night when she exerts herself) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), PYREXIA (fever) and FATIGUE (ver tired). On 17-Mar-2021, the patient experienced THIRST (very thirsty), MYALGIA (body pain) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (She feels like she was working all night when she exerts herself). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), THIRST (very thirsty), MYALGIA (body pain), PYREXIA (fever) and HEADACHE (headache) was resolving and FEELING ABNORMAL (She feels like she was working all night when she exerts herself) and FATIGUE (ver tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Event information updated
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia, Thirst
Clinical narrative: She feels like she was working all night when she exerts herself; body pain; very thirsty; headache; arm pain; cold; weakness/very week; fever; ver tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), THIRST (very thirsty) and FEELING ABNORMAL (She feels like she was working all night when she exerts herself) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), PYREXIA (fever) and FATIGUE (ver tired). On 17-Mar-2021, the patient experienced THIRST (very thirsty), MYALGIA (body pain) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (She feels like she was working all night when she exerts herself). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), NASOPHARYNGITIS (cold), ASTHENIA (weakness/very week), THIRST (very thirsty), MYALGIA (body pain), PYREXIA (fever) and HEADACHE (headache) was resolving and FEELING ABNORMAL (She feels like she was working all night when she exerts herself) and FATIGUE (ver tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Event information updated
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Not received second dose after 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received second dose after 36 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received second dose after 36 days). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Not received second dose after 36 days) had resolved.            Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Chills, Decreased appetite, Fatigue
Clinical narrative: extreme cold and hot; no appetite; sleeping a lot; still feeling ill; in bed for roughly 7 days; pain; sweating; extreme fatigue; severe fever of 100.4 / fever that produces sweat; shivers; pain in the knees; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot) and MALAISE (still feeling ill) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot), MALAISE (still feeling ill), BEDRIDDEN (in bed for roughly 7 days), HYPERHIDROSIS (sweating), FATIGUE (extreme fatigue), PYREXIA (still not able to get the fever under control it is between 100.2 to 100.4), PAIN (pain), CHILLS (shivers) and ARTHRALGIA (pain in the knees). At the time of the report, SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot), MALAISE (still feeling ill), BEDRIDDEN (in bed for roughly 7 days), HYPERHIDROSIS (sweating), FATIGUE (extreme fatigue), PYREXIA (still not able to get the fever under control it is between 100.2 to 100.4), PAIN (pain), CHILLS (shivers) and ARTHRALGIA (pain in the knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient takes thyroid medication; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hyperhidrosis, Hypersomnia, Pain, Pyrexia
Clinical narrative: extreme cold and hot; no appetite; sleeping a lot; still feeling ill; in bed for roughly 7 days; pain; sweating; extreme fatigue; severe fever of 100.4 / fever that produces sweat; shivers; pain in the knees; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot) and MALAISE (still feeling ill) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot), MALAISE (still feeling ill), BEDRIDDEN (in bed for roughly 7 days), HYPERHIDROSIS (sweating), FATIGUE (extreme fatigue), PYREXIA (still not able to get the fever under control it is between 100.2 to 100.4), PAIN (pain), CHILLS (shivers) and ARTHRALGIA (pain in the knees). At the time of the report, SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot), MALAISE (still feeling ill), BEDRIDDEN (in bed for roughly 7 days), HYPERHIDROSIS (sweating), FATIGUE (extreme fatigue), PYREXIA (still not able to get the fever under control it is between 100.2 to 100.4), PAIN (pain), CHILLS (shivers) and ARTHRALGIA (pain in the knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient takes thyroid medication; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: extreme cold and hot; no appetite; sleeping a lot; still feeling ill; in bed for roughly 7 days; pain; sweating; extreme fatigue; severe fever of 100.4 / fever that produces sweat; shivers; pain in the knees; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot) and MALAISE (still feeling ill) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot), MALAISE (still feeling ill), BEDRIDDEN (in bed for roughly 7 days), HYPERHIDROSIS (sweating), FATIGUE (extreme fatigue), PYREXIA (still not able to get the fever under control it is between 100.2 to 100.4), PAIN (pain), CHILLS (shivers) and ARTHRALGIA (pain in the knees). At the time of the report, SWEATING FEVER (fever that produce sweat), FEELING OF BODY TEMPERATURE CHANGE (extreme cold and hot), DECREASED APPETITE (no appetite), HYPERSOMNIA (sleeping a lot), MALAISE (still feeling ill), BEDRIDDEN (in bed for roughly 7 days), HYPERHIDROSIS (sweating), FATIGUE (extreme fatigue), PYREXIA (still not able to get the fever under control it is between 100.2 to 100.4), PAIN (pain), CHILLS (shivers) and ARTHRALGIA (pain in the knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient takes thyroid medication; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a 17 year old patient; A spontaneous report was received from a pharmacist concerning a 17-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)/Inappropriate schedule of product administration.  Medical history or concomitant product use was not reported.  On 14 Jan 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 11 Feb 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: 042L20A) intramuscularly in the left deltoid. It was reported that patient was only 17-year-old while vaccination.  The action taken with mRNA-1273 in response to the event was not applicable since the patient received both the doses.  The outcome of the event was considered as resolved on 11 Feb 2021.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 025J2--2A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: feeling like a truck hit; Extreme fatigue; Joint Pain; Muscle pain; injection site itchiness; injection site pain/tenderness; injection site swelling. It is pretty expansive almost the size of a small child fist; Injection site redness; Headache/ bad headache/ horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling like a truck hit), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hair loss.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist), VACCINATION SITE ERYTHEMA (Injection site redness) and HEADACHE (Headache/ bad headache/ horrible headache). On 09-Mar-2021, the patient experienced FATIGUE (Extreme fatigue), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain). On an unknown date, the patient experienced FEELING ABNORMAL (feeling like a truck hit). In March 2021, VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist), HEADACHE (Headache/ bad headache/ horrible headache), FATIGUE (Extreme fatigue), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, FEELING ABNORMAL (feeling like a truck hit) had resolved and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included a medication for her hair loss three times a week. No treatment information was provided.   This case was linked to MOD-2021-162218 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: feeling like a truck hit; Extreme fatigue; Joint Pain; Muscle pain; injection site itchiness; injection site pain/tenderness; injection site swelling. It is pretty expansive almost the size of a small child fist; Injection site redness; Headache/ bad headache/ horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling like a truck hit), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hair loss.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist), VACCINATION SITE ERYTHEMA (Injection site redness) and HEADACHE (Headache/ bad headache/ horrible headache). On 09-Mar-2021, the patient experienced FATIGUE (Extreme fatigue), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain). On an unknown date, the patient experienced FEELING ABNORMAL (feeling like a truck hit). In March 2021, VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE PAIN (injection site pain/tenderness), VACCINATION SITE SWELLING (injection site swelling. It is pretty expansive almost the size of a small child fist), HEADACHE (Headache/ bad headache/ horrible headache), FATIGUE (Extreme fatigue), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, FEELING ABNORMAL (feeling like a truck hit) had resolved and VACCINATION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included a medication for her hair loss three times a week. No treatment information was provided.   This case was linked to MOD-2021-162218 (Patient Link).   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Diarrhea; Body Aches; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MYALGIA (Body Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), MYALGIA (Body Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 16-Mar-2021, DIARRHOEA (Diarrhea), MYALGIA (Body Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Swelling of fingers. Concurrent medical conditions included Arthritis (left shoulder and right foot).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-047839 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pretty strong dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Pretty strong dizziness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS, HYALURONIC ACID and AMINOACIDS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Pretty strong dizziness). At the time of the report, DIZZINESS (Pretty strong dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included supplement chasteberry. The patient did not receive any treatment medication.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache). On 19-Feb-2021, HEADACHE (Headache) 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 relevant concomitant medications were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Symptom; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Symptom) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 VACCINATION COMPLICATION (Symptom). At the time of the report, VACCINATION COMPLICATION (Symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient wanted to know if should get the second dose.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache
Clinical narrative: COVID-19; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced HEADACHE (Headache). On 25-Dec-2020, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Fatigue, Feeling abnormal, Feeling cold, Pain
Clinical narrative: Cold; If lay on left or right it hurts; Tongue hasn't been too bad, last time my tongue was swollen; Every night is lousy; Tired; Right hand side hurts like hell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen) and FEELING ABNORMAL (Every night is lousy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SUNITINIB MALATE (SUTENT) for an unknown indication.    Concurrent medical conditions included Abnormal platelets (platelets up and down). Concomitant products included VITAMINS NOS for an unknown indication.   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. and SUNITINIB MALATE (SUTENT) (unknown route) 37.5 mg. On an unknown date, the patient experienced FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen), FEELING ABNORMAL (Every night is lousy) and FATIGUE (Tired). At the time of the report, FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen), FEELING ABNORMAL (Every night is lousy) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) blood tests are going good.         Concomitantly patient was also taking flaxseed  for abnormal platelets until he stopped them recently.  Treatment information was not provided.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Tongue discomfort, Vaccination site pain
Clinical narrative: Cold; If lay on left or right it hurts; Tongue hasn't been too bad, last time my tongue was swollen; Every night is lousy; Tired; Right hand side hurts like hell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen) and FEELING ABNORMAL (Every night is lousy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SUNITINIB MALATE (SUTENT) for an unknown indication.    Concurrent medical conditions included Abnormal platelets (platelets up and down). Concomitant products included VITAMINS NOS for an unknown indication.   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. and SUNITINIB MALATE (SUTENT) (unknown route) 37.5 mg. On an unknown date, the patient experienced FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen), FEELING ABNORMAL (Every night is lousy) and FATIGUE (Tired). At the time of the report, FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen), FEELING ABNORMAL (Every night is lousy) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) blood tests are going good.         Concomitantly patient was also taking flaxseed  for abnormal platelets until he stopped them recently.  Treatment information was not provided.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge, Wrong technique in product usage process
Clinical narrative: Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage; Something leaked out of the injection site- either blood or vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage) and VACCINATION SITE DISCHARGE (Something leaked out of the injection site- either blood or vaccine) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to some antibiotics. Causes rash and hives.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage) and VACCINATION SITE DISCHARGE (Something leaked out of the injection site- either blood or vaccine). On 17-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vaccine was administered through a BIOCLUSIVE adhesive dressing/bandage) had resolved. At the time of the report, VACCINATION SITE DISCHARGE (Something leaked out of the injection site- either blood or vaccine) outcome was unknown. Not Provided      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.   Products known to have been used by the patient, within two weeks prior to the event, included none. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-048265 (E2B Linked Report).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048265:Crosslinked case
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received Moderna for 2nd dose versus Pfizer which was given at first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna for 2nd dose versus Pfizer which was given at first dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).   On 15-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 15-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna for 2nd dose versus Pfizer which was given at first dose). On 15-Mar-2021, WRONG PRODUCT ADMINISTERED (Patient received Moderna for 2nd dose versus Pfizer which was given at first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: This report refers to a case of wrong technique in product usage process for mRNA-1273, lot # 002a21a with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: She missed second dose because she was sick; She missed second dose because she was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She missed second dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (She missed second dose because she was sick) 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She missed second dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (She missed second dose because she was sick). At the time of the report, ILLNESS (She missed second dose because she was sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She missed second dose because she was sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-048890 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under arm and on chest/rash over majority of body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under arm and on chest/rash over majority of body) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (Rash under arm and on chest/rash over majority of body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH RELIEF) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, RASH (Rash under arm and on chest/rash over majority of body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment medication included diphenhydramine, hydrocortisone cream and cold pack.   This case was linked to MODERNATX, INC.-MOD-2021-048236 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-048236:Crosslinked case
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed her second dose because she was sick; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed her second dose because she was sick) 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-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second dose because she was sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed her second dose because she was sick) had resolved.            Concomitant medications were not provided. Treatment information was not reported.   Treatment information was not provided.   This case was linked to MOD-2021-048873 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Pruritus, Rash, Urticaria
Clinical narrative: Patient thought it was dry skin, so he put lotion on. Then it kind of itched; Patient thought it was dry skin, so he put lotion on; welts; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient thought it was dry skin, so he put lotion on. Then it kind of itched), DRY SKIN (Patient thought it was dry skin, so he put lotion on), URTICARIA (welts) and RASH (rash) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (Patient thought it was dry skin, so he put lotion on. Then it kind of itched), DRY SKIN (Patient thought it was dry skin, so he put lotion on), URTICARIA (welts) and RASH (rash). At the time of the report, PRURITUS (Patient thought it was dry skin, so he put lotion on. Then it kind of itched), DRY SKIN (Patient thought it was dry skin, so he put lotion on), URTICARIA (welts) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medication included unspecified lotion.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Nasopharyngitis
Clinical narrative: cold; arm was sore; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (cold), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (arm was sore) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027620A and 026620A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and INJECTION SITE PAIN (arm was sore). At the time of the report, NASOPHARYNGITIS (cold), CHILLS (Chills), HEADACHE (Headache) and INJECTION SITE PAIN (arm was sore) outcome was unknown.            No relevant concomitant medications reported.  Patient's health care provider approved the use of aspirin to help with the side effects.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives on face; rash on right shoulder; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on face) and RASH (rash on right shoulder) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (hives on face) and RASH (rash on right shoulder). At the time of the report, URTICARIA (hives on face) and RASH (rash on right shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: COVID-Arm; The injection site is hot; The injection site is painful; The injection site is swelled/The injection site is round; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID-Arm), VACCINATION SITE WARMTH (The injection site is hot), VACCINATION SITE PAIN (The injection site is painful) and VACCINATION SITE SWELLING (The injection site is swelled/The injection site is round) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Gastrointestinal disorder.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE REACTION (COVID-Arm), VACCINATION SITE WARMTH (The injection site is hot), VACCINATION SITE PAIN (The injection site is painful) and VACCINATION SITE SWELLING (The injection site is swelled/The injection site is round). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID-Arm), VACCINATION SITE WARMTH (The injection site is hot), VACCINATION SITE PAIN (The injection site is painful) and VACCINATION SITE SWELLING (The injection site is swelled/The injection site is round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included blood pressure and stomach medicines.