chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm felt hot in the shoulder area), VACCINATION SITE ERYTHEMA (Red blotch about the size of patients' hand where patient received vaccine), VACCINATION SITE PAIN (Minor pain) and VACCINATION SITE SWELLING (Little bit swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced FEELING HOT (Arm felt hot in the shoulder area), VACCINATION SITE ERYTHEMA (Red blotch about the size of patients' hand where patient received vaccine), VACCINATION SITE PAIN (Minor pain) and VACCINATION SITE SWELLING (Little bit swollen). At the time of the report, FEELING HOT (Arm felt hot in the shoulder area), VACCINATION SITE ERYTHEMA (Red blotch about the size of patients' hand where patient received vaccine), VACCINATION SITE PAIN (Minor pain) and VACCINATION SITE SWELLING (Little bit swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling drunk, Swollen tongue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING DRUNK (felt "buzzed up") and SWOLLEN TONGUE (histongue started getting thicker and swelled up and interfering with his talking.) 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-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING DRUNK (felt "buzzed up") and SWOLLEN TONGUE (histongue started getting thicker and swelled up and interfering with his talking.). At the time of the report, FEELING DRUNK (felt "buzzed up") and SWOLLEN TONGUE (histongue started getting thicker and swelled up and interfering with his talking.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Mosquito bite redness, which has now progressed to elbow worsen's with agitation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Mosquito bite redness, which has now progressed to elbow worsen's with agitation) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Mosquito bite redness, which has now progressed to elbow worsen's with agitation). At the time of the report, VACCINATION SITE ERYTHEMA (Mosquito bite redness, which has now progressed to elbow worsen's with agitation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: She has a redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (She has a redness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (She has a redness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (She has a redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The medical history was not provided by the reporter. .  Concomitant products included QUETIAPINE FUMARATE for an unknown indication.    On 03-Feb-2021 at 7:49 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced RHINORRHOEA (Runny nose). The patient was treated with VITAMIN C [ASCORBIC ACID] on 05-Feb-2021 for Runny nose, at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that the event runny nose lasted for 1.5 days. Patient reported no events after second dose. Patient received second dose in Mar 2021 and did not experience any adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up document received on 12 Jul 2021, duration of event headache and second dose information updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Radicular pain
Clinical narrative: Intermittent radicular leg pain; This spontaneous case was reported by a patient and describes the occurrence of RADICULAR PAIN (Intermittent radicular leg pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced RADICULAR PAIN (Intermittent radicular leg pain). At the time of the report, RADICULAR PAIN (Intermittent radicular leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Soreness on his arm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on his arm), PYREXIA (Fever) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dyslipidemia and Heart rate abnormal.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness on his arm), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 05-Feb-2021 for Adverse event, at a dose of 1 dosage form. On 08-Feb-2021, VACCINATION SITE PAIN (Soreness on his arm), PYREXIA (Fever) and CHILLS (Chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medicine for cholesterol and heart rate.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up report included outcome of the events
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Headache and aches at the sinus area; Diagnosed positive of COVID-19; Diarrhea; 100°F fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Headache and aches at the sinus area; Diagnosed positive of COVID-19; Diarrhea; 100°F fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, SINUS HEADACHE (Headache and aches at the sinus area), COVID-19 (Diagnosed positive of COVID-19), DIARRHOEA (Diarrhea), PYREXIA (100°F fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Skin discolouration
Clinical narrative: Black and blue arm; Body Aches, soreness; Nausea; Fever 100 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Black and blue arm), PAIN (Body Aches, soreness), NAUSEA (Nausea), PYREXIA (Fever 100 F) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN (Body Aches, soreness), NAUSEA (Nausea), PYREXIA (Fever 100 F) and CHILLS (Chills). On 03-Feb-2021, the patient experienced SKIN DISCOLOURATION (Black and blue arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event following immunisation, at an unspecified dose and frequency. On 01-Feb-2021, NAUSEA (Nausea) and PYREXIA (Fever 100 F) had resolved. At the time of the report, SKIN DISCOLOURATION (Black and blue arm), PAIN (Body Aches, soreness) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Pyrexia: 100 Fever 100 F.         No relevant concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Vomiting
Clinical narrative: extremely dry mouth; Vomit one time; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (extremely dry mouth) and VOMITING (Vomit one time) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VOMITING (Vomit one time). On an unknown date, the patient experienced DRY MOUTH (extremely dry mouth). At the time of the report, DRY MOUTH (extremely dry mouth) outcome was unknown and VOMITING (Vomit one time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported using Biotin mouth rinse for treatment of dry mouth.   Reporter did not allow further contact
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Erythema, Fatigue, Myalgia
Clinical narrative: Cough; Face feels like red/irritated; Face feels like red/irritated; Body Ache; Nausea; Fever; Arm where they put the injection really hurts and cant raise it; Muscle pain; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ERYTHEMA (Face feels like red/irritated), SKIN IRRITATION (Face feels like red/irritated), PAIN (Body Ache) and NAUSEA (Nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced COUGH (Cough), ERYTHEMA (Face feels like red/irritated), SKIN IRRITATION (Face feels like red/irritated), PAIN (Body Ache), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE PAIN (Arm where they put the injection really hurts and cant raise it), MYALGIA (Muscle pain), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ERYTHEMA (Face feels like red/irritated), SKIN IRRITATION (Face feels like red/irritated), PAIN (Body Ache), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE PAIN (Arm where they put the injection really hurts and cant raise it), MYALGIA (Muscle pain), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Skin irritation, Vaccination site pain
Clinical narrative: Cough; Face feels like red/irritated; Face feels like red/irritated; Body Ache; Nausea; Fever; Arm where they put the injection really hurts and cant raise it; Muscle pain; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), ERYTHEMA (Face feels like red/irritated), SKIN IRRITATION (Face feels like red/irritated), PAIN (Body Ache) and NAUSEA (Nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced COUGH (Cough), ERYTHEMA (Face feels like red/irritated), SKIN IRRITATION (Face feels like red/irritated), PAIN (Body Ache), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE PAIN (Arm where they put the injection really hurts and cant raise it), MYALGIA (Muscle pain), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), ERYTHEMA (Face feels like red/irritated), SKIN IRRITATION (Face feels like red/irritated), PAIN (Body Ache), NAUSEA (Nausea), PYREXIA (Fever), VACCINATION SITE PAIN (Arm where they put the injection really hurts and cant raise it), MYALGIA (Muscle pain), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nausea, Paranasal sinus discomfort, SARS-CoV-2 test, Taste disorder
Clinical narrative: positive for Covid 19; Headaches (sinus pressure); Difficult to taste; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (positive for Covid 19), PARANASAL SINUS DISCOMFORT (Headaches (sinus pressure)), TASTE DISORDER (Difficult to taste) and NAUSEA (Nausea) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (positive for Covid 19), PARANASAL SINUS DISCOMFORT (Headaches (sinus pressure)), TASTE DISORDER (Difficult to taste) and NAUSEA (Nausea). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) on 16-Jan-2021 for Adverse event, at a dose of 81 mg once a day; CETIRIZINE on 16-Jan-2021 for Adverse event, at a dose of 10 mg once a day; FAMOTIDINE (PEPCID [FAMOTIDINE]) on 16-Jan-2021 for Nausea, at a dose of 1 dosage form; BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE (BROMFED) for COVID-19, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 26-Jan-2021, COVID-19 (positive for Covid 19), PARANASAL SINUS DISCOMFORT (Headaches (sinus pressure)), TASTE DISORDER (Difficult to taste) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included medication for nausea.  Patient reported that, she was retesting for virus on 05 Feb 2021 and wants to do a rapid test.  Patient also reported that, she was prescribed with vitamin d, zinc, z pack, ibuterol; but she had not taken these medications. She stated her second dose for vaccine on 08-Feb-2021.  Patient had a thermometer to check temperature/oxygen levels.  Treatment of the events included, cocktail injection and steroids.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness; Redness; Rash; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Rash) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE RASH (Rash) had not 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.   No relevant concomitant medications were reported. Treatment medication reported was cortisone.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Rash erythematous, Rash papular, Vaccination site pruritus
Clinical narrative: Tiny pimples; Red rash; Bumps on the arm; Itching on top of arm; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Tiny pimples), RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching on top of arm) and RASH PAPULAR (Bumps on the arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching on top of arm) and RASH PAPULAR (Bumps on the arm). On 05-Feb-2021, the patient experienced ACNE (Tiny pimples). On 05-Feb-2021, RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching on top of arm) and RASH PAPULAR (Bumps on the arm) had resolved. At the time of the report, ACNE (Tiny pimples) was resolving.        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 information was provided about treatment and concomitant medications.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Headache, Pyrexia
Clinical narrative: headaches; Fever; joint pain; diarrhea; abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), ARTHRALGIA (joint pain), HEADACHE (headaches) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Previously administered products included for Diverticulitis: Antibiotics (had diverticulitis and was taking antibiotics until the day before receiving the vaccine). Concurrent medical conditions included Diverticulitis.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN (abdominal cramping). On 17-Jan-2021, the patient experienced ARTHRALGIA (joint pain). On 19-Jan-2021, the patient experienced HEADACHE (headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping) and ARTHRALGIA (joint pain) outcome was unknown and HEADACHE (headaches) and PYREXIA (Fever) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-082322 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Second dose AE information; mailing address
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy Arm (Injection Site); Red Arm (Injection Site); Swollen Arm (Injection Site); Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)), VACCINATION SITE ERYTHEMA (Red Arm (Injection Site)), VACCINATION SITE SWELLING (Swollen Arm (Injection Site)) and MYALGIA (Body Aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)), VACCINATION SITE ERYTHEMA (Red Arm (Injection Site)), VACCINATION SITE SWELLING (Swollen Arm (Injection Site)) and MYALGIA (Body Aches). At the time of the report, VACCINATION SITE PRURITUS (Itchy Arm (Injection Site)), VACCINATION SITE ERYTHEMA (Red Arm (Injection Site)), VACCINATION SITE SWELLING (Swollen Arm (Injection Site)) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Pain in extremity
Clinical narrative: Arm  is sore; When raising elbow the shoulder have a big knot that is painful; big knot that is painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  is sore), ARTHRALGIA (When raising elbow the shoulder have a big knot that is painful) and LYMPH NODE PAIN (big knot that is painful) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm  is sore), ARTHRALGIA (When raising elbow the shoulder have a big knot that is painful) and LYMPH NODE PAIN (big knot that is painful). At the time of the report, PAIN IN EXTREMITY (Arm  is sore), ARTHRALGIA (When raising elbow the shoulder have a big knot that is painful) and LYMPH NODE PAIN (big knot that is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Extrasystoles, Heart rate, Heart rate increased
Clinical narrative: substantial rise in blood pressure to 170; rise in pulse; jittery and shaky; erratic heart rhythm; Heart beat skipped; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (substantial rise in blood pressure to 170), HEART RATE INCREASED (rise in pulse), NERVOUSNESS (jittery and shaky) and HEART RATE IRREGULAR (erratic heart rhythm) in a 79-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.     Concomitant products included ATENOLOL (TENORMIN) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness). On 22-Jan-2021, the patient experienced HYPERTENSION (substantial rise in blood pressure to 170), HEART RATE INCREASED (rise in pulse), NERVOUSNESS (jittery and shaky), HEART RATE IRREGULAR (erratic heart rhythm) and EXTRASYSTOLES (Heart beat skipped). At the time of the report, DIZZINESS (dizziness), HYPERTENSION (substantial rise in blood pressure to 170), HEART RATE INCREASED (rise in pulse), NERVOUSNESS (jittery and shaky), HEART RATE IRREGULAR (erratic heart rhythm) and EXTRASYSTOLES (Heart beat skipped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170 (High) substantial rise in blood pressure to 170. On an unknown date, Heart rate: rise (High) same rise in pulse.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication and "hypercholride". Treatment information were not provided. Patient did not consider her fast heart beat as severe allergic reaction and believes that it should not stop her from receiving second dose.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Hypertension, Nervousness
Clinical narrative: substantial rise in blood pressure to 170; rise in pulse; jittery and shaky; erratic heart rhythm; Heart beat skipped; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (substantial rise in blood pressure to 170), HEART RATE INCREASED (rise in pulse), NERVOUSNESS (jittery and shaky) and HEART RATE IRREGULAR (erratic heart rhythm) in a 79-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.     Concomitant products included ATENOLOL (TENORMIN) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness). On 22-Jan-2021, the patient experienced HYPERTENSION (substantial rise in blood pressure to 170), HEART RATE INCREASED (rise in pulse), NERVOUSNESS (jittery and shaky), HEART RATE IRREGULAR (erratic heart rhythm) and EXTRASYSTOLES (Heart beat skipped). At the time of the report, DIZZINESS (dizziness), HYPERTENSION (substantial rise in blood pressure to 170), HEART RATE INCREASED (rise in pulse), NERVOUSNESS (jittery and shaky), HEART RATE IRREGULAR (erratic heart rhythm) and EXTRASYSTOLES (Heart beat skipped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170 (High) substantial rise in blood pressure to 170. On an unknown date, Heart rate: rise (High) same rise in pulse.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication and "hypercholride". Treatment information were not provided. Patient did not consider her fast heart beat as severe allergic reaction and believes that it should not stop her from receiving second dose.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: little bit of itching on rash in the arm of the injection; rash in right arm; going down from his triceps to his hand in both sides; rash in the left arm of the injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (little bit of itching on rash in the arm of the injection) and VACCINATION SITE RASH (rash in the left arm of the injection) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], CETIRIZINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (rash in the left arm of the injection). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (little bit of itching on rash in the arm of the injection). The patient was treated with CORTISONE at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (little bit of itching on rash in the arm of the injection) and VACCINATION SITE RASH (rash in the left arm of the injection) 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.   The rash in the arm of the injection was 95% resolved, he only had a little bit of itching at the time of report. The a rash on the other right arm, now was 95% resolved at the time of report. For the past 3 weeks (prior to the report)  it had been going down from his triceps to his hand in both sides. He was diagnosed with a dermatological reaction to the vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: experiencing really bad headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (experiencing really bad headache) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (experiencing really bad headache) and NAUSEA (nausea). At the time of the report, HEADACHE (experiencing really bad headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not use any concomitant medication.  The patient was told to take Tylenol if experience any side effects after the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nocturia, Somnolence
Clinical narrative: wants to sleep; she feel week and not strong at all; urine all night long and is wetting herself; she feels fatigued and tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (wants to sleep), ASTHENIA (she feel week and not strong at all), NOCTURIA (urine all night long and is wetting herself) and FATIGUE (she feels fatigued and tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Cholesterol. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (wants to sleep), ASTHENIA (she feel week and not strong at all), NOCTURIA (urine all night long and is wetting herself) and FATIGUE (she feels fatigued and tired). At the time of the report, SOMNOLENCE (wants to sleep), ASTHENIA (she feel week and not strong at all), NOCTURIA (urine all night long and is wetting herself) and FATIGUE (she feels fatigued and tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included Sebreval the pill in the inhaler, nebulizer drops, blood pressure pill and cholesterol  pill.  The patient did not receive any treatment medications.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Dizziness, Dyspnoea
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Bones ached), DIZZINESS (Dizzy/bad balance), DYSPNOEA (Getting out-of-breath easily), MYALGIA (Body aches) and FATIGUE (Barely could get out of bed; Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (experienced some lingering symptoms from that) in January 2021.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (High fever). On 04-Feb-2021, the patient experienced BONE PAIN (Bones ached), DIZZINESS (Dizzy/bad balance), MYALGIA (Body aches), FATIGUE (Barely could get out of bed; Fatigue), HEADACHE (Felt like her head was exploding) and CHILLS (Chills). On 05-Feb-2021, the patient experienced DYSPNOEA (Getting out-of-breath easily). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Fever, at a dose of UNK dosage form. On 06-Feb-2021, DIZZINESS (Dizzy/bad balance), MYALGIA (Body aches), HEADACHE (Felt like her head was exploding) and CHILLS (Chills) had resolved. At the time of the report, BONE PAIN (Bones ached) and FATIGUE (Barely could get out of bed; Fatigue) had not resolved, DYSPNOEA (Getting out-of-breath easily) outcome was unknown and PYREXIA (High fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102 (High) 102 degrees F. On , Body temperature: high High.     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 medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Bones ached), DIZZINESS (Dizzy/bad balance), DYSPNOEA (Getting out-of-breath easily), MYALGIA (Body aches) and FATIGUE (Barely could get out of bed; Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (experienced some lingering symptoms from that) in January 2021.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (High fever). On 04-Feb-2021, the patient experienced BONE PAIN (Bones ached), DIZZINESS (Dizzy/bad balance), MYALGIA (Body aches), FATIGUE (Barely could get out of bed; Fatigue), HEADACHE (Felt like her head was exploding) and CHILLS (Chills). On 05-Feb-2021, the patient experienced DYSPNOEA (Getting out-of-breath easily). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) for Fever, at a dose of UNK dosage form. On 06-Feb-2021, DIZZINESS (Dizzy/bad balance), MYALGIA (Body aches), HEADACHE (Felt like her head was exploding) and CHILLS (Chills) had resolved. At the time of the report, BONE PAIN (Bones ached) and FATIGUE (Barely could get out of bed; Fatigue) had not resolved, DYSPNOEA (Getting out-of-breath easily) outcome was unknown and PYREXIA (High fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102 (High) 102 degrees F. On , Body temperature: high High.     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 medication was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort
Clinical narrative: 1 side of my face was very heavy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (1 side of my face was very heavy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included EZETIMIBE (ZETIA) and LATANOPROST (XALATAN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FACIAL DISCOMFORT (1 side of my face was very heavy). On 04-Feb-2021, FACIAL DISCOMFORT (1 side of my face was very heavy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not used. The event lasted for about 1 hour after getting up.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain that does not go away; This spontaneous case was reported by an other and describes the occurrence of MYALGIA (Muscle pain that does not go away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (Muscle pain that does not go away). At the time of the report, MYALGIA (Muscle pain that does not go away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Vaccination complication, Vaccination site pain
Clinical narrative: Arm is still hurting; Could not sleep; Felt very tired and awful; Sick and stayed in bed for a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is still hurting), INSOMNIA (Could not sleep), FATIGUE (Felt very tired and awful) and VACCINATION COMPLICATION (Sick and stayed in bed for a day and a half) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is still hurting), INSOMNIA (Could not sleep), FATIGUE (Felt very tired and awful) and VACCINATION COMPLICATION (Sick and stayed in bed for a day and a half). At the time of the report, VACCINATION SITE PAIN (Arm is still hurting), INSOMNIA (Could not sleep), FATIGUE (Felt very tired and awful) and VACCINATION COMPLICATION (Sick and stayed in bed for a day and a half) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hot flush, Palpitations, Swelling face
Clinical narrative: Hot flashes; Cold flush; Face is swollen; Heart raced a little; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), FEELING COLD (Cold flush), SWELLING FACE (Face is swollen) and PALPITATIONS (Heart raced a little) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diabetes mellitus.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HOT FLUSH (Hot flashes), FEELING COLD (Cold flush), SWELLING FACE (Face is swollen) and PALPITATIONS (Heart raced a little). At the time of the report, HOT FLUSH (Hot flashes), FEELING COLD (Cold flush), SWELLING FACE (Face is swollen) and PALPITATIONS (Heart raced a little) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Soreness in left arm; Redness around injection site/ redness increased to 3 inches; Felt hot around injection site; Hardness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Felt hot around injection site), VACCINATION SITE INDURATION (Hardness), PRURITUS (Itchiness), PAIN IN EXTREMITY (Soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness around injection site/ redness increased to 3 inches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Itchiness). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Felt hot around injection site), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness around injection site/ redness increased to 3 inches). On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in left arm). On 27-Jan-2021, PRURITUS (Itchiness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Felt hot around injection site), VACCINATION SITE INDURATION (Hardness), PAIN IN EXTREMITY (Soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness around injection site/ redness increased to 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.