chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: barely got out of bed; temperature of 101.5 degrees Fahrenheit; fatigued; muscle aches; headaches; felt great till night time; freezing cold to really hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt great till night time), FEELING OF BODY TEMPERATURE CHANGE (freezing cold to really hot), FEELING ABNORMAL (barely got out of bed), PYREXIA (temperature of 101.5 degrees Fahrenheit) and FATIGUE (fatigued) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 AMLODIPINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING ABNORMAL (felt great till night time), FEELING OF BODY TEMPERATURE CHANGE (freezing cold to really hot), PYREXIA (temperature of 101.5 degrees Fahrenheit), FATIGUE (fatigued), MYALGIA (muscle aches) and HEADACHE (headaches). On 25-Mar-2021, the patient experienced FEELING ABNORMAL (barely got out of bed). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 24-Mar-2021, FEELING ABNORMAL (felt great till night time) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (freezing cold to really hot), FEELING ABNORMAL (barely got out of bed), PYREXIA (temperature of 101.5 degrees Fahrenheit), FATIGUE (fatigued), MYALGIA (muscle aches) and HEADACHE (headaches) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included paracetamol.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up information was received as telephone contact report on  11 May 2021 wherein patient date of birth and event outcome was updated.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme fatigue). At the time of the report, FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: brain fog; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog) and HEADACHE (headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (brain fog) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (brain fog) outcome was unknown and HEADACHE (headache) had resolved.            Treatment details included took asprin.   This case was linked to MOD-2021-057756 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: arm is killing (hurting); she feels tired with chills; she feels tired with chills; temperature of 103.1 degrees Fahrenheit; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is killing (hurting)), FATIGUE (she feels tired with chills), CHILLS (she feels tired with chills) and PYREXIA (temperature of 103.1 degrees Fahrenheit) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is killing (hurting)), FATIGUE (she feels tired with chills), CHILLS (she feels tired with chills) and PYREXIA (temperature of 103.1 degrees Fahrenheit). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is killing (hurting)), FATIGUE (she feels tired with chills), CHILLS (she feels tired with chills) and PYREXIA (temperature of 103.1 degrees Fahrenheit) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 103.1 (Inconclusive) 103.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient felt tired with chills and a temperature of 103.1 degrees Fahrenheit for which she took aspirin.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore, stiff injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore, stiff injection arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore, stiff injection arm). On 10-Mar-2021, PAIN IN EXTREMITY (sore, stiff injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Headache, Vaccination site pain
Clinical narrative: sore arm; dizziness; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (slight headache) and VACCINATION SITE PAIN (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Hypertension.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (slight headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, DIZZINESS (dizziness), HEADACHE (slight headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-279444 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up received on 6-AUG-2021: Second dose information, Patient gender and initials were added On 06-Aug-2021: Reporter details, patient details and events added
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Peripheral swelling, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Growing bigger and bigger; Feel soar; 3 inch diameter knot towards the inside of the arm not on the injection site; Warm to touch; Reddish not bright red nor pink; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (3 inch diameter knot towards the inside of the arm not on the injection site), VACCINATION SITE WARMTH (Warm to touch), ERYTHEMA (Reddish not bright red nor pink), VACCINATION SITE SWELLING (Growing bigger and bigger) and MYALGIA (Feel soar) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Hypertension and Congestive heart failure.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (3 inch diameter knot towards the inside of the arm not on the injection site), VACCINATION SITE WARMTH (Warm to touch), ERYTHEMA (Reddish not bright red nor pink) and MYALGIA (Feel soar). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Growing bigger and bigger). At the time of the report, PERIPHERAL SWELLING (3 inch diameter knot towards the inside of the arm not on the injection site), VACCINATION SITE WARMTH (Warm to touch), ERYTHEMA (Reddish not bright red nor pink), VACCINATION SITE SWELLING (Growing bigger and bigger) and MYALGIA (Feel soar) 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 concomitant medications were reported.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received on 27-MAY-2021, updated contact information. Patient request that the forms be physically mailed to her.  She is unable to read them from her email due to her going legally blind.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: shoulder is burning/stinging; big oval mark at injection site; little itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (shoulder is burning/stinging), VACCINATION SITE RASH (big oval mark at injection site) and VACCINATION SITE PRURITUS (little itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN D3 and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (shoulder is burning/stinging), VACCINATION SITE RASH (big oval mark at injection site) and VACCINATION SITE PRURITUS (little itchy). At the time of the report, VACCINATION SITE PAIN (shoulder is burning/stinging), VACCINATION SITE RASH (big oval mark at injection site) and VACCINATION SITE PRURITUS (little itchy) outcome was unknown.            Concomitant product use include B complex with biotin.  Action taken with mRNA-1273 in response to the event was not applicable.  patient got the second dose after a month of the first dose.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patients age was added. Reporters email address added. Second dose information added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Induration, Peripheral swelling, Pruritus
Clinical narrative: swelling; red; hard; itching; finger joints swelled; finger joints painful; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (red), INDURATION (hard), PRURITUS (itching) and PERIPHERAL SWELLING (finger joints swelled) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (They cause itching), Dairy intolerance and Gluten intolerance.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING (swelling), ERYTHEMA (red), INDURATION (hard), PRURITUS (itching), PERIPHERAL SWELLING (finger joints swelled) and ARTHRALGIA (finger joints painful). At the time of the report, SWELLING (swelling), ERYTHEMA (red), INDURATION (hard), PRURITUS (itching), PERIPHERAL SWELLING (finger joints swelled) and ARTHRALGIA (finger joints painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling; red; hard; itching; finger joints swelled; finger joints painful; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), ERYTHEMA (red), INDURATION (hard), PRURITUS (itching) and PERIPHERAL SWELLING (finger joints swelled) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (They cause itching), Dairy intolerance and Gluten intolerance.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING (swelling), ERYTHEMA (red), INDURATION (hard), PRURITUS (itching), PERIPHERAL SWELLING (finger joints swelled) and ARTHRALGIA (finger joints painful). At the time of the report, SWELLING (swelling), ERYTHEMA (red), INDURATION (hard), PRURITUS (itching), PERIPHERAL SWELLING (finger joints swelled) and ARTHRALGIA (finger joints painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: fast heart beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heart beat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced TACHYCARDIA (fast heart beat). At the time of the report, TACHYCARDIA (fast heart beat) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headaches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headaches). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.            No relevant concomitant medications reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose administered to a 17 years and 2 months old person; A spontaneous report was received from a consumer concerning a 17-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) /product administered to patient of inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient under 18 years old received the Moderna COVID19 vaccine.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, under 18 years old received the Moderna COVID19 vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown, with no associated AEs.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chill; Headache; Fatigue; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chill), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Mild fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (chill), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Mild fever). The patient was treated with FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) at an unspecified dose and frequency. At the time of the report, CHILLS (chill), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Thyroid Medication.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Legs hurt below knee during sleep; Itching injection site; Rednss of Left arm, Injection site around 2 inch; Swelling , Injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt below knee during sleep), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE ERYTHEMA (Rednss of Left arm, Injection site around 2 inch) and VACCINATION SITE SWELLING (Swelling , Injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt below knee during sleep), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE ERYTHEMA (Rednss of Left arm, Injection site around 2 inch) and VACCINATION SITE SWELLING (Swelling , Injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs hurt below knee during sleep), VACCINATION SITE PRURITUS (Itching injection site), VACCINATION SITE ERYTHEMA (Rednss of Left arm, Injection site around 2 inch) and VACCINATION SITE SWELLING (Swelling , Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: not well for a week; Fatigue and no energy; Feels ill; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels ill), ASTHENIA (Feels weak), MALAISE (not well for a week) and FATIGUE (Fatigue and no energy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MALAISE (Feels ill), ASTHENIA (Feels weak) and FATIGUE (Fatigue and no energy). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (not well for a week). At the time of the report, MALAISE (Feels ill), ASTHENIA (Feels weak) and FATIGUE (Fatigue and no energy) outcome was unknown and MALAISE (not well for a week) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR - Event and outcome added.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: red spot on arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red spot on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ERYTHEMA (red spot on arm). At the time of the report, ERYTHEMA (red spot on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm) 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 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (Sore Arm). At the time of the report, MYALGIA (Sore Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Myalgia, Pain, Pyrexia, Vaccination site pain
Clinical narrative: hit with ton of brick; body ache; Fever; Disoriented; pain at injection left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (hit with ton of brick), DISORIENTATION (Disoriented), VACCINATION SITE PAIN (pain at injection left arm), MYALGIA (body ache) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DISORIENTATION (Disoriented) and VACCINATION SITE PAIN (pain at injection left arm). On 24-Mar-2021, the patient experienced PAIN (hit with ton of brick), MYALGIA (body ache) and PYREXIA (Fever). On 25-Feb-2021, DISORIENTATION (Disoriented) and VACCINATION SITE PAIN (pain at injection left arm) had resolved. At the time of the report, PAIN (hit with ton of brick), MYALGIA (body ache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: sore throat; runny nose; feels like a cold; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and NASOPHARYNGITIS (feels like a cold) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concurrent medical conditions included Cholesterol. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and NASOPHARYNGITIS (feels like a cold). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and NASOPHARYNGITIS (feels like a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included 3 blood pressure medications,  for cholesterol and Eliquis- blood thinner
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: red; swollen hard; itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), PERIPHERAL SWELLING (swollen hard) and PRURITUS (itching) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (red), PERIPHERAL SWELLING (swollen hard) and PRURITUS (itching). At the time of the report, ERYTHEMA (red), PERIPHERAL SWELLING (swollen hard) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Sore left arm; Redness; Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy), PAIN IN EXTREMITY (Sore left arm) and ERYTHEMA (Redness) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included Hypertension (Father), Diabetes (father and mother), Hyperlipidemia (Father), Gout (Father) and Hashimoto's disease (Mother). Concurrent medical conditions included Hypertension (Stage 1), Sinus tachycardia since 2015, Polycystic ovarian syndrome since 2015, Obesity since 2015 and Vitamin D deficiency since 2015. Concomitant products included METFORMIN, METOPROLOL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 16-Dec-2020 and the estimated date of delivery was 29-Sep-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm) and ERYTHEMA (Redness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore left arm) and ERYTHEMA (Redness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided..   This case was linked to US-MODERNATX, INC.-MOD-2021-057797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057797:CROSSLINKED WITH DOSE 2
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Concomitant product use was not provided by the reporter  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11 MAY 2021, TCR-Added outcome as recovered.
Sex: F
Vaccine: COVID19
Symptoms: Formication, Malaise, Pruritus, Rash, Urticaria
Clinical narrative: severe itching from her legs down; a rash that has gone away; had the Covid arm for 7 days; her whole body is itchy where the hives was, especially her legs; her whole body is itchy where the hives was, especially her legs; her skin is crawling; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs) and PRURITUS (her whole body is itchy where the hives was, especially her legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs), PRURITUS (her whole body is itchy where the hives was, especially her legs), FORMICATION (her skin is crawling) and MALAISE (very uncomfortable). At the time of the report, PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs), PRURITUS (her whole body is itchy where the hives was, especially her legs), FORMICATION (her skin is crawling) and MALAISE (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: severe itching from her legs down; a rash that has gone away; had the Covid arm for 7 days; her whole body is itchy where the hives was, especially her legs; her whole body is itchy where the hives was, especially her legs; her skin is crawling; very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs) and PRURITUS (her whole body is itchy where the hives was, especially her legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs), PRURITUS (her whole body is itchy where the hives was, especially her legs), FORMICATION (her skin is crawling) and MALAISE (very uncomfortable). At the time of the report, PRURITUS (severe itching from her legs down), RASH (a rash that has gone away), VACCINATION SITE REACTION (had the Covid arm for 7 days), URTICARIA (her whole body is itchy where the hives was, especially her legs), PRURITUS (her whole body is itchy where the hives was, especially her legs), FORMICATION (her skin is crawling) and MALAISE (very uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site pain
Clinical narrative: unable to raise his arm; red spot on his arm; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (unable to raise his arm), VACCINATION SITE ERYTHEMA (red spot on his arm) and VACCINATION SITE PAIN (arm hurt) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Bone cancer (bone cancer of the clavicle). Concurrent medical conditions included Prostate cancer. Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced LIMB DISCOMFORT (unable to raise his arm), VACCINATION SITE ERYTHEMA (red spot on his arm) and VACCINATION SITE PAIN (arm hurt). On 25-Mar-2021, LIMB DISCOMFORT (unable to raise his arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red spot on his arm) and VACCINATION SITE PAIN (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact details updated
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, SARS-CoV-2 test
Clinical narrative: body aches; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN ongoing from 24-Mar-2021 at a dose of UNK UNK, bid and AMOXICILLIN ongoing from 24-Mar-2021 at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: hot; slightly swollen; itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), PERIPHERAL SWELLING (slightly swollen), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included LETROZOLE for Breast cancer.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), PERIPHERAL SWELLING (slightly swollen), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (hot), PERIPHERAL SWELLING (slightly swollen), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Low grade fever; Shaking; Tremors; Fever to 102 F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), TREMOR (Tremors), PYREXIA (Fever to 102 F), CHILLS (Chills) and PYREXIA (Low grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included SIMVASTATIN, ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced TREMOR (Shaking), TREMOR (Tremors), PYREXIA (Fever to 102 F) and CHILLS (Chills). On 25-Mar-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, TREMOR (Shaking), TREMOR (Tremors), PYREXIA (Fever to 102 F), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Emai Address updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: huge rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (huge rash on her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (huge rash on her arm). At the time of the report, RASH (huge rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Drug interaction, SARS-CoV-2 test negative
Clinical narrative: Took probiotic and experienced a drop in blood pressure; negative for COVID-19; Drop in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (Drop in blood pressure), DRUG INTERACTION (Took probiotic and experienced a drop in blood pressure) and SARS-COV-2 TEST NEGATIVE (negative for COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced BLOOD PRESSURE DECREASED (Drop in blood pressure). On an unknown date, the patient experienced DRUG INTERACTION (Took probiotic and experienced a drop in blood pressure) and SARS-COV-2 TEST NEGATIVE (negative for COVID-19). At the time of the report, BLOOD PRESSURE DECREASED (Drop in blood pressure), DRUG INTERACTION (Took probiotic and experienced a drop in blood pressure) and SARS-COV-2 TEST NEGATIVE (negative for COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter  Treatment for the event included probiotics.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08 JUN2021 contains Information:- even tab updated by changing event coding; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information is requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Abdominal pain upper, Arthralgia, Chills, Fatigue
Clinical narrative: lower abdominal cramping; achy joints in arms; chills; very, very tired instantly; stomach pain; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMITRIPTYLINE, ATORVASTATIN, LEVOTHYROXINE, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PLANTAGO OVATA (METAMUCIL CITRON) and Dicyclomine as needed for IBS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 26-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms), CHILLS (chills) and FATIGUE (very, very tired instantly). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms), FATIGUE (fatigue), CHILLS (chills) and FATIGUE (very, very tired instantly) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: lower abdominal cramping; achy joints in arms; chills; very, very tired instantly; stomach pain; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMITRIPTYLINE, ATORVASTATIN, LEVOTHYROXINE, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PLANTAGO OVATA (METAMUCIL CITRON) and Dicyclomine as needed for IBS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 26-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms), CHILLS (chills) and FATIGUE (very, very tired instantly). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL PAIN LOWER (lower abdominal cramping), ARTHRALGIA (achy joints in arms), FATIGUE (fatigue), CHILLS (chills) and FATIGUE (very, very tired instantly) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.