chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: big red spot on her arm below injection site; A spontaneous report was received from a consumer who was also a 91-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a big red spot on arm below the injection site (injection site erythema).  The patient's medical history, as provided by the reporter, included breast cancer and left breast mastectomy. No relevant concomitant medication was reported.  On 23 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the patient received her epoetin alfa injection.  On 25 Feb 2021, the patient developed a big red spot on her arm below the injection site.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, big red spot on arm below the injection site, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, the prolonged latency from initiation of the vaccine to event onset along with epoetin alfa injection are considered a confounders.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state
Clinical narrative: got confused; short term memory loss/ multiple episodes of memory loss; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (got confused) and AMNESIA (short term memory loss/ multiple episodes of memory loss) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (got confused) and AMNESIA (short term memory loss/ multiple episodes of memory loss). At the time of the report, CONFUSIONAL STATE (got confused) and AMNESIA (short term memory loss/ multiple episodes of memory loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 92-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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). At the time of the report, PAIN IN EXTREMITY (little sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided No treatment information provided. Patient took  the second dose and has no reaction to it.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated action taken, updated event outcome from unknown to recovered/resolved and added 2nd dose details.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction) 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 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 REACTION (reaction). At the time of the report, VACCINATION SITE REACTION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain in the arm - left arm; Achy feeling and Muscle and joint pain has been worse than before; Muscle pain has been worse than before; Joint pain has been worse than before; Overwhelming fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm - left arm), PAIN (Achy feeling and Muscle and joint pain has been worse than before), MYALGIA (Muscle pain has been worse than before), ARTHRALGIA (Joint pain has been worse than before) and FATIGUE (Overwhelming fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm - left arm), PAIN (Achy feeling and Muscle and joint pain has been worse than before), MYALGIA (Muscle pain has been worse than before), ARTHRALGIA (Joint pain has been worse than before) and FATIGUE (Overwhelming fatigue). At the time of the report, PAIN IN EXTREMITY (Pain in the arm - left arm), PAIN (Achy feeling and Muscle and joint pain has been worse than before), MYALGIA (Muscle pain has been worse than before), ARTHRALGIA (Joint pain has been worse than before) and FATIGUE (Overwhelming fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by the reporter.  Patient did not took any treatment medication for her symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Contact information updated
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Palpitations, Panic attack
Clinical narrative: exhausting; Rapid heartbeat; felt like panic attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Rapid heartbeat), PANIC ATTACK (felt like panic attack) and FATIGUE (exhausting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis, LEVOTHYROXINE and COLCHICINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Feb-2021, the patient experienced PALPITATIONS (Rapid heartbeat) and PANIC ATTACK (felt like panic attack). On 18-Feb-2021, the patient experienced FATIGUE (exhausting). At the time of the report, PALPITATIONS (Rapid heartbeat), PANIC ATTACK (felt like panic attack) and FATIGUE (exhausting) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Electrocardiogram: unknown (Inconclusive) she is on heart monitor and started using from 24-02-2021. No medications were given at ER.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she was feeling better but still little anxious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Muscle spasms
Clinical narrative: body pain; leg weakness; flu-like symptoms; leg cramping; sweating; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body pain), MUSCULAR WEAKNESS (leg weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCLE SPASMS (leg cramping) and HYPERHIDROSIS (sweating) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Drug allergy (anaphylactic reaction to robinol). Concomitant products included AMLODIPINE for Blood pressure high.    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 MYALGIA (body pain), MUSCULAR WEAKNESS (leg weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCLE SPASMS (leg cramping), HYPERHIDROSIS (sweating), CHILLS (chills) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (body pain), MUSCULAR WEAKNESS (leg weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCLE SPASMS (leg cramping), HYPERHIDROSIS (sweating), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Followup received on 03-JUN-2021 and it contains No new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: body pain; leg weakness; flu-like symptoms; leg cramping; sweating; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body pain), MUSCULAR WEAKNESS (leg weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCLE SPASMS (leg cramping) and HYPERHIDROSIS (sweating) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Drug allergy (anaphylactic reaction to robinol). Concomitant products included AMLODIPINE for Blood pressure high.    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 MYALGIA (body pain), MUSCULAR WEAKNESS (leg weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCLE SPASMS (leg cramping), HYPERHIDROSIS (sweating), CHILLS (chills) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MYALGIA (body pain), MUSCULAR WEAKNESS (leg weakness), INFLUENZA LIKE ILLNESS (flu-like symptoms), MUSCLE SPASMS (leg cramping), HYPERHIDROSIS (sweating), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Followup received on 03-JUN-2021 and it contains No new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Malaise, Pain, Somnolence
Clinical narrative: really bad aches; Severe flue like symptoms; slept for an entire day and then 10 more hours at night; felt really terrible; their body felt so heavy they could hardly get to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really bad aches), INFLUENZA LIKE ILLNESS (Severe flue like symptoms), SOMNOLENCE (slept for an entire day and then 10 more hours at night), MALAISE (felt really terrible) and FEELING ABNORMAL (their body felt so heavy they could hardly get to the bathroom) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-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 PAIN (really bad aches), INFLUENZA LIKE ILLNESS (Severe flue like symptoms), SOMNOLENCE (slept for an entire day and then 10 more hours at night), MALAISE (felt really terrible) and FEELING ABNORMAL (their body felt so heavy they could hardly get to the bathroom). At the time of the report, PAIN (really bad aches), INFLUENZA LIKE ILLNESS (Severe flue like symptoms), SOMNOLENCE (slept for an entire day and then 10 more hours at night), MALAISE (felt really terrible) and FEELING ABNORMAL (their body felt so heavy they could hardly get to the bathroom) outcome was unknown.            no treatment and concomitant medication reported   This case was linked to MOD-2021-026582 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Pain
Clinical narrative: Difficulty breathing; tight Chest; dizziness; pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (tight Chest), DIZZINESS (dizziness) and PAIN (pain) in a 34-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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (tight Chest), DIZZINESS (dizziness) and PAIN (pain). At the time of the report, DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (tight Chest), DIZZINESS (dizziness) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: covid arm; Itchy; red welt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE URTICARIA (red welt) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE URTICARIA (red welt). At the time of the report, VACCINATION COMPLICATION (covid arm), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE URTICARIA (red welt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported No treatment medication information was reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHES; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (BODY ACHES) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21) 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 an unknown date, the patient experienced PAIN (BODY ACHES) and FATIGUE (tired). At the time of the report, PAIN (BODY ACHES) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Pruritus, Vomiting
Clinical narrative: dizzy; her body felt itchy; abdominal pain; vomited; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizzy, body felt itchy, abdominal pain, vomited.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A, 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) dizzy, body felt itchy, abdominal pain, vomited.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizzy, body felt itchy, abdominal pain, vomited was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: redness; injection site sore,Arm sore; site was also itchy; heat; hardness under the skin; not feeling well; A spontaneous report was received from a consumer concerning a 69 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore/Vaccination site pain, redness/Vaccination site erythema, heat/Vaccination site warmth, hardness under the skin/Vaccination site induration, fairly large as the size of three eggs, not feeling well/Malaise, injection site itchy/Vaccination site pruritus, injection site sore/Vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Arm sore, redness, heat, hardness under the skin, fairly large as the size of three eggs, not feeling well, injection site itchy, injection site sore.She has chronic fatigue syndrome and understands that her immune system is not the strongest  Treatment details included most heat, Tylenol, hydrocortisone cream, and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm sore, redness, heat, hardness under the skin, fairly large as the size of three eggs, not feeling well, injection site itchy, injection site sore was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: redness; injection site sore,Arm sore; site was also itchy; heat; hardness under the skin; not feeling well; A spontaneous report was received from a consumer concerning a 69 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore/Vaccination site pain, redness/Vaccination site erythema, heat/Vaccination site warmth, hardness under the skin/Vaccination site induration, fairly large as the size of three eggs, not feeling well/Malaise, injection site itchy/Vaccination site pruritus, injection site sore/Vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Arm sore, redness, heat, hardness under the skin, fairly large as the size of three eggs, not feeling well, injection site itchy, injection site sore.She has chronic fatigue syndrome and understands that her immune system is not the strongest  Treatment details included most heat, Tylenol, hydrocortisone cream, and Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm sore, redness, heat, hardness under the skin, fairly large as the size of three eggs, not feeling well, injection site itchy, injection site sore was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Myalgia, Nasopharyngitis
Clinical narrative: A really bad head cold; Runny nose; UTI; Severe aches and pains; Cough; slight headache; Arm is sore; the chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains) and COUGH (Cough) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains), COUGH (Cough), HEADACHE (slight headache), MYALGIA (Arm is sore) and CHILLS (the chills). At the time of the report, NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains), COUGH (Cough), HEADACHE (slight headache), MYALGIA (Arm is sore) and CHILLS (the 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 concomitant medications were provided No treatment information provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Urinary tract infection
Clinical narrative: A really bad head cold; Runny nose; UTI; Severe aches and pains; Cough; slight headache; Arm is sore; the chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains) and COUGH (Cough) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains), COUGH (Cough), HEADACHE (slight headache), MYALGIA (Arm is sore) and CHILLS (the chills). At the time of the report, NASOPHARYNGITIS (A really bad head cold), RHINORRHOEA (Runny nose), URINARY TRACT INFECTION (UTI), PAIN (Severe aches and pains), COUGH (Cough), HEADACHE (slight headache), MYALGIA (Arm is sore) and CHILLS (the 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 concomitant medications were provided No treatment information provided
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching about 3 inches either way, grew at the bottom, like it was running down my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching about 3 inches either way, grew at the bottom, like it was running down my arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching about 3 inches either way, grew at the bottom, like it was running down my arm). At the time of the report, VACCINATION SITE PRURITUS (Itching about 3 inches either way, grew at the bottom, like it was running down my arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder pain up to the neck (muscle pain).; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain up to the neck (muscle pain).) 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 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced ARTHRALGIA (Shoulder pain up to the neck (muscle pain).). At the time of the report, ARTHRALGIA (Shoulder pain up to the neck (muscle pain).) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Inflammation, Injection site erythema, Pain
Clinical narrative: ball between shoulder and neck; redness; discomfort; itching; Swelling; swelling; pain; discomfort; redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), the first episode of DISCOMFORT (discomfort), SWELLING (Swelling), SWELLING (swelling) and INFLAMMATION (ball between shoulder and neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (pain), the first episode of DISCOMFORT (discomfort), SWELLING (swelling) and INJECTION SITE ERYTHEMA (redness). On 26-Feb-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (redness), the second episode of DISCOMFORT (discomfort) and PRURITUS (itching). On an unknown date, the patient experienced INFLAMMATION (ball between shoulder and neck). At the time of the report, PAIN (pain), SWELLING (Swelling), SWELLING (swelling), INFLAMMATION (ball between shoulder and neck), ERYTHEMA (redness), the last episode of DISCOMFORT (discomfort), PRURITUS (itching) and INJECTION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include birth control pill and diuretic medication.  treatment information provided as, On day 3 I put some ice. I did not take medications
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: ball between shoulder and neck; redness; discomfort; itching; Swelling; swelling; pain; discomfort; redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), the first episode of DISCOMFORT (discomfort), SWELLING (Swelling), SWELLING (swelling) and INFLAMMATION (ball between shoulder and neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (pain), the first episode of DISCOMFORT (discomfort), SWELLING (swelling) and INJECTION SITE ERYTHEMA (redness). On 26-Feb-2021, the patient experienced SWELLING (Swelling), ERYTHEMA (redness), the second episode of DISCOMFORT (discomfort) and PRURITUS (itching). On an unknown date, the patient experienced INFLAMMATION (ball between shoulder and neck). At the time of the report, PAIN (pain), SWELLING (Swelling), SWELLING (swelling), INFLAMMATION (ball between shoulder and neck), ERYTHEMA (redness), the last episode of DISCOMFORT (discomfort), PRURITUS (itching) and INJECTION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include birth control pill and diuretic medication.  treatment information provided as, On day 3 I put some ice. I did not take medications
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient is scheduled to receive her second dose on 1 March 2021, after the 42 days mark; A spontaneous report was received from a consumer concerning herself as, 59-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and  scheduled to receive her second dose on 1 March 2021, after the 42 days mark.  The patient's medical history was not provided. Concomitant medications are not reported.  On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   Patient was scheduled to receive the second dose on February 17, 20, and 23 but all appointments were cancelled due to winter storm. Patient is scheduled to receive her second dose on 1 March 2021, after the 42 days mark.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was considered as unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot # unknown, with no associated AEs.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure dropped so low last night) and DIARRHOEA (diarrhea, it's been 8 times) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced BLOOD PRESSURE DECREASED (blood pressure dropped so low last night). On an unknown date, the patient experienced DIARRHOEA (diarrhea, it's been 8 times). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure dropped so low last night) and DIARRHOEA (diarrhea, it's been 8 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) Abnormal, blood pressure's like 90 over 60.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported  No treatment information was provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pallor, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: she says it started getting pale; warm to the touch; red circle about 5 cm from injection site; one edge was swollen; bruise on the arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (she says it started getting pale), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE BRUISING (bruise on the arm), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, LISINOPRIL, LEVOTHYROXINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruise on the arm) and MYALGIA (sore arm). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) and VACCINATION SITE SWELLING (one edge was swollen). On 24-Feb-2021, the patient experienced PALLOR (she says it started getting pale). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 12-Feb-2021, VACCINATION SITE BRUISING (bruise on the arm) and MYALGIA (sore arm) had resolved. On 24-Feb-2021, VACCINATION SITE SWELLING (one edge was swollen) had resolved. On 25-Feb-2021, PALLOR (she says it started getting pale), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: On 02-JUN-2021, follow up document was attached which contains Outcome of event
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: she says it started getting pale; warm to the touch; red circle about 5 cm from injection site; one edge was swollen; bruise on the arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (she says it started getting pale), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE BRUISING (bruise on the arm), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, LISINOPRIL, LEVOTHYROXINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ATORVASTATIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE BRUISING (bruise on the arm) and MYALGIA (sore arm). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) and VACCINATION SITE SWELLING (one edge was swollen). On 24-Feb-2021, the patient experienced PALLOR (she says it started getting pale). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 12-Feb-2021, VACCINATION SITE BRUISING (bruise on the arm) and MYALGIA (sore arm) had resolved. On 24-Feb-2021, VACCINATION SITE SWELLING (one edge was swollen) had resolved. On 25-Feb-2021, PALLOR (she says it started getting pale), VACCINATION SITE WARMTH (warm to the touch) and VACCINATION SITE ERYTHEMA (red circle about 5 cm from injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: On 02-JUN-2021, follow up document was attached which contains Outcome of event
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: nauseas and Queasy; body aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseas and Queasy), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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 25-Feb-2021, the patient experienced NAUSEA (nauseas and Queasy), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NAUSEA (nauseas and Queasy), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate increased, Pain
Clinical narrative: Chills; Increased Heart rate; body aches; headache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), HEART RATE INCREASED (Increased Heart rate), PAIN (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEART RATE INCREASED (Increased Heart rate), PAIN (body aches) and HEADACHE (headache). At the time of the report, CHILLS (Chills), HEART RATE INCREASED (Increased Heart rate), PAIN (body aches) and HEADACHE (headache) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge, Vaccination site pain
Clinical narrative: Arm was sore and in pain; Injection dripped off; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE DISCHARGE (Injection dripped off) and VACCINATION SITE PAIN (Arm was sore and in pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-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 22-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (Injection dripped off). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore and in pain). On 22-Feb-2021, VACCINATION SITE DISCHARGE (Injection dripped off) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm was sore and in pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Confusional state, Dizziness, Dyspnoea
Clinical narrative: extremely dizzy; weak; confused; fever 101.1 F; severe body pain in my arm, legs and jaw; severe headache; extreme fatigue; my body was painful to touch; heaviness on my chest; shortness of breath; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (extremely dizzy), ASTHENIA (weak), CONFUSIONAL STATE (confused), PYREXIA (fever 101.1 F) and PAIN (severe body pain in my arm, legs and jaw) in a 60-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.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (extremely dizzy), ASTHENIA (weak), CONFUSIONAL STATE (confused), PYREXIA (fever 101.1 F), PAIN (severe body pain in my arm, legs and jaw), HEADACHE (severe headache), FATIGUE (extreme fatigue), PAIN (my body was painful to touch), CHEST DISCOMFORT (heaviness on my chest) and DYSPNOEA (shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 16-Feb-2021, DIZZINESS (extremely dizzy), ASTHENIA (weak), CONFUSIONAL STATE (confused) and PYREXIA (fever 101.1 F) had resolved. At the time of the report, PAIN (severe body pain in my arm, legs and jaw), HEADACHE (severe headache), FATIGUE (extreme fatigue), PAIN (my body was painful to touch), CHEST DISCOMFORT (heaviness on my chest) and DYSPNOEA (shortness of breath) 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: extremely dizzy; weak; confused; fever 101.1 F; severe body pain in my arm, legs and jaw; severe headache; extreme fatigue; my body was painful to touch; heaviness on my chest; shortness of breath; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (extremely dizzy), ASTHENIA (weak), CONFUSIONAL STATE (confused), PYREXIA (fever 101.1 F) and PAIN (severe body pain in my arm, legs and jaw) in a 60-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.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (extremely dizzy), ASTHENIA (weak), CONFUSIONAL STATE (confused), PYREXIA (fever 101.1 F), PAIN (severe body pain in my arm, legs and jaw), HEADACHE (severe headache), FATIGUE (extreme fatigue), PAIN (my body was painful to touch), CHEST DISCOMFORT (heaviness on my chest) and DYSPNOEA (shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 16-Feb-2021, DIZZINESS (extremely dizzy), ASTHENIA (weak), CONFUSIONAL STATE (confused) and PYREXIA (fever 101.1 F) had resolved. At the time of the report, PAIN (severe body pain in my arm, legs and jaw), HEADACHE (severe headache), FATIGUE (extreme fatigue), PAIN (my body was painful to touch), CHEST DISCOMFORT (heaviness on my chest) and DYSPNOEA (shortness of breath) 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.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Schizoaffective disorder. Concomitant products included LITHIUM, TRAZODONE and PALIPERIDONE (INVEGA [PALIPERIDONE]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Erythema, Muscle rigidity, Pruritus, Swelling face
Clinical narrative: right hand knuckle looked like I had poison ivy; itchy; tight; face was red; face was swelling; swollen; bright red; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (right hand knuckle looked like I had poison ivy), PRURITUS (itchy), MUSCLE RIGIDITY (tight), ERYTHEMA (face was red) and SWELLING FACE (face was swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, METFORMIN, ATORVASTATIN, NAPROXEN SODIUM (ALEVE), VITAMIN B12 NOS and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.  On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced DERMATITIS CONTACT (right hand knuckle looked like I had poison ivy), PRURITUS (itchy), MUSCLE RIGIDITY (tight), ERYTHEMA (face was red), SWELLING FACE (face was swelling), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (bright red).   On 24-Feb-2021, DERMATITIS CONTACT (right hand knuckle looked like I had poison ivy), PRURITUS (itchy), MUSCLE RIGIDITY (tight), ERYTHEMA (face was red), SWELLING FACE (face was swelling), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (bright red) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: right hand knuckle looked like I had poison ivy; itchy; tight; face was red; face was swelling; swollen; bright red; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (right hand knuckle looked like I had poison ivy), PRURITUS (itchy), MUSCLE RIGIDITY (tight), ERYTHEMA (face was red) and SWELLING FACE (face was swelling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, METFORMIN, ATORVASTATIN, NAPROXEN SODIUM (ALEVE), VITAMIN B12 NOS and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.  On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced DERMATITIS CONTACT (right hand knuckle looked like I had poison ivy), PRURITUS (itchy), MUSCLE RIGIDITY (tight), ERYTHEMA (face was red), SWELLING FACE (face was swelling), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (bright red).   On 24-Feb-2021, DERMATITIS CONTACT (right hand knuckle looked like I had poison ivy), PRURITUS (itchy), MUSCLE RIGIDITY (tight), ERYTHEMA (face was red), SWELLING FACE (face was swelling), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (bright red) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.