chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Feeling abnormal, Hypokinesia, Limb discomfort, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (couldn't move arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (It was mild COVID infection.) on 15-Mar-2020 and Leukemia. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced LIMB DISCOMFORT (couldn't move arm). At the time of the report, LIMB DISCOMFORT (couldn't move arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2020, Antibody test: (Positive) Tested positive for COVID antibody test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Decreased appetite, Fatigue, Influenza, Pain in extremity
Clinical narrative: sore arm; bladder problem; temperature; fatigue; flu; loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue) and INFLUENZA (flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue), INFLUENZA (flu) and DECREASED APPETITE (loss of appetite). At the time of the report, PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue), INFLUENZA (flu) and DECREASED APPETITE (loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included Tylenol. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm; bladder problem; temperature; fatigue; flu; loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue) and INFLUENZA (flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue), INFLUENZA (flu) and DECREASED APPETITE (loss of appetite). At the time of the report, PAIN IN EXTREMITY (sore arm), BLADDER DISORDER (bladder problem), PYREXIA (temperature), FATIGUE (fatigue), INFLUENZA (flu) and DECREASED APPETITE (loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment included Tylenol. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: diagnosed with vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (diagnosed with vertigo) 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 02-Mar-2021, the patient experienced VERTIGO (diagnosed with vertigo). At the time of the report, VERTIGO (diagnosed with vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm is hurting very bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm is hurting very bad) 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 04-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 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm is hurting very bad). At the time of the report, VACCINATION SITE PAIN (My arm is hurting very bad) outcome was unknown.            No concomitant product was provided. No treatment medication was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Contact details updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Product dose omission issue
Clinical narrative: have not received the 2nd dose; face, tongue, and body went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (face, tongue, and body went numb) and PRODUCT DOSE OMISSION ISSUE (have not received the 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to bee sting and Allergic reaction to food (shrimp). Concomitant products included PROBIOTICS NOS for Gastrointestinal disorder NOS, GLA [GAMOLENIC ACID] for Supplementation therapy, LEVOTHYROXINE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPOAESTHESIA (face, tongue, and body went numb). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received the 2nd dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse reaction, at a dose of 1 dosage form. In February 2021, HYPOAESTHESIA (face, tongue, and body went numb) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (have not received the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient also took unspecified fiber pills since 2016 for stomach issues concomitantly.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information received on 07-Jul-2021 contains  significant information. Updated reporter information, added patient demographics, updated vaccination date, added facility information and concomitant levothyroxine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dysphonia, Malaise, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing), CHEST PAIN (chest hurts when I cough) and PAIN (achy) in a 68-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.  The patient's past medical history included No adverse event. Concomitant products included Osteo Bioflex, FISH OIL, Cinnamon pill and BIOTIN for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing) and CHEST PAIN (chest hurts when I cough). On 02-Mar-2021, the patient experienced PAIN (achy) and DYSPHONIA (voice is hoarse). At the time of the report, MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing), CHEST PAIN (chest hurts when I cough), PAIN (achy) and DYSPHONIA (voice is hoarse) 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing), CHEST PAIN (chest hurts when I cough) and PAIN (achy) in a 68-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.  The patient's past medical history included No adverse event. Concomitant products included Osteo Bioflex, FISH OIL, Cinnamon pill and BIOTIN for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing) and CHEST PAIN (chest hurts when I cough). On 02-Mar-2021, the patient experienced PAIN (achy) and DYSPHONIA (voice is hoarse). At the time of the report, MALAISE (don't feel well), THROAT IRRITATION (throat was tickling), COUGH (Coughing), CHEST PAIN (chest hurts when I cough), PAIN (achy) and DYSPHONIA (voice is hoarse) 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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Muscle twitching, Pyrexia
Clinical narrative: Muscle jerks; Can't stand or sit up because of muscle jerks; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle jerks), DYSSTASIA (Can't stand or sit up because of muscle jerks) and PYREXIA (Slight fever) in an 81-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle jerks), DYSSTASIA (Can't stand or sit up because of muscle jerks) and PYREXIA (Slight fever). At the time of the report, MUSCLE TWITCHING (Muscle jerks), DYSSTASIA (Can't stand or sit up because of muscle jerks) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Arm was sore; Every time I bend over, I'm little dizzy; Bad headache yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), DIZZINESS (Every time I bend over, I'm little dizzy) and HEADACHE (Bad headache yesterday) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), DIZZINESS (Every time I bend over, I'm little dizzy) and HEADACHE (Bad headache yesterday). At the time of the report, PAIN IN EXTREMITY (Arm was sore), DIZZINESS (Every time I bend over, I'm little dizzy) and HEADACHE (Bad headache yesterday) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided for the second dose.   This case was linked to MOD-2021-032387.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had pretty bad reactions after the 2nd dose; This spontaneous case was reported by a  and describes the occurrence of VACCINATION COMPLICATION (had pretty bad reactions after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (had pretty bad reactions after the 2nd dose).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever and chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (fever and chills) and PYREXIA (low grade fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included CHOLESTEROL for an unknown indication.    On 28-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 CHILLS (fever and chills) and PYREXIA (low grade fever). At the time of the report, CHILLS (fever and chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were thyroid medication as well.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Induration, Influenza like illness
Clinical narrative: area oblong shape 2 inches wide and 3 inches long that is bright red.; headache; mild chills; swelling at injection site-right arm; achy; soreness; tender arm; sore arm; felt like light flu; hard bumps; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm), INDURATION (hard bumps), INFLUENZA LIKE ILLNESS (felt like light flu) and ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-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. In February 2021, the patient experienced INDURATION (hard bumps). On 24-Feb-2021, the patient experienced TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like light flu), HEADACHE (headache), CHILLS (mild chills), VACCINATION SITE SWELLING (swelling at injection site-right arm), MYALGIA (achy) and MYALGIA (soreness). On 01-Mar-2021, the patient experienced ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.). In February 2021, INDURATION (hard bumps) had resolved. On 25-Feb-2021, TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm) and INFLUENZA LIKE ILLNESS (felt like light flu) had resolved. At the time of the report, ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.), HEADACHE (headache), CHILLS (mild chills), VACCINATION SITE SWELLING (swelling at injection site-right arm), MYALGIA (achy) and MYALGIA (soreness) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Tenderness, Vaccination site swelling
Clinical narrative: area oblong shape 2 inches wide and 3 inches long that is bright red.; headache; mild chills; swelling at injection site-right arm; achy; soreness; tender arm; sore arm; felt like light flu; hard bumps; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm), INDURATION (hard bumps), INFLUENZA LIKE ILLNESS (felt like light flu) and ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-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. In February 2021, the patient experienced INDURATION (hard bumps). On 24-Feb-2021, the patient experienced TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (felt like light flu), HEADACHE (headache), CHILLS (mild chills), VACCINATION SITE SWELLING (swelling at injection site-right arm), MYALGIA (achy) and MYALGIA (soreness). On 01-Mar-2021, the patient experienced ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.). In February 2021, INDURATION (hard bumps) had resolved. On 25-Feb-2021, TENDERNESS (tender arm), PAIN IN EXTREMITY (sore arm) and INFLUENZA LIKE ILLNESS (felt like light flu) had resolved. At the time of the report, ERYTHEMA (area oblong shape 2 inches wide and 3 inches long that is bright red.), HEADACHE (headache), CHILLS (mild chills), VACCINATION SITE SWELLING (swelling at injection site-right arm), MYALGIA (achy) and MYALGIA (soreness) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling hot, Tinnitus
Clinical narrative: pain in her ear; buzzing in her ear; Warm sensation inside her head; This spontaneous case was reported by a consumer and describes the occurrence of   in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Vaccination site bruising, Vaccination site pain
Clinical narrative: Sore bruised arm after 1st dose; Sore bruised arm after 1st dose; Arm with raised places after 1st dose; became fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Sore bruised arm after 1st dose), VACCINATION SITE PAIN (Sore bruised arm after 1st dose), LIMB DISCOMFORT (Arm with raised places after 1st dose) and FATIGUE (became fatigued) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL BESYLATE (CLOPIDOGREL +PHARM), AMLODIPINE, LEVOTHYROXINE, OMEPRAZOLE and OXYBUTYNIN for an unknown indication, EZETIMIBE (ZETIA).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Sore bruised arm after 1st dose), VACCINATION SITE PAIN (Sore bruised arm after 1st dose), LIMB DISCOMFORT (Arm with raised places after 1st dose) and FATIGUE (became fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Sore bruised arm after 1st dose), VACCINATION SITE PAIN (Sore bruised arm after 1st dose), LIMB DISCOMFORT (Arm with raised places after 1st dose) and FATIGUE (became fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: right arm hurts; headache; 100 degree fever; body ache; feels nauseated when eating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm hurts), HEADACHE (headache), PYREXIA (100 degree fever), MYALGIA (body ache) and NAUSEA (feels nauseated when eating) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PAIN IN EXTREMITY (right arm hurts), HEADACHE (headache), PYREXIA (100 degree fever), MYALGIA (body ache) and NAUSEA (feels nauseated when eating). At the time of the report, PAIN IN EXTREMITY (right arm hurts), HEADACHE (headache), PYREXIA (100 degree fever), MYALGIA (body ache) and NAUSEA (feels nauseated when eating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia
Clinical narrative: could not sleep; headache; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), HEADACHE (headache) and FATIGUE (felt tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (could not sleep), HEADACHE (headache) and FATIGUE (felt tired). At the time of the report, INSOMNIA (could not sleep), HEADACHE (headache) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: rash around the injection site/a rash a little below the injection site; arm started to itch; looked like hives; red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red). At the time of the report, INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red). At the time of the report, INJECTION SITE RASH (rash around the injection site/a rash a little below the injection site), INJECTION SITE PRURITUS (arm started to itch), INJECTION SITE URTICARIA (looked like hives) and INJECTION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Pelvic discomfort
Clinical narrative: Warmth going through his mid-section of the body; Flashes of heat in the Pelvic area; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmth going through his mid-section of the body), PELVIC DISCOMFORT (Flashes of heat in the Pelvic area) and DIZZINESS (Lightheaded) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE), ZOLPIDEM TARTRATE (AMBIEN) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FEELING HOT (Warmth going through his mid-section of the body), PELVIC DISCOMFORT (Flashes of heat in the Pelvic area) and DIZZINESS (Lightheaded). At the time of the report, FEELING HOT (Warmth going through his mid-section of the body), PELVIC DISCOMFORT (Flashes of heat in the Pelvic area) and DIZZINESS (Lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: it's still red and puffy; it's still red and puffy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (it's still red and puffy) and INJECTION SITE SWELLING (it's still red and puffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-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 INJECTION SITE ERYTHEMA (it's still red and puffy) and INJECTION SITE SWELLING (it's still red and puffy). At the time of the report, INJECTION SITE ERYTHEMA (it's still red and puffy) and INJECTION SITE SWELLING (it's still red and puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Further details could not be probed as consumer hung up the call abruptly. Hence, further probing could not be done and limited information available over the call. Reason of delay: Daily spike of incoming calls due to COVID-19 vaccine   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant follow up appended
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Migraine, Myalgia
Clinical narrative: migraine; feeling very faint; feeling very lightheaded; fever of 101.7; aches; no chills but she was cold all day and the next day; could not warm up; Sore arm; sore and hurts when she touches her arm; Arm red at the injection site and below injection site; headache that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), MIGRAINE (migraine) and PRESYNCOPE (feeling very faint) in a 65-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.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, FISH OIL, CALCIUM, MULTIVITAMIN [VITAMINS NOS], CURCUMIN (THERACURMIN BIOACTIVE), MENAQUINONE-7 (VITAMIN K 2) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 26-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 (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), PAIN IN EXTREMITY (Sore arm), MYALGIA (sore and hurts when she touches her arm), VACCINATION SITE ERYTHEMA (Arm red at the injection site and below injection site) and HEADACHE (headache that comes and goes). On 27-Feb-2021, the patient experienced PYREXIA (fever of 101.7). On 02-Mar-2021, the patient experienced MIGRAINE (migraine), PRESYNCOPE (feeling very faint) and DIZZINESS (feeling very lightheaded). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), MIGRAINE (migraine), PRESYNCOPE (feeling very faint), DIZZINESS (feeling very lightheaded), PAIN IN EXTREMITY (Sore arm), MYALGIA (sore and hurts when she touches her arm), VACCINATION SITE ERYTHEMA (Arm red at the injection site and below injection site), HEADACHE (headache that comes and goes) and PYREXIA (fever of 101.7) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101.7 (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: According to the TCR report received on 09-JUN-2021, patient took the second dose on an unknown date. so action taken was changed from unknown to not applicable and outcome of all the events were updated from unknown to resolved and captured the history of COVID-19 which was missed to capture in initial version.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Pain in extremity, Presyncope, Pyrexia
Clinical narrative: migraine; feeling very faint; feeling very lightheaded; fever of 101.7; aches; no chills but she was cold all day and the next day; could not warm up; Sore arm; sore and hurts when she touches her arm; Arm red at the injection site and below injection site; headache that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), MIGRAINE (migraine) and PRESYNCOPE (feeling very faint) in a 65-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.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, FISH OIL, CALCIUM, MULTIVITAMIN [VITAMINS NOS], CURCUMIN (THERACURMIN BIOACTIVE), MENAQUINONE-7 (VITAMIN K 2) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 26-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 (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), PAIN IN EXTREMITY (Sore arm), MYALGIA (sore and hurts when she touches her arm), VACCINATION SITE ERYTHEMA (Arm red at the injection site and below injection site) and HEADACHE (headache that comes and goes). On 27-Feb-2021, the patient experienced PYREXIA (fever of 101.7). On 02-Mar-2021, the patient experienced MIGRAINE (migraine), PRESYNCOPE (feeling very faint) and DIZZINESS (feeling very lightheaded). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), MIGRAINE (migraine), PRESYNCOPE (feeling very faint), DIZZINESS (feeling very lightheaded), PAIN IN EXTREMITY (Sore arm), MYALGIA (sore and hurts when she touches her arm), VACCINATION SITE ERYTHEMA (Arm red at the injection site and below injection site), HEADACHE (headache that comes and goes) and PYREXIA (fever of 101.7) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101.7 (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: According to the TCR report received on 09-JUN-2021, patient took the second dose on an unknown date. so action taken was changed from unknown to not applicable and outcome of all the events were updated from unknown to resolved and captured the history of COVID-19 which was missed to capture in initial version.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: migraine; feeling very faint; feeling very lightheaded; fever of 101.7; aches; no chills but she was cold all day and the next day; could not warm up; Sore arm; sore and hurts when she touches her arm; Arm red at the injection site and below injection site; headache that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), MIGRAINE (migraine) and PRESYNCOPE (feeling very faint) in a 65-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.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN, FISH OIL, CALCIUM, MULTIVITAMIN [VITAMINS NOS], CURCUMIN (THERACURMIN BIOACTIVE), MENAQUINONE-7 (VITAMIN K 2) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 26-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 (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), PAIN IN EXTREMITY (Sore arm), MYALGIA (sore and hurts when she touches her arm), VACCINATION SITE ERYTHEMA (Arm red at the injection site and below injection site) and HEADACHE (headache that comes and goes). On 27-Feb-2021, the patient experienced PYREXIA (fever of 101.7). On 02-Mar-2021, the patient experienced MIGRAINE (migraine), PRESYNCOPE (feeling very faint) and DIZZINESS (feeling very lightheaded). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (aches), NASOPHARYNGITIS (no chills but she was cold all day and the next day), VACCINATION SITE WARMTH (could not warm up), MIGRAINE (migraine), PRESYNCOPE (feeling very faint), DIZZINESS (feeling very lightheaded), PAIN IN EXTREMITY (Sore arm), MYALGIA (sore and hurts when she touches her arm), VACCINATION SITE ERYTHEMA (Arm red at the injection site and below injection site), HEADACHE (headache that comes and goes) and PYREXIA (fever of 101.7) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 101.7 (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: According to the TCR report received on 09-JUN-2021, patient took the second dose on an unknown date. so action taken was changed from unknown to not applicable and outcome of all the events were updated from unknown to resolved and captured the history of COVID-19 which was missed to capture in initial version.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (On his left arm soreness), PERIPHERAL SWELLING (On his left arm swelling) and ERYTHEMA (On his left arm redness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (On his left arm soreness), PERIPHERAL SWELLING (On his left arm swelling) and ERYTHEMA (On his left arm redness). At the time of the report, PAIN IN EXTREMITY (On his left arm soreness), PERIPHERAL SWELLING (On his left arm swelling) and ERYTHEMA (On his left arm redness) outcome was unknown.            Treatment included none
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 002A24A) 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 24-Feb-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Jun-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 24-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.            Date of positive pregnancy test 24-SEP-2021  The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant product use was provided.  Treatment details included 2 aspirins.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: injection arm red rash patch; injection arm itch; injection arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (injection arm red rash patch), PRURITUS (injection arm itch) and PAIN IN EXTREMITY (injection arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (injection arm red rash patch), PRURITUS (injection arm itch) and PAIN IN EXTREMITY (injection arm pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (injection arm red rash patch), PRURITUS (injection arm itch) and PAIN IN EXTREMITY (injection arm pain) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (sore). At the time of the report, PAIN (sore) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Upon internal review on 21-May-2021, the age was corrected to unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red enduration around injection site; Itching around injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), VACCINATION SITE INDURATION (Red enduration around injection site) and VACCINATION SITE PRURITUS (Itching around injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMINS NOS (DAILY VITAMINS) and MELOXICAM 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 VACCINATION SITE PAIN (Sore arm). On 27-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Red enduration around injection site) and VACCINATION SITE PRURITUS (Itching around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 01-Mar-2021, VACCINATION SITE PRURITUS (Itching around injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE INDURATION (Red enduration around 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 01-Jul-2021: AE outcome updated from unknown to recovered/resolved for the events of sore arm and red induration around injection site.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling, Oral discomfort, Swollen tongue, Tongue discomfort
Clinical narrative: Tongue burns; Tongue swollen; Tongue itches; Lips burns; Lips swollen; Lips itches; Tongue tingling; Lips tingling; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Tongue burns), SWOLLEN TONGUE (Tongue swollen), TONGUE PRURITUS (Tongue itches), ORAL DISCOMFORT (Lips burns) and LIP SWELLING (Lips swollen) in a 79-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.     The patient's past medical history included Stroke.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TONGUE DISCOMFORT (Tongue burns), SWOLLEN TONGUE (Tongue swollen), TONGUE PRURITUS (Tongue itches), ORAL DISCOMFORT (Lips burns), LIP SWELLING (Lips swollen), LIP PRURITUS (Lips itches), TONGUE DISCOMFORT (Tongue tingling) and ORAL DISCOMFORT (Lips tingling). At the time of the report, TONGUE DISCOMFORT (Tongue burns), SWOLLEN TONGUE (Tongue swollen), TONGUE PRURITUS (Tongue itches), ORAL DISCOMFORT (Lips burns), LIP SWELLING (Lips swollen), LIP PRURITUS (Lips itches), TONGUE DISCOMFORT (Tongue tingling) and ORAL DISCOMFORT (Lips tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was provided as diphenhydramine hydrochloride.