chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm was sore at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (left arm was sore at the injection site) outcome was unknown.            concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-060917 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site swelling; vaccination site erythema; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema ) and VACCINATION SITE PAIN (Vaccination site pain ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema ) and VACCINATION SITE PAIN (Vaccination site pain ). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (vaccination site erythema ) and VACCINATION SITE PAIN (Vaccination site pain ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Developed a rash below the injection site that is fading in and out; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Developed a rash below the injection site that is fading in and out) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cellulitis (prone to cellulitis). Concurrent medical conditions included Immune system disorder (medically fragile, has a weak immune system).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (Developed a rash below the injection site that is fading in and out). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Developed a rash below the injection site that is fading in and out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Tiny little Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Tiny little Sore throat) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Tiny little Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Tiny little Sore throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not provided. Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site). At the time of the report, VACCINATION SITE PAIN (Sore injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided.  The patient doesn't had email or fax.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Follow up information was received on 7-May-2021 and contains no new information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (skin warm) and VACCINATION SITE ERYTHEMA (redness around injection that is 10 cm) in a 63-year-old male 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 09-Mar-2021, the patient experienced SKIN WARM (skin warm) and VACCINATION SITE ERYTHEMA (redness around injection that is 10 cm). At the time of the report, SKIN WARM (skin warm) and VACCINATION SITE ERYTHEMA (redness around injection that is 10 cm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information includes ice packs. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: This follow-up was received on 04-MAY-2021 which updated event outcome as recovered/resolved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Headache
Clinical narrative: shaking; sick to the stomach; felt weak; chills; slight fever 100F; headache; arm was very painful during injection; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (slight fever 100F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event.  The patient's past medical history included SARS-CoV-2 infection in December 2020. Concomitant products included PRAVASTATIN and ATENOLOL for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was very painful during injection). On 22-Feb-2021, the patient experienced TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (slight fever 100F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (slight fever 100F), HEADACHE (headache) and VACCINATION SITE PAIN (arm was very painful during injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100f (Inconclusive) 100F. On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Tremor, Vaccination site pain
Clinical narrative: shaking; sick to the stomach; felt weak; chills; slight fever 100F; headache; arm was very painful during injection; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (slight fever 100F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event.  The patient's past medical history included SARS-CoV-2 infection in December 2020. Concomitant products included PRAVASTATIN and ATENOLOL for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was very painful during injection). On 22-Feb-2021, the patient experienced TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (slight fever 100F) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), ABDOMINAL DISCOMFORT (sick to the stomach), ASTHENIA (felt weak), CHILLS (chills), PYREXIA (slight fever 100F), HEADACHE (headache) and VACCINATION SITE PAIN (arm was very painful during injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Body temperature: 100f (Inconclusive) 100F. On 22-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Fatigue, Headache
Clinical narrative: cold; uncomfortable stomach; leg weak; pain in the back of the neck; weak; headache; tired; chills; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ABDOMINAL DISCOMFORT (uncomfortable stomach), MUSCULAR WEAKNESS (leg weak), NECK PAIN (pain in the back of the neck) and ASTHENIA (weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M200) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nauseous). On 01-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (uncomfortable stomach), MUSCULAR WEAKNESS (leg weak), NECK PAIN (pain in the back of the neck), ASTHENIA (weak), HEADACHE (headache), FATIGUE (tired) and CHILLS (chills). On an unknown date, the patient experienced NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, NAUSEA (nauseous) had resolved. At the time of the report, NASOPHARYNGITIS (cold), ABDOMINAL DISCOMFORT (uncomfortable stomach), MUSCULAR WEAKNESS (leg weak), NECK PAIN (pain in the back of the neck), ASTHENIA (weak), HEADACHE (headache), FATIGUE (tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nasopharyngitis, Nausea, Neck pain
Clinical narrative: cold; uncomfortable stomach; leg weak; pain in the back of the neck; weak; headache; tired; chills; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), ABDOMINAL DISCOMFORT (uncomfortable stomach), MUSCULAR WEAKNESS (leg weak), NECK PAIN (pain in the back of the neck) and ASTHENIA (weak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M200) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nauseous). On 01-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (uncomfortable stomach), MUSCULAR WEAKNESS (leg weak), NECK PAIN (pain in the back of the neck), ASTHENIA (weak), HEADACHE (headache), FATIGUE (tired) and CHILLS (chills). On an unknown date, the patient experienced NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Feb-2021, NAUSEA (nauseous) had resolved. At the time of the report, NASOPHARYNGITIS (cold), ABDOMINAL DISCOMFORT (uncomfortable stomach), MUSCULAR WEAKNESS (leg weak), NECK PAIN (pain in the back of the neck), ASTHENIA (weak), HEADACHE (headache), FATIGUE (tired) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pyrexia
Clinical narrative: Lower backache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower backache) and PYREXIA (Low grade fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Lower backache) and PYREXIA (Low grade fever). At the time of the report, BACK PAIN (Lower backache) and PYREXIA (Low grade fever) outcome was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Got only half dose of vaccine; A spontaneous report was received from a consumer concerning a 52-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and got only half dose of vaccine/ underdose.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 11 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032M20A) in the left non dominant arm for prophylaxis of COVID-19 infection.   On an unknown date, it was reported that her vaccine administrator told her that she received only half dose of vaccine, So she had to repeat the dose again. Also she noticed some of the vaccine running down her arms from injection site. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event, got only half dose of vaccine was considered as resolved.; Reporter's Comments: This report refers to a case of  Underdose for mRNA-1273, lot # 032M20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red and itchy; an area that has gradually grown from her site of injection and from her shoulder down; red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red and itchy), VACCINATION SITE SWELLING (an area that has gradually grown from her site of injection and from her shoulder down) and VACCINATION SITE ERYTHEMA (red and itchy) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (red and itchy), VACCINATION SITE SWELLING (an area that has gradually grown from her site of injection and from her shoulder down) and VACCINATION SITE ERYTHEMA (red and itchy). At the time of the report, VACCINATION SITE PRURITUS (red and itchy), VACCINATION SITE SWELLING (an area that has gradually grown from her site of injection and from her shoulder down) and VACCINATION SITE ERYTHEMA (red and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site induration, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Malaise), VACCINATION SITE INDURATION (Tenderness at injection site), FATIGUE (Generalize fatigue) and VACCINATION SITE SWELLING (Swelling at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for an unknown indication. No Medical History information was reported. On 19-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 19-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Tenderness at injection site), FATIGUE (Generalize fatigue) and VACCINATION SITE SWELLING (Swelling at injection site). On an unknown date, the patient experienced MALAISE (Malaise). At the time of the report, MALAISE (Malaise), VACCINATION SITE INDURATION (Tenderness at injection site), FATIGUE (Generalize fatigue) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: blood pressure high compared to normal; heart pounding faster than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure high compared to normal) and HEART RATE INCREASED (heart pounding faster than usual) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPERTENSION (blood pressure high compared to normal) and HEART RATE INCREASED (heart pounding faster than usual). At the time of the report, HYPERTENSION (blood pressure high compared to normal) and HEART RATE INCREASED (heart pounding faster than usual) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: 160/88 mmHg (High) 160/88. On 10-Mar-2021, Heart rate: 93 beats per minute (High) 93. In March 2021, Blood pressure measurement: 142/87 mmHg (Inconclusive) 142/87.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes antidepressant medications and sleeping medications.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: Additional information added
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Feet are both swollen, left foot more than usual; feet and he uses walker but now they are so swollen and unbearable; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Feet are both swollen, left foot more than usual) and PAIN IN EXTREMITY (feet and he uses walker but now they are so swollen and unbearable) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044M20A) for COVID-19 vaccination.     Concurrent medical conditions included Leg deformity NOS (Patient uses walker.) and Walker user.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (Feet are both swollen, left foot more than usual) and PAIN IN EXTREMITY (feet and he uses walker but now they are so swollen and unbearable). At the time of the report, PERIPHERAL SWELLING (Feet are both swollen, left foot more than usual) and PAIN IN EXTREMITY (feet and he uses walker but now they are so swollen and unbearable) 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: Vaccination site rash, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site rash; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (Vaccination site rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE, LISINOPRIL, METFORMIN, SIMVASTATIN, VERAPAMIL HYDROCHLORIDE (ISOPTIN DC) and AMLODIPINE 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 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (Vaccination site rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (Vaccination site rash) 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.   Treatment information included ice application.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Severe wheezing which began in his sleep; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Severe wheezing which began in his sleep) in a 64-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced WHEEZING (Severe wheezing which began in his sleep). At the time of the report, WHEEZING (Severe wheezing which began in his sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.  The patient's wife stated that it sounded as if the patient had an upper respiratory infection.  The patient was wheezing so severely that it resulted in him using his wife's oxygen machine to continue breathing. The patient had an appointment on Thursday 11-MAR-2021 with his healthcare provider.    Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Pain in extremity
Clinical narrative: Had a bad accident and fell; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FALL (Had a bad accident and fell) 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) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced FALL (Had a bad accident and fell). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FALL (Had a bad accident and fell) outcome was unknown.            No concomitant medications was reported Treatment information was not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Myalgia
Clinical narrative: More short of breath and having to use the inhaler more; Muscle aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (More short of breath and having to use the inhaler more), MYALGIA (Muscle aches) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MYALGIA (Muscle aches) and CHILLS (Chills). On an unknown date, the patient experienced DYSPNOEA (More short of breath and having to use the inhaler more). On 05-Mar-2021, CHILLS (Chills) had resolved. On 06-Mar-2021, MYALGIA (Muscle aches) had resolved. At the time of the report, DYSPNOEA (More short of breath and having to use the inhaler more) outcome was unknown.            No concomitant medications was reported Treatment information was not provided  Action taken with mRNA-1273 in response to the event was Not Applicable
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had a sore arm after getting the vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (had a sore arm after getting the vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (had a sore arm after getting the vaccine). At the time of the report, VACCINATION SITE PAIN (had a sore arm after getting the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment drug were not reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: toes started hurting. It was swollen, painful; toes started hurting. It was swollen, painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (toes started hurting. It was swollen, painful) and SWELLING (toes started hurting. It was swollen, painful) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (toes started hurting. It was swollen, painful) and SWELLING (toes started hurting. It was swollen, painful). At the time of the report, PAIN IN EXTREMITY (toes started hurting. It was swollen, painful) and SWELLING (toes started hurting. It was swollen, painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Delayed skin reaction; Below the injection site which was hot to the touch; Red rash on her arm below the injection site; Below the injection site which was swollen; Below the injection site which was itching; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (Delayed skin reaction), VACCINATION SITE WARMTH (Below the injection site which was hot to the touch), VACCINATION SITE RASH (Red rash on her arm below the injection site), VACCINATION SITE SWELLING (Below the injection site which was swollen) and VACCINATION SITE PRURITUS (Below the injection site which was itching) in a 53-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 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 SKIN REACTION (Delayed skin reaction), VACCINATION SITE WARMTH (Below the injection site which was hot to the touch), VACCINATION SITE RASH (Red rash on her arm below the injection site), VACCINATION SITE SWELLING (Below the injection site which was swollen) and VACCINATION SITE PRURITUS (Below the injection site which was itching). At the time of the report, SKIN REACTION (Delayed skin reaction), VACCINATION SITE WARMTH (Below the injection site which was hot to the touch), VACCINATION SITE RASH (Red rash on her arm below the injection site), VACCINATION SITE SWELLING (Below the injection site which was swollen) and VACCINATION SITE PRURITUS (Below the injection site which was itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Delayed skin reaction and Vaccination site warmth added as new event. Lower level term updated for all existing events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness
Clinical narrative: I felt muscles in my knees again.; My knees gave out on me and I fell to the floor; A spontaneous report was received from a  69-years-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events knees gave out  and fell to the floor.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date in Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 8 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event  knees gave out and fell to the floor.  Treatment details was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event  knees gave out and fell to the floor was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Headache, Pruritus, Pyrexia
Clinical narrative: Tiny Blisters on belly , breast and back; Felt itchy on all around her shoulders and neck; Fever; Chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (Tiny Blisters on belly , breast and back), PRURITUS (Felt itchy on all around her shoulders and neck), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination.     Patient's medical history included No Adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache). On 05-Mar-2021, the patient experienced PRURITUS (Felt itchy on all around her shoulders and neck). On 08-Mar-2021, the patient experienced BLISTER (Tiny Blisters on belly , breast and back). The patient was treated with CORTISONE at an unspecified dose and frequency. On 04-Mar-2021, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache) had resolved. At the time of the report, BLISTER (Tiny Blisters on belly , breast and back) and PRURITUS (Felt itchy on all around her shoulders and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Itching on arm where vaccine was given; Welt on arm where vaccine was given; Red where vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on arm where vaccine was given), VACCINATION SITE URTICARIA (Welt on arm where vaccine was given) and INJECTION SITE ERYTHEMA (Red where vaccine was given) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Patient's medical history included No Adverse event.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on arm where vaccine was given), VACCINATION SITE URTICARIA (Welt on arm where vaccine was given) and INJECTION SITE ERYTHEMA (Red where vaccine was given). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE PRURITUS (Itching on arm where vaccine was given) and VACCINATION SITE URTICARIA (Welt on arm where vaccine was given) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red where vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Heart rate, Myalgia
Clinical narrative: sore arm; chest tightness; muscle pain; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: high (High) pulse 98-104 (usually 60s).         Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-210746 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: sore arm; chest tightness; muscle pain; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), CHEST DISCOMFORT (chest tightness), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: high (High) pulse 98-104 (usually 60s).         Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-210746 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus
Clinical narrative: itching the injection site and it was a little red mark, had a knot; itching the injection site; a little red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (itching the injection site and it was a little red mark, had a knot), VACCINATION SITE PRURITUS (itching the injection site) and VACCINATION SITE ERYTHEMA (a little red at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included INFLIXIMAB (REMICADE) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (itching the injection site and it was a little red mark, had a knot), VACCINATION SITE PRURITUS (itching the injection site) and VACCINATION SITE ERYTHEMA (a little red at the injection site). At the time of the report, VACCINATION SITE NODULE (itching the injection site and it was a little red mark, had a knot), VACCINATION SITE PRURITUS (itching the injection site) and VACCINATION SITE ERYTHEMA (a little red at the injection site) outcome was unknown.            Treatment information was not provided.  Patient reported lack of side effects from the Remicade
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness) and LYMPHADENOPATHY (Lymph nodes under the left arm were swollen) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness), LYMPHADENOPATHY (Lymph nodes under the left arm were swollen), NAUSEA (Nausea), ARTHRALGIA (Joint pain), FATIGUE (Feeling really tired), HEADACHE (Head ache) and CHILLS (chills were the worst,). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness), LYMPHADENOPATHY (Lymph nodes under the left arm were swollen), NAUSEA (Nausea), ARTHRALGIA (Joint pain), FATIGUE (Feeling really tired), HEADACHE (Head ache) and CHILLS (chills were the worst,) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were not provided. Treatment with Aleve and Benadryl were provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Lymphadenopathy, Nausea, Pharyngeal swelling
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness) and LYMPHADENOPATHY (Lymph nodes under the left arm were swollen) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness), LYMPHADENOPATHY (Lymph nodes under the left arm were swollen), NAUSEA (Nausea), ARTHRALGIA (Joint pain), FATIGUE (Feeling really tired), HEADACHE (Head ache) and CHILLS (chills were the worst,). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness), LYMPHADENOPATHY (Lymph nodes under the left arm were swollen), NAUSEA (Nausea), ARTHRALGIA (Joint pain), FATIGUE (Feeling really tired), HEADACHE (Head ache) and CHILLS (chills were the worst,) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were not provided. Treatment with Aleve and Benadryl were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: sore arm, arm was hurting; fever; chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, arm was hurting), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm, arm was hurting), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm, arm was hurting), PYREXIA (fever), CHILLS (chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medications were not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: hard for her to breathe/hard time catching her breath; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard for her to breathe/hard time catching her breath) and PAIN IN EXTREMITY (arm pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A20A and 043120A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DYSPNOEA (hard for her to breathe/hard time catching her breath) and PAIN IN EXTREMITY (arm pain). At the time of the report, DYSPNOEA (hard for her to breathe/hard time catching her breath) and PAIN IN EXTREMITY (arm pain) outcome was unknown.            No concomitant medication reported   No treatment medication reported