chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to touch; rash of 2in diameter developed at injection site; redness; injection site on right arm started itching; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (injection site on right arm started itching), VACCINATION SITE RASH (rash of 2inch diameter developed at injection site) and VACCINATION SITE ERYTHEMA (redness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OT06L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site on right arm started itching). On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE RASH (rash of 2in diameter developed at injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (injection site on right arm started itching), VACCINATION SITE RASH (rash of 2in diameter developed at injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise
Clinical narrative: lousy; slept a lot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (lousy) and HYPERSOMNIA (slept a lot) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced MALAISE (lousy) and HYPERSOMNIA (slept a lot). At the time of the report, MALAISE (lousy) and HYPERSOMNIA (slept a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Influenza, Myalgia
Clinical narrative: enormous pain; injection site hot; flu symptoms; low energy; skin is hard; injection site is red; headache; really tired; slight soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy) and VACCINATION SITE INDURATION (skin is hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (slight soreness). On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy), VACCINATION SITE INDURATION (skin is hard), VACCINATION SITE ERYTHEMA (injection site is red), HEADACHE (headache) and FATIGUE (really tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy), VACCINATION SITE INDURATION (skin is hard), VACCINATION SITE ERYTHEMA (injection site is red), MYALGIA (slight soreness), HEADACHE (headache) and FATIGUE (really tired) 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: enormous pain; injection site hot; flu symptoms; low energy; skin is hard; injection site is red; headache; really tired; slight soreness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy) and VACCINATION SITE INDURATION (skin is hard) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (slight soreness). On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy), VACCINATION SITE INDURATION (skin is hard), VACCINATION SITE ERYTHEMA (injection site is red), HEADACHE (headache) and FATIGUE (really tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (enormous pain), VACCINATION SITE WARMTH (injection site hot), INFLUENZA (flu symptoms), ASTHENIA (low energy), VACCINATION SITE INDURATION (skin is hard), VACCINATION SITE ERYTHEMA (injection site is red), MYALGIA (slight soreness), HEADACHE (headache) and FATIGUE (really tired) 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: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature decreased, Swelling
Clinical narrative: lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry; temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F); This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F)) and SWELLING (lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced BODY TEMPERATURE DECREASED (temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F)). On 23-Jan-2021, the patient experienced SWELLING (lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry). At the time of the report, BODY TEMPERATURE DECREASED (temperature went down 4 degree below normal everyday since he got vaccinated ( Before vaccination: 97 deg. F after 92.6-94 deg. F)) and SWELLING (lump that is starting to grow below the patient's neck and shoulder that is movable and is of a size of a cherry) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Pyrexia, Tenderness, X-ray
Clinical narrative: Arm  soreness; Loss of appetite; Shortness of breath; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm  soreness), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery, High cholesterol and Diabetes. Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced TENDERNESS (Arm  soreness), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Shortness of breath) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TENDERNESS (Arm  soreness), DECREASED APPETITE (Loss of appetite), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Pyrexia: he also had fever He also had fever. In January 2021, X-ray: normal (normal) Took xrays and said lungs were clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching at site of injection; Rash; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itching at site of injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itching at site of injection). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itching at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Pain
Clinical narrative: Weak and Not feeling well; Achy; Headaches; very weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), PAIN (Achy), MALAISE (Weak and Not feeling well) and HEADACHE (Headaches) 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.     In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (very weak), PAIN (Achy) and HEADACHE (Headaches). On 22-Jan-2021, the patient experienced MALAISE (Weak and Not feeling well). At the time of the report, ASTHENIA (very weak), PAIN (Achy), MALAISE (Weak and Not feeling well) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-11364 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation
Clinical narrative: Injection site inflammation; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (Injection site inflammation) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammation). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INFLAMMATION (Injection site inflammation) 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.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Paraesthesia, Pruritus
Clinical narrative: Loose bowels; Tingling on the right hand, like in the fingers/ tingling down in both arms, wasn't real high; Itching on arms and forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arms and forehead) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRURITUS (Itching on arms and forehead). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on arms and forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: patient's email address was updated
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Periarthritis
Clinical narrative: terrible nerve pain and frozen shoulder; terrible nerve pain and frozen shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEURALGIA (terrible nerve pain and frozen shoulder) and PERIARTHRITIS (terrible nerve pain and frozen shoulder) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced NEURALGIA (terrible nerve pain and frozen shoulder) and PERIARTHRITIS (terrible nerve pain and frozen shoulder). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NEURALGIA (terrible nerve pain and frozen shoulder) and PERIARTHRITIS (terrible nerve pain and frozen shoulder) 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.   Products known to have been used by the patient, within two weeks prior to the event, included diabetic pills, blood pressure pills, blood thinner and pills for nerve pain leg.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Oropharyngeal pain
Clinical narrative: Sore throat; Tired; Sick/ Fell bad; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired), ILLNESS (Sick/ Fell bad) and OROPHARYNGEAL PAIN (Sore throat) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced FATIGUE (Tired) and ILLNESS (Sick/ Fell bad). On 25-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, FATIGUE (Tired), ILLNESS (Sick/ Fell bad) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Cough, Headache, Pain
Clinical narrative: Cough; All over body aches; Burning sensation in her chest; Chills; Fever of 100.6; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills) and PYREXIA (Fever of 100.6) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills), PYREXIA (Fever of 100.6) and HEADACHE (Headaches). At the time of the report, COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills), PYREXIA (Fever of 100.6) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cough; All over body aches; Burning sensation in her chest; Chills; Fever of 100.6; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills) and PYREXIA (Fever of 100.6) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills), PYREXIA (Fever of 100.6) and HEADACHE (Headaches). At the time of the report, COUGH (Cough), PAIN (All over body aches), CHEST PAIN (Burning sensation in her chest), CHILLS (Chills), PYREXIA (Fever of 100.6) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pruritus, Rash
Clinical narrative: saw some rashes on my chest and back; headache; lightheadedness; that night I had an itching on my back; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (lightheadedness), PRURITUS (that night I had an itching on my back), RASH (saw some rashes on my chest and back) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (lightheadedness) and PRURITUS (that night I had an itching on my back). On 16-Jan-2021, the patient experienced HEADACHE (headache). On 17-Jan-2021, the patient experienced RASH (saw some rashes on my chest and back). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheadedness), PRURITUS (that night I had an itching on my back), RASH (saw some rashes on my chest and back) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: large lymph node under her vaccinated arm; A spontaneous report  was received from an HCP concerning an unmentioned age female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced large lymph node under her vaccinated arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-JAN-2021, prior to the onset of the events, the patient received their first of the two planned dose of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 22-JAN-2021, the patient experienced large lymph node under her vaccinated arm. No lab details provided. No treatment information provided. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event large lymph node on vaccinated arm was unknown. Agent attempted callback, no answer. Filing with limited information.  The reporter assessed the event, [large lymph node on vaccinated arm] as listed to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Injection site erythema, Pain in extremity, Skin warm
Clinical narrative: Inflamed; The arm was sore; had a sensation of warm to touch; circled the redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflamed), PAIN IN EXTREMITY (The arm was sore), SKIN WARM (had a sensation of warm to touch) and INJECTION SITE ERYTHEMA (circled the redness in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INFLAMMATION (Inflamed), PAIN IN EXTREMITY (The arm was sore), SKIN WARM (had a sensation of warm to touch) and INJECTION SITE ERYTHEMA (circled the redness in the injection site). At the time of the report, INFLAMMATION (Inflamed), PAIN IN EXTREMITY (The arm was sore), SKIN WARM (had a sensation of warm to touch) and INJECTION SITE ERYTHEMA (circled the redness in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter No treatment was reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelled up; Very hard sore; Itchy at the site; Redness; Very rough; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Very hard sore), VACCINATION SITE PRURITUS (Itchy at the site), ERYTHEMA (Redness) and DRY SKIN (Very rough) in a 76-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 LETROZOLE, FISH OIL, CENTRUM SILVER +50 and VITAMIN D3.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Very hard sore), VACCINATION SITE PRURITUS (Itchy at the site), ERYTHEMA (Redness), DRY SKIN (Very rough) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Very hard sore), VACCINATION SITE PRURITUS (Itchy at the site), ERYTHEMA (Redness), DRY SKIN (Very rough) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Arm swelled up; Very hard sore; Itchy at the site; Redness; Very rough; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Very hard sore), VACCINATION SITE PRURITUS (Itchy at the site), ERYTHEMA (Redness) and DRY SKIN (Very rough) in a 76-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 LETROZOLE, FISH OIL, CENTRUM SILVER +50 and VITAMIN D3.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Very hard sore), VACCINATION SITE PRURITUS (Itchy at the site), ERYTHEMA (Redness), DRY SKIN (Very rough) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Arm swelled up), PAIN IN EXTREMITY (Very hard sore), VACCINATION SITE PRURITUS (Itchy at the site), ERYTHEMA (Redness), DRY SKIN (Very rough) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Sep-2020 and the estimated date of delivery was 18-Jun-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were provided No treatment were provided
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Pain in extremity
Clinical narrative: Dark urine; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (denies past medical history.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain). At the time of the report, CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Flushing, Headache, Pain, Pain in extremity
Clinical narrative: feel a burning sensation on his nose; painfulness; Headache; cheeks and nose are flushed; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (feel a burning sensation on his nose), PAIN (painfulness), HEADACHE (Headache), FLUSHING (cheeks and nose are flushed) and PAIN IN EXTREMITY (arm soreness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (No reported medical history). Concomitant products included RAMIPRIL.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 18-Jan-2021, the patient experienced BURNING SENSATION (feel a burning sensation on his nose), PAIN (painfulness), HEADACHE (Headache) and FLUSHING (cheeks and nose are flushed). At the time of the report, BURNING SENSATION (feel a burning sensation on his nose), PAIN (painfulness), HEADACHE (Headache), FLUSHING (cheeks and nose are flushed) and PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included antibiotic
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (body ache) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PAIN (body ache) and CHILLS (chills). At the time of the report, HEADACHE (headache), PAIN (body ache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain, Somnolence
Clinical narrative: aches; severe dull funny headache; Very Sleepy; very fatigued; just not feeling himself; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), HEADACHE (severe dull funny headache), SOMNOLENCE (Very Sleepy), FATIGUE (very fatigued) and FEELING ABNORMAL (just not feeling himself) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (aches), HEADACHE (severe dull funny headache), SOMNOLENCE (Very Sleepy), FATIGUE (very fatigued) and FEELING ABNORMAL (just not feeling himself). At the time of the report, PAIN (aches), HEADACHE (severe dull funny headache), SOMNOLENCE (Very Sleepy), FATIGUE (very fatigued) and FEELING ABNORMAL (just not feeling himself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medication were provided No treatment were provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Difficulty breathing; Fever; Chills; Joints pain; Fatigue; Area of injection pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joints pain) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (Patient is asthmatic.) since an unknown date.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joints pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Area of injection pain). At the time of the report, DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joints pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Area of injection pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided Treatment included Tylenol 500mg, Albuterol
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Difficulty breathing; Fever; Chills; Joints pain; Fatigue; Area of injection pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joints pain) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (Patient is asthmatic.) since an unknown date.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joints pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Area of injection pain). At the time of the report, DYSPNOEA (Difficulty breathing), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joints pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Area of injection pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided Treatment included Tylenol 500mg, Albuterol
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Pain in extremity
Clinical narrative: Dark urine; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) and EPINEPHRINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain). At the time of the report, CHROMATURIA (Dark urine) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment were provided
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Shortness of breath; Body aches; Fatigue; Minor headache; Arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  soreness), DYSPNOEA (Shortness of breath), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Minor headache) in a 39-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 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm  soreness). On 22-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Minor headache). On 18-Jan-2021, PAIN IN EXTREMITY (Arm  soreness) had resolved. At the time of the report, DYSPNOEA (Shortness of breath), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Minor headache) outcome was unknown.            No Concomitant medication were provided Treatment included Tylenol for soreness
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 (Arm hurt). At the time of the report, VACCINATION SITE PAIN (Arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were provided No treatment were provided
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Oropharyngeal pain, Pharyngeal swelling, Pyrexia, Rash
Clinical narrative: Swelling in my lips; Swelling in my throat; Sore throat; fever; eniter upper body rash; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling in my lips), PHARYNGEAL SWELLING (Swelling in my throat), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (fever) and RASH (eniter upper body rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swelling in my lips), PHARYNGEAL SWELLING (Swelling in my throat), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (fever) and RASH (eniter upper body rash). At the time of the report, LIP SWELLING (Swelling in my lips), PHARYNGEAL SWELLING (Swelling in my throat) and RASH (eniter upper body rash) had resolved and OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided Treatment included Steroids
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: injection site is red; injection site is swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dosage 2. On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is swollen). At the time of the report, INJECTION SITE ERYTHEMA (injection site is red) and INJECTION SITE SWELLING (injection site is swollen) outcome was unknown.            No Concomitant medication were provided No treatment were provided
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site movement impairment, Vaccination site rash, Vaccination site swelling
Clinical narrative: arm soreness; rash on the injection site; redness; swellling; hard to move the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swellling) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move the arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Acid reflux (esophageal) and Low back pain. Concomitant products included ALENDRONATE SODIUM (FOSAMAX), ESOMEPRAZOLE MAGNESIUM (NEXIUM 24HR) and TRAMADOL.    On 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swellling) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move the arm). At the time of the report, PAIN IN EXTREMITY (arm soreness), VACCINATION SITE RASH (rash on the injection site), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swellling) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching at the vaccination site; I notice it was red; Swollen, Bump under the skin; Patchy red, Rash type thing; Arm was pretty sore,Hurt to raise my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was pretty sore,Hurt to raise my arm), VACCINATION SITE PRURITUS (Itching at the vaccination site), VACCINATION SITE ERYTHEMA (I notice it was red), VACCINATION SITE SWELLING (Swollen, Bump under the skin) and RASH (Patchy red, Rash type thing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood disorder and Plasma cell disorder NOS (abnormal plasma cells so they don't produce antibodies or strong antibodies.).    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was pretty sore,Hurt to raise my arm). On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the vaccination site), VACCINATION SITE ERYTHEMA (I notice it was red), VACCINATION SITE SWELLING (Swollen, Bump under the skin) and RASH (Patchy red, Rash type thing). At the time of the report, PAIN IN EXTREMITY (Arm was pretty sore,Hurt to raise my arm), VACCINATION SITE PRURITUS (Itching at the vaccination site), VACCINATION SITE ERYTHEMA (I notice it was red), VACCINATION SITE SWELLING (Swollen, Bump under the skin) and RASH (Patchy red, Rash type thing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.