chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: ow grade fever 101 degrees; covid positive; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid positive) and PYREXIA (ow grade fever 101 degrees) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hepatitis B. Concurrent medical conditions included Hypertension.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced COVID-19 (covid positive). On 13-Jan-2021, the patient experienced PYREXIA (ow grade fever 101 degrees). On 24-Jan-2021, PYREXIA (ow grade fever 101 degrees) had resolved. At the time of the report, COVID-19 (covid positive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache
Clinical narrative: Knee pain; Back pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), HEADACHE (Headaches) and ARTHRALGIA (Knee pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced BACK PAIN (Back pain) and HEADACHE (Headaches). On 24-Jan-2021, the patient experienced ARTHRALGIA (Knee pain). At the time of the report, BACK PAIN (Back pain), HEADACHE (Headaches) and ARTHRALGIA (Knee pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included Tylenol. N o concomitant medications were provided by reporter.; 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: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Reaction at the site of injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Reaction at the site of injection) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Reaction at the site of injection). At the time of the report, VACCINATION SITE REACTION (Reaction at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Additional information received. Event was updated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling hot, Hypersomnia, Musculoskeletal discomfort, Myalgia
Clinical narrative: side effect in right or left arm (not clear) after 1st dose; Feel weak; like I got a shot on my hip; Slept through 20 some hours; Hive on both hands; injection site tender; Mild ache in lower extremities: Hips to knees; Hip tender and warm to touch; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees), FEELING HOT (Hip tender and warm to touch) and VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees) and FEELING HOT (Hip tender and warm to touch). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose), ASTHENIA (Feel weak), MUSCULOSKELETAL DISCOMFORT (like I got a shot on my hip) and HYPERSOMNIA (Slept through 20 some hours). At the time of the report, URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees) and FEELING HOT (Hip tender and warm to touch) had not resolved and VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose), ASTHENIA (Feel weak), MUSCULOSKELETAL DISCOMFORT (like I got a shot on my hip) and HYPERSOMNIA (Slept through 20 some hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication, Vaccination site pain
Clinical narrative: side effect in right or left arm (not clear) after 1st dose; Feel weak; like I got a shot on my hip; Slept through 20 some hours; Hive on both hands; injection site tender; Mild ache in lower extremities: Hips to knees; Hip tender and warm to touch; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees), FEELING HOT (Hip tender and warm to touch) and VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees) and FEELING HOT (Hip tender and warm to touch). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose), ASTHENIA (Feel weak), MUSCULOSKELETAL DISCOMFORT (like I got a shot on my hip) and HYPERSOMNIA (Slept through 20 some hours). At the time of the report, URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees) and FEELING HOT (Hip tender and warm to touch) had not resolved and VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose), ASTHENIA (Feel weak), MUSCULOSKELETAL DISCOMFORT (like I got a shot on my hip) and HYPERSOMNIA (Slept through 20 some hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Hypoaesthesia, Muscular weakness, Nausea, Pain
Clinical narrative: felt little bit achy; temperature elevated; numbness at the chin; heart beat raising; weakness in the legs; tightness in the throat; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr viraemia, Pericarditis, Allergy (Allergy to boric acid), Allergy (Allergy to Tagamet) and Dizziness since 22-Jan-2021.    On 22-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 HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat), NAUSEA (nausea) and BODY TEMPERATURE INCREASED (temperature elevated). On 23-Jan-2021, the patient experienced PAIN (felt little bit achy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat), NAUSEA (nausea), PAIN (felt little bit achy) and BODY TEMPERATURE INCREASED (temperature elevated) had not 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Throat tightness
Clinical narrative: felt little bit achy; temperature elevated; numbness at the chin; heart beat raising; weakness in the legs; tightness in the throat; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr viraemia, Pericarditis, Allergy (Allergy to boric acid), Allergy (Allergy to Tagamet) and Dizziness since 22-Jan-2021.    On 22-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 HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat), NAUSEA (nausea) and BODY TEMPERATURE INCREASED (temperature elevated). On 23-Jan-2021, the patient experienced PAIN (felt little bit achy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness at the chin), TACHYCARDIA (heart beat raising), MUSCULAR WEAKNESS (weakness in the legs), THROAT TIGHTNESS (tightness in the throat), NAUSEA (nausea), PAIN (felt little bit achy) and BODY TEMPERATURE INCREASED (temperature elevated) had not 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: hard 4inches diameter; swollen; also have headache that last all day; Injection site became red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (hard 4inches diameter), VACCINATION SITE ERYTHEMA (Injection site became red), VACCINATION SITE SWELLING (swollen) and HEADACHE (also have headache that last all day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site became red). On 23-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard 4inches diameter), VACCINATION SITE SWELLING (swollen) and HEADACHE (also have headache that last all day). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 23-Jan-2021 for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) 23-Jan-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE INDURATION (hard 4inches diameter), VACCINATION SITE ERYTHEMA (Injection site became red) and VACCINATION SITE SWELLING (swollen) had not resolved and HEADACHE (also have headache that last all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  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.; 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site is hot to the touch; injection site reddish with a 2 inch circle; injection site itchy; pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache), VACCINATION SITE WARMTH (Injection site is hot to the touch), VACCINATION SITE ERYTHEMA (injection site reddish with a 2 inch circle) and VACCINATION SITE PRURITUS (injection site itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Headache. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), FENOFIBRATE, METOPROLOL, CLONIDINE and PAROXETINE 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 PAIN IN EXTREMITY (pain in arm) and HEADACHE (Headache). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hot to the touch), VACCINATION SITE ERYTHEMA (injection site reddish with a 2 inch circle) and VACCINATION SITE PRURITUS (injection site itchy). At the time of the report, PAIN IN EXTREMITY (pain in arm) had resolved and HEADACHE (Headache), VACCINATION SITE WARMTH (Injection site is hot to the touch), VACCINATION SITE ERYTHEMA (injection site reddish with a 2 inch circle) and VACCINATION SITE PRURITUS (injection site itchy) had not 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 treatment medication was provided by Reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Contracted COVID-19; Dizziness; Chest tightness; Chest pains; Soreness in her chest and back; Headache; Tiredness; Muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains) and BACK PAIN (Soreness in her chest and back) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains), BACK PAIN (Soreness in her chest and back), HEADACHE (Headache), FATIGUE (Tiredness) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains) and HEADACHE (Headache) had not resolved and BACK PAIN (Soreness in her chest and back), FATIGUE (Tiredness) and MYALGIA (Muscle aches) 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Contracted COVID-19; Dizziness; Chest tightness; Chest pains; Soreness in her chest and back; Headache; Tiredness; Muscle aches; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains) and BACK PAIN (Soreness in her chest and back) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains), BACK PAIN (Soreness in her chest and back), HEADACHE (Headache), FATIGUE (Tiredness) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (Contracted COVID-19), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), CHEST PAIN (Chest pains) and HEADACHE (Headache) had not resolved and BACK PAIN (Soreness in her chest and back), FATIGUE (Tiredness) and MYALGIA (Muscle aches) 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness on her right arm; Extremely tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on her right arm) and FATIGUE (Extremely tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness on her right arm) and FATIGUE (Extremely tiredness). At the time of the report, PAIN IN EXTREMITY (Soreness on her right arm) and FATIGUE (Extremely tiredness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Induration, Muscular weakness, Myalgia
Clinical narrative: white outline; arm is weak & heavy; skin felt really thick and hard; hot to touch; hurts; itchy around the area of shot; Big red circle on arm 1inch around shot/hot and red; felt worked out; nauseous for 2 hours; heavy head like having helmet on head; felt dizzy for little while; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head) and DIZZINESS (felt dizzy for little while) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), OMEPRAZOLE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), NAUSEA (nauseous for 2 hours) and MYALGIA (felt worked out). On an unknown date, the patient experienced SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot) and VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qd. At the time of the report, SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot), NAUSEA (nauseous for 2 hours), VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red) and MYALGIA (felt worked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05-Jul-2021 contains significant information event outcome for all the reported side effects was updated as recovered/resolved, declined consent for further follow up and also concomitant medications were added from initial source document.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Skin discolouration, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: white outline; arm is weak & heavy; skin felt really thick and hard; hot to touch; hurts; itchy around the area of shot; Big red circle on arm 1inch around shot/hot and red; felt worked out; nauseous for 2 hours; heavy head like having helmet on head; felt dizzy for little while; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head) and DIZZINESS (felt dizzy for little while) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), OMEPRAZOLE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), NAUSEA (nauseous for 2 hours) and MYALGIA (felt worked out). On an unknown date, the patient experienced SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot) and VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qd. At the time of the report, SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot), NAUSEA (nauseous for 2 hours), VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red) and MYALGIA (felt worked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05-Jul-2021 contains significant information event outcome for all the reported side effects was updated as recovered/resolved, declined consent for further follow up and also concomitant medications were added from initial source document.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: white outline; arm is weak & heavy; skin felt really thick and hard; hot to touch; hurts; itchy around the area of shot; Big red circle on arm 1inch around shot/hot and red; felt worked out; nauseous for 2 hours; heavy head like having helmet on head; felt dizzy for little while; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head) and DIZZINESS (felt dizzy for little while) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), OMEPRAZOLE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), NAUSEA (nauseous for 2 hours) and MYALGIA (felt worked out). On an unknown date, the patient experienced SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot) and VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qd. At the time of the report, SKIN DISCOLOURATION (white outline), MUSCULAR WEAKNESS (arm is weak & heavy), INDURATION (skin felt really thick and hard), HEAD DISCOMFORT (heavy head like having helmet on head), DIZZINESS (felt dizzy for little while), VACCINATION SITE WARMTH (hot to touch), PAIN (hurts), VACCINATION SITE PRURITUS (itchy around the area of shot), NAUSEA (nauseous for 2 hours), VACCINATION SITE ERYTHEMA (Big red circle on arm 1inch around shot/hot and red) and MYALGIA (felt worked out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05-Jul-2021 contains significant information event outcome for all the reported side effects was updated as recovered/resolved, declined consent for further follow up and also concomitant medications were added from initial source document.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness; It got hard, spread almost until elbow; Swelling at the site; Hot to the touch; A spontaneous report was received from a consumer, concerning a 50 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced swelling at the site (vaccination site swelling), redness it got hard, spread almost until elbow, and hot to the touch.  The medical history of patient was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamins.  On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced swelling at the site and redness.  In the three days following, it got hard, spread almost to the elbow, and hot to the touch. Treatment for the event included diphenhydramine and icing it.  Action taken with mRNA-1273 in response to the events was not provided.  The events, swelling at the site and redness, were considered recovering. The outcome of the events, it got hard, spread almost until elbow, and hot to the touch, were considered unknown.  Reporter's Comments: Based on the current available information, a strong temporal association with onset of the reported events and the use of the product and the known safety profile of mRNA-1273 VACCINE, a causal association cannot be excluded.  Sender's Comments: MOD21-11767:Crosslinked: Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: High Fever; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High Fever) and HEADACHE (Really bad headache) in a 27-year-old female 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.    On 25-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 PYREXIA (High Fever) and HEADACHE (Really bad headache). At the time of the report, PYREXIA (High Fever) and HEADACHE (Really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No conmeds were provided.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: redness area 1.5-2 inches at the injection; Injection site hot to the touch; Itching at the injection site; Pain at the injection site; Redness at the injection site; Chills; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis. Concomitant products included VITAMIN D NOS for Osteoarthritis.    On 12-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 VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and MYALGIA (Muscle pain). On 24-Jan-2021, the patient experienced ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch) and VACCINATION SITE PRURITUS (Itching at the injection site). On 14-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Muscle pain) had resolved, CHILLS (Chills) had not resolved. At the time of the report, ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch) and VACCINATION SITE PRURITUS (Itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treated with cool pads in the injection site.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: redness area 1.5-2 inches at the injection; Injection site hot to the touch; Itching at the injection site; Pain at the injection site; Redness at the injection site; Chills; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis. Concomitant products included VITAMIN D NOS for Osteoarthritis.    On 12-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 VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills) and MYALGIA (Muscle pain). On 24-Jan-2021, the patient experienced ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch) and VACCINATION SITE PRURITUS (Itching at the injection site). On 14-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and MYALGIA (Muscle pain) had resolved, CHILLS (Chills) had not resolved. At the time of the report, ERYTHEMA (redness area 1.5-2 inches at the injection), VACCINATION SITE WARMTH (Injection site hot to the touch) and VACCINATION SITE PRURITUS (Itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treated with cool pads in the injection site.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching at injection; Redness at injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PRURITUS (itching at injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO REPORTED MEDICAL HISTORY).    On 15-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 VACCINATION SITE ERYTHEMA (Redness at injection). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PRURITUS (itching at injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Injection site pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: red part got bigger; arm got itchy; burny; kind of red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (arm got itchy), VACCINATION SITE PAIN (burny), VACCINATION SITE ERYTHEMA (kind of red) and CONDITION AGGRAVATED (red part got bigger) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE PRURITUS (arm got itchy), VACCINATION SITE PAIN (burny) and VACCINATION SITE ERYTHEMA (kind of red). On an unknown date, the patient experienced CONDITION AGGRAVATED (red part got bigger). At the time of the report, INJECTION SITE PRURITUS (arm got itchy) had resolved and VACCINATION SITE PAIN (burny), VACCINATION SITE ERYTHEMA (kind of red) and CONDITION AGGRAVATED (red part got bigger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Mild headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Mild headache). At the time of the report, PYREXIA (Fever) had not resolved and HEADACHE (Mild headache) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on her arm) 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) (unknown route) 1 dosage form. In January 2021, the patient experienced ERYTHEMA (redness on her arm). At the time of the report, ERYTHEMA (redness on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Localized, large rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Localized, large rash at the 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE RASH (Localized, large rash at the injection site). At the time of the report, VACCINATION SITE RASH (Localized, large rash at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment related information has been reported. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new significant information was received. Patient's contact information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Skin reaction, Vaccination site erythema
Clinical narrative: edema around injection site; Delayed skin reaction; Erythema around injection site; Rash and hives on shoulder; Body aches; Low grade fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site) and PYREXIA (Low grade fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN (Body aches) and PYREXIA (Low grade fever). On 15-Jan-2021, the patient experienced VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site) and RASH (Rash and hives on shoulder). At the time of the report, PAIN (Body aches), VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site), PYREXIA (Low grade fever) and RASH (Rash and hives on 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site oedema
Clinical narrative: edema around injection site; Delayed skin reaction; Erythema around injection site; Rash and hives on shoulder; Body aches; Low grade fever; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (Body aches), VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site) and PYREXIA (Low grade fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN (Body aches) and PYREXIA (Low grade fever). On 15-Jan-2021, the patient experienced VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site) and RASH (Rash and hives on shoulder). At the time of the report, PAIN (Body aches), VACCINATION SITE OEDEMA (edema around injection site), SKIN REACTION (Delayed skin reaction), VACCINATION SITE ERYTHEMA (Erythema around injection site), PYREXIA (Low grade fever) and RASH (Rash and hives on 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site was rock hard; injection site was red; injection site was hot; extremely sore; A spontaneous report was received from a consumer concerning a 36-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the injection site being "rock hard", red, hot, and extremely sore /vaccination site induration, erythema, warmth, and pain.   The patient's medical history was not provided. Concomitant medications reported included valacyclovir hydrochloride, diclofenac, and nitrofurantoin.   On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 15 Jan 2021, the patient received the Moderna Covid-19 vaccine. On 23 Jan 2021 she noticed that the injection site was rock hard, red, hot, and extremely sore. Treatment for the events was not provided.     Action taken with mRNA-1273 in response to the events was not reported.    The outcome events were 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 event, a causal relationship cannot be excluded.