chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; A spontaneous report was received from a Consumer concerning a 80-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events nausea and dizziness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, nausea and  dizziness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Ear pain, Fatigue, Headache
Clinical narrative: sore throat; mild pain the left ear; Headache; chills; fever; fatigue; weakness; arm soreness started same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness started same day), ASTHENIA (weakness), HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (mild pain the left ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE;VALSARTAN, VITAMINS NOS (DAILY MULTIVITAMIN), CALCIUM and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness started same day). On 01-Feb-2021, the patient experienced ASTHENIA (weakness), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 02-Feb-2021, the patient experienced HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (mild pain the left ear). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (arm soreness started same day), ASTHENIA (weakness), HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (mild pain the left ear), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment included Tylenol, then the patient stopped as she found from friend to not take anything.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: sore throat; mild pain the left ear; Headache; chills; fever; fatigue; weakness; arm soreness started same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness started same day), ASTHENIA (weakness), HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (mild pain the left ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE;VALSARTAN, VITAMINS NOS (DAILY MULTIVITAMIN), CALCIUM and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness started same day). On 01-Feb-2021, the patient experienced ASTHENIA (weakness), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 02-Feb-2021, the patient experienced HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat) and EAR PAIN (mild pain the left ear). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (arm soreness started same day), ASTHENIA (weakness), HEADACHE (Headache), OROPHARYNGEAL PAIN (sore throat), EAR PAIN (mild pain the left ear), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment included Tylenol, then the patient stopped as she found from friend to not take anything.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Malaise; Body ache; Arthralgia; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue) and CHILLS (Chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). On 25-Jan-2021, the patient experienced MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia) and PYREXIA (Fever). On 26-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Tylenol.   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.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Malaise; Body ache; Arthralgia; Fever; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue) and CHILLS (Chills) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). On 25-Jan-2021, the patient experienced MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia) and PYREXIA (Fever). On 26-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, MALAISE (Malaise), MYALGIA (Body ache), ARTHRALGIA (Arthralgia), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Tylenol.   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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Induration, Pain in extremity, Pruritus
Clinical narrative: Sore arm; Red; Warm to touch; Hard; Itch; Raised; Slight headache; Covid arm; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard) and PRURITUS (Itch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since 1998, Hypothyroidism since 1999, Obstructive sleep apnea syndrome since 2019 and Open angle glaucoma since 2018. Concomitant products included DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) from 2010 to an unknown date for Dizzy, LATANOPROST (XALATAN) from 2018 to an unknown date for Glaucoma, LEVOTHYROXINE SODIUM (LEVOXYL) from 1999 to an unknown date for Hypothyroidism, DIMETHYL FUMARATE (TECFIDERA) from 1998 to an unknown date for Multiple sclerosis, TAMSULOSIN (FLOMAX) from 2014 to an unknown date for Urinary retention.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Covid arm) and VACCINATION SITE RASH (Covid arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard), PRURITUS (Itch), RASH PAPULAR (Raised) and HEADACHE (Slight headache). On 12-Feb-2021, VACCINATION COMPLICATION (Covid arm) had resolved. On 15-Feb-2021, VACCINATION SITE RASH (Covid arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard), PRURITUS (Itch), RASH PAPULAR (Raised) and HEADACHE (Slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up Append. new event added which is recovered and resolved
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Skin warm, Vaccination complication, Vaccination site rash
Clinical narrative: Sore arm; Red; Warm to touch; Hard; Itch; Raised; Slight headache; Covid arm; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard) and PRURITUS (Itch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since 1998, Hypothyroidism since 1999, Obstructive sleep apnea syndrome since 2019 and Open angle glaucoma since 2018. Concomitant products included DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) from 2010 to an unknown date for Dizzy, LATANOPROST (XALATAN) from 2018 to an unknown date for Glaucoma, LEVOTHYROXINE SODIUM (LEVOXYL) from 1999 to an unknown date for Hypothyroidism, DIMETHYL FUMARATE (TECFIDERA) from 1998 to an unknown date for Multiple sclerosis, TAMSULOSIN (FLOMAX) from 2014 to an unknown date for Urinary retention.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Covid arm) and VACCINATION SITE RASH (Covid arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard), PRURITUS (Itch), RASH PAPULAR (Raised) and HEADACHE (Slight headache). On 12-Feb-2021, VACCINATION COMPLICATION (Covid arm) had resolved. On 15-Feb-2021, VACCINATION SITE RASH (Covid arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard), PRURITUS (Itch), RASH PAPULAR (Raised) and HEADACHE (Slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up Append. new event added which is recovered and resolved
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Soreness at the injection site/tenderness at injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site/tenderness at injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 VACCINATION SITE PAIN (Soreness at the injection site/tenderness at injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site/tenderness at injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; chills; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, HEADACHE (headache), CHILLS (chills), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient took vaccine at 12:45 PM on 02-FEB-2021 and started feeling adverse events after 10 PM.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Small red oval, the size of an egg; Arm had a welt; Started to swell again; Itchy; Fever that was over 100F; Arm was sore; A spontaneous report was received from a Consumer concerning a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever which was over 100F, arm was really sore and had a welt, started to swell again, itchy and small red oval like the size of an egg.  The patient's medical history was not provided. Concomitant medications reported were Calcium Supplementation and Vitamin D Supplementation.  On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced fever was over 100F and arm was really sore.   On 27 Jan 2021, the patient's arm had a welt and started to swell again which was itchy.   On 1 Feb 2021, the patient got a small red oval like the size of an egg.  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of event arm was really sore was resolved. At the time of this report, the event(s) fever was 100F, arm had a welt, started to swell again, itchy, small red oval and the size of an egg 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 events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: Small red oval, the size of an egg; Arm had a welt; Started to swell again; Itchy; Fever that was over 100F; Arm was sore; A spontaneous report was received from a Consumer concerning a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever which was over 100F, arm was really sore and had a welt, started to swell again, itchy and small red oval like the size of an egg.  The patient's medical history was not provided. Concomitant medications reported were Calcium Supplementation and Vitamin D Supplementation.  On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient experienced fever was over 100F and arm was really sore.   On 27 Jan 2021, the patient's arm had a welt and started to swell again which was itchy.   On 1 Feb 2021, the patient got a small red oval like the size of an egg.  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of event arm was really sore was resolved. At the time of this report, the event(s) fever was 100F, arm had a welt, started to swell again, itchy, small red oval and the size of an egg 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 events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: less energetic; minor pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (less energetic) and VACCINATION SITE PAIN (minor pain at the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Energy increased and Energy decreased.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced FATIGUE (less energetic) and VACCINATION SITE PAIN (minor pain at the injection site). At the time of the report, FATIGUE (less energetic) and VACCINATION SITE PAIN (minor pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pain in extremity
Clinical narrative: Respiratory problems; shortness of breath; Arm was sore; Coughing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COUGH (Coughing), DYSPNOEA (Respiratory problems; shortness of breath) and PAIN IN EXTREMITY (Arm was sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L0A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Brulenta. Past adverse reactions to the above products included Cough with Brulenta.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced COUGH (Coughing) and PAIN IN EXTREMITY (Arm was sore). On an unknown date, the patient experienced DYSPNOEA (Respiratory problems; shortness of breath). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (CORICIDIN HBP CHEST CONGESTION & COUGH) for Coughing, at a dose of UNK dosage form and OXYGEN for Shortness of breath, at a dose of UNK dosage form. On 23-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, COUGH (Coughing) and DYSPNOEA (Respiratory problems; shortness of breath) 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.   Concomitant medication was not reported. Right after the vaccination, about 15 minutes later the patient started coughing, then drank some water and kind of stopped; but ever since then she had been coughing periodically and last night (night prior to report) could not sleep or slept a few hours and woke up coughing.  Adding to a previous message, it was reported that it could be a side effect, because she had this kind of reaction before, and it was Brulenta that was given to her, the minute they took them off she stopped coughing. The arm was sore but went away the same day.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site became very red and itchy (4 inches in diameter); Injection site became very red and itchy (4 inches in diameter); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site became very red and itchy (4 inches in diameter)) and VACCINATION SITE ERYTHEMA (Injection site became very red and itchy (4 inches in diameter)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site became very red and itchy (4 inches in diameter)) and VACCINATION SITE ERYTHEMA (Injection site became very red and itchy (4 inches in diameter)). At the time of the report, VACCINATION SITE PRURITUS (Injection site became very red and itchy (4 inches in diameter)) and VACCINATION SITE ERYTHEMA (Injection site became very red and itchy (4 inches in diameter)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Large red round spot at injection site up to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Large red round spot at injection site up to elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Large red round spot at injection site up to elbow). On 27-Jan-2021, VACCINATION SITE ERYTHEMA (Large red round spot at injection site up to elbow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness, like vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness, like vertigo) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 12-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 DIZZINESS (Dizziness, like vertigo). At the time of the report, DIZZINESS (Dizziness, like vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used were Blood pressure medications. Treatment information includes Antibiotic.
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pruritus, Rash, Vaccination site erythema
Clinical narrative: itching on left side of body; rash on top of thigh stomach fingers and back; red circle around the injection site about 2 and a half inches diameter that is warm to the touch; red circle around the injection site about 2 and a half inches diameter that is warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on left side of body), RASH (rash on top of thigh stomach fingers and back), VACCINATION SITE ERYTHEMA (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) and INJECTION SITE WARMTH (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OD9L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (itching on left side of body), RASH (rash on top of thigh stomach fingers and back), VACCINATION SITE ERYTHEMA (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) and INJECTION SITE WARMTH (red circle around the injection site about 2 and a half inches diameter that is warm to the touch). At the time of the report, PRURITUS (itching on left side of body), RASH (rash on top of thigh stomach fingers and back), VACCINATION SITE ERYTHEMA (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) and INJECTION SITE WARMTH (red circle around the injection site about 2 and a half inches diameter that is warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash that is delayed after an injection of Moderna anywhere from 3-7 days after; This spontaneous case was reported by a physician and describes the occurrence of RASH (a rash that is delayed after an injection of Moderna anywhere from 3-7 days after) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 RASH (a rash that is delayed after an injection of Moderna anywhere from 3-7 days after). At the time of the report, RASH (a rash that is delayed after an injection of Moderna anywhere from 3-7 days after) 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.   Physician wanted to know if there is a documentation on delayed reactions and if the patient should get the second dose of the vaccine. Concomitant medications were not provided. Treatment information was not reported.   This case was linked to MOD-2021-023363, MOD-2021-021213 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy huge rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy huge rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OLANZAPINE (ZYPREXA), FLUOXETINE HYDROCHLORIDE (PROZAC), ARIPIPRAZOLE (ABILIFY) and CLONAZEPAM for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC (Itchy huge rash). At the time of the report, RASH PRURITIC (Itchy huge rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for the reported adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: The patient stated that she was feeling fine and only experienced symptoms for couple of days. She did not want to do any further follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Rash
Clinical narrative: rash on the chest area, neck, left arm and face; nauseous; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), RASH (rash on the chest area, neck, left arm and face) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (chills) and NAUSEA (nauseous). On 29-Jan-2021, the patient experienced RASH (rash on the chest area, neck, left arm and face). At the time of the report, CHILLS (chills) and NAUSEA (nauseous) outcome was unknown and RASH (rash on the chest area, neck, left arm and face) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included cetirizine.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash on the arm of injection was given; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash on the arm of injection was given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE RASH (Rash on the arm of injection was given). At the time of the report, INJECTION SITE RASH (Rash on the arm of injection was given) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient stated not interested in follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Mouth swelling, Myalgia, Nausea
Clinical narrative: Swollen tongue; swollen around  the mouth; hot flashes; shaky; nausea; fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), MOUTH SWELLING (swollen around  the mouth), HOT FLUSH (hot flashes), CHILLS (shaky) and NAUSEA (nausea) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue), MOUTH SWELLING (swollen around  the mouth), HOT FLUSH (hot flashes), CHILLS (shaky), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Body aches). At the time of the report, SWOLLEN TONGUE (Swollen tongue) and MOUTH SWELLING (swollen around  the mouth) was resolving, HOT FLUSH (hot flashes) and CHILLS (shaky) outcome was unknown and NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Swollen tongue; swollen around  the mouth; hot flashes; shaky; nausea; fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Swollen tongue), MOUTH SWELLING (swollen around  the mouth), HOT FLUSH (hot flashes), CHILLS (shaky) and NAUSEA (nausea) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SWOLLEN TONGUE (Swollen tongue), MOUTH SWELLING (swollen around  the mouth), HOT FLUSH (hot flashes), CHILLS (shaky), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Body aches). At the time of the report, SWOLLEN TONGUE (Swollen tongue) and MOUTH SWELLING (swollen around  the mouth) was resolving, HOT FLUSH (hot flashes) and CHILLS (shaky) outcome was unknown and NAUSEA (nausea), PYREXIA (fever) and MYALGIA (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Very Sore Arm, could lift over head; Red Blotchy Rash / Little bumps on rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Red Blotchy Rash / Little bumps on rash) and VACCINATION SITE PAIN (Very Sore Arm, could lift over head) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 29-Jan-2021, the patient experienced RASH (Red Blotchy Rash / Little bumps on rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (Very Sore Arm, could lift over head). At the time of the report, RASH (Red Blotchy Rash / Little bumps on rash) and VACCINATION SITE PAIN (Very Sore Arm, could lift over head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 29-Jan-2021, the patient she got a delayed reaction, hot itchy rash. A round rash, little bumps and some bumps on the rash. First day or two, very sore arm, could lift over head. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects that has been bothering for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects that has been bothering for 4 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE EVENT (side effects that has been bothering for 4 days). At the time of the report, ADVERSE EVENT (side effects that has been bothering for 4 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: bad shakes; chest pain; dizziness; Diarrhea; fever; chills; Lots of body pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (bad shakes), CHEST PAIN (chest pain), DIZZINESS (dizziness), DIARRHOEA (Diarrhea) and PYREXIA (fever) in a 77-year-old male 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.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2021, the patient experienced TREMOR (bad shakes), CHEST PAIN (chest pain), DIZZINESS (dizziness), DIARRHOEA (Diarrhea), PYREXIA (fever), CHILLS (chills), PAIN (Lots of body pain) and FATIGUE (tiredness). At the time of the report, TREMOR (bad shakes), CHEST PAIN (chest pain), DIZZINESS (dizziness), DIARRHOEA (Diarrhea), PYREXIA (fever), CHILLS (chills), PAIN (Lots of body pain) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient took unknown medication to treat diarrhea.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Treatment information about event diarrhea updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: bad shakes; chest pain; dizziness; Diarrhea; fever; chills; Lots of body pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (bad shakes), CHEST PAIN (chest pain), DIZZINESS (dizziness), DIARRHOEA (Diarrhea) and PYREXIA (fever) in a 77-year-old male 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.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2021, the patient experienced TREMOR (bad shakes), CHEST PAIN (chest pain), DIZZINESS (dizziness), DIARRHOEA (Diarrhea), PYREXIA (fever), CHILLS (chills), PAIN (Lots of body pain) and FATIGUE (tiredness). At the time of the report, TREMOR (bad shakes), CHEST PAIN (chest pain), DIZZINESS (dizziness), DIARRHOEA (Diarrhea), PYREXIA (fever), CHILLS (chills), PAIN (Lots of body pain) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient took unknown medication to treat diarrhea.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Treatment information about event diarrhea updated.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: severe aching; exhaustion/Fatigue; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe aching), FATIGUE (exhaustion/Fatigue) and FATIGUE (Exhaustion) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (severe aching), FATIGUE (exhaustion/Fatigue) and FATIGUE (Exhaustion). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at a dose of 1 dosage form. On 29-Jan-2021, MYALGIA (severe aching), FATIGUE (exhaustion/Fatigue) and FATIGUE (Exhaustion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.      Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Reporter first name and email address updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain down my leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain down my leg) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Stenosis (Stenosis in the back).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain down my leg). At the time of the report, PAIN IN EXTREMITY (Pain down my leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender'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.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: LARGE WELT ON ARM; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (LARGE WELT ON ARM) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (LARGE WELT ON ARM). At the time of the report, URTICARIA (LARGE WELT ON ARM) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included hydrocortisone cream.
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Fatigue, Hypoaesthesia, Paraesthesia, Sensation of foreign body
Clinical narrative: severe migraines and headaches; feels extremely tired; the right side of her face and head started feeling really numb; Tingling sensation from her cheek to down her neck; When she swallowed she felt like a lump on her throat on the right side; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (the right side of her face and head started feeling really numb), PARAESTHESIA (Tingling sensation from her cheek to down her neck), SENSATION OF FOREIGN BODY (When she swallowed she felt like a lump on her throat on the right side), CLUSTER HEADACHE (severe migraines and headaches) and FATIGUE (feels extremely tired) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOAESTHESIA (the right side of her face and head started feeling really numb), PARAESTHESIA (Tingling sensation from her cheek to down her neck) and SENSATION OF FOREIGN BODY (When she swallowed she felt like a lump on her throat on the right side). On 30-Jan-2021, the patient experienced CLUSTER HEADACHE (severe migraines and headaches) and FATIGUE (feels extremely tired). On 30-Jan-2021, HYPOAESTHESIA (the right side of her face and head started feeling really numb) and SENSATION OF FOREIGN BODY (When she swallowed she felt like a lump on her throat on the right side) had resolved. At the time of the report, PARAESTHESIA (Tingling sensation from her cheek to down her neck), CLUSTER HEADACHE (severe migraines and headaches) and FATIGUE (feels extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: Hot at injection site; Hardness at injection site; Redness at the injection site and darker in the middle/ Arm stayed red; Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site and darker in the middle/ Arm stayed red) and VACCINATION SITE PAIN (Soreness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site and darker in the middle/ Arm stayed red) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site and darker in the middle/ Arm stayed red) and VACCINATION SITE PAIN (Soreness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.   This case was linked to MOD-2021-253115 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow-up information received on 11-JUL-2021 contains non significant information.