chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: lack of appetite; body shaking; I could not go back to sleep; just really debilitating; Fever at 100.5; chills; Pretty bad nausea; Teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating) and PYREXIA (Fever at 100.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 medical history provided.).    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating), PYREXIA (Fever at 100.5), CHILLS (chills), NAUSEA (Pretty bad nausea) and CHILLS (Teeth chattering). At the time of the report, DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating), PYREXIA (Fever at 100.5), CHILLS (chills), NAUSEA (Pretty bad nausea) and CHILLS (Teeth chattering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information included Tylenol all day throughout the day on 23 Feb 2021.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site itchy; Soreness in arm; Redness at injection site; Swelling in injection site; Soreness in arm; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of the third episode of PAIN IN EXTREMITY (Soreness in arm), the second episode of PAIN IN EXTREMITY (Soreness in arm), the first episode of PAIN IN EXTREMITY (Soreness in arm), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling in injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced the first episode of PAIN IN EXTREMITY (Soreness in arm). On 05-Feb-2021, the patient experienced the second episode of PAIN IN EXTREMITY (Soreness in arm). On 06-Feb-2021, the patient experienced the third episode of PAIN IN EXTREMITY (Soreness in arm), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling in injection site). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy). At the time of the report, last episode of PAIN IN EXTREMITY (Soreness in arm), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling in injection site) and VACCINATION SITE PRURITUS (Injection site itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were medicine for cholesterol, vitamin B12 injection once a month for  unknown indication.  Treatment details were not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: low grade fever (99°F); muscle pain on her arm/pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever (99°F)) and INJECTION SITE PAIN (muscle pain on her arm/pain on her arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN for an unknown indication, LOSARTAN.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced INJECTION SITE PAIN (muscle pain on her arm/pain on her arm). On 08-Feb-2021, the patient experienced PYREXIA (low grade fever (99°F)). On 09-Feb-2021, PYREXIA (low grade fever (99°F)) had resolved. At the time of the report, INJECTION SITE PAIN (muscle pain on her arm/pain on her arm) outcome was unknown.            No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Dry skin, Pain
Clinical narrative: arm was red, hot, and swollen down to the elbow; arm was red, hot, and swollen down to the elbow; diarrhea; aches; vomiting; arm was red, hot, and swollen down to the elbow; chills; experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.; had diagnosed COVID19 in Nov 2020 before getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches) and COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (November  2020).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2020, the patient experienced COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine). On 05-Feb-2021, the patient experienced DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (arm was red, hot, and swollen down to the elbow), CHILLS (chills) and PYREXIA (experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches), COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (arm was red, hot, and swollen down to the elbow), CHILLS (chills) and PYREXIA (experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, COVID-19: (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site erythema, Vomiting
Clinical narrative: arm was red, hot, and swollen down to the elbow; arm was red, hot, and swollen down to the elbow; diarrhea; aches; vomiting; arm was red, hot, and swollen down to the elbow; chills; experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.; had diagnosed COVID19 in Nov 2020 before getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches) and COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (November  2020).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2020, the patient experienced COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine). On 05-Feb-2021, the patient experienced DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (arm was red, hot, and swollen down to the elbow), CHILLS (chills) and PYREXIA (experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, DRY SKIN (arm was red, hot, and swollen down to the elbow), PERIPHERAL SWELLING (arm was red, hot, and swollen down to the elbow), DIARRHOEA (diarrhea), PAIN (aches), COVID-19 (had diagnosed COVID19 in Nov 2020 before getting the vaccine), VOMITING (vomiting), VACCINATION SITE ERYTHEMA (arm was red, hot, and swollen down to the elbow), CHILLS (chills) and PYREXIA (experienced fever, vomiting, diarrhea, chills, aches, pains, and she couldn't keep any food down.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2021, COVID-19: (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling
Clinical narrative: a nut at the arm"; vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (a nut at the arm") and VACCINATION SITE SWELLING (vaccination site swelling) 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 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE REACTION (a nut at the arm") and VACCINATION SITE SWELLING (vaccination site swelling). At the time of the report, VACCINATION SITE REACTION (a nut at the arm") and VACCINATION SITE SWELLING (vaccination site swelling) outcome was unknown.            No concomitant medications reported by investigator.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient noticed a rash on her left thigh few hours after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient noticed a rash on her left thigh few hours after the second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Feb-2021, the patient experienced RASH (Patient noticed a rash on her left thigh few hours after the second dose). At the time of the report, RASH (Patient noticed a rash on her left thigh few hours after the second dose) outcome was unknown.             No relevant concomitant medications were reported. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Rash
Clinical narrative: rash on legs/rash on right arm; bumpy rash where the injection; swelling on her arm where the injection; itching on her arm where the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching on her arm where the injection), RASH (rash on legs/rash on right arm), INJECTION SITE RASH (bumpy rash where the injection) and INJECTION SITE SWELLING (swelling on her arm where the injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Drug allergy (Aspirin). Concomitant products included MONTELUKAST and EPINEPHRINE (EPIPEN) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching on her arm where the injection), INJECTION SITE RASH (bumpy rash where the injection) and INJECTION SITE SWELLING (swelling on her arm where the injection). On 26-Feb-2021, the patient experienced RASH (rash on legs/rash on right arm). At the time of the report, INJECTION SITE PRURITUS (itching on her arm where the injection), RASH (rash on legs/rash on right arm), INJECTION SITE RASH (bumpy rash where the injection) and INJECTION SITE SWELLING (swelling on her arm where the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Mild fever; fatigue; Soreness of arm; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever), FATIGUE (fatigue), VACCINATION SITE PAIN (Soreness of arm) and MYALGIA (Muscle ache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Mild fever), FATIGUE (fatigue), VACCINATION SITE PAIN (Soreness of arm) and MYALGIA (Muscle ache). At the time of the report, PYREXIA (Mild fever), FATIGUE (fatigue), VACCINATION SITE PAIN (Soreness of arm) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Advil.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: addt'l info  NNI.  Incorrect gender details in follow-up.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: itchy on injection site; burning/on fire; swollen; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchy on injection site), INJECTION SITE PAIN (burning/on fire), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (injection site red) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy on injection site), INJECTION SITE PAIN (burning/on fire), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, INJECTION SITE PRURITUS (itchy on injection site), INJECTION SITE PAIN (burning/on fire), INJECTION SITE SWELLING (swollen) and INJECTION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information include ice.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain on left shoulder and cannot raise the arm; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Pain on left shoulder and cannot raise the arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ARTHRALGIA (Pain on left shoulder and cannot raise the arm). At the time of the report, ARTHRALGIA (Pain on left shoulder and cannot raise the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product used was not provided by the reporter. Patient reported he doesn't require any further follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: followup received but no new information was updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Mental fatigue, Migraine, Night sweats
Clinical narrative: Felt terrible; Night sweats; No appetite; migraine headache; foggy brain; Couldnt lift arm; Arm pain; Chills; Injection sight redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache) and MENTAL FATIGUE (foggy brain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement (Hip replacement 6 weeks ago).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache), MENTAL FATIGUE (foggy brain), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift arm), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection sight redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache), MENTAL FATIGUE (foggy brain), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift arm), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection sight redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication, Vaccination site erythema, Vaccination site joint movement impairment
Clinical narrative: Felt terrible; Night sweats; No appetite; migraine headache; foggy brain; Couldnt lift arm; Arm pain; Chills; Injection sight redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache) and MENTAL FATIGUE (foggy brain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hip replacement (Hip replacement 6 weeks ago).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache), MENTAL FATIGUE (foggy brain), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift arm), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection sight redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Felt terrible), NIGHT SWEATS (Night sweats), DECREASED APPETITE (No appetite), MIGRAINE (migraine headache), MENTAL FATIGUE (foggy brain), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Couldnt lift arm), PAIN IN EXTREMITY (Arm pain), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection sight redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: trouble breathing; wheezing; headache; muscle aches; fatigue; fever; chills; nausea; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events trouble breathing, wheezing, headache, muscle aches, fatigue, fever, chills, nausea.  The patient's medical history was not provided. Concomitant medications reported were azithromycin, levothyroxine, simvastatin, paroxetine, aderall for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) trouble breathing, wheezing, headache, muscle aches, fatigue, fever, chills, nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), trouble breathing, wheezing, headache, muscle aches, fatigue, fever, chills, nausea was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Wheezing
Clinical narrative: trouble breathing; wheezing; headache; muscle aches; fatigue; fever; chills; nausea; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events trouble breathing, wheezing, headache, muscle aches, fatigue, fever, chills, nausea.  The patient's medical history was not provided. Concomitant medications reported were azithromycin, levothyroxine, simvastatin, paroxetine, aderall for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) trouble breathing, wheezing, headache, muscle aches, fatigue, fever, chills, nausea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), trouble breathing, wheezing, headache, muscle aches, fatigue, fever, chills, nausea was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: left hand turned bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (left hand turned bright red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (left hand turned bright red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (left hand turned bright red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include medicine for her depression and for constipation.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy Sensation - Neat Injection Site), INJECTION SITE RASH (Rash - Neat Injection Site), INJECTION SITE SWELLING (Swollen - Neat Injection Site) and INJECTION SITE ERYTHEMA (Redness - Neat Injection Site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy Sensation - Neat Injection Site), INJECTION SITE RASH (Rash - Neat Injection Site), INJECTION SITE SWELLING (Swollen - Neat Injection Site) and INJECTION SITE ERYTHEMA (Redness - Neat Injection Site). At the time of the report, INJECTION SITE PRURITUS (Itchy Sensation - Neat Injection Site), INJECTION SITE RASH (Rash - Neat Injection Site), INJECTION SITE SWELLING (Swollen - Neat Injection Site) and INJECTION SITE ERYTHEMA (Redness - Neat Injection Site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: big, very itchy rash, sensitive to touch; red blotch ~2.5 inches in diameter; right leg muscles extremely uncomfortable; sore arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm of injection site), VACCINATION SITE RASH (big, very itchy rash, sensitive to touch), VACCINATION SITE ERYTHEMA (red blotch ~2.5 inches in diameter) and MUSCLE DISORDER (right leg muscles extremely uncomfortable) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included OSPEMIFENE (OSPHENA) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm of injection site) and MUSCLE DISORDER (right leg muscles extremely uncomfortable). On 09-Feb-2021, the patient experienced VACCINATION SITE RASH (big, very itchy rash, sensitive to touch) and VACCINATION SITE ERYTHEMA (red blotch ~2.5 inches in diameter). At the time of the report, VACCINATION SITE PAIN (sore arm of injection site), VACCINATION SITE RASH (big, very itchy rash, sensitive to touch), VACCINATION SITE ERYTHEMA (red blotch ~2.5 inches in diameter) and MUSCLE DISORDER (right leg muscles extremely uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs included Topical anti-itch cream, as needed.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some soreness after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness after the first vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS). Concomitant products included GENTIANA LUTEA ROOT, PRIMULA VERIS FLOWER, RUMEX CRISPUS, SAMBUCUS NIGRA FLOWER, VERBENA OFFICINALIS (SINUPRET ACUTE), VALACICLOVIR HYDROCHLORIDE (VALTREX) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (some soreness after the first vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (some soreness after the first vaccination) had resolved.            Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-015668, MOD-2021-015668 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021contains significant information : Address and email were added, first dose start date and second dose details were added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Vomiting; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, vomiting,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010A21A) via unknown route for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) diarrhea, vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), diarrhea, vomiting was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) 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.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 23-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). At the time of the report, CHILLS (Chills) and PYREXIA (fever) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.    This case was linked to MOD-2021-026273 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Cellulitis at the injection site 9 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Cellulitis at the injection site 9 days after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE RASH (Cellulitis at the injection site 9 days after first shot). The patient was treated with DOXYCYCLINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE RASH (Cellulitis at the injection site 9 days after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.; Sender's Comments: Based on determined causality, the event is assessed as unlikely related to mRNA-1273.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Testicular pain
Clinical narrative: Chills; Body aches; Tiredness; Painful gonads (testicular pain); This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness) and TESTICULAR PAIN (Painful gonads (testicular pain)) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness) and TESTICULAR PAIN (Painful gonads (testicular pain)). At the time of the report, CHILLS (Chills), MYALGIA (Body aches), FATIGUE (Tiredness) and TESTICULAR PAIN (Painful gonads (testicular pain)) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.    This case was linked to MOD21-038710 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: reaction in her L arm (injection site); red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction in her L arm (injection site)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Blood pressure high and Heartbeats irregular.    On 12-Feb-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 VACCINATION SITE REACTION (reaction in her L arm (injection site)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE REACTION (reaction in her L arm (injection site)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported were diabetes type 2, high blood pressure, irregular heart bits medications. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: very very bad rash all over her body, like blisters; still getting new blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (still getting new blisters) and RASH (very very bad rash all over her body, like blisters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced BLISTER (still getting new blisters). On an unknown date, the patient experienced RASH (very very bad rash all over her body, like blisters). At the time of the report, BLISTER (still getting new blisters) and RASH (very very bad rash all over her body, like blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Lymphadenopathy, Oxygen saturation, Pyrexia
Clinical narrative: Shortness of breath; Lymph nodes on the right side were swollen; fever about 24 hours afterwards; elevated heart rate in 130s for several hours; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (elevated heart rate in 130s for several hours), DYSPNOEA (Shortness of breath), LYMPHADENOPATHY (Lymph nodes on the right side were swollen) and PYREXIA (fever about 24 hours afterwards) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEART RATE INCREASED (elevated heart rate in 130s for several hours) and PYREXIA (fever about 24 hours afterwards). On 23-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes on the right side were swollen). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). On 05-Feb-2021, PYREXIA (fever about 24 hours afterwards) had resolved. At the time of the report, HEART RATE INCREASED (elevated heart rate in 130s for several hours), DYSPNOEA (Shortness of breath) and LYMPHADENOPATHY (Lymph nodes on the right side were swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: between 92-94 Between 92-94.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  Treatment information includes the patient was prescribed doxycycline but he has not started taking it.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Headache, Influenza, Pain in extremity, Pyrexia
Clinical narrative: I lose my balance when I walk; sore arm; Fever; headache; Sick like flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Sick like flu), BALANCE DISORDER (I lose my balance when I walk), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 INFLUENZA (Sick like flu), PYREXIA (Fever) and HEADACHE (headache). On 29-Jan-2021, the patient experienced BALANCE DISORDER (I lose my balance when I walk) and PAIN IN EXTREMITY (sore arm). At the time of the report, INFLUENZA (Sick like flu), BALANCE DISORDER (I lose my balance when I walk), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Pain in extremity
Clinical narrative: so sick; weak; pain in arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (so sick), ASTHENIA (weak), PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination.     No medication history was reported by the reporter.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and OMEPRAZOLE 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 16-Feb-2021, the patient experienced MALAISE (so sick), ASTHENIA (weak), PAIN IN EXTREMITY (pain in arm) and CHILLS (chills). At the time of the report, MALAISE (so sick), ASTHENIA (weak), PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm soreness up until last night really bad pain; arm so sore extremely tender to the touch; pain; threw up from 11-12; nausea and fever of 100F to 102F; nausea and fever of 100F to 102F; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness up until last night really bad pain), TENDERNESS (arm so sore extremely tender to the touch), PAIN (pain), VOMITING (threw up from 11-12) and NAUSEA (nausea and fever of 100F to 102F) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not reported by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness up until last night really bad pain), TENDERNESS (arm so sore extremely tender to the touch), PAIN (pain), VOMITING (threw up from 11-12), NAUSEA (nausea and fever of 100F to 102F), PYREXIA (nausea and fever of 100F to 102F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness up until last night really bad pain), TENDERNESS (arm so sore extremely tender to the touch), PAIN (pain), VOMITING (threw up from 11-12), NAUSEA (nausea and fever of 100F to 102F), PYREXIA (nausea and fever of 100F to 102F) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vomiting
Clinical narrative: arm soreness up until last night really bad pain; arm so sore extremely tender to the touch; pain; threw up from 11-12; nausea and fever of 100F to 102F; nausea and fever of 100F to 102F; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness up until last night really bad pain), TENDERNESS (arm so sore extremely tender to the touch), PAIN (pain), VOMITING (threw up from 11-12) and NAUSEA (nausea and fever of 100F to 102F) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was not reported by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness up until last night really bad pain), TENDERNESS (arm so sore extremely tender to the touch), PAIN (pain), VOMITING (threw up from 11-12), NAUSEA (nausea and fever of 100F to 102F), PYREXIA (nausea and fever of 100F to 102F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness up until last night really bad pain), TENDERNESS (arm so sore extremely tender to the touch), PAIN (pain), VOMITING (threw up from 11-12), NAUSEA (nausea and fever of 100F to 102F), PYREXIA (nausea and fever of 100F to 102F) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: arm discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm discomfort) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included RANITIDINE for an unknown indication.    On 29-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 LIMB DISCOMFORT (arm discomfort). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, LIMB DISCOMFORT (arm discomfort) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-018648 (E2B Linked Report).; Sender's Comments:  MOD-2021-018648:same reporter, different patient and event