chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vaccination site pain
Clinical narrative: Migraine Headache; Sore Arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm at injection site) and MIGRAINE (Migraine Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm at injection site). On 16-Apr-2021, the patient experienced MIGRAINE (Migraine Headache). At the time of the report, VACCINATION SITE PAIN (Sore Arm at injection site) and MIGRAINE (Migraine Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: arm is very sore and tender; Headache; whole body just aches; chills; feel like I have to vomit but I can't; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is very sore and tender), HEADACHE (Headache), MYALGIA (whole body just aches), CHILLS (chills) and NAUSEA (feel like I have to vomit but I can't) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is very sore and tender), HEADACHE (Headache), MYALGIA (whole body just aches), CHILLS (chills) and NAUSEA (feel like I have to vomit but I can't). At the time of the report, PAIN IN EXTREMITY (arm is very sore and tender), HEADACHE (Headache), MYALGIA (whole body just aches), CHILLS (chills) and NAUSEA (feel like I have to vomit but I can't) had resolved.            Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-079210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The outcomes of the events were updated. The reporter declined further follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nausea, Vaccination site erythema, Vaccination site induration
Clinical narrative: cough; intermittent nausea; Injection site;pain,rash,itching,redness,swollen; Injection site;pain,rash,itching,redness,swollen; Injection site;pain,rash,itching,redness,swollen; general headache; Injection site;pain,rash,itching,redness,swollen; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NAUSEA (intermittent nausea), VACCINATION SITE SWELLING (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE ERYTHEMA (Injection site;pain,rash,itching,redness,swollen) and VACCINATION SITE RASH (Injection site;pain,rash,itching,redness,swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COUGH (cough), NAUSEA (intermittent nausea), VACCINATION SITE SWELLING (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE ERYTHEMA (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE RASH (Injection site;pain,rash,itching,redness,swollen), HEADACHE (general headache) and VACCINATION SITE INDURATION (Injection site;pain,rash,itching,redness,swollen). At the time of the report, COUGH (cough), NAUSEA (intermittent nausea), VACCINATION SITE SWELLING (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE ERYTHEMA (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE RASH (Injection site;pain,rash,itching,redness,swollen), HEADACHE (general headache) and VACCINATION SITE INDURATION (Injection site;pain,rash,itching,redness,swollen) 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 medication was reported. Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: cough; intermittent nausea; Injection site;pain,rash,itching,redness,swollen; Injection site;pain,rash,itching,redness,swollen; Injection site;pain,rash,itching,redness,swollen; general headache; Injection site;pain,rash,itching,redness,swollen; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NAUSEA (intermittent nausea), VACCINATION SITE SWELLING (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE ERYTHEMA (Injection site;pain,rash,itching,redness,swollen) and VACCINATION SITE RASH (Injection site;pain,rash,itching,redness,swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COUGH (cough), NAUSEA (intermittent nausea), VACCINATION SITE SWELLING (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE ERYTHEMA (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE RASH (Injection site;pain,rash,itching,redness,swollen), HEADACHE (general headache) and VACCINATION SITE INDURATION (Injection site;pain,rash,itching,redness,swollen). At the time of the report, COUGH (cough), NAUSEA (intermittent nausea), VACCINATION SITE SWELLING (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE ERYTHEMA (Injection site;pain,rash,itching,redness,swollen), VACCINATION SITE RASH (Injection site;pain,rash,itching,redness,swollen), HEADACHE (general headache) and VACCINATION SITE INDURATION (Injection site;pain,rash,itching,redness,swollen) 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 medication was reported. Treatment information not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: very dizzy; vertigo feeling/things were moving in circles in her room; very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very dizzy), VERTIGO (vertigo feeling/things were moving in circles in her room) and FATIGUE (very tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (very dizzy), VERTIGO (vertigo feeling/things were moving in circles in her room) and FATIGUE (very tired). At the time of the report, DIZZINESS (very dizzy) had resolved and VERTIGO (vertigo feeling/things were moving in circles in her room) and FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment information not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: numbness on my arms and legs; All of the sudden i started having cramps on my arms and legs; tingling, that it is not continuous, it comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my arms and legs), MUSCLE SPASMS (All of the sudden i started having cramps on my arms and legs) and PARAESTHESIA (tingling, that it is not continuous, it comes and goes) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037D214) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HYPOAESTHESIA (numbness on my arms and legs), MUSCLE SPASMS (All of the sudden i started having cramps on my arms and legs) and PARAESTHESIA (tingling, that it is not continuous, it comes and goes). At the time of the report, HYPOAESTHESIA (numbness on my arms and legs), MUSCLE SPASMS (All of the sudden i started having cramps on my arms and legs) and PARAESTHESIA (tingling, that it is not continuous, it comes and goes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. -Treatment information not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: little level one pain at the left arm; Swelling at the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little level one pain at the left arm) and VACCINATION SITE SWELLING (Swelling at the left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (little level one pain at the left arm) and VACCINATION SITE SWELLING (Swelling at the left arm). On 03-Apr-2021, VACCINATION SITE PAIN (little level one pain at the left arm) and VACCINATION SITE SWELLING (Swelling at the left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment information not provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: body aches; chills; fever at night; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills), PYREXIA (fever at night) and HEADACHE (headache) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020BZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (body aches), CHILLS (chills), PYREXIA (fever at night) and HEADACHE (headache). The patient was treated with KETOCONAZOLE (ALVIN I) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches), CHILLS (chills), PYREXIA (fever at night) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nodule, Peripheral swelling, Pruritus
Clinical narrative: 4 big knots on the opposite arm of injection; arm swelled up; itching on one finger; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (4 big knots on the opposite arm of injection), PERIPHERAL SWELLING (arm swelled up) and PRURITUS (itching on one finger) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced NODULE (4 big knots on the opposite arm of injection), PERIPHERAL SWELLING (arm swelled up) and PRURITUS (itching on one finger). At the time of the report, NODULE (4 big knots on the opposite arm of injection), PERIPHERAL SWELLING (arm swelled up) and PRURITUS (itching on one finger) outcome was unknown. Not Provided          No concomitant medication was reported. Treatment information not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-079258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079258:2ND DOSE
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: more arm soreness initially for first dose than second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (more arm soreness initially for first dose than second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (more arm soreness initially for first dose than second dose). At the time of the report, VACCINATION SITE PAIN (more arm soreness initially for first dose than second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-079240 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079240:2nd dose vaccine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Mobility decreased, Myalgia, Pain, Pyrexia
Clinical narrative: Pain radiates from lower back to pelvis and buttocks; Hot and cold sensation in right arm; Hard to sit down; Lower back aches; Needle is pricking me; Whole body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches) and PAIN (Needle is pricking me) in a 41-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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches), PAIN (Needle is pricking me), MYALGIA (Whole body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches), PAIN (Needle is pricking me), MYALGIA (Whole body aches) and PYREXIA (Fever) 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 medications include Multivitamin Gummi. Treatment details include herbal tea.   This case was linked to MOD-2021-079137 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Reversed hot-cold sensation
Clinical narrative: Pain radiates from lower back to pelvis and buttocks; Hot and cold sensation in right arm; Hard to sit down; Lower back aches; Needle is pricking me; Whole body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches) and PAIN (Needle is pricking me) in a 41-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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches), PAIN (Needle is pricking me), MYALGIA (Whole body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Pain radiates from lower back to pelvis and buttocks), REVERSED HOT-COLD SENSATION (Hot and cold sensation in right arm), MOBILITY DECREASED (Hard to sit down), BACK PAIN (Lower back aches), PAIN (Needle is pricking me), MYALGIA (Whole body aches) and PYREXIA (Fever) 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 medications include Multivitamin Gummi. Treatment details include herbal tea.   This case was linked to MOD-2021-079137 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients). At the time of the report, ACCIDENTAL OVERDOSE (nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medicines was not reported by reporter   treatment information was not provided
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: Arm having pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm having pain) and FATIGUE (Fatigue) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm having pain) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Arm having pain) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test positive: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 years old was vaccinated with Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old was vaccinated with Moderna vaccine) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old was vaccinated with Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 years old was vaccinated with Moderna vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  Treatment medication was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain, Vaccination site rash
Clinical narrative: Arm is hurting; "Itches like crazy"; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is hurting), PRURITUS ("Itches like crazy") and VACCINATION SITE RASH (rash at injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm is hurting), PRURITUS ("Itches like crazy") and VACCINATION SITE RASH (rash at injection site). At the time of the report, VACCINATION SITE PAIN (Arm is hurting), PRURITUS ("Itches like crazy") and VACCINATION SITE RASH (rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Minor soreness in arm; fever; chills; Minor muscle ache; Minor fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills), MYALGIA (Minor muscle ache) and FATIGUE (Minor fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills), MYALGIA (Minor muscle ache) and FATIGUE (Minor fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form once. On 15-Apr-2021, PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (Minor fatigue) had resolved. At the time of the report, MYALGIA (Minor muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 100.4 (High) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information included additional event. On 11-Jun-2021: Follow-up information included Concomitant drug and Medical history.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Minor soreness in arm; fever; chills; Minor muscle ache; Minor fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills), MYALGIA (Minor muscle ache) and FATIGUE (Minor fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills), MYALGIA (Minor muscle ache) and FATIGUE (Minor fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form once. On 15-Apr-2021, PAIN IN EXTREMITY (Minor soreness in arm), PYREXIA (fever), CHILLS (chills) and FATIGUE (Minor fatigue) had resolved. At the time of the report, MYALGIA (Minor muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: 100.4 (High) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information included additional event. On 11-Jun-2021: Follow-up information included Concomitant drug and Medical history.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: arm pain; arm hurt immediately/; vaccine injection was pounded and  thrushed in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (arm hurt immediately/) and VACCINATION SITE PAIN (vaccine injection was pounded and  thrushed in arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 007B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (arm hurt immediately/) and VACCINATION SITE PAIN (vaccine injection was pounded and  thrushed in arm). At the time of the report, PAIN IN EXTREMITY (arm pain), VACCINATION SITE PAIN (arm hurt immediately/) and VACCINATION SITE PAIN (vaccine injection was pounded and  thrushed in arm) outcome was unknown.            No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-079228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079228:1st dose vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Ear pain, Migraine, Nausea
Clinical narrative: sinus headache; bad reaction; migraine; earache; sluggish; couldn't stand up; vomiting; nausea; intense fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache) and SLUGGISHNESS (sluggish) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 14-Apr-2021, the patient experienced SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache), SLUGGISHNESS (sluggish), ASTHENIA (couldn't stand up), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (intense fever). At the time of the report, SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache), SLUGGISHNESS (sluggish), ASTHENIA (couldn't stand up), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (intense fever) outcome was unknown. Not Provided          Concomitant products included cholesterol meds. Patient informed that she had not taken concomitant products these days (at the time of report).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinus headache, Sluggishness, Vomiting
Clinical narrative: sinus headache; bad reaction; migraine; earache; sluggish; couldn't stand up; vomiting; nausea; intense fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache) and SLUGGISHNESS (sluggish) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 14-Apr-2021, the patient experienced SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache), SLUGGISHNESS (sluggish), ASTHENIA (couldn't stand up), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (intense fever). At the time of the report, SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache), SLUGGISHNESS (sluggish), ASTHENIA (couldn't stand up), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (intense fever) outcome was unknown. Not Provided          Concomitant products included cholesterol meds. Patient informed that she had not taken concomitant products these days (at the time of report).
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue
Clinical narrative: symptoms of COVID-19; Fatigue; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COVID-19 (symptoms of COVID-19) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and FATIGUE (Fatigue). On 29-Mar-2021, the patient experienced COVID-19 (symptoms of COVID-19). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COVID-19 (symptoms of COVID-19) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Headache; Vomitting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VOMITING (Vomitting) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and VOMITING (Vomitting). At the time of the report, HEADACHE (Headache) and VOMITING (Vomitting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Hot flush
Clinical narrative: headache aggravated; hot flashes aggravated; random pain throughout her body aggravated; blurring of vision aggravated; joint pain aggravated; fatigue aggravated; brain fog aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), FEELING ABNORMAL (brain fog aggravated), HEADACHE (headache aggravated) and HOT FLUSH (hot flashes aggravated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Metastatic breast cancer. Concomitant products included LETROZOLE.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (brain fog aggravated). On 20-Feb-2021, the patient experienced ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), HEADACHE (headache aggravated), HOT FLUSH (hot flashes aggravated), PAIN (random pain throughout her body aggravated) and VISION BLURRED (blurring of vision aggravated). At the time of the report, ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), FEELING ABNORMAL (brain fog aggravated), HEADACHE (headache aggravated), HOT FLUSH (hot flashes aggravated), PAIN (random pain throughout her body aggravated) and VISION BLURRED (blurring of vision aggravated) outcome was unknown.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vision blurred
Clinical narrative: headache aggravated; hot flashes aggravated; random pain throughout her body aggravated; blurring of vision aggravated; joint pain aggravated; fatigue aggravated; brain fog aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), FEELING ABNORMAL (brain fog aggravated), HEADACHE (headache aggravated) and HOT FLUSH (hot flashes aggravated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Metastatic breast cancer. Concomitant products included LETROZOLE.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (brain fog aggravated). On 20-Feb-2021, the patient experienced ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), HEADACHE (headache aggravated), HOT FLUSH (hot flashes aggravated), PAIN (random pain throughout her body aggravated) and VISION BLURRED (blurring of vision aggravated). At the time of the report, ARTHRALGIA (joint pain aggravated), FATIGUE (fatigue aggravated), FEELING ABNORMAL (brain fog aggravated), HEADACHE (headache aggravated), HOT FLUSH (hot flashes aggravated), PAIN (random pain throughout her body aggravated) and VISION BLURRED (blurring of vision aggravated) outcome was unknown.            Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Headache, Influenza
Clinical narrative: Muscle aches; Chills; Nausea; Headache; Soreness at the injetion site; Feels likke the flu; Coughing; Fever of 100.8°F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Feels likke the flu), COUGH (Coughing), PYREXIA (Fever of 100.8°F), MYALGIA (Muscle aches) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stones.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (Fever of 100.8°F). On 15-Apr-2021, the patient experienced INFLUENZA (Feels likke the flu), COUGH (Coughing), MYALGIA (Muscle aches), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injetion site). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency. At the time of the report, INFLUENZA (Feels likke the flu), COUGH (Coughing), PYREXIA (Fever of 100.8°F), MYALGIA (Muscle aches), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injetion site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 100.8°f (High) 100.8°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Muscle aches; Chills; Nausea; Headache; Soreness at the injetion site; Feels likke the flu; Coughing; Fever of 100.8°F; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Feels likke the flu), COUGH (Coughing), PYREXIA (Fever of 100.8°F), MYALGIA (Muscle aches) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Kidney stones.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (Fever of 100.8°F). On 15-Apr-2021, the patient experienced INFLUENZA (Feels likke the flu), COUGH (Coughing), MYALGIA (Muscle aches), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injetion site). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency. At the time of the report, INFLUENZA (Feels likke the flu), COUGH (Coughing), PYREXIA (Fever of 100.8°F), MYALGIA (Muscle aches), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injetion site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 100.8°f (High) 100.8°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Vaccination site bruising, Vaccination site pain
Clinical narrative: felt "like pulled the muscle" on right arm; "bruise but no color change" in injection site; tenderness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (felt "like pulled the muscle" on right arm), VACCINATION SITE BRUISING ("bruise but no color change" in injection site) and VACCINATION SITE PAIN (tenderness in injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 211B21A and 036A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Apr-2021, the patient experienced MUSCLE STRAIN (felt "like pulled the muscle" on right arm), VACCINATION SITE BRUISING ("bruise but no color change" in injection site) and VACCINATION SITE PAIN (tenderness in injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCLE STRAIN (felt "like pulled the muscle" on right arm), VACCINATION SITE BRUISING ("bruise but no color change" in injection site) and VACCINATION SITE PAIN (tenderness in injection site) outcome was unknown.            This case was linked to MOD-2021-079274 (E2B Linked Report).; Sender's Comments:  MOD-2021-079274:Husband's case
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Pyrexia, Vaccination site pain
Clinical narrative: nose blood that wont stop; fever; pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (nose blood that wont stop), PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Back pain (the patient stopped taking aspirin 1 year ago, when HCP changed patient to Mobic for back pain.). Previously administered products included for Product used for unknown indication: Aspirin (Aspirin). Concomitant products included MELOXICAM (MOBIC) for Back pain.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site). On 15-Apr-2021, the patient experienced EPISTAXIS (nose blood that wont stop). The patient was treated with OXYMETAZOLINE (AFRIN [OXYMETAZOLINE]) (nasal) on 16-Apr-2021 for Bleeding, at an unspecified dose and frequency. On 15-Apr-2021, PYREXIA (fever) and VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, EPISTAXIS (nose blood that wont stop) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that consulted ER at 2am-4am 16APRIL2021 Treatment Afrin spray up nose which stopped bleeding. Following discharge, at 7 am bleeding restarted.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Vaccination site pain
Clinical narrative: sore arm for 10 hours top; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 10 hours top) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 10 hours top). At the time of the report, PAIN IN EXTREMITY (sore arm for 10 hours top) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Heart rate increased: high heart beats per minute (High) rapid heartbeat for 10 hours.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-079259 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose received after 18 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Apr-2021 and was forwarded to Moderna on 16-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 18 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 18 days). On 15-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received after 18 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.