chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Muscle spasms, Myalgia, Pain
Clinical narrative: pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet; left leg is heavy when she walks; muscle spasms; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet), LIMB DISCOMFORT (left leg is heavy when she walks), MUSCLE SPASMS (muscle spasms), MYALGIA (muscle aches) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 15-Mar-2021, the patient experienced PAIN (pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet), LIMB DISCOMFORT (left leg is heavy when she walks) and MUSCLE SPASMS (muscle spasms). 15-Mar-2021, the patient experienced MYALGIA (muscle aches). On 14-Mar-2021, CHILLS (chills) had resolved. At the time of the report, PAIN (pain on the left side of body from head to feet, her head, neck, left arm, left leg, and feet), LIMB DISCOMFORT (left leg is heavy when she walks), MUSCLE SPASMS (muscle spasms) and MYALGIA (muscle aches) outcome was unknown.            No relevant concomitant medications were provided. Patient took a muscle cramp pill for her pain. The action taken for mRNA-1273 was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: injected air; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (injected air) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (injected air). On 16-Mar-2021, DEVICE CONNECTION ISSUE (injected air) had resolved. 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Lip dry, Oral discomfort, Vaccination site pain
Clinical narrative: face felt hot; burning lips; lips dry; achiness; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (face felt hot), ORAL DISCOMFORT (burning lips), LIP DRY (lips dry) and VACCINATION SITE PAIN (achiness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced HOT FLUSH (face felt hot), ORAL DISCOMFORT (burning lips), LIP DRY (lips dry) and VACCINATION SITE PAIN (achiness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Ache, at an unspecified dose and frequency. At the time of the report, HOT FLUSH (face felt hot), ORAL DISCOMFORT (burning lips), LIP DRY (lips dry) and VACCINATION SITE PAIN (achiness) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Contusion, Neck pain, Nodule
Clinical narrative: arm is bruised; arm swollen; neck pain; back pain; a little knot; shoulder pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain) and NODULE (a little knot) in a 75-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.     No medical history information was provided by the reporter.  Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), ATORVASTATIN for Cholesterol.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain), NODULE (a little knot) and ARTHRALGIA (shoulder pain). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 14-Mar-2021, CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain) and NODULE (a little knot) had resolved and ARTHRALGIA (shoulder pain) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the drug was not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm is bruised; arm swollen; neck pain; back pain; a little knot; shoulder pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain) and NODULE (a little knot) in a 75-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.     No medical history information was provided by the reporter.  Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), ATORVASTATIN for Cholesterol.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain), NODULE (a little knot) and ARTHRALGIA (shoulder pain). The patient was treated with IBUPROFEN at a dose of 1 dosage form. On 14-Mar-2021, CONTUSION (arm is bruised), PERIPHERAL SWELLING (arm swollen), NECK PAIN (neck pain), BACK PAIN (back pain) and NODULE (a little knot) had resolved and ARTHRALGIA (shoulder pain) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the drug was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Mobility decreased, Myalgia
Clinical narrative: Muscle pain; Mobility decreased; chills; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), MOBILITY DECREASED (Mobility decreased), CHILLS ( chills) and DIARRHOEA (Diarrhea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced MYALGIA (Muscle pain), MOBILITY DECREASED (Mobility decreased) and CHILLS ( chills). At the time of the report, MYALGIA (Muscle pain), MOBILITY DECREASED (Mobility decreased) and CHILLS ( chills) had resolved and DIARRHOEA (Diarrhea) outcome was unknown. Not Provided          No treatment information was provided. This case was linked to MOD-2021-046493 (E2B Linked Report). Reporter did not allow further contact no concomitant drugs included   This case was linked to MOD-2021-046493 (E2B Linked Report).; Sender's Comments:  MOD-2021-046493:Cross linked case for first dose
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; fever; fatigue; chillls; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chillls) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SIMVASTATIN, LEVOTHYROXINE SODIUM (LEVOTHYROXIN), GLUCOSAMINE, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) and ZINC for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chillls). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chillls) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) fever of 102 degrees.         The action taken for mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: Follow up information was received and contains no new information. On 28-May-2021: Follow up information was received and  patient demographics, concomitant medications, treatment  medications , new event were updated.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received a third dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of extra dose administered for mRNA-1273 with no associated AEs.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Erythema, Fatigue, Headache
Clinical narrative: itching; egg shape swelling; cough; headache; fatigue; chills; redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching), SWELLING (egg shape swelling), COUGH (cough) and HEADACHE (headache) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (redness). On 14-Mar-2021, the patient experienced PRURITUS (itching). 14-Mar-2021, the patient experienced SWELLING (egg shape swelling), COUGH (cough), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). On 14-Mar-2021, FATIGUE (fatigue) and CHILLS (chills) had resolved. On 16-Mar-2021, SWELLING (egg shape swelling), COUGH (cough) and HEADACHE (headache) had resolved. At the time of the report, ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown. Not Provided          No relevant concomitant medications were provided. Patient had consulted healthcare professional on 12 Mar 2021 but no treatment was prescribed. The action taken for mRNA-1273 was not applicable.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: itching; egg shape swelling; cough; headache; fatigue; chills; redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PRURITUS (itching), SWELLING (egg shape swelling), COUGH (cough) and HEADACHE (headache) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (redness). On 14-Mar-2021, the patient experienced PRURITUS (itching). 14-Mar-2021, the patient experienced SWELLING (egg shape swelling), COUGH (cough), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). On 14-Mar-2021, FATIGUE (fatigue) and CHILLS (chills) had resolved. On 16-Mar-2021, SWELLING (egg shape swelling), COUGH (cough) and HEADACHE (headache) had resolved. At the time of the report, ERYTHEMA (redness) and PRURITUS (itching) outcome was unknown. Not Provided          No relevant concomitant medications were provided. Patient had consulted healthcare professional on 12 Mar 2021 but no treatment was prescribed. The action taken for mRNA-1273 was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Influenza like illness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING and NASOPHARYNGITIS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING, NASOPHARYNGITIS and FATIGUE. At the time of the report, OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING, NASOPHARYNGITIS and FATIGUE outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Before getting the vaccine tested twice for COVID-19- negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Sneezing
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING and NASOPHARYNGITIS in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING, NASOPHARYNGITIS and FATIGUE. At the time of the report, OROPHARYNGEAL PAIN, INFLUENZA LIKE ILLNESS, DYSPHONIA, SNEEZING, NASOPHARYNGITIS and FATIGUE outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Before getting the vaccine tested twice for COVID-19- negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia
Clinical narrative: electrical shock going through her left arm/tingling in her left arm; opening and closing her left hand hurts; the joints in her left hand hurt; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (electrical shock going through her left arm/tingling in her left arm), PAIN IN EXTREMITY (opening and closing her left hand hurts) and ARTHRALGIA (the joints in her left hand hurt) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0100A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.)    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PARAESTHESIA (electrical shock going through her left arm/tingling in her left arm), PAIN IN EXTREMITY (opening and closing her left hand hurts) and ARTHRALGIA (the joints in her left hand hurt). At the time of the report, PARAESTHESIA (electrical shock going through her left arm/tingling in her left arm), PAIN IN EXTREMITY (opening and closing her left hand hurts) and ARTHRALGIA (the joints in her left hand hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination error
Clinical narrative: Received a shingles vaccine "shortly" after the Moderna vaccine; Appointment for second dose is not within 30 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (Received a shingles vaccine "shortly" after the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment for second dose is not within 30 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION ERROR (Received a shingles vaccine "shortly" after the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment for second dose is not within 30 days). At the time of the report, VACCINATION ERROR (Received a shingles vaccine "shortly" after the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment for second dose is not within 30 days) had resolved.            Concomitant medications were not provided. Treatment information was not reported.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Possible NNI
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lethargy, Pain, Pain in extremity
Clinical narrative: urinating a lot and noticed that the urine was cloudy; in bed for 2 days straight; low-grade fever; chills; typical flu-like symptoms; body aches; Pain at injection site; arm hurt so bad she couldn't lay on it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it), INFLUENZA LIKE ILLNESS (typical flu-like symptoms), PAIN (body aches), URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy) and LETHARGY (in bed for 2 days straight) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 11-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021 at 2:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (typical flu-like symptoms), PAIN (body aches), PYREXIA (low-grade fever) and CHILLS (chills). On 14-Mar-2021, the patient experienced URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy). 14-Mar-2021, the patient experienced LETHARGY (in bed for 2 days straight). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 12-Mar-2021, PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it) had resolved. On 14-Mar-2021, INFLUENZA LIKE ILLNESS (typical flu-like symptoms) had resolved. On 15-Mar-2021, PAIN (body aches), PYREXIA (low-grade fever), CHILLS (chills) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy) had not resolved and LETHARGY (in bed for 2 days straight) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient would be seeing her health care professional to rule out urinary tract infection.   This case was linked to MOD-2021-111119 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added concomitant drugs, treatment drug and one event. Updated the outcomes of events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine abnormality, Vaccination site pain
Clinical narrative: urinating a lot and noticed that the urine was cloudy; in bed for 2 days straight; low-grade fever; chills; typical flu-like symptoms; body aches; Pain at injection site; arm hurt so bad she couldn't lay on it; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it), INFLUENZA LIKE ILLNESS (typical flu-like symptoms), PAIN (body aches), URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy) and LETHARGY (in bed for 2 days straight) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 11-Mar-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it). On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 12-Mar-2021 at 2:00 AM, the patient experienced INFLUENZA LIKE ILLNESS (typical flu-like symptoms), PAIN (body aches), PYREXIA (low-grade fever) and CHILLS (chills). On 14-Mar-2021, the patient experienced URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy). 14-Mar-2021, the patient experienced LETHARGY (in bed for 2 days straight). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 12-Mar-2021, PAIN IN EXTREMITY (arm hurt so bad she couldn't lay on it) had resolved. On 14-Mar-2021, INFLUENZA LIKE ILLNESS (typical flu-like symptoms) had resolved. On 15-Mar-2021, PAIN (body aches), PYREXIA (low-grade fever), CHILLS (chills) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, URINE ABNORMALITY (urinating a lot and noticed that the urine was cloudy) had not resolved and LETHARGY (in bed for 2 days straight) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient would be seeing her health care professional to rule out urinary tract infection.   This case was linked to MOD-2021-111119 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Added concomitant drugs, treatment drug and one event. Updated the outcomes of events.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Extra dose administered, Incorrect dose administered, Medication error
Clinical narrative: a second full dose 3 days after the improper unsuccessful dos; didn't get his 2nd dose properly; needle popped out, and not sure if any medical product went in; did not get his 2nd dose properly; This spontaneous case was reported by a patient and describes the occurrence of MEDICATION ERROR ( didn't get his 2nd dose properly) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MEDICATION ERROR ( didn't get his 2nd dose properly). At the time of the report, MEDICATION ERROR ( didn't get his 2nd dose properly) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 031A21A  with no associated AEs
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 immunization. No medical history reported. On Mar 16, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced dizziness (dizzy). At the time of the report, dizziness (dizzy) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine); intramuscular: unknown. Concomitant medication and treatment medication not reported.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Few drops came out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Few drops came out) 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 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced UNDERDOSE (Few drops came out). On 16-Mar-2021, UNDERDOSE (Few drops came out) had resolved. 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.   Concomitant medications were not provided by the reporter.  Treatment medications were not provided by reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: sore arm; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore arm) and CHILLS (chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010NZ0A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Lungs are compromised).    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (sore arm) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue, Supraventricular tachycardia, Vaccination site bruising, Vaccination site rash
Clinical narrative: Due to these reactions, the patient has opted not to get their second dose of the vaccine; three bouts of SVTs (rapid heart beats); delayed injection site bruising that looked like a bull's eye around the injection site; asymmetrical rash from the injection site to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (delayed injection site bruising that looked like a bull's eye around the injection site), VACCINATION SITE RASH (asymmetrical rash from the injection site to the elbow), SUPRAVENTRICULAR TACHYCARDIA (three bouts of SVTs (rapid heart beats)) and INTENTIONAL PRODUCT USE ISSUE (Due to these reactions, the patient has opted not to get their second dose of the vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE BRUISING (delayed injection site bruising that looked like a bull's eye around the injection site) and VACCINATION SITE RASH (asymmetrical rash from the injection site to the elbow). On 22-Feb-2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (three bouts of SVTs (rapid heart beats)). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Due to these reactions, the patient has opted not to get their second dose of the vaccine). At the time of the report, VACCINATION SITE BRUISING (delayed injection site bruising that looked like a bull's eye around the injection site), VACCINATION SITE RASH (asymmetrical rash from the injection site to the elbow), SUPRAVENTRICULAR TACHYCARDIA (three bouts of SVTs (rapid heart beats)) and INTENTIONAL PRODUCT USE ISSUE (Due to these reactions, the patient has opted not to get their second dose of the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment information were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up included updated address information for the reporter/patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: waist they feel a pain that is horrible and comes and goes; itched a bit; got swollen; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (waist they feel a pain that is horrible and comes and goes), VACCINATION SITE PRURITUS (itched a bit) and VACCINATION SITE SWELLING (got swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01-A214) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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. In April 2021, the patient experienced PAIN (waist they feel a pain that is horrible and comes and goes), VACCINATION SITE PRURITUS (itched a bit) and VACCINATION SITE SWELLING (got swollen). At the time of the report, PAIN (waist they feel a pain that is horrible and comes and goes), VACCINATION SITE PRURITUS (itched a bit) and VACCINATION SITE SWELLING (got swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states he does not take any concomitant medication. Treatment medication not reported
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pyrexia
Clinical narrative: pain in the arm, and that it was hot with fever, after the first dose of the vaccine.; pain in the arm, and that it was hot with fever, after the first dose of the vaccine.; pain in the arm, and that it was hot with fever, after the first dose of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.), FEELING HOT (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.) and PYREXIA (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.), FEELING HOT (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.) and PYREXIA (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.). At the time of the report, PAIN IN EXTREMITY (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.), FEELING HOT (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.) and PYREXIA (pain in the arm, and that it was hot with fever, after the first dose of the vaccine.) outcome was unknown.            Concomitant product use was unknown by the reporter. No Treatment information was provided for the event. Action taken with mRNA-123 was not applicable.   This case was linked to MOD-2021-028157 (Patient Link).   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site bruising, Vaccination site erythema
Clinical narrative: slight bruise at the injection site; slightly swollen; red; warm to touch; Low grade fever; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), FATIGUE (fatigue), MYALGIA (body aches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE ERYTHEMA (red) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PYREXIA (Low grade fever), FATIGUE (fatigue) and MYALGIA (body aches). On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (slightly swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (warm to touch). On 16-Mar-2021, the patient experienced VACCINATION SITE BRUISING (slight bruise at the injection site). At the time of the report, PYREXIA (Low grade fever), FATIGUE (fatigue), MYALGIA (body aches), VACCINATION SITE SWELLING (slightly swollen), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE BRUISING (slight bruise at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. Treatment medications were not provided by reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: slight bruise at the injection site; slightly swollen; red; warm to touch; Low grade fever; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), FATIGUE (fatigue), MYALGIA (body aches), VACCINATION SITE SWELLING (slightly swollen) and VACCINATION SITE ERYTHEMA (red) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PYREXIA (Low grade fever), FATIGUE (fatigue) and MYALGIA (body aches). On 14-Mar-2021, the patient experienced VACCINATION SITE SWELLING (slightly swollen), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (warm to touch). On 16-Mar-2021, the patient experienced VACCINATION SITE BRUISING (slight bruise at the injection site). At the time of the report, PYREXIA (Low grade fever), FATIGUE (fatigue), MYALGIA (body aches), VACCINATION SITE SWELLING (slightly swollen), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE BRUISING (slight bruise at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. Treatment medications were not provided by reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It has been more than 2 months after receiving the first dose and she has not received the second; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been more than 2 months after receiving the first dose and she has not received the second) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PRODUCT DOSE OMISSION ISSUE (It has been more than 2 months after receiving the first dose and she has not received the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been more than 2 months after receiving the first dose and she has not received the second) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.  Treatment medications were not provided by reporter.; Sender's Comments: This report refers to a case of  Product dose omission issue for mRNA-1273,  with no associated AEs.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Diarrhoea, Musculoskeletal stiffness, Myalgia
Clinical narrative: Legs hurt; Legs swollen; Muscles started hurting; Joints started hurting; Skin tightness; Dry cough; Stiff up to neck; Diarrhea; Injected arm sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff up to neck), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Legs hurt), PERIPHERAL SWELLING (Legs swollen) and MYALGIA (Muscles started hurting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetes, Hyperlipidemia and Allergy (Nickel causes swelling). Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, METFORMIN for Diabetes, ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, HCTZ, TELMISARTAN (MICARDIS) and AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff up to neck), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injected arm sore). On 15-Mar-2021, the patient experienced MYALGIA (Muscles started hurting), ARTHRALGIA (Joints started hurting), SKIN TIGHTNESS (Skin tightness) and COUGH (Dry cough). On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt) and PERIPHERAL SWELLING (Legs swollen). On 17-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff up to neck), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Legs hurt), PERIPHERAL SWELLING (Legs swollen), MYALGIA (Muscles started hurting), ARTHRALGIA (Joints started hurting), VACCINATION SITE PAIN (Injected arm sore), SKIN TIGHTNESS (Skin tightness) and COUGH (Dry cough) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information included medical history and concomitant medications. Events have resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin tightness, Vaccination site pain
Clinical narrative: Legs hurt; Legs swollen; Muscles started hurting; Joints started hurting; Skin tightness; Dry cough; Stiff up to neck; Diarrhea; Injected arm sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff up to neck), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Legs hurt), PERIPHERAL SWELLING (Legs swollen) and MYALGIA (Muscles started hurting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetes, Hyperlipidemia and Allergy (Nickel causes swelling). Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression, METFORMIN for Diabetes, ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, HCTZ, TELMISARTAN (MICARDIS) and AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff up to neck), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Injected arm sore). On 15-Mar-2021, the patient experienced MYALGIA (Muscles started hurting), ARTHRALGIA (Joints started hurting), SKIN TIGHTNESS (Skin tightness) and COUGH (Dry cough). On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt) and PERIPHERAL SWELLING (Legs swollen). On 17-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff up to neck), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Legs hurt), PERIPHERAL SWELLING (Legs swollen), MYALGIA (Muscles started hurting), ARTHRALGIA (Joints started hurting), VACCINATION SITE PAIN (Injected arm sore), SKIN TIGHTNESS (Skin tightness) and COUGH (Dry cough) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information included medical history and concomitant medications. Events have resolved.