chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema
Clinical narrative: brown in color injection site; red in color injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (brown in color injection site) and VACCINATION SITE ERYTHEMA (red in color injection site) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) and FINASTERIDE (PROSCAR) for Urinary tract disorder.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (brown in color injection site) and VACCINATION SITE ERYTHEMA (red in color injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (brown in color injection site) and VACCINATION SITE ERYTHEMA (red in color injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications Flomax, Proscar. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Malaise; Sore arm, like "hard to move"; Fever of 101F; Headache; Fatigue; Serious chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent insertion NOS (Patient has two heart stints). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 24-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Serious chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Serious chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 101 (High) Body temperature high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included cardiac medications.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: Flu-like symptoms; Malaise; Sore arm, like "hard to move"; Fever of 101F; Headache; Fatigue; Serious chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent insertion NOS (Patient has two heart stints). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 24-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Serious chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MALAISE (Malaise), PAIN IN EXTREMITY (Sore arm, like "hard to move"), PYREXIA (Fever of 101F), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Serious chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 101 (High) Body temperature high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included cardiac medications.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pruritus, Vaccination site rash
Clinical narrative: It is not deep red, it is a light red rash that seems to be spreading; Rash below injection site; Itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (It is not deep red, it is a light red rash that seems to be spreading), VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE PRURITUS (Itches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced RASH ERYTHEMATOUS (It is not deep red, it is a light red rash that seems to be spreading), VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE PRURITUS (Itches). At the time of the report, RASH ERYTHEMATOUS (It is not deep red, it is a light red rash that seems to be spreading), VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE PRURITUS (Itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Bad Stomach Pain/bad stomach issues; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received both doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bad stomach pain.  The patient's medical history included stomach pain. No relevant concomitant medications were reported.  On 14 Jan 2021 and 12FEB202, the patient received first and second doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  After her second dose, the patient experienced bad stomach pain which was serious according to her but details were not reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), bad stomach pain was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: persistent headache; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (persistent headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (persistent headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (persistent headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Paraesthesia, Vaccination complication
Clinical narrative: felt funny and clarifies it was a sensation in his body that something was going on.; His left hand was tingly for a day and a half; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt funny and clarifies it was a sensation in his body that something was going on.), PARAESTHESIA (His left hand was tingly for a day and a half), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION COMPLICATION (felt funny and clarifies it was a sensation in his body that something was going on.), PARAESTHESIA (His left hand was tingly for a day and a half), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 24-Jan-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (felt funny and clarifies it was a sensation in his body that something was going on.) and FATIGUE (Fatigue) outcome was unknown and PARAESTHESIA (His left hand was tingly for a day and a half) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizziness; Fatigue; Headache; Chills; Nausea; A spontaneous report was received from a Consumer (reporting on self) concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache, chills, nausea and dizziness.  The patient's medical history was not provided. Concomitant medications included Thyroid medications.  On 20 Jan 2021, approximately 4 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced the events fatigue, headache, chills, nausea and dizziness.  Treatment details included BC Powder.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events of fatigue, headache, chills,  nausea, dizziness was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A spontaneous report was received from a Healthcare Professional concerning a 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spot just below the injection site with 4 to 5 cm in diameter, red spread and the area covered almost to the elbow, swollen and itchy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 15 Jan 2021, approximately 9 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient experienced red spot just below the injection site with 4 to 5 cm in diameter which was swollen and itchy. within 2-3 days, red spread and the area covered almost to the elbow. Treatment details included Antibiotics and anti inflammatory like Ibuprofen and Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s) red spot just below the injection site with 4 to 5 cm in diameter, swollen, itchy, red spread and the area covered almost to the elbow were considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 24-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-018243 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-018243:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dehydration, Headache, Pyrexia
Clinical narrative: abdominal pain; dehydration; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal pain), DEHYDRATION (dehydration), PYREXIA (fever) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 ABDOMINAL PAIN (abdominal pain), DEHYDRATION (dehydration), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN (abdominal pain), DEHYDRATION (dehydration), PYREXIA (fever) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment included fluids for dehydration.   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Night sweats
Clinical narrative: whole arm hurt; arm hurt more than after 1st vaccine; night sweats; fever of 102F; Headache; Chills; body was all achy; Under his arm he had a swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F), HEADACHE (Headache), CHILLS (Chills), MYALGIA (body was all achy) and LYMPHADENOPATHY (Under his arm he had a swollen lymph node). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F), HEADACHE (Headache), CHILLS (Chills), MYALGIA (body was all achy) and LYMPHADENOPATHY (Under his arm he had a swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: whole arm hurt; arm hurt more than after 1st vaccine; night sweats; fever of 102F; Headache; Chills; body was all achy; Under his arm he had a swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F), HEADACHE (Headache), CHILLS (Chills), MYALGIA (body was all achy) and LYMPHADENOPATHY (Under his arm he had a swollen lymph node). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F), HEADACHE (Headache), CHILLS (Chills), MYALGIA (body was all achy) and LYMPHADENOPATHY (Under his arm he had a swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm was swollen; Red from the shoulder all the way down to her elbow; All the way around, itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was swollen), VACCINATION SITE ERYTHEMA (Red from the shoulder all the way down to her elbow) and VACCINATION SITE PRURITUS (All the way around, itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE SWELLING (Arm was swollen), VACCINATION SITE ERYTHEMA (Red from the shoulder all the way down to her elbow) and VACCINATION SITE PRURITUS (All the way around, itching). At the time of the report, VACCINATION SITE SWELLING (Arm was swollen), VACCINATION SITE ERYTHEMA (Red from the shoulder all the way down to her elbow) and VACCINATION SITE PRURITUS (All the way around, itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Injection site itching; Injection site redness; Injection site swelling; Injection site rash; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE RASH (Injection site rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE RASH (Injection site rash). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE RASH (Injection site rash) 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.   .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.   This case was linked to MOD-2021-025324 (Patient Link).; Reporter's Comments: .Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for Covid) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L204) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-024399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: The reporter was sent follow-up request but asked us to contact another person for more details. Safety is working on this request.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Became itchy and hot; Became itchy; Develop a rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Became itchy and hot), VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE RASH (Develop a rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O29K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High blood pressure medication) and Thyroid disorder (Thyroid medication).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Became itchy and hot), VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE RASH (Develop a rash). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Became itchy and hot), VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE RASH (Develop a rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: A spontaneous report was received from a consumer who Is 73-year-old female that received Moderna's COVID-19 vaccine and experienced persistent shoulder redness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 19-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 016M20A) via (intramuscular) route for COVID-19 infection prophylaxis. On an unspecified date, after the first dose of vaccine, the patient developed redness on the shoulder that has not gone away. No treatment medication was reported. No lab tests were reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, persistent shoulder redness was considered to be not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Itching; Pain in upper body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and PAIN (Pain in upper body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (Itching) and PAIN (Pain in upper body). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) and PAIN (Pain in upper body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Pain, Paraesthesia, Peripheral coldness
Clinical narrative: after the injection she felt like liquid was running through her; Numbness and tingling on left side; Numbness and tingling on left side; No sleep; two fingers and toes numb and ice cold; two fingers and toes numb and ice cold; Two fingers on left hand swollen; redness in left arm that was painful; Redness in left arm that was painful; Constant pain; This spontaneous case was reported by a patient and describes the occurrence of SENSATION OF BLOOD FLOW (after the injection she felt like liquid was running through her), HYPOAESTHESIA (Numbness and tingling on left side), PARAESTHESIA (Numbness and tingling on left side), PAIN (Constant pain) and INSOMNIA (No sleep) in a 40-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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (Constant pain). On an unknown date, the patient experienced SENSATION OF BLOOD FLOW (after the injection she felt like liquid was running through her), HYPOAESTHESIA (Numbness and tingling on left side), PARAESTHESIA (Numbness and tingling on left side), INSOMNIA (No sleep), HYPOAESTHESIA (two fingers and toes numb and ice cold), PERIPHERAL COLDNESS (two fingers and toes numb and ice cold), PERIPHERAL SWELLING (Two fingers on left hand swollen), VACCINATION SITE PAIN (redness in left arm that was painful) and VACCINATION SITE ERYTHEMA (Redness in left arm that was painful). At the time of the report, SENSATION OF BLOOD FLOW (after the injection she felt like liquid was running through her), HYPOAESTHESIA (Numbness and tingling on left side), PARAESTHESIA (Numbness and tingling on left side), PAIN (Constant pain), INSOMNIA (No sleep), HYPOAESTHESIA (two fingers and toes numb and ice cold), PERIPHERAL COLDNESS (two fingers and toes numb and ice cold), PERIPHERAL SWELLING (Two fingers on left hand swollen), VACCINATION SITE PAIN (redness in left arm that was painful) and VACCINATION SITE ERYTHEMA (Redness in left arm that was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sensation of blood flow, Vaccination site erythema, Vaccination site pain
Clinical narrative: after the injection she felt like liquid was running through her; Numbness and tingling on left side; Numbness and tingling on left side; No sleep; two fingers and toes numb and ice cold; two fingers and toes numb and ice cold; Two fingers on left hand swollen; redness in left arm that was painful; Redness in left arm that was painful; Constant pain; This spontaneous case was reported by a patient and describes the occurrence of SENSATION OF BLOOD FLOW (after the injection she felt like liquid was running through her), HYPOAESTHESIA (Numbness and tingling on left side), PARAESTHESIA (Numbness and tingling on left side), PAIN (Constant pain) and INSOMNIA (No sleep) in a 40-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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (Constant pain). On an unknown date, the patient experienced SENSATION OF BLOOD FLOW (after the injection she felt like liquid was running through her), HYPOAESTHESIA (Numbness and tingling on left side), PARAESTHESIA (Numbness and tingling on left side), INSOMNIA (No sleep), HYPOAESTHESIA (two fingers and toes numb and ice cold), PERIPHERAL COLDNESS (two fingers and toes numb and ice cold), PERIPHERAL SWELLING (Two fingers on left hand swollen), VACCINATION SITE PAIN (redness in left arm that was painful) and VACCINATION SITE ERYTHEMA (Redness in left arm that was painful). At the time of the report, SENSATION OF BLOOD FLOW (after the injection she felt like liquid was running through her), HYPOAESTHESIA (Numbness and tingling on left side), PARAESTHESIA (Numbness and tingling on left side), PAIN (Constant pain), INSOMNIA (No sleep), HYPOAESTHESIA (two fingers and toes numb and ice cold), PERIPHERAL COLDNESS (two fingers and toes numb and ice cold), PERIPHERAL SWELLING (Two fingers on left hand swollen), VACCINATION SITE PAIN (redness in left arm that was painful) and VACCINATION SITE ERYTHEMA (Redness in left arm that was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty of Breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty of Breathing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZOA) for COVID-19 vaccination.     Concurrent medical conditions included Clotting disorder and Kidney disorder. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR), ZINC, APIXABAN (ELIQUIS) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 12-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 DYSPNOEA (Difficulty of Breathing). At the time of the report, DYSPNOEA (Difficulty of Breathing) 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Became very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Became very 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Became very fatigue). At the time of the report, FATIGUE (Became very fatigue) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  The concomitant medications and treatment details were not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Oral pain, Pain in extremity, Palatal swelling
Clinical narrative: Roof of the mouth sore; roof of my mouth is swollen; sore arm; Fatigue; Muscle ache; itching; rash spreading all over my torso and neck; rash on her thighs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ORAL PAIN (Roof of the mouth sore), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm) and RASH (rash on her thighs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and DILTIAZEM (CARDIZEM [DILTIAZEM]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (rash on her thighs). On 16-Feb-2021, the patient experienced PRURITUS (itching) and RASH (rash spreading all over my torso and neck). On an unknown date, the patient experienced ORAL PAIN (Roof of the mouth sore), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and MYALGIA (Muscle ache). At the time of the report, PRURITUS (itching), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm), RASH (rash on her thighs), RASH (rash spreading all over my torso and neck), FATIGUE (Fatigue) and MYALGIA (Muscle ache) outcome was unknown and ORAL PAIN (Roof of the mouth sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Roof of the mouth sore; roof of my mouth is swollen; sore arm; Fatigue; Muscle ache; itching; rash spreading all over my torso and neck; rash on her thighs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), ORAL PAIN (Roof of the mouth sore), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm) and RASH (rash on her thighs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and DILTIAZEM (CARDIZEM [DILTIAZEM]) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (rash on her thighs). On 16-Feb-2021, the patient experienced PRURITUS (itching) and RASH (rash spreading all over my torso and neck). On an unknown date, the patient experienced ORAL PAIN (Roof of the mouth sore), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and MYALGIA (Muscle ache). At the time of the report, PRURITUS (itching), PALATAL SWELLING (roof of my mouth is swollen), PAIN IN EXTREMITY (sore arm), RASH (rash on her thighs), RASH (rash spreading all over my torso and neck), FATIGUE (Fatigue) and MYALGIA (Muscle ache) outcome was unknown and ORAL PAIN (Roof of the mouth sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; Excruciating headache; excruciating body ache; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, excruciating headache and excruciating body ache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly in the right arm shoulder deltoid muscle for prophylaxis of COVID-19 infection.  On an unknown date in Feb 2021, the patient experienced the event(s) sore arm, excruciating headache and body ache. The headache and body aches resolved when patient stopped lying down, when the patient sat or was standing the headache and body ache resolved.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm was unknown.  The outcome of event(s), excruciating headache, excruciating body ache was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Epicondylitis, Malaise, Oropharyngeal pain, Sinus congestion, Sinusitis
Clinical narrative: Diagnosed with tennis elbow in the right arm and was on prednisone for a week; Feeling sick; Sinus infection; sore throat on left side; congestion on left side; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), SINUSITIS (Sinus infection), OROPHARYNGEAL PAIN (sore throat on left side), SINUS CONGESTION (congestion on left side) and EPICONDYLITIS (Diagnosed with tennis elbow in the right arm and was on prednisone for a week) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MALAISE (Feeling sick), SINUSITIS (Sinus infection), OROPHARYNGEAL PAIN (sore throat on left side) and SINUS CONGESTION (congestion on left side). On an unknown date, the patient experienced EPICONDYLITIS (Diagnosed with tennis elbow in the right arm and was on prednisone for a week). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling sick), SINUSITIS (Sinus infection), OROPHARYNGEAL PAIN (sore throat on left side), SINUS CONGESTION (congestion on left side) and EPICONDYLITIS (Diagnosed with tennis elbow in the right arm and was on prednisone for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (warm and achy like I'm getting the flu), PAIN (body aches), PYREXIA (fever/ high temperatures/ warm) and HEADACHE (headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (warm and achy like I'm getting the flu), PAIN (body aches), PYREXIA (fever/ high temperatures/ warm) and HEADACHE (headaches). At the time of the report, INFLUENZA LIKE ILLNESS (warm and achy like I'm getting the flu), PAIN (body aches), PYREXIA (fever/ high temperatures/ warm) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details was not reported by the reporter. Concomitant medications details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Immediate injection sight reaction of redness and swelling; Immediate injection sight reaction of redness and swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (Immediate injection sight reaction of redness and swelling) and VACCINATION SITE SWELLING (Immediate injection sight reaction of redness and swelling) 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 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Immediate injection sight reaction of redness and swelling) and VACCINATION SITE SWELLING (Immediate injection sight reaction of redness and swelling). At the time of the report, VACCINATION SITE ERYTHEMA (Immediate injection sight reaction of redness and swelling) and VACCINATION SITE SWELLING (Immediate injection sight reaction of redness and swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: joint pain; fatigue; headache; fatigue headache muscle pain joint pain (24 to 36 hs of duration of the symptoms) chills (10min of the symptom)nausea; nausea; chills; slight itching on her face and cheek bones,; a tingling sensation move down to the middle of her cheeks and to her chin area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight itching on her face and cheek bones,), PARAESTHESIA (a tingling sensation move down to the middle of her cheeks and to her chin area), ARTHRALGIA (joint pain), FATIGUE (fatigue) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MESALAZINE (PENTASA) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (slight itching on her face and cheek bones,) and PARAESTHESIA (a tingling sensation move down to the middle of her cheeks and to her chin area). On 17-Feb-2021, the patient experienced ARTHRALGIA (joint pain), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (fatigue headache muscle pain joint pain (24 to 36 hs of duration of the symptoms) chills (10min of the symptom)nausea), NAUSEA (nausea) and CHILLS (chills). On 16-Feb-2021, PRURITUS (slight itching on her face and cheek bones,) and PARAESTHESIA (a tingling sensation move down to the middle of her cheeks and to her chin area) had resolved. On 17-Feb-2021, ARTHRALGIA (joint pain), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (fatigue headache muscle pain joint pain (24 to 36 hs of duration of the symptoms) chills (10min of the symptom)nausea) and CHILLS (chills) had resolved. At the time of the report, NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.