chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Large red plaque on arm; Not able to lift arm; Severe pain shooting from ear and neck to pinky finger; Arm a rash, 6 inch circle; Fever; Lethargy; Pain localized to arm; Severe Diarrhea; Nausea; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Lethargy), DIARRHOEA (Severe Diarrhea), PAIN (Pain localized to arm), ERYTHEMA (Large red plaque on arm) and INJECTED LIMB MOBILITY DECREASED (Not able to lift arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced LETHARGY (Lethargy), PAIN (Pain localized to arm) and PYREXIA (Fever). In January 2021, the patient experienced DIARRHOEA (Severe Diarrhea) and NAUSEA (Nausea). On 23-Jan-2021, the patient experienced ERYTHEMA (Large red plaque on arm), INJECTED LIMB MOBILITY DECREASED (Not able to lift arm), PAIN IN EXTREMITY (Severe pain shooting from ear and neck to pinky finger) and RASH (Arm a rash, 6 inch circle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In January 2021, LETHARGY (Lethargy), PAIN (Pain localized to arm), ERYTHEMA (Large red plaque on arm), PAIN IN EXTREMITY (Severe pain shooting from ear and neck to pinky finger) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Severe Diarrhea), INJECTED LIMB MOBILITY DECREASED (Not able to lift arm), RASH (Arm a rash, 6 inch circle) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  Treatment information includes ice and heat.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: dizziness; difficulty of breathing; fast heart rate 80bpm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm). At the time of the report, DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (Inconclusive) 80bpm and (Inconclusive) 50bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Experienced dizziness, difficulty of breathing and fast heart rate:80bpm. According to the patient his resting heart rate is only 50bpm.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site movement impairment, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Can not move the arm; Itchy arm; Red arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     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 22-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Platelet count of zero; This spontaneous case was reported by a physician and describes the occurrence of PLATELET COUNT DECREASED (Platelet count of zero) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 PLATELET COUNT DECREASED (Platelet count of zero). At the time of the report, PLATELET COUNT DECREASED (Platelet count of zero) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Vaccination site pain
Clinical narrative: cant lift arm past 45 degrees; arm sore/pain in left arm at the injection site; A spontaneous report (United States) was received from a healthcare professional concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore/vaccination site pain, cant lift arm past 45 degrees/muscular weakness.  The patient's medical history included a mastectomy ten years ago. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 16 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events, arm sore, cant lift arm past 45 degrees. The patient could take other hand and use it to assist in order to raise left arm, but cannot lift higher than 45 degrees without assistance  Treatment details included Tylenol.  The patient received both the doses of mRNA-1273  prior to the events, therefore action taken against the drug in response to the events was not applicable.  The outcome of events, arm sore, cant lift arm past 45 degrees was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Pain
Clinical narrative: shortness of breath; sore arm; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm), FATIGUE (fatigue), ARTHRALGIA (joint pain) and DYSPNOEA (shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia and Asthma.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 28-Jan-2021, the patient experienced PAIN (sore arm), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On 29-Jan-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, PAIN (sore arm), FATIGUE (fatigue), ARTHRALGIA (joint pain) and DYSPNOEA (shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pain, Pruritus, Pyrexia
Clinical narrative: Burning; itching; fever; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for an unknown indication.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Jan-2021, the patient experienced BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection). At the time of the report, BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis
Clinical narrative: Cold; Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) 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 NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19). At the time of the report, NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive date - unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red circle around the injection site; Painful at injection site; Itchy at injection site; Rash in the neck, face and chest; CHILLS; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Rash in the neck, face and chest) and CHILLS (CHILLS) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Rash in the neck, face and chest) and CHILLS (CHILLS). On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around the injection site). On 14-Feb-2021, VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching/burning from neck down to chest; rash is not red or bumpy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.    Co-suspect products included non-company products DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication and CORTISONE for an unknown indication.    The patient's past medical history included No adverse event.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) (unknown route) at an unspecified dose and CORTISONE (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy). At the time of the report, PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bone swelling
Clinical narrative: swelling around collar bone that may or may not be due to vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE SWELLING (swelling around collar bone that may or may not be due to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE SWELLING (swelling around collar bone that may or may not be due to vaccine). At the time of the report, BONE SWELLING (swelling around collar bone that may or may not be due to vaccine) had resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen arm Near the Injection Site; Sore Arm Near the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes mellitus.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site). On 25-Jan-2021, VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site) had resolved.            Treatment medication included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-020539 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020539:Same patient, 2nd dose
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested Covid-19 positive; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested Covid-19 positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced COVID-19 (Tested Covid-19 positive). At the time of the report, COVID-19 (Tested Covid-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, COVID-19: positive (Positive) COVID 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.  Treatment for the events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: Cold; Congestion; Bad Cough; Body Aches; Headache; Joint Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 16-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ROBITUSSIN TOTAL COUGH, COLD & FLU EXTR.STR.N) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Cold; Congestion; Bad Cough; Body Aches; Headache; Joint Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 16-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ROBITUSSIN TOTAL COUGH, COLD & FLU EXTR.STR.N) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: rash or hives on my left arm where I had my shot; rash or hives on my left arm where I had my shot; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot). At the time of the report, INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot) 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.  Company comment: 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; A spontaneous report was received from a health care provider concerning a 61 year old, male patient who developed COVID-19.     The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On 05-JAN-2021, approximately 7 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.     On 13-JAN-2021, the patient started showing symptoms of COVID-19 after being exposed on the weekend of 09-10-JAN-2021. On 15-JAN-2021, the patient tested positive for COVID-19.  The patient is still symptomatic and has a second dose scheduled for 02-FEB-2021. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event(s), COVID-19, was considered recovering/resolving.     Follow up: Follow-up received on 28-JAN-2021 included HCP was given the 1st dose of the vaccine on 05Jan2021 (with 2nd dose scheduled on 02Feb2021) at a health care facility. He had it on his R deltoid. He was exposed to a Covid-19 positive case the weekend of 19-10Jan2021. He started to develop symptoms of Covid-19 on 13Jan2021 and tested positive on 15Jan2021. He is still currently symptomatic. Consent to follow up obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: Had arm pain when got vaccine; Pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Had arm pain when got vaccine) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included LORATADINE for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Sep-2020 and the estimated date of delivery was 27-Jun-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On an unknown date, the patient experienced VACCINATION SITE PAIN (Had arm pain when got vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 26-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Had arm pain when got vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2020, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 31 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her second dose of mRNA-1273 vaccine 3 months after she had a positive pregnancy test. Also, she experienced an event of arm pain (vaccination site pain). 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. Further information has been requested.; Sender's Comments: This case concerns a 31 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her second dose of mRNA-1273 vaccine 3 months after she had a positive pregnancy test. Also, she experienced an event of arm pain (vaccination site pain). 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. Further information has been requested.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Limb discomfort, Musculoskeletal stiffness, Pruritus
Clinical narrative: red circle; itchy; heavy; stiff; warm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff), INJECTION SITE WARMTH (warm), ERYTHEMA (red circle) and PRURITUS (itchy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff) and INJECTION SITE WARMTH (warm). On 25-Jan-2021, the patient experienced ERYTHEMA (red circle) and PRURITUS (itchy). At the time of the report, LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff), INJECTION SITE WARMTH (warm), ERYTHEMA (red circle) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Advil.   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria, Vaccination site pain
Clinical narrative: arm pain; arm itchy/itchy is getting bigger and getting worse; really bad, like a welts; poilus skin; really hurt at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site). At the time of the report, PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; felt like bugs were all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (felt like bugs were all over body) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Amputation (Leg amputated below the knee). Concurrent medical conditions included Diabetic, Renal failure, Liver failure, Blind (Blind in one eye) and Dialysis. Concomitant products included INSULIN for Diabetes mellitus, APIXABAN (ELIQUIS), LISINOPRIL, ISOSORBIDE, METOPROLOL and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (itching) and RASH (felt like bugs were all over body). At the time of the report, PRURITUS (itching) and RASH (felt like bugs were all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included 4 different eye drops. Treatment details included diphenhydramine.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: knot; painful (knot); red (knot; warm to the touch at the site of injection; headache; sore arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot), INJECTION SITE WARMTH (warm to the touch at the site of injection) and HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-Jan-2021, the patient experienced HEADACHE (headache) and INJECTION SITE PAIN (sore arm). On 20-Jan-2021, the patient experienced INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot) and INJECTION SITE WARMTH (warm to the touch at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form; ANTIBIOTICS ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot), INJECTION SITE WARMTH (warm to the touch at the site of injection), HEADACHE (headache) and INJECTION SITE PAIN (sore arm) had resolved.        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.   Patient took acetaminophen(Tylenol), antibiotics and diphenhydramine ( Benadryl).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: knot; painful (knot); red (knot; warm to the touch at the site of injection; headache; sore arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot), INJECTION SITE WARMTH (warm to the touch at the site of injection) and HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-Jan-2021, the patient experienced HEADACHE (headache) and INJECTION SITE PAIN (sore arm). On 20-Jan-2021, the patient experienced INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot) and INJECTION SITE WARMTH (warm to the touch at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form; ANTIBIOTICS ongoing since an unknown date for Adverse event, at a dose of UNK dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, INJECTION SITE MASS (knot), PAIN IN EXTREMITY (painful (knot)), ERYTHEMA (red (knot), INJECTION SITE WARMTH (warm to the touch at the site of injection), HEADACHE (headache) and INJECTION SITE PAIN (sore arm) had resolved.        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.   Patient took acetaminophen(Tylenol), antibiotics and diphenhydramine ( Benadryl).
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: sore arm at the injection site; ached all over (body ache); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm at the injection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A.) 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 26-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm at the injection site). At the time of the report, INJECTION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cold sweat, Headache, Hyperhidrosis, Pain
Clinical narrative: cold sweats profusely on hands and feet; cold sweats profusely on hands and feet; Arm was burning; Arm was itching; headache; soreness; A spontaneous case was received from the consumer concerning female patient of 53 years who received Moderna's COVID-19 vaccine and experienced soreness, arm was burning, arm was itching, headache, cold sweats profusely on hands and cold sweats profusely on feet.  The patient's medical history reported that she was allergic seasonally and allergic to sea foods.  No relevant concomitant medications were reported.  On 22-Jan-2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number: 030L20A) on the left upper arm for the prophylaxis of COVID-19 infection.  On 22-Jan-2021 the patient experienced soreness. On 24-Jan-2021 the patient experienced arm was burning and itching. On 27-Jan-2021 she had cold sweats profusely on hands and feet. Treatment of the event was not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, soreness, arm was burning, arm was itching, headache, cold sweats profusely on hands and cold sweats profusely on feet was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: cold sweats profusely on hands and feet; cold sweats profusely on hands and feet; Arm was burning; Arm was itching; headache; soreness; A spontaneous case was received from the consumer concerning female patient of 53 years who received Moderna's COVID-19 vaccine and experienced soreness, arm was burning, arm was itching, headache, cold sweats profusely on hands and cold sweats profusely on feet.  The patient's medical history reported that she was allergic seasonally and allergic to sea foods.  No relevant concomitant medications were reported.  On 22-Jan-2021 prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273 (Lot Number: 030L20A) on the left upper arm for the prophylaxis of COVID-19 infection.  On 22-Jan-2021 the patient experienced soreness. On 24-Jan-2021 the patient experienced arm was burning and itching. On 27-Jan-2021 she had cold sweats profusely on hands and feet. Treatment of the event was not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events, soreness, arm was burning, arm was itching, headache, cold sweats profusely on hands and cold sweats profusely on feet was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Itch around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PRURITUS (Itch around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetic.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.    On 18-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itch around the injection site).   At the time of the report, INJECTION SITE PRURITUS (Itch around the injection site) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain, Pruritus, Vaccination site pain
Clinical narrative: itching on a previous scar; pain from the xifoid to her back; burning in the arm; joint pain; head ache; This spontaneous case was reported by a  and describes the occurrence of PAIN (pain from the xifoid to her back), VACCINATION SITE PAIN (burning in the arm), ARTHRALGIA (joint pain), HEADACHE (head ache) and PRURITUS (itching on a previous scar) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain from the xifoid to her back), VACCINATION SITE PAIN (burning in the arm), ARTHRALGIA (joint pain), HEADACHE (head ache) and PRURITUS (itching on a previous scar). At the time of the report, PAIN (pain from the xifoid to her back), VACCINATION SITE PAIN (burning in the arm), ARTHRALGIA (joint pain) and HEADACHE (head ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Injection site erythema, Lethargy, Musculoskeletal stiffness, Myalgia
Clinical narrative: Swollen arm; Intense itching; Really uncomfortable; Rash; A bullseye like red blood area around the site of injection; Muscle aches; Lethargy; Stiffness of the neck; Itchiness on their body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Intense itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included VITAMIN D3 for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body) and MYALGIA (Muscle aches). On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PRURITUS (Intense itching), FEELING ABNORMAL (Really uncomfortable), RASH (Rash) and INJECTION SITE ERYTHEMA (A bullseye like red blood area around the site of injection). On 16-Jan-2021, LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body) and MYALGIA (Muscle aches) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), PRURITUS (Intense itching), FEELING ABNORMAL (Really uncomfortable), RASH (Rash) and INJECTION SITE ERYTHEMA (A bullseye like red blood area around the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product used was statins. Treatment for the events included lotion, ice pack, fexofenadine, diphenhydramine, some steroid and hydrocortisone.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Swollen arm; Intense itching; Really uncomfortable; Rash; A bullseye like red blood area around the site of injection; Muscle aches; Lethargy; Stiffness of the neck; Itchiness on their body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Intense itching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included VITAMIN D3 for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body) and MYALGIA (Muscle aches). On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PRURITUS (Intense itching), FEELING ABNORMAL (Really uncomfortable), RASH (Rash) and INJECTION SITE ERYTHEMA (A bullseye like red blood area around the site of injection). On 16-Jan-2021, LETHARGY (Lethargy), MUSCULOSKELETAL STIFFNESS (Stiffness of the neck), PRURITUS (Itchiness on their body) and MYALGIA (Muscle aches) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), PRURITUS (Intense itching), FEELING ABNORMAL (Really uncomfortable), RASH (Rash) and INJECTION SITE ERYTHEMA (A bullseye like red blood area around the site of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant product used was statins. Treatment for the events included lotion, ice pack, fexofenadine, diphenhydramine, some steroid and hydrocortisone.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chills, Lethargy, Pain, Pyrexia
Clinical narrative: Positive for covid; Lethargy; Body aches; Got sick with Fever; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive for covid), LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since 17-Jan-2021.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills). On 15-Jan-2021, the patient experienced COVID-19 (Positive for covid). At the time of the report, COVID-19 (Positive for covid), LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; 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 of lethargy, fever, chills and pain, a causal relationship cannot be excluded. Limited information regarding the COVID-19 event was provided. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Positive for covid; Lethargy; Body aches; Got sick with Fever; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive for covid), LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since 17-Jan-2021.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills). On 15-Jan-2021, the patient experienced COVID-19 (Positive for covid). At the time of the report, COVID-19 (Positive for covid), LETHARGY (Lethargy), PAIN (Body aches), PYREXIA (Got sick with Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; 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 of lethargy, fever, chills and pain, a causal relationship cannot be excluded. Limited information regarding the COVID-19 event was provided. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine