chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: His left arm was extremely sore in the shoulder area; A spontaneous report was received from a consumer concerning a 76 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm  extremely sore in the shoulder area.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their dose of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the left arm was extremely sore in the shoulder area.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events left arm was extremely sore in the shoulder area was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain
Clinical narrative: Whole body was in severe pain including her teeth; Not able to get up or sit down; she was shivering so bad; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Whole body was in severe pain including her teeth), ASTHENIA (Not able to get up or sit down) and CHILLS (she was shivering so bad) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Whole body was in severe pain including her teeth), ASTHENIA (Not able to get up or sit down) and CHILLS (she was shivering so bad). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of Advil every 6 hours. At the time of the report, PAIN (Whole body was in severe pain including her teeth), ASTHENIA (Not able to get up or sit down) and CHILLS (she was shivering so bad) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Suspect product Dose 1 body site was updated as upper arm. Patient was taken steroids to relieve the symptoms. After appointments with general practioner for infectious disease, neurology, allergy and immunology along with a  lot of lab/bloodwork, Patient made the decision to go ahead with the second vaccine.   This case was linked.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021: Reporter contact details updated. Secondary reporter details added. Patient demographic details updated. Suspect product body site was updated and route of administration was updated from Intramuscular to Sub cutaneous. Concomitant medication Singulair was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Skin sensitisation, Vaccination site discomfort
Clinical narrative: Sensitivity; Vaccination site discomfort; This spontaneous case was reported by a consumer and describes the occurrence of SKIN SENSITISATION (Sensitivity) and VACCINATION SITE DISCOMFORT (Vaccination site discomfort) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, LEVETIRACETAM (KEPPRA), VITAMINS NOS (MULTIPLE VITAMIN), ROSUVASTATIN CALCIUM (CRESTOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-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 SKIN SENSITISATION (Sensitivity) and VACCINATION SITE DISCOMFORT (Vaccination site discomfort). At the time of the report, SKIN SENSITISATION (Sensitivity) and VACCINATION SITE DISCOMFORT (Vaccination site discomfort) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication: ICE pack     This case was linked to MOD-2021-031409.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: The outcome of the events is updated; 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. Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hard swelling arm which feels warm to the touch at the injection site; itching; swelling; hardness; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching, swelling, hardness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) itching, swelling, hardness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itching, swelling, hardness was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Mobility decreased, Vaccination site pain
Clinical narrative: arm was so sore to the point that she could not lift her arm to put on a T-shir; she experienced arm soreness/arm was so sore; felt very tired; blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021), MOBILITY DECREASED (arm was so sore to the point that she could not lift her arm to put on a T-shir), VACCINATION SITE PAIN (she experienced arm soreness/arm was so sore) and FATIGUE (felt very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for Diabetes, SEMAGLUTIDE (RYBELSUS).   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 BLOOD GLUCOSE INCREASED (blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021). On 10-Feb-2021, the patient experienced MOBILITY DECREASED (arm was so sore to the point that she could not lift her arm to put on a T-shir), VACCINATION SITE PAIN (she experienced arm soreness/arm was so sore) and FATIGUE (felt very tired). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021) had not resolved and MOBILITY DECREASED (arm was so sore to the point that she could not lift her arm to put on a T-shir), VACCINATION SITE PAIN (she experienced arm soreness/arm was so sore) and FATIGUE (felt very tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Blood glucose increased: (Inconclusive) morning-141 night-167. On 10-Feb-2021, Blood glucose increased: (Inconclusive) morning-170 night-173. On 11-Feb-2021, Blood glucose increased: (Inconclusive) morning-175. On an unknown date, Blood glucose increased: (High) Patients normal sugar-126-130.         Treatment information include one additional metformin.  Action taken with mRNA-1273 in response to the events was not applicable.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: Feeling like getting the flu again; Body aches and pain; Body aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling like getting the flu again), PAIN (Body aches and pain) and MYALGIA (Body aches and pains) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 immunisation.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Cholesterol.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling like getting the flu again), PAIN (Body aches and pain) and MYALGIA (Body aches and pains). At the time of the report, INFLUENZA LIKE ILLNESS (Feeling like getting the flu again), PAIN (Body aches and pain) and MYALGIA (Body aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Feeding disorder, Headache
Clinical narrative: feeling dizzy; unable to eat; feeling knocked out all day; dull headache; feeling so tired/not able to get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling knocked out all day), DIZZINESS (feeling dizzy), FEEDING DISORDER (unable to eat), FATIGUE (feeling so tired/not able to get out of bed) and HEADACHE (dull headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. WT012AZ1A) for COVID-19 vaccination.     The patient's past medical history was not reported .  Concomitant products included ROSUVASTATIN and TIZANIDINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-1900, the patient experienced FATIGUE (feeling so tired/not able to get out of bed). On 27-Feb-2021, the patient experienced ASTHENIA (feeling knocked out all day), FEEDING DISORDER (unable to eat) and HEADACHE (dull headache). On 01-Mar-2021, the patient experienced DIZZINESS (feeling dizzy). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 28-Feb-2021, FEEDING DISORDER (unable to eat) and FATIGUE (feeling so tired/not able to get out of bed) had resolved. At the time of the report, ASTHENIA (feeling knocked out all day), DIZZINESS (feeling dizzy) and HEADACHE (dull 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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (has developed a lump), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032l20A) for COVID-19 vaccination. The patient's past medical history was not reported. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), CITALOPRAM, FLECAINIDE, IPRATROPIUM, MELATONIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TRAMADOL and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication. On 11-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 VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red arm). On an unknown date, the patient experienced VACCINATION SITE MASS (has developed a lump). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (has developed a lump), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (Red arm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Rash
Clinical narrative: Rash; Difficulty Breathing; Dizziness; A spontaneous report was received from a consumer concerning a 47-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, difficulty breathing, dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 23 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) rash. difficulty breathing, dizziness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash, difficulty breathing, dizziness was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: terrible headache; chills; fever; A spontaneous report was received from a consumer concerning a 46-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, pyrexia, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route in the right arm  for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced chills, pyrexia, headache.  No Treatment details were included.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of chills, pyrexia, headache was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Dizziness, Fatigue, Lymphadenopathy
Clinical narrative: Fever; Chills; Nauseous around food; Body aches; Swollen lymph node underneath right arm the size of an egg; array of side effects; Dizzy; Tired; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food), MYALGIA (Body aches) and LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was reported.  Concurrent medical conditions included Allergy to antibiotic (Sulfa).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (Tired) and DIZZINESS (Light headed). On 23-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food), MYALGIA (Body aches), LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) and ADVERSE REACTION (array of side effects). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food) and LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) had resolved and MYALGIA (Body aches), DIZZINESS (Dizzy), FATIGUE (Tired), DIZZINESS (Light headed) and ADVERSE REACTION (array of side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was included water, Gatorade, Flonase.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nauseous around food; Body aches; Swollen lymph node underneath right arm the size of an egg; array of side effects; Dizzy; Tired; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food), MYALGIA (Body aches) and LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was reported.  Concurrent medical conditions included Allergy to antibiotic (Sulfa).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (Tired) and DIZZINESS (Light headed). On 23-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food), MYALGIA (Body aches), LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) and ADVERSE REACTION (array of side effects). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nauseous around food) and LYMPHADENOPATHY (Swollen lymph node underneath right arm the size of an egg) had resolved and MYALGIA (Body aches), DIZZINESS (Dizzy), FATIGUE (Tired), DIZZINESS (Light headed) and ADVERSE REACTION (array of side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was included water, Gatorade, Flonase.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Shaking; Very week; Lethargy; Did not feel well; Pain in injection site; Fever of 102.00 Degree F; Severe chills; Tired; Headache; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in injection site/vaccination site pain, fever/ pyrexia, severe chills/ chills, shaking/tremor, very weak/asthenia, tired/fatigue, lethargy, headache, did not feel well/ malaise.  The patient's medical history included Covid-19 (1 Feb 2021). No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013N20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced pain in injection site, fever, severe chills, shaking, very weak, tired, lethargy, headache and did not feel well. On the same day, the lab test performed included body temperature 102 degree F (high)  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events pain in injection site, fever, severe chills, shaking, very weak, tired, lethargy, headache, did not feel well were recovering.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Shaking; Very week; Lethargy; Did not feel well; Pain in injection site; Fever of 102.00 Degree F; Severe chills; Tired; Headache; A spontaneous report was received from a consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in injection site/vaccination site pain, fever/ pyrexia, severe chills/ chills, shaking/tremor, very weak/asthenia, tired/fatigue, lethargy, headache, did not feel well/ malaise.  The patient's medical history included Covid-19 (1 Feb 2021). No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013N20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced pain in injection site, fever, severe chills, shaking, very weak, tired, lethargy, headache and did not feel well. On the same day, the lab test performed included body temperature 102 degree F (high)  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events pain in injection site, fever, severe chills, shaking, very weak, tired, lethargy, headache, did not feel well were recovering.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypersomnia, Pain in extremity, Pyrexia
Clinical narrative: Feeling dizzy; Low graded fever; Feeling tired; Arm Hurting; Feeling sluggish; Spending most times in bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed), DIZZINESS (Feeling dizzy) and FATIGUE (Feeling tired) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed) and FATIGUE (Feeling tired). On 02-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy) and PYREXIA (Low graded fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed), DIZZINESS (Feeling dizzy) and FATIGUE (Feeling tired) outcome was unknown and PYREXIA (Low graded fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Feeling dizzy; Low graded fever; Feeling tired; Arm Hurting; Feeling sluggish; Spending most times in bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed), DIZZINESS (Feeling dizzy) and FATIGUE (Feeling tired) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed) and FATIGUE (Feeling tired). On 02-Mar-2021, the patient experienced DIZZINESS (Feeling dizzy) and PYREXIA (Low graded fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm Hurting), SLUGGISHNESS (Feeling sluggish), HYPERSOMNIA (Spending most times in bed), DIZZINESS (Feeling dizzy) and FATIGUE (Feeling tired) outcome was unknown and PYREXIA (Low graded fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0BM20A) for COVID-19 vaccination.     The patient's past medical history was not reported .     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested COVID positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Vomiting
Clinical narrative: On 28-Feb-1021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (headache) and BACK PAIN (Pain back). At the time of the report, VOMITING (vomiting), HEADACHE (headache) and BACK PAIN (Pain back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations, Pharyngeal swelling, Pruritus, Vaccination site swelling
Clinical narrative: itching; throat swelling; rapid heart beat; headache; swelling at her right arm which is the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PHARYNGEAL SWELLING (throat swelling), PALPITATIONS (rapid heart beat), HEADACHE (headache) and VACCINATION SITE SWELLING (swelling at her right arm which is the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (had the side effects 5 days later after eating crab legs) and Drug allergy (bothered in her throat).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), PHARYNGEAL SWELLING (throat swelling), PALPITATIONS (rapid heart beat), HEADACHE (headache) and VACCINATION SITE SWELLING (swelling at her right arm which is the injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ALBUTEROL [SALBUTAMOL] at a dose of 1 dosage form. At the time of the report, PRURITUS (itching), PHARYNGEAL SWELLING (throat swelling), PALPITATIONS (rapid heart beat), HEADACHE (headache) and VACCINATION SITE SWELLING (swelling at her right arm which is the injection site) outcome was unknown. patient experienced such symptoms 5 days later after eating crab legs      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant product was reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 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 SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 virus test positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pain in extremity
Clinical narrative: soreness in left arm; back pain; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm), BACK PAIN (back pain), HEADACHE (headache) and FATIGUE (fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm), BACK PAIN (back pain), HEADACHE (headache) and FATIGUE (fatigue). On 11-Feb-2021, PAIN IN EXTREMITY (soreness in left arm), BACK PAIN (back pain), HEADACHE (headache) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also include cholesterol med, hypertension medicine.  Treatment information was not provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Dyspnoea, Headache, Malaise
Clinical narrative: SOB; malaise; Chest tightness; blurred vision; poor circulation in hand and feet; headache; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision) and POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision), POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 200 milligram every eight hours. At the time of the report, DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision), POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Patient was  tested positive for COVID-19 around two months prior to vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor peripheral circulation, Vision blurred
Clinical narrative: SOB; malaise; Chest tightness; blurred vision; poor circulation in hand and feet; headache; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision) and POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    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 DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision), POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) and HEADACHE (headache). The patient was treated with IBUPROFEN at a dose of 200 milligram every eight hours. At the time of the report, DYSPNOEA (SOB), MALAISE (malaise), CHEST DISCOMFORT (Chest tightness), VISION BLURRED (blurred vision), POOR PERIPHERAL CIRCULATION (poor circulation in hand and feet) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Patient was  tested positive for COVID-19 around two months prior to vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mouth ulceration, Myalgia, Nausea
Clinical narrative: Patient feels weak; Mouth ulcers (it's hard to eat, drink and talk according to her); Body aches; Nausea; A spontaneous report was received from a consumer concerning a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient felt weak, body aches, mouth ulcers and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient felt weak, had body aches, mouth ulcers, nausea. It was hard to eat, drink and talk due to mouth ulcer.  Treatment details included lidocaine gel.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events patient felt weak, body aches, mouth ulcers and nausea were unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Headache, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), PAIN (Aching), PAIN (Body hurts), ANXIETY (Felt a little anxious) and HEADACHE (Head hurt) in a 65-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. The patient's past medical history included No adverse event. Concomitant products included Thyroid meds and Boost bar for an unknown indication, VITAMINS NOS. On 11-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 DYSPNOEA (Hard time breathing), PAIN (Aching), PAIN (Body hurts), ANXIETY (Felt a little anxious), HEADACHE (Head hurt) and HEADACHE (Severe headache). At the time of the report, DYSPNOEA (Hard time breathing), PAIN (Aching), PAIN (Body hurts), ANXIETY (Felt a little anxious), HEADACHE (Head hurt) and HEADACHE (Severe headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity, Vaccination site pain
Clinical narrative: Sensitivity; Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Sensitivity) and VACCINATION SITE PAIN (Pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007NL20A) for COVID-19 vaccination.     The patient's past medical history was not reported .     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 VACCINATION SITE HYPERSENSITIVITY (Sensitivity) and VACCINATION SITE PAIN (Pain). At the time of the report, VACCINATION SITE HYPERSENSITIVITY (Sensitivity) and VACCINATION SITE PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment information include Ice Pack   This case was linked to MOD-2021-031381, MOD-2021-142201 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Lymphadenopathy, Neck pain, Pyrexia
Clinical narrative: Feel like she had pression in her ear; Enlargement lymph node reaction on her collarbone; That area hurt a little until near her ear, neck; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (That area hurt a little until near her ear, neck), EAR PAIN (Feel like she had pression in her ear), LYMPHADENOPATHY (Enlargement lymph node reaction on her collarbone) and PYREXIA (Fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history was not reported .    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Fever). On 28-Feb-2021, the patient experienced NECK PAIN (That area hurt a little until near her ear, neck) and LYMPHADENOPATHY (Enlargement lymph node reaction on her collarbone). On an unknown date, the patient experienced EAR PAIN (Feel like she had pression in her ear). At the time of the report, NECK PAIN (That area hurt a little until near her ear, neck), EAR PAIN (Feel like she had pression in her ear), LYMPHADENOPATHY (Enlargement lymph node reaction on her collarbone) and PYREXIA (Fever) had not resolved.            Concomitant medications reported were thyroids medication No Treatment information provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: arm was also sore for a bit; headache; muscle pain; joint pain; chills; nausea; ran a fever for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Diabetes, COPD, Asthma and Hypertension. Concomitant products included WARFARIN SODIUM (COUMADIN) for Clot blood.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (ran a fever for about 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (ran a fever for about 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm was also sore for a bit; headache; muscle pain; joint pain; chills; nausea; ran a fever for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Diabetes, COPD, Asthma and Hypertension. Concomitant products included WARFARIN SODIUM (COUMADIN) for Clot blood.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (ran a fever for about 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was also sore for a bit), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (ran a fever for about 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Syringe issue, Underdose
Clinical narrative: some drops on her arm; drops on the side of the syringe; invalid dose; This spontaneous case was reported by a pharmacist and describes the occurrence of MEDICATION ERROR (some drops on her arm), SYRINGE ISSUE (drops on the side of the syringe) and UNDERDOSE (invalid dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history was not reported.     On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced MEDICATION ERROR (some drops on her arm), SYRINGE ISSUE (drops on the side of the syringe) and UNDERDOSE (invalid dose). On 25-Feb-2021, MEDICATION ERROR (some drops on her arm), SYRINGE ISSUE (drops on the side of the syringe) and UNDERDOSE (invalid dose) 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.   No Concomitant medications were provided by the reporter. No Treatment history was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: NNI On 21-May-2021: NNI On 21-May-2021: NNI; Sender's Comments: This report refers to a case of Underdose for mRNA-1273, lot # 031M20A with no associated AEs.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Loss of Appetite; Fever - Temperature of 101.0F; Chills; Headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 101.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Loss of Appetite; Fever - Temperature of 101.0F; Chills; Headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Loss of Appetite), PYREXIA (Fever - Temperature of 101.0F), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 101.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Confused; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confused) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CONFUSIONAL STATE (Confused). At the time of the report, CONFUSIONAL STATE (Confused) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment details were provided.    This case was linked to MOD-2021-029441 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR