chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pain in extremity, Pruritus, Vaccination site reaction
Clinical narrative: sore arm; Covid arm; itchiness; hard; a little pink about 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE REACTION (Covid arm), PRURITUS (itchiness), INDURATION (hard) and ERYTHEMA (a little pink about 3 inches in diameter) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (controlled by meds), High cholesterol (controlled by meds), Pre-diabetes (controlled by diet), Drug allergy (sulfa drugs) and Penicillin allergy. Concomitant products included LISINOPRIL for Blood pressure high, ESTRADIOL (VAGIFEM) for Estrogen deficiency, SIMVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE REACTION (Covid arm), PRURITUS (itchiness), INDURATION (hard) and ERYTHEMA (a little pink about 3 inches in diameter). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, VACCINATION SITE REACTION (Covid arm) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itchiness), INDURATION (hard) and ERYTHEMA (a little pink about 3 inches in diameter) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant product includes NATURE'S BOUNTY VITAMINS for biotin/vitamins.   This case was linked to MOD-2021-024929 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Reporter Information, Patient demographics, Relevant medical history, Concomitant medication and event were updated
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Dizziness, Fatigue
Clinical narrative: stomach was upset; Rapid heart rate (160s bpm); nausea; Joint ache; fatigue; headache; dizzy; fluid retention; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FLUID RETENTION (fluid retention), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach was upset) and HEART RATE INCREASED (Rapid heart rate (160s bpm)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to codeine.), Drug allergy (Allergy to morphine.) and Drug allergy (Allergy to pain pills.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUID RETENTION (fluid retention), ASTHENIA (weakness), HEART RATE INCREASED (Rapid heart rate (160s bpm)), NAUSEA (nausea), ARTHRALGIA (Joint ache), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach was upset). On 06-Feb-2021, DIZZINESS (dizzy), NAUSEA (nausea), ARTHRALGIA (Joint ache), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae. On 10-Feb-2021, ASTHENIA (weakness) had resolved with sequelae. At the time of the report, FLUID RETENTION (fluid retention) and HEART RATE INCREASED (Rapid heart rate (160s bpm)) had not resolved and ABDOMINAL DISCOMFORT (stomach was upset) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate: 160 bpm (High) 160 bpm.     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.   The patient was taking no concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant Follow; Additional adverse events (weakness, fluid retention) added, event outcome 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 events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Headache, Heart rate, Heart rate increased, Nausea
Clinical narrative: stomach was upset; Rapid heart rate (160s bpm); nausea; Joint ache; fatigue; headache; dizzy; fluid retention; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FLUID RETENTION (fluid retention), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach was upset) and HEART RATE INCREASED (Rapid heart rate (160s bpm)) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to codeine.), Drug allergy (Allergy to morphine.) and Drug allergy (Allergy to pain pills.).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUID RETENTION (fluid retention), ASTHENIA (weakness), HEART RATE INCREASED (Rapid heart rate (160s bpm)), NAUSEA (nausea), ARTHRALGIA (Joint ache), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach was upset). On 06-Feb-2021, DIZZINESS (dizzy), NAUSEA (nausea), ARTHRALGIA (Joint ache), FATIGUE (fatigue) and HEADACHE (headache) had resolved with sequelae. On 10-Feb-2021, ASTHENIA (weakness) had resolved with sequelae. At the time of the report, FLUID RETENTION (fluid retention) and HEART RATE INCREASED (Rapid heart rate (160s bpm)) had not resolved and ABDOMINAL DISCOMFORT (stomach was upset) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate: 160 bpm (High) 160 bpm.     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.   The patient was taking no concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant Follow; Additional adverse events (weakness, fluid retention) added, event outcome 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 events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). The patient was treated with CLONIDINE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: gait and disturbance; Ankle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Ankle pain) and GAIT DISTURBANCE (gait and disturbance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (Ankle pain). On an unknown date, the patient experienced GAIT DISTURBANCE (gait and disturbance). At the time of the report, ARTHRALGIA (Ankle pain) and GAIT DISTURBANCE (gait and disturbance) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy Sensation - All Over Body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy Sensation - All Over Body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (Itchy Sensation - All Over Body). The patient was treated with HYDROXYZINE at an unspecified dose and frequency. On 25-Feb-2021, PRURITUS (Itchy Sensation - All Over Body) 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.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Rash
Clinical narrative: Low back pain; Rash; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain) and RASH (Rash) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029620A and 091A21A) for COVID-19 vaccination.     The patient's past medical history included Rash.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced BACK PAIN (Low back pain) and RASH (Rash). On 25-Feb-2021, BACK PAIN (Low back pain) had resolved. At the time of the report, RASH (Rash) outcome was unknown.            Treatment details included dermatology cream.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae, Pruritus, Rash
Clinical narrative: Flesh colored rash all over her body; itchy; Looks like patches of ruptured blood vessels; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Flesh colored rash all over her body), PRURITUS (itchy) and PETECHIAE (Looks like patches of ruptured blood vessels) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included VALSARTAN, HCTZ, LEVOTHYROXINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), MAGNESIUM, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and FISH OIL for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (Flesh colored rash all over her body), PRURITUS (itchy) and PETECHIAE (Looks like patches of ruptured blood vessels). At the time of the report, RASH (Flesh colored rash all over her body), PRURITUS (itchy) and PETECHIAE (Looks like patches of ruptured blood vessels) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) 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 reaction.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achy). At the time of the report, PAIN (Achy) outcome was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Having issue raising his hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Having issue raising his hand) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Having issue raising his hand). At the time of the report, PAIN IN EXTREMITY (Having issue raising his hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PYREXIA (fever). On 23-Feb-2021, PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 103 103.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: wrong, outfeeling; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (wrong, outfeeling) and VACCINATION SITE PAIN (Sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (wrong, outfeeling) and VACCINATION SITE PAIN (Sore arm). At the time of the report, FEELING ABNORMAL (wrong, outfeeling) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait disturbance, Headache
Clinical narrative: Very Tired; Dizziness; She can't walk right"; Headaches after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), GAIT DISTURBANCE (She can't walk right"), HEADACHE (Headaches after the vaccination) and FATIGUE (Very Tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (compazine) and Penicillin allergy.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021, the patient experienced HEADACHE (Headaches after the vaccination). On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness) and GAIT DISTURBANCE (She can't walk right"). On an unknown date, the patient experienced FATIGUE (Very Tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), GAIT DISTURBANCE (She can't walk right"), HEADACHE (Headaches after the vaccination) and FATIGUE (Very Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up document was received on 03-MAY-2021.Newevent very tired was reported. It contains significant information.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: pain; fever of 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain) and PYREXIA (fever of 100 degrees) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided.).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain) and PYREXIA (fever of 100 degrees). At the time of the report, PAIN IN EXTREMITY (pain) and PYREXIA (fever of 100 degrees) outcome was unknown. Not Provided          No treatment information was provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-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 URINARY TRACT INFECTION (Urinary Tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Parosmia, Pyrexia, Taste disorder, Vaccination site mass
Clinical narrative: Red bump at site of injection; Sense of smell has improved; Sense of taste has improved; Slightly swollen at site of injection; fever of 99.6; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved), VACCINATION SITE SWELLING (Slightly swollen at site of injection) and PYREXIA (fever of 99.6) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis and Pansinusitis (chronic pansinusitis).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved), VACCINATION SITE SWELLING (Slightly swollen at site of injection) and PYREXIA (fever of 99.6). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved) and VACCINATION SITE SWELLING (Slightly swollen at site of injection) outcome was unknown and PYREXIA (fever of 99.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 99.6 (Inconclusive) Fever of 99.6.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Patient demographics, Relevant medical history, Dose details were updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Red bump at site of injection; Sense of smell has improved; Sense of taste has improved; Slightly swollen at site of injection; fever of 99.6; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved), VACCINATION SITE SWELLING (Slightly swollen at site of injection) and PYREXIA (fever of 99.6) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis and Pansinusitis (chronic pansinusitis).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved), VACCINATION SITE SWELLING (Slightly swollen at site of injection) and PYREXIA (fever of 99.6). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Red bump at site of injection), PAROSMIA (Sense of smell has improved), TASTE DISORDER (Sense of taste has improved) and VACCINATION SITE SWELLING (Slightly swollen at site of injection) outcome was unknown and PYREXIA (fever of 99.6) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 99.6 (Inconclusive) Fever of 99.6.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Patient demographics, Relevant medical history, Dose details were updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Feverish; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish) and INJECTION SITE ERYTHEMA (injection site redness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Feverish) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, PYREXIA (Feverish) and INJECTION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site reaction
Clinical narrative: covid arm; site of injection is itching; red mark (8 cm long and 8 cm wide); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), INJECTION SITE PRURITUS (site of injection is itching) and INJECTION SITE ERYTHEMA (red mark (8 cm long and 8 cm wide)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 immunization.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE REACTION (covid arm), INJECTION SITE PRURITUS (site of injection is itching) and INJECTION SITE ERYTHEMA (red mark (8 cm long and 8 cm wide)). At the time of the report, VACCINATION SITE REACTION (covid arm), INJECTION SITE PRURITUS (site of injection is itching) and INJECTION SITE ERYTHEMA (red mark (8 cm long and 8 cm wide)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pruritus
Clinical narrative: Itching everywhere: hair, chest, neck; Lethargic; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching everywhere: hair, chest, neck), LETHARGY (Lethargic) and FATIGUE (Tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Drug allergy (Morphine, Demerol, and Toradol,Tetracycline and Amoxicillin.). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Itching everywhere: hair, chest, neck), LETHARGY (Lethargic) and FATIGUE (Tired). On 06-Feb-2021, PRURITUS (Itching everywhere: hair, chest, neck) had resolved. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Muscle fatigue
Clinical narrative: short-winded; muscle fatigue in my arms and thighs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short-winded) and MUSCLE FATIGUE (muscle fatigue in my arms and thighs) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPNOEA (short-winded) and MUSCLE FATIGUE (muscle fatigue in my arms and thighs). At the time of the report, DYSPNOEA (short-winded) and MUSCLE FATIGUE (muscle fatigue in my arms and thighs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: achiness; Throat is sore; Stomach borderline upset; Flu like symptoms; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), OROPHARYNGEAL PAIN (Throat is sore), ABDOMINAL DISCOMFORT (Stomach borderline upset), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (achiness), OROPHARYNGEAL PAIN (Throat is sore), ABDOMINAL DISCOMFORT (Stomach borderline upset), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN (achiness), OROPHARYNGEAL PAIN (Throat is sore), ABDOMINAL DISCOMFORT (Stomach borderline upset), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: achiness; Throat is sore; Stomach borderline upset; Flu like symptoms; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), OROPHARYNGEAL PAIN (Throat is sore), ABDOMINAL DISCOMFORT (Stomach borderline upset), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (achiness), OROPHARYNGEAL PAIN (Throat is sore), ABDOMINAL DISCOMFORT (Stomach borderline upset), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN (achiness), OROPHARYNGEAL PAIN (Throat is sore), ABDOMINAL DISCOMFORT (Stomach borderline upset), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pyrexia
Clinical narrative: Weakness; 99 degree Fahrenheit fever, but later came back with 100.7 degree Fahrenheit fever; A spontaneous report (United States) was received from a consumer concerning a relative 75-years-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a 99 degree Fahrenheit fever, but later came back with 100.7 degree Fahrenheit fever and weakness.  The patient's medical history was not provided. No concomitant medications were provided.   The patient received their first of two planned doses of mRNA-1273 (Lot/batch number: unknown) on an unspecified date. On 20 Feb 2021, approximately 5 days prior to onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced 99 degree Fahrenheit fever, was treated with paracetamol, but later came back with 100.7 degree Fahrenheit fever. The patient visited emergency room as experienced weakness.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore action taken with the drug in response to the events was not applicable.  The events, a 99 degree Fahrenheit fever, but later came back with 100.7 degree Fahrenheit fever and weakness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Pain in extremity, Vaccination site rash
Clinical narrative: Arm was a little sore; Something similar to little pimples; Red; A little bit of rash right around the injection area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), ACNE (Something similar to little pimples), ERYTHEMA (Red) and VACCINATION SITE RASH (A little bit of rash right around the injection area) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore), ACNE (Something similar to little pimples), ERYTHEMA (Red) and VACCINATION SITE RASH (A little bit of rash right around the injection area). On 30-Jan-2021, ACNE (Something similar to little pimples) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), ERYTHEMA (Red) and VACCINATION SITE RASH (A little bit of rash right around the injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event , included methimazole, metoprolol , folic acid and vitamin B12. Treatment information includes cortisone cream.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: Body hurt; Coughing; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body hurt), COUGH (Coughing), CHILLS (Chills) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DOM 2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Body hurt), COUGH (Coughing), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Body hurt), COUGH (Coughing), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: nausea; Fatigue; soreness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), FATIGUE (Fatigue), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) 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.    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 NAUSEA (nausea), FATIGUE (Fatigue), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, NAUSEA (nausea), FATIGUE (Fatigue), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Gait disturbance, Headache
Clinical narrative: body aches; chills; pain in arm injection site; really weak; wobbly; felt very ill; faint; persistent headache (worsening); Neck pain; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak) and GAIT DISTURBANCE (wobbly) in a 73-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.     The patient's past medical history included No adverse event.    On 05-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 MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak), GAIT DISTURBANCE (wobbly), MALAISE (felt very ill), DIZZINESS (faint), HEADACHE (persistent headache (worsening)) and NECK PAIN (Neck pain). At the time of the report, MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak), GAIT DISTURBANCE (wobbly), MALAISE (felt very ill), DIZZINESS (faint), HEADACHE (persistent headache (worsening)) and NECK PAIN (Neck pain) 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Neck pain, Vaccination site pain
Clinical narrative: body aches; chills; pain in arm injection site; really weak; wobbly; felt very ill; faint; persistent headache (worsening); Neck pain; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak) and GAIT DISTURBANCE (wobbly) in a 73-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.     The patient's past medical history included No adverse event.    On 05-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 MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak), GAIT DISTURBANCE (wobbly), MALAISE (felt very ill), DIZZINESS (faint), HEADACHE (persistent headache (worsening)) and NECK PAIN (Neck pain). At the time of the report, MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm injection site), ASTHENIA (really weak), GAIT DISTURBANCE (wobbly), MALAISE (felt very ill), DIZZINESS (faint), HEADACHE (persistent headache (worsening)) and NECK PAIN (Neck pain) 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: very mild pain in left arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (very mild pain in left arm of injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Cholesterol and Hypertension.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (very mild pain in left arm of injection). At the time of the report, VACCINATION SITE PAIN (very mild pain in left arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: 3 inch circle in the injection site; raised in injection site; itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (3 inch circle in the injection site), VACCINATION SITE SWELLING (raised in injection site) and VACCINATION SITE PRURITUS (itchy injection site) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (3 inch circle in the injection site), VACCINATION SITE SWELLING (raised in injection site) and VACCINATION SITE PRURITUS (itchy injection site). At the time of the report, VACCINATION SITE REACTION (3 inch circle in the injection site), VACCINATION SITE SWELLING (raised in injection site) and VACCINATION SITE PRURITUS (itchy injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: light headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (light headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Spice allergy.    On 23-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 HEADACHE (light headache). At the time of the report, HEADACHE (light headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Confusional state, Dehydration, Fatigue, Headache
Clinical narrative: Cognitive disfunction; extreme confusion; sleepyness; Dehydration; Pain at the injection site; muscle ache; fever; Headache; extreme exhaustion; A spontaneous report was received from a consumer concerning a 72-year-old, male patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  experienced pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense.    The patient's medical history, is not provided by the reporter.  Concomitant medications were reported, levodopa, carbidopa and entacapona, pramipexole, fludrocortisone, rasagiline, omega-3 acid ethyl esters, coenzyme Q10, glucosamine, and chondroitin    The patient received their first of two planned dose of mRNA-1273 on 31 Jan 2021.  Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 01 Feb 202, the patient, experienced pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense.    Treatment for the events included intravenous fluids.    Action taken with mRNA-1273 in response to the events was unknown.     The outcome of pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense were unknown.; Reporter's Comments: This case concerns a 72 year old, male patient, with a history of COVID (April 2020), who experienced an unexpected event of cognitive disorder among others, 2 days after receiving 1st dose of mRNA- 1273 (Lot# 041L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pyrexia, Somnolence
Clinical narrative: Cognitive disfunction; extreme confusion; sleepyness; Dehydration; Pain at the injection site; muscle ache; fever; Headache; extreme exhaustion; A spontaneous report was received from a consumer concerning a 72-year-old, male patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  experienced pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense.    The patient's medical history, is not provided by the reporter.  Concomitant medications were reported, levodopa, carbidopa and entacapona, pramipexole, fludrocortisone, rasagiline, omega-3 acid ethyl esters, coenzyme Q10, glucosamine, and chondroitin    The patient received their first of two planned dose of mRNA-1273 on 31 Jan 2021.  Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 01 Feb 202, the patient, experienced pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense.    Treatment for the events included intravenous fluids.    Action taken with mRNA-1273 in response to the events was unknown.     The outcome of pain at the injection site, muscle ache, fever, dehydration, headache. Later on he experienced cognitive disfunction, extreme confusion, extreme exhaustion, sleepiness, inability to rise or follow  instructions, he didn´t know where he was, he wasn´t making sense were unknown.; Reporter's Comments: This case concerns a 72 year old, male patient, with a history of COVID (April 2020), who experienced an unexpected event of cognitive disorder among others, 2 days after receiving 1st dose of mRNA- 1273 (Lot# 041L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.