chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Sneezing
Clinical narrative: Chills; Sneezing; head cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), SNEEZING (Sneezing) and NASOPHARYNGITIS (head cold) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MELOXICAM, ATORVASTATIN, HYDROCHLOROTHIAZIDE, AMLODIPINE and FLUOXETINE for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced SNEEZING (Sneezing) and NASOPHARYNGITIS (head cold). On 04-Mar-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYNELOL) for Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), SNEEZING (Sneezing) and NASOPHARYNGITIS (head cold) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose on day 18; A spontaneous report was received from a consumer concerning herself, 66- years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient was supposed to get second dose on 15 Mar 2021 and instead she got it at day 18 (inappropriate schedule of product administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 15 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (batch: 024M20A) via unknown route for prophylaxis of COVID-19 infection.  On 05 Mar 2021 (day 18), the patient received their second of two planned doses of mRNA-1273 (batch: 037M20A) via unknown route for prophylaxis of COVID-19 infection.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the event, received second dose on day 18 was recovered on 05 Mar 2021; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 037M20A with second dose day 18) with no associated AEs reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: a little bit of coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a little bit of coughing) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 COUGH (a little bit of coughing). At the time of the report, COUGH (a little bit of coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Headache; Fever; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe) and Crohn's disease (Moderate to severe).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Pre-filled pen. On 17-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) had not 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 reported.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administerd 8 doses to 8 patients from a vial punctured 24 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administerd 8 doses to 8 patients from a vial punctured 24 hours ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administerd 8 doses to 8 patients from a vial punctured 24 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administerd 8 doses to 8 patients from a vial punctured 24 hours ago) had resolved.        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.; Sender's Comments: This report refers to a case of 'expired vaccine administered' for mRNA-1273, lot number unknown with no associated AEs. Causality for this medication error is not applicable
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash on her left arm; "Moderna arm" [Rash]; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on her left arm; "Moderna arm" [Rash]) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dyskinesia and Parkinson's disease. Concomitant products included AMANTADINE HYDROCHLORIDE (GOCOVRI) from 30-Jan-2018 to an unknown date for Dyskinesia and Parkinson's disease.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Rash on her left arm; "Moderna arm" [Rash]). At the time of the report, VACCINATION SITE RASH (Rash on her left arm; "Moderna arm" [Rash]) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications was not provided by the reporter   This case was linked to MOD-2021-223796 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up report included no new information
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin reaction, Vaccination complication
Clinical narrative: rash 10 days after shot; rash 10 days after the shot; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (rash 10 days after shot), VACCINATION COMPLICATION (covid arm) and RASH (rash 10 days after the shot) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (covid arm). On 24-Feb-2021, the patient experienced SKIN REACTION (rash 10 days after shot) and RASH (rash 10 days after the shot). At the time of the report, SKIN REACTION (rash 10 days after shot), VACCINATION COMPLICATION (covid arm) and RASH (rash 10 days after the shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Nausea, Pulse abnormal
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PULSE ABNORMAL (feeling her pulse through out her body), HEART RATE INCREASED (Heart rate spikes ranging between 50 to 116 bpm recorded with apple watch), NAUSEA (Nausea) and FATIGUE (Generalized fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. HRS011A21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PULSE ABNORMAL (feeling her pulse through out her body) and HEART RATE INCREASED (Heart rate spikes ranging between 50 to 116 bpm recorded with apple watch). On 06-Mar-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Generalized fatigue). On 05-Mar-2021, PULSE ABNORMAL (feeling her pulse through out her body) and HEART RATE INCREASED (Heart rate spikes ranging between 50 to 116 bpm recorded with apple watch) had resolved. At the time of the report, NAUSEA (Nausea) and FATIGUE (Generalized fatigue) had not resolved.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Heart rate: variable (abnormal) baseline:72 bpm variable reading ranging from 50 bpm as high as 116 bpm. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient did not use any concomitant medications. Patient did not use any treatment medicines for the symptoms.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: Left arm redness/ "redness all the way to elbow"; Arm warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Left arm redness/ "redness all the way to elbow") and FEELING HOT (Arm warm to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013A211A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 ERYTHEMA (Left arm redness/ "redness all the way to elbow") and FEELING HOT (Arm warm to touch). The patient was treated with ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Feb-2021, FEELING HOT (Arm warm to touch) had resolved. On 22-Feb-2021, ERYTHEMA (Left arm redness/ "redness all the way to elbow") had resolved.            No concomitant medications were provided.  Treatment for the event also included antibiotics.   This case was linked to MOD-2021-037847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 03-MAY-2021 included: The duration of the event (Left arm redness/ "redness all the way to elbow") changed (from 1 week to 3 weeks). The patient reported that she does not have access to email or fax to receive ADR form. She also reported that she experienced the same "redness" after the second vaccine but that it "wrapped around my arm". She states that this reaction lasted for approximately 3 weeks and resolved after taking antihistamines. She was seen at Urgent Care and Emergency Room but could not remember dates of either visit.
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) Inconclusive.         No Concomitant medications were reported.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Followup document received on 22-JUL-2021 contains updated event outcome
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: inadvertently administered doses from a vial that was in refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (inadvertently administered doses from a vial that was in refrigerator for more than 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT STORAGE ERROR (inadvertently administered doses from a vial that was in refrigerator for more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (inadvertently administered doses from a vial that was in refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-017961 (Patient Link).; Sender's Comments: This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Lacrimation increased, Pain in extremity
Clinical narrative: left arm warmth; left arm redness; swelling; Redness turned blue; left arm itching; Weeping left eye; left arm pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Weeping left eye), PAIN IN EXTREMITY (left arm pain), SKIN DISCOLOURATION (Redness turned blue), FEELING HOT (left arm warmth) and PRURITUS (left arm itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A211A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced LACRIMATION INCREASED (Weeping left eye), PAIN IN EXTREMITY (left arm pain) and CHILLS (Chills). On 03-Mar-2021, the patient experienced SKIN DISCOLOURATION (Redness turned blue), PRURITUS (left arm itching) and PERIPHERAL SWELLING (swelling). On 08-Mar-2021, the patient experienced FEELING HOT (left arm warmth) and ERYTHEMA (left arm redness). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 02-Mar-2021, CHILLS (Chills) had resolved. On 04-Mar-2021, LACRIMATION INCREASED (Weeping left eye) and PAIN IN EXTREMITY (left arm pain) had resolved. On 06-Mar-2021, PERIPHERAL SWELLING (swelling) had not resolved. At the time of the report, SKIN DISCOLOURATION (Redness turned blue) outcome was unknown, FEELING HOT (left arm warmth) and PRURITUS (left arm itching) had not resolved and ERYTHEMA (left arm redness) had resolved.            No concomitant drugs were reported.  Treatment drugs for second dose include pepcid, Zyrtec and antihistamines used for Erythema   This case was linked to MOD-2021-037797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received: Per reporter, she had "redness all the way to elbow" that lasted for 3 weeks after receiving first vaccine. She also reported that she experienced the same "redness" after the second vaccine but that it "wrapped around my arm". She states that this reaction lasted for approximately 3 weeks and resolved after taking antihistamines.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin discolouration
Clinical narrative: left arm warmth; left arm redness; swelling; Redness turned blue; left arm itching; Weeping left eye; left arm pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Weeping left eye), PAIN IN EXTREMITY (left arm pain), SKIN DISCOLOURATION (Redness turned blue), FEELING HOT (left arm warmth) and PRURITUS (left arm itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A211A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced LACRIMATION INCREASED (Weeping left eye), PAIN IN EXTREMITY (left arm pain) and CHILLS (Chills). On 03-Mar-2021, the patient experienced SKIN DISCOLOURATION (Redness turned blue), PRURITUS (left arm itching) and PERIPHERAL SWELLING (swelling). On 08-Mar-2021, the patient experienced FEELING HOT (left arm warmth) and ERYTHEMA (left arm redness). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 02-Mar-2021, CHILLS (Chills) had resolved. On 04-Mar-2021, LACRIMATION INCREASED (Weeping left eye) and PAIN IN EXTREMITY (left arm pain) had resolved. On 06-Mar-2021, PERIPHERAL SWELLING (swelling) had not resolved. At the time of the report, SKIN DISCOLOURATION (Redness turned blue) outcome was unknown, FEELING HOT (left arm warmth) and PRURITUS (left arm itching) had not resolved and ERYTHEMA (left arm redness) had resolved.            No concomitant drugs were reported.  Treatment drugs for second dose include pepcid, Zyrtec and antihistamines used for Erythema   This case was linked to MOD-2021-037797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received: Per reporter, she had "redness all the way to elbow" that lasted for 3 weeks after receiving first vaccine. She also reported that she experienced the same "redness" after the second vaccine but that it "wrapped around my arm". She states that this reaction lasted for approximately 3 weeks and resolved after taking antihistamines.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Headache; chills; fever; nauseous; skin feels like its on fire; wet sweat; difficulty breathing; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (skin feels like its on fire), HYPERHIDROSIS (wet sweat), DYSPNOEA (difficulty breathing), FATIGUE (felt tired) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient is having high cholesterol, prematire atrial contraction,acid reflux.  Concurrent medical conditions included Hypertension, Arthritis, Cholesterol high, Sleep apnea, Acid reflux (esophageal) and Premature atrial contraction. Concomitant products included SIMVASTATIN, LISINOPRIL, METOPROLOL and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for an unknown indication.   On 27-Feb-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (felt tired). On 01-Mar-2021, the patient experienced SKIN BURNING SENSATION (skin feels like its on fire), HYPERHIDROSIS (wet sweat), DYSPNOEA (difficulty breathing), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseous). On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, HYPERHIDROSIS (wet sweat), DYSPNOEA (difficulty breathing), CHILLS (chills) and PYREXIA (fever) had resolved. On 08-Mar-2021, SKIN BURNING SENSATION (skin feels like its on fire) had resolved. At the time of the report, FATIGUE (felt tired) and NAUSEA (nauseous) had not resolved and HEADACHE (Headache) outcome was unknown.            Concomitant Medications taken by the patient also included other OTC.  Treatment medications taken by the patient was Tylenol (paracetamol).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received captured concomitant medications, patient demographics and dosage details.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Skin burning sensation
Clinical narrative: Headache; chills; fever; nauseous; skin feels like its on fire; wet sweat; difficulty breathing; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (skin feels like its on fire), HYPERHIDROSIS (wet sweat), DYSPNOEA (difficulty breathing), FATIGUE (felt tired) and CHILLS (chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient is having high cholesterol, prematire atrial contraction,acid reflux.  Concurrent medical conditions included Hypertension, Arthritis, Cholesterol high, Sleep apnea, Acid reflux (esophageal) and Premature atrial contraction. Concomitant products included SIMVASTATIN, LISINOPRIL, METOPROLOL and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for an unknown indication.   On 27-Feb-2021 at 10:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (felt tired). On 01-Mar-2021, the patient experienced SKIN BURNING SENSATION (skin feels like its on fire), HYPERHIDROSIS (wet sweat), DYSPNOEA (difficulty breathing), CHILLS (chills), PYREXIA (fever) and NAUSEA (nauseous). On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, HYPERHIDROSIS (wet sweat), DYSPNOEA (difficulty breathing), CHILLS (chills) and PYREXIA (fever) had resolved. On 08-Mar-2021, SKIN BURNING SENSATION (skin feels like its on fire) had resolved. At the time of the report, FATIGUE (felt tired) and NAUSEA (nauseous) had not resolved and HEADACHE (Headache) outcome was unknown.            Concomitant Medications taken by the patient also included other OTC.  Treatment medications taken by the patient was Tylenol (paracetamol).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received captured concomitant medications, patient demographics and dosage details.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not yet received the second dose of the vaccine due to shortages(today is day 58.)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Mild Tenderness of arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Mild Tenderness of arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TENDERNESS (Mild Tenderness of arm). At the time of the report, TENDERNESS (Mild Tenderness of arm) outcome was unknown.            No concomitant medications reported.  Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-037880 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Patient's Race information was added
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness at injection site). At the time of the report, INJECTION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-038236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-038236:Crosslinked case
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error, Vaccination site pain
Clinical narrative: The arm was squeezed when the vaccine was administered; Soreness; A spontaneous report was received from a Consumer concerning a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as sore arm , and that the arm of the injection was squeezed.  The patient's medical history was not provided.  No relevant concomitant medications were reported.    On 1st Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch: 012L20A) in the Arm for prophylaxis of COVID-19 infection.  On 3 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch: 012L20A) in the Arm for prophylaxis of COVID-19 infection.  On 8 Mar 2021, the patient had sore arm, and concerned whether the vaccination technique by squeezing the area during injection is OK.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   On an unknown date, the outcome of the events as sore arm, and that the arm of the injection was squeezed were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe tenderness in the arm/my arm was slightly sore for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe tenderness in the arm/my arm was slightly sore for a day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe tenderness in the arm/my arm was slightly sore for a day). On 06-Feb-2021, PAIN IN EXTREMITY (severe tenderness in the arm/my arm was slightly sore for a day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.  Treatment medications was not provided by the reporter   This case was linked to MOD-2021-037864 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received updated patient details, suspect dosage details, event details and outcome.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 19-Feb-2021, VACCINATION SITE PAIN (Pain at injection site) 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 treatment (mild) Pain scale 1 out of 10.  No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No patient details provided  No treatment and concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue on the second day of vaccination; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue on the second day of vaccination) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue on the second day of vaccination) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue on the second day of vaccination) and CHILLS (Chills) had resolved.            Concomitant medications were not provided by reporter. No treatment information was provided by reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramp; A spontaneous report was received from a consumer concerning an 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stomach cramp.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately two days prior to the onset of the event, the patient received their dose of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient experienced stomach cramp. It was not quiet bad and getting better. Treatment for the event  included paracetamol.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event stomach cramp was recovering (getting better).; 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 event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: 2 1/2  inch red hive around the injection site; 2 1/2 inch red hive around the injection site, its slightly puffy; 2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle; Arm was sore; tiny bruise around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE BRUISING (tiny bruise around the injection site), VACCINATION SITE URTICARIA (2 1/2  inch red hive around the injection site), VACCINATION SITE SWELLING (2 1/2 inch red hive around the injection site, its slightly puffy) and VACCINATION SITE ERYTHEMA (2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), LEVOTHYROXINE, LIOTHYRONINE, ATORVASTATIN, AMLODIPINE, CENTRUM SILVER +50, VITAMIN D3 and BIOTIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and VACCINATION SITE BRUISING (tiny bruise around the injection site). On 04-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (2 1/2  inch red hive around the injection site), VACCINATION SITE SWELLING (2 1/2 inch red hive around the injection site, its slightly puffy) and VACCINATION SITE ERYTHEMA (2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle). On 19-Feb-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. On 23-Feb-2021, VACCINATION SITE BRUISING (tiny bruise around the injection site) had resolved. At the time of the report, VACCINATION SITE URTICARIA (2 1/2  inch red hive around the injection site), VACCINATION SITE SWELLING (2 1/2 inch red hive around the injection site, its slightly puffy) and VACCINATION SITE ERYTHEMA (2 1/2 inch red hive around the injection site, its slightly puffy, slightly red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20 Jul 2021. contains no significant information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Gait disturbance, Pain in extremity, Pleurisy
Clinical narrative: patient was walking and lungs felt like they were on fire; has to cut walk down; pleurisy; feels short of breath; sore arm; This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (patient was walking and lungs felt like they were on fire), PAIN IN EXTREMITY (sore arm), GAIT DISTURBANCE (has to cut walk down), PLEURISY (pleurisy) and DYSPNOEA (feels short of breath) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement (20 years ago). Concurrent medical conditions included Type 2 diabetes mellitus (controlled by diet and exercise, last A1C 5.5). Concomitant products included WARFARIN SODIUM (COUMADIN) for Heart valve replacement, FUROSEMIDE (LASIX [FUROSEMIDE]), ATORVASTATIN, DOCUSATE SODIUM (COLACE), METOPROLOL, POTASSIUM, LISINOPRIL, MULTIVITAMINS [VITAMINS NOS], TOPIRAMATE (TOPAMAX), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CALCIUM and METFORMIN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-Feb-2021, the patient experienced CHEST PAIN (patient was walking and lungs felt like they were on fire), GAIT DISTURBANCE (has to cut walk down), PLEURISY (pleurisy) and DYSPNOEA (feels short of breath). At the time of the report, CHEST PAIN (patient was walking and lungs felt like they were on fire), PAIN IN EXTREMITY (sore arm), GAIT DISTURBANCE (has to cut walk down), PLEURISY (pleurisy) and DYSPNOEA (feels short of breath) had not resolved.        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.   Patient did not use any treatments medicines for the symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (bodyaches) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), GABAPENTIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (bodyaches). On 05-Mar-2021, the patient experienced PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) on 05-Mar-2021 for Fever, at an unspecified dose and frequency. On 05-Mar-2021, CHILLS (chills) and MYALGIA (bodyaches) had resolved. At the time of the report, PYREXIA (fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 100 deg (High) fever. Patient's concomitant medications included unspecified blood pressure medicines. The patient took ACETAMINOPHEN and ASPIRIN as treatment for fever. This case was linked to MOD-2021-036365.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: Tingling on the Arm, Face, and / or Legs; arm was heavy; Numbness on the Arm, Face, and / or Legs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (Tingling on the Arm, Face, and / or Legs), LIMB DISCOMFORT (arm was heavy) and HYPOAESTHESIA (Numbness on the Arm, Face, and / or Legs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Numbness on the Arm, Face, and / or Legs). On an unknown date, the patient experienced PARAESTHESIA (Tingling on the Arm, Face, and / or Legs) and LIMB DISCOMFORT (arm was heavy). At the time of the report, PARAESTHESIA (Tingling on the Arm, Face, and / or Legs), LIMB DISCOMFORT (arm was heavy) and HYPOAESTHESIA (Numbness on the Arm, Face, and / or Legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-037928 (Linked Report).; Sender's Comments:  MOD-2021-037928:multiple patient case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pyrexia, Urinary tract infection
Clinical narrative: UTI; Weakness; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI), ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever). On 06-Mar-2021, ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bradykinesia, Confusional state, Fatigue, Hypertension, Palpitations
Clinical narrative: left side of body slow; left arm shaking; Brain locking; heart is beating fast and hard; BP was 200+/97; can't get out of bed; right arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard) and HYPERTENSION (BP was 200+/97) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard), HYPERTENSION (BP was 200+/97), FATIGUE (can't get out of bed) and VACCINATION SITE PAIN (right arm pain). On 04-Mar-2021, HYPERTENSION (BP was 200+/97) and VACCINATION SITE PAIN (right arm pain) outcome was unknown. At the time of the report, BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard) and FATIGUE (can't get out of bed) had not 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.   Treatment information not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: left side of body slow; left arm shaking; Brain locking; heart is beating fast and hard; BP was 200+/97; can't get out of bed; right arm pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard) and HYPERTENSION (BP was 200+/97) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard), HYPERTENSION (BP was 200+/97), FATIGUE (can't get out of bed) and VACCINATION SITE PAIN (right arm pain). On 04-Mar-2021, HYPERTENSION (BP was 200+/97) and VACCINATION SITE PAIN (right arm pain) outcome was unknown. At the time of the report, BRADYKINESIA (left side of body slow), TREMOR (left arm shaking), CONFUSIONAL STATE (Brain locking), PALPITATIONS (heart is beating fast and hard) and FATIGUE (can't get out of bed) had not 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.   Treatment information not provided.