chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Body aches) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced HEADACHE (Headache), PAIN (Body aches) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), PAIN (Body aches) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not reported Treatment information were not provided Action taken with mRNA-1273 in response to the event was not applicable
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and ARTHRALGIA (joint aches and pains) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TELMISARTAN (MICARDIS), CLONIDINE, DILTIAZEM, METOPROLOL TARTRATE, METFORMIN and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (headache). In March 2021, the patient experienced ARTHRALGIA (joint aches and pains). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 12-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, ARTHRALGIA (joint aches and pains) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was born on ??-???-1955. Reporter did not allow further contact.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Thought blocking
Clinical narrative: severe brain fog; trouble navigating thoughts; tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (severe brain fog), THOUGHT BLOCKING (trouble navigating thoughts) and FATIGUE (tired and fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (severe brain fog), THOUGHT BLOCKING (trouble navigating thoughts) and FATIGUE (tired and fatigue). At the time of the report, FEELING ABNORMAL (severe brain fog), THOUGHT BLOCKING (trouble navigating thoughts) and FATIGUE (tired and fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant FU-Event Outcome Updated. TCR Received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: very sore arm; a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm) and RASH (a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy. Concomitant products included CARVEDILOL (CARVEDIOL) for an unknown indication.   On 06-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 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (very sore arm) and RASH (a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark). On 06-Jan-2021, PAIN IN EXTREMITY (very sore arm) and RASH (a little bit of a rash/ a huge rash from the top of her shoulder to her elbow, very dark like a birth mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication also include statin (low dose). Action taken with mRNA-1273 in response to the event was not applicable.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Headache, Myalgia, Nausea, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose taken more than 35 days ago, did not get second dose), ADVERSE REACTION (Severe reaction), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Slight headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D40A21A) for COVID-19 vaccination. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA), DOXEPIN, LEVOTHYROXINE, LANSOPRAZOLE, FAMOTIDINE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), METHYLCELLULOSE (CITRUCEL), VITAMIN D3, FLUTICASONE PROPIONATE (FLOVENT), ALBUTEROL SULFATE, CHONDROITIN SULFATE (BIOFLEX CHONDROITIN), GUAIFENESIN (MUCINEX), OMALIZUMAB (XOLAIR), FLUTICASONE, MELOXICAM, GABAPENTIN (NEURONTIN), IVERMECTIN and METRONIDAZOLE for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Slight headache). On 09-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose taken more than 35 days ago, did not get second dose). On an unknown date, the patient experienced ADVERSE REACTION (Severe reaction). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose taken more than 35 days ago, did not get second dose) had resolved and ADVERSE REACTION (Severe reaction), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Slight headache) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was provided. The patient had a severe reaction after the first dose, so the patient did not get the second dose. The patient asked if the patient could get a second dose. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: follow up information : reporter address updated, first dose start date was updated,  New events were added (missed dose and adverse reaction), added concomitant medications
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Nausea, Pyrexia
Clinical narrative: Weakness; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Weakness), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). On 01-Mar-2021, ASTHENIA (Weakness), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) 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 relevant concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea
Clinical narrative: COLD; some running nose; cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD), RHINORRHOEA (some running nose) and COUGH (cough) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Hypertension. Concomitant products included LISINOPRIL, LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, METOPROLOL and FUROSEMIDE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced NASOPHARYNGITIS (COLD), RHINORRHOEA (some running nose) and COUGH (cough). At the time of the report, NASOPHARYNGITIS (COLD), RHINORRHOEA (some running nose) and COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment received for the event is cough syrup
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Head discomfort, Myalgia, Pain, Pain in extremity
Clinical narrative: Tingling sensation in the right leg; Pain in the right leg; Soreness; Joint pain; Pressure in head; Pain all over body; Drowsy; Pressure in head; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy), the first episode of HEAD DISCOMFORT (Pressure in head), the second episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body) and PARAESTHESIA (Tingling sensation in the right leg) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herniated disc and GERD since an unknown date. Concurrent medical conditions included Cholesterol and Sjogren's syndrome. Concomitant products included SIMVASTATIN for Cholesterol, PANTOPRAZOLE for GERD, CEVIMELINE for Sjogren's syndrome.    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 SOMNOLENCE (Drowsy) and the first episode of HEAD DISCOMFORT (Pressure in head). On 02-Mar-2021, the patient experienced the second episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body), MYALGIA (Soreness) and ARTHRALGIA (Joint pain). On 07-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation in the right leg) and PAIN IN EXTREMITY (Pain in the right leg). On 18-Feb-2021, SOMNOLENCE (Drowsy) had resolved. At the time of the report, last episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body), PARAESTHESIA (Tingling sensation in the right leg), PAIN IN EXTREMITY (Pain in the right leg), MYALGIA (Soreness) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided   This case was linked to MOD-2021-183795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Reporter contact information was updated, relevant medical history was updated, vaccine facility details were added, concomitant medications were added, new events were added.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Somnolence
Clinical narrative: Tingling sensation in the right leg; Pain in the right leg; Soreness; Joint pain; Pressure in head; Pain all over body; Drowsy; Pressure in head; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsy), the first episode of HEAD DISCOMFORT (Pressure in head), the second episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body) and PARAESTHESIA (Tingling sensation in the right leg) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20N) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herniated disc and GERD since an unknown date. Concurrent medical conditions included Cholesterol and Sjogren's syndrome. Concomitant products included SIMVASTATIN for Cholesterol, PANTOPRAZOLE for GERD, CEVIMELINE for Sjogren's syndrome.    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 SOMNOLENCE (Drowsy) and the first episode of HEAD DISCOMFORT (Pressure in head). On 02-Mar-2021, the patient experienced the second episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body), MYALGIA (Soreness) and ARTHRALGIA (Joint pain). On 07-Mar-2021, the patient experienced PARAESTHESIA (Tingling sensation in the right leg) and PAIN IN EXTREMITY (Pain in the right leg). On 18-Feb-2021, SOMNOLENCE (Drowsy) had resolved. At the time of the report, last episode of HEAD DISCOMFORT (Pressure in head), PAIN (Pain all over body), PARAESTHESIA (Tingling sensation in the right leg), PAIN IN EXTREMITY (Pain in the right leg), MYALGIA (Soreness) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided   This case was linked to MOD-2021-183795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Reporter contact information was updated, relevant medical history was updated, vaccine facility details were added, concomitant medications were added, new events were added.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain in her left wrist; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in her left wrist) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain in her left wrist). At the time of the report, ARTHRALGIA (pain in her left wrist) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Malaise, Vaccination complication
Clinical narrative: laid up for about 36 hours; Not feeling well; a reaction after first dose; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (laid up for about 36 hours), MALAISE (Not feeling well) and VACCINATION COMPLICATION (a reaction after first dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 BEDRIDDEN (laid up for about 36 hours), MALAISE (Not feeling well) and VACCINATION COMPLICATION (a reaction after first dose). At the time of the report, BEDRIDDEN (laid up for about 36 hours), MALAISE (Not feeling well) and VACCINATION COMPLICATION (a reaction after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-060141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Additional information included reporter's contact details and an additional event.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site pain
Clinical narrative: Pregnant; Soreness at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Soreness at injection site) in a 35-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 13-Aug-2003, Pregnancy on 03-Nov-2008 and Pregnancy on 24-Nov-2014.    On 06-Mar-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Feb-2021 and the estimated date of delivery was 12-Nov-2021. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (Soreness at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 06-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 08-Mar-2021, VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, TAMSULOSIN, SIMVASTATIN, FINASTERIDE, TRIAMTERENE, APIXABAN (ELIQUIS), METOPROLOL, DIGOXIN and IPRATROPIUM BROMIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up 01: No new information received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at injection site; Swelling; Redness; Itching; Pain; Sore at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PAIN (Sore at the injection), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Pain) and VACCINATION SITE SWELLING (Swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SIMVASTATIN for High cholesterol, VITAMIN D2 from 25-Feb-2021 to an unknown date for Vitamin D low.    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 VACCINATION SITE PAIN (Sore at the injection). On 12-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at injection site) and VACCINATION SITE SWELLING (Swelling). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and DICLOFENAC DIETHYLAMINE (VOLTAREN EMULGEL) at an unspecified dose and frequency. On 08-Mar-2021, VACCINATION SITE PAIN (Sore at the injection) had resolved. On 20-Mar-2021, VACCINATION SITE WARMTH (Hot at injection site) and VACCINATION SITE SWELLING (Swelling) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl, voltaren gel and ice.   This case was linked to MOD-2021-044218, MOD-2021-160917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Follow up received on 22-May-2021 contains patient demographics, concomitant products and add new event and updated outcome.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site reaction
Clinical narrative: Sore Arm; Rash on the arm/rash from his knees down; had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE REACTION (had a reaction) and RASH (Rash on the arm/rash from his knees down) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE REACTION (had a reaction). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and RASH (Rash on the arm/rash from his knees down). The patient was treated with CORTISONE at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE REACTION (had a reaction) and RASH (Rash on the arm/rash from his knees down) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information also included Anti-histamines.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received: Added event.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Patient tested positive for covid few days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for covid few days after receiving 1st dose) 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 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced COVID-19 (Patient tested positive for covid few days after receiving 1st dose). At the time of the report, COVID-19 (Patient tested positive for covid few days after receiving 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: positive (Positive) reported on 15-Mar-2021 he tested positive last week for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the event.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Tachycardia (Heart Rate: 110 BPM); This spontaneous case was reported by a pharmacist and describes the occurrence of TACHYCARDIA (Tachycardia (Heart Rate: 110 BPM)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) 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 15-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia (Heart Rate: 110 BPM)). On 15-Feb-2021, TACHYCARDIA (Tachycardia (Heart Rate: 110 BPM)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 110 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment was reported for the events.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Little itchy; Pretty large, red oval in the injection site; Sore; This spontaneous case was reported by a physical therapist and describes the occurrence of VACCINATION SITE PRURITUS (Little itchy), VACCINATION SITE ERYTHEMA (Pretty large, red oval in the injection site) and VACCINATION SITE PAIN (Sore) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfas). Concomitant products included VITAMINS NOS and FISH OIL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Little itchy), VACCINATION SITE ERYTHEMA (Pretty large, red oval in the injection site) and VACCINATION SITE PAIN (Sore). On 08-Feb-2021, VACCINATION SITE PRURITUS (Little itchy) and VACCINATION SITE PAIN (Sore) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Pretty large, red oval in the injection site) 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 medications for treatment.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had an achy arm after receiving both doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had an achy arm after receiving both doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 022M20A) for COVID-19 vaccination.     Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Dry eye, POTASSIUM for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (Had an achy arm after receiving both doses). At the time of the report, PAIN IN EXTREMITY (Had an achy arm after receiving both doses) outcome was unknown.            No treatment  information was reported.   This case was linked to MOD-2021-059146 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Vaccination site erythema, Vaccination site rash
Clinical narrative: Felt hot and cold; 2 inch circle rash; Dark pink in color; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), VACCINATION SITE RASH (2 inch circle rash) and VACCINATION SITE ERYTHEMA (Dark pink in color) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Seasonal allergy. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, VITAMIN D [VITAMIN D NOS] for an unknown indication.    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 FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), VACCINATION SITE RASH (2 inch circle rash) and VACCINATION SITE ERYTHEMA (Dark pink in color). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), VACCINATION SITE RASH (2 inch circle rash) and VACCINATION SITE ERYTHEMA (Dark pink in color) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: Arm soreness; Bruising; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and CONTUSION (Bruising) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol, Reflux esophagitis, Thyroid disorder and Gout. Concomitant products included ALLOPURINOL for Gout, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CONTUSION (Bruising). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). The patient was treated with MENTHOL, METHYL SALICYLATE (SALONPAS [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and CONTUSION (Bruising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Included no new information.; Reporter's Comments: This report refers to a case of Missed Dose for mRNA-1273, lot # unknown  with no associated AEs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: flu; Lethargic; Shortness of breath; Patient has issues with her both her knee; she said jokingly that she had good knees at one time; real bad headaches; Chills; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), LETHARGY (Lethargic), DYSPNOEA (Shortness of breath), ARTHRALGIA (Patient has issues with her both her knee; she said jokingly that she had good knees at one time) and HEADACHE (real bad headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee pain. Previously administered products included for an unreported indication: Flu shot (Patient had the flu shot; she didn't know the date bit said that it was last year 2020) in 2020.   On 13-Mar-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 14-Mar-2021, the patient experienced INFLUENZA (flu), LETHARGY (Lethargic), DYSPNOEA (Shortness of breath), ARTHRALGIA (Patient has issues with her both her knee; she said jokingly that she had good knees at one time), HEADACHE (real bad headaches), CHILLS (Chills) and FATIGUE (Real tired). The patient was treated with IBUPROFEN for Knee pain, at a dose of 800 mg. At the time of the report, INFLUENZA (flu), LETHARGY (Lethargic), DYSPNOEA (Shortness of breath), HEADACHE (real bad headaches) and FATIGUE (Real tired) was resolving, ARTHRALGIA (Patient has issues with her both her knee; she said jokingly that she had good knees at one time) outcome was unknown and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Report included updated email id.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Lethargy
Clinical narrative: flu; Lethargic; Shortness of breath; Patient has issues with her both her knee; she said jokingly that she had good knees at one time; real bad headaches; Chills; Real tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), LETHARGY (Lethargic), DYSPNOEA (Shortness of breath), ARTHRALGIA (Patient has issues with her both her knee; she said jokingly that she had good knees at one time) and HEADACHE (real bad headaches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee pain. Previously administered products included for an unreported indication: Flu shot (Patient had the flu shot; she didn't know the date bit said that it was last year 2020) in 2020.   On 13-Mar-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 14-Mar-2021, the patient experienced INFLUENZA (flu), LETHARGY (Lethargic), DYSPNOEA (Shortness of breath), ARTHRALGIA (Patient has issues with her both her knee; she said jokingly that she had good knees at one time), HEADACHE (real bad headaches), CHILLS (Chills) and FATIGUE (Real tired). The patient was treated with IBUPROFEN for Knee pain, at a dose of 800 mg. At the time of the report, INFLUENZA (flu), LETHARGY (Lethargic), DYSPNOEA (Shortness of breath), HEADACHE (real bad headaches) and FATIGUE (Real tired) was resolving, ARTHRALGIA (Patient has issues with her both her knee; she said jokingly that she had good knees at one time) outcome was unknown and CHILLS (Chills) had resolved.            Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Report included updated email id.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Limb discomfort, Vomiting
Clinical narrative: Legs felt so heavy; Dizziness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs felt so heavy), DIZZINESS (Dizziness) and VOMITING (vomiting) 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 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced LIMB DISCOMFORT (Legs felt so heavy), DIZZINESS (Dizziness) and VOMITING (vomiting). At the time of the report, LIMB DISCOMFORT (Legs felt so heavy), DIZZINESS (Dizziness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bruxism, Chills, Fatigue, Impaired work ability, Movement disorder
Clinical narrative: could not get out of couch; could not go to work; she felt tired; chills; muscle ache; fever; teeth are clatterig; bite side of her tongue; This spontaneous case was reported by a consumer and describes the occurrence of BRUXISM (teeth are clatterig), TONGUE BITING (bite side of her tongue), MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE for an unknown indication.   On 12-Mar-2021 at 11:30 AM, 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BRUXISM (teeth are clatterig). 12-Mar-2021, the patient experienced TONGUE BITING (bite side of her tongue). On 12-Mar-2021 at 9:00 PM, the patient experienced CHILLS (chills), MYALGIA (muscle ache) and PYREXIA (fever). On 13-Mar-2021, the patient experienced MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work) and FATIGUE (she felt tired). On 13-Mar-2021, BRUXISM (teeth are clatterig), TONGUE BITING (bite side of her tongue), CHILLS (chills) and PYREXIA (fever) had resolved. On 15-Mar-2021, MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work), MYALGIA (muscle ache) and FATIGUE (she felt tired) had resolved.            No treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tongue biting
Clinical narrative: could not get out of couch; could not go to work; she felt tired; chills; muscle ache; fever; teeth are clatterig; bite side of her tongue; This spontaneous case was reported by a consumer and describes the occurrence of BRUXISM (teeth are clatterig), TONGUE BITING (bite side of her tongue), MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE for an unknown indication.   On 12-Mar-2021 at 11:30 AM, 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BRUXISM (teeth are clatterig). 12-Mar-2021, the patient experienced TONGUE BITING (bite side of her tongue). On 12-Mar-2021 at 9:00 PM, the patient experienced CHILLS (chills), MYALGIA (muscle ache) and PYREXIA (fever). On 13-Mar-2021, the patient experienced MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work) and FATIGUE (she felt tired). On 13-Mar-2021, BRUXISM (teeth are clatterig), TONGUE BITING (bite side of her tongue), CHILLS (chills) and PYREXIA (fever) had resolved. On 15-Mar-2021, MOVEMENT DISORDER (could not get out of couch), IMPAIRED WORK ABILITY (could not go to work), MYALGIA (muscle ache) and FATIGUE (she felt tired) had resolved.            No treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Felt nausea; Headache after first dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Felt nausea) and HEADACHE (Headache after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 NAUSEA (Felt nausea) and HEADACHE (Headache after first dose). At the time of the report, NAUSEA (Felt nausea) and HEADACHE (Headache after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.   This case was linked to MOD-2021-045353 (E2B Linked Report).; Sender's Comments:  MOD-2021-045353:Cross linked case
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Medication leaked down my arm; the needle hub wasn't screwed on all the way; A spontaneous report  was received from a dentist concerning a 29-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication leaked down my arm/ Vaccine under dose and the needle hub wasn't screwed on all the way/ syringe connection issue.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 2 Feb 2021, approximately same day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection.   On 2 Feb 2021, prior to receiving mRNA-1273, the patient experienced medication leaked down my arm and the needle hub wasn't screwed on all the way. Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, medication leaked down my arm and the needle hub wasn't screwed on all the way were considered resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered and  Device connection issue for mRNA-1273, lot # unknown  with no associated Adverse Events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Pyrexia
Clinical narrative: Disoriented; Dizzy/lightheaded; Fever for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented), DIZZINESS (Dizzy/lightheaded) and PYREXIA (Fever for 1 day) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DISORIENTATION (Disoriented), DIZZINESS (Dizzy/lightheaded) and PYREXIA (Fever for 1 day). On 10-Mar-2021, PYREXIA (Fever for 1 day) had resolved. At the time of the report, DISORIENTATION (Disoriented) and DIZZINESS (Dizzy/lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatments were taken.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder
Clinical narrative: no immune response; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (no immune response) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MYCOPHENOLATE MOFETIL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (no immune response). At the time of the report, IMMUNE SYSTEM DISORDER (no immune response) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Treatment information was  provided.