chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster, Immune system disorder, Lethargy, Vaccination site pain
Clinical narrative: weakened immune system; brain fog; felt an intense burning "like a match was in arm" / sore arm; Diagnosed with shingles; lethargy after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with shingles), IMMUNE SYSTEM DISORDER (weakened immune system), LETHARGY (lethargy after 2nd dose), FEELING ABNORMAL (brain fog) and VACCINATION SITE PAIN (felt an intense burning "like a match was in arm" / sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) 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-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced LETHARGY (lethargy after 2nd dose). On 15-Mar-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles). On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (weakened immune system), FEELING ABNORMAL (brain fog) and VACCINATION SITE PAIN (felt an intense burning "like a match was in arm" / sore arm). On 15-Mar-2021, LETHARGY (lethargy after 2nd dose) had resolved. At the time of the report, HERPES ZOSTER (Diagnosed with shingles) had resolved and IMMUNE SYSTEM DISORDER (weakened immune system), FEELING ABNORMAL (brain fog) and VACCINATION SITE PAIN (felt an intense burning "like a match was in arm" / sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-090238 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Patient developed Shingles eruptions under arms, under breasts and over the back) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, ISOSORBIDE, OMEPRAZOLE, ATORVASTATIN, ZOLPIDEM TARTRATE, DULOXETINE, METOPROLOL, BUSPIRONE, CHLORPROPAMIDE, VITAMIN D3 and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced HERPES ZOSTER (Patient developed Shingles eruptions under arms, under breasts and over the back). At the time of the report, HERPES ZOSTER (Patient developed Shingles eruptions under arms, under breasts and over the back) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient visited ER on Friday, 23 Apr2021, who confirmed it as shingles eruption and gave prescription for pain medications and discharged the patient back home. Gave consent for safety team and HCP for follow up and the preferred method of contact is by email.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Gait inability, Hypoaesthesia
Clinical narrative: Numbness in feet; Tingling in feet; Unable to walk; Swelling in knees; Swelling in feet when over exerted; Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets; Extreme fatigue; Had a flare up of her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Had a flare up of her arthritis), HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk) and JOINT SWELLING (Swelling in knees) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Celiac disease and Sulfonamide allergy (Allergy to sulfa drugs).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced ARTHRITIS (Had a flare up of her arthritis). 12-Apr-2021, the patient experienced ARTHRALGIA (Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk), JOINT SWELLING (Swelling in knees) and PERIPHERAL SWELLING (Swelling in feet when over exerted). At the time of the report, ARTHRITIS (Had a flare up of her arthritis), HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk), JOINT SWELLING (Swelling in knees), PERIPHERAL SWELLING (Swelling in feet when over exerted) and FATIGUE (Extreme fatigue) outcome was unknown and ARTHRALGIA (Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included various supplements and digestive enzymes. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Added patient demographics, relevant medical history, concomitant medications. New events (extreme fatigue, joint pain, numbness in feet, tingling in feet, swelling in knees) were added. The outcome of the event (joint pain) changed (from unknown to not resolved). On 25-Jul-2021: No new information was received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Paraesthesia, Peripheral swelling
Clinical narrative: Numbness in feet; Tingling in feet; Unable to walk; Swelling in knees; Swelling in feet when over exerted; Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets; Extreme fatigue; Had a flare up of her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Had a flare up of her arthritis), HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk) and JOINT SWELLING (Swelling in knees) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Celiac disease and Sulfonamide allergy (Allergy to sulfa drugs).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced ARTHRITIS (Had a flare up of her arthritis). 12-Apr-2021, the patient experienced ARTHRALGIA (Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk), JOINT SWELLING (Swelling in knees) and PERIPHERAL SWELLING (Swelling in feet when over exerted). At the time of the report, ARTHRITIS (Had a flare up of her arthritis), HYPOAESTHESIA (Numbness in feet), PARAESTHESIA (Tingling in feet), GAIT INABILITY (Unable to walk), JOINT SWELLING (Swelling in knees), PERIPHERAL SWELLING (Swelling in feet when over exerted) and FATIGUE (Extreme fatigue) outcome was unknown and ARTHRALGIA (Acute and debilitating joint pain in fingers, wrists, elbows, knees, feets) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included various supplements and digestive enzymes. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Added patient demographics, relevant medical history, concomitant medications. New events (extreme fatigue, joint pain, numbness in feet, tingling in feet, swelling in knees) were added. The outcome of the event (joint pain) changed (from unknown to not resolved). On 25-Jul-2021: No new information was received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Illness, Lymphadenopathy, Myalgia
Clinical narrative: extremely sick; nothing tastes right; chills; fever; extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking); vomiting; swollen lymph nodes (swollen and sore) in right breast; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), VACCINATION SITE SWELLING (injection site swollen) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site swollen). On 20-Apr-2021, the patient experienced ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), PYREXIA (fever), MYALGIA (extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking)), VOMITING (vomiting) and LYMPHADENOPATHY (swollen lymph nodes (swollen and sore) in right breast). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 21-Apr-2021, VACCINATION SITE SWELLING (injection site swollen) had resolved. At the time of the report, ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), PYREXIA (fever), MYALGIA (extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking)), VOMITING (vomiting) and LYMPHADENOPATHY (swollen lymph nodes (swollen and sore) in right breast) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-066330 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066330:dose 1
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: extremely sick; nothing tastes right; chills; fever; extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking); vomiting; swollen lymph nodes (swollen and sore) in right breast; injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), VACCINATION SITE SWELLING (injection site swollen) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site swollen). On 20-Apr-2021, the patient experienced ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), PYREXIA (fever), MYALGIA (extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking)), VOMITING (vomiting) and LYMPHADENOPATHY (swollen lymph nodes (swollen and sore) in right breast). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 21-Apr-2021, VACCINATION SITE SWELLING (injection site swollen) had resolved. At the time of the report, ILLNESS (extremely sick), AGEUSIA (nothing tastes right), CHILLS (chills), PYREXIA (fever), MYALGIA (extreme body pain (her feet felt like she had frost bite, joint pain so bad she was shaking)), VOMITING (vomiting) and LYMPHADENOPATHY (swollen lymph nodes (swollen and sore) in right breast) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-066330 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066330:dose 1
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness when the getting the vaccine injected; Her arm swelled up; Soreness of arm; She developed a big hard lump in her injection site; Injection site was painful.; She had muscle pain all over her body; Headache; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site) and VACCINATION SITE PAIN (Injection site was painful.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site), VACCINATION SITE PAIN (Injection site was painful.), MYALGIA (She had muscle pain all over her body), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site), VACCINATION SITE PAIN (Injection site was painful.), MYALGIA (She had muscle pain all over her body), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         The patient didn't take any medications to alleviate their symptoms.  The patient post receiving the vaccine experienced the huge lump in their arm lasted about 3 weeks.  No Concomitant product use was reported.   This case was linked to MOD-2021-180135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up was received on 27-May-2021 and contains outcome of the event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Vaccination site induration, Vaccination site pain
Clinical narrative: Dizziness when the getting the vaccine injected; Her arm swelled up; Soreness of arm; She developed a big hard lump in her injection site; Injection site was painful.; She had muscle pain all over her body; Headache; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site) and VACCINATION SITE PAIN (Injection site was painful.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site), VACCINATION SITE PAIN (Injection site was painful.), MYALGIA (She had muscle pain all over her body), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness when the getting the vaccine injected), PERIPHERAL SWELLING (Her arm swelled up), PAIN IN EXTREMITY (Soreness of arm), VACCINATION SITE INDURATION (She developed a big hard lump in her injection site), VACCINATION SITE PAIN (Injection site was painful.), MYALGIA (She had muscle pain all over her body), HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         The patient didn't take any medications to alleviate their symptoms.  The patient post receiving the vaccine experienced the huge lump in their arm lasted about 3 weeks.  No Concomitant product use was reported.   This case was linked to MOD-2021-180135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up was received on 27-May-2021 and contains outcome of the event.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Pain at injection site right arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site right arm), PYREXIA (fever) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site right arm), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at injection site right arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided          No treatment information provided  No concomitant medication listed
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: sore arm; red splotch on arm at injection site that feels hot; red splotch on arm at injection site that feels hot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (red splotch on arm at injection site that feels hot) and INJECTION SITE ERYTHEMA (red splotch on arm at injection site that feels hot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (red splotch on arm at injection site that feels hot) and INJECTION SITE ERYTHEMA (red splotch on arm at injection site that feels hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), INJECTION SITE WARMTH (red splotch on arm at injection site that feels hot) and INJECTION SITE ERYTHEMA (red splotch on arm at injection site that feels hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were mentioned.  The second dose was scheduled for 10-May-2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous, Rash macular
Clinical narrative: left foot swells in the evening; red dots on thigh, top of feet, knees; red dots are on both legs; red dots spreading; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left foot swells in the evening), RASH MACULAR (red dots on thigh, top of feet, knees), RASH ERYTHEMATOUS (red dots are on both legs) and RASH MACULAR (red dots spreading) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID] and GLIPIZIDE for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left foot swells in the evening), RASH MACULAR (red dots on thigh, top of feet, knees), RASH ERYTHEMATOUS (red dots are on both legs) and RASH MACULAR (red dots spreading). At the time of the report, PERIPHERAL SWELLING (left foot swells in the evening), RASH ERYTHEMATOUS (red dots are on both legs) and RASH MACULAR (red dots spreading) outcome was unknown and RASH MACULAR (red dots on thigh, top of feet, knees) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history, lab data,  and treatment medications are provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Hypoaesthesia
Clinical narrative: head numbness; Throwing up; low grade temperature; Headache; severe weakness; dizziness; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (severe weakness), DIZZINESS (dizziness), DIARRHOEA (Diarrhoea), HYPOAESTHESIA (head numbness) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 15-Jan-2021 to 01-Feb-2021. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMIN & MINERAL for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ASTHENIA (severe weakness), DIZZINESS (dizziness), HYPOAESTHESIA (head numbness), VOMITING (Throwing up), PYREXIA (low grade temperature) and HEADACHE (Headache). In April 2021, the patient experienced DIARRHOEA (Diarrhoea). On 06-Apr-2021, ASTHENIA (severe weakness), DIZZINESS (dizziness), HYPOAESTHESIA (head numbness), VOMITING (Throwing up), PYREXIA (low grade temperature) and HEADACHE (Headache) had resolved. In April 2021, DIARRHOEA (Diarrhoea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Water pill and Blood pressure pill. Treatment medication not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: head numbness; Throwing up; low grade temperature; Headache; severe weakness; dizziness; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (severe weakness), DIZZINESS (dizziness), DIARRHOEA (Diarrhoea), HYPOAESTHESIA (head numbness) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 15-Jan-2021 to 01-Feb-2021. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMIN & MINERAL for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ASTHENIA (severe weakness), DIZZINESS (dizziness), HYPOAESTHESIA (head numbness), VOMITING (Throwing up), PYREXIA (low grade temperature) and HEADACHE (Headache). In April 2021, the patient experienced DIARRHOEA (Diarrhoea). On 06-Apr-2021, ASTHENIA (severe weakness), DIZZINESS (dizziness), HYPOAESTHESIA (head numbness), VOMITING (Throwing up), PYREXIA (low grade temperature) and HEADACHE (Headache) had resolved. In April 2021, DIARRHOEA (Diarrhoea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Water pill and Blood pressure pill. Treatment medication not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dehydration, Feeling abnormal, Headache, Myalgia
Clinical narrative: Feeling miserable; Dehydrates quicker than normal; Joint pain; headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable), DEHYDRATION (Dehydrates quicker than normal), ARTHRALGIA (Joint pain), HEADACHE (headache) and MYALGIA (Muscle pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetic.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling miserable), DEHYDRATION (Dehydrates quicker than normal), ARTHRALGIA (Joint pain), HEADACHE (headache) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Feeling miserable), DEHYDRATION (Dehydrates quicker than normal), ARTHRALGIA (Joint pain), HEADACHE (headache) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include Blood pressure medication and Diabetic medication. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090387, US-MODERNATX, INC.-MOD-2021-090392 (E2B Linked Report). This case was linked to MOD-2021-090264 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090392:Husband dose 2 case US-MODERNATX, INC.-MOD-2021-090387:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose that lasted for 40 to 45 minutes; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (runny nose that lasted for 40 to 45 minutes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042b2117 and 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for Diabetes.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced RHINORRHOEA (runny nose that lasted for 40 to 45 minutes). On 25-Apr-2021, RHINORRHOEA (runny nose that lasted for 40 to 45 minutes) had resolved. Not provided.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 28-5-21 via TCR. Denied further follow-up
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: arm swollen at injection site about 10 inches wide,redness, the area is hot; the area at injection site is hard; arm swollen at injection site about 10 inches wide,redness, the area is hot; arm swollen at injection site about 10 inches wide,redness, the area is hot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (arm swollen at injection site about 10 inches wide,redness, the area is hot), INJECTION SITE INDURATION (the area at injection site is hard), INJECTION SITE SWELLING (arm swollen at injection site about 10 inches wide,redness, the area is hot) and INJECTION SITE ERYTHEMA (arm swollen at injection site about 10 inches wide,redness, the area is hot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (arm swollen at injection site about 10 inches wide,redness, the area is hot), INJECTION SITE INDURATION (the area at injection site is hard), INJECTION SITE SWELLING (arm swollen at injection site about 10 inches wide,redness, the area is hot) and INJECTION SITE ERYTHEMA (arm swollen at injection site about 10 inches wide,redness, the area is hot). At the time of the report, INJECTION SITE WARMTH (arm swollen at injection site about 10 inches wide,redness, the area is hot), INJECTION SITE INDURATION (the area at injection site is hard), INJECTION SITE SWELLING (arm swollen at injection site about 10 inches wide,redness, the area is hot) and INJECTION SITE ERYTHEMA (arm swollen at injection site about 10 inches wide,redness, the area is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Sciatica
Clinical narrative: all over aches and pains; shooting pains down her right leg; sciatica-like pain, but only occasionally; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (shooting pains down her right leg), SCIATICA (sciatica-like pain, but only occasionally) and PAIN (all over aches and pains) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) from 19-Apr-2021 to an unknown date and NAPROXEN SODIUM (ALEVE) from 19-Apr-2021 to an unknown date for Pain.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (shooting pains down her right leg) and SCIATICA (sciatica-like pain, but only occasionally). On 16-Apr-2021, the patient experienced PAIN (all over aches and pains). At the time of the report, PAIN IN EXTREMITY (shooting pains down her right leg) and SCIATICA (sciatica-like pain, but only occasionally) outcome was unknown and PAIN (all over aches and pains) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include IUD mirena. Treatments include muscle relaxers, pain medications, steroids.    This case was linked to MOD-2021-090313 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site induration, Vaccination site mass
Clinical narrative: Got big ball on her injeciton site arm; Ball on her injection site arm. was huge & hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Mar-2021, the patient experienced VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard). At the time of the report, VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications provided. No treatment information provided.    This case was linked to MODERNATX, INC.-MOD-2021-090356 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Got big ball on her injeciton site arm; Ball on her injection site arm. was huge & hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Mar-2021, the patient experienced VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard). At the time of the report, VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications provided. No treatment information provided.    This case was linked to MODERNATX, INC.-MOD-2021-090356 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site induration, Vaccination site mass
Clinical narrative: Body aches; Feeling tired; Fever of 101°F; Single bout of vomiting; Throbbing pain in arm in her injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), FATIGUE (Feeling tired), VACCINATION SITE PAIN (Throbbing pain in arm in her injection site arm), PYREXIA (Fever of 101°F) and VOMITING (Single bout of vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (Throbbing pain in arm in her injection site arm). On 24-Apr-2021, the patient experienced MYALGIA (Body aches), FATIGUE (Feeling tired), PYREXIA (Fever of 101°F) and VOMITING (Single bout of vomiting). At the time of the report, MYALGIA (Body aches) and FATIGUE (Feeling tired) had not resolved and VACCINATION SITE PAIN (Throbbing pain in arm in her injection site arm), PYREXIA (Fever of 101°F) and VOMITING (Single bout of vomiting) outcome was unknown.            No concomitant medications provided. The patient applied ice on her injection site arm.. Patient stated that she  continues to feel fatigued. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090289 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Body aches; Feeling tired; Fever of 101°F; Single bout of vomiting; Throbbing pain in arm in her injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), FATIGUE (Feeling tired), VACCINATION SITE PAIN (Throbbing pain in arm in her injection site arm), PYREXIA (Fever of 101°F) and VOMITING (Single bout of vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (Throbbing pain in arm in her injection site arm). On 24-Apr-2021, the patient experienced MYALGIA (Body aches), FATIGUE (Feeling tired), PYREXIA (Fever of 101°F) and VOMITING (Single bout of vomiting). At the time of the report, MYALGIA (Body aches) and FATIGUE (Feeling tired) had not resolved and VACCINATION SITE PAIN (Throbbing pain in arm in her injection site arm), PYREXIA (Fever of 101°F) and VOMITING (Single bout of vomiting) outcome was unknown.            No concomitant medications provided. The patient applied ice on her injection site arm.. Patient stated that she  continues to feel fatigued. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090289 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Burning Red Area when shower water touches the red area; Rash on the Right Arm (3") and Back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the Right Arm (3") and Back) and ERYTHEMA (Burning Red Area when shower water touches the red area) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for Covid-19 Vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced RASH (Rash on the Right Arm (3") and Back) and ERYTHEMA (Burning Red Area when shower water touches the red area). At the time of the report, RASH (Rash on the Right Arm (3") and Back) and ERYTHEMA (Burning Red Area when shower water touches the red area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received first dose at 17 years old; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at 17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Disabled child.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose at 17 years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medications were not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Thirst
Clinical narrative: Dizziness; extremely thirsty; Fatigue, little tired; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), THIRST (extremely thirsty), FATIGUE (Fatigue, little tired), HEADACHE (Headache) and NAUSEA (Nausea) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001C21A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Not clear if allergic reaction to amoxicillin is historical or related to recent tooth extraction) since an unknown date and Tooth extraction on 16-Apr-2021. Concomitant products included AMOXICILLIN, CLINDAMYCIN, VALACYCLOVIR [VALACICLOVIR], IBUPROFEN and TRAMADOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (Dizziness), THIRST (extremely thirsty), FATIGUE (Fatigue, little tired), HEADACHE (Headache) and NAUSEA (Nausea). On 27-Mar-2021, DIZZINESS (Dizziness), THIRST (extremely thirsty), FATIGUE (Fatigue, little tired), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Specific treatment information was not reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Dizzy, it comes and goes, Feels dizzy when moves head; Sweating; Had incontrollable vomiting; felt nauseas; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy, it comes and goes, Feels dizzy when moves head), HYPERHIDROSIS (Sweating), VOMITING (Had incontrollable vomiting) and NAUSEA (felt nauseas) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in 2007 and Surgery (for Heart attack) in 2007. Concurrent medical conditions included Anxiety and Pollen allergy. Concomitant products included CITALOPRAM, LISINOPRIL, ATORVASTATIN, CLONAZEPAM and METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (Dizzy, it comes and goes, Feels dizzy when moves head), HYPERHIDROSIS (Sweating), VOMITING (Had incontrollable vomiting) and NAUSEA (felt nauseas). At the time of the report, DIZZINESS (Dizzy, it comes and goes, Feels dizzy when moves head), HYPERHIDROSIS (Sweating), VOMITING (Had incontrollable vomiting) and NAUSEA (felt nauseas) had resolved.        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 27-May-2021: Update event outcome in events tab., Sender's comment in analysis tab updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Malaise, Nausea
Clinical narrative: feel really sick; light-headedness; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel really sick), DIZZINESS (light-headedness), NAUSEA (nausea) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018821A) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced MALAISE (feel really sick), DIZZINESS (light-headedness), NAUSEA (nausea) and CHILLS (chills). The patient was treated with ONDANSETRON at a dose of 1 dosage form. At the time of the report, MALAISE (feel really sick), DIZZINESS (light-headedness), NAUSEA (nausea) and CHILLS (chills) had not resolved.            No Concomitant medications were reported.  The patient drank coco cola and took Ondansetron 4mg at 11:00AM  to settle his stomach.