chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eating disorder, Influenza, Lethargy, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow) and VACCINATION SITE WARMTH (extremely hot, ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 002A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised, Sjogren's disease and Thyroid disorder NOS.On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ), MYALGIA (overall severe body aches), PYREXIA (high fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, MYALGIA (overall severe body aches), PYREXIA (high fever) and CHILLS (chills) had resolved. At the time of the report, EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ) and NAUSEA (nausea) outcome was unknown and LETHARGY (feels a little lethargic) was resolving.No concomitant drug details were reported.This case was linked to MOD-2021-395848, MOD-2021-395849 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow) and VACCINATION SITE WARMTH (extremely hot, ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 002A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised, Sjogren's disease and Thyroid disorder NOS.On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ), MYALGIA (overall severe body aches), PYREXIA (high fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, MYALGIA (overall severe body aches), PYREXIA (high fever) and CHILLS (chills) had resolved. At the time of the report, EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ) and NAUSEA (nausea) outcome was unknown and LETHARGY (feels a little lethargic) was resolving.No concomitant drug details were reported.This case was linked to MOD-2021-395848, MOD-2021-395849 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow) and VACCINATION SITE WARMTH (extremely hot, ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 002A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunocompromised, Sjogren's disease and Thyroid disorder NOS.On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), LETHARGY (feels a little lethargic), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ), MYALGIA (overall severe body aches), PYREXIA (high fever), CHILLS (chills) and NAUSEA (nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In November 2021, MYALGIA (overall severe body aches), PYREXIA (high fever) and CHILLS (chills) had resolved. At the time of the report, EATING DISORDER (could not eat), INFLUENZA (it felt like a very very  bad case of the flu), RASH (breakout from top of arm to elbow), VACCINATION SITE WARMTH (extremely hot, ), PAIN IN EXTREMITY (severe arm ache and  painful), VACCINATION SITE ERYTHEMA (extremely red, ) and NAUSEA (nausea) outcome was unknown and LETHARGY (feels a little lethargic) was resolving.No concomitant drug details were reported.This case was linked to MOD-2021-395848, MOD-2021-395849 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received two different types of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received two different types of vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received two different types of vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received two different types of vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction to the booster, given three days ago.  Still having side effects.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a bad reaction to the booster, given three days ago.  Still having side effects.). At the time of the report, VACCINATION COMPLICATION (Had a bad reaction to the booster, given three days ago.  Still having side effects.) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (arm is quite hard near injection site), VACCINATION SITE SWELLING (arm is swollen near injection site) and VACCINATION SITE ERYTHEMA (arm is red near injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (arm is quite hard near injection site), VACCINATION SITE SWELLING (arm is swollen near injection site) and VACCINATION SITE ERYTHEMA (arm is red near injection site). At the time of the report, VACCINATION SITE INDURATION (arm is quite hard near injection site), VACCINATION SITE SWELLING (arm is swollen near injection site) and VACCINATION SITE ERYTHEMA (arm is red near injection site) outcome was unknown. Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Teething, Vaccination site pain
Clinical narrative: teeth in the left side of my face are aching; legs ache; arms ache; muscle aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of TEETHING (teeth in the left side of my face are aching), PAIN IN EXTREMITY (legs ache), VACCINATION SITE PAIN (arms ache), MYALGIA (muscle aches) and HEADACHE (headaches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 037A211B and 011A21A) for COVID-19 vaccination. No Medical History information was reported.On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced TEETHING (teeth in the left side of my face are aching), PAIN IN EXTREMITY (legs ache), VACCINATION SITE PAIN (arms ache), MYALGIA (muscle aches) and HEADACHE (headaches). At the time of the report, TEETHING (teeth in the left side of my face are aching), PAIN IN EXTREMITY (legs ache), VACCINATION SITE PAIN (arms ache), MYALGIA (muscle aches) and HEADACHE (headaches) had not resolved.Concomitant product use was not provided by the reporter.No treatment information was provided.This case was linked to MOD-2021-395789 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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.The patient reported that she was taking blood pressure medications.No treatment information was reported.This case was linked to MOD-2021-375273, MOD-2021-395812 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal discomfort, Pyrexia
Clinical narrative: Sore throat/nasal condition; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Sore throat/nasal condition), MYALGIA (Body aches) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included GABAPENTIN for an unknown indication. On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Sore throat/nasal condition), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, OROPHARYNGEAL DISCOMFORT (Sore throat/nasal condition), MYALGIA (Body aches) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired dose of the Moderna COVID-19 vaccine. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiffness in both legs; Achiness in both legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in both legs) and PAIN IN EXTREMITY (Achiness in both legs) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in both legs) and PAIN IN EXTREMITY (Achiness in both legs). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness in both legs) and PAIN IN EXTREMITY (Achiness in both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking other medications. No treatment medications were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm; Painful and at night he sleeps on his side to avoid laying on the affected arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm) and PAIN IN EXTREMITY (Painful and at night he sleeps on his side to avoid laying on the affected arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LIMB DISCOMFORT (Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm) and PAIN IN EXTREMITY (Painful and at night he sleeps on his side to avoid laying on the affected arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm) and PAIN IN EXTREMITY (Painful and at night he sleeps on his side to avoid laying on the affected arm) had not resolved.      No concomitant medications were reported.  It was reported that the symptoms were intermittent.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 degree Fahrenheit fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (103 degree Fahrenheit fever). At the time of the report, PYREXIA (103 degree Fahrenheit fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Body temperature: 103 (High) 103 degree Fahrenheit.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-395802 (Patient Link). Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (read about an orthopedist who had "pain so bad" from the Moderna vaccine he can no longer practice anymore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (read about an orthopedist who had "pain so bad" from the Moderna vaccine he can no longer practice anymore). At the time of the report, PAIN (read about an orthopedist who had "pain so bad" from the Moderna vaccine he can no longer practice anymore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medication were provided.No treatment information were given.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness
Clinical narrative: 2 or 3 weeks after the second vaccine my legs felt stiff.; exhaustion after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (2 or 3 weeks after the second vaccine my legs felt stiff.) and FATIGUE (exhaustion after second vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination.  No Medical History information was reported.On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (exhaustion after second vaccine). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (2 or 3 weeks after the second vaccine my legs felt stiff.). At the time of the report, MUSCULOSKELETAL STIFFNESS (2 or 3 weeks after the second vaccine my legs felt stiff.) and FATIGUE (exhaustion after second vaccine) outcome was unknown.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.This case was linked to MOD-2021-395727, MOD-2021-395871 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Limb discomfort
Clinical narrative: Legs were very heavy; left leg was burning; Very tired on Friday, Saturday, and Sunday; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (left leg was burning), LIMB DISCOMFORT (Legs were very heavy) and FATIGUE (Very tired on Friday, Saturday, and Sunday) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. L14F21A, 030A21A and 032B21A) for COVID-19 vaccination. No Medical History information was reported.On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced FATIGUE (Very tired on Friday, Saturday, and Sunday). On 20-Nov-2021, the patient experienced BURNING SENSATION (left leg was burning). On 21-Nov-2021, the patient experienced LIMB DISCOMFORT (Legs were very heavy). On 21-Nov-2021, FATIGUE (Very tired on Friday, Saturday, and Sunday) had resolved. At the time of the report, BURNING SENSATION (left leg was burning) and LIMB DISCOMFORT (Legs were very heavy) was resolving.    Concomitant medications were not reported.No treatment information was provided.This case was linked to MOD-2021-395727, MOD-2021-395870 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 005C21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021)). On 22-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (they administered a booster dose (on 22Nov2021) early (2nd dose on 21Jun2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided. It was reported that booster dose was given early to the patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication reported. No treatment information was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Myalgia, Pain in extremity, Vaccination site erythema
Clinical narrative: very bad sore arm, left side/it's in pain; worried and anxious; inflamed; it's red; very tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red) and FATIGUE (very tired) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red), FATIGUE (very tired) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red), FATIGUE (very tired) and MYALGIA (muscle pain) had not resolved. Patient is taking blood thinner medication,No treatment details were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation
Clinical narrative: very bad sore arm, left side/it's in pain; worried and anxious; inflamed; it's red; very tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red) and FATIGUE (very tired) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red), FATIGUE (very tired) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red), FATIGUE (very tired) and MYALGIA (muscle pain) had not resolved. Patient is taking blood thinner medication,No treatment details were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: My right arm is painful. My fingers were cold & numb, & I could hardly touch anything to where I could feel it, or lift anything.; I thought I was going to die; Every muscle in my body hurt; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (My right arm is painful.), HYPOAESTHESIA (My fingers were cold & numb, & I could hardly touch anything to where I could feel it, or lift anything.), FEELING ABNORMAL (I thought I was going to die) and MYALGIA (Every muscle in my body hurt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 011J20A) for COVID-19 vaccination. No Medical History information was reported.On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced HYPOAESTHESIA (My fingers were cold & numb, & I could hardly touch anything to where I could feel it, or lift anything.), FEELING ABNORMAL (I thought I was going to die) and MYALGIA (Every muscle in my body hurt). On 22-Nov-2021, the patient experienced PAIN IN EXTREMITY (My right arm is painful.). At the time of the report, PAIN IN EXTREMITY (My right arm is painful.) had not resolved and HYPOAESTHESIA (My fingers were cold & numb, & I could hardly touch anything to where I could feel it, or lift anything.), FEELING ABNORMAL (I thought I was going to die) and MYALGIA (Every muscle in my body hurt) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No relevant concomitant medications were reported. No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave expired vaccine to 9 patients) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave expired vaccine to 9 patients). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (They gave expired vaccine to 9 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant and Treatment medications were not reported. The vial was initially stored in the refrigerator on 11Nov2021 and the vial was first punctured at 10 AM on 18Nov2021.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: Very bad severe reaction with the booster vaccine; Severe neck pain; Arm sore; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very bad severe reaction with the booster vaccine), NECK PAIN (Severe neck pain), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Very bad severe reaction with the booster vaccine), NECK PAIN (Severe neck pain), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Very bad severe reaction with the booster vaccine), NECK PAIN (Severe neck pain), PAIN IN EXTREMITY (Arm sore) and PYREXIA (Fever) outcome was unknown.No Concomitant medications were provided by the reporter.No Treatment information was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: minor hives on their neck; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (minor hives on their neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included POTASSIUM CITRATE, METRONIDAZOLE and VITAMIN D NOS for an unknown indication.On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 19-Nov-2021 at 12:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced URTICARIA (minor hives on their neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 mg. On 20-Nov-2021, URTICARIA (minor hives on their neck) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant drug included calcium supplement (citrate, chloride).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Renal pain, Visual impairment, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (altered vision), RENAL PAIN (right side kidney flank  pain), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer vaccine.Past adverse reactions to the above products included Muscle ache with Pfizer vaccine.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced VISUAL IMPAIRMENT (altered vision). On 20-Nov-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). On an unknown date, the patient experienced RENAL PAIN (right side kidney flank  pain) and HEADACHE (headache). At the time of the report, VISUAL IMPAIRMENT (altered vision), RENAL PAIN (right side kidney flank  pain), VOMITING (vomiting) and HEADACHE (headache) outcome was unknown and NAUSEA (nausea) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medication were provided.No Treatment medication were provided. Patient reports some side effects to the Pfizer vaccine. Patient reports muscle aches.  Patient says Moderna vaccine had more symptoms. The patient received her booster Moderna Covid-19 vaccine on 19NOV2021 lot number 065F21A expiration date  is not provided. Patient received the vaccine in her right arm. The patient has a headache and altered vision. Patient reports nausea and vomiting on Saturday 20NOV2021 The patient reports right side kidney flank pain. Patient does not any longer experience nausea and no longer.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (simultaneously his whole body started itching, Itching has been constant since then, clearly correlates with the shot. Now on fluocinonide topical solution 0.05% for itching.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. W1B2A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to metals (Allergic to gold.). Concomitant products included FENOFIBRATE, FAMOTIDINE (PEPCID [FAMOTIDINE]), FAMOTIDINE and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication.On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (simultaneously his whole body started itching, Itching has been constant since then, clearly correlates with the shot. Now on fluocinonide topical solution 0.05% for itching.). The patient was treated with FLUOCINONIDE (topical) ongoing since an unknown date for Itching, at an unspecified dose and frequency and MONTELUKAST on 21-Nov-2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (simultaneously his whole body started itching, Itching has been constant since then, clearly correlates with the shot. Now on fluocinonide topical solution 0.05% for itching.) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.This case was linked to MOD-2021-396111 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (the itching got worse. Itching has been constant since then) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and W1B2A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to gold.Concomitant products included FENOFIBRATE, FAMOTIDINE (PEPCID [FAMOTIDINE]), FAMOTIDINE and DEXLANSOPRAZOLE (DEXILANT) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PRURITUS (the itching got worse. Itching has been constant since then). The patient was treated with FLUOCINONIDE (topical) ongoing since an unknown date for Itching, at an unspecified dose and frequency and MONTELUKAST ongoing from 21-Nov-2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (the itching got worse. Itching has been constant since then) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Patient stated that he has seen his doctors, dermatologist and allergist.This case was linked to MOD-2021-396067 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported.On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment information was provided.The vial was kept under Moderna's recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medications details were not reported by the reporter.Treatment details was not reported by the reporter.Company comment : This is a case of expired product administered for this 57-year-old male patient. No adverse events were reported. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report. Sender's Comments: This is a case of expired product administered for this 57-year-old male patient. No adverse events were reported. The benefit-risk relationship of mRNA-1273  vaccine is not affected by this report.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2 booster doses (1 to each patient) to 2 patients who were less than then age of 18 years/Less than 18 years of age) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2 booster doses (1 to each patient) to 2 patients who were less than then age of 18 years/Less than 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 2 booster doses (1 to each patient) to 2 patients who were less than then age of 18 years/Less than 18 years of age) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant informations were reported.No Treatment informations were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site erythema
Clinical narrative: Red spot on the injection site for 6 days after booster; Expired vaccine received for booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot on the injection site for 6 days after booster) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine received for booster dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 013A21A and 00M20A) for COVID-19 vaccination. Concurrent medical conditions included COPD.On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot on the injection site for 6 days after booster) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine received for booster dose). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine received for booster dose) had resolved. On 16-Nov-2021, VACCINATION SITE ERYTHEMA (Red spot on the injection site for 6 days after booster) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Booster after being contacting COVID and being treated with remdisivir; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Booster after being contacting COVID and being treated with remdisivir) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Booster after being contacting COVID and being treated with remdisivir). The patient was treated with REMDESIVIR for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Booster after being contacting COVID and being treated with remdisivir) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Company Comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred on an unknown date before the third dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.Concomitant medications was not provided by the reporter.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of COVID 19. The event occurred on an unknown date before the third dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.