chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Sleep disorder
Clinical narrative: Left arm soreness; She cannot sleep on the left side; Chills at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), SLEEP DISORDER (She cannot sleep on the left side) and CHILLS (Chills at night) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, VITAMIN D [VITAMIN D NOS], PRAVASTATIN, LISINOPRIL, PAROXETINE and OMEPRAZOLE for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm soreness), SLEEP DISORDER (She cannot sleep on the left side) and CHILLS (Chills at night). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm soreness), SLEEP DISORDER (She cannot sleep on the left side) and CHILLS (Chills at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received Tylenol as treatment medication.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (Mild headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (Mild headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No Treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: both legs broke out with a rash; low-grade fever; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH (both legs broke out with a rash), PYREXIA (low-grade fever) and FATIGUE (fatigued) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced RASH (both legs broke out with a rash), PYREXIA (low-grade fever) and FATIGUE (fatigued). At the time of the report, RASH (both legs broke out with a rash), PYREXIA (low-grade fever) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided. Patient had an appointment with her doctor for rash.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Influenza
Clinical narrative: Arm is very painful/I can barely raise it; Lethargic; Flu symptoms; I feel like I have a cold; Shoulder pain/ Shooting pains like nerve pain in different joints; Headache; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very painful/I can barely raise it), LETHARGY (Lethargic), INFLUENZA (Flu symptoms), NASOPHARYNGITIS (I feel like I have a cold) and ARTHRALGIA (Shoulder pain/ Shooting pains like nerve pain in different joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is very painful/I can barely raise it), LETHARGY (Lethargic), INFLUENZA (Flu symptoms), NASOPHARYNGITIS (I feel like I have a cold), ARTHRALGIA (Shoulder pain/ Shooting pains like nerve pain in different joints), HEADACHE (Headache) and CHILLS (Freezing). The patient was treated with PARACETAMOL (TYLENOL) on 08-Mar-2021 at a dose of 8 UNK. At the time of the report, PAIN IN EXTREMITY (Arm is very painful/I can barely raise it), LETHARGY (Lethargic), INFLUENZA (Flu symptoms), NASOPHARYNGITIS (I feel like I have a cold), ARTHRALGIA (Shoulder pain/ Shooting pains like nerve pain in different joints), HEADACHE (Headache) and CHILLS (Freezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 99.6 (High) temperature is up to 99.6.         Concomitant medications was not provided.  At the time of reporting, the patient stated that she had taken 8 Tylenol since 08 Mar 2021.   This case was linked to MOD-2021-039856 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nasopharyngitis, Pain in extremity
Clinical narrative: Arm is very painful/I can barely raise it; Lethargic; Flu symptoms; I feel like I have a cold; Shoulder pain/ Shooting pains like nerve pain in different joints; Headache; Freezing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very painful/I can barely raise it), LETHARGY (Lethargic), INFLUENZA (Flu symptoms), NASOPHARYNGITIS (I feel like I have a cold) and ARTHRALGIA (Shoulder pain/ Shooting pains like nerve pain in different joints) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is very painful/I can barely raise it), LETHARGY (Lethargic), INFLUENZA (Flu symptoms), NASOPHARYNGITIS (I feel like I have a cold), ARTHRALGIA (Shoulder pain/ Shooting pains like nerve pain in different joints), HEADACHE (Headache) and CHILLS (Freezing). The patient was treated with PARACETAMOL (TYLENOL) on 08-Mar-2021 at a dose of 8 UNK. At the time of the report, PAIN IN EXTREMITY (Arm is very painful/I can barely raise it), LETHARGY (Lethargic), INFLUENZA (Flu symptoms), NASOPHARYNGITIS (I feel like I have a cold), ARTHRALGIA (Shoulder pain/ Shooting pains like nerve pain in different joints), HEADACHE (Headache) and CHILLS (Freezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 99.6 (High) temperature is up to 99.6.         Concomitant medications was not provided.  At the time of reporting, the patient stated that she had taken 8 Tylenol since 08 Mar 2021.   This case was linked to MOD-2021-039856 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Skin warm, Vaccination site pain
Clinical narrative: Felt like she had the vaccine again, she is very confused; Left arm warmer than her right arm; Sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Felt like she had the vaccine again, she is very confused), SKIN WARM (Left arm warmer than her right arm) and VACCINATION SITE PAIN (Sore at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041?(A)20A - not sure) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). On 09-Mar-2021, the patient experienced CONFUSIONAL STATE (Felt like she had the vaccine again, she is very confused) and SKIN WARM (Left arm warmer than her right arm). At the time of the report, CONFUSIONAL STATE (Felt like she had the vaccine again, she is very confused) and SKIN WARM (Left arm warmer than her right arm) outcome was unknown and VACCINATION SITE PAIN (Sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Pruritus, Urticaria
Clinical narrative: hives on all upper joints, right hip, and in middle of back; feeling itchy on back, arms, hands.; Injected arm very difficult to use; Aches; Tiredness; Very sore injected arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on all upper joints, right hip, and in middle of back), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches), PRURITUS (feeling itchy on back, arms, hands.) and PAIN IN EXTREMITY (Very sore injected arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very sore injected arm). On 26-Feb-2021, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches) and FATIGUE (Tiredness). On 06-Mar-2021, the patient experienced PRURITUS (feeling itchy on back, arms, hands.). On 07-Mar-2021, the patient experienced URTICARIA (hives on all upper joints, right hip, and in middle of back). The patient was treated with CORTISONE on 07-Mar-2021 for Hives, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Mar-2021 for Hives, at a dose of UNK dosage form. On 10-Mar-2021, URTICARIA (hives on all upper joints, right hip, and in middle of back), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches), PRURITUS (feeling itchy on back, arms, hands.), PAIN IN EXTREMITY (Very sore injected arm) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medication and antihyperlipidemic..   This case was linked to MOD-2021-103076 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint movement impairment
Clinical narrative: hives on all upper joints, right hip, and in middle of back; feeling itchy on back, arms, hands.; Injected arm very difficult to use; Aches; Tiredness; Very sore injected arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on all upper joints, right hip, and in middle of back), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches), PRURITUS (feeling itchy on back, arms, hands.) and PAIN IN EXTREMITY (Very sore injected arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very sore injected arm). On 26-Feb-2021, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches) and FATIGUE (Tiredness). On 06-Mar-2021, the patient experienced PRURITUS (feeling itchy on back, arms, hands.). On 07-Mar-2021, the patient experienced URTICARIA (hives on all upper joints, right hip, and in middle of back). The patient was treated with CORTISONE on 07-Mar-2021 for Hives, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Mar-2021 for Hives, at a dose of UNK dosage form. On 10-Mar-2021, URTICARIA (hives on all upper joints, right hip, and in middle of back), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Injected arm very difficult to use), MYALGIA (Aches), PRURITUS (feeling itchy on back, arms, hands.), PAIN IN EXTREMITY (Very sore injected arm) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medication and antihyperlipidemic..   This case was linked to MOD-2021-103076 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature). At the time of the report, PRODUCT STORAGE ERROR (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: 027L20A)  with no associated AEs.; Sender's Comments: This report refers to a case of Product Storage Error for mRNA-1273 (Lot #: 027L20A)  with no associated AEs.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Rash
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (discomfort in her arm) and RASH (rash on her face) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Gluten sensitivity (Gets rash).    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in her arm) and RASH (rash on her face). At the time of the report, LIMB DISCOMFORT (discomfort in her arm) had resolved and RASH (rash on her face) was resolving.            Concomitant medications were not reported. Treatment information in response to events was not provided. The patient had consulted Dermatologist and the HCP was unsure of the cause.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: feeling weak; not being able to do anything; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak; not being able to do anything), PYREXIA (fever) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ASTHENIA (feeling weak; not being able to do anything), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) in March 2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, ASTHENIA (feeling weak; not being able to do anything), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at he injection site) and MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 immunisation. Previously administered products included for an unreported indication: VACCINES (For whooping cough) in December 2020. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 16-Mar-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant). On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at he injection site). On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) had resolved. On 07-Mar-2021, VACCINATION SITE PAIN (pain at he injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. The patient did not receive any treatment medications as it was reported that the pain at the injection site resolved quickly without any medications.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 09-Mar-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.  Action taken was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: symptoms started residing except for a little numbness in her lips; lips and tongue went numb and she had some trouble swallowing but no trouble breathing; lips and tongue went numb and she had some trouble swallowing but no trouble breathing; symptoms came back and she experienced tingling in her lips; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), DYSPHAGIA (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), PARAESTHESIA ORAL (symptoms came back and she experienced tingling in her lips) and HYPOAESTHESIA ORAL (symptoms started residing except for a little numbness in her lips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), DYSPHAGIA (lips and tongue went numb and she had some trouble swallowing but no trouble breathing) and PARAESTHESIA ORAL (symptoms came back and she experienced tingling in her lips). On an unknown date, the patient experienced HYPOAESTHESIA ORAL (symptoms started residing except for a little numbness in her lips). On 03-Mar-2021, HYPOAESTHESIA ORAL (lips and tongue went numb and she had some trouble swallowing but no trouble breathing), DYSPHAGIA (lips and tongue went numb and she had some trouble swallowing but no trouble breathing) and PARAESTHESIA ORAL (symptoms came back and she experienced tingling in her lips) had resolved. At the time of the report, HYPOAESTHESIA ORAL (symptoms started residing except for a little numbness in her lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient herself took Benadryl for treating events.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm was hurt; Arm was swollen; Left shoulder hurts really bad today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurt), PERIPHERAL SWELLING (Arm was swollen) and ARTHRALGIA (Left shoulder hurts really bad today) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00106950) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurt), PERIPHERAL SWELLING (Arm was swollen) and ARTHRALGIA (Left shoulder hurts really bad today). At the time of the report, PAIN IN EXTREMITY (Arm was hurt), PERIPHERAL SWELLING (Arm was swollen) and ARTHRALGIA (Left shoulder hurts really bad today) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient received Ibuprofen for treating these events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Lymphadenopathy, Pain
Clinical narrative: soreness; diarrhea; fever(between 101-103 F); vomiting; chills; headache; swollen lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes) 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.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-011004 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Valid case (patient identifier provided) On 11-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-011004:Same reporter/Different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: soreness; diarrhea; fever(between 101-103 F); vomiting; chills; headache; swollen lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN (soreness), DIARRHOEA (diarrhea), PYREXIA (fever(between 101-103 F)), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes) 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.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-011004 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Valid case (patient identifier provided) On 11-Mar-2021: No specific follow-up information recorded.; Sender's Comments:  MOD-2021-011004:Same reporter/Different patient
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Contusion, Haemoglobin, Red blood cell count
Clinical narrative: Anemia; 3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose) and ANAEMIA (Anemia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination.     Concomitant products included CLOBETASOL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONTUSION (3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose). On an unknown date, the patient experienced ANAEMIA (Anemia). At the time of the report, CONTUSION (3 bruises in total (2 in upper right hand, 1 in arm) and there is one underneath wrist of the left arm after receiving 2nd dose) had not resolved and ANAEMIA (Anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Haemoglobin: 11 (Low) dropped from 13 to 11, reported as "erythrocytes" by reporter (wife) who is concerned about possible anemia. In 2021, Haemoglobin: 11.4 (Inconclusive) 11.4 and. In June 2021, Haemoglobin 12 (Inconclusive) 12. In 2021, Red blood cell count: (Low) low erythrocyte levels that had not returned to normal.         Concomitant medications included unspecified thyroid medication, blood pressure medication, and cholesterol medication. The patient was seeing a hematologist. Specific treatment for the events was not provided by the reporter.   This case was linked to MOD-2021-205644 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Additional event was added. Laboratory data was updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity, Sleep disorder, Vaccination complication
Clinical narrative: She felt as if she was hit by a truck; Fatigued; Myalgia; Her arm started hurting/Could not sleep all night after the vaccination because of severe pain; Could not sleep all night after the vaccination because of severe pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm started hurting/Could not sleep all night after the vaccination because of severe pain), SLEEP DISORDER (Could not sleep all night after the vaccination because of severe pain), VACCINATION COMPLICATION (She felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Myalgia) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]), IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) and LEVOTHYROXINE for an unknown indication.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm started hurting/Could not sleep all night after the vaccination because of severe pain) and SLEEP DISORDER (Could not sleep all night after the vaccination because of severe pain). On 04-Mar-2021, the patient experienced VACCINATION COMPLICATION (She felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Myalgia). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 28-Feb-2021, SLEEP DISORDER (Could not sleep all night after the vaccination because of severe pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Her arm started hurting/Could not sleep all night after the vaccination because of severe pain) outcome was unknown and VACCINATION COMPLICATION (She felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Myalgia) had not resolved.            No treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Hypersensitivity, Peripheral swelling, Pruritus
Clinical narrative: Arm turned red; Arm got hot / hot to touch; Arm has itching; Arm swelled up; hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm turned red), FEELING HOT (Arm got hot / hot to touch), PRURITUS (Arm has itching), PERIPHERAL SWELLING (Arm swelled up) and HYPERSENSITIVITY (hypersensitivity reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Mercury sensitivity (mercury/ thimerosal -red rash if on skin, burning and red in eyes) since 1968, Allergy to topical drugs (Chlorhexidine-Burning red skin on area of application then spread to armpits and groin) since November 2019, Allergy to antibiotic (Cefaclor- Hives on arms when taken as pill) since 1990, Latex allergy (Skin irritation), Osteoporosis in 1998 and Hypersensitivity reaction. Concomitant products included ATORVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for Stroke, UBIQUINOL (COQNOL) and DENOSUMAB (PROLIA) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (Arm turned red), FEELING HOT (Arm got hot / hot to touch), PRURITUS (Arm has itching), PERIPHERAL SWELLING (Arm swelled up) and HYPERSENSITIVITY (hypersensitivity reaction). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 16-Mar-2021, ERYTHEMA (Arm turned red), FEELING HOT (Arm got hot / hot to touch), PRURITUS (Arm has itching), PERIPHERAL SWELLING (Arm swelled up) and HYPERSENSITIVITY (hypersensitivity reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Significant follow up received on 21-JUN-2021. Included medical history, concomitant medications, treatment medication Tylenol and ethnicity. Dose 2 information was added. Event hypersensitivity reaction, events stop date and outcome was updated
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Broken out in shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Broken out in shingles) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Broken out in shingles). At the time of the report, HERPES ZOSTER (Broken out in shingles) 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 medication use was not provided. Treatment information was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Rash, Rash erythematous, Rash pruritic
Clinical narrative: scalp tenderness; Rashes are really very itchy; Rashes are red; rashes on face, neck and it spread/ rashes are travelling all over her body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (scalp tenderness), RASH PRURITIC (Rashes are really very itchy), RASH ERYTHEMATOUS (Rashes are red) and RASH (rashes on face, neck and it spread/ rashes are travelling all over her body) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M214 or 013MZ14 and 041L208) for COVID-19 vaccination.     The patient's past medical history included Shingles (The patient said that she already had shingles before.). Concomitant products included AMLODIPINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PAIN OF SKIN (scalp tenderness), RASH PRURITIC (Rashes are really very itchy), RASH ERYTHEMATOUS (Rashes are red) and RASH (rashes on face, neck and it spread/ rashes are travelling all over her body). The patient was treated with CETIRIZINE for Adverse event, at a dose of UNK dosage form; PREDNISONE for Adverse event, at a dose of UNK dosage form and HYDROXYZINE HCL for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN OF SKIN (scalp tenderness), RASH PRURITIC (Rashes are really very itchy), RASH ERYTHEMATOUS (Rashes are red) and RASH (rashes on face, neck and it spread/ rashes are travelling all over her body) had not resolved.            On 01-Mar-2021, the patient went to see her primary care physician and the physician diagnosed her symptoms as shingles. But the patient reported that she already had shingles before and went to see another doctor who stated that it was not shingles and could be reactions from vaccine. The physician prescribed the patient with allergy medications.
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Tongue blistering
Clinical narrative: bumps/blisters at the tip of her tongue; painful bumps/blisters at tip of her tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONGUE BLISTERING (bumps/blisters at the tip of her tongue) and GLOSSODYNIA (painful bumps/blisters at tip of her tongue) 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 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE BLISTERING (bumps/blisters at the tip of her tongue) and GLOSSODYNIA (painful bumps/blisters at tip of her tongue). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of UNK dosage form. At the time of the report, TONGUE BLISTERING (bumps/blisters at the tip of her tongue) and GLOSSODYNIA (painful bumps/blisters at tip of her tongue) outcome was unknown. Not Provided
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine; Stomach cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine) and ABDOMINAL PAIN UPPER (Stomach cramping) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome. Concomitant products included MAGNESIUM for Supplementation therapy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIARRHOEA (On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine) and ABDOMINAL PAIN UPPER (Stomach cramping). The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) for Adverse event, at a dose of UNK dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (On and off diarrhea every day/Having diarrhea much more than usual/No solid stool since receiving the vaccine) and ABDOMINAL PAIN UPPER (Stomach cramping) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included pepto bismol and Imodium to alleviate the symptoms. It was reported that Imodium had been helpful but not for long It was reported that diarrhea slowed after about 10 days along with all other symptoms. The patient was concerned that chemical polyethylene glycol in the shot could have an effect on his system. The patient discovered that he was taking magnesium supplement which could have been the culprit or could have been both. The patient went off the supplement and his system settled down in 10 day period. It was reported that most of the diarrhea happened in the morning time which was when most of his Inflammatory Bowel Syndrome (IBS) seemed to happen.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Outcome of events updated,  medical history added
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Productive cough, Vomiting
Clinical narrative: spitting up phlegm; upset tummy; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (spitting up phlegm), ABDOMINAL DISCOMFORT (upset tummy), VOMITING (vomiting) and NAUSEA (nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRODUCTIVE COUGH (spitting up phlegm), ABDOMINAL DISCOMFORT (upset tummy), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, PRODUCTIVE COUGH (spitting up phlegm), ABDOMINAL DISCOMFORT (upset tummy), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported . No treatment information was provided. .   This case was linked to MOD21-050084, MOD-2021-039826 (E2B Linked Report).; Sender's Comments:  MOD21-050084, MOD-2021-039826:patient case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: First dose of vaccine administered to pregnant patient; Little soreness at injection arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (First dose of vaccine administered to pregnant patient) and PAIN IN EXTREMITY (Little soreness at injection arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0104214) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 05-Jun-2021. On 01-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (First dose of vaccine administered to pregnant patient) and PAIN IN EXTREMITY (Little soreness at injection arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 01-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (First dose of vaccine administered to pregnant patient) had resolved. In March 2021, PAIN IN EXTREMITY (Little soreness at injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported. The patient wanted to go for glucose test at ultrasound clinic lab and her concern was if they would take blood from her right arm  where she received her first dose of vaccine as she had some condition with her left arm. The patient was not sure of her last menstrual period (LMP) and it was reported to be last week of Aug-2020. It was reported that patient developed little soreness at injection site which disappeared in 24 hours.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anticonvulsant drug level, Fatigue
Clinical narrative: Fatigue/Fatigued in and out; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/Fatigued in and out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included PHENYTOIN SODIUM (DILANTIN) for Convulsion prophylaxis.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FATIGUE (Fatigue/Fatigued in and out). At the time of the report, FATIGUE (Fatigue/Fatigued in and out) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anticonvulsant drug level: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. The patient thought if something happened with her Dilantin (Anticonvulsive) blood levels and consulted her health care professional for bloodwork to measure the levels. It was reported that it was higher than normal after vaccination and might be dangerous. It was reported that patient was experiencing fatigue in and out, not constant and was disturbing her daily activities, she could not finish anything that has to go to bed.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Follow up was received on 17-MAR-2021contains  concomitant medication added, lab data added, event updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard swollen knot from shoulder to where arm bends) and ILLNESS (She was ill) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE MASS (Hard swollen knot from shoulder to where arm bends). On an unknown date, the patient experienced ILLNESS (She was ill). On 09-Mar-2021, VACCINATION SITE MASS (Hard swollen knot from shoulder to where arm bends) had resolved. At the time of the report, ILLNESS (She was ill) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. No Treatment information  provided. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: additional event added.