chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose give 49 days after 1st injection; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose give 49 days after 1st injection) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose give 49 days after 1st injection). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose give 49 days after 1st injection) outcome 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 11-Jun-2021: Non significant follow up received on 11-JUN-2021, no new information
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Unevaluable event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Other symptoms post vaccination), HEADACHE (Headache) and FATIGUE (Fatigue) 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 UNEVALUABLE EVENT (Other symptoms post vaccination), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, UNEVALUABLE EVENT (Other symptoms post vaccination), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were reported; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Wrong Medicine Administered; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong Medicine Administered) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong Medicine Administered). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong Medicine Administered) outcome was unknown.            There was no treatment medication reported by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Blood pressure high; puffy at injection site; red at injection site; itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high), INJECTION SITE SWELLING (puffy at injection site), INJECTION SITE ERYTHEMA (red at injection site) and INJECTION SITE PRURITUS (itchy at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure high), INJECTION SITE SWELLING (puffy at injection site), INJECTION SITE ERYTHEMA (red at injection site) and INJECTION SITE PRURITUS (itchy at injection site). On 07-Mar-2021, INJECTION SITE SWELLING (puffy at injection site) and INJECTION SITE ERYTHEMA (red at injection site) had resolved. At the time of the report, HYPERTENSION (Blood pressure high) and INJECTION SITE PRURITUS (itchy at injection site) outcome was unknown.            No concomitant product use was reported No treatment information was provided   This case was linked to MOD-2021-041072 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: pain at the arm of the injection; vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and INJECTION SITE PAIN (pain at the arm of the injection) in a 36-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Induced abortion (blood problem , the baby did not come out, had to have surgery) in 2018, Spontaneous abortion in 2012, Hemochromatosis and Blood disorder NOS. Concurrent medical conditions included Allergy NOS. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Jan-2021 and the estimated date of delivery was 03-Oct-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On an unknown date, the patient experienced INJECTION SITE PAIN (pain at the arm of the injection). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, INJECTION SITE PAIN (pain at the arm of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Pregnancy test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications include unspecified allergy medicine.  No treatment medications were reported.   This case was linked to MOD-2021-039519 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Have 38.6 degree C; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have 38.6 degree C) 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 06-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced PYREXIA (Have 38.6 degree C). At the time of the report, PYREXIA (Have 38.6 degree C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Body temperature: 38.6 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was reported. No concomitant medication information was reported.  The reporter reported that, after taking vaccination on 06Jun2021, the patient had 38.6 degree C.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really sick for 30 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.     This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick for 30 hours) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ILLNESS (really sick for 30 hours).   At the time of the report, ILLNESS (really sick for 30 hours) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  Most recent FOLLOW-UP information incorporated above includes:  On 07-Jun-2021: Source Document(additional) added
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really sick for 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick for 30 hours) 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 ILLNESS (really sick for 30 hours). At the time of the report, ILLNESS (really sick for 30 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.    This case was linked to MOD-2021-210459 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Source Doc(additional) added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: sore arm; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SWELLING (swelling) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Diagnosed 1.5 years ago). Concomitant products included LENALIDOMIDE (REVLIMID) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and SWELLING (swelling). At the time of the report, PAIN IN EXTREMITY (sore arm) and SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.   This case was linked to MOD-2021-041328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Information on Medical history received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: had symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (had symptoms) 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) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (had symptoms). At the time of the report, ILLNESS (had symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia
Clinical narrative: Heart is bouncing all over the place; Fluctuating fast heart rate; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart is bouncing all over the place) and TACHYCARDIA (Fluctuating fast heart rate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Gastrointestinal disorder (Digestive Issues). Concomitant products included METOPROLOL and CLOPIDOGREL for an unknown indication.    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 PALPITATIONS (Heart is bouncing all over the place) and TACHYCARDIA (Fluctuating fast heart rate). At the time of the report, PALPITATIONS (Heart is bouncing all over the place) and TACHYCARDIA (Fluctuating fast heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-041285 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, Malaise
Clinical narrative: She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time; a week later, she got an email to come back for 2nd vaccine, she got second one; got very sick; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time), MALAISE (got very sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a week later, she got an email to come back for 2nd vaccine, she got second one) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 25-Feb-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a week later, she got an email to come back for 2nd vaccine, she got second one). In March 2021, the patient experienced MALAISE (got very sick). On 05-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (She got the first vaccine on 25Feb 2021, which was the Pfizer one and She got Moderna the second time) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a week later, she got an email to come back for 2nd vaccine, she got second one) had resolved. At the time of the report, MALAISE (got very sick) outcome was unknown.            No concomitant information was reported. No treatment information was reported.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .; Recieved Moderna vaccina at 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recieved Moderna vaccina at 16 years of age) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recieved Moderna vaccina at 16 years of age). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recieved Moderna vaccina at 16 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided    This case was linked to MOD-2021-065366 (Patient Link).
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .; Recived moderna vaccine at 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recived moderna vaccine at 16 years of age) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recived moderna vaccine at 16 years of age). On 22-Jan-2021, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose,its almost 9 weeks and 2 days passed after the 1st dose .) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Recived moderna vaccine at 16 years of age) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; slight head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight head ache) 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 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 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight head ache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (slight head ache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported  No treatment information was provided    This case was linked to MOD-2021-041056 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt under the weather) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt under the weather). At the time of the report, MALAISE (felt under the weather) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms). At the time of the report, PAIN IN EXTREMITY (sore arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.    Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: weakness; not feeling well; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MALAISE (not feeling well) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced ASTHENIA (weakness), MALAISE (not feeling well) and FATIGUE (fatigue). On 28-Mar-2021, ASTHENIA (weakness), MALAISE (not feeling well) and FATIGUE (fatigue) had resolved.            No medical history was provided by the reporter. No concomitant medications reported by investigator   This case was linked to MOD-2021-040701 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Tiredness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products EPOPROSTENOL SODIUM (VELETRI) for an unknown indication and MACITENTAN for an unknown indication.    Concurrent medical conditions included Pulmonary hypertension.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, EPOPROSTENOL SODIUM (VELETRI) (Intravenous) 1.5 milligram and MACITENTAN (Oral) 10 milligram. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Sensory loss
Clinical narrative: Loss of sensation in legs/lost feeling in both of their legs; left leg was still numb; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (Loss of sensation in legs/lost feeling in both of their legs) and HYPOAESTHESIA (left leg was still numb) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced SENSORY LOSS (Loss of sensation in legs/lost feeling in both of their legs) and HYPOAESTHESIA (left leg was still numb). At the time of the report, SENSORY LOSS (Loss of sensation in legs/lost feeling in both of their legs) and HYPOAESTHESIA (left leg was still numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Consumer tested positive for Covid-19 after getting the first vaccine dose; >42 days of not administered the second vaccine dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Consumer tested positive for Covid-19 after getting the first vaccine dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days of not administered the second vaccine dose.) 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 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Consumer tested positive for Covid-19 after getting the first vaccine dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days of not administered the second vaccine dose.). At the time of the report, SARS-COV-2 TEST POSITIVE (Consumer tested positive for Covid-19 after getting the first vaccine dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days of not administered the second vaccine dose.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Pharmacist reported that consumer tested positive after first dose of vaccine and also took antibody treatment. Treatment information include the antibody treatment.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Weight decreased
Clinical narrative: Loosing weight; Received second Moderna Covid-19 injection on 03Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Loosing weight) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna Covid-19 injection on 03Mar2021) 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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna Covid-19 injection on 03Mar2021). On an unknown date, the patient experienced WEIGHT DECREASED (Loosing weight). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna Covid-19 injection on 03Mar2021) outcome was unknown. At the time of the report, WEIGHT DECREASED (Loosing weight) outcome was unknown.            No concomitant information was reported. No treatment information was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vomiting
Clinical narrative: vomiting; muscle pain; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), MYALGIA (muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) 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 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced VOMITING (vomiting), MYALGIA (muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache). On 06-Jun-2021, VOMITING (vomiting), MYALGIA (muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Hair growth abnormal, Parosmia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Rancid smell), ABNORMAL FECES (Vile odor stool) and HAIR GROWTH ABNORMAL (Hair stopped growing) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Heartburn. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Heartburn, ASPIRIN [ACETYLSALICYLIC ACID], CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), HYDROCHLOROTHIAZIDE, SIMVASTATIN, METOPROLOL, VITAMINS NOS, FISH OIL, VITAMIN D NOS and PROBIOTICS NOS for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PAROSMIA (Rancid smell), ABNORMAL FAECES (Vile odor stool) and HAIR GROWTH ABNORMAL (Hair stopped growing). At the time of the report, PAROSMIA (Rancid smell), ABNORMAL FAECES (Vile odor stool) and HAIR GROWTH ABNORMAL (Hair stopped growing) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: daughter is 17 years old; she is 4 months out form her first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is 17 years old) and PRODUCT DOSE OMISSION ISSUE (she is 4 months out form her first shot) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autism.    On 03-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is 17 years old) and PRODUCT DOSE OMISSION ISSUE (she is 4 months out form her first shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is 17 years old) had resolved and PRODUCT DOSE OMISSION ISSUE (she is 4 months out form her first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Pain, Pyrexia
Clinical narrative: Very sick for 48 hours / wasn't able to work for two days; Body aches; Chills; 103 fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 48 hours / wasn't able to work for two days), PAIN (Body aches), PYREXIA (103 fever for 48 hours) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Previously administered products included for Product used for unknown indication: Shingles (Patient had a worse reaction) in February 2021. Past adverse reactions to the above products included Adverse event with Shingles.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick for 48 hours / wasn't able to work for two days), PAIN (Body aches), PYREXIA (103 fever for 48 hours) and CHILLS (Chills). At the time of the report, ILLNESS (Very sick for 48 hours / wasn't able to work for two days), PAIN (Body aches), PYREXIA (103 fever for 48 hours) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (Inconclusive) Fever of 103F for 48 hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After receiving the 1st dose vaccine, patient had a fever of 103 F for 48 hours along with chills and body aches. Patient also reported that, he was sick for 48 hours and was not able to work for two days.  Concomitant medications were not reported.  No treatment details were provided    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up was received and it contain significant information: new event added, very sick for 48 hours and wasn't able to work for two days.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Insomnia, Myalgia, Nausea
Clinical narrative: received a total of 4 doses of the Moderna Covid 19 vaccine; Huge Muscle pain; Nausea; lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received a total of 4 doses of the Moderna Covid 19 vaccine), INSOMNIA (lack of sleep), MYALGIA (Huge Muscle pain) and NAUSEA (Nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INSOMNIA (lack of sleep). On 13-Feb-2021, the patient experienced MYALGIA (Huge Muscle pain) and NAUSEA (Nausea). On 01-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (received a total of 4 doses of the Moderna Covid 19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (received a total of 4 doses of the Moderna Covid 19 vaccine), INSOMNIA (lack of sleep), MYALGIA (Huge Muscle pain) and NAUSEA (Nausea) outcome was unknown.            No concomitant information was reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of an expired vial; 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 EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial) 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.   ? No treatment information was provided.   This case was linked to MOD-2021-211360, MOD-2021-211360 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided    This case was linked to MOD-2021-211358 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia
Clinical narrative: numbness in her arm down to her figure tips; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her arm down to her figure tips) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in her arm down to her figure tips) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness in her arm down to her figure tips) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. Treatment activities for event was done with  ice.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past the 42 day window/didn't get my second dosage yet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past the 42 day window/didn't get my second dosage yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day window/didn't get my second dosage yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past the 42 day window/didn't get my second dosage yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information were not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of Bell's palsy (mild on left-side of the face) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 038C21A) for COVID-19 immunization. No medical history reported. On May 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 19, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced Bell's palsy (mild on left-side of the face). On May 21, 2021, Bell's palsy (mild on left-side of the face) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Jun 7, 2021: Additional information received: Patient demographics, product use and event details updated. Sender's comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: developing a dry cough as soon as he got the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (developing a dry cough as soon as he got the 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COUGH (developing a dry cough as soon as he got the 1st dose). At the time of the report, COUGH (developing a dry cough as soon as he got the 1st dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant medication history included blood pressure med.  Treatment information was provided cough drops.   This case was linked to MOD-2021-211391 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: pain in the lymph nodes; The patient received her first dose (lot #027C21A) of Moderna COVID19 Vaccine on 26May2021; Body aches; Lymph node swollen; throat pain; pain in her navel area; loose stools; diarrhea that was quite severe, multiple episodes per day for 10 days; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days), OROPHARYNGEAL PAIN (throat pain), ABDOMINAL PAIN (pain in her navel area), DIARRHEA (loose stools) and LYMPH NODE PAIN (pain in the lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days). On 07-Jun-2021, the patient experienced DIARRHEA (loose stools). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), ABDOMINAL PAIN (pain in her navel area) and LYMPH NODE PAIN (pain in the lymph nodes). On 07-Jun-2021, DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (throat pain) had resolved and ABDOMINAL PAIN (pain in her navel area), DIARRHEA (loose stools) and LYMPH NODE PAIN (pain in the 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.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Product dose omission issue
Clinical narrative: pain in the lymph nodes; The patient received her first dose (lot #027C21A) of Moderna COVID19 Vaccine on 26May2021; Body aches; Lymph node swollen; throat pain; pain in her navel area; loose stools; diarrhea that was quite severe, multiple episodes per day for 10 days; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days), OROPHARYNGEAL PAIN (throat pain), ABDOMINAL PAIN (pain in her navel area), DIARRHEA (loose stools) and LYMPH NODE PAIN (pain in the lymph nodes) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days). On 07-Jun-2021, the patient experienced DIARRHEA (loose stools). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), ABDOMINAL PAIN (pain in her navel area) and LYMPH NODE PAIN (pain in the lymph nodes). On 07-Jun-2021, DIARRHEA (diarrhea that was quite severe, multiple episodes per day for 10 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (throat pain) had resolved and ABDOMINAL PAIN (pain in her navel area), DIARRHEA (loose stools) and LYMPH NODE PAIN (pain in the 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.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: greater than 35 days since patient received first dose. Patient not yet received their second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (greater than 35 days since patient received first dose. Patient not yet received their second dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (greater than 35 days since patient received first dose. Patient not yet received their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (greater than 35 days since patient received first dose. Patient not yet received their second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.