chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Confusional state, Dizziness, Eye irritation, Fear
Clinical narrative: she was really confused; "shh" noise in her ears; eyes drop burn more; dizziness when she moves or bends down; Brain fog; fear that symptoms won't go away; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down) and BRADYPHRENIA (Brain fog) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VALSARTAN, AMLODIPINE, ATENOLOL and OMEPRAZOLE for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down), BRADYPHRENIA (Brain fog) and FEAR (fear that symptoms won't go away). At the time of the report, CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down), BRADYPHRENIA (Brain fog) and FEAR (fear that symptoms won't go away) had not resolved.            Concomitant medications also included Vitamins and eye drops. Concomitant product were used for high blood pressure in the morning, bone, heartburn acid indications. No treatment was given.   This case was linked to MOD-2021-248210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up received. New events were added. On 06-Aug-2021: Follow-up received and contains no new information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: she was really confused; "shh" noise in her ears; eyes drop burn more; dizziness when she moves or bends down; Brain fog; fear that symptoms won't go away; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down) and BRADYPHRENIA (Brain fog) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VALSARTAN, AMLODIPINE, ATENOLOL and OMEPRAZOLE for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down), BRADYPHRENIA (Brain fog) and FEAR (fear that symptoms won't go away). At the time of the report, CONFUSIONAL STATE (she was really confused), TINNITUS ("shh" noise in her ears), EYE IRRITATION (eyes drop burn more), DIZZINESS (dizziness when she moves or bends down), BRADYPHRENIA (Brain fog) and FEAR (fear that symptoms won't go away) had not resolved.            Concomitant medications also included Vitamins and eye drops. Concomitant product were used for high blood pressure in the morning, bone, heartburn acid indications. No treatment was given.   This case was linked to MOD-2021-248210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant follow up received. New events were added. On 06-Aug-2021: Follow-up received and contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: who can no longer drive/unable to drive; Muscle weakness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (who can no longer drive/unable to drive), MUSCULAR WEAKNESS (Muscle weakness) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (who can no longer drive/unable to drive), MUSCULAR WEAKNESS (Muscle weakness) and FATIGUE (fatigue). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (who can no longer drive/unable to drive), MUSCULAR WEAKNESS (Muscle weakness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant FUP: event verbatim updated, additional events added
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-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 EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site left arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.   This case was linked to MOD-2021-248300 (Patient Link).
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 76-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 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: > 35 day after the first dose; Was COVID positive after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Was COVID positive after the first dose) and PRODUCT DOSE OMISSION ISSUE (> 35 day after the first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (Was COVID positive after the first dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (> 35 day after the first dose). At the time of the report, COVID-19 (Was COVID positive after the first dose) and PRODUCT DOSE OMISSION ISSUE (> 35 day after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Pimples appeared on left shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Pimples appeared on left shoulder) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACNE (Pimples appeared on left shoulder). At the time of the report, ACNE (Pimples appeared on left shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (Respiratory issues) 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 RESPIRATORY DISORDER (Respiratory issues). At the time of the report, RESPIRATORY DISORDER (Respiratory issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported   Reporter did not allow further contact
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: Woke with the eyes shut/ face swollen; Whole body covered in a rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Woke with the eyes shut/ face swollen) and RASH (Whole body covered in a rash) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Type I diabetes mellitus.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Woke with the eyes shut/ face swollen) and RASH (Whole body covered in a rash). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of 40 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Woke with the eyes shut/ face swollen) and RASH (Whole body covered in a rash) outcome was unknown.            Concomitant medication included Medication for Type I diabetes. Treatment medication also included IV and Steroids in a pill form.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache; Fever; Chills; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Psoriasis. Concomitant products included VITAMINS NOS for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Tiredness) outcome was unknown. Not Provided          Patient had all the side effects in the first dose also.  Treatment information reported that she did not take any medications for the side effects she received from the second dose, she just stayed in bed and drank ginger ale and ate crackers.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Felt sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (Felt sick) and PYREXIA (Fever). On 17-Feb-2021, ILLNESS (Felt sick) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-248261 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Extrasystoles, Illness, Malaise
Clinical narrative: Heart skipping a beat; He got sick; He is losing his voice; Health condition is not good after the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXTRASYSTOLES (Heart skipping a beat), ILLNESS (He got sick), APHONIA (He is losing his voice) and MALAISE (Health condition is not good after the vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 016R21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRASYSTOLES (Heart skipping a beat), ILLNESS (He got sick), APHONIA (He is losing his voice) and MALAISE (Health condition is not good after the vaccine). At the time of the report, EXTRASYSTOLES (Heart skipping a beat), ILLNESS (He got sick), APHONIA (He is losing his voice) and MALAISE (Health condition is not good after the vaccine) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information received. Reporter details updated and a new event Malaise was added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-19 vaccine was given after being left out then given at 19hr mark; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given after being left out then given at 19hr mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given after being left out then given at 19hr mark). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given after being left out then given at 19hr mark) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Culture urine, Illness
Clinical narrative: sick; blood in his urine; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick) and BLOOD URINE PRESENT (blood in his urine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced ILLNESS (sick) and BLOOD URINE PRESENT (blood in his urine). At the time of the report, ILLNESS (sick) and BLOOD URINE PRESENT (blood in his urine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Culture urine: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient was given a prescription for antibiotics based on the assumption that culture will come back positive for UTI.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Soreness in his arm; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm) and FATIGUE (Fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Soreness in his arm) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   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.   Treatment information was not provided.   This case was linked to MOD-2021-248032 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-significant follow up which mentions only consent for follow-up
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Influenza like illness, Lymphadenopathy
Clinical narrative: swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan); flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and LYMPHADENOPATHY (swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 10-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan)). The patient was treated with PARACETAMOL (TYLENOL) on 09-Mar-2021 for Flu like symptoms, at an unspecified dose and frequency. On 09-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, LYMPHADENOPATHY (swelling on his left armpit, half a dollar in size, non tender, lymphadenopathy (in CT scan)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: normal (normal) Normal blood works came out all normal. In April 2021, Computerised tomogram: normal (normal) Normal CT scan was done which came out all normal (other than lymphadenopathy).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Reporter contact information and route of administration updated.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a vaccine that was 17 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received a vaccine that was 17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received a vaccine that was 17 years old). On 06-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received a vaccine that was 17 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks). On 06-Jul-2021, PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-248540 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Updated patient demographics: Race; Updated route of administration of the vaccine: Intramuscular; Updated anatomical site: Deltoid;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Numbness in the left arm and leg; Tingling in the left arm and leg; Hard to sleep; Weakness; Dizziness; Very tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the left arm and leg), PARAESTHESIA (Tingling in the left arm and leg), INSOMNIA (Hard to sleep), ASTHENIA (Weakness) and DIZZINESS (Dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced HEADACHE (Headache). On 05-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness in the left arm and leg), PARAESTHESIA (Tingling in the left arm and leg), INSOMNIA (Hard to sleep), ASTHENIA (Weakness), DIZZINESS (Dizziness) and FATIGUE (Very tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in the left arm and leg), PARAESTHESIA (Tingling in the left arm and leg), INSOMNIA (Hard to sleep), ASTHENIA (Weakness), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Very tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include muscle relaxant.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Paraesthesia
Clinical narrative: Numbness in the left arm and leg; Tingling in the left arm and leg; Hard to sleep; Weakness; Dizziness; Very tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the left arm and leg), PARAESTHESIA (Tingling in the left arm and leg), INSOMNIA (Hard to sleep), ASTHENIA (Weakness) and DIZZINESS (Dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jul-2021, the patient experienced HEADACHE (Headache). On 05-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness in the left arm and leg), PARAESTHESIA (Tingling in the left arm and leg), INSOMNIA (Hard to sleep), ASTHENIA (Weakness), DIZZINESS (Dizziness) and FATIGUE (Very tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in the left arm and leg), PARAESTHESIA (Tingling in the left arm and leg), INSOMNIA (Hard to sleep), ASTHENIA (Weakness), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Very tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include muscle relaxant.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Myalgia
Clinical narrative: noticed hair might be thinning; Muscle soreness,achiness; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (noticed hair might be thinning) and MYALGIA (Muscle soreness,achiness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included TOCOPHERYL ACETATE (VITAMIN E-400), VITAMIN C [ASCORBIC ACID], VITAMIN D3, VITAMIN K2 [MENAQUINONE], VITAMIN B COMPLEX, NIACIN, FISH OIL, CALCIUM, MAGNESIUM and ZINC for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MYALGIA (Muscle soreness,achiness). On 08-Feb-2021, the patient experienced ALOPECIA (noticed hair might be thinning). At the time of the report, ALOPECIA (noticed hair might be thinning) and MYALGIA (Muscle soreness,achiness) had not 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.   Treatment information was not provided   This case was linked to MOD-2021-248944 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up received. New reporter, allergy medication and concomitant medications was updated
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeding) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EPISTAXIS (Nose bleeding). At the time of the report, EPISTAXIS (Nose bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19 after 1st dose; Received her 1st dose on 05 Feb 2021; This spontaneous case was reported by an other health professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Received her 1st dose on 05 Feb 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Received her 1st dose on 05 Feb 2021). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient tested positive for COVID-19 after 1st dose) and PRODUCT DOSE OMISSION ISSUE (Received her 1st dose on 05 Feb 2021) 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 relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received contain No new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021; Received Moderna as second dose after Pfizer as first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021) and OFF LABEL USE (Received Moderna as second dose after Pfizer as first) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced OFF LABEL USE (Received Moderna as second dose after Pfizer as first). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021). On 12-Mar-2021, OFF LABEL USE (Received Moderna as second dose after Pfizer as first) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 19FEB2021 and Moderna for his second dose on 12MAR2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired vaccines that were administered to less than 10 patients; The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccines that were administered to less than 10 patients) and PRODUCT STORAGE ERROR (The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) 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 EXPIRED PRODUCT ADMINISTERED (expired vaccines that were administered to less than 10 patients) and PRODUCT STORAGE ERROR (The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccines that were administered to less than 10 patients) and PRODUCT STORAGE ERROR (The pharmacist stated that they were pulled out on 27May2021 from the freezer and placed in the fridge until past weekend) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Peripheral swelling, Vision blurred, Vomiting
Clinical narrative: Vomiting; Woke up with blurry/hazy vision; Arm swelling; Nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Woke up with blurry/hazy vision), PERIPHERAL SWELLING (Arm swelling), NAUSEA (Nausea), MYALGIA (Sore arm) and VOMITING (Vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced VISION BLURRED (Woke up with blurry/hazy vision), PERIPHERAL SWELLING (Arm swelling), NAUSEA (Nausea) and MYALGIA (Sore arm). On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VISION BLURRED (Woke up with blurry/hazy vision), PERIPHERAL SWELLING (Arm swelling), NAUSEA (Nausea), MYALGIA (Sore arm) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: they gave out 5 doses out of an expired vial beyond 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave out 5 doses out of an expired vial beyond 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave out 5 doses out of an expired vial beyond 30 days). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (they gave out 5 doses out of an expired vial beyond 30 days) 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.   Concomitant medications were not provided by the reporter. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Vaccine facility centre information, Product Expiry date and Batch Number Updated.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Appetite disorder, Diarrhoea
Clinical narrative: Diarrhea; Hair loss; Appetite change; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ALOPECIA (Hair loss) and APPETITE DISORDER (Appetite change) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TUCATINIB (TUKYSA) for Breast cancer.    Concurrent medical conditions included Breast cancer (Breast cancer / malign neoplm of upper-outer quadrant of right female breast /  2+ breast cancer.).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TUCATINIB (TUKYSA) (unknown route) 150 mg. On an unknown date, TUCATINIB (TUKYSA) (unknown route) dosage was changed to 150 mg and TUCATINIB (TUKYSA) (unknown route) dosage was changed to 150 mg. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ALOPECIA (Hair loss) and APPETITE DISORDER (Appetite change). At the time of the report, DIARRHOEA (Diarrhea), ALOPECIA (Hair loss) and APPETITE DISORDER (Appetite change) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Patient reported date of birth as 1948 (Adult)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnacy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnacy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, IBUPROFEN, BUTALBITAL, LORATADINE (LORATADIN), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN B12 NOS, CYCLOBENZAPRINE and PANTOPRAZOLE for an unknown indication.    On 05-Jul-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 21-Aug-2021. On 05-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnacy). On 05-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnacy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Date of last menstrual period was probably at the end of Jan 2021.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received updated regarding the Last menstrual period.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna Vaccine past the 19 hour mark at room temperature after punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-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 EXPIRED PRODUCT ADMINISTERED (Given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. No concomitant medications were provided. No treatment information was reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Did not receive 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) had resolved.            The patient stated that she failed to get the 2nd dose of the vaccine because being busy with children and their virtual school. And the clinic where she received the vaccine is only open on Monday. No concomitant medication was reported. No treatment medication was reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Hasn't gotten the second vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second vaccine). On 06-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported..