chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sneezing, Somnolence
Clinical narrative: Horrible reaction to 2nd dose; Soaking wet with sweat; Very constipated after 2nd dose; Sneezing for the past 2-3 days; Upset stomach; Sore arm; Sleeping a lot since 2nd dose; Headache; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days) and ABDOMINAL DISCOMFORT (Upset stomach) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037b21a and 027c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-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 ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Sleeping a lot since 2nd dose), HEADACHE (Headache) and PYREXIA (Fever after 2nd dose). At the time of the report, ADVERSE EVENT (Horrible reaction to 2nd dose), HYPERHIDROSIS (Soaking wet with sweat), CONSTIPATION (Very constipated after 2nd dose), SNEEZING (Sneezing for the past 2-3 days), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Sleeping a lot since 2nd dose), HEADACHE (Headache) and PYREXIA (Fever after 2nd dose) outcome was unknown.            The reporter was calling on behalf of their son who received both shots of the Moderna vaccine. The patient post receiving their second dose of vaccine experienced horrible reactions. The reporter said the patient had fevers and was soaking wet with sweat. The patient also had sore arms.  Reportedly, the patient was a brittle diabetic. The reporter states that the patient has been sleeping a lot and also had a headache, upset stomach and was very constipated after the 2nd dose. The reporter also mentioned that the patient has been sneezing for the past 2-3 days.   No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-148969 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148969:Husbands case
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: After 1st vaccine my right arm was little bigger than left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (After 1st vaccine my right arm was little bigger than left arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUDROCORTISONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 PERIPHERAL SWELLING (After 1st vaccine my right arm was little bigger than left arm). At the time of the report, PERIPHERAL SWELLING (After 1st vaccine my right arm was little bigger than left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that "after 1st vaccine my right arm was little bigger than left arm but after 2nd vaccine it got worst"  Additional concomitant medication included "birth control pills"  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-148267 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up information received on 19 May 2021 contains and does not contain no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148267:Second Dose Case
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: syringe fallen apart; she was not sure how much did she administer; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (syringe fallen apart) and UNDERDOSE (she was not sure how much did she administer) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced DEVICE CONNECTION ISSUE (syringe fallen apart) and UNDERDOSE (she was not sure how much did she administer). On 19-May-2021, DEVICE CONNECTION ISSUE (syringe fallen apart) and UNDERDOSE (she was not sure how much did she administer) 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.   Treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Very tired after 1st dose; Chills after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired after 1st dose) and CHILLS (Chills after 1st dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Very tired after 1st dose) and CHILLS (Chills after 1st dose). At the time of the report, FATIGUE (Very tired after 1st dose) and CHILLS (Chills after 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.  Treatment information not reported. It was reported patient got second dose on 17-May-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-148126, US-MODERNATX, INC.-MOD-2021-148165 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: NNI.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148126:Mother 1st dose case US-MODERNATX, INC.-MOD-2021-148165:Mother 2nd dose case
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Big droplet of the vaccine fell out of the syringe; Big droplet of the vaccine fell out of the syringe; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Big droplet of the vaccine fell out of the syringe) and DEVICE CONNECTION ISSUE (Big droplet of the vaccine fell out of the syringe) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced UNDERDOSE (Big droplet of the vaccine fell out of the syringe) and DEVICE CONNECTION ISSUE (Big droplet of the vaccine fell out of the syringe). On 12-May-2021, UNDERDOSE (Big droplet of the vaccine fell out of the syringe) and DEVICE CONNECTION ISSUE (Big droplet of the vaccine fell out of the syringe) had resolved.            No concomitant medication was reported by reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 contains no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired 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.   Pharmacist reported that two patients received the expired vaccine. The vial was opened on 14 MAY 2021 at 3:30 PM MST and administered on 19 MAY 2021 which exceeds the viable time for the vaccine. No adverse events were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Patient received the second dose with an interval of 49 days; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (Patient received the second dose with an interval of 49 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE, VALPROATE SEMISODIUM (DEPAKOTE) and BENZTROPINE [BENZATROPINE] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced OFF LABEL USE (Patient received the second dose with an interval of 49 days). On 19-May-2021, OFF LABEL USE (Patient received the second dose with an interval of 49 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone marrow, Condition aggravated, Fatigue, Headache, Pain in extremity
Clinical narrative: legs began weeping; swelling of her legs got worse; bad fatigue; terrible headache; vasculitis of both legs; legs became swollen; This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), PAIN IN EXTREMITY (legs began weeping), CONDITION AGGRAVATED (swelling of her legs got worse) and FATIGUE (bad fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), FATIGUE (bad fatigue) and HEADACHE (terrible headache). On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (legs began weeping) and CONDITION AGGRAVATED (swelling of her legs got worse). At the time of the report, VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), PAIN IN EXTREMITY (legs began weeping), CONDITION AGGRAVATED (swelling of her legs got worse), FATIGUE (bad fatigue) and HEADACHE (terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Biopsy bone marrow: other (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included: Heart medication. Treatment information was not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vasculitis
Clinical narrative: legs began weeping; swelling of her legs got worse; bad fatigue; terrible headache; vasculitis of both legs; legs became swollen; This spontaneous case was reported by a consumer and describes the occurrence of VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), PAIN IN EXTREMITY (legs began weeping), CONDITION AGGRAVATED (swelling of her legs got worse) and FATIGUE (bad fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), FATIGUE (bad fatigue) and HEADACHE (terrible headache). On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (legs began weeping) and CONDITION AGGRAVATED (swelling of her legs got worse). At the time of the report, VASCULITIS (vasculitis of both legs), PERIPHERAL SWELLING (legs became swollen), PAIN IN EXTREMITY (legs began weeping), CONDITION AGGRAVATED (swelling of her legs got worse), FATIGUE (bad fatigue) and HEADACHE (terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Biopsy bone marrow: other (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included: Heart medication. Treatment information was not provided
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: pain in injection site left right; fatigue; pain in injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site left right), FATIGUE (fatigue) and PAIN (pain in injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Fibromyalgia.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site left right), FATIGUE (fatigue) and PAIN (pain in injection site). On 23-Apr-2021, FATIGUE (fatigue) had resolved. On 04-May-2021, PAIN (pain in injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in injection site left right) outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-148380, US-MODERNATX, INC.-MOD-2021-148880 (E2B Linked Report). This case was linked to MOD-2021-148183 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148880: US-MODERNATX, INC.-MOD-2021-148380:
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Viral test
Clinical narrative: diarrhea 2 weeks after the second dose; 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 DIARRHOEA (diarrhea 2 weeks after the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea 2 weeks after the second dose). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea 2 weeks after the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral test: normal (normal) stool tested - no issues.         Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Aches; low grade fever; chills; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (Aches), PYREXIA (low grade fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Undiclosed) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Aches), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MYALGIA (Aches), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD21-091918, US-MODERNATX, INC.-MOD-2021-156255 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant follow-up - Cross linked numbers were updated by HCP; Sender's Comments:  MOD21-091918: US-MODERNATX, INC.-MOD-2021-156255:
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: itching; red rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching) and RASH ERYTHEMATOUS (red rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and RASH ERYTHEMATOUS (red rash). At the time of the report, PRURITUS (itching) and RASH ERYTHEMATOUS (red rash) outcome was unknown.            no concomitant drugs included no treatment drugs included
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pharyngeal swelling, Pyrexia, Rash
Clinical narrative: Shortness of breath; Throat swelling; rash on legs, ankles and feet; Headache; hives on legs, ankles, and feet; low grade fever; local injection site pain; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (hives on legs, ankles, and feet), DYSPNOEA (Shortness of breath), PHARYNGEAL SWELLING (Throat swelling), RASH (rash on legs, ankles and feet) and VACCINATION SITE PAIN (local injection site pain) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 17-May-2021, the patient experienced VACCINATION SITE PAIN (local injection site pain). On 18-May-2021, the patient experienced PYREXIA (low grade fever). On 19-May-2021, the patient experienced URTICARIA (hives on legs, ankles, and feet), RASH (rash on legs, ankles and feet) and HEADACHE (Headache). In 2021, the patient experienced DYSPNOEA (Shortness of breath) and PHARYNGEAL SWELLING (Throat swelling). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) for Adverse event, at an unspecified dose and frequency. On 19-May-2021, PYREXIA (low grade fever) outcome was unknown. At the time of the report, URTICARIA (hives on legs, ankles, and feet), DYSPNOEA (Shortness of breath), PHARYNGEAL SWELLING (Throat swelling), RASH (rash on legs, ankles and feet), VACCINATION SITE PAIN (local injection site pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous), the reporter did not provide any causality assessments.   Concomitant products included a birth control for an unknown indication.  On unknown date patient was submitted to CT scan which was negative for clots. On unknown date, the patient went to the urgent care where she received a Decadron shot and Inhaler to treat the events. Treatment also included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up report was received and include information two new events, lab information and treatment for the new events.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: Shortness of breath; Throat swelling; rash on legs, ankles and feet; Headache; hives on legs, ankles, and feet; low grade fever; local injection site pain; This spontaneous case was reported by a health care professional and describes the occurrence of URTICARIA (hives on legs, ankles, and feet), DYSPNOEA (Shortness of breath), PHARYNGEAL SWELLING (Throat swelling), RASH (rash on legs, ankles and feet) and VACCINATION SITE PAIN (local injection site pain) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 17-May-2021, the patient experienced VACCINATION SITE PAIN (local injection site pain). On 18-May-2021, the patient experienced PYREXIA (low grade fever). On 19-May-2021, the patient experienced URTICARIA (hives on legs, ankles, and feet), RASH (rash on legs, ankles and feet) and HEADACHE (Headache). In 2021, the patient experienced DYSPNOEA (Shortness of breath) and PHARYNGEAL SWELLING (Throat swelling). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) for Adverse event, at an unspecified dose and frequency. On 19-May-2021, PYREXIA (low grade fever) outcome was unknown. At the time of the report, URTICARIA (hives on legs, ankles, and feet), DYSPNOEA (Shortness of breath), PHARYNGEAL SWELLING (Throat swelling), RASH (rash on legs, ankles and feet), VACCINATION SITE PAIN (local injection site pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous), the reporter did not provide any causality assessments.   Concomitant products included a birth control for an unknown indication.  On unknown date patient was submitted to CT scan which was negative for clots. On unknown date, the patient went to the urgent care where she received a Decadron shot and Inhaler to treat the events. Treatment also included Tylenol.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up report was received and include information two new events, lab information and treatment for the new events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) 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 18-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Dysphagia, Ear discomfort, Mouth swelling
Clinical narrative: A little disoriented; Mildly confused; had tightening of the throat; Felt like she couldn't swallow; Slight swelling of mouth; Mouth felt strange; ear felt strange; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow) and MOUTH SWELLING (Slight swelling of mouth) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow), MOUTH SWELLING (Slight swelling of mouth), ORAL DISCOMFORT (Mouth felt strange) and EAR DISCOMFORT (ear felt strange). At the time of the report, DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow), MOUTH SWELLING (Slight swelling of mouth), ORAL DISCOMFORT (Mouth felt strange) and EAR DISCOMFORT (ear felt strange) outcome was unknown.        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 concomitant and treatment medications were reported
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Throat tightness
Clinical narrative: A little disoriented; Mildly confused; had tightening of the throat; Felt like she couldn't swallow; Slight swelling of mouth; Mouth felt strange; ear felt strange; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow) and MOUTH SWELLING (Slight swelling of mouth) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow), MOUTH SWELLING (Slight swelling of mouth), ORAL DISCOMFORT (Mouth felt strange) and EAR DISCOMFORT (ear felt strange). At the time of the report, DISORIENTATION (A little disoriented), CONFUSIONAL STATE (Mildly confused), THROAT TIGHTNESS (had tightening of the throat), DYSPHAGIA (Felt like she couldn't swallow), MOUTH SWELLING (Slight swelling of mouth), ORAL DISCOMFORT (Mouth felt strange) and EAR DISCOMFORT (ear felt strange) outcome was unknown.        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 concomitant and treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D29A21A and 00BB21A or 008B21A) for COVID-19 vaccination.     The patient's past medical history included Seasonal allergy. Concomitant products included TIMOLOL for Glaucoma, unspecified, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-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 RHINORRHOEA (nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue). At the time of the report, RHINORRHOEA (nose has been running non-stop/like a faucet/constantly needing the Kleenex tissue) outcome was unknown.            Action taken with suspect drug Moderna 1273 COVID-19 vaccine was not applicable. No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: might have tracked a germ; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFECTION (might have tracked a germ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INFECTION (might have tracked a germ). At the time of the report, INFECTION (might have tracked a germ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided   This case was linked to MOD21-091802, US-MODERNATX, INC.-MOD-2021-148856 (E2B Linked Report).; Sender's Comments:  MOD21-091802:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-148856:Same Reporter
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: threw up 13 times in the same day; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (threw up 13 times in the same day) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CHOLESTEROL, Vitamin D, LEVOCARNITINE TARTRATE (WEIGHT LOSS) and Acid reflux medication.    On 19-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Apr-2021, the patient experienced VOMITING (threw up 13 times in the same day). At the time of the report, VOMITING (threw up 13 times in the same day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported .   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Chills, Fatigue, Pyrexia
Clinical narrative: Back pain; Tested positive of COVID-19; Fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014CZIA) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included ENALAPRIL, LINAGLIPTIN (TRADJENTA), LEVOTHYROXINE and TAMSULOSIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced BACK PAIN (Back pain), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills). On 03-May-2021, BACK PAIN (Back pain), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive of covid19 (twice). On 15-May-2021, SARS-CoV-2 test: positive (Positive) tested positive again on the  15MAy2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Back pain; Tested positive of COVID-19; Fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014CZIA) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included ENALAPRIL, LINAGLIPTIN (TRADJENTA), LEVOTHYROXINE and TAMSULOSIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced BACK PAIN (Back pain), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills). On 03-May-2021, BACK PAIN (Back pain), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, SARS-CoV-2 test: positive (Positive) tested positive of covid19 (twice). On 15-May-2021, SARS-CoV-2 test: positive (Positive) tested positive again on the  15MAy2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: aches; low grade fever; chills; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (aches), PYREXIA (low grade fever) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 MYALGIA (aches), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MYALGIA (aches), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were provided.   This case was linked to MOD21-091918, US-MODERNATX, INC.-MOD-2021-156255 (E2B Linked Report). This case was linked to MOD-2021-148248 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: FW Added on 20-MAY-2021 .Possible-NNI; Sender's Comments:  MOD21-091918: US-MODERNATX, INC.-MOD-2021-156255:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Dermatitis acneiform, Fatigue, Headache
Clinical narrative: blistering rash on hands; pimples with extreme swelling; itching; burning near the knuckles; fingers became swollen; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), BLISTER (blistering rash on hands), DERMATITIS ACNEIFORM (pimples with extreme swelling) and PRURITUS (itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). On 03-Apr-2021, the patient experienced BLISTER (blistering rash on hands), DERMATITIS ACNEIFORM (pimples with extreme swelling), PRURITUS (itching), BURNING SENSATION (burning near the knuckles) and PERIPHERAL SWELLING (fingers became swollen). The patient was treated with TRIAMCINOLONE at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, FATIGUE (fatigue), HEADACHE (headache), BLISTER (blistering rash on hands), DERMATITIS ACNEIFORM (pimples with extreme swelling), PRURITUS (itching), BURNING SENSATION (burning near the knuckles) and PERIPHERAL SWELLING (fingers became swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicine was reported by the reporter.   This case was linked to MOD-2021-148374.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: blistering rash on hands; pimples with extreme swelling; itching; burning near the knuckles; fingers became swollen; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), BLISTER (blistering rash on hands), DERMATITIS ACNEIFORM (pimples with extreme swelling) and PRURITUS (itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). On 03-Apr-2021, the patient experienced BLISTER (blistering rash on hands), DERMATITIS ACNEIFORM (pimples with extreme swelling), PRURITUS (itching), BURNING SENSATION (burning near the knuckles) and PERIPHERAL SWELLING (fingers became swollen). The patient was treated with TRIAMCINOLONE at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, FATIGUE (fatigue), HEADACHE (headache), BLISTER (blistering rash on hands), DERMATITIS ACNEIFORM (pimples with extreme swelling), PRURITUS (itching), BURNING SENSATION (burning near the knuckles) and PERIPHERAL SWELLING (fingers became swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicine was reported by the reporter.   This case was linked to MOD-2021-148374.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash; Rash on legs,feet,arm,face and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) and RASH (Rash on legs,feet,arm,face and back) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension. Concomitant products included POTASSIUM for Potassium supplementation, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Jan-2021, the patient experienced RASH PRURITIC (itchy rash) and RASH (Rash on legs,feet,arm,face and back). At the time of the report, RASH PRURITIC (itchy rash) and RASH (Rash on legs,feet,arm,face and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment include  Benadryl and OTC lotion to keep itchy calm down. Concomitant medication include blood pressure medication and potassium supplement.   This case was linked to MOD-2021-039859 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Feels dizzy; Vision is off; Terrible headache; Fever; Vomiting; Stomach issues; Felt like hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), FEELING ABNORMAL (Felt like hit by a truck), DIZZINESS (Feels dizzy), VISUAL IMPAIRMENT (Vision is off) and VOMITING (Vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues), FEELING ABNORMAL (Felt like hit by a truck), VOMITING (Vomiting) and PYREXIA (Fever). On 13-May-2021, the patient experienced DIZZINESS (Feels dizzy), VISUAL IMPAIRMENT (Vision is off) and HEADACHE (Terrible headache). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues), FEELING ABNORMAL (Felt like hit by a truck), DIZZINESS (Feels dizzy), VISUAL IMPAIRMENT (Vision is off), VOMITING (Vomiting), HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: Feels dizzy; Vision is off; Terrible headache; Fever; Vomiting; Stomach issues; Felt like hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), FEELING ABNORMAL (Felt like hit by a truck), DIZZINESS (Feels dizzy), VISUAL IMPAIRMENT (Vision is off) and VOMITING (Vomiting) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues), FEELING ABNORMAL (Felt like hit by a truck), VOMITING (Vomiting) and PYREXIA (Fever). On 13-May-2021, the patient experienced DIZZINESS (Feels dizzy), VISUAL IMPAIRMENT (Vision is off) and HEADACHE (Terrible headache). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues), FEELING ABNORMAL (Felt like hit by a truck), DIZZINESS (Feels dizzy), VISUAL IMPAIRMENT (Vision is off), VOMITING (Vomiting), HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Passed 128 days from first dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed 128 days from first dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Jan-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 DOSE OMISSION ISSUE (Passed 128 days from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed 128 days from first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.