chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: product administration error; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (product administration error) in a 51-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 27-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (product administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (product administration error) 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.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Glomerular filtration rate decreased, Seborrhoeic keratosis, Skin disorder
Clinical narrative: 1/25/21 - 1ST COVID SHOT 2/19/21 - MONTHLY LAB, GFR DECREASED FROM11 TO 10.      2/23/21 - 2ND COVID SHOT 3/15/21 - MONTHLY LAB, GFR DECREASED TO 9        4.14.21 - MONTHLY LAB, GFR INCREASED TO 10 5/19/21 - MONTHLY LAB - GFR DECREASED TO 8      6/21/21 - MONTHLY LAB - GFR RETURNED TO 10 I am reporting this because people with chronic kidney disease may not be doing monthly labs like me.  Recommend perform lab to check GFR for these people. Also, on 8/18/2021, i had several growths on my scalp that came up gradually sometime after the 2nd shot.  They were diagnosed on 8//18/21 as seboreheic keratosis.  Never had these in my life. I also struggled through about 4 months of extreme fatigue after the 2nd shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: chills, body aches, muscle and joint pain, headache, nausea, felt feverish but did not have fever; symptoms lasted for almost three days
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: chills, body aches, muscle and joint pain, headache, nausea, felt feverish but did not have fever; symptoms lasted for almost three days
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms- fever, chills, body ache, fatigue lasted about 20 hours, pain in left shoulder, swollen lymph nodes in left armpit for 3-4 days. Intense headache followed for 5 days after flu like symptoms eased up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Flu like symptoms- fever, chills, body ache, fatigue lasted about 20 hours, pain in left shoulder, swollen lymph nodes in left armpit for 3-4 days. Intense headache followed for 5 days after flu like symptoms eased up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Laboratory test, Magnetic resonance imaging
Clinical narrative: 36 hours after getting vaccinated I have severe muscle aches, fatigue, cough, and fever. Doctor said I have COVID. I have no contact with anybody with positive COVID. I have not had a social life because I telework very late. I know 5 people who had the same thing. My 19 year old son has no symptoms, we got vaccinated the same day at the same center. Therefore, please assess if COVID is an adverse reaction itself. More than 6 months ago I should have been vaccinated because of my age. I the vaccine and 36 hours later I get COVID.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: 36 hours after getting vaccinated I have severe muscle aches, fatigue, cough, and fever. Doctor said I have COVID. I have no contact with anybody with positive COVID. I have not had a social life because I telework very late. I know 5 people who had the same thing. My 19 year old son has no symptoms, we got vaccinated the same day at the same center. Therefore, please assess if COVID is an adverse reaction itself. More than 6 months ago I should have been vaccinated because of my age. I the vaccine and 36 hours later I get COVID.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: Arm hurt at site of injection; Rash at site of injection 9 days after vaccination; Hardness to touch at site of injection; Redness at site of injection; Slept for 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for 16 hours), VACCINATION SITE PAIN (Arm hurt at site of injection), VACCINATION SITE RASH (Rash at site of injection 9 days after vaccination), VACCINATION SITE INDURATION (Hardness to touch at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE, IBUPROFEN, GABAPENTIN and AMITRIPTYLINE for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced SOMNOLENCE (Slept for 16 hours). On 04-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt at site of injection), VACCINATION SITE RASH (Rash at site of injection 9 days after vaccination), VACCINATION SITE INDURATION (Hardness to touch at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection). At the time of the report, SOMNOLENCE (Slept for 16 hours), VACCINATION SITE PAIN (Arm hurt at site of injection), VACCINATION SITE RASH (Rash at site of injection 9 days after vaccination), VACCINATION SITE INDURATION (Hardness to touch at site of injection) and VACCINATION SITE ERYTHEMA (Redness at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Asthenia, Chills, Contusion, Headache
Clinical narrative: swelling in her fingers; fever; chills; nausea/nausea; felt weak/weakness; lethargic/lethargy; pounding headaches/pounding headaches; tingling in her left hand got worse; 5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs; appetite was affected; tingling in left hand (ulnar distribution); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in left hand (ulnar distribution)), PERIPHERAL SWELLING (swelling in her fingers), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea/nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (MIBELAS 24 FE) for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (tingling in left hand (ulnar distribution)). On 01-Jun-2021, the patient experienced PERIPHERAL SWELLING (swelling in her fingers), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea/nausea), ASTHENIA (felt weak/weakness), LETHARGY (lethargic/lethargy), HEADACHE (pounding headaches/pounding headaches), PARAESTHESIA (tingling in her left hand got worse), CONTUSION (5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs) and APPETITE DISORDER (appetite was affected). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. On 02-Jun-2021, PYREXIA (fever) and CHILLS (chills) had resolved. On 04-Jun-2021, APPETITE DISORDER (appetite was affected) had resolved. At the time of the report, PARAESTHESIA (tingling in left hand (ulnar distribution)), PERIPHERAL SWELLING (swelling in her fingers), NAUSEA (nausea/nausea), ASTHENIA (felt weak/weakness), LETHARGY (lethargic/lethargy), HEADACHE (pounding headaches/pounding headaches) and PARAESTHESIA (tingling in her left hand got worse) had resolved and CONTUSION (5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs) outcome was unknown.            This case was linked to MOD-2021-209181 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: swelling in her fingers; fever; chills; nausea/nausea; felt weak/weakness; lethargic/lethargy; pounding headaches/pounding headaches; tingling in her left hand got worse; 5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs; appetite was affected; tingling in left hand (ulnar distribution); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in left hand (ulnar distribution)), PERIPHERAL SWELLING (swelling in her fingers), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea/nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (MIBELAS 24 FE) for an unknown indication.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (tingling in left hand (ulnar distribution)). On 01-Jun-2021, the patient experienced PERIPHERAL SWELLING (swelling in her fingers), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea/nausea), ASTHENIA (felt weak/weakness), LETHARGY (lethargic/lethargy), HEADACHE (pounding headaches/pounding headaches), PARAESTHESIA (tingling in her left hand got worse), CONTUSION (5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs) and APPETITE DISORDER (appetite was affected). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. On 02-Jun-2021, PYREXIA (fever) and CHILLS (chills) had resolved. On 04-Jun-2021, APPETITE DISORDER (appetite was affected) had resolved. At the time of the report, PARAESTHESIA (tingling in left hand (ulnar distribution)), PERIPHERAL SWELLING (swelling in her fingers), NAUSEA (nausea/nausea), ASTHENIA (felt weak/weakness), LETHARGY (lethargic/lethargy), HEADACHE (pounding headaches/pounding headaches) and PARAESTHESIA (tingling in her left hand got worse) had resolved and CONTUSION (5 -10 bruises (looked like little broken blood vessels) popped up on both upper thighs) outcome was unknown.            This case was linked to MOD-2021-209181 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injury associated with device, Syringe issue, Underdose
Clinical narrative: pressing hard and the syringe broke; fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in; needle still in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYRINGE ISSUE (pressing hard and the syringe broke), UNDERDOSE (fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in) and INJURY ASSOCIATED WITH DEVICE (needle still in arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced SYRINGE ISSUE (pressing hard and the syringe broke), UNDERDOSE (fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in) and INJURY ASSOCIATED WITH DEVICE (needle still in arm). On 04-Jun-2021, SYRINGE ISSUE (pressing hard and the syringe broke), UNDERDOSE (fluid sprayed on his face and hand, HCP/pharmacist said that he did not think any medication went in) and INJURY ASSOCIATED WITH DEVICE (needle still in arm) had resolved.            Concomitant medications were not reported.   On 04 Jun 2021, the patient received the second dose of the Moderna COVID-19 vaccine. Per the reporter, the health care professional (HCP) that administered the vaccine was pressing hard which caused the needle to break off into the patient's left arm. This cause the fluid from the vaccine to the spray the patient in the face. The needle was removed by the HCP. Per the reported, the HCP stated, they did not believe the patient to get the full dose of the vaccine due.  Treatment information was not provided.  This report refers to a case of Product administration error for mRNA-1273 with no associated AEs.  The causality assessment of the events remains as not applicable.; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273 with no associated AEs.  The causality assessment of the events remains as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: bones hurt; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (bones hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 BONE PAIN (bones hurt). At the time of the report, BONE PAIN (bones hurt) outcome was unknown.            Concomitant product details were not provided. Treatment details were not provided by the reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye pruritus, Rash, Urticaria
Clinical narrative: Hives; Neck rash; Itchy eyes; Weakness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Itchy eyes), ASTHENIA (Weakness), DIZZINESS (Dizziness), URTICARIA (Hives) and RASH (Neck rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced EYE PRURITUS (Itchy eyes), ASTHENIA (Weakness), DIZZINESS (Dizziness) and RASH (Neck rash). On an unknown date, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milliliter tube. At the time of the report, EYE PRURITUS (Itchy eyes), ASTHENIA (Weakness), DIZZINESS (Dizziness), URTICARIA (Hives) and RASH (Neck rash) 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.   Reporter confirmed no concomitant medication taking.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient was administered with a vaccine that had experienced a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion). On 03-Jun-2021, PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medication were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Little light headed; Tire easily; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Little light headed) and FATIGUE (Tire easily) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 DIZZINESS (Little light headed) and FATIGUE (Tire easily). At the time of the report, DIZZINESS (Little light headed) and FATIGUE (Tire easily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. Treatment information was not provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) 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.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Lost of taste after first covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (Lost of taste after first covid vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost of taste after first covid vaccine). At the time of the report, AGEUSIA (Lost of taste after first covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Erythema, Paraesthesia, Pruritus
Clinical narrative: blisters; a little burning on legs; redness; itchy skin; Hives; Tingling sensation; rash on both lower legs, wrists, and thigh; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (blisters), BURNING SENSATION (a little burning on legs), ERYTHEMA (redness), PRURITUS (itchy skin) and URTICARIA (Hives) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itchy skin), URTICARIA (Hives), PARAESTHESIA (Tingling sensation) and RASH (rash on both lower legs, wrists, and thigh). On an unknown date, the patient experienced BLISTER (blisters) and BURNING SENSATION (a little burning on legs). At the time of the report, BLISTER (blisters) and BURNING SENSATION (a little burning on legs) outcome was unknown and ERYTHEMA (redness), PRURITUS (itchy skin), URTICARIA (Hives), PARAESTHESIA (Tingling sensation) and RASH (rash on both lower legs, wrists, and thigh) had not resolved.            No concomitant medications was reported by the reporter. No treatment medications was  provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information contains updated patient demography, first dose information, second dose batch/lot number, Added new events( Urticaria, Paresthesia), Events start date and Updated events outcome.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: blisters; a little burning on legs; redness; itchy skin; Hives; Tingling sensation; rash on both lower legs, wrists, and thigh; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (blisters), BURNING SENSATION (a little burning on legs), ERYTHEMA (redness), PRURITUS (itchy skin) and URTICARIA (Hives) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (redness), PRURITUS (itchy skin), URTICARIA (Hives), PARAESTHESIA (Tingling sensation) and RASH (rash on both lower legs, wrists, and thigh). On an unknown date, the patient experienced BLISTER (blisters) and BURNING SENSATION (a little burning on legs). At the time of the report, BLISTER (blisters) and BURNING SENSATION (a little burning on legs) outcome was unknown and ERYTHEMA (redness), PRURITUS (itchy skin), URTICARIA (Hives), PARAESTHESIA (Tingling sensation) and RASH (rash on both lower legs, wrists, and thigh) had not resolved.            No concomitant medications was reported by the reporter. No treatment medications was  provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information contains updated patient demography, first dose information, second dose batch/lot number, Added new events( Urticaria, Paresthesia), Events start date and Updated events outcome.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice; Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice) and MUSCULOSKELETAL DISCOMFORT (Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice) and MUSCULOSKELETAL DISCOMFORT (Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice). At the time of the report, MUSCULOSKELETAL STIFFNESS (Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice) and MUSCULOSKELETAL DISCOMFORT (Cannot move my neck/Cannot move my right shoulder/My left gave up on me twice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore right arm after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm after first vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MYALGIA (sore right arm after first vaccine). At the time of the report, MYALGIA (sore right arm after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Treatment information not provided.       Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in her fingers; Tingling in left hand (ulnar distribution); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in left hand (ulnar distribution)) and PERIPHERAL SWELLING (Swelling in her fingers) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (Patient had bad reaction to this vaccine.). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (MIBELAS 24 FE) for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-May-2021, the patient experienced PARAESTHESIA (Tingling in left hand (ulnar distribution)). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her fingers). At the time of the report, PARAESTHESIA (Tingling in left hand (ulnar distribution)) and PERIPHERAL SWELLING (Swelling in her fingers) 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 treatment medications were reported.   This case was linked to MOD-2021-209168 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Influenza like illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.; Feel like I have a light flu; Feeling weak; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had chronic COVID in January 2021). Concomitant products included OMEPRAZOLE and SERTRALINE for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever). The patient was treated with ACETAMINOPHEN for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Had chronic COVID. On 03-Jun-2021, Heart rate: 170 beats per minute (High) 170 beats per minute. On 04-Jun-2021, Heart rate: 120 beats per minute.     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.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.; Feel like I have a light flu; Feeling weak; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Had chronic COVID in January 2021). Concomitant products included OMEPRAZOLE and SERTRALINE for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever). The patient was treated with ACETAMINOPHEN for Flu like symptoms, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Yesterday I ended up in Emergency Room with tachycardia, sort of developed over the day and tachycardia as high as 170 beats per minute.), INFLUENZA LIKE ILLNESS (Feel like I have a light flu), ASTHENIA (Feeling weak) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: (Positive) Had chronic COVID. On 03-Jun-2021, Heart rate: 170 beats per minute (High) 170 beats per minute. On 04-Jun-2021, Heart rate: 120 beats per minute.     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.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) 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 NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; 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 VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history provided.     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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Leg discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Leg discomfort) 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 LIMB DISCOMFORT (Leg discomfort). At the time of the report, LIMB DISCOMFORT (Leg discomfort) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Hay fever; Runny nose; Sore throat; Tired; stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: Hay fever; Runny nose; Sore throat; Tired; stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, SEASONAL ALLERGY (Hay fever), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tired) and NASAL CONGESTION (stuffy nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Little bit of liquid leaked out  while administering the vaccine; Liquid mixed with blood while administering the vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SYRINGE ISSUE (Little bit of liquid leaked out  while administering the vaccine) and UNDERDOSE (Liquid mixed with blood while administering the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-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 04-Jun-2021, the patient experienced SYRINGE ISSUE (Little bit of liquid leaked out  while administering the vaccine) and UNDERDOSE (Liquid mixed with blood while administering the vaccine). On 04-Jun-2021, SYRINGE ISSUE (Little bit of liquid leaked out  while administering the vaccine) and UNDERDOSE (Liquid mixed with blood while administering the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: heavy and painful periods; heavy and painful periods; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (heavy and painful periods) and DYSMENORRHEA (heavy and painful periods) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (heavy and painful periods) and DYSMENORRHEA (heavy and painful periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (heavy and painful periods) and DYSMENORRHEA (heavy and painful periods) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pains). At the time of the report, CHEST PAIN (Chest pains) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of asthma in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had asthma. Patient treated with prednisone for asthma; 1 dosage form. At the time of the report, asthma outcome: unknown. Concomitant product information not provided. Most recent follow-up information incorporated: On Jul 28, 2021: Follow-up received and contained non-significant information.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache that evening; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache that evening) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy (Allergic to oysters and gets hives when eating oysters.). Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HEADACHE (Headache that evening). On 25-Apr-2021, HEADACHE (Headache that evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Flatulence
Clinical narrative: Gassy; Diarrhea; Constipated, absent bowel movement; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (Gassy), CONSTIPATION (Constipated, absent bowel movement) and DIARRHOEA (Diarrhea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced CONSTIPATION (Constipated, absent bowel movement). On 04-Jun-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced FLATULENCE (Gassy). At the time of the report, FLATULENCE (Gassy), CONSTIPATION (Constipated, absent bowel movement) and DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not reported.  The action taken with mRNA1273 with the events was considered as not applicable
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: where can you report side effects to moderna covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (where can you report side effects to moderna covid vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (where can you report side effects to moderna covid vaccine). At the time of the report, VACCINATION COMPLICATION (where can you report side effects to moderna covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in my hand; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (numbness in my hand) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in my hand). At the time of the report, HYPOAESTHESIA (numbness in my hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose received more than 35 days ago and second dose yet to be received; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose received more than 35 days ago and second dose yet to be received) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Physical therapy and Occupational therapy.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose received more than 35 days ago and second dose yet to be received). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose received more than 35 days ago and second dose yet to be received) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.