chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pollakiuria, Pyrexia, Retching
Clinical narrative: Flu like symptoms; Dry heaves; Fever; Chills; Frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (Frequent urination), RETCHING (Dry heaves), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Atherosclerosis in 2009 and Stent replacement. Concurrent medical conditions included Drug allergy (erythromycin, tramadol.). Concomitant products included NIACIN for Blood cholesterol increased, LOSARTAN for Hypertension, KRILL OIL for Pain, ASCORBIC ACID (VITAMIN C ASC ACID), VITAMIN B COMPLEX (B COMPLEX (B50)), CURCUMA LONGA ROOT (TURMERIC [CURCUMA LONGA ROOT]), ZINC and APIXABAN (ELIQUIS) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced POLLAKIURIA (Frequent urination) and CHILLS (Chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), RETCHING (Dry heaves) and PYREXIA (Fever). On 11-Feb-2021, POLLAKIURIA (Frequent urination) and CHILLS (Chills) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), RETCHING (Dry heaves) and PYREXIA (Fever) was resolving. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of the events included , paracetamol.   This case was linked to US-MODERNATX, INC.-MOD-2021-056849 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Contact information updated On 17-May-2021: Completed ADR, additional event information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056849:2nd dose case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm from the injection site was itchy which got worse as the day went on; Arm from the injection site was swollen which got worse as the day went on, looked like an egg; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm from the injection site was itchy which got worse as the day went on) and VACCINATION SITE SWELLING (Arm from the injection site was swollen which got worse as the day went on, looked like an egg) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Arm from the injection site was itchy which got worse as the day went on) and VACCINATION SITE SWELLING (Arm from the injection site was swollen which got worse as the day went on, looked like an egg). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 24-Mar-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Arm from the injection site was itchy which got worse as the day went on) had not resolved and VACCINATION SITE SWELLING (Arm from the injection site was swollen which got worse as the day went on, looked like an egg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient also treated with  some ice on the affected area.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; Cough; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (COVID-19), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) (oral) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site feeling warm to the touch; Redcircle about two inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site feeling warm to the touch) and VACCINATION SITE ERYTHEMA (Redcircle about two inches at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site feeling warm to the touch) and VACCINATION SITE ERYTHEMA (Redcircle about two inches at the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site feeling warm to the touch) and VACCINATION SITE ERYTHEMA (Redcircle about two inches at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received on 09 Aug 2021 and updated outcome of events to recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye contusion, Feeling cold, Nasal congestion, Pain, Paraesthesia
Clinical narrative: "I looked like I had black eyes"; Neck and left facial swelling; Neck and left facial swelling; Nose felt plugged from facial swelling; Felt cold; Body aches; Fever of 102.9 degrees F; Pins and needles of left arm, top of hand and face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles of left arm, top of hand and face), EYE CONTUSION ("I looked like I had black eyes"), FEELING COLD (Felt cold), NASAL CONGESTION (Nose felt plugged from facial swelling) and SWELLING FACE (Neck and left facial swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA (Pins and needles of left arm, top of hand and face). On 16-Mar-2021, the patient experienced FEELING COLD (Felt cold), PAIN (Body aches) and PYREXIA (Fever of 102.9 degrees F). On 17-Mar-2021, the patient experienced NASAL CONGESTION (Nose felt plugged from facial swelling). On 19-Mar-2021, the patient experienced EYE CONTUSION ("I looked like I had black eyes"), SWELLING FACE (Neck and left facial swelling) and SWELLING (Neck and left facial swelling). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Ache, at an unspecified dose and frequency. On 16-Mar-2021, PARAESTHESIA (Pins and needles of left arm, top of hand and face) had resolved. On 18-Mar-2021, NASAL CONGESTION (Nose felt plugged from facial swelling) had resolved. On 20-Mar-2021, EYE CONTUSION ("I looked like I had black eyes"), FEELING COLD (Felt cold), SWELLING FACE (Neck and left facial swelling), SWELLING (Neck and left facial swelling), PAIN (Body aches) and PYREXIA (Fever of 102.9 degrees F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included topical creams. Treatment details included Tylenol.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Swelling face
Clinical narrative: "I looked like I had black eyes"; Neck and left facial swelling; Neck and left facial swelling; Nose felt plugged from facial swelling; Felt cold; Body aches; Fever of 102.9 degrees F; Pins and needles of left arm, top of hand and face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles of left arm, top of hand and face), EYE CONTUSION ("I looked like I had black eyes"), FEELING COLD (Felt cold), NASAL CONGESTION (Nose felt plugged from facial swelling) and SWELLING FACE (Neck and left facial swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PARAESTHESIA (Pins and needles of left arm, top of hand and face). On 16-Mar-2021, the patient experienced FEELING COLD (Felt cold), PAIN (Body aches) and PYREXIA (Fever of 102.9 degrees F). On 17-Mar-2021, the patient experienced NASAL CONGESTION (Nose felt plugged from facial swelling). On 19-Mar-2021, the patient experienced EYE CONTUSION ("I looked like I had black eyes"), SWELLING FACE (Neck and left facial swelling) and SWELLING (Neck and left facial swelling). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Ache, at an unspecified dose and frequency. On 16-Mar-2021, PARAESTHESIA (Pins and needles of left arm, top of hand and face) had resolved. On 18-Mar-2021, NASAL CONGESTION (Nose felt plugged from facial swelling) had resolved. On 20-Mar-2021, EYE CONTUSION ("I looked like I had black eyes"), FEELING COLD (Felt cold), SWELLING FACE (Neck and left facial swelling), SWELLING (Neck and left facial swelling), PAIN (Body aches) and PYREXIA (Fever of 102.9 degrees F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included topical creams. Treatment details included Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: Sleepy; Sore arm; Tired, Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired, Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Anemia.    On 23-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 SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired, Fatigue). At the time of the report, SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired, Fatigue) 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 assessment.  Concurrent products included medicine for high blood pressure and anemia. No treatment details were provided
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: invalid dose: pediatrics; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatrics) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 019B21A) for COVID-19 vaccination.     Concomitant products included DIENOGEST, ETHINYLESTRADIOL (LARISSA) for Birth control.   On 12-Mar-2021 at 4:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 1:03 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatrics). On 12-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (invalid dose: pediatrics) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up includes Concomitant medication was added. 2nd dose information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: tired; fever; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (tired), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills). At the time of the report, FATIGUE (tired), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills) had resolved.            no concomitant drugs included no treatment drugs included
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased
Clinical narrative: Elevated D-dimer; This spontaneous case was reported by a consumer and describes the occurrence of FIBRIN D DIMER INCREASED (Elevated D-dimer) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FIBRIN D DIMER INCREASED (Elevated D-dimer). At the time of the report, FIBRIN D DIMER INCREASED (Elevated D-dimer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After receiving the vaccine, the patient went to the family doctor for other reasons and they ordered a Ddimer test which resulted elevated. She stated didn't had any side effects from vaccine, but like to know if the vaccine elevated the test. Concomitant information were not reported. Treatment information were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given 2 hours after the 6 hour vial puncture expiration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given 2 hours after the 6 hour vial puncture expiration) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given 2 hours after the 6 hour vial puncture expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given 2 hours after the 6 hour vial puncture expiration) 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 medications were reported.   No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash papular, Swelling, Urticaria
Clinical narrative: Red; Had a big welt on the side of my arm; Size of a coffee cup opening; It's raised; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red), URTICARIA (Had a big welt on the side of my arm), SWELLING (Size of a coffee cup opening) and RASH PAPULAR (It's raised) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (Red), URTICARIA (Had a big welt on the side of my arm), SWELLING (Size of a coffee cup opening) and RASH PAPULAR (It's raised). At the time of the report, ERYTHEMA (Red), URTICARIA (Had a big welt on the side of my arm), SWELLING (Size of a coffee cup opening) and RASH PAPULAR (It's raised) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; headache; fatigue; A spontaneous report was received from a consumer, concerning a female patient of 78 years old, who received Moderna's COVID-19 vaccine and experienced Headache, Fatigue, Sore arm/ Pain at extremities.  The patient's medical history was not provided. Concomitant product use was provided by the reporter as Potassium, Cholesterol medication, High blood pressure medication, Levothyroxine used for unknown indication.  On 21 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis and experienced sore arm.  On 22 FEB 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route in right arm for COVID-19 infection prophylaxis. On 22 FEB 2021 , after second dose of vaccine, the patient experienced events Headache , Fatigue and the events were resolved on the same day. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; "move swollen legs bad",; "hurt when touched" arm; felt "tired"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING ("move swollen legs bad",), PAIN IN EXTREMITY ("hurt when touched" arm) and FATIGUE (felt "tired") in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Swelling of legs. Concurrent medical conditions included Diabetes (had diabetes and swollen legs). Concomitant products included METFORMIN, GLIMEPIRIDE, ROPINIROLE, CLONAZEPAM (KLONOPIN) and GABAPENTIN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING ("move swollen legs bad",), PAIN IN EXTREMITY ("hurt when touched" arm) and FATIGUE (felt "tired"). At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING ("move swollen legs bad",), PAIN IN EXTREMITY ("hurt when touched" arm) and FATIGUE (felt "tired") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown.       No treatment medication was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-054493, US-MODERNATX, INC.-MOD-2021-054456, US-MODERNATX, INC.-MOD-2021-056977 (E2B Linked Report). This case was linked to MOD-2021-056977 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054456:1st dose patient's case US-MODERNATX, INC.-MOD-2021-054493:2nd dose patient's case US-MODERNATX, INC.-MOD-2021-056977:2nd dose case of patient's husband
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Moderna vaccination during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Moderna vaccination during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 029A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Moderna vaccination during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Moderna vaccination during pregnancy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   No treatment medication were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose received 2 hours after the 6 hour vial puncture expiration; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose received 2 hours after the 6 hour vial puncture expiration) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose received 2 hours after the 6 hour vial puncture expiration). On 23-Mar-2021, EXPIRED PRODUCT ADMINISTERED (dose received 2 hours after the 6 hour vial puncture expiration) 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.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: 041L20A)  with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: she is beyond the recommended dosing interval; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (she is beyond the recommended dosing interval) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (she is beyond the recommended dosing interval). On 28-Mar-2021, PRODUCT DOSE OMISSION ISSUE (she is beyond the recommended dosing interval) had resolved.            No concomitant medication use was provided by the reporter.  Husband of patient reported that he and his wife did not have any adverse events with the two shots.   No treatment of events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: ADR form was received with updated reporter address and Dose 2 information,; Reporter's Comments: This report refers to a case of Missed dose, for mRNA-1273, lot #: 012M20A,  with no associated AEs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Myalgia
Clinical narrative: Loss Sense of Taste; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss Sense of Taste) and MYALGIA (Body Aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant historical event reported.).   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 14-Mar-2021, the patient experienced AGEUSIA (Loss Sense of Taste) and MYALGIA (Body Aches). At the time of the report, AGEUSIA (Loss Sense of Taste) and MYALGIA (Body Aches) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Chills; Fever; Vomiting all day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting all day) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, CHILLS (Chills), PYREXIA (Fever) and VOMITING (Vomiting all day) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: positive (Positive) positive. On 05-Mar-2021, Body temperature: 102 (High) 102 Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003d21a and 004m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE PAIN outcome was unknown.            No concomitant medication reported.  No treatment medication reported.   Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-232158.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: my arm was just red for two weeks; This spontaneous case was reported by a physician assistant and describes the occurrence of ERYTHEMA (my arm was just red for two weeks) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included METOPROLOL for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced ERYTHEMA (my arm was just red for two weeks). On 20-Jan-2021, ERYTHEMA (my arm was just red for two weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported. It was reported that the arm was red for two weeks.   This case was linked to MOD-2021-017387 (Patient Link).
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Two days of deep fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Two days of deep fatigue) and HEADACHE (Headache) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 FATIGUE (Two days of deep fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Two days of deep fatigue) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment for the events included none.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Trembling and shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Trembling and shaking) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.  No Medical History information was reported.   On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (Trembling and shaking). At the time of the report, TREMOR (Trembling and shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Can't use her left arm; Very sore left arm from injection; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Can't use her left arm) and PAIN IN EXTREMITY (Very sore left arm from injection) in a 67-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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced LIMB DISCOMFORT (Can't use her left arm) and PAIN IN EXTREMITY (Very sore left arm from injection). At the time of the report, LIMB DISCOMFORT (Can't use her left arm) and PAIN IN EXTREMITY (Very sore left arm from injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no  concomitant medications are provided. treatment to the events not reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Visual impairment
Clinical narrative: "eye problem with focusing" for 2 hours; muscle pain; felt "extremely tired"; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT ("eye problem with focusing" for 2 hours), MYALGIA (muscle pain) and FATIGUE (felt "extremely tired") in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes. Concomitant products included METFORMIN, GLIMEPIRIDE, ROPINIROLE, CLONAZEPAM (KLONOPIN) and GABAPENTIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (muscle pain) and FATIGUE (felt "extremely tired"). On 20-Mar-2021, the patient experienced VISUAL IMPAIRMENT ("eye problem with focusing" for 2 hours). On 21-Mar-2021, VISUAL IMPAIRMENT ("eye problem with focusing" for 2 hours) and MYALGIA (muscle pain) had resolved. On 22-Mar-2021, FATIGUE (felt "extremely tired") had resolved. Not Provided          The action taken with mRNA-1273 in response to the event was not applicable.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-054493, US-MODERNATX, INC.-MOD-2021-054456, US-MODERNATX, INC.-MOD-2021-056898 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054493:1st dose case  US-MODERNATX, INC.-MOD-2021-054456:2nd dose case US-MODERNATX, INC.-MOD-2021-056898:1st dose case
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Headache
Clinical narrative: Burnt eyes; Feeling tired; Headache; A spontaneous report was received from a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced burnt eyes(eye irritation), headache (Headache) and feeling tired(fatigue).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Mar 2021, two days prior to the onset of the events, the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.   On 17 Mar 2021, two days after receiving the vaccine, the patient had headache, burnt eyes and was feeling tired. Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, burnt eyes, headache and feeling tired, was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site movement impairment, Nausea, Pain in extremity
Clinical narrative: Pain in arm; Sleepiness; Injection site movement impairmen; Vaccination site swelling; Vaccination site erythema; Exhaustion; Low grade fever; Nausea; Headache; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (Sleepiness), INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (Left scar damage) on 24-Dec-1999, Endometrial cancer in 2007, Rotator cuff repair (Rotator cuff surgery) in 2019, Surgery (Surgery for an artificial right ankle) in 2009 and Surgery (Surgery for a left knee prosthetic) in 2011. Concurrent medical conditions included Lymphocytic colitis (Autoimmune lymphatic colitis) and Asthma (needs a rescue inhaler). Concomitant products included PREDNISONE and EPINEPHRINE (EPIPEN) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Feb-2021, the patient experienced INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Exhaustion), PYREXIA (Low grade fever), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SOMNOLENCE (Sleepiness). On 21-Feb-2021, PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved. On 22-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, SOMNOLENCE (Sleepiness), INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (Vaccination site swelling), FATIGUE (Exhaustion) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication including allergy shots and rescue Inhaler was reported   This case was linked to MOD-2021-057061 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain in arm; Sleepiness; Injection site movement impairmen; Vaccination site swelling; Vaccination site erythema; Exhaustion; Low grade fever; Nausea; Headache; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (Sleepiness), INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (Left scar damage) on 24-Dec-1999, Endometrial cancer in 2007, Rotator cuff repair (Rotator cuff surgery) in 2019, Surgery (Surgery for an artificial right ankle) in 2009 and Surgery (Surgery for a left knee prosthetic) in 2011. Concurrent medical conditions included Lymphocytic colitis (Autoimmune lymphatic colitis) and Asthma (needs a rescue inhaler). Concomitant products included PREDNISONE and EPINEPHRINE (EPIPEN) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Feb-2021, the patient experienced INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Exhaustion), PYREXIA (Low grade fever), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SOMNOLENCE (Sleepiness). On 21-Feb-2021, PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved. On 22-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, SOMNOLENCE (Sleepiness), INJECTION SITE MOVEMENT IMPAIRMENT (Injection site movement impairmen), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (Vaccination site swelling), FATIGUE (Exhaustion) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medication including allergy shots and rescue Inhaler was reported   This case was linked to MOD-2021-057061 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: lightheaded; Headache; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded), HEADACHE (Headache), FATIGUE (fatigue) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EZETIMIBE (ZETIA), LISINOPRIL, METOPROLOL, ATORVASTATIN, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMIN D NOS for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (lightheaded), HEADACHE (Headache), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, DIZZINESS (lightheaded), HEADACHE (Headache), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021, no new information
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: high fever 102.5; chills; Myalgia; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever 102.5), CHILLS (chills), MYALGIA (Myalgia) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    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 PYREXIA (high fever 102.5), CHILLS (chills), MYALGIA (Myalgia) and HEADACHE (Headache). At the time of the report, PYREXIA (high fever 102.5), CHILLS (chills), MYALGIA (Myalgia) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) Fever.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-057097 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Trouble breathing; Sore throat; Headache; Aches all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and MYALGIA (Aches all over) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Trouble breathing), OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache) and MYALGIA (Aches all over). At the time of the report, DYSPNOEA (Trouble breathing) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown and HEADACHE (Headache) and MYALGIA (Aches all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-121550 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received on 11 MAY 2021 has Event outcome and hospitalization reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.