chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site was hot; tchy; Injection site was hard; redness around the injection site; injection site looked significantly worse and larger in size; Fatigue; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (tchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore). On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (tchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE SWELLING (injection site looked significantly worse and larger in size) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE SWELLING (injection site looked significantly worse and larger in size) and FATIGUE (Fatigue) outcome was unknown and VACCINATION SITE PRURITUS (tchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (redness around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included prednisone 20mg for 4 days, Patient started taking it on 13 Apr 2021, use ice pack on the injection site and take diphenhydramine.  Patient reported that after starting the Prednisone the injection site got a little better. Patient reported that the injection site is still itchy, red, and sore.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was hot; tchy; Injection site was hard; redness around the injection site; injection site looked significantly worse and larger in size; Fatigue; sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (tchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (redness around the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore). On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE PRURITUS (tchy), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE SWELLING (injection site looked significantly worse and larger in size) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Injection site was hot), VACCINATION SITE INDURATION (Injection site was hard), VACCINATION SITE SWELLING (injection site looked significantly worse and larger in size) and FATIGUE (Fatigue) outcome was unknown and VACCINATION SITE PRURITUS (tchy), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (redness around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included prednisone 20mg for 4 days, Patient started taking it on 13 Apr 2021, use ice pack on the injection site and take diphenhydramine.  Patient reported that after starting the Prednisone the injection site got a little better. Patient reported that the injection site is still itchy, red, and sore.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test positive, Vaccination complication
Clinical narrative: He reports that he is asymptomatic; He doesn't feel like he has a common cold; Patient tested positive for covid after completion of vaccination series; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He reports that he is asymptomatic), FEELING ABNORMAL (He doesn't feel like he has a common cold) and SARS-COV-2 TEST POSITIVE (Patient tested positive for covid after completion of vaccination series) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for covid after completion of vaccination series). On 14-Apr-2021, the patient experienced VACCINATION COMPLICATION (He reports that he is asymptomatic) and FEELING ABNORMAL (He doesn't feel like he has a common cold). At the time of the report, VACCINATION COMPLICATION (He reports that he is asymptomatic), FEELING ABNORMAL (He doesn't feel like he has a common cold) and SARS-COV-2 TEST POSITIVE (Patient tested positive for covid after completion of vaccination series) outcome was unknown.            Concomitant medications also included: BP medicine and Cholesterol medicine.  No treatment information was provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Dementia and Heart disease, unspecified.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced URTICARIA (hives). On 30-Mar-2021, URTICARIA (hives) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red rash; Rash around the injection site on her left arm in the shape of a square; The site as been itchy all along; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (The site as been itchy all along) and VACCINATION SITE RASH (Rash around the injection site on her left arm in the shape of a square) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy (Allergy to adhesive).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (The site as been itchy all along). On 14-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE RASH (Rash around the injection site on her left arm in the shape of a square). At the time of the report, RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (The site as been itchy all along) and VACCINATION SITE RASH (Rash around the injection site on her left arm in the shape of a square) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received on 05-Aug-2021 and included No new information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 101 degree f High. On 14-Apr-2021, Body temperature: 102 degree f High.         No relevant concomitant medications were reported. Treatment information included paracetamol 500 mg. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Heavy, stiffness in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Heavy, stiffness in injected arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and TRAMADOL for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Heavy, stiffness in injected arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Heavy, stiffness in injected arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products included high blood pressure medications, Diabetes medication, Allegra, Tramadol. Treatment products included Tramadol.   This case was linked to US-MODERNATX, INC.-MOD-2021-076421 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076421:2 dose
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: chills; swelling to left arm at the injection site; redness to injection site; heat to injection site; felt hot inside; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot inside), CHILLS (chills), VACCINATION SITE SWELLING (swelling to left arm at the injection site), VACCINATION SITE ERYTHEMA (redness to injection site) and VACCINATION SITE WARMTH (heat to injection site) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING HOT (felt hot inside). On 06-Apr-2021, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (swelling to left arm at the injection site), VACCINATION SITE ERYTHEMA (redness to injection site) and VACCINATION SITE WARMTH (heat to injection site). At the time of the report, FEELING HOT (felt hot inside), CHILLS (chills), VACCINATION SITE SWELLING (swelling to left arm at the injection site), VACCINATION SITE ERYTHEMA (redness to injection site) and VACCINATION SITE WARMTH (heat to injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medicine has been reported by reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Myalgia, Taste disorder
Clinical narrative: administered expired dose; medicine taste; sore arm; fatigue; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired dose), TASTE DISORDER (medicine taste), MYALGIA (sore arm) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-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) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MYALGIA (sore arm). 12-Apr-2021, the patient experienced FATIGUE (fatigue). On 13-Apr-2021, the patient experienced TASTE DISORDER (medicine taste). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired dose), TASTE DISORDER (medicine taste), MYALGIA (sore arm) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medications and treatment information was not provided.  "Follow-up received on 21 May 2021 included no new information.   This case was linked to MOD21-074055, MOD21-075500, MOD21-075517, MOD21-075527, MOD21-075540, MOD21-075532, MOD21-075544, MOD21-075549 (Linked Report). This case was linked to MOD-2021-076892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up information received on 05-MAY-2021,patient demographic details was updated, dose information was updated, event was updated. On 21-May-2021: Additional information received on 21-MAY-2021 and does not contain any new information NNI; Sender's Comments:  MOD21-074055:Cross linked case MOD21-075500:Cross linked case MOD21-075517:Cross linked case MOD21-075527:Cross linked case MOD21-075540:Cross linked case MOD21-075532:Cross linked case MOD21-075544:Cross linked case MOD21-075549:Cross linked case
Sex: M
Vaccine: COVID19
Symptoms: Eye injury
Clinical narrative: shard of metal caught in eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE INJURY (shard of metal caught in eye) 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 EYE INJURY (shard of metal caught in eye). At the time of the report, EYE INJURY (shard of metal caught in eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient on painkillers
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash
Clinical narrative: bumpy; rash at the injection site that has growth to about softball size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bumpy) and VACCINATION SITE RASH (rash at the injection site that has growth to about softball size) 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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE MASS (bumpy) and VACCINATION SITE RASH (rash at the injection site that has growth to about softball size). At the time of the report, VACCINATION SITE MASS (bumpy) and VACCINATION SITE RASH (rash at the injection site that has growth to about softball size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. On 12 APR 2021 patient noticed a rash at the injection site that has growth to about softball size and was bumpy. Patient stated there was a line from the injection site to his chest where there was a second rash the size of a quarter. Reporter stated the patient has had no treatment.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fatigue, Somnolence
Clinical narrative: weakness; sleepiness (hard to keep his eyes open); confusion; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), SOMNOLENCE (sleepiness (hard to keep his eyes open)), CONFUSIONAL STATE (confusion) and FATIGUE (fatigue) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Hypertension and Diabetes.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ASTHENIA (weakness), SOMNOLENCE (sleepiness (hard to keep his eyes open)), CONFUSIONAL STATE (confusion) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), SOMNOLENCE (sleepiness (hard to keep his eyes open)), CONFUSIONAL STATE (confusion) and FATIGUE (fatigue) outcome was unknown. Not Provided      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 medication information was not reported. Treatment information as not reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysmenorrhoea, Headache, Myalgia
Clinical narrative: Menstrual Cramps/Period Started; Body Aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Menstrual Cramps/Period Started), CHILLS (Chills), MYALGIA (Body Aches) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). On 13-Apr-2021, the patient experienced CHILLS (Chills). On 14-Apr-2021, the patient experienced DYSMENORRHOEA (Menstrual Cramps/Period Started) and MYALGIA (Body Aches). On 14-Mar-2021, HEADACHE (Headache) had resolved. On 14-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, DYSMENORRHOEA (Menstrual Cramps/Period Started) and MYALGIA (Body Aches) outcome was unknown.            Treatment information not provided. List of concomitant medication were not given.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm is so sore she can't lift it; So tired as if she ran a marathon; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is so sore she can't lift it) and FATIGUE (So tired as if she ran a marathon) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (So tired as if she ran a marathon). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is so sore she can't lift it). At the time of the report, PAIN IN EXTREMITY (Arm is so sore she can't lift it) and FATIGUE (So tired as if she ran a marathon) outcome was unknown. Not Provided      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: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: red dots on arm, welt like; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red dots on arm, welt like) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (red dots on arm, welt like). At the time of the report, URTICARIA (red dots on arm, welt like) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included birth control for an unknown indication.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: At the time of the vaccination the daughter was 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (At the time of the vaccination the daughter was 16 years of age) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (At the time of the vaccination the daughter was 16 years of age). On 14-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (At the time of the vaccination the daughter was 16 years of age) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information received on 20-APR-2021 contains non-significant information: Consumer reported denial for follow-up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: chills; muscle ache; fever; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle ache), PYREXIA (fever) and HEADACHE (Slight Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), MYALGIA (muscle ache), PYREXIA (fever) and HEADACHE (Slight Headache). At the time of the report, CHILLS (chills), MYALGIA (muscle ache), PYREXIA (fever) and HEADACHE (Slight Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Periorbital swelling, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site began Swelling; puffy eyes; trouble breathing; injection site  hard and warm; injection site hard and warm; tenderness of arm after injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (puffy eyes), DYSPNOEA (trouble breathing), VACCINATION SITE WARMTH (injection site  hard and warm), VACCINATION SITE INDURATION (injection site hard and warm) and VACCINATION SITE PAIN (tenderness of arm after injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001652) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL 12 HOUR), Preindopril and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (tenderness of arm after injection). On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site  hard and warm) and VACCINATION SITE INDURATION (injection site hard and warm). On 14-Apr-2021, the patient experienced PERIORBITAL SWELLING (puffy eyes) and DYSPNOEA (trouble breathing). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site began Swelling). At the time of the report, PERIORBITAL SWELLING (puffy eyes), DYSPNOEA (trouble breathing), VACCINATION SITE WARMTH (injection site  hard and warm), VACCINATION SITE INDURATION (injection site hard and warm), VACCINATION SITE PAIN (tenderness of arm after injection) and VACCINATION SITE SWELLING (Injection site began Swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site began Swelling; puffy eyes; trouble breathing; injection site  hard and warm; injection site hard and warm; tenderness of arm after injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (puffy eyes), DYSPNOEA (trouble breathing), VACCINATION SITE WARMTH (injection site  hard and warm), VACCINATION SITE INDURATION (injection site hard and warm) and VACCINATION SITE PAIN (tenderness of arm after injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001652) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL 12 HOUR), Preindopril and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (tenderness of arm after injection). On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site  hard and warm) and VACCINATION SITE INDURATION (injection site hard and warm). On 14-Apr-2021, the patient experienced PERIORBITAL SWELLING (puffy eyes) and DYSPNOEA (trouble breathing). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site began Swelling). At the time of the report, PERIORBITAL SWELLING (puffy eyes), DYSPNOEA (trouble breathing), VACCINATION SITE WARMTH (injection site  hard and warm), VACCINATION SITE INDURATION (injection site hard and warm), VACCINATION SITE PAIN (tenderness of arm after injection) and VACCINATION SITE SWELLING (Injection site began Swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Vaccination site pain
Clinical narrative: Shortness or breath / breathing difficulty; weak; Sore arm / mild soreness in arm; fatigue; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021. The most recent information was received on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness or breath / breathing difficulty), ASTHENIA (weak), VACCINATION SITE PAIN (Sore arm / mild soreness in arm) and FATIGUE (fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included HYDROCODONE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (Shortness or breath / breathing difficulty), ASTHENIA (weak), VACCINATION SITE PAIN (Sore arm / mild soreness in arm) and FATIGUE (fatigue). On 19-Mar-2021, VACCINATION SITE PAIN (Sore arm / mild soreness in arm) had resolved. At the time of the report, DYSPNOEA (Shortness or breath / breathing difficulty), ASTHENIA (weak) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included steroids for COPD No treatment information was provided.  Patient took the second dose on an unknown date. Upon follow up received on05/Aug/2021 reporter stated vaccine was more like the flu shot. Patient had mild soreness in arm and some breathing and fatigue difficulty.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received on 05-Aug-2021. Updated event intensity for sore arm and added dose 2 information. Reporter's comment added. Corresponding field and narrative updated accordingly. On 09-Aug-2021: Non-Significant Follow up added on 09-Aug-2021 and contains no new information.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain in extremity
Clinical narrative: Sharp pain in right thigh; Pain in left side of the chest; Sharp pain in right ankle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp pain in right thigh), CHEST PAIN (Pain in left side of the chest) and ARTHRALGIA (Sharp pain in right ankle) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sharp pain in right thigh), CHEST PAIN (Pain in left side of the chest) and ARTHRALGIA (Sharp pain in right ankle). At the time of the report, PAIN IN EXTREMITY (Sharp pain in right thigh), CHEST PAIN (Pain in left side of the chest) and ARTHRALGIA (Sharp pain in right ankle) outcome was unknown. Not Provided      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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: The antibodies test result came back negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (The antibodies test result came back negative) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS) (She had similar response with other vaccines like Hep C vaccine at 3 different times in her life.).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (The antibodies test result came back negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (The antibodies test result came back negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-2 antibody test: unknown (Negative) Patient didn't have any response from the vaccine..         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test, Pain in extremity
Clinical narrative: Tested positive for covid-19; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (Tested positive for covid-19) in a 68-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.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 31-Mar-2021, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, PAIN IN EXTREMITY (Sore arm) and COVID-19 (Tested positive for covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Coronavirus test: (Positive) Covid-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included azithromycin.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes mellitus.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (fatigue). On 25-Mar-2021, FATIGUE (fatigue) had resolved. Not Provided      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.   Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: two small pink rashes on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (two small pink rashes on injection arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE RASH (two small pink rashes on injection arm). At the time of the report, VACCINATION SITE RASH (two small pink rashes on injection arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event Outcome Updated from not recovered to resolved.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Pain in extremity
Clinical narrative: sore arm; low grade temp; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and BODY TEMPERATURE DECREASED (low grade temp) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and BODY TEMPERATURE DECREASED (low grade temp). At the time of the report, PAIN IN EXTREMITY (sore arm) and BODY TEMPERATURE DECREASED (low grade temp) outcome was unknown. Not Provided      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 provided. No treatment drugs were reported.    This case was linked to MOD21-075527, MOD21-075517, MOD21-074055, MOD21-075351, MOD21-075500, MOD21-075532, MOD21-075540, MOD21-075544 (E2B Linked Report).; Sender's Comments:  MOD21-075527:Cross linked case MOD21-075517:Cross linked case MOD21-074055:Cross linked case MOD21-075351:Cross linked case MOD21-075500:Cross linked case MOD21-075532:Cross linked case MOD21-075540:Cross linked case MOD21-075544:Cross linked case
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Hyperhidrosis
Clinical narrative: threw up; tired; nauseous; sweaty; lost my appetite; warm; diarrhea; had low energy, lethargic; lethargic; getting the flu; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea) and ASTHENIA (had low energy, lethargic) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Allergy to animals (cat dander) and Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-Apr-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea), ASTHENIA (had low energy, lethargic), LETHARGY (lethargic), INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous). On 13-Apr-2021, the patient experienced FATIGUE (tired). On 14-Apr-2021, the patient experienced VOMITING (threw up). On 11-Apr-2021, DECREASED APPETITE (lost my appetite) had resolved. On 14-Apr-2021, FATIGUE (tired) had resolved. On 15-Apr-2021, DIARRHOEA (diarrhea) and VOMITING (threw up) had resolved. On 08-May-2021, LETHARGY (lethargic) had resolved. At the time of the report, HYPERHIDROSIS (sweaty), SKIN WARM (warm) and ASTHENIA (had low energy, lethargic) outcome was unknown and INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-139980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18 may 2021  included  patient's demographics and medical history, second dose details, concomitant drug added and events resolved was updated for lethargy, vomiting, diarrhea.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Lethargy, Myalgia, Nausea, SARS-CoV-2 test
Clinical narrative: threw up; tired; nauseous; sweaty; lost my appetite; warm; diarrhea; had low energy, lethargic; lethargic; getting the flu; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea) and ASTHENIA (had low energy, lethargic) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Allergy to animals (cat dander) and Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-Apr-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea), ASTHENIA (had low energy, lethargic), LETHARGY (lethargic), INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous). On 13-Apr-2021, the patient experienced FATIGUE (tired). On 14-Apr-2021, the patient experienced VOMITING (threw up). On 11-Apr-2021, DECREASED APPETITE (lost my appetite) had resolved. On 14-Apr-2021, FATIGUE (tired) had resolved. On 15-Apr-2021, DIARRHOEA (diarrhea) and VOMITING (threw up) had resolved. On 08-May-2021, LETHARGY (lethargic) had resolved. At the time of the report, HYPERHIDROSIS (sweaty), SKIN WARM (warm) and ASTHENIA (had low energy, lethargic) outcome was unknown and INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-139980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18 may 2021  included  patient's demographics and medical history, second dose details, concomitant drug added and events resolved was updated for lethargy, vomiting, diarrhea.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vomiting
Clinical narrative: threw up; tired; nauseous; sweaty; lost my appetite; warm; diarrhea; had low energy, lethargic; lethargic; getting the flu; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea) and ASTHENIA (had low energy, lethargic) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy, Allergy to animals (cat dander) and Hypothyroidism. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-Apr-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HYPERHIDROSIS (sweaty), DECREASED APPETITE (lost my appetite), SKIN WARM (warm), DIARRHOEA (diarrhea), ASTHENIA (had low energy, lethargic), LETHARGY (lethargic), INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous). On 13-Apr-2021, the patient experienced FATIGUE (tired). On 14-Apr-2021, the patient experienced VOMITING (threw up). On 11-Apr-2021, DECREASED APPETITE (lost my appetite) had resolved. On 14-Apr-2021, FATIGUE (tired) had resolved. On 15-Apr-2021, DIARRHOEA (diarrhea) and VOMITING (threw up) had resolved. On 08-May-2021, LETHARGY (lethargic) had resolved. At the time of the report, HYPERHIDROSIS (sweaty), SKIN WARM (warm) and ASTHENIA (had low energy, lethargic) outcome was unknown and INFLUENZA (getting the flu), MYALGIA (body aches) and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-139980 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18 may 2021  included  patient's demographics and medical history, second dose details, concomitant drug added and events resolved was updated for lethargy, vomiting, diarrhea.