chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: hot; redness; good red; uncomfortable; hardness; swollen; injection site turn red; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), ERYTHEMA (redness), ERYTHEMA (good red), FEELING ABNORMAL (uncomfortable) and VACCINATION SITE INDURATION (hardness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 29-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), ERYTHEMA (redness), ERYTHEMA (good red), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (hardness), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (injection site turn red). On 20-Mar-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved. On 05-Apr-2021, VACCINATION SITE WARMTH (hot), ERYTHEMA (redness), ERYTHEMA (good red), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (hardness), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (injection site turn red) 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.   Treatment include Benadryl at night  and Cetrizina at morning
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot; redness; good red; uncomfortable; hardness; swollen; injection site turn red; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), ERYTHEMA (redness), ERYTHEMA (good red), FEELING ABNORMAL (uncomfortable) and VACCINATION SITE INDURATION (hardness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 29-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), ERYTHEMA (redness), ERYTHEMA (good red), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (hardness), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (injection site turn red). On 20-Mar-2021, VACCINATION SITE PAIN (pain at the injection site) had resolved. On 05-Apr-2021, VACCINATION SITE WARMTH (hot), ERYTHEMA (redness), ERYTHEMA (good red), FEELING ABNORMAL (uncomfortable), VACCINATION SITE INDURATION (hardness), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (injection site turn red) 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.   Treatment include Benadryl at night  and Cetrizina at morning
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MULTIVITAMIN & MINERAL and MELATONIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information provided.; Sender's Comments:  :CROSSLINKED WITH DOSE 2
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Limb discomfort, Vaccination site pain
Clinical narrative: got dizzy; Soreness at the injection site; Arm felt a little hard; Blood pressure shot up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure shot up), LIMB DISCOMFORT (Arm felt a little hard), DIZZINESS (got dizzy) and VACCINATION SITE PAIN (Soreness at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, COPD, Glaucoma, Post-traumatic stress disorder and Herniated disc. Concomitant products included TELMISARTAN (MICARDIS), CELECOXIB (CELEBREX), GABAPENTIN, LAMOTRIGINE (LAMICTAL), ATORVASTATIN, LANSOPRAZOLE (PREVACID), HYDROCHLOROTHIAZIDE, MONTELUKAST, BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ALPRAZOLAM, MULTIVITAMIN [VITAMINS NOS], VITAMIN B12 NOS, VITAMIN D NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]) and BIOTIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HYPERTENSION (Blood pressure shot up). On 27-Feb-2021, the patient experienced LIMB DISCOMFORT (Arm felt a little hard) and VACCINATION SITE PAIN (Soreness at the injection site). On an unknown date, the patient experienced DIZZINESS (got dizzy). On 01-Mar-2021, LIMB DISCOMFORT (Arm felt a little hard) had resolved. On 02-Mar-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. At the time of the report, HYPERTENSION (Blood pressure shot up) and DIZZINESS (got dizzy) 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.   Treatment included ice pack to the injection on and off for 48 hours.   This case was linked to MOD-2021-071480, US-MODERNATX, INC.-MOD-2021-071480 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up appended. Contact information updated; Sender's Comments:  MOD-2021-071480:2nd dose US-MODERNATX, INC.-MOD-2021-071480:First dose case
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient that was under 18 that has received the vaccine/ 17 year and 9 months old received the 1st dose of the Moderna vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that was under 18 that has received the vaccine/ 17 year and 9 months old received the 1st dose of the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that was under 18 that has received the vaccine/ 17 year and 9 months old received the 1st dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient that was under 18 that has received the vaccine/ 17 year and 9 months old received the 1st dose of the Moderna vaccine) 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.   No concomitant medications were provided. Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Patient age was 17 years was received first dose of Moderna Vaccine on 29-Mar-2021
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: sore arm; did not sleep well that night after receiving dose #2; chills; "slight fever"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), INSOMNIA (did not sleep well that night after receiving dose #2), CHILLS (chills) and PYREXIA ("slight fever") in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for an unknown indication.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), INSOMNIA (did not sleep well that night after receiving dose #2), CHILLS (chills) and PYREXIA ("slight fever"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Apr-2021, INSOMNIA (did not sleep well that night after receiving dose #2) outcome was unknown. On 03-Apr-2021, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and PYREXIA ("slight fever") outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Lethargy, Magnetic resonance imaging head
Clinical narrative: Lack of energy; Severe headache; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lack of energy), HEADACHE (Severe headache) and LETHARGY (Lethargy) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 22L20A) for COVID-19 vaccination.     No medical history was reported. No concomitant medication was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Lack of energy), HEADACHE (Severe headache) and LETHARGY (Lethargy). At the time of the report, ASTHENIA (Lack of energy), HEADACHE (Severe headache) and LETHARGY (Lethargy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: unk.         Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD21-066084 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY-2021 contains non-significant information. Contact information updated.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Positive for covid 19; Sore throat; Mild cough; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), COUGH (Mild cough) and COVID-19 (Positive for covid 19) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and LAMOTRIGINE for an unknown indication.    On 02-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 OROPHARYNGEAL PAIN (Sore throat) and COUGH (Mild cough). On 15-Apr-2021, the patient experienced COVID-19 (Positive for covid 19). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), COUGH (Mild cough) and COVID-19 (Positive for covid 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gastrooesophageal reflux disease
Clinical narrative: abdominal, stomach pain. pain located in umbilical region/ diagnosed with acid reflux; pain in her back; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (abdominal, stomach pain. pain located in umbilical region/ diagnosed with acid reflux) and BACK PAIN (pain in her back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (abdominal, stomach pain. pain located in umbilical region/ diagnosed with acid reflux) and BACK PAIN (pain in her back).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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.   No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077929 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077929:second dose case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Fatigue, Headache, Nasopharyngitis
Clinical narrative: some parts are very very red in her neck; fatigue; burning sensation all over her neck and shoulders; cold; night sweat; fever\little higher fever; headache\extreme headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (night sweat), ERYTHEMA (some parts are very very red in her neck) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (no medical history reported.). Concomitant products included VITAMIN D3, CYANOCOBALAMIN (VIT B12), PYRIDOXINE HYDROCHLORIDE (VIT B6) and ZINC for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), NIGHT SWEATS (night sweat), PYREXIA (fever\little higher fever) and HEADACHE (headache\extreme headache). On 12-Apr-2021, the patient experienced BURNING SENSATION (burning sensation all over her neck and shoulders), ERYTHEMA (some parts are very very red in her neck) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (night sweat), ERYTHEMA (some parts are very very red in her neck), FATIGUE (fatigue), PYREXIA (fever\little higher fever) and HEADACHE (headache\extreme headache) outcome was unknown.            Treatment is with Benadryl, Hydroxyzine 25 mg 1 every 8 hour and prednisone 20 mg 1 tablet for 5 days. concomitant medications include high blood pressure medicine and HIV medicine along with mentioned above.   This case was linked to US-MODERNATX, INC.-MOD-2021-079307 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079307:DOSE 1
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: some parts are very very red in her neck; fatigue; burning sensation all over her neck and shoulders; cold; night sweat; fever\little higher fever; headache\extreme headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (night sweat), ERYTHEMA (some parts are very very red in her neck) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction (no medical history reported.). Concomitant products included VITAMIN D3, CYANOCOBALAMIN (VIT B12), PYRIDOXINE HYDROCHLORIDE (VIT B6) and ZINC for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced NASOPHARYNGITIS (cold), NIGHT SWEATS (night sweat), PYREXIA (fever\little higher fever) and HEADACHE (headache\extreme headache). On 12-Apr-2021, the patient experienced BURNING SENSATION (burning sensation all over her neck and shoulders), ERYTHEMA (some parts are very very red in her neck) and FATIGUE (fatigue). At the time of the report, BURNING SENSATION (burning sensation all over her neck and shoulders), NASOPHARYNGITIS (cold), NIGHT SWEATS (night sweat), ERYTHEMA (some parts are very very red in her neck), FATIGUE (fatigue), PYREXIA (fever\little higher fever) and HEADACHE (headache\extreme headache) outcome was unknown.            Treatment is with Benadryl, Hydroxyzine 25 mg 1 every 8 hour and prednisone 20 mg 1 tablet for 5 days. concomitant medications include high blood pressure medicine and HIV medicine along with mentioned above.   This case was linked to US-MODERNATX, INC.-MOD-2021-079307 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079307:DOSE 1
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: patiet developed shingles after first vaccine; patient developed a rash between two doses but not immediatedly after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (patiet developed shingles after first vaccine) and RASH (patient developed a rash between two doses but not immediatedly after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (patiet developed shingles after first vaccine) and RASH (patient developed a rash between two doses but not immediatedly after first dose). At the time of the report, HERPES ZOSTER (patiet developed shingles after first vaccine) and RASH (patient developed a rash between two doses but not immediatedly after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dyspnoea, Dyspnoea exertional, Electrocardiogram
Clinical narrative: SOB on exertion; Retaining fluid; could not walk far (10-15 ft)  hindered walking; diarrhea; shortness of breath on exertion; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking) and FLUID RETENTION (Retaining fluid) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension, TADALAFIL for an unknown indication and MACITENTAN (OPSUMIT) for an unknown indication.    The patient's past medical history included Post procedural complication and Hip surgery on 20-Jan-2020. Concurrent medical conditions included Pulmonary arterial hypertension, Interstitial lung disease, Fibrosis and Chronic obstructive pulmonary disease.   On 24-Nov-2020, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to .6 milligram per millilitre. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose On an unknown date, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to at an unspecified dose., TADALAFIL (unknown route) 40 milligram and MACITENTAN (OPSUMIT) (unknown route) 10 milligram once a day. In January 2021, the patient experienced DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion) and GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking). On an unknown date, the patient experienced DYSPNOEA EXERTIONAL (SOB on exertion) and FLUID RETENTION (Retaining fluid). At the time of the report, DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking) and FLUID RETENTION (Retaining fluid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown Unknown. On an unknown date, Electrocardiogram: unknown Unknown.         On 20 Jan 2020, the patient underwent a hip surgery, which also hindered his walking. The patient had shortness of breath upon exertion. The patient also had heavy oxygen around the neck which the patient also said that he needed to get something else that was lighter to carry.   No treatment information was reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Gait disturbance
Clinical narrative: SOB on exertion; Retaining fluid; could not walk far (10-15 ft)  hindered walking; diarrhea; shortness of breath on exertion; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking) and FLUID RETENTION (Retaining fluid) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension, TADALAFIL for an unknown indication and MACITENTAN (OPSUMIT) for an unknown indication.    The patient's past medical history included Post procedural complication and Hip surgery on 20-Jan-2020. Concurrent medical conditions included Pulmonary arterial hypertension, Interstitial lung disease, Fibrosis and Chronic obstructive pulmonary disease.   On 24-Nov-2020, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to .6 milligram per millilitre. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose On an unknown date, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to at an unspecified dose., TADALAFIL (unknown route) 40 milligram and MACITENTAN (OPSUMIT) (unknown route) 10 milligram once a day. In January 2021, the patient experienced DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion) and GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking). On an unknown date, the patient experienced DYSPNOEA EXERTIONAL (SOB on exertion) and FLUID RETENTION (Retaining fluid). At the time of the report, DIARRHOEA (diarrhea), DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)  hindered walking) and FLUID RETENTION (Retaining fluid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown Unknown. On an unknown date, Electrocardiogram: unknown Unknown.         On 20 Jan 2020, the patient underwent a hip surgery, which also hindered his walking. The patient had shortness of breath upon exertion. The patient also had heavy oxygen around the neck which the patient also said that he needed to get something else that was lighter to carry.   No treatment information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizzy immediately after shot; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy immediately after shot) and VERTIGO (vertigo) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (dizzy immediately after shot) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizzy immediately after shot) and VERTIGO (vertigo) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT MEDICATION WAS REPORTED , NO TREATMENT MEDICATION WAS REPORTED .   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Additional info received ON 24-MAY-2021 NON SIGNIFIVANT INFORMATION WAS REPORTED .
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Pain in extremity
Clinical narrative: sore arm; day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MUSCLE STRAIN (day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), VITAMIN D3 and VITAMIN B6 for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and MUSCLE STRAIN (day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade). At the time of the report, PAIN IN EXTREMITY (sore arm) and MUSCLE STRAIN (day 4-5, I have this interesting muscle strain in my upper left flank under my shoulder blade) outcome was unknown. Not Related      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.   Treatment information not provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Eye pruritus, Hypersensitivity, Muscle spasms
Clinical narrative: muscle spasm/ spasms in all his old injuries; eyes were itchy; one nostril started bleeding; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasm/ spasms in all his old injuries), EYE PRURITUS (eyes were itchy), EPISTAXIS (one nostril started bleeding) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included Sinus disorder and Fall (In the past he fell of a ladder onto his back). Concurrent medical conditions included Blood pressure high, Allergy and Cholesterol. Concomitant products included SIMVASTATIN for Blood pressure high, LISINOPRIL for an unknown indication.   On 19-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasm/ spasms in all his old injuries), EYE PRURITUS (eyes were itchy) and EPISTAXIS (one nostril started bleeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (muscle spasm/ spasms in all his old injuries), EYE PRURITUS (eyes were itchy), EPISTAXIS (one nostril started bleeding) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow up information received contains added Patient demographics, concomitant medication, new event hypersensitivity and event outcome updated.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed positive of Covid19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed positive of Covid19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Seasonal allergy.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (Diagnosed positive of Covid19). At the time of the report, COVID-19 (Diagnosed positive of Covid19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are taken. No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyposmia, Parosmia
Clinical narrative: really bad smell coming out of my pores; Sense of smell; cough drops called "breath", to open up nasal passage; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (really bad smell coming out of my pores), HYPOSMIA (Sense of smell) and DYSPNOEA (cough drops called "breath", to open up nasal passage) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAROSMIA (really bad smell coming out of my pores), HYPOSMIA (Sense of smell) and DYSPNOEA (cough drops called "breath", to open up nasal passage). At the time of the report, PAROSMIA (really bad smell coming out of my pores), HYPOSMIA (Sense of smell) and DYSPNOEA (cough drops called "breath", to open up nasal passage) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was using Eye drops as concomitant. Treatment medication was not provided.    Patient was treated with Cough drops called Breath.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Significant follow-up appended as outcome of event and patient demographics are updated
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dyspnoea, Dyspnoea exertional, Electrocardiogram
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)) and DIARRHEA (diarrhea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension, TADALAFIL for an unknown indication and MACITENTAN (OPSUMIT) for an unknown indication. The patient's past medical history included Post procedural complication and Hip surgery on 20-Jan-2020. Concurrent medical conditions included Pulmonary arterial hypertension, Interstitial lung disease, Fibrosis and Chronic obstructive pulmonary disease. On 24-Nov-2020, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to .6 milligram per millilitre. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose, TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose. On an unknown date, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to at an unspecified dose., TADALAFIL (unknown route) 40 milligram and MACITENTAN (OPSUMIT) (unknown route) 10 milligram once a day. On 17-Feb-2021, the patient experienced DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)) and DIARRHEA (diarrhea). At the time of the report, DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)) and DIARRHEA (diarrhea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown Unknown. On an unknown date, Electrocardiogram: unknown Unknown. On 20 Jan 2020, the patient underwent a hip surgery, which also hindered his walking. The patient had shortness of breath upon exertion. The patient also had heavy oxygen around the neck which the patient also said that he needed to get something else that was lighter to carry. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided. Reporter did not allow further contact.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)) and DIARRHEA (diarrhea) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products TREPROSTINIL SODIUM (TYVASO) inhalation gas for Secondary pulmonary arterial hypertension, TADALAFIL for an unknown indication and MACITENTAN (OPSUMIT) for an unknown indication. The patient's past medical history included Post procedural complication and Hip surgery on 20-Jan-2020. Concurrent medical conditions included Pulmonary arterial hypertension, Interstitial lung disease, Fibrosis and Chronic obstructive pulmonary disease. On 24-Nov-2020, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to .6 milligram per millilitre. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose, TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose. On an unknown date, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to at an unspecified dose., TADALAFIL (unknown route) 40 milligram and MACITENTAN (OPSUMIT) (unknown route) 10 milligram once a day. On 17-Feb-2021, the patient experienced DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)) and DIARRHEA (diarrhea). At the time of the report, DYSPNOEA (shortness of breath on exertion), DYSPNOEA EXERTIONAL (SOB on exertion), GAIT DISTURBANCE (could not walk far (10-15 ft)) and DIARRHEA (diarrhea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown Unknown. On an unknown date, Electrocardiogram: unknown Unknown. On 20 Jan 2020, the patient underwent a hip surgery, which also hindered his walking. The patient had shortness of breath upon exertion. The patient also had heavy oxygen around the neck which the patient also said that he needed to get something else that was lighter to carry. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided. Reporter did not allow further contact.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Myalgia, Vaccination site pain
Clinical narrative: "armpit is swollen and painful of the arm I received vaccine in"; "armpit is swollen and painful of the arm I received vaccine in"; "underarm armpit lymph node sensitive to touch"; achy body; headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYALGIA (achy body), HEADACHE (headache), VACCINATION SITE PAIN ("armpit is swollen and painful of the arm I received vaccine in"), LYMPH NODE PAIN ("underarm armpit lymph node sensitive to touch") and LYMPHADENOPATHY ("armpit is swollen and painful of the arm I received vaccine in") in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and #031A21A) for COVID-19 vaccination.     Concomitant products included AMBEREN for Menopause, LACTOBACILLUS NOS (CULTURELLE) 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 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (achy body) and HEADACHE (headache). On 25-Apr-2021, the patient experienced VACCINATION SITE PAIN ("armpit is swollen and painful of the arm I received vaccine in") and LYMPH NODE PAIN ("underarm armpit lymph node sensitive to touch"). On an unknown date, the patient experienced LYMPHADENOPATHY ("armpit is swollen and painful of the arm I received vaccine in"). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. In April 2021, HEADACHE (headache) had resolved. At the time of the report, MYALGIA (achy body) had resolved and VACCINATION SITE PAIN ("armpit is swollen and painful of the arm I received vaccine in"), LYMPH NODE PAIN ("underarm armpit lymph node sensitive to touch") and LYMPHADENOPATHY ("armpit is swollen and painful of the arm I received vaccine in") outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: pain; Chills; Headache; muscle aches and pains; Fatigue; Hot all over; Hard to breathe/shortness of breath/short winded; dizzy/feeling lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded), PAIN (pain), FEELING HOT (Hot all over) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FAMOTIDINE, ROSUVASTATIN, METOPROLOL, SPIRONOLACTONE, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded) and FEELING HOT (Hot all over). On an unknown date, the patient experienced PAIN (pain). an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle aches and pains) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded), FEELING HOT (Hot all over), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle aches and pains) and FATIGUE (Fatigue) had not resolved and PAIN (pain) outcome was unknown.            Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up document received on 29-May--2021 and does not contain any new information On 28-Jun-2021: follow-up document received on 28-06-2021 and does not contain any new information
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain
Clinical narrative: pain; Chills; Headache; muscle aches and pains; Fatigue; Hot all over; Hard to breathe/shortness of breath/short winded; dizzy/feeling lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded), PAIN (pain), FEELING HOT (Hot all over) and CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FAMOTIDINE, ROSUVASTATIN, METOPROLOL, SPIRONOLACTONE, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMINS NOS for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded) and FEELING HOT (Hot all over). On an unknown date, the patient experienced PAIN (pain). an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle aches and pains) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Hard to breathe/shortness of breath/short winded), DIZZINESS (dizzy/feeling lightheaded), FEELING HOT (Hot all over), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle aches and pains) and FATIGUE (Fatigue) had not resolved and PAIN (pain) outcome was unknown.            Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up document received on 29-May--2021 and does not contain any new information On 28-Jun-2021: follow-up document received on 28-06-2021 and does not contain any new information