chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Pruritus
Clinical narrative: arm was red size of my palm; hot arm; itchy arm; hard arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red size of my palm), FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, PRAVASTATIN, POTASSIUM (POTASIUM M), ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, METOPROLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (arm was red size of my palm), FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm). On 03-Feb-2021, FEELING HOT (hot arm), PRURITUS (itchy arm) and INDURATION (hard arm) had resolved. At the time of the report, ERYTHEMA (arm was red size of my palm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Benadryl when itching badly.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Delayed Swelling bruise; Delayed itchy brusie; Delayed red bruise; Tiny bruise the size of a penny; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Tiny bruise the size of a penny), VACCINATION SITE SWELLING (Delayed Swelling bruise), INJECTION SITE PRURITUS (Delayed itchy brusie) and INJECTION SITE ERYTHEMA (Delayed red bruise) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE BRUISING (Tiny bruise the size of a penny). On 19-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Delayed Swelling bruise), INJECTION SITE PRURITUS (Delayed itchy brusie) and INJECTION SITE ERYTHEMA (Delayed red bruise). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE BRUISING (Tiny bruise the size of a penny), VACCINATION SITE SWELLING (Delayed Swelling bruise), INJECTION SITE PRURITUS (Delayed itchy brusie) and INJECTION SITE ERYTHEMA (Delayed red bruise) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information includes ice.  No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: ADR Form received on 11-MAY-2021 Contains patient details updated , medical history was updated.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Lethargy
Clinical narrative: having sweats; lethargy; body aches; low grade fever; joint pain; headache; muscle pain; chills; A spontaneous report was received from a Consumer concerning a 65- years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sweats(hyperhidrosis), lethargy(lethargy), chills(chills), low grade fever(pyrexia), headache(headache), joint pain(arthralgia), muscle pain(myalgia ) and body aches(pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 023M20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Feb 2021, at 8 PM the patient experienced sweats, lethargy, chills, low grade fever, headache, joint pain, muscle pain and body aches.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, sweats, lethargy, chills, low grade fever, headache, joint pain, muscle pain and body aches were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: having sweats; lethargy; body aches; low grade fever; joint pain; headache; muscle pain; chills; A spontaneous report was received from a Consumer concerning a 65- years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sweats(hyperhidrosis), lethargy(lethargy), chills(chills), low grade fever(pyrexia), headache(headache), joint pain(arthralgia), muscle pain(myalgia ) and body aches(pain).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On24 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 023M20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Feb 2021, at 8 PM the patient experienced sweats, lethargy, chills, low grade fever, headache, joint pain, muscle pain and body aches.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, sweats, lethargy, chills, low grade fever, headache, joint pain, muscle pain and body aches were unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site discolouration, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at the injection site 4.5 to 5 inches; blotchy at the injection site; arm sort of itchy; headache; swelling at the injection site after the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site after the shot), VACCINATION SITE ERYTHEMA (redness at the injection site 4.5 to 5 inches), INJECTION SITE DISCOLOURATION (blotchy at the injection site), PRURITUS (arm sort of itchy) and HEADACHE (headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included blood pressure medicine for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site after the shot) and HEADACHE (headache). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site 4.5 to 5 inches), INJECTION SITE DISCOLOURATION (blotchy at the injection site) and PRURITUS (arm sort of itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site after the shot), VACCINATION SITE ERYTHEMA (redness at the injection site 4.5 to 5 inches), INJECTION SITE DISCOLOURATION (blotchy at the injection site) and PRURITUS (arm sort of itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Minor itching; Oval shaped rash; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness), VACCINATION SITE PRURITUS (Minor itching) and VACCINATION SITE RASH (Oval shaped rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Soreness). On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Minor itching) and VACCINATION SITE RASH (Oval shaped rash). On 12-Feb-2021, MYALGIA (Soreness) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (Minor itching) and VACCINATION SITE RASH (Oval shaped rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: Violent shaking; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shaking) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no historical condition was reported).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced TREMOR (Violent shaking) and CHILLS (Chills). At the time of the report, TREMOR (Violent shaking) and CHILLS (Chills) 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.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: lethargy; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargy). At the time of the report, LETHARGY (lethargy) outcome was unknown.            No concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 103.1; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 103.1) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PYREXIA (fever of 103.1). At the time of the report, PYREXIA (fever of 103.1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported.  The reporter not sure whether the patient and Patient's partner had food poisoning and that was caused the fever.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sluggishness
Clinical narrative: Extremely tired and sluggish; More tired and sluggish than usual thereafter; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely tired and sluggish) and SLUGGISHNESS (More tired and sluggish than usual thereafter) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extremely tired and sluggish) and SLUGGISHNESS (More tired and sluggish than usual thereafter). At the time of the report, FATIGUE (Extremely tired and sluggish) and SLUGGISHNESS (More tired and sluggish than usual thereafter) outcome was unknown.            No concomitants or treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site rash (rash at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included: No historical conditions reported. On Feb 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced injection site rash (rash at the injection site). At the time of the report, injection site rash (rash at the injection site): not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitants or treatment medications reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a pain they have from a ruptured disk, they had since before but sometimes it flairs up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a pain they have from a ruptured disk, they had since before but sometimes it flairs up) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Cholesterol.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (a pain they have from a ruptured disk, they had since before but sometimes it flairs up). At the time of the report, PAIN (a pain they have from a ruptured disk, they had since before but sometimes it flairs up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patients medical history included ruptured disk.  Concomitant product included high  blood pressure medications, diabetes oral medication and cholesterol medication. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, Sinusitis
Clinical narrative: Pain in her arm; Sinus disorder; Drainage from nose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm), SINUSITIS (Sinus disorder) and RHINORRHOEA (Drainage from nose) 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) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm), SINUSITIS (Sinus disorder) and RHINORRHOEA (Drainage from nose). At the time of the report, PAIN IN EXTREMITY (Pain in her arm), SINUSITIS (Sinus disorder) and RHINORRHOEA (Drainage from nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medications reported. no treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Feeling abnormal, Headache, Malaise
Clinical narrative: nausea again; her eyes were sensitive to the light; they don't feel right; it was the worst day; a very bad nausea; splitting headache; backache; muscle ache; didn't have any appetite; she began with symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (she began with symptoms), FEELING ABNORMAL (it was the worst day), NAUSEA (a very bad nausea), HEADACHE (splitting headache) and BACK PAIN (backache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica and Sjogren's. Concomitant products included HYDROXYCHLOROQUINE, VALSARTAN, HYDROCHLOROTHIAZIDE and FAMOTIDINE for an unknown indication.  On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SYMPTOM RECURRENCE (she began with symptoms). On 20-Feb-2021, the patient experienced FEELING ABNORMAL (it was the worst day), NAUSEA (a very bad nausea), HEADACHE (splitting headache), BACK PAIN (backache), MYALGIA (muscle ache) and DECREASED APPETITE (didn't have any appetite). On 23-Feb-2021, the patient experienced NAUSEA (nausea again), PHOTOPHOBIA (her eyes were sensitive to the light) and MALAISE (they don't feel right). At the time of the report, SYMPTOM RECURRENCE (she began with symptoms), NAUSEA (a very bad nausea), HEADACHE (splitting headache), BACK PAIN (backache), MYALGIA (muscle ache), DECREASED APPETITE (didn't have any appetite), NAUSEA (nausea again), PHOTOPHOBIA (her eyes were sensitive to the light) and MALAISE (they don't feel right) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included Excedrin: Aspirin/Paracetamol/Caffeine.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Photophobia, Symptom recurrence
Clinical narrative: nausea again; her eyes were sensitive to the light; they don't feel right; it was the worst day; a very bad nausea; splitting headache; backache; muscle ache; didn't have any appetite; she began with symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (she began with symptoms), FEELING ABNORMAL (it was the worst day), NAUSEA (a very bad nausea), HEADACHE (splitting headache) and BACK PAIN (backache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica and Sjogren's. Concomitant products included HYDROXYCHLOROQUINE, VALSARTAN, HYDROCHLOROTHIAZIDE and FAMOTIDINE for an unknown indication.  On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SYMPTOM RECURRENCE (she began with symptoms). On 20-Feb-2021, the patient experienced FEELING ABNORMAL (it was the worst day), NAUSEA (a very bad nausea), HEADACHE (splitting headache), BACK PAIN (backache), MYALGIA (muscle ache) and DECREASED APPETITE (didn't have any appetite). On 23-Feb-2021, the patient experienced NAUSEA (nausea again), PHOTOPHOBIA (her eyes were sensitive to the light) and MALAISE (they don't feel right). At the time of the report, SYMPTOM RECURRENCE (she began with symptoms), NAUSEA (a very bad nausea), HEADACHE (splitting headache), BACK PAIN (backache), MYALGIA (muscle ache), DECREASED APPETITE (didn't have any appetite), NAUSEA (nausea again), PHOTOPHOBIA (her eyes were sensitive to the light) and MALAISE (they don't feel right) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included Excedrin: Aspirin/Paracetamol/Caffeine.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Muscular weakness, Nasal congestion, Nausea
Clinical narrative: shivering; is real hot; stuffy nose; nausea; arm has lump on it; can't even lift arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea) and SKIN MASS (arm has lump on it) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea), SKIN MASS (arm has lump on it) and MUSCULAR WEAKNESS (can't even lift arm). At the time of the report, CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea), SKIN MASS (arm has lump on it) and MUSCULAR WEAKNESS (can't even lift arm) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-037683 (E2B Linked Report).; Sender's Comments:  MOD21-037683:cross link
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: shivering; is real hot; stuffy nose; nausea; arm has lump on it; can't even lift arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea) and SKIN MASS (arm has lump on it) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea), SKIN MASS (arm has lump on it) and MUSCULAR WEAKNESS (can't even lift arm). At the time of the report, CHILLS (shivering), HOT FLUSH (is real hot), NASAL CONGESTION (stuffy nose), NAUSEA (nausea), SKIN MASS (arm has lump on it) and MUSCULAR WEAKNESS (can't even lift arm) outcome was unknown.      No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-037683 (E2B Linked Report).; Sender's Comments:  MOD21-037683:cross link
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Some kind of rash at the injection site with a bump in it; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2DA) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with PARAFFIN SOFT (VASELINE [PARAFFIN SOFT]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19 virus; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19 virus) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19 virus). At the time of the report, COVID-19 (Tested positive for COVID-19 virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, COVID-19: unknown (Positive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was reported.  Patient gave consent to safety for Follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: bad rash reaction to the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (bad rash reaction to the moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (bad rash reaction to the moderna vaccine). At the time of the report, VACCINATION SITE RASH (bad rash reaction to the moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Cholesterol since an unknown date and Pace maker (Patient has a pacemaker). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (knee pain). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) on 22-Jan-2021 for Knee pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported were medication for high blood pressure, blood thinner, and medication for cholesterol. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date, Cholesterol since an unknown date and Pace maker (Patient has a pacemaker). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (knee pain). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) on 22-Jan-2021 for Knee pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported were medication for high blood pressure, blood thinner, and medication for cholesterol.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Diarrhoea, Feeling hot, Hot flush
Clinical narrative: weak; on the toilet with diarrhea; has not been to bed all night; hot flashes; toes were hot; stomach was bloated; in the bathroom every half hour during the night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated) and HYPERTONIC BLADDER (in the bathroom every half hour during the night) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated) and HYPERTONIC BLADDER (in the bathroom every half hour during the night). On 25-Feb-2021, the patient experienced ASTHENIA (weak) and DIARRHOEA (on the toilet with diarrhea). At the time of the report, INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated), HYPERTONIC BLADDER (in the bathroom every half hour during the night), ASTHENIA (weak) and DIARRHOEA (on the toilet with diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertonic bladder, Insomnia
Clinical narrative: weak; on the toilet with diarrhea; has not been to bed all night; hot flashes; toes were hot; stomach was bloated; in the bathroom every half hour during the night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated) and HYPERTONIC BLADDER (in the bathroom every half hour during the night) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated) and HYPERTONIC BLADDER (in the bathroom every half hour during the night). On 25-Feb-2021, the patient experienced ASTHENIA (weak) and DIARRHOEA (on the toilet with diarrhea). At the time of the report, INSOMNIA (has not been to bed all night), HOT FLUSH (hot flashes), FEELING HOT (toes were hot), ABDOMINAL DISTENSION (stomach was bloated), HYPERTONIC BLADDER (in the bathroom every half hour during the night), ASTHENIA (weak) and DIARRHOEA (on the toilet with diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Nasal congestion, Pyrexia
Clinical narrative: fever; having allergic reaction; having stuffy, congestion; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 19-Feb-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 PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 19-Feb-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 PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever ), HYPERSENSITIVITY (having allergic reaction), NASAL CONGESTION (having stuffy, congestion) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: black and blue bruise on my shoulder but it was very faint; my vision got blurry; headache; nausea; vomiting; low-grade fever on and off; arm hurt bad/arm hurting again; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (black and blue bruise on my shoulder but it was very faint), VISION BLURRED (my vision got blurry), PAIN IN EXTREMITY (arm hurt bad/arm hurting again), HEADACHE (mild headache) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, CYANOCOBALAMIN (VITAMIN B-12), VITAMIN D [VITAMIN D NOS], CLONAZEPAM, PIROXICAM (OXICAM), OXYCODONE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA), HYDROCORTISONE, ASPIRIN [ACETYLSALICYLIC ACID] and ALIROCUMAB (PRALUENT) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt bad/arm hurting again) and HEADACHE (mild headache). On 17-Feb-2021, the patient experienced VISION BLURRED (my vision got blurry), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (low-grade fever on and off). On an unknown date, the patient experienced CONTUSION (black and blue bruise on my shoulder but it was very faint). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 20-Jan-2021, HEADACHE (mild headache) had resolved. On 23-Jan-2021, PAIN IN EXTREMITY (arm hurt bad/arm hurting again) had resolved. At the time of the report, CONTUSION (black and blue bruise on my shoulder but it was very faint), VISION BLURRED (my vision got blurry), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (low-grade fever on and off) outcome was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: black and blue bruise on my shoulder but it was very faint; my vision got blurry; headache; nausea; vomiting; low-grade fever on and off; arm hurt bad/arm hurting again; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (black and blue bruise on my shoulder but it was very faint), VISION BLURRED (my vision got blurry), PAIN IN EXTREMITY (arm hurt bad/arm hurting again), HEADACHE (mild headache) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE, CYANOCOBALAMIN (VITAMIN B-12), VITAMIN D [VITAMIN D NOS], CLONAZEPAM, PIROXICAM (OXICAM), OXYCODONE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA), HYDROCORTISONE, ASPIRIN [ACETYLSALICYLIC ACID] and ALIROCUMAB (PRALUENT) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt bad/arm hurting again) and HEADACHE (mild headache). On 17-Feb-2021, the patient experienced VISION BLURRED (my vision got blurry), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (low-grade fever on and off). On an unknown date, the patient experienced CONTUSION (black and blue bruise on my shoulder but it was very faint). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. On 20-Jan-2021, HEADACHE (mild headache) had resolved. On 23-Jan-2021, PAIN IN EXTREMITY (arm hurt bad/arm hurting again) had resolved. At the time of the report, CONTUSION (black and blue bruise on my shoulder but it was very faint), VISION BLURRED (my vision got blurry), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (low-grade fever on and off) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Vomiting) 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 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 25-Feb-2021, the patient experienced VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Vomiting) 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 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 25-Feb-2021, the patient experienced VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had not resolved.        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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin exfoliation, Urticaria
Clinical narrative: Dry scaly; itchy; sore red; circular Patchy 1 diameter; hives to his left and right thighs, knee to groin area, top of left foot; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives to his left and right thighs, knee to groin area, top of left foot), SKIN EXFOLIATION (Dry scaly), RASH (circular Patchy 1 diameter), PRURITUS (itchy) and ERYTHEMA (sore red) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Allergic dermatitis (Caller also shared that he was diagnosed with ALLERGIC DERMATITIS (High Eosinophil level)). Concurrent medical conditions included Hypertension, Hyperlipidemia and Functional blood flow disorder (uses Blood thinner). Concomitant products included EZETIMIBE and ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Functional blood flow disorder.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced URTICARIA (hives to his left and right thighs, knee to groin area, top of left foot), RASH (circular Patchy 1 diameter), PRURITUS (itchy) and ERYTHEMA (sore red). On an unknown date, the patient experienced SKIN EXFOLIATION (Dry scaly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at a dose of 25 milligram, 2 dosage form. At the time of the report, URTICARIA (hives to his left and right thighs, knee to groin area, top of left foot), SKIN EXFOLIATION (Dry scaly), RASH (circular Patchy 1 diameter), PRURITUS (itchy) and ERYTHEMA (sore red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In addition to above patient also reported using Essential one vitamins and Barbedilol twice daily for unknown indication.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Achy; Fever; Chillls; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PYREXIA (Fever) and CHILLS (Chillls) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure inadequately controlled. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), BIOTIN, VITAMIN B3, VITAMIN B12 NOS and Blood Pressure Medicine for an unknown indication.    On 24-Feb-2021 at 2:20 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021 at 8:00 PM, the patient experienced PAIN (Achy), PYREXIA (Fever) and CHILLS (Chillls). On 25-Feb-2021 at 4:00 AM, PAIN (Achy), PYREXIA (Fever) and CHILLS (Chillls) had resolved.            No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: left arm with a rash; left arm redness; left arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm redness), PRURITUS (left arm itchy) and RASH (left arm with a rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) and TRAZODONE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (left arm itchy). On 21-Feb-2021, the patient experienced ERYTHEMA (left arm redness). On an unknown date, the patient experienced RASH (left arm with a rash). At the time of the report, ERYTHEMA (left arm redness), PRURITUS (left arm itchy) and RASH (left arm with a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Diarrhoea, Vaccination site pain
Clinical narrative: temperature runs colder although feels hotter; pain at injection site came back; Diarrhea; Injection site pain; shivering feeling like freezing; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BODY TEMPERATURE DECREASED (temperature runs colder although feels hotter), CHILLS (shivering feeling like freezing), VACCINATION SITE PAIN (Injection site pain) and VACCINATION SITE PAIN (pain at injection site came back) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Cholecystectomy and Heart valve operation (The patient has an artificial heart valve). Concomitant products included WARFARIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (shivering feeling like freezing). On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 22-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 23-Feb-2021, the patient experienced BODY TEMPERATURE DECREASED (temperature runs colder although feels hotter) and VACCINATION SITE PAIN (pain at injection site came back). At the time of the report, DIARRHOEA (Diarrhea), BODY TEMPERATURE DECREASED (temperature runs colder although feels hotter), CHILLS (shivering feeling like freezing) and VACCINATION SITE PAIN (pain at injection site came back) outcome was unknown and VACCINATION SITE PAIN (Injection site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 94.1f to 96 f (abnormal) Temperature tends to run colder although they feel hotter.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.