chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Disturbance in attention, Dizziness, Erythema, Fatigue
Clinical narrative: she cannot move her arm as it hurts so bad; She is having a hard time concentrating; sensitive to light; no energy today; Her first dose injection site has turned red again and it looks like the rash is about to star; felt nauseous and dizzy; tingling in her neck, tingling went down to her hands; a taste in her mouth; felt nauseous and dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in her neck, tingling went down to her hands), TASTE DISORDER (a taste in her mouth), DIZZINESS (felt nauseous and dizzy), PAIN IN EXTREMITY (she cannot move her arm as it hurts so bad) and DISTURBANCE IN ATTENTION (She is having a hard time concentrating) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PARAESTHESIA (tingling in her neck, tingling went down to her hands), TASTE DISORDER (a taste in her mouth), DIZZINESS (felt nauseous and dizzy) and NAUSEA (felt nauseous and dizzy). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (she cannot move her arm as it hurts so bad), DISTURBANCE IN ATTENTION (She is having a hard time concentrating), PHOTOPHOBIA (sensitive to light), FATIGUE (no energy today) and ERYTHEMA (Her first dose injection site has turned red again and it looks like the rash is about to star). At the time of the report, PARAESTHESIA (tingling in her neck, tingling went down to her hands) had not resolved and TASTE DISORDER (a taste in her mouth), DIZZINESS (felt nauseous and dizzy), PAIN IN EXTREMITY (she cannot move her arm as it hurts so bad), DISTURBANCE IN ATTENTION (She is having a hard time concentrating), PHOTOPHOBIA (sensitive to light), FATIGUE (no energy today), ERYTHEMA (Her first dose injection site has turned red again and it looks like the rash is about to star) and NAUSEA (felt nauseous and dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Low) low grade fever about 99.9.         patient take some ibuprofen (for her back and knee pain) but has not taking any Ibuprofen for the second dose and taken Benadryl post vaccination of both doses.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Photophobia, Taste disorder
Clinical narrative: she cannot move her arm as it hurts so bad; She is having a hard time concentrating; sensitive to light; no energy today; Her first dose injection site has turned red again and it looks like the rash is about to star; felt nauseous and dizzy; tingling in her neck, tingling went down to her hands; a taste in her mouth; felt nauseous and dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in her neck, tingling went down to her hands), TASTE DISORDER (a taste in her mouth), DIZZINESS (felt nauseous and dizzy), PAIN IN EXTREMITY (she cannot move her arm as it hurts so bad) and DISTURBANCE IN ATTENTION (She is having a hard time concentrating) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PARAESTHESIA (tingling in her neck, tingling went down to her hands), TASTE DISORDER (a taste in her mouth), DIZZINESS (felt nauseous and dizzy) and NAUSEA (felt nauseous and dizzy). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (she cannot move her arm as it hurts so bad), DISTURBANCE IN ATTENTION (She is having a hard time concentrating), PHOTOPHOBIA (sensitive to light), FATIGUE (no energy today) and ERYTHEMA (Her first dose injection site has turned red again and it looks like the rash is about to star). At the time of the report, PARAESTHESIA (tingling in her neck, tingling went down to her hands) had not resolved and TASTE DISORDER (a taste in her mouth), DIZZINESS (felt nauseous and dizzy), PAIN IN EXTREMITY (she cannot move her arm as it hurts so bad), DISTURBANCE IN ATTENTION (She is having a hard time concentrating), PHOTOPHOBIA (sensitive to light), FATIGUE (no energy today), ERYTHEMA (Her first dose injection site has turned red again and it looks like the rash is about to star) and NAUSEA (felt nauseous and dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Low) low grade fever about 99.9.         patient take some ibuprofen (for her back and knee pain) but has not taking any Ibuprofen for the second dose and taken Benadryl post vaccination of both doses.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache). In March 2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: 9 days after the first dose patient developed rash on same arm vaccine was administered in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (9 days after the first dose patient developed rash on same arm vaccine was administered in) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (9 days after the first dose patient developed rash on same arm vaccine was administered in). At the time of the report, VACCINATION SITE RASH (9 days after the first dose patient developed rash on same arm vaccine was administered in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Chills, Dizziness, Feeling abnormal, Illness
Clinical narrative: got super nauseous when standing; body chills; Five minutes after getting the shot her hand started hurting; sluggish; dizzy; felt like she had COVID again; really felt sick; whole body hurt she was in tears; slight temperature change of 99F; felt like she was hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting), SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills) and ILLNESS (really felt sick) in a 24-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.     The patient's past medical history included COVID-19 in December 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting), SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills), ILLNESS (really felt sick), PAIN (whole body hurt she was in tears), BODY TEMPERATURE FLUCTUATION (slight temperature change of 99F), FEELING ABNORMAL (felt like she was hit by a truck) and MALAISE (felt like she had COVID again). On 18-Mar-2021, the patient experienced NAUSEA (got super nauseous when standing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills), ILLNESS (really felt sick), PAIN (whole body hurt she was in tears), BODY TEMPERATURE FLUCTUATION (slight temperature change of 99F), FEELING ABNORMAL (felt like she was hit by a truck), NAUSEA (got super nauseous when standing) and MALAISE (felt like she had COVID again) had resolved. At the time of the report, VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Sluggishness, Vaccination site pain
Clinical narrative: got super nauseous when standing; body chills; Five minutes after getting the shot her hand started hurting; sluggish; dizzy; felt like she had COVID again; really felt sick; whole body hurt she was in tears; slight temperature change of 99F; felt like she was hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting), SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills) and ILLNESS (really felt sick) in a 24-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.     The patient's past medical history included COVID-19 in December 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting), SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills), ILLNESS (really felt sick), PAIN (whole body hurt she was in tears), BODY TEMPERATURE FLUCTUATION (slight temperature change of 99F), FEELING ABNORMAL (felt like she was hit by a truck) and MALAISE (felt like she had COVID again). On 18-Mar-2021, the patient experienced NAUSEA (got super nauseous when standing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, SLUGGISHNESS (sluggish), DIZZINESS (dizzy), CHILLS (body chills), ILLNESS (really felt sick), PAIN (whole body hurt she was in tears), BODY TEMPERATURE FLUCTUATION (slight temperature change of 99F), FEELING ABNORMAL (felt like she was hit by a truck), NAUSEA (got super nauseous when standing) and MALAISE (felt like she had COVID again) had resolved. At the time of the report, VACCINATION SITE PAIN (Five minutes after getting the shot her hand started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Pain, Pyrexia
Clinical narrative: Unable to Get Up; Body Aches; Fever; Chills; This spontaneous case was reported by a health care professional and describes the occurrence of MOBILITY DECREASED (Unable to Get Up), PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced MOBILITY DECREASED (Unable to Get Up), PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, MOBILITY DECREASED (Unable to Get Up), PAIN (Body Aches), PYREXIA (Fever) and CHILLS (Chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: Lost some pounds; Diarrhea; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea) and WEIGHT DECREASED (Lost some pounds) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L208 and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced WEIGHT DECREASED (Lost some pounds). The patient was treated with CIPROFLOXACIN HYDROCHLORIDE, DEXAMETHASONE (CIPRODEX [CIPROFLOXACIN HYDROCHLORIDE;DEXAMETHASONE]) ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency; METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) had not resolved and WEIGHT DECREASED (Lost some pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient visited the doctor twice and they prescribed her Ciprodex for diarrhea, thinking it was bacterial, but it didn't help. Patient reported that after being on Ciprodex for two weeks, one week Flagyl and many months Prednisone the diarrhea stopped. Patient states that on reducing Prednisone slowly and when she was on 5 milligram of Prednisone, the diarrhea returned. Patient reports that she also had a Colonoscopy to rule out more serious problems.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Treatment information added
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever of 100.4 degrees Fahrenheit; Body soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.4 degrees Fahrenheit) and MYALGIA (Body soreness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.4 degrees Fahrenheit) and MYALGIA (Body soreness). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.4 degrees Fahrenheit) and MYALGIA (Body soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) Fever of 100.4 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nightmare, Pyrexia, Vaccination complication
Clinical narrative: Typical side effects; Nightmares/bad night; Headaches; Chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Typical side effects), NIGHTMARE (Nightmares/bad night), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (slight fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (The patient is allergic to plants (ragweed) and many trees.), Dust allergy (The patient is allergic to dust mites.), Allergy to feathers and Drug allergy (The patient is hypersensitive to certain medications, most recent an antifungal.). Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), LORATADINE (CLARITINE) and DOXYCYCLINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION COMPLICATION (Typical side effects), NIGHTMARE (Nightmares/bad night), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (slight fever). On 04-Mar-2021, NIGHTMARE (Nightmares/bad night), HEADACHE (Headaches) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION COMPLICATION (Typical side effects) and PYREXIA (slight fever) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: This follow-up was received on 18-MAY-2021 which updated event( slight fever ).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypersensitivity, Infection, Pain, Pruritus
Clinical narrative: Warm; Itching; Feels Infected; Looks Allergic; Sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), FEELING HOT (Warm), PRURITUS (Itching), INFECTION (Feels Infected) and HYPERSENSITIVITY (Looks Allergic) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included TOPIRAMATE and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Sore). On 16-Mar-2021, the patient experienced FEELING HOT (Warm), PRURITUS (Itching), INFECTION (Feels Infected) and HYPERSENSITIVITY (Looks Allergic). At the time of the report, PAIN (Sore), FEELING HOT (Warm), PRURITUS (Itching), INFECTION (Feels Infected) and HYPERSENSITIVITY (Looks Allergic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Lightheadness; Headache; Chills; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Lightheadness), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Mar-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 08-Mar-2021, the patient experienced DIZZINESS (Lightheadness), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, DIZZINESS (Lightheadness), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   .
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pharyngeal swelling, Speech disorder, Vertigo
Clinical narrative: swollen throat; feels that the voice goes away; feels dizzy; her head turns; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swollen throat), SPEECH DISORDER (feels that the voice goes away), DIZZINESS (feels dizzy) and VERTIGO (her head turns) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swollen throat), SPEECH DISORDER (feels that the voice goes away), DIZZINESS (feels dizzy) and VERTIGO (her head turns). At the time of the report, PHARYNGEAL SWELLING (swollen throat), SPEECH DISORDER (feels that the voice goes away), DIZZINESS (feels dizzy) and VERTIGO (her head turns) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: knot on the arm the size of an egg over the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (knot on the arm the size of an egg over the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (Allergy to Chocolate), Thyroid disorder and Cholesterolosis NOS. Concomitant products included SIMVASTATIN for Cholesterolosis NOS, LEVOTHYROXINE for Thyroid disorder, AMLODIPINE and CHLORTHALIDONE for an unknown indication.   On 24-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021 at 4:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE INDURATION (knot on the arm the size of an egg over the injection site). At the time of the report, VACCINATION SITE INDURATION (knot on the arm the size of an egg over the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In laboratory data doctor x-rayed the knot and it was something else. Treatment medicines was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated Reporter details, patient demographics, Medical history, concomitant medications, Event details, Reporter casuality On 30-Jul-2021: Significant Follow up appended for document attachment
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Tachycardia
Clinical narrative: heart rate is steadily between110-120; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate is steadily between110-120), PAIN (body aches) and CHILLS (chills) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced TACHYCARDIA (heart rate is steadily between110-120), PAIN (body aches) and CHILLS (chills). At the time of the report, TACHYCARDIA (heart rate is steadily between110-120), PAIN (body aches) and CHILLS (chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Patient take At 11 took one Tylenol and at 1 pm took another Tylenol
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: Feel a lump it is exactly where they gave the vaccine; Swelling at injection site; Redness at injection site; Arm felt heavy like 100 pounds the first day; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm felt heavy like 100 pounds the first day), VACCINATION SITE MASS (Feel a lump it is exactly where they gave the vaccine), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced LIMB DISCOMFORT (Arm felt heavy like 100 pounds the first day). On 03-Mar-2021, the patient experienced VACCINATION SITE MASS (Feel a lump it is exactly where they gave the vaccine) and VACCINATION SITE ERYTHEMA (Redness at injection site). 03-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). On 04-Mar-2021, LIMB DISCOMFORT (Arm felt heavy like 100 pounds the first day) had resolved. At the time of the report, VACCINATION SITE MASS (Feel a lump it is exactly where they gave the vaccine), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Feeling hot at site; Swelling at site going down to left arm and to elbow; delayed injection site itchiness; delayed injection site redness; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID Arm), VACCINATION SITE WARMTH (Feeling hot at site), PERIPHERAL SWELLING (Swelling at site going down to left arm and to elbow), VACCINATION SITE PRURITUS (delayed injection site itchiness) and VACCINATION SITE ERYTHEMA (delayed injection site redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Rash, hives as a baby) since 1956.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION COMPLICATION (COVID Arm), PERIPHERAL SWELLING (Swelling at site going down to left arm and to elbow), VACCINATION SITE PRURITUS (delayed injection site itchiness) and VACCINATION SITE ERYTHEMA (delayed injection site redness). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Feeling hot at site). On 20-Mar-2021, PERIPHERAL SWELLING (Swelling at site going down to left arm and to elbow), VACCINATION SITE PRURITUS (delayed injection site itchiness) and VACCINATION SITE ERYTHEMA (delayed injection site redness) had resolved. At the time of the report, VACCINATION COMPLICATION (COVID Arm) and VACCINATION SITE WARMTH (Feeling hot at site) 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 were provided.   No treatment details pertained to the events were provided.  The patient wanted to know if she could take Benadryl to lessen the side effects after second dose.   This case was linked to MOD-2021-114276.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Significant follow up received. Events are updated i.e., Vaccine complication, Vaccine site warmth, peripheral swelling.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chest pain, Chills, Headache
Clinical narrative: Weakness; Slight chest pains; Fever that wouldn't go down; Muscle aches; Headaches; Chills; Temp that went up to 107; Congestion; Stomachache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomachache), HYPERPYREXIA (Temp that went up to 107), NASAL CONGESTION (Congestion), ASTHENIA (Weakness) and CHEST PAIN (Slight chest pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On 16-Mar-2021, the patient experienced HYPERPYREXIA (Temp that went up to 107), NASAL CONGESTION (Congestion), HEADACHE (Headaches) and CHILLS (Chills). On 17-Mar-2021, the patient experienced ASTHENIA (Weakness), CHEST PAIN (Slight chest pains), PYREXIA (Fever that wouldn't go down) and MYALGIA (Muscle aches). On 15-Mar-2021, ABDOMINAL PAIN UPPER (Stomachache) had resolved. On 18-Mar-2021, HYPERPYREXIA (Temp that went up to 107), NASAL CONGESTION (Congestion), ASTHENIA (Weakness), CHEST PAIN (Slight chest pains), PYREXIA (Fever that wouldn't go down), MYALGIA (Muscle aches), HEADACHE (Headaches) and CHILLS (Chills) had resolved.            No concomitant medications were reported. Treatment for the event included a flu pill for people with high blood pressure.   This case was linked to MOD-2021-051206 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Address updated. no new significant information added
Sex: F
Vaccine: COVID19
Symptoms: Hyperpyrexia, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Weakness; Slight chest pains; Fever that wouldn't go down; Muscle aches; Headaches; Chills; Temp that went up to 107; Congestion; Stomachache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomachache), HYPERPYREXIA (Temp that went up to 107), NASAL CONGESTION (Congestion), ASTHENIA (Weakness) and CHEST PAIN (Slight chest pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Egg allergy.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On 16-Mar-2021, the patient experienced HYPERPYREXIA (Temp that went up to 107), NASAL CONGESTION (Congestion), HEADACHE (Headaches) and CHILLS (Chills). On 17-Mar-2021, the patient experienced ASTHENIA (Weakness), CHEST PAIN (Slight chest pains), PYREXIA (Fever that wouldn't go down) and MYALGIA (Muscle aches). On 15-Mar-2021, ABDOMINAL PAIN UPPER (Stomachache) had resolved. On 18-Mar-2021, HYPERPYREXIA (Temp that went up to 107), NASAL CONGESTION (Congestion), ASTHENIA (Weakness), CHEST PAIN (Slight chest pains), PYREXIA (Fever that wouldn't go down), MYALGIA (Muscle aches), HEADACHE (Headaches) and CHILLS (Chills) had resolved.            No concomitant medications were reported. Treatment for the event included a flu pill for people with high blood pressure.   This case was linked to MOD-2021-051206 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Address updated. no new significant information added
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Fatigue, Vaccination site pain
Clinical narrative: I've had irregular bowel movements. They've been normal BM's, but just more frequent; my arm was sore where I got the shot; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (I've had irregular bowel movements. They've been normal BM's, but just more frequent), VACCINATION SITE PAIN (my arm was sore where I got the shot) and FATIGUE (Tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (my arm was sore where I got the shot) and FATIGUE (Tired). On 17-Mar-2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (I've had irregular bowel movements. They've been normal BM's, but just more frequent). At the time of the report, BOWEL MOVEMENT IRREGULARITY (I've had irregular bowel movements. They've been normal BM's, but just more frequent), VACCINATION SITE PAIN (my arm was sore where I got the shot) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: mild fever; chills; Second dose of vaccine adminsitered on 25-Feb-2021>35 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (mild fever), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy (Allergic to ace-inhibitors and penicillin).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days). On an unknown date, the patient experienced PYREXIA (mild fever) and CHILLS (chills). At the time of the report, PYREXIA (mild fever) and CHILLS (chills) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days) 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 considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine adminsitered on 25-Feb-2021>35 days) to be not related. No further causality assessments were provided for PYREXIA (mild fever) and CHILLS (chills).    No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to MOD-2021-002585, MOD-2021-002585 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Eye irritation, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Legs hurt; Eyes were burning; Felt very sleepy; Fever 101.0; Lymph nodes are swollen under left arm pit towards chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt), EYE IRRITATION (Eyes were burning), SOMNOLENCE (Felt very sleepy), PYREXIA (Fever 101.0) and LYMPHADENOPATHY (Lymph nodes are swollen under left arm pit towards chest) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive (tested positive December 2020 (around Christmas time) and was in hospital) in December 2020.    On 15-Mar-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 (Legs hurt), EYE IRRITATION (Eyes were burning), SOMNOLENCE (Felt very sleepy), PYREXIA (Fever 101.0) and LYMPHADENOPATHY (Lymph nodes are swollen under left arm pit towards chest). At the time of the report, PAIN IN EXTREMITY (Legs hurt), EYE IRRITATION (Eyes were burning), SOMNOLENCE (Felt very sleepy), PYREXIA (Fever 101.0) and LYMPHADENOPATHY (Lymph nodes are swollen under left arm pit towards chest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive Tested positive and was in hospital. On an unknown date, Body temperature: 101.0 (High) 101.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment drugs were reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence
Clinical narrative: Legs hurt; Eyes were burning; Felt very sleepy; Fever 101.0; Lymph nodes are swollen under left arm pit towards chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt), EYE IRRITATION (Eyes were burning), SOMNOLENCE (Felt very sleepy), PYREXIA (Fever 101.0) and LYMPHADENOPATHY (Lymph nodes are swollen under left arm pit towards chest) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive (tested positive December 2020 (around Christmas time) and was in hospital) in December 2020.    On 15-Mar-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 (Legs hurt), EYE IRRITATION (Eyes were burning), SOMNOLENCE (Felt very sleepy), PYREXIA (Fever 101.0) and LYMPHADENOPATHY (Lymph nodes are swollen under left arm pit towards chest). At the time of the report, PAIN IN EXTREMITY (Legs hurt), EYE IRRITATION (Eyes were burning), SOMNOLENCE (Felt very sleepy), PYREXIA (Fever 101.0) and LYMPHADENOPATHY (Lymph nodes are swollen under left arm pit towards chest) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive Tested positive and was in hospital. On an unknown date, Body temperature: 101.0 (High) 101.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment drugs were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via eye contact, Underdose
Clinical narrative: some of the vaccine sprayed out in to the HCP eyes; some of the vaccine sprayed out while giving 1st dose using Vanish point needle; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE VIA EYE CONTACT (some of the vaccine sprayed out in to the HCP eyes), UNDERDOSE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) and DEVICE CONNECTION ISSUE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPOSURE VIA EYE CONTACT (some of the vaccine sprayed out in to the HCP eyes), UNDERDOSE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) and DEVICE CONNECTION ISSUE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle). On 15-Mar-2021, EXPOSURE VIA EYE CONTACT (some of the vaccine sprayed out in to the HCP eyes) outcome was unknown and UNDERDOSE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) and DEVICE CONNECTION ISSUE (some of the vaccine sprayed out while giving 1st dose using Vanish point needle) 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.   This report refers to a case of vaccine underdose, syringe connection issue and exposure via eye contact for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: This report refers to a case of vaccine underdose, syringe connection issue and exposure via eye contact for mRNA-1273, lot # unknown with no associated AEs.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: can't move my arm."/I can't swim; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (can't move my arm."/I can't swim) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOBILITY DECREASED (can't move my arm."/I can't swim). At the time of the report, MOBILITY DECREASED (can't move my arm."/I can't swim) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported  Treatment information was not provided.   This case was linked to MOD-2021-267751 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Event outcome updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: The patient had Chills; The patient had Fever; The patient had Headache; The patient had joint pain; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (The patient had Chills), PYREXIA (The patient had Fever), HEADACHE (The patient had Headache) and ARTHRALGIA (The patient had joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 029L20A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 2 UNK. On 03-Feb-2021, the patient experienced CHILLS (The patient had Chills). 03-Feb-2021, the patient experienced PYREXIA (The patient had Fever), HEADACHE (The patient had Headache) and ARTHRALGIA (The patient had joint pain). At the time of the report, CHILLS (The patient had Chills), PYREXIA (The patient had Fever), HEADACHE (The patient had Headache) and ARTHRALGIA (The patient had joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Implant), the reporter did not provide any causality assessments.   No Concomitant medicines were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pyrexia
Clinical narrative: can barely lift her arm; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can barely lift her arm), HEADACHE (headache) and PYREXIA (fever) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LIMB DISCOMFORT (can barely lift her arm), HEADACHE (headache) and PYREXIA (fever). At the time of the report, LIMB DISCOMFORT (can barely lift her arm), HEADACHE (headache) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: swelling at injection site; stomach ache; fever; Felt severe fatigue; flu like symptoms; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), PYREXIA (fever) and FATIGUE (Felt severe fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (diarrhea), PYREXIA (fever) and FATIGUE (Felt severe fatigue). On 21-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 22-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), PYREXIA (fever), FATIGUE (Felt severe fatigue) and VACCINATION SITE SWELLING (swelling at injection site) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported by investigator o No treatment medications provided by the reporter.