chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site bruising, Vaccination site erythema, Vaccination site pain
Clinical narrative: Bruising at injection site about 3 inches in diameter; Red spot at injection site; Pain to touch at injection site; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE BRUISING (Bruising at injection site about 3 inches in diameter), VACCINATION SITE ERYTHEMA (Red spot at injection site), VACCINATION SITE PAIN (Pain to touch at injection site) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) 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) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain to touch at injection site) and FATIGUE (Fatigue). On 02-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruising at injection site about 3 inches in diameter) and VACCINATION SITE ERYTHEMA (Red spot at injection site). On 22-Mar-2021, FATIGUE (Fatigue) had resolved. On 24-Mar-2021, VACCINATION SITE PAIN (Pain to touch at injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruising at injection site about 3 inches in diameter) and VACCINATION SITE ERYTHEMA (Red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-significant Follow-up.Email updated
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear discomfort, Face oedema, Hypoaesthesia, Oropharyngeal discomfort
Clinical narrative: face puffy; face went numb; couldn't breathe through nose; ears felt pressurized; hives; throat scratchy; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized) and URTICARIA (hives) in a 29-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 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 FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized), URTICARIA (hives) and OROPHARYNGEAL DISCOMFORT (throat scratchy). At the time of the report, FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized), URTICARIA (hives) and OROPHARYNGEAL DISCOMFORT (throat scratchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: face puffy; face went numb; couldn't breathe through nose; ears felt pressurized; hives; throat scratchy; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized) and URTICARIA (hives) in a 29-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 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 FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized), URTICARIA (hives) and OROPHARYNGEAL DISCOMFORT (throat scratchy). At the time of the report, FACE OEDEMA (face puffy), HYPOAESTHESIA (face went numb), DYSPNOEA (couldn't breathe through nose), EAR DISCOMFORT (ears felt pressurized), URTICARIA (hives) and OROPHARYNGEAL DISCOMFORT (throat scratchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Fatigue, Nausea, Parosmia
Clinical narrative: Nausea; brief but intense depression and despair; Acutely Heightened sense of smell; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA (Nausea), DEPRESSION (brief but intense depression and despair), FATIGUE (fatigue) and PAROSMIA (Acutely Heightened sense of smell) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Mar-2021, the patient experienced FATIGUE (fatigue). On 25-Mar-2021, the patient experienced NAUSEA (Nausea), DEPRESSION (brief but intense depression and despair) and PAROSMIA (Acutely Heightened sense of smell). On 26-Mar-2021, NAUSEA (Nausea), DEPRESSION (brief but intense depression and despair) and FATIGUE (fatigue) had resolved. At the time of the report, PAROSMIA (Acutely Heightened sense of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol. Concomitant medications included Diabetic medication and statin.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperglycaemia, Pain in extremity, Thirst, Urinary tract infection
Clinical narrative: Always thirsty; Hyperglycemia; Urinary Tract Infection; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HYPERGLYCAEMIA (Hyperglycemia), URINARY TRACT INFECTION (Urinary Tract Infection), THIRST (Always thirsty) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and CHILLS (Chills). On 31-Mar-2021, the patient experienced HYPERGLYCAEMIA (Hyperglycemia) and URINARY TRACT INFECTION (Urinary Tract Infection). On an unknown date, the patient experienced THIRST (Always thirsty). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm soreness), HYPERGLYCAEMIA (Hyperglycemia), URINARY TRACT INFECTION (Urinary Tract Infection), THIRST (Always thirsty) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also include d an antibiotic.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Pain in extremity, Rash
Clinical narrative: arm very sore; can barely pick anything up; chills; rash under arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm very sore), MOBILITY DECREASED (can barely pick anything up), CHILLS (chills) and RASH (rash under arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm very sore), MOBILITY DECREASED (can barely pick anything up), CHILLS (chills) and RASH (rash under arm). At the time of the report, PAIN IN EXTREMITY (arm very sore), MOBILITY DECREASED (can barely pick anything up) and CHILLS (chills) outcome was unknown and RASH (rash under arm) had resolved.            no concomitant medications are provided.. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.  rash under the arms was due to eczema not the vaccine, and its resolved, they denied further follow up.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: new event is added rash under the arm and it is resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warmth at the side of the injection site in her left arm; itching at the side of the injection site in her left arm; redness at the side of the injection site in her left arm; swelling at the side of the injection site in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at the side of the injection site in her left arm), VACCINATION SITE PRURITUS (itching at the side of the injection site in her left arm), VACCINATION SITE ERYTHEMA (redness at the side of the injection site in her left arm) and VACCINATION SITE SWELLING (swelling at the side of the injection site in her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warmth at the side of the injection site in her left arm), VACCINATION SITE PRURITUS (itching at the side of the injection site in her left arm), VACCINATION SITE ERYTHEMA (redness at the side of the injection site in her left arm) and VACCINATION SITE SWELLING (swelling at the side of the injection site in her left arm). At the time of the report, VACCINATION SITE WARMTH (warmth at the side of the injection site in her left arm), VACCINATION SITE PRURITUS (itching at the side of the injection site in her left arm), VACCINATION SITE ERYTHEMA (redness at the side of the injection site in her left arm) and VACCINATION SITE SWELLING (swelling at the side of the injection site in her left arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Felt some itchiness; Allergic reaction "hives" on both shoulders/Inside of right arm has more red marking hives, like small blisters/Hives disappeared overnight, then came back & includes neck this am/developed hives on chest/ Hives started coming and going; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Felt some itchiness) and URTICARIA (Allergic reaction "hives" on both shoulders/Inside of right arm has more red marking hives, like small blisters/Hives disappeared overnight, then came back & includes neck this am/developed hives on chest/ Hives started coming and going) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced URTICARIA (Allergic reaction "hives" on both shoulders/Inside of right arm has more red marking hives, like small blisters/Hives disappeared overnight, then came back & includes neck this am/developed hives on chest/ Hives started coming and going). On 28-Mar-2021, the patient experienced PRURITUS (Felt some itchiness). At the time of the report, PRURITUS (Felt some itchiness) and URTICARIA (Allergic reaction "hives" on both shoulders/Inside of right arm has more red marking hives, like small blisters/Hives disappeared overnight, then came back & includes neck this am/developed hives on chest/ Hives started coming and going) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Feeling drunk, Insomnia
Clinical narrative: sensation like he is a little out of balance; 5 on a scale of 1-10 on lightheadedness; felt like he had "drank a big glass of vodk; night is when he feels worse; hasn't slept in 2 days; Significant fatigue; feeling of being off-balance; Dizziness / Light-headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness / Light-headedness), DIZZINESS (5 on a scale of 1-10 on lightheadedness), BALANCE DISORDER (feeling of being off-balance), BALANCE DISORDER (sensation like he is a little out of balance) and FEELING DRUNK (felt like he had "drank a big glass of vodk) in a male patient of an unknown age 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 information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (Dizziness / Light-headedness), BALANCE DISORDER (feeling of being off-balance) and FATIGUE (Significant fatigue). On 30-Mar-2021, the patient experienced INSOMNIA (hasn't slept in 2 days). On 01-Apr-2021, the patient experienced FEELING DRUNK (felt like he had "drank a big glass of vodk) and FEELING DRUNK (night is when he feels worse). On 02-Apr-2021, the patient experienced DIZZINESS (5 on a scale of 1-10 on lightheadedness) and BALANCE DISORDER (sensation like he is a little out of balance). On 01-Apr-2021, FEELING DRUNK (felt like he had "drank a big glass of vodk) had resolved. On 16-Apr-2021, DIZZINESS (5 on a scale of 1-10 on lightheadedness) had resolved. At the time of the report, DIZZINESS (Dizziness / Light-headedness), BALANCE DISORDER (sensation like he is a little out of balance), FEELING DRUNK (night is when he feels worse), INSOMNIA (hasn't slept in 2 days) and FATIGUE (Significant fatigue) outcome was unknown and BALANCE DISORDER (feeling of being off-balance) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information  received on  27 May 2021 contains outcome of adverse event(dizziness)updated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Dizziness; Upset stomach; Horrible headache; Chills; Body aches/hurts everywhere; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Horrible headache), CHILLS (Chills) and MYALGIA (Body aches/hurts everywhere) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 immunization.     The patient's past medical history included COVID-19 in December 2020.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Horrible headache), CHILLS (Chills) and MYALGIA (Body aches/hurts everywhere). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Horrible headache), CHILLS (Chills) and MYALGIA (Body aches/hurts everywhere) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-036065 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09-JUL-2021 and contains NNI
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst drainage
Clinical narrative: cyst on his back that is draining; This spontaneous case was reported by a consumer and describes the occurrence of CYST DRAINAGE (cyst on his back that is draining) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, FLUDROCORTISONE, ATORVASTATIN CALCIUM, CENTRUM SILVER +50, ACETYLSALICYLIC ACID (BABY ASPIRIN) and PLANTAGO OVATA (METAMUCIL CITRON).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CYST DRAINAGE (cyst on his back that is draining). At the time of the report, CYST DRAINAGE (cyst on his back that is draining) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Jerk motion of arm his shoulder blew out; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Jerk motion of arm his shoulder blew out) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Jerk motion of arm his shoulder blew out). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Jerk motion of arm his shoulder blew out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Movement disorder, Musculoskeletal stiffness, Myalgia
Clinical narrative: Rash; Sore on her both underarms; Lymph nodes are swollen; Barely lift her arms; Extremely painful when pressed; hard time opening doors; Restricting her activity; Her muscles are stiff; Extreme muscle soreness in upper arms and upper legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed) and LIMB DISCOMFORT (hard time opening doors) in a 67-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.     Concurrent medical conditions included Hypertension and Acid reflux (oesophageal).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed), LIMB DISCOMFORT (hard time opening doors), MOVEMENT DISORDER (restricting her activity), MUSCULOSKELETAL STIFFNESS (her muscles are stiff) and MYALGIA (extreme muscle soreness in upper arms and upper legs). On an unknown date, the patient experienced RASH (a rash). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed), LIMB DISCOMFORT (hard time opening doors), MOVEMENT DISORDER (restricting her activity), MUSCULOSKELETAL STIFFNESS (her muscles are stiff) and MYALGIA (extreme muscle soreness in upper arms and upper legs) had not resolved and RASH (a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  No new clinical information was provided in follow-up. Reporter is waiting for hard-copy form to fill out due to computer limitations.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow-up information received on contain No New  Information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: Rash; Sore on her both underarms; Lymph nodes are swollen; Barely lift her arms; Extremely painful when pressed; hard time opening doors; Restricting her activity; Her muscles are stiff; Extreme muscle soreness in upper arms and upper legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed) and LIMB DISCOMFORT (hard time opening doors) in a 67-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.     Concurrent medical conditions included Hypertension and Acid reflux (oesophageal).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed), LIMB DISCOMFORT (hard time opening doors), MOVEMENT DISORDER (restricting her activity), MUSCULOSKELETAL STIFFNESS (her muscles are stiff) and MYALGIA (extreme muscle soreness in upper arms and upper legs). On an unknown date, the patient experienced RASH (a rash). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed), LIMB DISCOMFORT (hard time opening doors), MOVEMENT DISORDER (restricting her activity), MUSCULOSKELETAL STIFFNESS (her muscles are stiff) and MYALGIA (extreme muscle soreness in upper arms and upper legs) had not resolved and RASH (a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  No new clinical information was provided in follow-up. Reporter is waiting for hard-copy form to fill out due to computer limitations.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow-up information received on contain No New  Information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Autoimmune disorder presented itself much differently; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Autoimmune disorder presented itself much differently) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (Autoimmune disorder presented itself much differently). At the time of the report, CONDITION AGGRAVATED (Autoimmune disorder presented itself much differently) outcome was unknown.            No concomitant product use was provided. Treatment information was not available.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy skin; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) and RASH (rash) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (Itchy skin) and RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash pruritic, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy skin) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included high blood pressure and cholesterol medications.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        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.   The healthcare facility had an power outage on 01 April 2021. This dropped the temperature of the vials stored in freezer and refrigerator to -  Frozen vaccine 47 minutes -13.79 degree celsius Refrigerator 59 minutes 12 degree Celsius  Treatment information was not provided.  Concomitant medications were not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Pain in extremity, Vomiting
Clinical narrative: Headache/head feels heavy; Very Dizzy; Threw up; Couldn't breathe well/heavy; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), HEADACHE (Headache/head feels heavy), DIZZINESS (Very Dizzy), VOMITING (Threw up) and DYSPNOEA (Couldn't breathe well/heavy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 02-Apr-2021, the patient experienced HEADACHE (Headache/head feels heavy), DIZZINESS (Very Dizzy), VOMITING (Threw up) and DYSPNOEA (Couldn't breathe well/heavy). At the time of the report, PAIN IN EXTREMITY (Arm was sore) had resolved and HEADACHE (Headache/head feels heavy), DIZZINESS (Very Dizzy), VOMITING (Threw up) and DYSPNOEA (Couldn't breathe well/heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Feeling abnormal, Fungal infection, Rash
Clinical narrative: MISERABLE AT FIRST; NO APPETITE; RED LIKE YEAST INFECTION UNDER BREAST; RED LIKE YEAST INFECTION UNDER BREAST; RASH UNDER THE BREAST; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Apr-2021 and was forwarded to Moderna on 03-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (MISERABLE AT FIRST), DECREASED APPETITE (NO APPETITE), FUNGAL INFECTION (RED LIKE YEAST INFECTION UNDER BREAST), ERYTHEMA (RED LIKE YEAST INFECTION UNDER BREAST) and RASH (RASH UNDER THE BREAST) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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. On an unknown date, the patient experienced FEELING ABNORMAL (MISERABLE AT FIRST), DECREASED APPETITE (NO APPETITE), FUNGAL INFECTION (RED LIKE YEAST INFECTION UNDER BREAST), ERYTHEMA (RED LIKE YEAST INFECTION UNDER BREAST) and RASH (RASH UNDER THE BREAST). At the time of the report, FEELING ABNORMAL (MISERABLE AT FIRST), DECREASED APPETITE (NO APPETITE), FUNGAL INFECTION (RED LIKE YEAST INFECTION UNDER BREAST), ERYTHEMA (RED LIKE YEAST INFECTION UNDER BREAST) and RASH (RASH UNDER THE BREAST) 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 03-Apr-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain; Severe muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe muscle pain) and ARTHRALGIA (Joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myotonia congenital. Concomitant products included TRAMADOL for an unknown indication.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Severe muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (Severe muscle pain) and ARTHRALGIA (Joint pain) had not resolved.            Treatment information provided mentioned Tramadol and Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). At the time of the report, PAIN IN EXTREMITY (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Fatigue, Hyperhidrosis, Vomiting
Clinical narrative: stomach pain; woke up throwing up, with nausea; exhausted; sweating profusely; coughing; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (woke up throwing up, with nausea), FATIGUE (exhausted), HYPERHIDROSIS (sweating profusely), COUGH (coughing) and ABDOMINAL PAIN UPPER (stomach pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VOMITING (woke up throwing up, with nausea), FATIGUE (exhausted), HYPERHIDROSIS (sweating profusely) and COUGH (coughing). On 02-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 01-Apr-2021, VOMITING (woke up throwing up, with nausea), HYPERHIDROSIS (sweating profusely) and COUGH (coughing) outcome was unknown. At the time of the report, FATIGUE (exhausted) had not resolved and ABDOMINAL PAIN UPPER (stomach pain) outcome was unknown. Not Provided          Patient is on concomitant medication but did not specify   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, Nasopharyngitis
Clinical narrative: Covid Positive; Flu like; Cold like; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like), NASOPHARYNGITIS (Cold like) and COVID-19 (Covid Positive) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like) and NASOPHARYNGITIS (Cold like). On 27-Mar-2021, the patient experienced COVID-19 (Covid Positive). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like), NASOPHARYNGITIS (Cold like) and COVID-19 (Covid Positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: Patient received the second dose more than 36 days after the first dose.; Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Apr-2021 and was forwarded to Moderna on 03-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose.). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose more than 36 days after the first dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received contains No new information. On 06-Aug-2021: Follow up information received contains significant information. Added Second dose details. Added Events. Medical error case.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain rated at times 6/10 sometimes 3/10; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (pain rated at times 6/10 sometimes 3/10) 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. Concomitant products included Prostate Medication                                            Not on hand for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain rated at times 6/10 sometimes 3/10). The patient was treated with CAFFEINE, DIHYDROCODEINE BITARTRATE, PARACETAMOL (ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain rated at times 6/10 sometimes 3/10) 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.   Treatment medications include acetaminophen, , advil
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: she has a UTI.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (she has a UTI.) 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 URINARY TRACT INFECTION (she has a UTI.). At the time of the report, URINARY TRACT INFECTION (she has a UTI.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The UTI was cultured but she does not have the name of the bacteria. She could not tolerate the antibiotic. She took something else that helped, but the UTI has returned.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Power outage, vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Power outage, vaccine administered after temperature excursion) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Power outage, vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Power outage, vaccine administered after temperature excursion) 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.   Concomitant product use was not provided by the reporter. No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site pain
Clinical narrative: mild soreness at the site of the injection; "feels like 1 drop came out" after the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness at the site of the injection) and UNDERDOSE ("feels like 1 drop came out" after the vaccine was given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild soreness at the site of the injection) and UNDERDOSE ("feels like 1 drop came out" after the vaccine was given). On 03-Apr-2021, UNDERDOSE ("feels like 1 drop came out" after the vaccine was given) had resolved. At the time of the report, VACCINATION SITE PAIN (mild soreness at the site of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment was provided. Second dose was scheduled on 01-MAY-2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Soreness of lymph node in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Soreness of lymph node in left arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Soreness of lymph node in left arm). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Soreness of lymph node in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-223729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Additional information received on 16 Jun 2021 contains second dose information, added reporter E mail ID, updated re-challenge from not applicable to negative.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered 60hours after the vial was punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered 60hours after the vial was punctured) in a patient of an unknown age and gender 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 EXPIRED PRODUCT ADMINISTERED (Dose was administered 60hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered 60hours after the vial was punctured) had resolved.        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 product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Unknown)  with no associated AEs.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Unknown)  with no associated AEs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Headache, Memory impairment, Mental status changes
Clinical narrative: diarrhea; Doesn't remember an entire day; Altered mental status; Injection site warm to touch; Headache; Swollen red injection site; Swollen red injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL STATUS CHANGES (Altered mental status), DIARRHOEA (diarrhea), MEMORY IMPAIRMENT (Doesn't remember an entire day), VACCINATION SITE WARMTH (Injection site warm to touch) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient reports contracting COVID-19 for 8 days in December) in December 2020. Concomitant products included METFORMIN, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), FAMOTIDINE, LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), HEADACHE (Headache), VACCINATION SITE SWELLING (Swollen red injection site) and VACCINATION SITE ERYTHEMA (Swollen red injection site). On 20-Mar-2021, the patient experienced MENTAL STATUS CHANGES (Altered mental status) and MEMORY IMPAIRMENT (Doesn't remember an entire day). On 21-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 20-Mar-2021, MENTAL STATUS CHANGES (Altered mental status) and MEMORY IMPAIRMENT (Doesn't remember an entire day) had resolved. On 21-Mar-2021, DIARRHOEA (diarrhea) had resolved. On 26-Mar-2021, VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE SWELLING (Swollen red injection site) and VACCINATION SITE ERYTHEMA (Swollen red injection site) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19: positive (Positive) Positive. On 18-Jan-2021, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she did not took any treatment for the adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up was received on 06-Apr-2021 which did not update any new information.