chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Bad headache; Some shaking; Chills; Fever, still have a fever, but it is lower; Nauseous; Vomiting; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Some shaking), CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower), NAUSEA (Nauseous) and VOMITING (Vomiting) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMOXICILLIN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced TREMOR (Some shaking), CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower), NAUSEA (Nauseous), VOMITING (Vomiting) and ARTHRALGIA (Aching joints). On 16-Apr-2021, the patient experienced HEADACHE (Bad headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (Some shaking), VOMITING (Vomiting) and HEADACHE (Bad headache) outcome was unknown, CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower) and NAUSEA (Nauseous) was resolving and ARTHRALGIA (Aching joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Bad headache; Some shaking; Chills; Fever, still have a fever, but it is lower; Nauseous; Vomiting; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Some shaking), CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower), NAUSEA (Nauseous) and VOMITING (Vomiting) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMOXICILLIN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced TREMOR (Some shaking), CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower), NAUSEA (Nauseous), VOMITING (Vomiting) and ARTHRALGIA (Aching joints). On 16-Apr-2021, the patient experienced HEADACHE (Bad headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, TREMOR (Some shaking), VOMITING (Vomiting) and HEADACHE (Bad headache) outcome was unknown, CHILLS (Chills), PYREXIA (Fever, still have a fever, but it is lower) and NAUSEA (Nauseous) was resolving and ARTHRALGIA (Aching joints) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events included Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Vaccination site rash size grown to 6-8 inches in upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash size grown to 6-8 inches in upper left arm) 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 (No reported medical history). Concomitant products included ATORVASTATIN, POTASSIUM CHLORIDE, TAMSULOSIN, TORSEMIDE, INSULIN DETEMIR (LEVEMIR), OXYCODONE and MORPHINE for an unknown indication.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash size grown to 6-8 inches in upper left arm). At the time of the report, VACCINATION SITE RASH (Vaccination site rash size grown to 6-8 inches in upper left arm) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable  No treatment information was provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal discomfort, Urticaria, Vaccination site bruising
Clinical narrative: Bruises a bit lower on her injection site; The first little bruise, a little bump on most of her arm and hands; Headache; Trouble clearing her throat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruises a bit lower on her injection site), OROPHARYNGEAL DISCOMFORT (Trouble clearing her throat), URTICARIA (The first little bruise, a little bump on most of her arm and hands) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Allergic to sulfur.) since an unknown date.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL DISCOMFORT (Trouble clearing her throat). On 14-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruises a bit lower on her injection site), URTICARIA (The first little bruise, a little bump on most of her arm and hands) and HEADACHE (Headache). At the time of the report, VACCINATION SITE BRUISING (Bruises a bit lower on her injection site), OROPHARYNGEAL DISCOMFORT (Trouble clearing her throat), URTICARIA (The first little bruise, a little bump on most of her arm and hands) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity, Pyrexia, Tremor, Varicose vein
Clinical narrative: fever; stomach ache; leg pain; enlarged veins on legs and hands; shaking; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (leg pain), VARICOSE VEIN (enlarged veins on legs and hands) and TREMOR (shaking) in a 55-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.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (fever), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (leg pain), VARICOSE VEIN (enlarged veins on legs and hands) and TREMOR (shaking). At the time of the report, PYREXIA (fever), ABDOMINAL PAIN UPPER (stomach ache), PAIN IN EXTREMITY (leg pain), VARICOSE VEIN (enlarged veins on legs and hands) and TREMOR (shaking) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Lymphoedema, Pain
Clinical narrative: Trouble breathing; Chest pain; Pain; Achiness; Left shoulder swollen - Lymphedema; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN (Pain), PAIN (Achiness) and LYMPHOEDEMA (Left shoulder swollen - Lymphedema) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN (Pain), PAIN (Achiness), LYMPHOEDEMA (Left shoulder swollen - Lymphedema) and HEADACHE (Really bad headache). On 06-Apr-2021, DYSPNOEA (Trouble breathing), CHEST PAIN (Chest pain), PAIN (Pain), PAIN (Achiness), LYMPHOEDEMA (Left shoulder swollen - Lymphedema) and HEADACHE (Really bad headache) had resolved.            Relevant concomitant medications were not reported. Treatment information was included paracetamol. Action taken with mRNA-1273 in response to the event was not applicable. Patient had been to emergency.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up received on 19 MAY 2021 and does not contain any new information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site urticaria
Clinical narrative: Red welt itchy rash at injection site; Red welt itchy rash at injection site; Red welt itchy rash at injection site; Red welt itchy rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red welt itchy rash at injection site), VACCINATION SITE URTICARIA (Red welt itchy rash at injection site), VACCINATION SITE PRURITUS (Red welt itchy rash at injection site) and VACCINATION SITE RASH (Red welt itchy rash at injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESTRADIOL for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red welt itchy rash at injection site), VACCINATION SITE URTICARIA (Red welt itchy rash at injection site), VACCINATION SITE PRURITUS (Red welt itchy rash at injection site) and VACCINATION SITE RASH (Red welt itchy rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red welt itchy rash at injection site), VACCINATION SITE URTICARIA (Red welt itchy rash at injection site), VACCINATION SITE PRURITUS (Red welt itchy rash at injection site) and VACCINATION SITE RASH (Red welt itchy rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Papule, Rash
Clinical narrative: Little red spots on her hand; Little red spots on  hand; Rash; This spontaneous case was reported by a physician and describes the occurrence of PAPULE (Little red spots on her hand), ERYTHEMA (Little red spots on  hand) and RASH (Rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Atopic dermatitis (Atopic dermatitis - chronic recurrent).   On 19-Mar-2021 at 11:33 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAPULE (Little red spots on her hand), ERYTHEMA (Little red spots on  hand) and RASH (Rash). On 23-Mar-2021, PAPULE (Little red spots on her hand), ERYTHEMA (Little red spots on  hand) and RASH (Rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up received: added new event of rash, updated patient demographics, second dose and medical history.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site rash
Clinical narrative: Itchy rash on arm; Rash is from the injection site down, 4-5 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on arm) and VACCINATION SITE RASH (Rash is from the injection site down, 4-5 inches) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash on arm) and VACCINATION SITE RASH (Rash is from the injection site down, 4-5 inches). At the time of the report, RASH PRURITIC (Itchy rash on arm) and VACCINATION SITE RASH (Rash is from the injection site down, 4-5 inches) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: chills; achy; arm for sore with 2nd dose; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), CHILLS (chills), PAIN (achy) and MYALGIA (arm for sore with 2nd dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 029a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 02-Feb-2021, the patient experienced MYALGIA (Sore arm). On 04-Mar-2021, the patient experienced CHILLS (chills), PAIN (achy) and MYALGIA (arm for sore with 2nd dose). On 04-Feb-2021, MYALGIA (Sore arm) had resolved. On 05-Mar-2021, CHILLS (chills) and PAIN (achy) had resolved. On 07-Mar-2021, MYALGIA (arm for sore with 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       the patients medical history , lab data, concomitant history was not provided by the reporter .   This case was linked to MOD21-077212, US-MODERNATX, INC.-MOD-2021-079178 (E2B Linked Report).; Sender's Comments:  MOD21-077212:Wife Report US-MODERNATX, INC.-MOD-2021-079178:Wife Report
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose scheduled for 22Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose scheduled for 22Apr2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-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 PRODUCT DOSE OMISSION ISSUE (second dose scheduled for 22Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose scheduled for 22Apr2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site warmth
Clinical narrative: L arm of injection warm to touch; pain on L arm of injection; Headache mild in intesity; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (L arm of injection warm to touch), VACCINATION SITE PAIN (pain on L arm of injection) and HEADACHE (Headache mild in intesity) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 630B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN (INSULIN HUMULIN-N) and GLIPIZIDE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (L arm of injection warm to touch), VACCINATION SITE PAIN (pain on L arm of injection) and HEADACHE (Headache mild in intesity). At the time of the report, VACCINATION SITE WARMTH (L arm of injection warm to touch), VACCINATION SITE PAIN (pain on L arm of injection) and HEADACHE (Headache mild in intesity) had resolved.            Treatment details included two ibuprofen  and application of ice. Action taken with mRNA-1273 in response to events were not applicable.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  No treatment information was provided.   This case was linked to MOD-2021-079301 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; chest pain; chills; fever; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (Headache) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Advil. Concomitant medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair fall; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair fall) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Apr-2021, the patient experienced ALOPECIA (hair fall). At the time of the report, ALOPECIA (hair fall) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: itchiness on their leg; 'severe headache (described as the patient thought she was gonna stroke out); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness on their leg) and HEADACHE ('severe headache (described as the patient thought she was gonna stroke out)) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Ulcerative colitis. Concomitant products included ATORVASTATIN for Cholesterol, MESALAZINE (ASACOL) for Ulcerative colitis, VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchiness on their leg) and HEADACHE ('severe headache (described as the patient thought she was gonna stroke out)). At the time of the report, PRURITUS (itchiness on their leg) and HEADACHE ('severe headache (described as the patient thought she was gonna stroke out)) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment includes heating pad.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Biliary colic, Chills, Pain, Pyrexia
Clinical narrative: gallbladder pain; pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of BILIARY COLIC (gallbladder pain), PAIN (pain), PYREXIA (fever) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) 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. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced BILIARY COLIC (gallbladder pain), PAIN (pain), PYREXIA (fever) and CHILLS (chills). At the time of the report, BILIARY COLIC (gallbladder pain), PAIN (pain), PYREXIA (fever) and CHILLS (chills) 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Malaise
Clinical narrative: feeling sick; inability to get warm; monster headache; mild nausea; fatigue; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), MYALGIA (body aches), FEELING COLD (inability to get warm), CHILLS (chills) and HEADACHE (monster headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04132A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, ALPRAZOLAM for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced FEELING COLD (inability to get warm), HEADACHE (monster headache), NAUSEA (mild nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced MALAISE (feeling sick), MYALGIA (body aches) and CHILLS (chills). At the time of the report, MALAISE (feeling sick), MYALGIA (body aches), FEELING COLD (inability to get warm) and CHILLS (chills) outcome was unknown and HEADACHE (monster headache), NAUSEA (mild nausea) and FATIGUE (fatigue) had not resolved.            Treatment medications included Ibuprofen, aspirin, Zofran and ginger ale beverage.  Concomitant medication included albuterol inhaler and alprazolam 0.5 mg takes half a tablet daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-078362 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: ADR received however it is reporting on the first dose, not this second dose, therefore NNI.; Sender's Comments:  MOD-2021-078362:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: feeling sick; inability to get warm; monster headache; mild nausea; fatigue; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), MYALGIA (body aches), FEELING COLD (inability to get warm), CHILLS (chills) and HEADACHE (monster headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04132A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, ALPRAZOLAM for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced FEELING COLD (inability to get warm), HEADACHE (monster headache), NAUSEA (mild nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced MALAISE (feeling sick), MYALGIA (body aches) and CHILLS (chills). At the time of the report, MALAISE (feeling sick), MYALGIA (body aches), FEELING COLD (inability to get warm) and CHILLS (chills) outcome was unknown and HEADACHE (monster headache), NAUSEA (mild nausea) and FATIGUE (fatigue) had not resolved.            Treatment medications included Ibuprofen, aspirin, Zofran and ginger ale beverage.  Concomitant medication included albuterol inhaler and alprazolam 0.5 mg takes half a tablet daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-078362 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: ADR received however it is reporting on the first dose, not this second dose, therefore NNI.; Sender's Comments:  MOD-2021-078362:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Myalgia
Clinical narrative: aches all over; headache; weakness in legs and arms; no energy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches all over), HEADACHE (headache), ASTHENIA (weakness in legs and arms) and ASTHENIA (no energy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches all over), HEADACHE (headache), ASTHENIA (weakness in legs and arms) and ASTHENIA (no energy). At the time of the report, MYALGIA (aches all over), ASTHENIA (weakness in legs and arms) and ASTHENIA (no energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue
Clinical narrative: feeling dizzy; trouble breathing; I do continue to have periods of being very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feeling dizzy), DYSPNOEA (trouble breathing) and FATIGUE (I do continue to have periods of being very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 10-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 DIZZINESS (feeling dizzy), DYSPNOEA (trouble breathing) and FATIGUE (I do continue to have periods of being very tired). At the time of the report, DIZZINESS (feeling dizzy) and DYSPNOEA (trouble breathing) had resolved and FATIGUE (I do continue to have periods of being very tired) outcome was unknown. Not Provided          No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU-NewAE and Outcome provided
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: severe pain in the left arm; unable to move the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in the left arm) and MOVEMENT DISORDER (unable to move the left arm) in a 51-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 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 PAIN IN EXTREMITY (severe pain in the left arm) and MOVEMENT DISORDER (unable to move the left arm). On 19-Mar-2021, MOVEMENT DISORDER (unable to move the left arm) had resolved. At the time of the report, PAIN IN EXTREMITY (severe pain in the left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Influenza like illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms), asthenia (weakness) and arthralgia (joint pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had influenza-like illness (flu-like symptoms), asthenia (weakness) and arthralgia). The patient treated with Tylenol (paracetamol), oral, at a dose of 500 milligram; two pills. At the time of the report, influenza-like illness (flu-like symptoms), asthenia (weakness) and arthralgia) outcome: unknown. No concomitant medication provided. Action taken with mRNA1273 Moderna vaccine: not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat; cough with yellow phlegm; back ache; chills; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), OROPHARYNGEAL PAIN (sore throat), COUGH (cough with yellow phlegm), BACK PAIN (back ache) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 041B21A) for COVID-19 vaccination.     NO medical history was reported by reporter.  Concomitant products included IBUPROFEN for Arthritis, SALBUTAMOL (ALBUTEROL HFA), FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), FOLIC ACID (FOLIC), TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT), HYDROCHLOROTHIAZIDE, AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CALCIUM, MAGNESIUM OXIDE, ATORVASTATIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.   On 12-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), COUGH (cough with yellow phlegm), BACK PAIN (back ache) and CHILLS. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurt), OROPHARYNGEAL PAIN (sore throat), COUGH (cough with yellow phlegm), BACK PAIN (back ache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red itchy spot on arm at the injection site; Red itchy spot on arm at the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red itchy spot on arm at the injection site) and VACCINATION SITE PRURITUS (Red itchy spot on arm at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red itchy spot on arm at the injection site) and VACCINATION SITE PRURITUS (Red itchy spot on arm at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red itchy spot on arm at the injection site) and VACCINATION SITE PRURITUS (Red itchy spot on arm at the injection site) outcome was unknown. Not Provided          Treatment information included cortisone cream.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to the touch; itchy (itches like the dickens); swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy (itches like the dickens)) and VACCINATION SITE SWELLING (swollen) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy (itches like the dickens)) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy (itches like the dickens)) and VACCINATION SITE SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided. Treatment information provided as applying cold washcloth sparingly as treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: outcome updated to recovered as patient (consumer) reported
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: Achy; Chills; Arm for sore with 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), CHILLS (Chills) and VACCINATION SITE PAIN (Arm for sore with 2nd dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011m20a and 029a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Achy), CHILLS (Chills) and VACCINATION SITE PAIN (Arm for sore with 2nd dose). On 05-Mar-2021, PAIN (Achy) and CHILLS (Chills) had resolved. On 07-Mar-2021, VACCINATION SITE PAIN (Arm for sore with 2nd dose) had resolved.            No concomitant medication provided. No treatment information provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-079157 (E2B Linked Report). This case was linked to MOD-2021-079157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: F/U-1 : To confirm no clinical information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079157:Wife Report
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Rash erythematous
Clinical narrative: Red Rash on the Side of the neck, Face and Arms; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on the Side of the neck, Face and Arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on the Side of the neck, Face and Arms). The patient also complained of a rapid heart rate of 72 and 78 BPM however, it resolved on the same day. On 09-Apr-2021, RASH ERYTHEMATOUS (Red Rash on the Side of the neck, Face and Arms) 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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Tremor, Vaccination site pain
Clinical narrative: whole body was vibrating; Dehydrated; arm hurt real bad; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (whole body was vibrating), DEHYDRATION (Dehydrated) and VACCINATION SITE PAIN (arm hurt real bad) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced TREMOR (whole body was vibrating), DEHYDRATION (Dehydrated) and VACCINATION SITE PAIN (arm hurt real bad). On 06-Apr-2021, TREMOR (whole body was vibrating), DEHYDRATION (Dehydrated) and VACCINATION SITE PAIN (arm hurt real bad) 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.   No concomitant medication was provided  No treatment medication was provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: Tired and achy; Tired and achy; Mouth full of saliva; diarrhea; head hurting; vomiting; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY HYPERSECRETION (Mouth full of saliva), DIARRHOEA (diarrhea), HEADACHE (head hurting), VOMITING (vomiting) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced SALIVARY HYPERSECRETION (Mouth full of saliva), DIARRHOEA (diarrhea), HEADACHE (head hurting), VOMITING (vomiting), CHILLS (chills) and PYREXIA (fever). On 16-Apr-2021, the patient experienced FATIGUE (Tired and achy). On an unknown date, the patient experienced PAIN (Tired and achy). At the time of the report, SALIVARY HYPERSECRETION (Mouth full of saliva), DIARRHOEA (diarrhea), HEADACHE (head hurting), VOMITING (vomiting), CHILLS (chills), PYREXIA (fever), FATIGUE (Tired and achy) and PAIN (Tired and achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Salivary hypersecretion, Vomiting
Clinical narrative: Tired and achy; Tired and achy; Mouth full of saliva; diarrhea; head hurting; vomiting; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY HYPERSECRETION (Mouth full of saliva), DIARRHOEA (diarrhea), HEADACHE (head hurting), VOMITING (vomiting) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced SALIVARY HYPERSECRETION (Mouth full of saliva), DIARRHOEA (diarrhea), HEADACHE (head hurting), VOMITING (vomiting), CHILLS (chills) and PYREXIA (fever). On 16-Apr-2021, the patient experienced FATIGUE (Tired and achy). On an unknown date, the patient experienced PAIN (Tired and achy). At the time of the report, SALIVARY HYPERSECRETION (Mouth full of saliva), DIARRHOEA (diarrhea), HEADACHE (head hurting), VOMITING (vomiting), CHILLS (chills), PYREXIA (fever), FATIGUE (Tired and achy) and PAIN (Tired and achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait inability, Myalgia, Somnolence
Clinical narrative: Body aches; sleepy; Cannot walk for 3 hrs; incredibly ill; exhausted; Weak; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), GAIT INABILITY (Cannot walk for 3 hrs), VACCINATION COMPLICATION (incredibly ill), FATIGUE (exhausted) and ASTHENIA (Weak) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SOMNOLENCE (sleepy), GAIT INABILITY (Cannot walk for 3 hrs), VACCINATION COMPLICATION (incredibly ill), FATIGUE (exhausted) and ASTHENIA (Weak). On 16-Apr-2021, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Apr-2021, GAIT INABILITY (Cannot walk for 3 hrs) had resolved. On 15-Apr-2021, SOMNOLENCE (sleepy) and FATIGUE (exhausted) had resolved. On 16-Apr-2021, VACCINATION COMPLICATION (incredibly ill) and ASTHENIA (Weak) had resolved. At the time of the report, MYALGIA (Body aches) outcome was unknown.            No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received and contain Non significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Body aches; sleepy; Cannot walk for 3 hrs; incredibly ill; exhausted; Weak; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), GAIT INABILITY (Cannot walk for 3 hrs), VACCINATION COMPLICATION (incredibly ill), FATIGUE (exhausted) and ASTHENIA (Weak) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced SOMNOLENCE (sleepy), GAIT INABILITY (Cannot walk for 3 hrs), VACCINATION COMPLICATION (incredibly ill), FATIGUE (exhausted) and ASTHENIA (Weak). On 16-Apr-2021, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Apr-2021, GAIT INABILITY (Cannot walk for 3 hrs) had resolved. On 15-Apr-2021, SOMNOLENCE (sleepy) and FATIGUE (exhausted) had resolved. On 16-Apr-2021, VACCINATION COMPLICATION (incredibly ill) and ASTHENIA (Weak) had resolved. At the time of the report, MYALGIA (Body aches) outcome was unknown.            No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received and contain Non significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.