chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: my injection site was sore; cough; nasal drainage; tested positive for Covid-19; severe tiredness; no appetite; vomiting; diarrhea; fever of 100.3°F; chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), FATIGUE (severe tiredness), DECREASED APPETITE (no appetite), VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (severe tiredness), DECREASED APPETITE (no appetite), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever of 100.3°F), CHILLS (chills), PAIN (body aches) and HEADACHE (headache). On 11-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19). On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (my injection site was sore), COUGH (cough) and RHINORRHOEA (nasal drainage). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), FATIGUE (severe tiredness), DECREASED APPETITE (no appetite), VOMITING (vomiting), DIARRHOEA (diarrhea), PYREXIA (fever of 100.3°F), CHILLS (chills), PAIN (body aches), HEADACHE (headache), INJECTION SITE PAIN (my injection site was sore), COUGH (cough) and RHINORRHOEA (nasal drainage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included I took Tylenol for the headache   Reporter did not allow further contact
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site warmth
Clinical narrative: sore arm; pink arm; vaccination site warm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (pink arm) and VACCINATION SITE WARMTH (vaccination site warm) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20A.) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), ERYTHEMA (pink arm) and VACCINATION SITE WARMTH (vaccination site warm). At the time of the report, PAIN IN EXTREMITY (sore arm), ERYTHEMA (pink arm) and VACCINATION SITE WARMTH (vaccination site warm) 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.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: Arm started to swel; could barely raise his arm, painful; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Arm started to swel) and PAIN IN EXTREMITY (could barely raise his arm, painful) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20N) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced SWELLING (Arm started to swel) and PAIN IN EXTREMITY (could barely raise his arm, painful). At the time of the report, SWELLING (Arm started to swel) and PAIN IN EXTREMITY (could barely raise his arm, painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye disorder, Headache, Nausea, Vertigo
Clinical narrative: slight headache; Nausea; Woke up very dizzy; head was spinning; Could not focus his eyes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up very dizzy), VERTIGO (head was spinning), EYE DISORDER (Could not focus his eyes), HEADACHE (slight headache) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (Woke up very dizzy), VERTIGO (head was spinning) and EYE DISORDER (Could not focus his eyes). On 01-Feb-2021, the patient experienced HEADACHE (slight headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Woke up very dizzy), VERTIGO (head was spinning), EYE DISORDER (Could not focus his eyes), HEADACHE (slight headache) and NAUSEA (Nausea) 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.    Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Myalgia, Pyrexia
Clinical narrative: headache; warm sensation through neck and shoulder; body ache; fever 101.6; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever 101.6), HEADACHE (headache), CHILLS (chills), FEELING HOT (warm sensation through neck and shoulder) and MYALGIA (body ache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills). On 02-Feb-2021, the patient experienced PYREXIA (fever 101.6). On an unknown date, the patient experienced HEADACHE (headache), FEELING HOT (warm sensation through neck and shoulder) and MYALGIA (body ache). On 01-Feb-2021, CHILLS (chills) had resolved. At the time of the report, PYREXIA (fever 101.6), HEADACHE (headache), FEELING HOT (warm sensation through neck and shoulder) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchial hyperreactivity, Cough, Nasal congestion
Clinical narrative: asthma; Reactive airways disease; COUGH; head cold that included nasal congestion; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (asthma), BRONCHIAL HYPERREACTIVITY (Reactive airways disease), NASAL CONGESTION (head cold that included nasal congestion) and COUGH (COUGH) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced NASAL CONGESTION (head cold that included nasal congestion). On 31-Jan-2021, the patient experienced COUGH (COUGH). On 01-Feb-2021, the patient experienced ASTHMA (asthma) and BRONCHIAL HYPERREACTIVITY (Reactive airways disease). At the time of the report, ASTHMA (asthma), BRONCHIAL HYPERREACTIVITY (Reactive airways disease), NASAL CONGESTION (head cold that included nasal congestion) and COUGH (COUGH) 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.   Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Vaccination site pain
Clinical narrative: Ached all over (bones hurt); Very tired (slept 10-15 hours); Left arm was really sore; A spontaneous report was received from a Consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in extremity, fatigue, bone pain , fatigue, bone pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events pain in extremity, fatigue, bone pain.   On 16 Jan 2021, the patient experienced the events fatigue, bone pain   The treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, pain in extremity, fatigue, bone pain not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site warmth
Clinical narrative: swollen lymph node in injection arm; pinkness at injection site; warm to the touch at injection site; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE), ARTHRALGIA (swollen lymph node in injection arm), INJECTION SITE ERYTHEMA (pinkness at injection site) and INJECTION SITE WARMTH (warm to the touch at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included LEVETIRACETAM (KEPPRA), CARBAMAZEPINE (TEGRETOL) and PANTOPRAZOLE 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 22-Jan-2021, the patient experienced HEADACHE (HEADACHE). On 27-Jan-2021, the patient experienced ARTHRALGIA (swollen lymph node in injection arm), INJECTION SITE ERYTHEMA (pinkness at injection site) and INJECTION SITE WARMTH (warm to the touch at injection site). On 23-Jan-2021, HEADACHE (HEADACHE) had resolved. At the time of the report, ARTHRALGIA (swollen lymph node in injection arm), INJECTION SITE ERYTHEMA (pinkness at injection site) and INJECTION SITE WARMTH (warm to the touch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details Included advil on 22 Jan 2021 for headache   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: Dizziness; Body aches; Headache; Chills; Fever; Big rash at the injection site; Warm to the touch at injection site; Tender to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE RASH (Big rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and VACCINATION SITE PAIN (Tender to the touch at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE RASH (Big rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and VACCINATION SITE PAIN (Tender to the touch at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported    Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Dizziness; Body aches; Headache; Chills; Fever; Big rash at the injection site; Warm to the touch at injection site; Tender to the touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE RASH (Big rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and VACCINATION SITE PAIN (Tender to the touch at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), MYALGIA (Body aches), HEADACHE (Headache), CHILLS (Chills), PYREXIA (Fever), VACCINATION SITE RASH (Big rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and VACCINATION SITE PAIN (Tender to the touch at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported    Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy Injection Site; Red Injection Site; Swollen Injection Site; Tender Injection Site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itchy Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE PAIN (Tender Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Came back  red and redder; Redness at injection site; Swelling at injection site; Hardness at injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE INDURATION (Hardness at injection site), PRURITUS (Itching), ERYTHEMA (Came back  red and redder) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE INDURATION (Hardness at injection site), PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 30-Jan-2021, the patient experienced ERYTHEMA (Came back  red and redder). At the time of the report, VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved and PRURITUS (Itching) and ERYTHEMA (Came back  red and redder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eye swelling, Headache, Rash
Clinical narrative: Swelling of the right eye; Spreading rash on the trunk area; Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling of the right eye), RASH (Spreading rash on the trunk area), DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced EYE SWELLING (Swelling of the right eye), RASH (Spreading rash on the trunk area), DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, EYE SWELLING (Swelling of the right eye), RASH (Spreading rash on the trunk area), DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported  Treatment details included the patient was recommended Allegra by the doctor. The patient also took Tylenol and steroid before consulting the physician, who told not to take steroid again
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Big, red, pink lump; Itchy; Big, red, pink lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Big, red, pink lump) and VACCINATION SITE ERYTHEMA (Big, red, pink lump) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Big, red, pink lump) and VACCINATION SITE ERYTHEMA (Big, red, pink lump). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE INDURATION (Big, red, pink lump) and VACCINATION SITE ERYTHEMA (Big, red, pink lump) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Nausea, Pain, Pain in extremity
Clinical narrative: Felt cold; Body hurt; Shivering; Nauseated; A little fever of 100.3°F; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering) and NAUSEA (Nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 02-Feb-2021, the patient experienced FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering), NAUSEA (Nauseated) and PYREXIA (A little fever of 100.3°F). At the time of the report, PAIN IN EXTREMITY (Arm sore), FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering), NAUSEA (Nauseated) and PYREXIA (A little fever of 100.3°F) 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 included unknown medication for nausea.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt cold; Body hurt; Shivering; Nauseated; A little fever of 100.3°F; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering) and NAUSEA (Nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 02-Feb-2021, the patient experienced FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering), NAUSEA (Nauseated) and PYREXIA (A little fever of 100.3°F). At the time of the report, PAIN IN EXTREMITY (Arm sore), FEELING COLD (Felt cold), PAIN (Body hurt), CHILLS (Shivering), NAUSEA (Nauseated) and PYREXIA (A little fever of 100.3°F) 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 included unknown medication for nausea.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Pain
Clinical narrative: Difficulty Breathing; diarrhea; body aches; Fever; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were blood thinners.  No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-154538:Wife's case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Difficulty Breathing; diarrhea; body aches; Fever; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (fatigue). At the time of the report, DYSPNOEA (Difficulty Breathing), DIARRHOEA (diarrhea), PAIN (body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were blood thinners.  No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product. US-MODERNATX, INC.-MOD-2021-154538:Wife's case
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy Sensation - Near Injection Site; Hives - Near Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itchy Sensation - Near Injection Site) and URTICARIA (Hives - Near Injection Site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itchy Sensation - Near Injection Site) and URTICARIA (Hives - Near Injection Site). On 25-Jan-2021, PRURITUS (Itchy Sensation - Near Injection Site) and URTICARIA (Hives - Near Injection Site) 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.   No concomitant medications were reported.  Steroids were reported as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 19-APR-2021 contains no new information. On 25-Apr-2021: Follow-up received on 25-APR-2021 contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Small red mark same day of vaccine; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events small red spot, the mark resurfaced and had grown in size to approximately 6 inches in length and 3 inches in width (vaccination site erythema).  The patient's medical history was not reported.  The patients current condition include Parkinson's disease.  Concomitant medications reported were Acetylsalicylic Acid.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient experienced the event- small red spot, On 2 Feb 2021, the patient experienced the events  the mark resurfaced and had grown in size to approximately 6 inches in length and 3 inches in width.  The treatment details included Sarna lotion.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event vaccination site erythema was unknown.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. vaccination site erythema is consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dysarthria, Feeling abnormal, Nausea, Pyrexia
Clinical narrative: Started falling asleep at the table; Slurring of speech; Memory Loss; Unstable; Fever 102.5F; NAUSEA; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unstable), SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech), AMNESIA (Memory Loss) and NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (Nausea). On 26-Jan-2021, the patient experienced PYREXIA (Fever 102.5F) and NAUSEA (NAUSEA). On 27-Jan-2021, the patient experienced FEELING ABNORMAL (Unstable). On 30-Jan-2021, the patient experienced SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech) and AMNESIA (Memory Loss). On 28-Jan-2021, NAUSEA (NAUSEA) had resolved. At the time of the report, FEELING ABNORMAL (Unstable), SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech) and AMNESIA (Memory Loss) outcome was unknown and NAUSEA (Nausea) and PYREXIA (Fever 102.5F) 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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Started falling asleep at the table; Slurring of speech; Memory Loss; Unstable; Fever 102.5F; NAUSEA; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unstable), SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech), AMNESIA (Memory Loss) and NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (Nausea). On 26-Jan-2021, the patient experienced PYREXIA (Fever 102.5F) and NAUSEA (NAUSEA). On 27-Jan-2021, the patient experienced FEELING ABNORMAL (Unstable). On 30-Jan-2021, the patient experienced SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech) and AMNESIA (Memory Loss). On 28-Jan-2021, NAUSEA (NAUSEA) had resolved. At the time of the report, FEELING ABNORMAL (Unstable), SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech) and AMNESIA (Memory Loss) outcome was unknown and NAUSEA (Nausea) and PYREXIA (Fever 102.5F) 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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm was sore; Tired for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired for 3 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired for 3 days). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use included thyroid medication.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having a reaction) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having a reaction). At the time of the report, VACCINATION COMPLICATION (Having a reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (Itch injection site), VACCINATION SITE PAIN (Pain in the arm) and VACCINATION SITE ERYTHEMA (redness around injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (Pain in the arm) and VACCINATION SITE ERYTHEMA (redness around injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itch injection site) and VACCINATION SITE ERYTHEMA (redness injection site). On 28-Jan-2021, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (Pain in the arm) and VACCINATION SITE ERYTHEMA (redness around injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itch injection site) and VACCINATION SITE ERYTHEMA (redness injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dyspnoea, Oropharyngeal pain, Peripheral swelling
Clinical narrative: Sore throat; Chills; Fever; Tested COVID19 positive; Shortness of breath; Swelling in legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Swelling in legs), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Tested COVID19 positive) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Liver disorder (Liver disease).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and PERIPHERAL SWELLING (Swelling in legs). On 22-Jan-2021, the patient experienced COVID-19 (Tested COVID19 positive). On 23-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Swelling in legs), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Tested COVID19 positive), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: other (Positive) Tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore throat; Chills; Fever; Tested COVID19 positive; Shortness of breath; Swelling in legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Swelling in legs), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Tested COVID19 positive) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Liver disorder (Liver disease).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and PERIPHERAL SWELLING (Swelling in legs). On 22-Jan-2021, the patient experienced COVID-19 (Tested COVID19 positive). On 23-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, DYSPNOEA (Shortness of breath), PERIPHERAL SWELLING (Swelling in legs), OROPHARYNGEAL PAIN (Sore throat), COVID-19 (Tested COVID19 positive), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: other (Positive) Tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Soreness has now progressed up into her right shoulder; Soreness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and ARTHRALGIA (Soreness has now progressed up into her right shoulder) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and CLL. Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE and BISOPROLOL for Blood pressure high.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 03-Feb-2021, the patient experienced ARTHRALGIA (Soreness has now progressed up into her right shoulder). On 03-Feb-2021, VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) and ARTHRALGIA (Soreness has now progressed up into her right shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Stress urinary incontinence
Clinical narrative: started feeling funny; tired; This spontaneous case was reported by a consumer and describes the occurrence of STRESS URINARY INCONTINENCE (started feeling funny) and FATIGUE (tired) 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 STRESS URINARY INCONTINENCE (started feeling funny) and FATIGUE (tired). At the time of the report, STRESS URINARY INCONTINENCE (started feeling funny) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: fatigue; chills; Pain at injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Pain at injection) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection). On 28-Jan-2021, the patient experienced FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (Pain at injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Headache, Injection site rash
Clinical narrative: Temperature was a little elevated; Developed a rash in my arm; Pain in my shoulder; Headache; Joint pain; A spontaneous report was received from a consumer concerning a 43-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash in arm (injection site rash), pain in shoulder (shoulder pain), headache, joint pain (shoulder pain) and temperature was a little elevated (temperature elevation).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch Number: 032L20A) in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient developed rash in arm, pain in my shoulder, headache and joint pain. On 01 Feb 2021, the patient experienced temperature was a little elevated.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, rash in arm, pain in shoulder, headache, joint pain and temperature was a little elevated was not reported.; Reporter's Comments: Based on the information provided, a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. The reported events are consistent with the known safety profile of the vaccine
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) (batch no. 028L20A) 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) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.