chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: arm was red from her shoulder to her elbow; arm swollen; arm a little itchy; arm tender; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (arm was red from her shoulder to her elbow), PERIPHERAL SWELLING (arm swollen), PRURITUS (arm a little itchy) and TENDERNESS (arm tender) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure inadequately controlled and Hyperlipidemia (cholesterol).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced ERYTHEMA (arm was red from her shoulder to her elbow), PERIPHERAL SWELLING (arm swollen), PRURITUS (arm a little itchy) and TENDERNESS (arm tender). On 13-Jan-2021, ERYTHEMA (arm was red from her shoulder to her elbow), PERIPHERAL SWELLING (arm swollen), PRURITUS (arm a little itchy) and TENDERNESS (arm tender) 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.   Patient reported using medications for Blood pressure and cholesterol concomitantly. Patient took diphenhydramine and ibuprofen for treatment.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Pain in jaw
Clinical narrative: Jaw pain; Blood pressure it ended up very high; Headache; Dizzy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy), PAIN IN JAW (Jaw pain), BLOOD PRESSURE INCREASED (Blood pressure it ended up very high) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIZZINESS (Dizzy), BLOOD PRESSURE INCREASED (Blood pressure it ended up very high) and HEADACHE (Headache). On 09-Jan-2021, the patient experienced PAIN IN JAW (Jaw pain). On 06-Jan-2021, DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure it ended up very high) had resolved. At the time of the report, PAIN IN JAW (Jaw pain) was resolving and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/100 (High) blood pressure it ended up very high and 120/80 (normal) her blood pressure decreased.     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.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, METOPROLOL SUCCINATE (TOPROL) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (Tenderness at the 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.   Treatment details included Tylenol.; 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Felt burning for 2 to 3 minutes; Hives all over the body; Itching a lot; Sore arm; This spontaneous case was reported by a dentist and describes the occurrence of PAIN IN EXTREMITY (Sore arm), URTICARIA (Hives all over the body), PRURITUS (Itching a lot) and SKIN BURNING SENSATION (Felt burning for 2 to 3 minutes) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 22-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 PAIN IN EXTREMITY (Sore arm). On 24-Jan-2021, the patient experienced URTICARIA (Hives all over the body) and PRURITUS (Itching a lot). On 25-Jan-2021, the patient experienced SKIN BURNING SENSATION (Felt burning for 2 to 3 minutes). At the time of the report, PAIN IN EXTREMITY (Sore arm), URTICARIA (Hives all over the body), PRURITUS (Itching a lot) and SKIN BURNING SENSATION (Felt burning for 2 to 3 minutes) 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. Treatment details included Diphenhydramine and Cetirizine
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Breaking out in rash almost 2 weeks after the shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Breaking out in rash almost 2 weeks after the shot) in an 80-year-old female patient 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 RASH (Breaking out in rash almost 2 weeks after the shot). At the time of the report, RASH (Breaking out in rash almost 2 weeks after the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications reported by investigator   No treatment medications provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Lot of coughing; Back pain: "felt like my back was breaking in half"; Couldn't walk Life Threatening; Crumps that felt like came from her kidneys; Body aches; Headaches; Fever of 100.4° F; Couldn't eat because of the nausea; Flu like symptoms; Chills; Sore throat; Diarrhea; Felt achy after walking; Runny nose; Fatigue/Felt weak; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PAIN (Felt achy after walking), RHINORRHOEA (Runny nose), DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (Sore throat) in a 76-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.     The patient's past medical history included Lung disease (Lung problems + MBP). Concomitant products included VITAMINS NOS, AMLODIPINE, BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) and Cilapro for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HYPERTENSION (High blood pressure). On 12-Jan-2021, the patient experienced FATIGUE (Fatigue/Felt weak). On 13-Jan-2021, the patient experienced PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose). On 15-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 16-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), NAUSEA (Couldn't eat because of the nausea) and PYREXIA (Fever of 100.4° F). On 18-Jan-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys). On 11-Jan-2021, HYPERTENSION (High blood pressure) had resolved. On 12-Jan-2021, FATIGUE (Fatigue/Felt weak) had resolved. On 13-Jan-2021, PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose) had resolved. On 15-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 16-Jan-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. On 17-Jan-2021, CHILLS (Chills) and PYREXIA (Fever of 100.4° F) had resolved. On 18-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), NAUSEA (Couldn't eat because of the nausea) and HEADACHE (Headaches) had resolved. At the time of the report, COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included Paracetamol, Fluticasone propionate, Alprazolam (the day of the injection for nerves)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Hypertension, Influenza like illness, Myalgia
Clinical narrative: Lot of coughing; Back pain: "felt like my back was breaking in half"; Couldn't walk Life Threatening; Crumps that felt like came from her kidneys; Body aches; Headaches; Fever of 100.4° F; Couldn't eat because of the nausea; Flu like symptoms; Chills; Sore throat; Diarrhea; Felt achy after walking; Runny nose; Fatigue/Felt weak; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PAIN (Felt achy after walking), RHINORRHOEA (Runny nose), DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (Sore throat) in a 76-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.     The patient's past medical history included Lung disease (Lung problems + MBP). Concomitant products included VITAMINS NOS, AMLODIPINE, BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) and Cilapro for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HYPERTENSION (High blood pressure). On 12-Jan-2021, the patient experienced FATIGUE (Fatigue/Felt weak). On 13-Jan-2021, the patient experienced PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose). On 15-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 16-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), NAUSEA (Couldn't eat because of the nausea) and PYREXIA (Fever of 100.4° F). On 18-Jan-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys). On 11-Jan-2021, HYPERTENSION (High blood pressure) had resolved. On 12-Jan-2021, FATIGUE (Fatigue/Felt weak) had resolved. On 13-Jan-2021, PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose) had resolved. On 15-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 16-Jan-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. On 17-Jan-2021, CHILLS (Chills) and PYREXIA (Fever of 100.4° F) had resolved. On 18-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), NAUSEA (Couldn't eat because of the nausea) and HEADACHE (Headaches) had resolved. At the time of the report, COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included Paracetamol, Fluticasone propionate, Alprazolam (the day of the injection for nerves)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Renal pain
Clinical narrative: Lot of coughing; Back pain: "felt like my back was breaking in half"; Couldn't walk Life Threatening; Crumps that felt like came from her kidneys; Body aches; Headaches; Fever of 100.4° F; Couldn't eat because of the nausea; Flu like symptoms; Chills; Sore throat; Diarrhea; Felt achy after walking; Runny nose; Fatigue/Felt weak; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PAIN (Felt achy after walking), RHINORRHOEA (Runny nose), DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (Sore throat) in a 76-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.     The patient's past medical history included Lung disease (Lung problems + MBP). Concomitant products included VITAMINS NOS, AMLODIPINE, BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) and Cilapro for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HYPERTENSION (High blood pressure). On 12-Jan-2021, the patient experienced FATIGUE (Fatigue/Felt weak). On 13-Jan-2021, the patient experienced PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose). On 15-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 16-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), NAUSEA (Couldn't eat because of the nausea) and PYREXIA (Fever of 100.4° F). On 18-Jan-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys). On 11-Jan-2021, HYPERTENSION (High blood pressure) had resolved. On 12-Jan-2021, FATIGUE (Fatigue/Felt weak) had resolved. On 13-Jan-2021, PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose) had resolved. On 15-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 16-Jan-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. On 17-Jan-2021, CHILLS (Chills) and PYREXIA (Fever of 100.4° F) had resolved. On 18-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), NAUSEA (Couldn't eat because of the nausea) and HEADACHE (Headaches) had resolved. At the time of the report, COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included Paracetamol, Fluticasone propionate, Alprazolam (the day of the injection for nerves)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Lot of coughing; Back pain: "felt like my back was breaking in half"; Couldn't walk Life Threatening; Crumps that felt like came from her kidneys; Body aches; Headaches; Fever of 100.4° F; Couldn't eat because of the nausea; Flu like symptoms; Chills; Sore throat; Diarrhea; Felt achy after walking; Runny nose; Fatigue/Felt weak; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), PAIN (Felt achy after walking), RHINORRHOEA (Runny nose), DIARRHOEA (Diarrhea) and OROPHARYNGEAL PAIN (Sore throat) in a 76-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.     The patient's past medical history included Lung disease (Lung problems + MBP). Concomitant products included VITAMINS NOS, AMLODIPINE, BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) and Cilapro for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HYPERTENSION (High blood pressure). On 12-Jan-2021, the patient experienced FATIGUE (Fatigue/Felt weak). On 13-Jan-2021, the patient experienced PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose). On 15-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 16-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), NAUSEA (Couldn't eat because of the nausea) and PYREXIA (Fever of 100.4° F). On 18-Jan-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys). On 11-Jan-2021, HYPERTENSION (High blood pressure) had resolved. On 12-Jan-2021, FATIGUE (Fatigue/Felt weak) had resolved. On 13-Jan-2021, PAIN (Felt achy after walking) and RHINORRHOEA (Runny nose) had resolved. On 15-Jan-2021, DIARRHOEA (Diarrhea) had resolved. On 16-Jan-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. On 17-Jan-2021, CHILLS (Chills) and PYREXIA (Fever of 100.4° F) had resolved. On 18-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches), NAUSEA (Couldn't eat because of the nausea) and HEADACHE (Headaches) had resolved. At the time of the report, COUGH (Lot of coughing), BACK PAIN (Back pain: "felt like my back was breaking in half"), GAIT DISTURBANCE (Couldn't walk Life Threatening) and RENAL PAIN (Crumps that felt like came from her kidneys) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included Paracetamol, Fluticasone propionate, Alprazolam (the day of the injection for nerves)
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lip swelling, Malaise, Pain in extremity
Clinical narrative: Ocular black zig zig lines; paraesthesia; mild enlargement nodular heterogeneity of the bilateral lingual tonsils; Headaches; Chills; Slight feeling of not quite right; Swelling on face; Swelling of lips; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right) and PARAESTHESIA (paraesthesia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Jan-2021, the patient experienced SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right), HEADACHE (Headaches) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (paraesthesia), TONSILLAR HYPERTROPHY (mild enlargement nodular heterogeneity of the bilateral lingual tonsils) and VISUAL IMPAIRMENT (Ocular black zig zig lines). At the time of the report, SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right), PARAESTHESIA (paraesthesia), TONSILLAR HYPERTROPHY (mild enlargement nodular heterogeneity of the bilateral lingual tonsils), VISUAL IMPAIRMENT (Ocular black zig zig lines), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details include Tylenol , MRI and CT scan.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded. On 05-May-2021: No specific follow-up information recorded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face, Tonsillar hypertrophy, Visual impairment
Clinical narrative: Ocular black zig zig lines; paraesthesia; mild enlargement nodular heterogeneity of the bilateral lingual tonsils; Headaches; Chills; Slight feeling of not quite right; Swelling on face; Swelling of lips; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right) and PARAESTHESIA (paraesthesia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 31-Jan-2021, the patient experienced SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right), HEADACHE (Headaches) and CHILLS (Chills). On an unknown date, the patient experienced PARAESTHESIA (paraesthesia), TONSILLAR HYPERTROPHY (mild enlargement nodular heterogeneity of the bilateral lingual tonsils) and VISUAL IMPAIRMENT (Ocular black zig zig lines). At the time of the report, SWELLING FACE (Swelling on her face and lips), LIP SWELLING (Swelling on her face and lips), PAIN IN EXTREMITY (Pain in her arm), MALAISE (Slight feeling of not quite right), PARAESTHESIA (paraesthesia), TONSILLAR HYPERTROPHY (mild enlargement nodular heterogeneity of the bilateral lingual tonsils), VISUAL IMPAIRMENT (Ocular black zig zig lines), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details include Tylenol , MRI and CT scan.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded. On 05-May-2021: No specific follow-up information recorded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Dyspnoea, Head discomfort
Clinical narrative: stuffy head; couldn't breathe through his nose; lost sense of taste and smell; lost sense of taste and smell; diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose), AGEUSIA (lost sense of taste and smell), ANOSMIA (lost sense of taste and smell) and COVID-19 (diagnosed with COVID) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CARVEDILOL, AMLODIPINE, OMEPRAZOLE, VITAMIN D NOS, FERRIC CITRATE (AURYXIA), SEVELAMER CARBONATE and Sensitar for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose), AGEUSIA (lost sense of taste and smell), ANOSMIA (lost sense of taste and smell) and COVID-19 (diagnosed with COVID). On 02-Feb-2021, AGEUSIA (lost sense of taste and smell) and ANOSMIA (lost sense of taste and smell) had resolved. At the time of the report, HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose) and COVID-19 (diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included guaifenesin.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: stuffy head; couldn't breathe through his nose; lost sense of taste and smell; lost sense of taste and smell; diagnosed with COVID; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose), AGEUSIA (lost sense of taste and smell), ANOSMIA (lost sense of taste and smell) and COVID-19 (diagnosed with COVID) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CARVEDILOL, AMLODIPINE, OMEPRAZOLE, VITAMIN D NOS, FERRIC CITRATE (AURYXIA), SEVELAMER CARBONATE and Sensitar for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose), AGEUSIA (lost sense of taste and smell), ANOSMIA (lost sense of taste and smell) and COVID-19 (diagnosed with COVID). On 02-Feb-2021, AGEUSIA (lost sense of taste and smell) and ANOSMIA (lost sense of taste and smell) had resolved. At the time of the report, HEAD DISCOMFORT (stuffy head), DYSPNOEA (couldn't breathe through his nose) and COVID-19 (diagnosed with COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included guaifenesin.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Big round red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Big round red spot at the injection site) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big round red spot at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Big round red spot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-018078 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-018078:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Vaccination site pain, Vaccination site warmth
Clinical narrative: vaccination site warmth; red thing (swelling) on my arm is still the size of a flower; pains, aches, and redness at the injection site; redness at the injection site; had pains, aches, and redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), INJECTION SITE SWELLING (red thing (swelling) on my arm is still the size of a flower), MYALGIA (pains, aches, and redness at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (had pains, aches, and redness at the injection site) in a 71-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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), INJECTION SITE SWELLING (red thing (swelling) on my arm is still the size of a flower), MYALGIA (pains, aches, and redness at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (had pains, aches, and redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), INJECTION SITE SWELLING (red thing (swelling) on my arm is still the size of a flower), MYALGIA (pains, aches, and redness at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (had pains, aches, and redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment for the events included Aspirin.  On 25-Mar-2021 the patient reported events after the second dose of the vaccine and commented that it took about three weeks for her arm to return to normal after each vaccine administration but that she has fully recovered.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Initial Additional; Reporter's Comments: This case concerns a 72-year-old female who experienced NS expected events of injection site pain, injection site erythema, injection site swelling, and injection site warmth.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included aspirin. Events resolved, except for ongoing erythema. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Silver dime size hard red spot at injection site; Injection site hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Silver dime size hard red spot at injection site) and VACCINATION SITE PAIN (Injection site hot to touch) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 051k02A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Silver dime size hard red spot at injection site) and VACCINATION SITE PAIN (Injection site hot to touch). At the time of the report, VACCINATION SITE ERYTHEMA (Silver dime size hard red spot at injection site) and VACCINATION SITE PAIN (Injection site hot to touch) outcome was unknown.            Treatment information included using ice on the area.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea for 3 times; Fever of 100.4; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea for 3 times) and PYREXIA (Fever of 100.4) 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 08-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 DIARRHOEA (Diarrhea for 3 times) and PYREXIA (Fever of 100.4). At the time of the report, DIARRHOEA (Diarrhea for 3 times) and PYREXIA (Fever of 100.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.4 (High) 100.4.     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 relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Developed a headache; Chills within a few hours following vaccination; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills within a few hours following vaccination) and HEADACHE (Developed a headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills within a few hours following vaccination). On 26-Jan-2021, the patient experienced HEADACHE (Developed a headache). At the time of the report, CHILLS (Chills within a few hours following vaccination) and HEADACHE (Developed a headache) outcome was unknown.            No relevant concomitant medications were reported. The patient wanted to find out if he could take pain medication like Tylenol (acetaminophen). No treatment information was provided.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Hyperhidrosis, Vaccination site pain
Clinical narrative: SWEAT; DIARRHEA; DIZZINESS; vaccination site pain; This spontaneous case was reported by a health care professional and describes the occurrence of HYPERHIDROSIS (SWEAT), DIARRHOEA (DIARRHEA), DIZZINESS (DIZZINESS) and VACCINATION SITE PAIN (vaccination site pain) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CENTRUM ACTIVE, IVERMECTIN and CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HYPERHIDROSIS (SWEAT), DIARRHOEA (DIARRHEA), DIZZINESS (DIZZINESS) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, HYPERHIDROSIS (SWEAT), DIARRHOEA (DIARRHEA), DIZZINESS (DIZZINESS) and VACCINATION SITE PAIN (vaccination site pain) 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 information was not provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Euphoric mood, Swelling, Tenderness
Clinical narrative: little swelling; Tenderness; boost of energy/felt rejuventaed; euphoric feeling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (little swelling), TENDERNESS (Tenderness), ENERGY INCREASED (boost of energy/felt rejuventaed) and EUPHORIC MOOD (euphoric feeling) 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 29-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 SWELLING (little swelling), TENDERNESS (Tenderness), ENERGY INCREASED (boost of energy/felt rejuventaed) and EUPHORIC MOOD (euphoric feeling). At the time of the report, SWELLING (little swelling), TENDERNESS (Tenderness), ENERGY INCREASED (boost of energy/felt rejuventaed) and EUPHORIC MOOD (euphoric feeling) 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 reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash at the injection site; Itchy rash at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy rash at the injection site), INJECTION SITE RASH (Itchy rash at the injection site) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, MULTIVITAMINS [VITAMINS NOS] and LISINOPRIL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itchy rash at the injection site), INJECTION SITE RASH (Itchy rash at the injection site) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy rash at the injection site), INJECTION SITE RASH (Itchy rash at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19APR2021, No new information invalid contact details
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Headache, Hypoaesthesia
Clinical narrative: Low blood pressure; Felt really week/weakness; Numbness in the whole body; High Fever 139.9; Severe muscle pain; Severe Headache; This spontaneous case was reported by a dentist and describes the occurrence of HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9) and MYALGIA (Severe muscle pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 29-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 HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9), MYALGIA (Severe muscle pain) and HEADACHE (Severe Headache). At the time of the report, HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9), MYALGIA (Severe muscle pain) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Body temperature: 139.9 High.   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.; Sender'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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Myalgia, Pyrexia
Clinical narrative: Low blood pressure; Felt really week/weakness; Numbness in the whole body; High Fever 139.9; Severe muscle pain; Severe Headache; This spontaneous case was reported by a dentist and describes the occurrence of HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9) and MYALGIA (Severe muscle pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 29-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 HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9), MYALGIA (Severe muscle pain) and HEADACHE (Severe Headache). At the time of the report, HYPOTENSION (Low blood pressure), ASTHENIA (Felt really week/weakness), HYPOAESTHESIA (Numbness in the whole body), PYREXIA (High Fever 139.9), MYALGIA (Severe muscle pain) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Body temperature: 139.9 High.   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.; Sender'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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Tenderness
Clinical narrative: tenderness of arm; stiffness of the muscle; Injection site area was red, bump; Injection site area was red, bump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TENDERNESS (tenderness of arm), MUSCULOSKELETAL STIFFNESS (stiffness of the muscle), INJECTION SITE ERYTHEMA (Injection site area was red, bump) and INJECTION SITE SWELLING (Injection site area was red, bump) in a 69-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 30-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 TENDERNESS (tenderness of arm), MUSCULOSKELETAL STIFFNESS (stiffness of the muscle), INJECTION SITE ERYTHEMA (Injection site area was red, bump) and INJECTION SITE SWELLING (Injection site area was red, bump). At the time of the report, TENDERNESS (tenderness of arm), MUSCULOSKELETAL STIFFNESS (stiffness of the muscle), INJECTION SITE ERYTHEMA (Injection site area was red, bump) and INJECTION SITE SWELLING (Injection site area was red, bump) outcome was unknown. Not Provided      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 reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Pyrexia, Swelling
Clinical narrative: Swelling; Tenderness; Upset Stomach; Fever; Head ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever) and HEADACHE (Head ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever), HEADACHE (Head ache) and NAUSEA (Nausea). At the time of the report, SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever), HEADACHE (Head ache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  No concomitant medications reported. No treatment medications were reported.