chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Sleep disorder, Tachycardia
Clinical narrative: Dry mouth; Did not sleep much for two days after Vaccination; Experienced rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Experienced rapid heart beat), DRY MOUTH (Dry mouth) and SLEEP DISORDER (Did not sleep much for two days after Vaccination) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 032MZ09) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), VALSARTAN (DIOVAN) for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, GLIPIZIDE and METFORMIN for Diabetes, CLONAZEPAM for Sleep disorder, POTASSIUM and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced TACHYCARDIA (Experienced rapid heart beat). On an unknown date, the patient experienced DRY MOUTH (Dry mouth) and SLEEP DISORDER (Did not sleep much for two days after Vaccination). At the time of the report, TACHYCARDIA (Experienced rapid heart beat) was resolving and DRY MOUTH (Dry mouth) and SLEEP DISORDER (Did not sleep much for two days after Vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-JUN-2021 contains the information updated patient initials. On 23-Jul-2021: Significant Followup- 2nd dose information updated. New Events (Dry mouth and unable to sleep) were updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: the area where I got the shot felt a little warm - left arm; the area where I got the shot is itchy - left arm; the area where I got the shot is red- left arm; the area where I got the shot is swollen - left arm a little bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (the area where I got the shot felt a little warm - left arm), INJECTION SITE PRURITUS (the area where I got the shot is itchy - left arm), INJECTION SITE ERYTHEMA (the area where I got the shot is red- left arm) and INJECTION SITE SWELLING (the area where I got the shot is swollen - left arm a little bit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (the area where I got the shot felt a little warm - left arm), INJECTION SITE PRURITUS (the area where I got the shot is itchy - left arm), INJECTION SITE ERYTHEMA (the area where I got the shot is red- left arm) and INJECTION SITE SWELLING (the area where I got the shot is swollen - left arm a little bit). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, INJECTION SITE WARMTH (the area where I got the shot felt a little warm - left arm), INJECTION SITE PRURITUS (the area where I got the shot is itchy - left arm) and INJECTION SITE SWELLING (the area where I got the shot is swollen - left arm a little bit) had not resolved and INJECTION SITE ERYTHEMA (the area where I got the shot is red- left arm) was resolving.        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. Treatment included cold compress.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus, Swelling
Clinical narrative: Experiencing itching, swelling, hard, large red spot; Experiencing itching, swelling, hard, large red spot; Experiencing itching, swelling, hard, large red spot; Experiencing itching, swelling, hard, large red spot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Experiencing itching, swelling, hard, large red spot), INDURATION (Experiencing itching, swelling, hard, large red spot), ERYTHEMA (Experiencing itching, swelling, hard, large red spot) and SWELLING (Experiencing itching, swelling, hard, large red spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ROSUVASTATIN and ESTRADIOL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PRURITUS (Experiencing itching, swelling, hard, large red spot), INDURATION (Experiencing itching, swelling, hard, large red spot), ERYTHEMA (Experiencing itching, swelling, hard, large red spot) and SWELLING (Experiencing itching, swelling, hard, large red spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE ACETATE at a dose of UNK dosage form. At the time of the report, PRURITUS (Experiencing itching, swelling, hard, large red spot), INDURATION (Experiencing itching, swelling, hard, large red spot), ERYTHEMA (Experiencing itching, swelling, hard, large red spot) and SWELLING (Experiencing itching, swelling, hard, large red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Heart rate, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: breaking out in sweats; Sore throat; Sore arm; Low grade fever; difficulty breathing (kind of shortness of breath) - labored breathing; Dry cough; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing), COUGH (Dry cough), HYPERHIDROSIS (breaking out in sweats), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) in a 53-year-old male 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 Rheumatoid arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing), COUGH (Dry cough), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever). On an unknown date, the patient experienced HYPERHIDROSIS (breaking out in sweats) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Feb-2021, COUGH (Dry cough) had resolved. On 16-Feb-2021, DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing) and PYREXIA (Low grade fever) had resolved. At the time of the report, HYPERHIDROSIS (breaking out in sweats), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   This case was linked to MOD-2021-015147.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: breaking out in sweats; Sore throat; Sore arm; Low grade fever; difficulty breathing (kind of shortness of breath) - labored breathing; Dry cough; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing), COUGH (Dry cough), HYPERHIDROSIS (breaking out in sweats), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) in a 53-year-old male 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 Rheumatoid arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing), COUGH (Dry cough), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Low grade fever). On an unknown date, the patient experienced HYPERHIDROSIS (breaking out in sweats) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Feb-2021, COUGH (Dry cough) had resolved. On 16-Feb-2021, DYSPNOEA (difficulty breathing (kind of shortness of breath) - labored breathing) and PYREXIA (Low grade fever) had resolved. At the time of the report, HYPERHIDROSIS (breaking out in sweats), OROPHARYNGEAL PAIN (Sore throat) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   This case was linked to MOD-2021-015147.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: The site of injection is sore; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (The site of injection is sore), PYREXIA (fever) and PAIN (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (The site of injection is sore), PYREXIA (fever) and PAIN (body aches). At the time of the report, VACCINATION SITE PAIN (The site of injection is sore), PYREXIA (fever) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Transsphenoidal surgery in September 2012. Concomitant products included LEVOTHYROXINE, DEXAMETHASONE, HYDROCORTISONE, TESTOSTERONE, DENOSUMAB (PROLIA), VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN B12 [VITAMIN B12 NOS], CALCIUM and VITAMIN D3 for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is on a regimen of steroid. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Extreme dizziness). At the time of the report, DIZZINESS (Extreme dizziness) was resolving.        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 was given for the event.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: No specific follow-up information recorded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Severe pain in stomach; Diarrhea; A spontaneous report was received from a consumer, concerning an 82-year-old female patient, who received Moderna's COVID-19 vaccine and experienced severe pain in the stomach/abdominal pain upper and diarrhea.  The patient medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were carvedilol, rosuvastatin, spironolactone, losartan and acetylsalicylic acid.  On 12 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) on her left arm for COVID-19 infection prophylaxis.  On Friday 12 Feb 2021, after receiving Moderna's COVID-19 vaccine, the patient had no problem. On Saturday 13 Feb 2021,  the patient had severe pain in the stomach and diarrhea which lasted till Sunday (14 Feb 2021). T reatment medications included omeprazole for 14 days.  Action taken with mRNA-1273 in response to the event was unknown  The outcome of the events severe pain in stomach/abdominal pain upper and diarrhea were considered as resolved on 14 Feb 2021.; Reporter'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.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M201) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). The patient was treated with ACETAMINOPHEN at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take concomitant medication.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Urticaria
Clinical narrative: arm redness; welts; Fever; This spontaneous case was reported by a consumer and describes the occurrence of   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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Pain, Peripheral swelling, Pruritus
Clinical narrative: can not sleep comfortably; delayed reaction; radiating pain/radiates through her arm from her elbow to her shoulder; Fatigue; Itchy; Feeling of warmth; Tender; Swollen; Red rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Feeling of warmth), TENDERNESS (Tender), PERIPHERAL SWELLING (Swollen), RASH ERYTHEMATOUS (Red rash) and SLEEP DISORDER (can not sleep comfortably) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced FEELING HOT (Feeling of warmth), TENDERNESS (Tender), PERIPHERAL SWELLING (Swollen), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itchy). On an unknown date, the patient experienced SLEEP DISORDER (can not sleep comfortably), SKIN REACTION (delayed reaction), PAIN (radiating pain/radiates through her arm from her elbow to her shoulder) and FATIGUE (Fatigue). At the time of the report, FEELING HOT (Feeling of warmth), TENDERNESS (Tender), PERIPHERAL SWELLING (Swollen), RASH ERYTHEMATOUS (Red rash), SLEEP DISORDER (can not sleep comfortably), SKIN REACTION (delayed reaction), PRURITUS (Itchy), PAIN (radiating pain/radiates through her arm from her elbow to her shoulder) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported . On 23-Feb-2021, the patient her visited, the doctor could see outline on arm and was speculating that nerve might have been hit during injection.  The patient received an email from safety but was not comfortable emailing back safety form because of personal information contained within it. She did not want to be contacted by email. No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-238616 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received- New events updated and clinical course updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin reaction, Sleep disorder, Tenderness
Clinical narrative: can not sleep comfortably; delayed reaction; radiating pain/radiates through her arm from her elbow to her shoulder; Fatigue; Itchy; Feeling of warmth; Tender; Swollen; Red rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Feeling of warmth), TENDERNESS (Tender), PERIPHERAL SWELLING (Swollen), RASH ERYTHEMATOUS (Red rash) and SLEEP DISORDER (can not sleep comfortably) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced FEELING HOT (Feeling of warmth), TENDERNESS (Tender), PERIPHERAL SWELLING (Swollen), RASH ERYTHEMATOUS (Red rash) and PRURITUS (Itchy). On an unknown date, the patient experienced SLEEP DISORDER (can not sleep comfortably), SKIN REACTION (delayed reaction), PAIN (radiating pain/radiates through her arm from her elbow to her shoulder) and FATIGUE (Fatigue). At the time of the report, FEELING HOT (Feeling of warmth), TENDERNESS (Tender), PERIPHERAL SWELLING (Swollen), RASH ERYTHEMATOUS (Red rash), SLEEP DISORDER (can not sleep comfortably), SKIN REACTION (delayed reaction), PRURITUS (Itchy), PAIN (radiating pain/radiates through her arm from her elbow to her shoulder) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported . On 23-Feb-2021, the patient her visited, the doctor could see outline on arm and was speculating that nerve might have been hit during injection.  The patient received an email from safety but was not comfortable emailing back safety form because of personal information contained within it. She did not want to be contacted by email. No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-238616 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received- New events updated and clinical course updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness and swelling at Injection site; Itchiness and swelling at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness and swelling at Injection site) and VACCINATION SITE SWELLING (Itchiness and swelling at Injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness and swelling at Injection site) and VACCINATION SITE SWELLING (Itchiness and swelling at Injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness and swelling at Injection site) and VACCINATION SITE SWELLING (Itchiness and swelling at Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications included.  Cold Pack, cortisone cream, alcohol swab are added as treatment medications.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: slightly warm to touch; itchy; bumpy; having a little bit of rash in that area; Little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (slightly warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (bumpy), VACCINATION SITE RASH (having a little bit of rash in that area) and VACCINATION SITE ERYTHEMA (Little red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (slightly warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (bumpy), VACCINATION SITE RASH (having a little bit of rash in that area) and VACCINATION SITE ERYTHEMA (Little red). At the time of the report, VACCINATION SITE WARMTH (slightly warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (bumpy), VACCINATION SITE RASH (having a little bit of rash in that area) and VACCINATION SITE ERYTHEMA (Little red) 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 treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up document received contain no new information.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, COVID-19, Fatigue, Pain
Clinical narrative: positive for COVID; Felt weakness; slight ache; Pain in center of his back and upper back; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weakness), PAIN (slight ache), BACK PAIN (Pain in center of his back and upper back), COVID-19 (positive for COVID) and FATIGUE (tiredness) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 FATIGUE (tiredness). On 25-Jan-2021, the patient experienced ASTHENIA (Felt weakness), PAIN (slight ache) and BACK PAIN (Pain in center of his back and upper back). On 26-Jan-2021, the patient experienced COVID-19 (positive for COVID). On 25-Jan-2021, FATIGUE (tiredness) had resolved. On 26-Jan-2021, BACK PAIN (Pain in center of his back and upper back) had resolved. At the time of the report, ASTHENIA (Felt weakness), PAIN (slight ache) and COVID-19 (positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, COVID-19: positive (Positive) positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Stuffy nose, cough,lost sense of smell, lost sense of taste were considered as symptoms and are subsumed under Covid-19.  No concomitant medications were reported. No Treatments were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: malaise; headache; and fatigue for 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (malaise), HEADACHE (headache) and FATIGUE (and fatigue for 24 hours) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise), HEADACHE (headache) and FATIGUE (and fatigue for 24 hours). At the time of the report, MALAISE (malaise), HEADACHE (headache) and FATIGUE (and fatigue for 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No Treatments were reported.   This case was linked to MOD-2021-015012 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching on right arm; Rash on right arm near injection site; Raised area near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE RASH (Rash on right arm near injection site) and VACCINATION SITE INDURATION (Raised area near injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE RASH (Rash on right arm near injection site) and VACCINATION SITE INDURATION (Raised area near injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itching on right arm), VACCINATION SITE RASH (Rash on right arm near injection site) and VACCINATION SITE INDURATION (Raised area near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: Chills; headache; Felt tired; vaccination site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), FATIGUE (Felt tired) and VACCINATION SITE PAIN (vaccination site tenderness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     no specified medical history was reported.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), FATIGUE (Felt tired) and VACCINATION SITE PAIN (vaccination site tenderness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, VACCINATION SITE PAIN (vaccination site tenderness) had resolved. On 09-Feb-2021, CHILLS (Chills), HEADACHE (headache) and FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient uses unspecified concomitant medications which includes heart , blood pressure and cholesterol medication,
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Product dose omission issue
Clinical narrative: Dizziness; Did not get 2nd dose on due date; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose on due date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose on due date). At the time of the report, DIZZINESS (Dizziness) was resolving and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose on due date) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, COVID-19: Positive.     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 had a steroid shot on hip, and have been taking a z-pack of antibiotics and some Antivert for the dizziness, also received Bamlanivimab infusion on 12FEB2021. She has not yet received the 2nd dose as per the report because she heard that she has to wait 90 days after the infusion. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant follow up appended
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: cold sores; sore lymph nodes; chills; Headache; Fever; muscle pain; Felt tired; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (cold sores), PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (sore lymph nodes), FATIGUE (Felt tired) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired). On 12-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (muscle pain). On an unknown date, the patient experienced ORAL HERPES (cold sores), LYMPHADENOPATHY (sore lymph nodes), CHILLS (chills) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sores), LYMPHADENOPATHY (sore lymph nodes), FATIGUE (Felt tired), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: cold sores; sore lymph nodes; chills; Headache; Fever; muscle pain; Felt tired; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (cold sores), PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (sore lymph nodes), FATIGUE (Felt tired) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired). On 12-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (muscle pain). On an unknown date, the patient experienced ORAL HERPES (cold sores), LYMPHADENOPATHY (sore lymph nodes), CHILLS (chills) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ORAL HERPES (cold sores), LYMPHADENOPATHY (sore lymph nodes), FATIGUE (Felt tired), PYREXIA (Fever), MYALGIA (muscle pain), CHILLS (chills) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: potential side effect from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (potential side effect from the vaccine) 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 15-Feb-2021, the patient experienced VACCINATION COMPLICATION (potential side effect from the vaccine). At the time of the report, VACCINATION COMPLICATION (potential side effect from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-May-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: follow-up received.No new information added
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Pain
Clinical narrative: Big red spot; Very very sore arm; Lost appetite; Very achy; Chills; Fatigue; Low grade fever; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm), DECREASED APPETITE (Lost appetite), ERYTHEMA (Big red spot), PAIN (Very achy) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (Lost appetite), PAIN (Very achy), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Very very sore arm) and ERYTHEMA (Big red spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very very sore arm), DECREASED APPETITE (Lost appetite), ERYTHEMA (Big red spot), PAIN (Very achy), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Big red spot; Very very sore arm; Lost appetite; Very achy; Chills; Fatigue; Low grade fever; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm), DECREASED APPETITE (Lost appetite), ERYTHEMA (Big red spot), PAIN (Very achy) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced DECREASED APPETITE (Lost appetite), PAIN (Very achy), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Very very sore arm) and ERYTHEMA (Big red spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very very sore arm), DECREASED APPETITE (Lost appetite), ERYTHEMA (Big red spot), PAIN (Very achy), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Paraesthesia oral, Pyrexia, Swollen tongue, Tongue pigmentation
Clinical narrative: A temperature 101 fever; Tongue felt different/ Not severe tongue issue; Tongue felt a bit bigger; Tongue color is greyish; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue felt different/ Not severe tongue issue), SWOLLEN TONGUE (Tongue felt a bit bigger), TONGUE PIGMENTATION (Tongue color is greyish) and PYREXIA (A temperature 101 fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tongue felt different/ Not severe tongue issue), SWOLLEN TONGUE (Tongue felt a bit bigger) and TONGUE PIGMENTATION (Tongue color is greyish). On 14-Feb-2021, the patient experienced PYREXIA (A temperature 101 fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Feb-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Tongue felt different/ Not severe tongue issue), SWOLLEN TONGUE (Tongue felt a bit bigger), TONGUE PIGMENTATION (Tongue color is greyish) and PYREXIA (A temperature 101 fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 101 High.         No concomitant medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information was added: Event outcome were updated from unknown to recovered as patient reported she is doing fine and declined consent for further follow up
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, SARS-CoV-2 test
Clinical narrative: Phlegm Continued post first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm Continued post first shot) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Phlegm (Patient states that he had phlegm since after Christmas (about 7 weeks prior to vaccination).).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRODUCTIVE COUGH (Phlegm Continued post first shot). The patient was treated with AZITHROMYCIN on 11-Feb-2021 for Phlegm, at a dose of 1 dosage form. At the time of the report, PRODUCTIVE COUGH (Phlegm Continued post first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative 7 weeks prior to the vaccination and negative (Negative) Negative 3 weeks prior to the vaccination.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's doctor prescribed Azithromycin on 11FEB2021  a day before vaccine, but patient did not take it because patient  thought it might interfere with the vaccine efficacy. No concomitant drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-Significant follow up : Address was updated. Email ID was added.; Sender's Comments: Based on the 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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus
Clinical narrative: its 3.5 inch red circle around injection; I got itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I got itchy arm) and INJECTION SITE ERYTHEMA (its 3.5 inch red circle around injection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN, AMLODIPINE, LEVOTHYROXINE, FOLIC ACID, ZINC, MAGNESIUM, POTASSIUM and VITAMIN B COMPLEX for an unknown indication, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL F), APPLE CIDER VINEGAR, ASCORBIC ACID, DOCOSAHEXAENOIC ACID, VITAMIN E NOS, XANTOFYL, ZEAXANTHIN, ZINC (OCUVITE MAX), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LOSARTAN, TAMSULOSIN, TERAZOSIN, ALLOPURINOL, TRAZODONE and HYDROCODONE.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (I got itchy arm). On 14-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (its 3.5 inch red circle around injection). At the time of the report, PRURITUS (I got itchy arm) and INJECTION SITE ERYTHEMA (its 3.5 inch red circle around injection) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (sore shoulder). At the time of the report, ARTHRALGIA (sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-015102 (E2B Linked Report).; Sender's Comments:  MOD-2021-015102:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lethargy, Myalgia, Vaccination site erythema
Clinical narrative: Swelling in his left armpit area; Soreness in the muscle area/ Tenderness in the muscle; Little lethargic; Pink; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Swelling in his left armpit area), MYALGIA (Soreness in the muscle area/ Tenderness in the muscle), LETHARGY (Little lethargic) and VACCINATION SITE ERYTHEMA (Pink) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history recorded.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (Swelling in his left armpit area), MYALGIA (Soreness in the muscle area/ Tenderness in the muscle), LETHARGY (Little lethargic) and VACCINATION SITE ERYTHEMA (Pink). At the time of the report, AXILLARY PAIN (Swelling in his left armpit area), MYALGIA (Soreness in the muscle area/ Tenderness in the muscle), LETHARGY (Little lethargic) and VACCINATION SITE ERYTHEMA (Pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.