chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: slightly swollen red rash on the site of the injection the size of her hand, not itchy; slightly swollen red rash on the site of the injection the size of her hand, not itchy; slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slightly swollen red rash on the site of the injection the size of her hand, not itchy), VACCINATION SITE ERYTHEMA (slightly swollen red rash on the site of the injection the size of her hand, not itchy) and VACCINATION SITE RASH (slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm) in a 78-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 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (slightly swollen red rash on the site of the injection the size of her hand, not itchy), VACCINATION SITE ERYTHEMA (slightly swollen red rash on the site of the injection the size of her hand, not itchy) and VACCINATION SITE RASH (slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm). At the time of the report, VACCINATION SITE SWELLING (slightly swollen red rash on the site of the injection the size of her hand, not itchy), VACCINATION SITE ERYTHEMA (slightly swollen red rash on the site of the injection the size of her hand, not itchy) and VACCINATION SITE RASH (slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  The patient's weight was provided as 168 (units not specified).  The rash on the patient's right arm, she was advised to take the second shot in her left dominant arm.  No treatment information was provided.   This case was linked to MOD-2021-227801 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient demographics were updated. Information was received stating the patient received her second dose. Action taken with suspect product was updated. Additional event information was provided. On 25-Jul-2021: No new information was received.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: Tonsillitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TONSILLITIS (Tonsillitis) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced TONSILLITIS (Tonsillitis). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) ongoing from 17-Feb-2021 for Tonsillitis, at an unspecified dose and frequency. At the time of the report, TONSILLITIS (Tonsillitis) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  The patient was additionally prescribed an unspecified antibacterial as treatment for the events. Treatment was not administered until approximately 8 hours after his second dose of mRNA-1273.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: soreness in muscles of left side of neck; Arm soreness; Slight Fever; Had some shivering; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (soreness in muscles of left side of neck), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Slight Fever) and CHILLS (Had some shivering) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced NECK PAIN (soreness in muscles of left side of neck), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Slight Fever) and CHILLS (Had some shivering). At the time of the report, NECK PAIN (soreness in muscles of left side of neck) had not resolved and PAIN IN EXTREMITY (Arm soreness), PYREXIA (Slight Fever) and CHILLS (Had some shivering) was resolving.            No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: He only has arm soreness; He got a good reaction / After getting the shot he is not using cane; This spontaneous case was reported by a respiratory therapist (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (He only has arm soreness) and THERAPEUTIC RESPONSE UNEXPECTED (He got a good reaction / After getting the shot he is not using cane) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis, Osteoarthritis and Cane user. Concomitant products included HYDROCODONE, GABAPENTIN, CLONAZEPAM (KLONOPIN), IBUPROFEN, VITAMIN D3 and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (He only has arm soreness) and THERAPEUTIC RESPONSE UNEXPECTED (He got a good reaction / After getting the shot he is not using cane). At the time of the report, PAIN IN EXTREMITY (He only has arm soreness) and THERAPEUTIC RESPONSE UNEXPECTED (He got a good reaction / After getting the shot he is not using cane) 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 was reported for the event of arm soreness.   This case was linked to MOD-2021-089572 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Vaccination complication, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Warm to the touch; Tenderness; Itchy is getting worse, looks like pink points at the injection site; Swollen; Red; Minor reaction to the vaccine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor reaction to the vaccine), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness) and VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site) in a 70-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.     Concomitant products included BERBERINE, ACETYLSALICYLIC ACID (ASPIRIN 81), CHOLESTEROL and AMLODIPINE for an unknown indication.    On 09-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 PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (Minor reaction to the vaccine), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness), VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION COMPLICATION (Minor reaction to the vaccine), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness), VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was provided blood pressure pills but not coded No laboratory was provided by the reporter. Treatment information not available.   This case was linked to MOD-2021-240189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-JUN-2021 and it does not contain any new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch; Tenderness; Itchy is getting worse, looks like pink points at the injection site; Swollen; Red; Minor reaction to the vaccine; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor reaction to the vaccine), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness) and VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site) in a 70-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.     Concomitant products included BERBERINE, ACETYLSALICYLIC ACID (ASPIRIN 81), CHOLESTEROL and AMLODIPINE for an unknown indication.    On 09-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 PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (Minor reaction to the vaccine), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness), VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION COMPLICATION (Minor reaction to the vaccine), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to the touch), TENDERNESS (Tenderness), VACCINATION SITE DISCOLOURATION (Itchy is getting worse, looks like pink points at the injection site), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was provided blood pressure pills but not coded No laboratory was provided by the reporter. Treatment information not available.   This case was linked to MOD-2021-240189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received on 29-JUN-2021 and it does not contain any new information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Warmness to the injection site; Redness to the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warmness to the injection site) and VACCINATION SITE ERYTHEMA (Redness to the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 11-Feb-2021.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness to the injection site) and VACCINATION SITE ERYTHEMA (Redness to the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness to the injection site) and VACCINATION SITE ERYTHEMA (Redness to the injection site) outcome was unknown.        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 details included.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on lower back and hives on buttocks; A spontaneous report was received from a 66-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on lower back and on buttocks.  The patients' medical history was not reported. The information about patients concomitant medication was not reported.    On 14-Feb-2021, prior to the onset of the events hives on lower back and on buttocks, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route in unknown anatomical location for prophylaxis of COVID-19 infection.  On 15-Feb-2021, the patient experienced events hives on lower back and on buttocks. The patient informed that hives only lasted a few hours. The information about the treatment was not provided.  Laboratory details was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events hives on lower back and on buttocks was as resolved on 15-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 event, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash pruritic
Clinical narrative: Bruising was starting to form from the scratching; Itching / Rash with an itch on lower extremities; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itching / Rash with an itch on lower extremities) and CONTUSION (Bruising was starting to form from the scratching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. M0D012M0A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Urticaria (Autoimmune urticarial (skin infections)), Drug allergy (sulfa, most antibiotics and codeine), Latex allergy, Gastroparesis, COPD, Coronary artery disease, Hypercholesterolaemia and Skin infection. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal, DUPILUMAB (DUPIXENT) for COPD, Eosinophilia and Urticaria, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METOPROLOL TARTRATE and LOSARTAN for Coronary artery disease.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced RASH PRURITIC (Itching / Rash with an itch on lower extremities). On an unknown date, the patient experienced CONTUSION (Bruising was starting to form from the scratching). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE) for Itchy rash, at a dose of UNK dosage form; DIPHENHYDRAMINE for Itchy rash, at a dose of UNK dosage form and METHYLPREDNISOLONE (MEDROL DOSEPAK) for Itchy rash, at a dose of UNK dosage form. On 22-Feb-2021, RASH PRURITIC (Itching / Rash with an itch on lower extremities) had resolved. At the time of the report, CONTUSION (Bruising was starting to form from the scratching) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient developed a rash with an itch on her lower extremities about 48 hours after vaccination. After a few days of scratching bruising started to form. The patient contacted her dermatologist and requested treatment with prednisone but her dermatologist denied to prescribe the drug due to a contraindication with the vaccine and instead recommended treatment with levocetrizine and diphenhydramine. When that regimen did not work the patient presented to her general practitioner and was prescribed Medrol-dosepak and the symptoms resolved.   This case was linked to MOD-2021-089738 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Added second dosage details. On 26-Apr-2021: Added patient demographics, medical history and concomitant medications, event, treatment medication and updated second dosage details. On 21-Jun-2021: No new information was received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache
Clinical narrative: Bad cough / hard and deep cough; Headache / slight headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough / hard and deep cough) and HEADACHE (Headache / slight headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache / slight headache). On 17-Feb-2021, the patient experienced COUGH (Bad cough / hard and deep cough). The patient was treated with PARACETAMOL (TYLENOL RAPID RELEASE GELS) for Headache, at an unspecified dose and frequency. At the time of the report, COUGH (Bad cough / hard and deep cough) and HEADACHE (Headache / slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Additional information received: The patient had declined further follow-up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.    Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: itches; Rash; red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itches), RASH (Rash) and ERYTHEMA (red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, 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 experienced PRURITUS (itches), RASH (Rash) and ERYTHEMA (red). At the time of the report, PRURITUS (itches), RASH (Rash) and ERYTHEMA (red) outcome was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: weakness; fever; fatigue; chill; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chill) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chill). At the time of the report, ASTHENIA (weakness), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event nausea.  Treatment details included peppermint tea.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, nausea was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site swelling, Pain in extremity, Vaccination site erythema, Vaccination site mass
Clinical narrative: Red spot she can still see at injection site; Hand hurting; lightheaded; bump at injection site; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hand hurting), DIZZINESS (lightheaded), INJECTION SITE SWELLING (injection site swelling), VACCINATION SITE MASS (bump at injection site) and VACCINATION SITE ERYTHEMA (Red spot she can still see at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included METFORMIN and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Diabetes.    On 06-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 PAIN IN EXTREMITY (Hand hurting), DIZZINESS (lightheaded), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (bump at injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot she can still see at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Hand pain, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Hand hurting), DIZZINESS (lightheaded), INJECTION SITE SWELLING (injection site swelling) and VACCINATION SITE MASS (bump at injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (Red spot she can still see at injection site) had not 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.   As additional treatment for the events, the patient applied a cold compress to the vaccination site.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in left non dominant arm for prophylaxis of COVID-19 infection.  On last Friday(05 Feb 2021) or saturday, the patient experienced the event shingles.It still continues. They are starting to alleviate a little bit. I had the pain and then they started to come out open. Consent given Treatment information was include valacyclovir.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, shingles was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: painful site of injection; rash on the site of injection; Headache; swelling site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling site of injection), VACCINATION SITE PAIN (painful site of injection), VACCINATION SITE RASH (rash on the site of injection) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE, ROSUVASTATIN, CALCIUM, CHLORTHALIDON, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), UBIDECARENONE (COENZYME Q-GEL) and MAGNESIUM for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling site of injection). On an unknown date, the patient experienced VACCINATION SITE PAIN (painful site of injection), VACCINATION SITE RASH (rash on the site of injection) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling site of injection), VACCINATION SITE RASH (rash on the site of injection) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE PAIN (painful site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye swelling, Pain in extremity
Clinical narrative: Eye swelling in her right eye; Some pain in her arm; Eye was goopy; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling in her right eye), PAIN IN EXTREMITY (Some pain in her arm) and EYE DISCHARGE (Eye was goopy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06M20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 17-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 EYE SWELLING (Eye swelling in her right eye), PAIN IN EXTREMITY (Some pain in her arm) and EYE DISCHARGE (Eye was goopy). At the time of the report, EYE SWELLING (Eye swelling in her right eye), PAIN IN EXTREMITY (Some pain in her arm) and EYE DISCHARGE (Eye was goopy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  Treatment details included Compress, eye drops, ice and Tylenol.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Maternal exposure during pregnancy, Myalgia, Pain in extremity
Clinical narrative: Arm hurts; Fever of 101.5 to 101.6; Muscle pain; Really bad headache; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache). On 17-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: increased (High) Fever between 101.5 to 101.6 degrees.         No concomitant medications were reported. No treatment information was reported.  It was reported that patient received the first dose of mRNA-1273 on or around 17 Jan 2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm hurts; Fever of 101.5 to 101.6; Muscle pain; Really bad headache; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache). On 17-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: increased (High) Fever between 101.5 to 101.6 degrees.         No concomitant medications were reported. No treatment information was reported.  It was reported that patient received the first dose of mRNA-1273 on or around 17 Jan 2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). The patient was treated with DIETHYLAMINE SALICYLATE, METHYL NICOTINATE (ASPERCREME [DIETHYLAMINE SALICYLATE;METHYL NICOTINATE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Treatment medications also included: Bio-freeze and bengay cream.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received: Updated event outcome to recovered. Patient had declined further follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: Hardness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 11-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 INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications on use were also not provided No treatment information was provided
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Taste loss, Constipation, Hemorrhage and Bladder disorder NOS. Concomitant products included PLANTAGO OVATA (METAMUCIL CITRON) 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 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-015720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received: Updated second dose details, medical history and concomitant medication.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Nausea, Oropharyngeal discomfort
Clinical narrative: scratchy sore throat no swelling; Difficulty swallowing due to sore throat; Nausea; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, scratchy sore throat no swelling, difficulty swallowing due to sore throat.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event nausea, scratchy sore throat no swelling, difficulty swallowing due to sore throat.Practice Administrator did not provide any patient identifiers or contact information.Administrator was calling for her sister-in-law who was experiencing these symptoms. Vaccination was not given at their  clinic; did not have any other information. Told practice administrator to refer patient to HCP if symptoms continue or worsen. Administrator denied information in writing.Administrator does not want follow-up with Safety.  Treatment details included acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events nausea, scratchy sore throat no swelling, difficulty swallowing due to sore throat was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site reaction, Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm  soreness), INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE URTICARIA (Injection site hives) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm  soreness). On 03-Jan-2021, the patient experienced INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE URTICARIA (Injection site hives), VACCINATION SITE INDURATION (Injection site induration) and VACCINATION SITE ERYTHEMA (Injection site redness). On 26-Dec-2020, PAIN IN EXTREMITY (Arm  soreness) had resolved. At the time of the report, INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE URTICARIA (Injection site hives), VACCINATION SITE INDURATION (Injection site induration) and VACCINATION SITE ERYTHEMA (Injection site redness) 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 were provided by the reporter. Patient was instructed to use Benadryl cream or over the counter anti-histamine to treat the events.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm  soreness), INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE URTICARIA (Injection site hives) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm  soreness). On 03-Jan-2021, the patient experienced INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE URTICARIA (Injection site hives), VACCINATION SITE INDURATION (Injection site induration) and VACCINATION SITE ERYTHEMA (Injection site redness). On 26-Dec-2020, PAIN IN EXTREMITY (Arm  soreness) had resolved. At the time of the report, INJECTION SITE REACTION (Delayed injection site reaction), INJECTION SITE BRUISING (Bruise at injection site), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE URTICARIA (Injection site hives), VACCINATION SITE INDURATION (Injection site induration) and VACCINATION SITE ERYTHEMA (Injection site redness) 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 were provided by the reporter. Patient was instructed to use Benadryl cream or over the counter anti-histamine to treat the events.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: Heart rate gone upto 112; Fatigue; Myalgia in extremities; Low grade fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Myalgia in extremities), PYREXIA (Low grade fever) and HEART RATE INCREASED (Heart rate gone upto 112) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included AFib.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Myalgia in extremities) and PYREXIA (Low grade fever). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate gone upto 112). At the time of the report, FATIGUE (Fatigue), MYALGIA (Myalgia in extremities), PYREXIA (Low grade fever) and HEART RATE INCREASED (Heart rate gone upto 112) had not 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 relevant concomitant medications were reported.    No treatment information was provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: The injection area is itchy; The injection area is red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (The injection area is itchy) and INJECTION SITE ERYTHEMA (The injection area is red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.  Concomitant products included VITAMIN D NOS, LISINOPRIL and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE PRURITUS (The injection area is itchy) and INJECTION SITE ERYTHEMA (The injection area is red). At the time of the report, INJECTION SITE PRURITUS (The injection area is itchy) and INJECTION SITE ERYTHEMA (The injection area is red) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information received: Patient took second dose of vaccine, outcome of event updated from unknown to recovered and patient had declined further follow-up
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Slight headache; A spontaneous report was received from a healthcare professional concerning a 69-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, slight headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events chills, slight headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable. On 18 Feb 2021 the outcome of events, chills was resolved. The outcome of events, slight headache was unresolved, still ongoing.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. Patient gave consent to follow up given.  On 29 Jan 2021, the patient experienced the events sore arm at injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm at injection site was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, 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 experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       This case was linked to MOD-2021-015815 (Patient Link).; Reporter'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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dry mouth, Headache, Myalgia
Clinical narrative: Dry mouth; Diarrhea; Sleepy; Joint aches and pain; Headache; joint aches and pain; A spontaneous report (United States) was received from a consumer concerning a 44-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dry mouth, diarrhea, sleepy, joint aches and pain, headache.  The patient's medical history was not provided. Concomitant medications reported were laxatives for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the events dry mouth,diarrhea, sleepy, joint aches and pain, headache. Consent given to follow up No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 16 Feb 2021 the outcome of events, joint aches and pain was resolved. The outcome of events, dry mouth, diarrhea, sleepy, headache were unknown.