chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Insomnia, Musculoskeletal discomfort, Nausea, Pain
Clinical narrative: Arm sore; Back hurt; Left hip felt weird and was hardly able to stand on it.; I am not sleeping; Panic attack; Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping) and PANIC ATTACK (Panic attack) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included LOSARTAN and PREDNISONE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information received on 07-Jul-2021 and does not contain any new information
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Panic attack
Clinical narrative: Arm sore; Back hurt; Left hip felt weird and was hardly able to stand on it.; I am not sleeping; Panic attack; Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping) and PANIC ATTACK (Panic attack) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included LOSARTAN and PREDNISONE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore), BACK PAIN (Back hurt), MUSCULOSKELETAL DISCOMFORT (Left hip felt weird and was hardly able to stand on it.), INSOMNIA (I am not sleeping), PANIC ATTACK (Panic attack), PAIN (Pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information received on 07-Jul-2021 and does not contain any new information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Neck pain
Clinical narrative: Pain in the neck and shoulder area; Pain in the neck and shoulder area; Diarrhea five days after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea five days after getting the vaccine), NECK PAIN (Pain in the neck and shoulder area) and ARTHRALGIA (Pain in the neck and shoulder area) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy (Patient have had a problem in the past with a medication administered in a colonoscopy procedure.). Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), IRBESARTAN, PARACETAMOL (TYLENOL), MONTELUKAST SODIUM (SINGULAIR), TAMSULOSIN, GUAIFENESIN (MUCINEX), METFORMIN and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DIARRHOEA (Diarrhea five days after getting the vaccine). On an unknown date, the patient experienced NECK PAIN (Pain in the neck and shoulder area) and ARTHRALGIA (Pain in the neck and shoulder area). At the time of the report, DIARRHOEA (Diarrhea five days after getting the vaccine), NECK PAIN (Pain in the neck and shoulder area) and ARTHRALGIA (Pain in the neck and shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No new information; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: Localized rash below injection site; Rash under site of injection; This spontaneous case was reported by a physician and describes the occurrence of RASH (Localized rash below injection site) and INJECTION SITE RASH (Rash under site of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE RASH (Rash under site of injection). On 22-Jan-2021, the patient experienced RASH (Localized rash below injection site). The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. On 23-Jan-2021, INJECTION SITE RASH (Rash under site of injection) had resolved. On 24-Jan-2021, RASH (Localized rash below injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Added event. Updated Address, age, route of administration, anatomical location. Added patient demographics.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Pain in extremity
Clinical narrative: pain in arm; diarrhoea; stomach pains; vomited; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 07-Dec-2020. Concomitant products included ATORVASTATIN, FLUOXETINE and AMOXICILLIN TRIHYDRATE (AMOXISOL) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. 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.   This case was linked to MOD-2021-133408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information was received on 15-MAY-2021, Additional information included onset date of medical history, updated additional events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: pain in arm; diarrhoea; stomach pains; vomited; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), DIARRHOEA (diarrhoea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited) and PYREXIA (fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 07-Dec-2020. Concomitant products included ATORVASTATIN, FLUOXETINE and AMOXICILLIN TRIHYDRATE (AMOXISOL) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomited), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) and DIARRHOEA (diarrhoea) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. 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.   This case was linked to MOD-2021-133408 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up information was received on 15-MAY-2021, Additional information included onset date of medical history, updated additional events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain in extremity
Clinical narrative: throat felt funny,felt like she had cotton in her throat; arm was very painful; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (throat felt funny,felt like she had cotton in her throat) and PAIN IN EXTREMITY (arm was very painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), BUPROPION, LORAZEPAM (ATIVAN), ZOLEDRONIC ACID (RECLAST), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), COLFORSIN, CURCUMA LONGA (TURMERIC + FORSKOLIN) and FOLIC ACID (FOLATE) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt funny,felt like she had cotton in her throat) and PAIN IN EXTREMITY (arm was very painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of unknown and PARACETAMOL (TYLENOL) at a dose of unknown. On 18-Jan-2021, OROPHARYNGEAL DISCOMFORT (throat felt funny,felt like she had cotton in her throat) had resolved. On 20-Jan-2021, PAIN IN EXTREMITY (arm was very painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Skin lesion, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included UTI, Heart valve replacement in June 2020 and Pacemaker insertion (cardiac) (Had pacemaker (left)) in June 2020. Concurrent medical conditions included AFib. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, DILTIAZEM for Cardiac valve disease, FUROSEMIDE (FUROSIMIDE) for Diuretic therapy, VITAMIN D [VITAMIN D NOS] for Supplementation therapy, ASCORBIC ACID, OLIGOMERIC PROANTHOCYANIDIN, VACCINIUM MACROCARPON (CRANBERRY CHOCOLATE) for Urinary tract infection.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-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 SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site). At the time of the report, SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Adverse event reporting form completed. Updated the reporter details and vaccination details. On 27-Jul-2021: Non-significant follow-up received. Best doctor/HCP contact detail updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Scar, Vaccination site pain, Vaccination site warmth
Clinical narrative: Rectangle on skin of right arm; Pain at injection site; Skin is hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Skin is hot to touch), SCAR (Rectangle on skin of right arm) and VACCINATION SITE PAIN (Pain at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Skin is hot to touch) and VACCINATION SITE PAIN (Pain at injection site). On 31-Jan-2021, the patient experienced SCAR (Rectangle on skin of right arm). On 01-Feb-2021, VACCINATION SITE WARMTH (Skin is hot to touch) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, SCAR (Rectangle on skin of right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were taken by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021 does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red bumpy rash that was warm to the touch at the injection site; Red bumpy rash that was warm to the touch at the injection site; Red bumpy rash that was warm to the touch at the injection site; Headache; Vaccination Site Rash; Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (30 years ago).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Vaccination Site Rash). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Vaccination Site Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Case comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up received captured reporter email address.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Red bumpy rash that was warm to the touch at the injection site; Red bumpy rash that was warm to the touch at the injection site; Red bumpy rash that was warm to the touch at the injection site; Headache; Vaccination Site Rash; Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (30 years ago).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced URTICARIA (Hives). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Vaccination Site Rash). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE PRURITUS (Red bumpy rash that was warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (Red bumpy rash that was warm to the touch at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Vaccination Site Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Case comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up received captured reporter email address.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pain in the injection arm; Pain in the neck; Pain in the Shoulder; Numbness of the Face; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder), HYPOAESTHESIA (Numbness of the Face) and INJECTION SITE PAIN (Pain in the injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Psoriasis. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder) and HYPOAESTHESIA (Numbness of the Face). On 02-Feb-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 26-Jan-2021, NECK PAIN (Pain in the neck), PAIN IN EXTREMITY (Pain in the Shoulder) and HYPOAESTHESIA (Numbness of the Face) had resolved. At the time of the report, INJECTION SITE PAIN (Pain in the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-248297 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received and contains information about 2nd dose, Concomitant medication was added and medical history was added.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Ear disorder, Hypokinesia, Nausea
Clinical narrative: Improper balance; Inner ear issue like improper balance; Nausea; Dizziness; Hard time moving; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Improper balance), DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving), EAR DISORDER (Inner ear issue like improper balance) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Walker user (Using a walker to prevent risk of fall) and Contrast media allergy (Contrast dye). Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), SOTALOL, WARFARIN, CALCIUM and MAGNESIUM for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving) and NAUSEA (Nausea). On 16-Jan-2021, the patient experienced BALANCE DISORDER (Improper balance) and EAR DISORDER (Inner ear issue like improper balance). On 16-Jan-2021, DIZZINESS (Dizziness), HYPOKINESIA (Hard time moving) and NAUSEA (Nausea) had resolved. At the time of the report, BALANCE DISORDER (Improper balance) and EAR DISORDER (Inner ear issue like improper balance) 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.   Treatment information include OTC Meclizine 35 mg: on empty stomach in AM of 10th January then after 25 mg on empty stomach in AM (changed dosage 5 days ago)   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: NNI
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Peripheral swelling, Throat irritation, Vomiting
Clinical narrative: arm hurt; vomiting; trouble getting her throat cleared; arm was a little red; arm was swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (arm hurt), VOMITING (vomiting), THROAT IRRITATION (trouble getting her throat cleared), ERYTHEMA (arm was a little red) and PERIPHERAL SWELLING (arm was swollen) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (arm hurt), VOMITING (vomiting), THROAT IRRITATION (trouble getting her throat cleared), ERYTHEMA (arm was a little red) and PERIPHERAL SWELLING (arm was swollen). The patient was treated with ONDANSETRON (ZOFRAN MELT) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 27-Jan-2021, VOMITING (vomiting) and THROAT IRRITATION (trouble getting her throat cleared) had resolved. On 30-Jan-2021, PAIN (arm hurt), ERYTHEMA (arm was a little red) and PERIPHERAL SWELLING (arm was swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash; Itchy; Swollen; Red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE SWELLING (Swollen), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Influenza like illness, Pain
Clinical narrative: Aches; weakness; loose stool; flu like symptoms; Not eating well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well). At the time of the report, PAIN (Aches), ASTHENIA (weakness), DIARRHOEA (loose stool), INFLUENZA LIKE ILLNESS (flu like symptoms) and DECREASED APPETITE (Not eating well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Heart rate abnormal
Clinical narrative: Dizzy; Erratic heart rate; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (almost to every antibiotic). Concomitant products included B-COMPLEX + VITAMIN C for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate). On 21-Jan-2021, DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 110/60 (normal) 110/60 on average. On an unknown date, Heart rate: 62 (normal) resting heart rate in bed is 62 beats per minute, 72 (normal) when moving around is usually about 72 beats per minute and When it (heart rate) was erratic it ranged from 40-83 beats per minute.     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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Followup received on 31-mar-2021. NNI
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia, Skin discolouration
Clinical narrative: Tingling Sensation; Black and Blue mark; Don't feel good; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling Sensation), SKIN DISCOLOURATION (Black and Blue mark) and FEELING ABNORMAL (Don't feel good) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, VITAMINS NOS for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling Sensation), SKIN DISCOLOURATION (Black and Blue mark) and FEELING ABNORMAL (Don't feel good). At the time of the report, PARAESTHESIA (Tingling Sensation), SKIN DISCOLOURATION (Black and Blue mark) and FEELING ABNORMAL (Don't feel good) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Email address of reporter updated.; 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: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm had welts; Arm was red; arm was itchy; arm was blotchy; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). On 26-Jan-2021, the patient experienced URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy). At the time of the report, PAIN IN EXTREMITY (My arm was sore), URTICARIA (Arm had welts), VACCINATION SITE ERYTHEMA (Arm was red), VACCINATION SITE PRURITUS (arm was itchy) and RASH MACULAR (arm was blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: The followup does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pruritus, Pyrexia, Vaccination site reaction
Clinical narrative: swelling up and down her arm; itchiness in her arm; heat in her arm; fever in her arm; moderate site reaction; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling up and down her arm), PRURITUS (itchiness in her arm), FEELING HOT (heat in her arm), VACCINATION SITE REACTION (moderate site reaction) and PYREXIA (fever in her arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 15-Jan-2021, the patient experienced VACCINATION SITE REACTION (moderate site reaction). On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling up and down her arm), PRURITUS (itchiness in her arm), FEELING HOT (heat in her arm) and PYREXIA (fever in her arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (swelling up and down her arm), PRURITUS (itchiness in her arm), FEELING HOT (heat in her arm), VACCINATION SITE REACTION (moderate site reaction) and PYREXIA (fever in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was provided by the reporter Other treatment information: ice   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up document is received on 08-JUN-2021 and it is NNI
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Vaccination site urticaria
Clinical narrative: got round and swollen, oval; itchy; developed big hives at the site of the injection, about a 3-inch welt; a little sore at the site when she touched it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little sore at the site when she touched it), PERIPHERAL SWELLING (got round and swollen, oval), PRURITUS (itchy) and VACCINATION SITE URTICARIA (developed big hives at the site of the injection, about a 3-inch welt) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Drug allergy (allergic to codeine). Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN and ERGOCALCIFEROL for Allergy, DESLORATADINE (CLARINEX [DESLORATADINE]), MONTELUKAST and TRIAMCINOLONE for Allergy NOS.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (a little sore at the site when she touched it). On 01-Feb-2021, the patient experienced PERIPHERAL SWELLING (got round and swollen, oval), PRURITUS (itchy) and VACCINATION SITE URTICARIA (developed big hives at the site of the injection, about a 3-inch welt). The patient was treated with DESLORATADINE (CLARINEX [DESLORATADINE]) at an unspecified dose and frequency; TRIAMCINOLONE at an unspecified dose and frequency and MONTELUKAST at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little sore at the site when she touched it), PERIPHERAL SWELLING (got round and swollen, oval), PRURITUS (itchy) and VACCINATION SITE URTICARIA (developed big hives at the site of the injection, about a 3-inch welt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants-Ergocalciferol, Triamcinolone Cream   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-june-2021 and does not contain any significant information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Limb discomfort, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Whole Upper arm red; Whole Upper arm itching; Upper arm harden; Sore at injection site; Upper arm swollen; Left upper arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site), VACCINATION SITE SWELLING (Upper arm swollen), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching) and VACCINATION SITE INDURATION (Upper arm harden) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension (Under Control) in 1975. Concurrent medical conditions included Drug allergy (Cephhalexin) since 05-Jun-2021. Concomitant products included ATENOLOL and CHLORTHALIDONE for Hypertension, OXYMETHOLONE (ANADROL) and LOSARTAN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Upper arm swollen) and LIMB DISCOMFORT (Left upper arm sore). On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching) and VACCINATION SITE INDURATION (Upper arm harden). The patient was treated with SERTRALINE HYDROCHLORIDE (ZEPHYR) (oral) from 27-Jan-2021 to 31-Jan-2021 for Vaccination site erythema, at a dose of 1 dosage form, 2/days and NAPROXEN SODIUM (ALEVE) (oral) on 27-Jan-2021 for Injection site reaction, at a dose of 1 dosage form, 4 /days. At the time of the report, VACCINATION SITE PAIN (Sore at injection site), VACCINATION SITE SWELLING (Upper arm swollen), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching), VACCINATION SITE INDURATION (Upper arm harden) and LIMB DISCOMFORT (Left upper arm sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 23 Jan 2021, left upper arm started getting sore in the afternoon.  On 24 Jan 2021 the left arm sore was worsening.  On 25 Jan 2021, the injection site area hardened and turned red and itchy.  On 27 Jan 2021, The patient called her doctor and was advised to take Zephyr and Aleve four times a day for five days as the symptoms disappeared.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-JUN-2021.Patient information Updated. Second dose information Updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Whole Upper arm red; Whole Upper arm itching; Upper arm harden; Sore at injection site; Upper arm swollen; Left upper arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site), VACCINATION SITE SWELLING (Upper arm swollen), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching) and VACCINATION SITE INDURATION (Upper arm harden) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension (Under Control) in 1975. Concurrent medical conditions included Drug allergy (Cephhalexin) since 05-Jun-2021. Concomitant products included ATENOLOL and CHLORTHALIDONE for Hypertension, OXYMETHOLONE (ANADROL) and LOSARTAN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Upper arm swollen) and LIMB DISCOMFORT (Left upper arm sore). On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching) and VACCINATION SITE INDURATION (Upper arm harden). The patient was treated with SERTRALINE HYDROCHLORIDE (ZEPHYR) (oral) from 27-Jan-2021 to 31-Jan-2021 for Vaccination site erythema, at a dose of 1 dosage form, 2/days and NAPROXEN SODIUM (ALEVE) (oral) on 27-Jan-2021 for Injection site reaction, at a dose of 1 dosage form, 4 /days. At the time of the report, VACCINATION SITE PAIN (Sore at injection site), VACCINATION SITE SWELLING (Upper arm swollen), INJECTION SITE ERYTHEMA (Whole Upper arm red), VACCINATION SITE PRURITUS (Whole Upper arm itching), VACCINATION SITE INDURATION (Upper arm harden) and LIMB DISCOMFORT (Left upper arm sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 23 Jan 2021, left upper arm started getting sore in the afternoon.  On 24 Jan 2021 the left arm sore was worsening.  On 25 Jan 2021, the injection site area hardened and turned red and itchy.  On 27 Jan 2021, The patient called her doctor and was advised to take Zephyr and Aleve four times a day for five days as the symptoms disappeared.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-JUN-2021.Patient information Updated. Second dose information Updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: chills; got hard; arm was puffy, swelled up very badly, and it got hard and red.; hurt when needle put in arm still sore; got red; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE INDURATION (got hard), VACCINATION SITE SWELLING (arm was puffy, swelled up very badly, and it got hard and red.), VACCINATION SITE PAIN (hurt when needle put in arm still sore), VACCINATION SITE ERYTHEMA (got red) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE INDURATION (got hard), VACCINATION SITE SWELLING (arm was puffy, swelled up very badly, and it got hard and red.), VACCINATION SITE PAIN (hurt when needle put in arm still sore) and VACCINATION SITE ERYTHEMA (got red). On 29-Jan-2021, the patient experienced CHILLS (chills). At the time of the report, VACCINATION SITE INDURATION (got hard), VACCINATION SITE SWELLING (arm was puffy, swelled up very badly, and it got hard and red.), VACCINATION SITE PAIN (hurt when needle put in arm still sore), VACCINATION SITE ERYTHEMA (got red) and CHILLS (chills) 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 relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Additional information received: Updated event outcome updated