chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Pyrexia, Vaccination site cellulitis, Vaccination site erythema
Clinical narrative: Mouth dry; Looked like cellulitis; Fever; red at the injection site; Pain at the injection site; fatigue; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Looked like cellulitis), DRY MOUTH (Mouth dry), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's thyroiditis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Looked like cellulitis), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (red at the injection site). On 20-Jan-2021, the patient experienced DRY MOUTH (Mouth dry). On 10-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (fatigue) had resolved. On 24-Jan-2021, VACCINATION SITE CELLULITIS (Looked like cellulitis) and VACCINATION SITE ERYTHEMA (red at the injection site) had resolved. At the time of the report, DRY MOUTH (Mouth dry) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included clindamycin for cellulitis.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mouth dry; Looked like cellulitis; Fever; red at the injection site; Pain at the injection site; fatigue; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Looked like cellulitis), DRY MOUTH (Mouth dry), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (red at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's thyroiditis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (fatigue). On 17-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Looked like cellulitis), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (red at the injection site). On 20-Jan-2021, the patient experienced DRY MOUTH (Mouth dry). On 10-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) and FATIGUE (fatigue) had resolved. On 24-Jan-2021, VACCINATION SITE CELLULITIS (Looked like cellulitis) and VACCINATION SITE ERYTHEMA (red at the injection site) had resolved. At the time of the report, DRY MOUTH (Mouth dry) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included clindamycin for cellulitis.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site rash warm to touch; injection site swelling; Injection site red; Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site rash warm to touch), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site rash warm to touch), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE WARMTH (Injection site rash warm to touch), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot on Injection site; Red patch on arm; vaccination site swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache occurring.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injected limb mobility decreased, Injection site bruising, Pain in extremity, Peripheral swelling
Clinical narrative: Bruise at injection site; Feels fatigued; Developed fever of 99 degrees; Unbearable itch at injection site; Injection site was swollen about the size of golf ball; Injection site was red; Injection site hurt extremly bad; Injection site was hot; Lost grip strength in right hand; Right arm was hurting; Neck swelling on right side; Right arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side), VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand) and INJECTION SITE BRUISING (Bruise at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side) and PERIPHERAL SWELLING (Right arm was swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand), VACCINATION SITE SWELLING (Injection site was swollen about the size of golf ball), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site hurt extremly bad). On 16-Jan-2021, the patient experienced PYREXIA (Developed fever of 99 degrees) and VACCINATION SITE PRURITUS (Unbearable itch at injection site). On 17-Jan-2021, the patient experienced FATIGUE (Feels fatigued). On 19-Jan-2021, the patient experienced INJECTION SITE BRUISING (Bruise at injection site). At the time of the report, PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side), VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand), INJECTION SITE BRUISING (Bruise at injection site), PERIPHERAL SWELLING (Right arm was swollen), VACCINATION SITE SWELLING (Injection site was swollen about the size of golf ball), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE PAIN (Injection site hurt extremly bad), PYREXIA (Developed fever of 99 degrees), VACCINATION SITE PRURITUS (Unbearable itch at injection site) and FATIGUE (Feels fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was taken by the patient and was reported as follows :Benadryl, Advil, Ice, Hydrocortisone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Bruise at injection site; Feels fatigued; Developed fever of 99 degrees; Unbearable itch at injection site; Injection site was swollen about the size of golf ball; Injection site was red; Injection site hurt extremly bad; Injection site was hot; Lost grip strength in right hand; Right arm was hurting; Neck swelling on right side; Right arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side), VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand) and INJECTION SITE BRUISING (Bruise at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side) and PERIPHERAL SWELLING (Right arm was swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand), VACCINATION SITE SWELLING (Injection site was swollen about the size of golf ball), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site hurt extremly bad). On 16-Jan-2021, the patient experienced PYREXIA (Developed fever of 99 degrees) and VACCINATION SITE PRURITUS (Unbearable itch at injection site). On 17-Jan-2021, the patient experienced FATIGUE (Feels fatigued). On 19-Jan-2021, the patient experienced INJECTION SITE BRUISING (Bruise at injection site). At the time of the report, PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side), VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand), INJECTION SITE BRUISING (Bruise at injection site), PERIPHERAL SWELLING (Right arm was swollen), VACCINATION SITE SWELLING (Injection site was swollen about the size of golf ball), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE PAIN (Injection site hurt extremly bad), PYREXIA (Developed fever of 99 degrees), VACCINATION SITE PRURITUS (Unbearable itch at injection site) and FATIGUE (Feels fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was taken by the patient and was reported as follows :Benadryl, Advil, Ice, Hydrocortisone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Bruise at injection site; Feels fatigued; Developed fever of 99 degrees; Unbearable itch at injection site; Injection site was swollen about the size of golf ball; Injection site was red; Injection site hurt extremly bad; Injection site was hot; Lost grip strength in right hand; Right arm was hurting; Neck swelling on right side; Right arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side), VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand) and INJECTION SITE BRUISING (Bruise at injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side) and PERIPHERAL SWELLING (Right arm was swollen). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand), VACCINATION SITE SWELLING (Injection site was swollen about the size of golf ball), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE PAIN (Injection site hurt extremly bad). On 16-Jan-2021, the patient experienced PYREXIA (Developed fever of 99 degrees) and VACCINATION SITE PRURITUS (Unbearable itch at injection site). On 17-Jan-2021, the patient experienced FATIGUE (Feels fatigued). On 19-Jan-2021, the patient experienced INJECTION SITE BRUISING (Bruise at injection site). At the time of the report, PAIN IN EXTREMITY (Right arm was hurting), SWELLING (Neck swelling on right side), VACCINATION SITE WARMTH (Injection site was hot), INJECTED LIMB MOBILITY DECREASED (Lost grip strength in right hand), INJECTION SITE BRUISING (Bruise at injection site), PERIPHERAL SWELLING (Right arm was swollen), VACCINATION SITE SWELLING (Injection site was swollen about the size of golf ball), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE PAIN (Injection site hurt extremly bad), PYREXIA (Developed fever of 99 degrees), VACCINATION SITE PRURITUS (Unbearable itch at injection site) and FATIGUE (Feels fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was taken by the patient and was reported as follows :Benadryl, Advil, Ice, Hydrocortisone cream.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Occasional accelerated heart rate; Swollen left axillary lymph node; Injection site warmth; Injection site itchiness; Injection site swelling; Injection site redness; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Occasional accelerated heart rate), VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE SWELLING (Injection site swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness). On 15-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen left axillary lymph node). On 16-Jan-2021, the patient experienced HEART RATE INCREASED (Occasional accelerated heart rate). On 19-Jan-2021, HEART RATE INCREASED (Occasional accelerated heart rate), VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE LYMPHADENOPATHY (Swollen left axillary lymph node) had resolved.        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 concomitant medications were provided. No treatment information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Occasional accelerated heart rate; Swollen left axillary lymph node; Injection site warmth; Injection site itchiness; Injection site swelling; Injection site redness; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Occasional accelerated heart rate), VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE SWELLING (Injection site swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness). On 15-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen left axillary lymph node). On 16-Jan-2021, the patient experienced HEART RATE INCREASED (Occasional accelerated heart rate). On 19-Jan-2021, HEART RATE INCREASED (Occasional accelerated heart rate), VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE LYMPHADENOPATHY (Swollen left axillary lymph node) had resolved.        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 concomitant medications were provided. No treatment information provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SERTRALINE 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 SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) 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.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pruritus
Clinical narrative: rash like little spots and lightly pink; itchy at times; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash like little spots and lightly pink) and PRURITUS (itchy at times) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced INJECTION SITE RASH (rash like little spots and lightly pink) and PRURITUS (itchy at times). At the time of the report, INJECTION SITE RASH (rash like little spots and lightly pink) and PRURITUS (itchy at times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia
Clinical narrative: excruciating and debilitating low back pain; chills for about 10 hrs; body aches for about 10 hrs; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (excruciating and debilitating low back pain), CHILLS (chills for about 10 hrs) and MYALGIA (body aches for about 10 hrs) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced BACK PAIN (excruciating and debilitating low back pain), CHILLS (chills for about 10 hrs) and MYALGIA (body aches for about 10 hrs). At the time of the report, BACK PAIN (excruciating and debilitating low back pain), CHILLS (chills for about 10 hrs) and MYALGIA (body aches for about 10 hrs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: hard time trying to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time trying to sleep) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (hard time trying to sleep). At the time of the report, INSOMNIA (hard time trying to sleep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient takes medication for allergies.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal
Clinical narrative: rapid heart beat all day long; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (rapid heart beat all day long) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 HEART RATE ABNORMAL (rapid heart beat all day long). At the time of the report, HEART RATE ABNORMAL (rapid heart beat all day long) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Type IV hypersensitivity reaction, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Delayed hypersensitivity reaction in his right shoulder; A lot of itching; Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction in his right shoulder), PRURITUS (A lot of itching), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (The patient reports that he takes eye drops for his glaucoma.). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction in his right shoulder), PRURITUS (A lot of itching), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). The patient was treated with DIPHENHYDRAMINE HCL at an unspecified dose and frequency. At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction in his right shoulder), PRURITUS (A lot of itching), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness at the injection site; Burning and painful rash of 6 inches long and 4inches wide at the injection site; Sore armpit; Redness at the injection site; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Burning and painful rash of 6 inches long and 4inches wide at the injection site), AXILLARY PAIN (Sore armpit), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Burning and painful rash of 6 inches long and 4inches wide at the injection site), AXILLARY PAIN (Sore armpit) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Burning and painful rash of 6 inches long and 4inches wide at the injection site), AXILLARY PAIN (Sore armpit), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included antihistamine.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site not hot, but warm; Injection site swollen, 1x3inches in size; Injection site not red, but medium pink; slightly tender when touches it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swollen, 1x3inches in size), VACCINATION SITE ERYTHEMA (Injection site not red, but medium pink), VACCINATION SITE WARMTH (Injection site not hot, but warm) and VACCINATION SITE PAIN (slightly tender when touches it) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Cholesterol and Acid reflux (oesophageal). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), CORTICOSTEROIDS for COPD, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Cholesterol, ERGOCALCIFEROL (CALCIFEROL VIT D) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen, 1x3inches in size), VACCINATION SITE ERYTHEMA (Injection site not red, but medium pink), VACCINATION SITE WARMTH (Injection site not hot, but warm) and VACCINATION SITE PAIN (slightly tender when touches it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Injection site swollen, 1x3inches in size), VACCINATION SITE ERYTHEMA (Injection site not red, but medium pink), VACCINATION SITE WARMTH (Injection site not hot, but warm) and VACCINATION SITE PAIN (slightly tender when touches it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site is itchy; Injection site is slightly swollen; Little stiff arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Little stiff arm), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is slightly swollen) 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 the reporter.     On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Little stiff arm). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is slightly swollen). At the time of the report, MUSCULOSKELETAL STIFFNESS (Little stiff arm) had resolved and VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Slight low grade fever; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-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 PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 18-Jan-2021, PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Pyrexia, Vaccination site pain
Clinical narrative: severe intestinal cramping; Slight low grade fever; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe intestinal cramping), PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-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 ABDOMINAL PAIN (severe intestinal cramping), PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with ACETAMINOPHEN for Slight fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (severe intestinal cramping) outcome was unknown and PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: erratic heart rate; elevated heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE IRREGULAR (erratic heart rate) and HEART RATE INCREASED (elevated heart rate) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HEART RATE IRREGULAR (erratic heart rate) and HEART RATE INCREASED (elevated heart rate). At the time of the report, HEART RATE IRREGULAR (erratic heart rate) and HEART RATE INCREASED (elevated heart rate) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Diarrhoea
Clinical narrative: loss weight; diarrhea; loss of appetite; joint pain; slight fever; chills; feeling sluggy; coughing; could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), WEIGHT DECREASED (loss weight) and DIARRHOEA (diarrhea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ARTHRALGIA (joint pain), PYREXIA (slight fever) and CHILLS (chills). On an unknown date, the patient experienced WEIGHT DECREASED (loss weight). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), WEIGHT DECREASED (loss weight), DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ARTHRALGIA (joint pain), PYREXIA (slight fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pyrexia, Sluggishness, Weight decreased
Clinical narrative: loss weight; diarrhea; loss of appetite; joint pain; slight fever; chills; feeling sluggy; coughing; could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), WEIGHT DECREASED (loss weight) and DIARRHOEA (diarrhea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ARTHRALGIA (joint pain), PYREXIA (slight fever) and CHILLS (chills). On an unknown date, the patient experienced WEIGHT DECREASED (loss weight). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (feeling sluggy), COUGH (coughing), GAIT DISTURBANCE (could barely walk), WEIGHT DECREASED (loss weight), DIARRHOEA (diarrhea), DECREASED APPETITE (loss of appetite), ARTHRALGIA (joint pain), PYREXIA (slight fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness on the injection site). At the time of the report, INJECTION SITE PAIN (soreness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Pain, Pyrexia
Clinical narrative: shortness of breath; fever; body aches; bad fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (bad fatigue), CHILLS (chills), PYREXIA (fever), PAIN (body aches) and DYSPNOEA (shortness of breath) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and OMEPRAZOLE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHILLS (chills). On 14-Jan-2021, the patient experienced FATIGUE (bad fatigue). On 15-Jan-2021, the patient experienced PYREXIA (fever) and PAIN (body aches). On 17-Jan-2021, the patient experienced DYSPNOEA (shortness of breath). On 15-Jan-2021, FATIGUE (bad fatigue) had resolved. On 16-Jan-2021, PAIN (body aches) had resolved. On 17-Jan-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol and Ibuprofen.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red marks and a spot around the injection site; A spontaneous report was received from a 54 year old male patient, who received  Moderna's covid 19 vaccine (mRNA-1273) and experienced red mark and a spot around the injection site. They are getting bigger and bigger.   The patient has previous medical history of high blood pressure and high cholesterol. Concomitant medications were reported.    On 06 Jan 2021 prior to the onset of event, the patient received first of two planned doses of mRNA-1273 (Batch NO:041LZ0A ) injection on left upper arm for prophylaxis of covid 19 infection.  On 17 Jan the patient experienced red marks and a spot around the injection site. They are getting bigger and bigger. Denies allergies.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  Outcome of the event, red marks and a spot around the injection site,  unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Tremor, Vaccination site induration
Clinical narrative: sore arm; swelling at injection site; it was hard; horrible headache, from shoulder to base of neck to other shoulder; Felt really tired; feeling really cold; woke up shaking; A spontaneous report was received from a Consumer concerning a 70  Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced , sore arm, shaking and feeling really cold, headache from shoulder to base of neck to other shoulder, tired, swelling at injection site and it was hard.               The patient's medical history included Blood pressure and high cholesterol. The concomitant medications taken by the patient, for unspecified indications, levothyroxine, metoprolol, Torvavastin, omeprazole and baby aspirin.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced sore arm, horrible headache from shoulder to base of neck to the shoulder, shaking and feeling really cold, swelling at the injection site. Patient treated with Tylenol. Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event(s) (sore arm, headaches, swelling at injection site, shaking and feeling cold, injection site pain) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: sore arm; swelling at injection site; it was hard; horrible headache, from shoulder to base of neck to other shoulder; Felt really tired; feeling really cold; woke up shaking; A spontaneous report was received from a Consumer concerning a 70  Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced , sore arm, shaking and feeling really cold, headache from shoulder to base of neck to other shoulder, tired, swelling at injection site and it was hard.               The patient's medical history included Blood pressure and high cholesterol. The concomitant medications taken by the patient, for unspecified indications, levothyroxine, metoprolol, Torvavastin, omeprazole and baby aspirin.  On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced sore arm, horrible headache from shoulder to base of neck to the shoulder, shaking and feeling really cold, swelling at the injection site. Patient treated with Tylenol. Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event(s) (sore arm, headaches, swelling at injection site, shaking and feeling cold, injection site pain) was unknown.