chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Still feel the injection; Red; Lumpy; Warm to touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Still feel the injection), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Lumpy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM, LEVOTHYROXINE, OMEPRAZOLE, ATORVASTATIN, DOCUSATE SODIUM (COL RITE STOOL SOFTENER), NIFEDIPINE, CELECOXIB (CELEBREX), GINKGO BILOBA (GINGKO BILOBA), PREDNISONE and FLUTICASONE FUROATE (ARNUITY ELLIPTA) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Lumpy). On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Still feel the injection). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Still feel the injection), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Lumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site warmth
Clinical narrative: soreness initially; arm was very very hot to the touch; very very sore; nausea; fever; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness initially), VACCINATION SITE WARMTH (arm was very very hot to the touch), PAIN (very very sore), NAUSEA (nausea) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (soreness initially), VACCINATION SITE WARMTH (arm was very very hot to the touch), PAIN (very very sore), NAUSEA (nausea), PYREXIA (fever) and PAIN (pain). At the time of the report, PAIN (soreness initially), VACCINATION SITE WARMTH (arm was very very hot to the touch), PAIN (very very sore), NAUSEA (nausea), PYREXIA (fever) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate going fast about 105 for about an hour; This spontaneous case was reported by a nurse and describes the occurrence of HEART RATE INCREASED (heart rate going fast about 105 for about an hour) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEART RATE INCREASED (heart rate going fast about 105 for about an hour). At the time of the report, HEART RATE INCREASED (heart rate going fast about 105 for about an hour) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Heart rate: 105 (High) 105.     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 medication was provided by the reporter. No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Pain in extremity, Skin burning sensation
Clinical narrative: Sore arm with no rash on it; severe burning on skin with no rash; pain in lower left abdomen, mild and persistent stomachache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm with no rash on it), ABDOMINAL PAIN LOWER (pain in lower left abdomen, mild and persistent stomachache) and SKIN BURNING SENSATION (severe burning on skin with no rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Previously administered products included for an unreported indication: shingles vaccine (She had Shingles vaccine 5 and 2 years ago. She experienced not a unique reaction, after the first dose of the two series shingles vaccine and two years ago.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with no rash on it), ABDOMINAL PAIN LOWER (pain in lower left abdomen, mild and persistent stomachache) and SKIN BURNING SENSATION (severe burning on skin with no rash). At the time of the report, PAIN IN EXTREMITY (Sore arm with no rash on it) and ABDOMINAL PAIN LOWER (pain in lower left abdomen, mild and persistent stomachache) had resolved and SKIN BURNING SENSATION (severe burning on skin with no rash) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant medication included an unspecified antidepressant.  Patient did not took any treatment for the events.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia, Oedema, Product dose omission issue
Clinical narrative: Did not get second dose; Edema in right foot; Generalized arthralgia/every joint in bodyis painful and difficult; Cannot floss teeth/cannot pour coffee from carafe/cannot drive car; Muscle soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get second dose), OEDEMA (Edema in right foot), MALAISE (Cannot floss teeth/cannot pour coffee from carafe/cannot drive car), MYALGIA (Muscle soreness in left arm) and ARTHRALGIA (Generalized arthralgia/every joint in bodyis painful and difficult) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 399043L20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, LOSARTAN, FISH OIL, COLECALCIFEROL (VITAMIN D 3) and COENZYME Q10 [UBIDECARENONE] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MALAISE (Cannot floss teeth/cannot pour coffee from carafe/cannot drive car) and MYALGIA (Muscle soreness in left arm). On 13-Feb-2021, the patient experienced OEDEMA (Edema in right foot) and ARTHRALGIA (Generalized arthralgia/every joint in bodyis painful and difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 13-Feb-2021, MALAISE (Cannot floss teeth/cannot pour coffee from carafe/cannot drive car) and MYALGIA (Muscle soreness in left arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get second dose) had resolved and OEDEMA (Edema in right foot) and ARTHRALGIA (Generalized arthralgia/every joint in bodyis painful and difficult) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Percuman was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: slightly sore arm; Tired and couldn't get out of bed for four days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slightly sore arm) and FATIGUE (Tired and couldn't get out of bed for four days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (slightly sore arm) and FATIGUE (Tired and couldn't get out of bed for four days). On 04-Mar-2021, PAIN IN EXTREMITY (slightly sore arm) had resolved. On 06-Mar-2021, FATIGUE (Tired and couldn't get out of bed for four days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood pressure medications.  Treatment information was not provided.    This case was linked.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oxygen saturation, Oxygen saturation abnormal, Vaccination site pain
Clinical narrative: Varying oxygen levels; Fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION ABNORMAL (Varying oxygen levels), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced OXYGEN SATURATION ABNORMAL (Varying oxygen levels), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Arm soreness). On 13-Mar-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, OXYGEN SATURATION ABNORMAL (Varying oxygen levels) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Oxygen saturation: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcomes for varying oxygen levels, fatigue and arm soreness was updated from unknown to recovered/resolved.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Chills, Hyperhidrosis, Pruritus
Clinical narrative: Weakness; Episodic cold sweats; Itchiness; soreness in the arms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) elevated BP.         Concomitant products included blood pressure medication and eye drops. ?No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Weakness; Episodic cold sweats; Itchiness; soreness in the arms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), HYPERHIDROSIS (Episodic cold sweats), PRURITUS (Itchiness), VACCINATION SITE PAIN (soreness in the arms) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: high (High) elevated BP.         Concomitant products included blood pressure medication and eye drops. ?No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Feeling cold, Hyperhidrosis
Clinical narrative: couldn't get warm; diarrhea; ache on the joints; really bad chills; broke up into sweat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (couldn't get warm), DIARRHOEA (diarrhea), HYPERHIDROSIS (broke up into sweat), ARTHRALGIA (ache on the joints) and CHILLS (really bad chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HYPERHIDROSIS (broke up into sweat). On an unknown date, the patient experienced FEELING COLD (couldn't get warm), DIARRHOEA (diarrhea), ARTHRALGIA (ache on the joints) and CHILLS (really bad chills). At the time of the report, FEELING COLD (couldn't get warm), DIARRHOEA (diarrhea), HYPERHIDROSIS (broke up into sweat), ARTHRALGIA (ache on the joints) and CHILLS (really bad chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Alieve.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal septum disorder, Vaccination site swelling
Clinical narrative: mild stiffness at the injection site; nasal bridge swollen and painful; This spontaneous case was reported by a consumer and describes the occurrence of NASAL SEPTUM DISORDER (nasal bridge swollen and painful) and VACCINATION SITE SWELLING (mild stiffness at the injection site) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced NASAL SEPTUM DISORDER (nasal bridge swollen and painful). On an unknown date, the patient experienced VACCINATION SITE SWELLING (mild stiffness at the injection site). At the time of the report, NASAL SEPTUM DISORDER (nasal bridge swollen and painful) outcome was unknown and VACCINATION SITE SWELLING (mild stiffness at the injection site) had resolved.            He denied any other issues after receiving the vaccine and reports he was doing well.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Narrative was updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Hypokinesia
Clinical narrative: dizzy; could not move for 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and HYPOKINESIA (could not move for 30 hours) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LATANOPROST, AMLODIPINE, VITAMIN 15 and DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE/TIMOLOL ACTAVIS) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (dizzy) and HYPOKINESIA (could not move for 30 hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy) outcome was unknown and HYPOKINESIA (could not move for 30 hours) had resolved. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 102 (High) 102 degrees Fahrenheit.         Patient had a temperature of 102 degrees Fahrenheit and patient could not move for 30 hours.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Itching; Swelling; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itching) and SWELLING (Swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LLZ0A) for COVID-19 vaccination.     Concomitant products included CLONAZEPAM and PREDNISONE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (Itching) and SWELLING (Swelling). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; FAMOTIDINE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) at an unspecified dose and frequency. On 03-Mar-2021, PRURITUS (Itching) and SWELLING (Swelling) 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.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Somnolence, Taste disorder
Clinical narrative: Slept for 12-15 hours; Odd taste in mouth; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept for 12-15 hours), TASTE DISORDER (Odd taste in mouth), CHILLS (Chills) and PYREXIA (Fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient stated that he had COVID before and has not fully recovered after). Concomitant products included APIXABAN (ELIQUIS), AMLODIPINE, ACETYLSALICYLIC ACID (ASPIN), FLECAINIDE, ATORVASTATIN, LEVOTHYROXINE and EZETIMIBE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced SOMNOLENCE (Slept for 12-15 hours), TASTE DISORDER (Odd taste in mouth), CHILLS (Chills) and PYREXIA (Fever). On 05-Mar-2021, PYREXIA (Fever) had resolved. On 06-Mar-2021, SOMNOLENCE (Slept for 12-15 hours), TASTE DISORDER (Odd taste in mouth) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up  received and contains no new information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site mass, Pain in extremity, Pruritus
Clinical narrative: itchiness; redness; Headache; Arm was sore; knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), INJECTION SITE MASS (knot at injection site), PRURITUS (itchiness), ERYTHEMA (redness) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), INJECTION SITE MASS (knot at injection site), ERYTHEMA (redness) and HEADACHE (Headache). On 15-Mar-2021, the patient experienced PRURITUS (itchiness). On 14-Mar-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), INJECTION SITE MASS (knot at injection site), PRURITUS (itchiness) and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications information was not reported.  Treatment information was not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site discolouration
Clinical narrative: Injection site was warm; Injection site was blotchy; Injection site was red; Soreness at the injection site; Body ache; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy) and VACCINATION SITE ERYTHEMA (Injection site was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy), PYREXIA (Fever), CHILLS (chills), HEADACHE (headache), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the events included cold compresses.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Injection site was warm; Injection site was blotchy; Injection site was red; Soreness at the injection site; Body ache; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy) and VACCINATION SITE ERYTHEMA (Injection site was red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site was warm), VACCINATION SITE DISCOLOURATION (Injection site was blotchy), PYREXIA (Fever), CHILLS (chills), HEADACHE (headache), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment for the events included cold compresses.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Stiff neck and pain to touch to bottom of her head on the left side; Soreness to back of her head, under her ear to the bottom of her head; Had left arm soreness after the injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck and pain to touch to bottom of her head on the left side), HEADACHE (Soreness to back of her head, under her ear to the bottom of her head) and VACCINATION SITE PAIN (Had left arm soreness after the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Spinal fusion. Concurrent medical conditions included Hypertension.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Had left arm soreness after the injection). On 14-Mar-2021, the patient experienced HEADACHE (Soreness to back of her head, under her ear to the bottom of her head). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck and pain to touch to bottom of her head on the left side). The patient was treated with OXYCODONE for Head pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck and pain to touch to bottom of her head on the left side), HEADACHE (Soreness to back of her head, under her ear to the bottom of her head) and VACCINATION SITE PAIN (Had left arm soreness after the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication  The patient experienced back of head on the left side was painful to touch and avoided sleeping on the left arm. The patient was on pain management for back.  The patient experienced big ache to back of her head and back.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Swelling of ankles; Swelling of feet/Swelling of lower legs; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling of ankles) and PERIPHERAL SWELLING (Swelling of feet/Swelling of lower legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL BISULFATE (PLAVIX), AMIODARONE, AMLODIPINE, CARVEDILOL, HYDROXYCHLOROQUINE, LORAZEPAM and EZETIMIBE (ZETIA) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced JOINT SWELLING (Swelling of ankles) and PERIPHERAL SWELLING (Swelling of feet/Swelling of lower legs). At the time of the report, JOINT SWELLING (Swelling of ankles) and PERIPHERAL SWELLING (Swelling of feet/Swelling of lower legs) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not receive any treatment for the symptoms. His symptoms are  ongoing and were getting worse even after 4 days.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: trying to speed up the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (trying to speed up the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (trying to speed up the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (trying to speed up the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon internal review on 21-May-2021, the age was corrected to unknown.   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild symptoms after vaccination after second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild symptoms after vaccination after second dose). At the time of the report, VACCINATION COMPLICATION (Mild symptoms after vaccination after second dose) outcome was unknown.            No concomitant medication was reported.  No treatment medicine has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Reporter information and vaccine information is updated.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: found out she was pregnant after receiving the first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (found out she was pregnant after receiving the first dose of the vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Feb-2021 and the estimated date of delivery was 07-Jan-2022. On 06-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (found out she was pregnant after receiving the first dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 06-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (found out she was pregnant after receiving the first dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: fever; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (very tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced FATIGUE (very tired). On 15-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) and FATIGUE (very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.9 100.9.         Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Followup information was received on 21-May-2021 contains no new information.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Lymphadenopathy, Pyrexia
Clinical narrative: Bad reaction; Swollen lymph node; High fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Bad reaction), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (High fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Bad reaction), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (High fever). At the time of the report, ADVERSE EVENT (Bad reaction), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (High fever) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.  Reporter agreed for follow-up with safety via email.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; FATIGUE; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (FATIGUE) and CHILLS (CHILLS) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (FATIGUE) and CHILLS (CHILLS). At the time of the report, HEADACHE (Headache), FATIGUE (FATIGUE) and CHILLS (CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details were not reported.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012AZ1A and 042LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chills) had resolved.            Patient did not experience any side effects with first dose. After second dose symptoms started after 24 hours &  lasted for at least 24 hours. Patient is not on any medication.  Treatment was not given for the side effects.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: cut with a saw; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of WOUND (cut with a saw) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Previously administered products included for an unreported indication: TETANUS VACCINE (last tetanus shot was in 2014).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced WOUND (cut with a saw). At the time of the report, WOUND (cut with a saw) was resolving.        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.   Concomitant product information not provided.  Patient washed the wound & applied antibiotic cream.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: super dizzy; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (super dizzy) and HEADACHE (really bad headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date. Concomitant products included SIMVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), FAMOTIDINE, PROBIOTIC 10, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FLUOXETINE HYDROCHLORIDE (PROZAC), ALPRAZOLAM (XANAX) and DOCUSATE SODIUM for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (super dizzy) and HEADACHE (really bad headache). At the time of the report, DIZZINESS (super dizzy) and HEADACHE (really bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient developed really bad headache at 3 0'clock but 12 hours later was super dizzy ang her husband helped her to walk to the bathroom before going to bed. She was fine by next day.   Concomitant medications also include blood pressure medication, diuretic, water pills, blood thinner.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at the vaccination site). At the time of the report, VACCINATION SITE HAEMORRHAGE (Bleeding at the vaccination site) outcome was unknown. Not Provided          Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up information was received from the initial reporter: The reporter stated that the internist indicated that the vaccinator most likely hit a vein but most of the vaccine should have gotten into the muscle
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Epistaxis, Fatigue, Pain in extremity
Clinical narrative: ongoing nosebleeds; tired; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (ongoing nosebleeds), FATIGUE (tired) and PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.    Co-suspect product included non-company product IBUPROFEN for an unknown indication.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced EPISTAXIS (ongoing nosebleeds), FATIGUE (tired) and PAIN IN EXTREMITY (sore arm). On 07-Mar-2021, FATIGUE (tired) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, EPISTAXIS (ongoing nosebleeds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: pyrexia; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and PYREXIA (pyrexia) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A2114) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Felt tired). On 14-Mar-2021, the patient experienced PYREXIA (pyrexia). On 14-Mar-2021, FATIGUE (Felt tired) had resolved. At the time of the report, PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Pyrexia: 101.3 (High) 101.3 and 103.3 (High) 103.3 for 2 hours before dropping.         concomitant medication information not provided.  Treatment provided is none.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Body temperature, Chills, Fatigue, Pain in extremity
Clinical narrative: No medical history was provided by the reporter.  Concomitant products included DICYCLOVERINE HYDROCHLORIDE (BENTYL) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was extremely painful/ couldn't move arm for 4 days). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (cramping in lower right abdomen.), VACCINATION SITE WARMTH (Injection site hot), SWELLING (Swelling), RASH (Rash), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site red), PYREXIA (Low Grade Fever) and FATIGUE (Extreme Fatigue). At the time of the report, PAIN IN EXTREMITY (arm was extremely painful/ couldn't move arm for 4 days), ABDOMINAL PAIN LOWER (cramping in lower right abdomen.), VACCINATION SITE WARMTH (Injection site hot), SWELLING (Swelling), RASH (Rash), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site red), PYREXIA (Low Grade Fever) and FATIGUE (Extreme Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99.9 to 100.1 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-040722 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up information received on 04-MAY-2021 was updated with event details.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: No medical history was provided by the reporter.  Concomitant products included DICYCLOVERINE HYDROCHLORIDE (BENTYL) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was extremely painful/ couldn't move arm for 4 days). On 04-Mar-2021, the patient experienced ABDOMINAL PAIN LOWER (cramping in lower right abdomen.), VACCINATION SITE WARMTH (Injection site hot), SWELLING (Swelling), RASH (Rash), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site red), PYREXIA (Low Grade Fever) and FATIGUE (Extreme Fatigue). At the time of the report, PAIN IN EXTREMITY (arm was extremely painful/ couldn't move arm for 4 days), ABDOMINAL PAIN LOWER (cramping in lower right abdomen.), VACCINATION SITE WARMTH (Injection site hot), SWELLING (Swelling), RASH (Rash), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Injection site red), PYREXIA (Low Grade Fever) and FATIGUE (Extreme Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 99.9 to 100.1 High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-040722 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up information received on 04-MAY-2021 was updated with event details.