chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Pain in extremity, Vaccination complication
Clinical narrative: foggy brain and can't remember who he is; "feeling like an idiot."; has difficulty to remember where he can't speak or remember anything; eyes feel pain and are uncomfortable; sick; "brain is so bland and empty."; cannot focus or concentrate; had so many side effects; had some headaches and some brain pain that affected his two eyes; on the right side of brain, it is painful on the backside; fatigue; arm pain; felt numb in his two hands, two feet; sweaty; cannot sleep all night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm pain), HYPOAESTHESIA (felt numb in his two hands, two feet), HYPERHIDROSIS (sweaty), INSOMNIA (cannot sleep all night) and FEELING ABNORMAL (foggy brain and can't remember who he is; "feeling like an idiot.") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced INSOMNIA (cannot sleep all night). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), HYPOAESTHESIA (felt numb in his two hands, two feet), HYPERHIDROSIS (sweaty), FEELING ABNORMAL (foggy brain and can't remember who he is; "feeling like an idiot."), MEMORY IMPAIRMENT (has difficulty to remember where he can't speak or remember anything), EYE PAIN (eyes feel pain and are uncomfortable), ILLNESS (sick), CONFUSIONAL STATE ("brain is so bland and empty."), DISTURBANCE IN ATTENTION (cannot focus or concentrate), VACCINATION COMPLICATION (had so many side effects), HEADACHE (had some headaches and some brain pain that affected his two eyes; on the right side of brain, it is painful on the backside) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (arm pain), HYPOAESTHESIA (felt numb in his two hands, two feet), HYPERHIDROSIS (sweaty), INSOMNIA (cannot sleep all night), FEELING ABNORMAL (foggy brain and can't remember who he is; "feeling like an idiot."), MEMORY IMPAIRMENT (has difficulty to remember where he can't speak or remember anything), EYE PAIN (eyes feel pain and are uncomfortable), ILLNESS (sick), CONFUSIONAL STATE ("brain is so bland and empty."), DISTURBANCE IN ATTENTION (cannot focus or concentrate), VACCINATION COMPLICATION (had so many side effects), HEADACHE (had some headaches and some brain pain that affected his two eyes; on the right side of brain, it is painful on the backside) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  The patient went to the emergency room on 12APR2021, but "they did not detect anything."  Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: hives at injection site; swelling; itchy; redness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives at injection site), SWELLING (swelling), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced URTICARIA (hives at injection site), SWELLING (swelling), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 14-Apr-2021, SWELLING (swelling) had resolved. At the time of the report, URTICARIA (hives at injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment for the event include hydrocortisone cream.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever that is "on and off"; headache that is "on and off"; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever that is "on and off") and HEADACHE (headache that is "on and off") in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) 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 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever that is "on and off") and HEADACHE (headache that is "on and off"). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever that is "on and off") and HEADACHE (headache that is "on and off") outcome was unknown. Not Provided          No concomitant medications were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076822 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076822:first dose
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Lethargy, Pyrexia
Clinical narrative: lethargic; warm; tired; fever of 99.5, unusual; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), FEELING HOT (warm), FATIGUE (tired) and PYREXIA (fever of 99.5, unusual) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.      The patient's past medical history included Multiple myeloma. Concomitant products included GABAPENTIN, NALOXEGOL OXALATE (MOVANTIK) and FENTANYL CITRATE (NARCO) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced LETHARGY (lethargic), FEELING HOT (warm), FATIGUE (tired) and PYREXIA (fever of 99.5, unusual). At the time of the report, LETHARGY (lethargic), FEELING HOT (warm), FATIGUE (tired) and PYREXIA (fever of 99.5, unusual) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (Inconclusive) 99.5 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 15-APR-2021 Contains Reporter details and concomitant medication was updated
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fall, Gait disturbance
Clinical narrative: Nausea; vomitting; Head feel like its broken; Severe staggering not able to walk without walker; Weakness; sore arm could not lift arm; fall; neck feel like its broken; Hit her head; sweats; Dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall) and NECK PAIN (neck feel like its broken) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), DIZZINESS (Dizziness), CHILLS (Chills), VOMITING (vomitting) and HEADACHE (Head feel like its broken). On an unknown date, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, DIZZINESS (Dizziness) and CHILLS (Chills) outcome was unknown. At the time of the report, GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), NAUSEA (Nausea), VOMITING (vomitting) and HEADACHE (Head feel like its broken) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076181 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076181:Second Dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Headache, Hyperhidrosis, Nausea, Neck pain
Clinical narrative: Nausea; vomitting; Head feel like its broken; Severe staggering not able to walk without walker; Weakness; sore arm could not lift arm; fall; neck feel like its broken; Hit her head; sweats; Dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall) and NECK PAIN (neck feel like its broken) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), DIZZINESS (Dizziness), CHILLS (Chills), VOMITING (vomitting) and HEADACHE (Head feel like its broken). On an unknown date, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, DIZZINESS (Dizziness) and CHILLS (Chills) outcome was unknown. At the time of the report, GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), NAUSEA (Nausea), VOMITING (vomitting) and HEADACHE (Head feel like its broken) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076181 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076181:Second Dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Nausea; vomitting; Head feel like its broken; Severe staggering not able to walk without walker; Weakness; sore arm could not lift arm; fall; neck feel like its broken; Hit her head; sweats; Dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall) and NECK PAIN (neck feel like its broken) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), DIZZINESS (Dizziness), CHILLS (Chills), VOMITING (vomitting) and HEADACHE (Head feel like its broken). On an unknown date, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, DIZZINESS (Dizziness) and CHILLS (Chills) outcome was unknown. At the time of the report, GAIT DISTURBANCE (Severe staggering not able to walk without walker), ASTHENIA (Weakness), PAIN IN EXTREMITY (sore arm could not lift arm), FALL (fall), NECK PAIN (neck feel like its broken), HEAD INJURY (Hit her head), HYPERHIDROSIS (sweats), NAUSEA (Nausea), VOMITING (vomitting) and HEADACHE (Head feel like its broken) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076181 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076181:Second Dose
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes). At the time of the report, HOT FLUSH (hot flashes) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue ulceration
Clinical narrative: ulcer on tongue in mouth about the size of a dime; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (ulcer on tongue in mouth about the size of a dime) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D3), MAGNESIUM, VITAMIN E NOS (VITAMIN E), MAGNESIUM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FOLIC ACID, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 12), MELATONIN, MELOXICAM, ALPRAZOLAM (XANAX), PRAVASTATIN, ESCITALOPRAM, CYCLOBENZAPRINE, HYDROCHLOROTHIAZIDE, METOPROLOL, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY + C), SALBUTAMOL (ALBUTEROL HFA), PROBIOTICS NOS (PROBIOTICS), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) and DICLOFENAC (Pennasaid) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced TONGUE ULCERATION (ulcer on tongue in mouth about the size of a dime). At the time of the report, TONGUE ULCERATION (ulcer on tongue in mouth about the size of a dime) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Viscous Lidocaine Oral Solution. Concomitant medications includes singular.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Swelling of eyelid
Clinical narrative: his left eyelid almost swollen shut; rash does itch; rash in mostly on his face, neck, right arm, groin area slowly getting worse; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (his left eyelid almost swollen shut), RASH PRURITIC (rash does itch) and RASH (rash in mostly on his face, neck, right arm, groin area slowly getting worse) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SWELLING OF EYELID (his left eyelid almost swollen shut), RASH PRURITIC (rash does itch) and RASH (rash in mostly on his face, neck, right arm, groin area slowly getting worse). At the time of the report, SWELLING OF EYELID (his left eyelid almost swollen shut), RASH PRURITIC (rash does itch) and RASH (rash in mostly on his face, neck, right arm, groin area slowly getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment details provided for these events.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site rash
Clinical narrative: rash around injection site; Arm sore; itchy; breaking out with red spots around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (breaking out with red spots around injection site) and VACCINATION SITE RASH (rash around injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (breaking out with red spots around injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash around injection site). At the time of the report, PAIN IN EXTREMITY (Arm sore), PRURITUS (itchy), VACCINATION SITE ERYTHEMA (breaking out with red spots around injection site) and VACCINATION SITE RASH (rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.  Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant Follow-up: event injection site rash added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal stiffness
Clinical narrative: stiffiness arm, legs, shoulders, neck; stiffiness arm, legs, shoulders, neck; stiffiness arm, legs, shoulders, neck; chills; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the second episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the third episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones, COVID-19 (Previous diagnosis of COVID-19.) and Hysterectomy (Uterus removed in 2020) in 2020. Concurrent medical conditions included Scar (Scar tissue from previous stone).    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced the first episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the second episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the third episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck) and CHILLS (chills). At the time of the report, last episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck) and CHILLS (chills) 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. Treatment drugs reported included self administered pain relievers on 13-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of asthenia (low energy) and nausea in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 7, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 14, 2021, patient experienced asthenia (low energy) and nausea. At the time of the report, asthenia (low energy) and nausea outcome: unknown. No concomitant medication or treatment information provided. Action taken with mRNA-1273 in response to the event: not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SWELLING (Swelling). At the time of the report, SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: migraines; low grade fever of 100.6 F; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines) and PYREXIA (low grade fever of 100.6 F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MIGRAINE (migraines) and PYREXIA (low grade fever of 100.6 F). At the time of the report, MIGRAINE (migraines) and PYREXIA (low grade fever of 100.6 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.6 Farad (High) low grade fever of 100.6 F.         Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information included tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PYREXIA (fever) and MYALGIA (muscle aches) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness), PYREXIA (fever) and MYALGIA (muscle aches). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown and PYREXIA (fever) and MYALGIA (muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) 102 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm,  where the shot went in; hard, where the shot went in; Swollen, where the shot went in; good size red circle where the shot went in; red circle around the injection site, swollen and hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm,  where the shot went in), VACCINATION SITE INDURATION (hard, where the shot went in), VACCINATION SITE SWELLING (Swollen, where the shot went in), VACCINATION SITE ERYTHEMA (good size red circle where the shot went in) and VACCINATION SITE PAIN (red circle around the injection site, swollen and hurting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LISINOPRIL and METOPROLOL for Blood pressure high.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (red circle around the injection site, swollen and hurting). On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm,  where the shot went in), VACCINATION SITE INDURATION (hard, where the shot went in), VACCINATION SITE SWELLING (Swollen, where the shot went in) and VACCINATION SITE ERYTHEMA (good size red circle where the shot went in). At the time of the report, VACCINATION SITE WARMTH (warm,  where the shot went in), VACCINATION SITE INDURATION (hard, where the shot went in), VACCINATION SITE SWELLING (Swollen, where the shot went in) and VACCINATION SITE PAIN (red circle around the injection site, swollen and hurting) had resolved and VACCINATION SITE ERYTHEMA (good size red circle where the shot went in) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information in response to events was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Flushing, Peripheral swelling, Respiratory tract congestion
Clinical narrative: chest congestion; increased shortness of breath; feet swelling; face flushed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (increased shortness of breath), PERIPHERAL SWELLING (feet swelling) and FLUSHING (face flushed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (increased shortness of breath), PERIPHERAL SWELLING (feet swelling) and FLUSHING (face flushed). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (increased shortness of breath), PERIPHERAL SWELLING (feet swelling) and FLUSHING (face flushed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. treatment information included recuse inhaler   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non-significant follow-up received on 28-MAY-2021 Contains contact information was updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second Moderna vaccine on 4-14-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna vaccine on 4-14-2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01a21a) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna vaccine on 4-14-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second Moderna vaccine on 4-14-2021) had resolved. Not Provided          no concomitant medicines and treatment information  were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-076164 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076164:For First dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Night sweats
Clinical narrative: Night Sweats; Dizziness/Light headed; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night Sweats), DIZZINESS (Dizziness/Light headed) and FATIGUE (Fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced NIGHT SWEATS (Night Sweats), DIZZINESS (Dizziness/Light headed) and FATIGUE (Fatigue). At the time of the report, NIGHT SWEATS (Night Sweats), DIZZINESS (Dizziness/Light headed) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia
Clinical narrative: felt out of breath; sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (felt out of breath), MYALGIA (sore arm) and FATIGUE (Tired) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 DYSPNOEA (felt out of breath), MYALGIA (sore arm) and FATIGUE (Tired). At the time of the report, DYSPNOEA (felt out of breath), MYALGIA (sore arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Rash, Throat tightness
Clinical narrative: Upset stomach; chest started getting tight; throat started closing up; breaking out in rash all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), CHEST DISCOMFORT (chest started getting tight), THROAT TIGHTNESS (throat started closing up) and RASH (breaking out in rash all over) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021 at 4:00 PM, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), CHEST DISCOMFORT (chest started getting tight), THROAT TIGHTNESS (throat started closing up) and RASH (breaking out in rash all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Mar-2021 at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) on 19-Mar-2021 at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), CHEST DISCOMFORT (chest started getting tight), THROAT TIGHTNESS (throat started closing up) and RASH (breaking out in rash all over) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided.  The patient was treated in the emergency room  for 4 hours on 19MAR2021.  The patient  stated he would not be getting the second dose of the vaccine because he doesn't want to "go through this again". The patient reported consulting with his HCP.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Immediate post-injection reaction, Injection site pain
Clinical narrative: Injection site pain immediately after and continuing currently at 3:34 am. Extreme chills starting 1 am still in effect currently at 3:34 am. 101.4 Fever recorded from armpit at 3 am, have taken suggested dose of ibuprofen, still at same temp now half hour later. Loss of balance/lightheaded noticed at 3 am, still in affect now, a half hour later.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Injection site pain immediately after and continuing currently at 3:34 am. Extreme chills starting 1 am still in effect currently at 3:34 am. 101.4 Fever recorded from armpit at 3 am, have taken suggested dose of ibuprofen, still at same temp now half hour later. Loss of balance/lightheaded noticed at 3 am, still in affect now, a half hour later.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: Chest pain, sob, swelling of extremities, numbness in extremities,  severe migrain, couldn't get out of bed for 3 days, couldn't walk,  fever, and general body pain. I refused to have my wife call EMS and be admitted to the hospital. I was told afterwards it wost likely myocarditis.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Myocarditis, Pain, Peripheral swelling
Clinical narrative: Chest pain, sob, swelling of extremities, numbness in extremities,  severe migrain, couldn't get out of bed for 3 days, couldn't walk,  fever, and general body pain. I refused to have my wife call EMS and be admitted to the hospital. I was told afterwards it wost likely myocarditis.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Feeling hot, Vomiting
Clinical narrative: coughing like crazy; hot; dizziness; fatigue; vomited; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing like crazy), FEELING HOT (hot), DIZZINESS (dizziness), FATIGUE (fatigue) and VOMITING (vomited) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VENLAFAXINE, CLONAZEPAM and TRAZODONE for an unknown indication.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced COUGH (coughing like crazy), FEELING HOT (hot), DIZZINESS (dizziness), FATIGUE (fatigue) and VOMITING (vomited). At the time of the report, COUGH (coughing like crazy), FEELING HOT (hot), DIZZINESS (dizziness), FATIGUE (fatigue) and VOMITING (vomited) outcome was unknown.            Treatment drugs reported includes Cough syrup. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: 2nd dose taken after 90 days as recommended; Hurting left arm at injection; Headache; Tired feeling; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended), VACCINATION SITE PAIN (Hurting left arm at injection), HEADACHE (Headache) and FATIGUE (Tired feeling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007A21A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (She had Covid after the 1st dose).   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended), VACCINATION SITE PAIN (Hurting left arm at injection), HEADACHE (Headache) and FATIGUE (Tired feeling). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose taken after 90 days as recommended), VACCINATION SITE PAIN (Hurting left arm at injection), HEADACHE (Headache) and FATIGUE (Tired feeling) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-011079, MOD-2021-026867 (E2B Linked Report).; Sender's Comments:  MOD-2021-011079:Crosslinked case MOD-2021-026867:Crosslinked case
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Feeling cold, Headache, Pain
Clinical narrative: entire body felt very cold; body pains; voice turned hoarse; itched all over; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over) and CHILLS (chills) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over), CHILLS (chills) and HEADACHE (bad headache). At the time of the report, FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over), CHILLS (chills) and HEADACHE (bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: entire body felt very cold; body pains; voice turned hoarse; itched all over; chills; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over) and CHILLS (chills) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over), CHILLS (chills) and HEADACHE (bad headache). At the time of the report, FEELING COLD (entire body felt very cold), PAIN (body pains), DYSPHONIA (voice turned hoarse), PRURITUS (itched all over), CHILLS (chills) and HEADACHE (bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness and tingling on the left side of the face, and left arm; numbness and tingling on the left side of the face, and left arm; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (numbness and tingling on the left side of the face, and left arm) and PARAESTHESIA (numbness and tingling on the left side of the face, and left arm) in a 59-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness and tingling on the left side of the face, and left arm) and PARAESTHESIA (numbness and tingling on the left side of the face, and left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Numbness and Tingling, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness and tingling on the left side of the face, and left arm) and PARAESTHESIA (numbness and tingling on the left side of the face, and left arm) 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. Treatment included fluids.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: Swollen middle finger of right hand; in excruciating pain for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen middle finger of right hand) and PAIN (in excruciating pain for 30 minutes) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   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 PERIPHERAL SWELLING (Swollen middle finger of right hand) and PAIN (in excruciating pain for 30 minutes). At the time of the report, PERIPHERAL SWELLING (Swollen middle finger of right hand) and PAIN (in excruciating pain for 30 minutes) outcome was unknown.            He was in excruciating pain for about 30 minutes and it was swollen twice in size.  He takes monthly medication for arthritis.  Treatment information was not provided.   This case was linked to MOD21-074521 (E2B Linked Report).; Sender's Comments:  MOD21-074521:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Hurt back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Hurt back) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BACK PAIN (Hurt back). The patient was treated with METHYLPREDNISOLONE ongoing since an unknown date for Back pain, at a dose of 7 day pack. At the time of the report, BACK PAIN (Hurt back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is not taking any concomitant medications.