chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: soreness in the arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue) outcome was unknown.            Concomitant medication was not reported. Treatment medication was not reported.    This case was linked to MOD-2021-029671, MOD-2021-038923, MOD-2021-038496, MOD-2021-038840 (E2B Linked Report).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Event outcome was updated to resolved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Therapeutic response unexpected
Clinical narrative: hands are stiff in the morning; Arthritis is gone,I feel great/better than I have ever felt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Arthritis is gone,I feel great/better than I have ever felt) and MUSCULOSKELETAL STIFFNESS (hands are stiff in the morning) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (Open heart surgery 4 years ago). Concurrent medical conditions included Arthritis (Regular arthritis, not rheumatoid arthritis reported.), Atrial fibrillation, Blood pressure high and Penicillin allergy (I).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Arthritis is gone,I feel great/better than I have ever felt). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (hands are stiff in the morning). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Arthritis is gone,I feel great/better than I have ever felt) and MUSCULOSKELETAL STIFFNESS (hands are stiff in the morning) 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.   Patient takes two pills a day one for blood pressure and another for A.fib. she is perfect and active. no treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Factitious disorder, Feeling abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: Big welt on my arm; 7 days later in the area where she got the shot; doesn't feel good; feels generally like when you're kind of getting sick; rash; hot; hard; very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Big welt on my arm), PERIPHERAL SWELLING (7 days later in the area where she got the shot), RASH (rash), DRY SKIN (hot) and PAIN IN EXTREMITY (hard) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash), DRY SKIN (hot), PAIN IN EXTREMITY (hard) and PRURITUS (very itchy). On 09-Mar-2021, the patient experienced FEELING ABNORMAL (doesn't feel good) and FACTITIOUS DISORDER (feels generally like when you're kind of getting sick). On an unknown date, the patient experienced PERIPHERAL SWELLING (Big welt on my arm) and PERIPHERAL SWELLING (7 days later in the area where she got the shot). On 06-Mar-2021, RASH (rash), DRY SKIN (hot), PAIN IN EXTREMITY (hard) and PRURITUS (very itchy) outcome was unknown. At the time of the report, PERIPHERAL SWELLING (Big welt on my arm), PERIPHERAL SWELLING (7 days later in the area where she got the shot), FEELING ABNORMAL (doesn't feel good) and FACTITIOUS DISORDER (feels generally like when you're kind of getting sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consent given for safety to contact patient. Corrective treatment was not provided   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information was recieved
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Big welt on my arm; 7 days later in the area where she got the shot; doesn't feel good; feels generally like when you're kind of getting sick; rash; hot; hard; very itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Big welt on my arm), PERIPHERAL SWELLING (7 days later in the area where she got the shot), RASH (rash), DRY SKIN (hot) and PAIN IN EXTREMITY (hard) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash), DRY SKIN (hot), PAIN IN EXTREMITY (hard) and PRURITUS (very itchy). On 09-Mar-2021, the patient experienced FEELING ABNORMAL (doesn't feel good) and FACTITIOUS DISORDER (feels generally like when you're kind of getting sick). On an unknown date, the patient experienced PERIPHERAL SWELLING (Big welt on my arm) and PERIPHERAL SWELLING (7 days later in the area where she got the shot). On 06-Mar-2021, RASH (rash), DRY SKIN (hot), PAIN IN EXTREMITY (hard) and PRURITUS (very itchy) outcome was unknown. At the time of the report, PERIPHERAL SWELLING (Big welt on my arm), PERIPHERAL SWELLING (7 days later in the area where she got the shot), FEELING ABNORMAL (doesn't feel good) and FACTITIOUS DISORDER (feels generally like when you're kind of getting sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consent given for safety to contact patient. Corrective treatment was not provided   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information was recieved
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Nasopharyngitis, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (feels cold), FEELING ABNORMAL (feels worse today), PYREXIA (fever reached 101 F) and CHILLS (chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, the patient experienced NASOPHARYNGITIS (feels cold), FEELING ABNORMAL (feels worse today), PYREXIA (fever reached 101 F) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (feels cold), FEELING ABNORMAL (feels worse today), PYREXIA (fever reached 101 F) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever reached 101 f, fever is starting to come down.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication include stress and hypertension medications. Treatment method include cold compress. Upon follow up it was reported by the patient's friend that the patient was feeling fine and she doesn't knowhis email id and asked us to close the case and no more calls , she also mentioned she had sore arm after the injection but now she is fine and no more calls in future for this one.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: no new information was recieved
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches; chills; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events aches, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not available) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event(s) aches, chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), aches, chills was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot (injection site area); injection side swollen; red (injection site area); itching on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot (injection site area)), VACCINATION SITE PRURITUS (itching on the injection site), VACCINATION SITE SWELLING (injection side swollen) and VACCINATION SITE ERYTHEMA (red (injection site area)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Flu vaccination ("Not an allergic person but previously had some reaction (unspecified) for her flu vaccine too."). Concomitant products included FLUOXETINE, MELOXICAM, VITAMIN B [VITAMIN B NOS] and VITAMIN D NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching on the injection site). On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot (injection site area)), VACCINATION SITE SWELLING (injection side swollen) and VACCINATION SITE ERYTHEMA (red (injection site area)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and AMIKACIN SULFATE (AMICA) at an unspecified dose and frequency. On 08-Mar-2021, VACCINATION SITE WARMTH (hot (injection site area)), VACCINATION SITE PRURITUS (itching on the injection site), VACCINATION SITE SWELLING (injection side swollen) and VACCINATION SITE ERYTHEMA (red (injection site area)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included ice.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin disorder
Clinical narrative: experiencing itchiness; the skins of the patient's hands has broken up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (experiencing itchiness) and SKIN DISORDER (the skins of the patient's hands has broken up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history      ). Concomitant products included Blood pressure tablets for Blood pressure, ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 02-Mar-2021, the patient experienced PRURITUS (experiencing itchiness) and SKIN DISORDER (the skins of the patient's hands has broken up). At the time of the report, PRURITUS (experiencing itchiness) and SKIN DISORDER (the skins of the patient's hands has broken up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included hand lotion.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Exfoliative rash, Fatigue
Clinical narrative: arm goes numb; diarrhea; feels like pins and needles going from shoulder to baby finger; itchy rash; scaly rash; patient reports that she still has tingling and numbness in her right arm injection site; dry, patchy, scaly, itchy rash; fever; chills; shoulder pain; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash) and EXFOLIATIVE RASH (scaly rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-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 HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash), EXFOLIATIVE RASH (scaly rash), PARAESTHESIA (patient reports that she still has tingling and numbness in her right arm injection site), RASH (dry, patchy, scaly, itchy rash), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder pain) and FATIGUE (extremely tired). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) (topical) for Shoulder pain, at a dose of 1 dosage form; DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) for Shoulder pain, at a dose of 1 dosage form and Physical therapy for Paraesthesia. At the time of the report, HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash), EXFOLIATIVE RASH (scaly rash), PARAESTHESIA (patient reports that she still has tingling and numbness in her right arm injection site), RASH (dry, patchy, scaly, itchy rash), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder pain) and FATIGUE (extremely tired) outcome was unknown.            No concomitant medications were reported.  Patient was given steroid injections in her right shoulder and right elbow for the event tingling in her right arm.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: follow-up received on 21jun2021. Event - Tingling in arm treatment information was appended like physical therapy and steroid injection.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Pyrexia, Rash, Rash pruritic
Clinical narrative: arm goes numb; diarrhea; feels like pins and needles going from shoulder to baby finger; itchy rash; scaly rash; patient reports that she still has tingling and numbness in her right arm injection site; dry, patchy, scaly, itchy rash; fever; chills; shoulder pain; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash) and EXFOLIATIVE RASH (scaly rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-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 HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash), EXFOLIATIVE RASH (scaly rash), PARAESTHESIA (patient reports that she still has tingling and numbness in her right arm injection site), RASH (dry, patchy, scaly, itchy rash), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder pain) and FATIGUE (extremely tired). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) (topical) for Shoulder pain, at a dose of 1 dosage form; DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) for Shoulder pain, at a dose of 1 dosage form and Physical therapy for Paraesthesia. At the time of the report, HYPOAESTHESIA (arm goes numb), DIARRHOEA (diarrhea), PARAESTHESIA (feels like pins and needles going from shoulder to baby finger), RASH PRURITIC (itchy rash), EXFOLIATIVE RASH (scaly rash), PARAESTHESIA (patient reports that she still has tingling and numbness in her right arm injection site), RASH (dry, patchy, scaly, itchy rash), PYREXIA (fever), CHILLS (chills), ARTHRALGIA (shoulder pain) and FATIGUE (extremely tired) outcome was unknown.            No concomitant medications were reported.  Patient was given steroid injections in her right shoulder and right elbow for the event tingling in her right arm.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: follow-up received on 21jun2021. Event - Tingling in arm treatment information was appended like physical therapy and steroid injection.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain, Pain goes from muscle between butt and knee; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain, Pain goes from muscle between butt and knee) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle pain.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain, Pain goes from muscle between butt and knee). At the time of the report, MYALGIA (Muscle pain, Pain goes from muscle between butt and knee) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event, included statins.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: Possible Incomplete dose; leaked onto patient's arm; needle attached to the syringe was loose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Possible Incomplete dose), EXPOSURE VIA SKIN CONTACT (leaked onto patient's arm) and DEVICE CONNECTION ISSUE (needle attached to the syringe was loose) 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 09-Mar-2021, the patient experienced UNDERDOSE (Possible Incomplete dose), EXPOSURE VIA SKIN CONTACT (leaked onto patient's arm) and DEVICE CONNECTION ISSUE (needle attached to the syringe was loose). On 09-Mar-2021, UNDERDOSE (Possible Incomplete dose), EXPOSURE VIA SKIN CONTACT (leaked onto patient's arm) and DEVICE CONNECTION ISSUE (needle attached to the syringe was loose) 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.   Concomitant medications were not provided. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-jun-2021 with no new significant information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 01M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-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 PAIN IN EXTREMITY (pain in her arm). At the time of the report, PAIN IN EXTREMITY (pain in her arm) outcome was unknown.            Concomitant medications reported were Blood pressure medicine. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD21-050363, MOD-2021-039063 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dysgeusia, Ear pain, Ear pruritus, Erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek) and JOINT STIFFNESS (Tightness in shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included THYROID and BETA GLUCAN (CHOLESTEROL BALANCE [BETA GLUCAN]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine). On an unknown date, the patient experienced PRURITUS (Itching on spine), ERYTHEMA (Red spot 2 inches long on the middle of her spine), EYE PRURITUS (Itching around her eyes), PRURITUS (Itching around face), EAR PAIN (Ears were painful) and PRURITUS (Back was itching). At the time of the report, HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Feeling hot, Hypersensitivity, Injection site pain, Joint stiffness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek) and JOINT STIFFNESS (Tightness in shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included THYROID and BETA GLUCAN (CHOLESTEROL BALANCE [BETA GLUCAN]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine). On an unknown date, the patient experienced PRURITUS (Itching on spine), ERYTHEMA (Red spot 2 inches long on the middle of her spine), EYE PRURITUS (Itching around her eyes), PRURITUS (Itching around face), EAR PAIN (Ears were painful) and PRURITUS (Back was itching). At the time of the report, HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle tightness, Pain in extremity, Pruritus, Skin tightness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek) and JOINT STIFFNESS (Tightness in shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included THYROID and BETA GLUCAN (CHOLESTEROL BALANCE [BETA GLUCAN]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine). On an unknown date, the patient experienced PRURITUS (Itching on spine), ERYTHEMA (Red spot 2 inches long on the middle of her spine), EYE PRURITUS (Itching around her eyes), PRURITUS (Itching around face), EAR PAIN (Ears were painful) and PRURITUS (Back was itching). At the time of the report, HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek) and JOINT STIFFNESS (Tightness in shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included THYROID and BETA GLUCAN (CHOLESTEROL BALANCE [BETA GLUCAN]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine). On an unknown date, the patient experienced PRURITUS (Itching on spine), ERYTHEMA (Red spot 2 inches long on the middle of her spine), EYE PRURITUS (Itching around her eyes), PRURITUS (Itching around face), EAR PAIN (Ears were painful) and PRURITUS (Back was itching). At the time of the report, HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Pain all over her body; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain all over her body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (Pain all over her body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Pain all over her body), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant product use included unspecified blood pressure medication. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-039060 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) 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 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Sars-covid 2-antibody test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: felling dizziness; Weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (felling dizziness) and ASTHENIA (Weakness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia stage 0 (under oncologist follow-up) and Blood pressure abnormal. Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure abnormal, IBRUTINIB (IMBRUVICA) for Chemotherapy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 11:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (felling dizziness) and ASTHENIA (Weakness). At the time of the report, DIZZINESS (felling dizziness) and ASTHENIA (Weakness) outcome was unknown.            The reporter stated that patient did not seem to be in extreme distress, so she was driving the patient to nearby emergency room (ER) to have checked at the time of this report. The reporter also stated that when patient developed symptoms, patient contacted her oncologist who recommended, not to take chemotherapy medications for 2 days (on the day of vaccination and next day). No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Slight fever). At the time of the report, PYREXIA (Slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: large red area; itches; arm started to get sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started to get sore), ERYTHEMA (large red area) and PRURITUS (itches) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm started to get sore). On 10-Mar-2021, the patient experienced ERYTHEMA (large red area) and PRURITUS (itches). At the time of the report, PAIN IN EXTREMITY (arm started to get sore), ERYTHEMA (large red area) and PRURITUS (itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Legs were swollen from the bottom of legs to knees.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Legs were swollen from the bottom of legs to knees.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (Legs were swollen from the bottom of legs to knees.). At the time of the report, PERIPHERAL SWELLING (Legs were swollen from the bottom of legs to knees.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Slight swelling on right side of cheek; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Slight swelling on right side of cheek) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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. On an unknown date, the patient experienced SWELLING FACE (Slight swelling on right side of cheek). At the time of the report, SWELLING FACE (Slight swelling on right side of cheek) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Flatulence, Limb discomfort
Clinical narrative: constant stools/ diarrhea; stomach gurgling; full of gas; No appetite; Nauseous/ in between diarrhea and normal stools; Discomfort in the left arm in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in the left arm in the muscle), DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas) and DECREASED APPETITE (No appetite) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 LIMB DISCOMFORT (Discomfort in the left arm in the muscle). On 13-Feb-2021, the patient experienced DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas), DECREASED APPETITE (No appetite) and NAUSEA (Nauseous/ in between diarrhea and normal stools). At the time of the report, LIMB DISCOMFORT (Discomfort in the left arm in the muscle), DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas), DECREASED APPETITE (No appetite) and NAUSEA (Nauseous/ in between diarrhea and normal stools) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided. The reporter did not provided a causality assessment.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: constant stools/ diarrhea; stomach gurgling; full of gas; No appetite; Nauseous/ in between diarrhea and normal stools; Discomfort in the left arm in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in the left arm in the muscle), DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas) and DECREASED APPETITE (No appetite) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 LIMB DISCOMFORT (Discomfort in the left arm in the muscle). On 13-Feb-2021, the patient experienced DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas), DECREASED APPETITE (No appetite) and NAUSEA (Nauseous/ in between diarrhea and normal stools). At the time of the report, LIMB DISCOMFORT (Discomfort in the left arm in the muscle), DIARRHOEA (constant stools/ diarrhea), ABDOMINAL DISCOMFORT (stomach gurgling), FLATULENCE (full of gas), DECREASED APPETITE (No appetite) and NAUSEA (Nauseous/ in between diarrhea and normal stools) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided. The reporter did not provided a causality assessment.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.