chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Euphoric mood, Pruritus, Vaccination site erythema
Clinical narrative: BUMP; angry looking; itchy; REDNESS AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS (BUMP), EUPHORIC MOOD (angry looking), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ABSCESS (BUMP), EUPHORIC MOOD (angry looking), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE). On 29-Jan-2021, ABSCESS (BUMP), EUPHORIC MOOD (angry looking), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (REDNESS AT INJECTION SITE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: pain in the eyes; the eye lids are swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain in the eyes) and EYE SWELLING (the eye lids are swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced EYE PAIN (pain in the eyes) and EYE SWELLING (the eye lids are swollen). At the time of the report, EYE PAIN (pain in the eyes) and EYE SWELLING (the eye lids are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Compress of cold water. Patient reports vision is fine, not cloudy and is able to focus.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Illness, Injection site pain
Clinical narrative: he looks sick; really weak; right arm became sore at the injection site; right arm became swollen and is worsening; top part of his right arm was sore initially but now it is not sore like it was; dizziness; he can't straighten his right arm out; wore out since the shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (right arm became sore at the injection site), INJECTION SITE SWELLING (right arm became swollen and is worsening), PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was), JOINT STIFFNESS (he can't straighten his right arm out) and ILLNESS (he looks sick) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01119121) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Throat cancer and Radiation therapy on 02-Dec-2020. Concurrent medical conditions included High cholesterol (and "complex nerve symptoms") and Drug allergy (certain "pain pills"). Concomitant products included PREGABALIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (wore out since the shot). On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (right arm became sore at the injection site), INJECTION SITE SWELLING (right arm became swollen and is worsening), PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was) and JOINT STIFFNESS (he can't straighten his right arm out). On 01-Feb-2021, the patient experienced ILLNESS (he looks sick) and ASTHENIA (really weak). On 23-Jan-2021, JOINT STIFFNESS (he can't straighten his right arm out) had resolved. At the time of the report, INJECTION SITE PAIN (right arm became sore at the injection site) and INJECTION SITE SWELLING (right arm became swollen and is worsening) had not resolved and PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was), ILLNESS (he looks sick), ASTHENIA (really weak) and FATIGUE (wore out since the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Joint stiffness, Pain in extremity
Clinical narrative: he looks sick; really weak; right arm became sore at the injection site; right arm became swollen and is worsening; top part of his right arm was sore initially but now it is not sore like it was; dizziness; he can't straighten his right arm out; wore out since the shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (right arm became sore at the injection site), INJECTION SITE SWELLING (right arm became swollen and is worsening), PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was), JOINT STIFFNESS (he can't straighten his right arm out) and ILLNESS (he looks sick) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01119121) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Throat cancer and Radiation therapy on 02-Dec-2020. Concurrent medical conditions included High cholesterol (and "complex nerve symptoms") and Drug allergy (certain "pain pills"). Concomitant products included PREGABALIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (wore out since the shot). On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (right arm became sore at the injection site), INJECTION SITE SWELLING (right arm became swollen and is worsening), PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was) and JOINT STIFFNESS (he can't straighten his right arm out). On 01-Feb-2021, the patient experienced ILLNESS (he looks sick) and ASTHENIA (really weak). On 23-Jan-2021, JOINT STIFFNESS (he can't straighten his right arm out) had resolved. At the time of the report, INJECTION SITE PAIN (right arm became sore at the injection site) and INJECTION SITE SWELLING (right arm became swollen and is worsening) had not resolved and PAIN IN EXTREMITY (top part of his right arm was sore initially but now it is not sore like it was), ILLNESS (he looks sick), ASTHENIA (really weak) and FATIGUE (wore out since the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site rash
Clinical narrative: Slight redness in the shot; Light rash; A little tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (A little tenderness), VACCINATION SITE ERYTHEMA (Slight redness in the shot) and VACCINATION SITE RASH (Light rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient is allergic to surgical paste and tomatoes.). Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    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 TENDERNESS (A little tenderness). On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slight redness in the shot) and VACCINATION SITE RASH (Light rash). On 20-Jan-2021, TENDERNESS (A little tenderness) had resolved. On 02-Feb-2021, VACCINATION SITE ERYTHEMA (Slight redness in the shot) and VACCINATION SITE RASH (Light rash) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient uses unspecified eye medicine for glaucoma and peltex for bones as concomitant medicines.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Skin irritation, Vaccination site erythema, Vaccination site mass
Clinical narrative: swollen lymph node underneath the arm pit a couple inches in diameter; skin is irritated; redness; lump on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE MASS (lump on arm), LYMPHADENOPATHY (swollen lymph node underneath the arm pit a couple inches in diameter) and SKIN IRRITATION (skin is irritated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE MASS (lump on arm). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node underneath the arm pit a couple inches in diameter) and SKIN IRRITATION (skin is irritated). At the time of the report, VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE MASS (lump on arm), LYMPHADENOPATHY (swollen lymph node underneath the arm pit a couple inches in diameter) and SKIN IRRITATION (skin is irritated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient used Tylenol as treatment medication.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: tingling sensation in her arm; large inflamed area; itchy; red; arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PARAESTHESIA (tingling sensation in her arm), VACCINATION SITE INFLAMMATION (large inflamed area), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0128L20A) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, DICLOFENAC for Arthritis, ASCORBIC ACID (VITAMIIN C) for Combined immunity deficiency, MAGNESIUM for Cramps, OMEPRAZOLE for GERD, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Routine health maintenance.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 30-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (large inflamed area), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). On 31-Jan-2021, the patient experienced PARAESTHESIA (tingling sensation in her arm). On 30-Jan-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, PARAESTHESIA (tingling sensation in her arm), VACCINATION SITE INFLAMMATION (large inflamed area), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient had Tylenol and little bit of ice as treatment measures.   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red at the site; itchy 2 spots that emerged on the other arm; swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE ERYTHEMA (red at the site) and VACCINATION SITE PRURITUS (itchy 2 spots that emerged on the other arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZQA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she got COVID 5months ago). Concurrent medical conditions included Asthma.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling on the injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at the site) and VACCINATION SITE PRURITUS (itchy 2 spots that emerged on the other arm). At the time of the report, VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE ERYTHEMA (red at the site) and VACCINATION SITE PRURITUS (itchy 2 spots that emerged on the other arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment and medication history was not provided
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Pyrexia, Tremor
Clinical narrative: Chest pain; Uncontrollable shaking; Chills which lasted for 3 hours; Fever 102.9 F; This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (Chest pain), TREMOR (Uncontrollable shaking), CHILLS (Chills which lasted for 3 hours) and PYREXIA (Fever 102.9 F) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced CHEST PAIN (Chest pain), TREMOR (Uncontrollable shaking), CHILLS (Chills which lasted for 3 hours) and PYREXIA (Fever 102.9 F). At the time of the report, CHEST PAIN (Chest pain), TREMOR (Uncontrollable shaking), CHILLS (Chills which lasted for 3 hours) and PYREXIA (Fever 102.9 F) 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.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Vaccination site rash
Clinical narrative: it's a little bit itchy and bumpy and dry; a rash on the arm where received the vaccine; head aches that come and go, a head ache that never had before; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it's a little bit itchy and bumpy and dry), VACCINATION SITE RASH (a rash on the arm where received the vaccine) and HEADACHE (head aches that come and go, a head ache that never had before) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (a rash on the arm where received the vaccine) and HEADACHE (head aches that come and go, a head ache that never had before). On an unknown date, the patient experienced PRURITUS (it's a little bit itchy and bumpy and dry). At the time of the report, PRURITUS (it's a little bit itchy and bumpy and dry), VACCINATION SITE RASH (a rash on the arm where received the vaccine) and HEADACHE (head aches that come and go, a head ache that never had before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient had advil as treatment medication.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headache) 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 02-Feb-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 03-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Sweat; Increased HR; Mild fever; Body Ache; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat), TACHYCARDIA (Increased HR), PYREXIA (Mild fever), MYALGIA (Body Ache) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HYPERHIDROSIS (Sweat), TACHYCARDIA (Increased HR), PYREXIA (Mild fever), MYALGIA (Body Ache), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweat), TACHYCARDIA (Increased HR), PYREXIA (Mild fever), MYALGIA (Body Ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: (Negative) quick test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient gave PCR test and waiting for the result. Patient used unspecified birth control pills as concomitant medication.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Sweat; Increased HR; Mild fever; Body Ache; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweat), TACHYCARDIA (Increased HR), PYREXIA (Mild fever), MYALGIA (Body Ache) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HYPERHIDROSIS (Sweat), TACHYCARDIA (Increased HR), PYREXIA (Mild fever), MYALGIA (Body Ache), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweat), TACHYCARDIA (Increased HR), PYREXIA (Mild fever), MYALGIA (Body Ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: (Negative) quick test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient gave PCR test and waiting for the result. Patient used unspecified birth control pills as concomitant medication.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: minor soreness in arm; swollen gland in armpit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor soreness in arm) and LYMPHADENOPATHY (swollen gland in armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (minor soreness in arm) and LYMPHADENOPATHY (swollen gland in armpit). At the time of the report, PAIN IN EXTREMITY (minor soreness in arm) and LYMPHADENOPATHY (swollen gland in armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  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.   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Upon internal review on 28 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: red circle at the vaccination site; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle at the vaccination site) and VACCINATION SITE RASH (rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle at the vaccination site) and VACCINATION SITE RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red circle at the vaccination site) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pruritus, Injection site swelling, Muscle spasms, Rash erythematous
Clinical narrative: Shortness of breath; Very swollen and red rash; Swelling at the injection site; Itching at the injection site; Cramping; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Cramping), DYSPNOEA (Shortness of breath), RASH ERYTHEMATOUS (Very swollen and red rash), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PRURITUS (Itching at the injection site) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Lactose intolerance and Seafood allergy (scallops). Concomitant products included TRAMADOL HCL, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), LORAZEPAM (ATIVAN) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced MUSCLE SPASMS (Cramping). On 20-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PRURITUS (Itching at the injection site). On 21-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and RASH ERYTHEMATOUS (Very swollen and red rash). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Cramping), DYSPNOEA (Shortness of breath), RASH ERYTHEMATOUS (Very swollen and red rash), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site redness; injection site swelling; injection site itching; warm to touch injection site; injection site lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE WARMTH (warm to touch injection site) and VACCINATION SITE MASS (injection site lump) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE WARMTH (warm to touch injection site) and VACCINATION SITE MASS (injection site lump). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE WARMTH (warm to touch injection site) and VACCINATION SITE MASS (injection site lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Pyrexia
Clinical narrative: Rash - Around Injection Site; Itchy Sensation - Around Injection Site; Diarrhea; Fever; Chills; Nausea; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches). On 01-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash - Around Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Around Injection Site). On 31-Jan-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches) had resolved. At the time of the report, VACCINATION SITE RASH (Rash - Around Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Around Injection Site) outcome was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash - Around Injection Site; Itchy Sensation - Around Injection Site; Diarrhea; Fever; Chills; Nausea; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches). On 01-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash - Around Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Around Injection Site). On 31-Jan-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches) had resolved. At the time of the report, VACCINATION SITE RASH (Rash - Around Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Around Injection Site) outcome was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: hard spot; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (hard spot) and RASH (rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20H) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE REACTION (hard spot) and RASH (rash). At the time of the report, VACCINATION SITE REACTION (hard spot) and RASH (rash) 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.   This case was linked to MOD-2020-016505 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Erythema, Headache, Hyperhidrosis
Clinical narrative: Swatting a lot almost her bedsheet was wait; upset stomach; Joint pain,; tempera100.2C; extreme headache; 7 days she got hives; redness at upper arm dawn to elbow; burning; swelling for 5 days and after that symptoms subside; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning), SWELLING (swelling for 5 days and after that symptoms subside) and HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 11-Jan-2021, the patient experienced URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning) and SWELLING (swelling for 5 days and after that symptoms subside). On 02-Feb-2021, the patient experienced HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (Joint pain,), PYREXIA (tempera100.2C) and HEADACHE (extreme headache). At the time of the report, URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning), SWELLING (swelling for 5 days and after that symptoms subside), HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (Joint pain,), PYREXIA (tempera100.2C) and HEADACHE (extreme headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Swelling, Urticaria
Clinical narrative: Swatting a lot almost her bedsheet was wait; upset stomach; Joint pain,; tempera100.2C; extreme headache; 7 days she got hives; redness at upper arm dawn to elbow; burning; swelling for 5 days and after that symptoms subside; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning), SWELLING (swelling for 5 days and after that symptoms subside) and HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 11-Jan-2021, the patient experienced URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning) and SWELLING (swelling for 5 days and after that symptoms subside). On 02-Feb-2021, the patient experienced HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (Joint pain,), PYREXIA (tempera100.2C) and HEADACHE (extreme headache). At the time of the report, URTICARIA (7 days she got hives), ERYTHEMA (redness at upper arm dawn to elbow), PAIN IN EXTREMITY (burning), SWELLING (swelling for 5 days and after that symptoms subside), HYPERHIDROSIS (Swatting a lot almost her bedsheet was wait), ABDOMINAL DISCOMFORT (upset stomach), ARTHRALGIA (Joint pain,), PYREXIA (tempera100.2C) and HEADACHE (extreme headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site pain, Vaccination site warmth
Clinical narrative: Raised area 2inches in size, red and slightly itchy; Itchiness; Raised area on arm that was red and warm to touch; Raised area on arm that was red and warm to touch; Soreness that lasted 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Raised area on arm that was red and warm to touch), VACCINATION SITE WARMTH (Raised area on arm that was red and warm to touch), PRURITUS (Raised area 2inches in size, red and slightly itchy) and VACCINATION SITE PAIN (Soreness that lasted 3 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness that lasted 3 days). On 31-Jan-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Raised area on arm that was red and warm to touch) and VACCINATION SITE WARMTH (Raised area on arm that was red and warm to touch). On an unknown date, the patient experienced PRURITUS (Raised area 2inches in size, red and slightly itchy). The patient was treated with Over counter cream at an unspecified dose and frequency. On 27-Jan-2021, VACCINATION SITE PAIN (Soreness that lasted 3 days) had resolved. At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Raised area on arm that was red and warm to touch), VACCINATION SITE WARMTH (Raised area on arm that was red and warm to touch) and PRURITUS (Raised area 2inches in size, red and slightly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Cough, Myalgia, Oropharyngeal pain
Clinical narrative: lost of smell; sore throat; cough; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost of smell), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 since 22-Jan-2021.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ANOSMIA (lost of smell), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and MYALGIA (Body ache). At the time of the report, ANOSMIA (lost of smell), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and MYALGIA (Body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Heart rate was fast and that it was 68; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate was fast and that it was 68) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 TACHYCARDIA (Heart rate was fast and that it was 68). At the time of the report, TACHYCARDIA (Heart rate was fast and that it was 68) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Myalgia, Tremor
Clinical narrative: Felt very weak; hands were shaking a lot; every joint in her body ached; Every part of her body ached; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt very weak), TREMOR (hands were shaking a lot), ARTHRALGIA (every joint in her body ached) and MYALGIA (Every part of her body ached) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no specified medical information was reported.  Concomitant products included LOSARTAN, POTASSIUM, AMLODIPINE, ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 28-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ASTHENIA (Felt very weak), TREMOR (hands were shaking a lot), ARTHRALGIA (every joint in her body ached) and MYALGIA (Every part of her body ached). At the time of the report, ASTHENIA (Felt very weak), TREMOR (hands were shaking a lot), ARTHRALGIA (every joint in her body ached) and MYALGIA (Every part of her body ached) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Face oedema, Lip oedema
Clinical narrative: Lip and lower part of the face is getting puffy; Lip and lower part of the face is getting puffy; This spontaneous case was reported by a consumer and describes the occurrence of FACE OEDEMA (Lip and lower part of the face is getting puffy) and LIP OEDEMA (Lip and lower part of the face is getting puffy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACE OEDEMA (Lip and lower part of the face is getting puffy) and LIP OEDEMA (Lip and lower part of the face is getting puffy). At the time of the report, FACE OEDEMA (Lip and lower part of the face is getting puffy) and LIP OEDEMA (Lip and lower part of the face is getting puffy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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. Further information has been requested. Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Upon internal review on 04 Jun 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Upon internal review on 04 Jun 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Herpes zoster, Rash, Vaccination site pain
Clinical narrative: Shingles; Rash; Pain in her stomach; Pain in her hips; injection site soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (Pain in her stomach), RASH (Rash), VACCINATION SITE PAIN (injection site soreness) and ARTHRALGIA (Pain in her hips) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness). On 27-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in her stomach) and ARTHRALGIA (Pain in her hips). On 31-Jan-2021, the patient experienced RASH (Rash). On 01-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles), ABDOMINAL PAIN UPPER (Pain in her stomach), RASH (Rash), VACCINATION SITE PAIN (injection site soreness) and ARTHRALGIA (Pain in her hips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: minor soreness at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (minor soreness at the injection site) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (minor soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (minor soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Headache, Injection site swelling, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature), HEADACHE (headache) and NAUSEA (feeling of wanting to vomit). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), INJECTION SITE SWELLING (Swollen arm at injection site), TENDERNESS (tenderness in arm), PYREXIA (low grade temperature), HEADACHE (headache) and NAUSEA (feeling of wanting to vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade temperature (abnormal) low grade temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.