chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Headache, Nervousness, Peripheral swelling
Clinical narrative: fingers were swollen and red; At the site of injection is a white mark with 2 red dots; Headache; She was nervous; a metallic taste; fingers were swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (She was nervous), DYSGEUSIA (a metallic taste), PERIPHERAL SWELLING (fingers were swollen and red), ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced NERVOUSNESS (She was nervous), DYSGEUSIA (a metallic taste), PERIPHERAL SWELLING (fingers were swollen and red) and HEADACHE (Headache). On 26-Mar-2021, the patient experienced ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots). On 25-Mar-2021, NERVOUSNESS (She was nervous) and DYSGEUSIA (a metallic taste) had resolved. On 26-Mar-2021, PERIPHERAL SWELLING (fingers were swollen and red) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) outcome was unknown.            no treatment medication provided.  no concomitant medication provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: fingers were swollen and red; At the site of injection is a white mark with 2 red dots; Headache; She was nervous; a metallic taste; fingers were swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (She was nervous), DYSGEUSIA (a metallic taste), PERIPHERAL SWELLING (fingers were swollen and red), ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced NERVOUSNESS (She was nervous), DYSGEUSIA (a metallic taste), PERIPHERAL SWELLING (fingers were swollen and red) and HEADACHE (Headache). On 26-Mar-2021, the patient experienced ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots). On 25-Mar-2021, NERVOUSNESS (She was nervous) and DYSGEUSIA (a metallic taste) had resolved. On 26-Mar-2021, PERIPHERAL SWELLING (fingers were swollen and red) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (fingers were swollen and red) and VACCINATION SITE ERYTHEMA (At the site of injection is a white mark with 2 red dots) outcome was unknown.            no treatment medication provided.  no concomitant medication provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tiny tenderness on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tiny tenderness on left arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Tiny tenderness on left arm). On 10-Feb-2021, VACCINATION SITE PAIN (Tiny tenderness on left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported  It was reported in the first follow up that the customer's symptoms resolved and requested no further follow-up   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: No specific follow-up information recorded.; Sender's Comments:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vertigo
Clinical narrative: injection site red mark about 4 inches long and 2 inches wide; it is still hard; Vertigo; A spontaneous report was received from a consumer concerning herself, who is a 63-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events below the injection site red mark about 4inches long and 2inches wide, it is still hard, vertigo.  The patient's medical history was vertigo diverticulitis. Concomitant medications reported were guaifenesin, pseudoephedrine hydrochloride for drug use for unknown indication.  On 16 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038821A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events below the injection site red mark about 4inches long and 2inches wide, it is still hard and vertigo.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events below the injection site red mark about 4inches long and 2inches wide, vertigo was unknown. The outcome of event it is still hard was not resolved at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Movement disorder, Vaccination site swelling
Clinical narrative: my arm at the injection site swelled up; the lymph nodes of my neck are swollen; dizzy; trouble standing up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (my arm at the injection site swelled up), LYMPHADENOPATHY (the lymph nodes of my neck are swollen), DIZZINESS (dizzy) and MOVEMENT DISORDER (trouble standing up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE SWELLING (my arm at the injection site swelled up), LYMPHADENOPATHY (the lymph nodes of my neck are swollen), DIZZINESS (dizzy) and MOVEMENT DISORDER (trouble standing up). At the time of the report, VACCINATION SITE SWELLING (my arm at the injection site swelled up), LYMPHADENOPATHY (the lymph nodes of my neck are swollen), DIZZINESS (dizzy) and MOVEMENT DISORDER (trouble standing up) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include High blood pressure medication, Nerve pain medication, Depression medication and Thyroid medication.  No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Depressed mood, Fatigue, Oropharyngeal discomfort
Clinical narrative: cough; runny nose; discomfort in throat; depressed; fatigued; arm was sore; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), ABDOMINAL PAIN UPPER (stomach ache), FATIGUE (fatigued), DEPRESSED MOOD (depressed) and RHINORRHOEA (runny nose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and ABDOMINAL PAIN UPPER (stomach ache). On 18-Mar-2021, the patient experienced FATIGUE (fatigued). On 22-Mar-2021, the patient experienced DEPRESSED MOOD (depressed). On 23-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and OROPHARYNGEAL DISCOMFORT (discomfort in throat). On 26-Mar-2021, the patient experienced COUGH (cough). On 18-Mar-2021, VACCINATION SITE PAIN (arm was sore) and ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown. At the time of the report, FATIGUE (fatigued), DEPRESSED MOOD (depressed), RHINORRHOEA (runny nose), OROPHARYNGEAL DISCOMFORT (discomfort in throat) and COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs included
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: cough; runny nose; discomfort in throat; depressed; fatigued; arm was sore; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), ABDOMINAL PAIN UPPER (stomach ache), FATIGUE (fatigued), DEPRESSED MOOD (depressed) and RHINORRHOEA (runny nose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore) and ABDOMINAL PAIN UPPER (stomach ache). On 18-Mar-2021, the patient experienced FATIGUE (fatigued). On 22-Mar-2021, the patient experienced DEPRESSED MOOD (depressed). On 23-Mar-2021, the patient experienced RHINORRHOEA (runny nose) and OROPHARYNGEAL DISCOMFORT (discomfort in throat). On 26-Mar-2021, the patient experienced COUGH (cough). On 18-Mar-2021, VACCINATION SITE PAIN (arm was sore) and ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown. At the time of the report, FATIGUE (fatigued), DEPRESSED MOOD (depressed), RHINORRHOEA (runny nose), OROPHARYNGEAL DISCOMFORT (discomfort in throat) and COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs included
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: Developed a cough; Terrible headache; fever of 100F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Developed a cough), HEADACHE (Terrible headache) and PYREXIA (fever of 100F) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CARBAMAZEPINE (TEGRETOL), FENOFIBRATE, FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), LISINOPRIL DIHYDRATE (PRINIVIL) and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Terrible headache) and PYREXIA (fever of 100F). On an unknown date, the patient experienced COUGH (Developed a cough). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) at an unspecified dose and frequency. At the time of the report, COUGH (Developed a cough), HEADACHE (Terrible headache) and PYREXIA (fever of 100F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: sore throat; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore arm at injection site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and VACCINATION SITE PAIN (sore arm at injection site). The patient was treated with ASCORBIC ACID (VITAMIN C ACID) at a dose of 4000 IU; CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ALKA-SELTZER PLUS COLD [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency; ORIGANUM MINUTIFLORUM OIL (OREGANO OIL) at an unspecified dose and frequency and CURCUMA LONGA ROOT, PIPER NIGRUM FRUIT (TURMERIC SUPREME EXTRA STRENGTH) at an unspecified dose and frequency. On 06-Mar-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hepatitis C
Clinical narrative: Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01SM20A or 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Little tired). On 11-Feb-2021, FATIGUE (Little tired) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Hepatitis C: false positive (abnormal) False positive result.         Patient reported that before donating blood, he received a false positive Hepatitis C result. Concomitant medication was not provided Treatment information was not provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-059819 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document was received on 26-MAY-2021. Reporter's address was added. Patient's first dose date, second dose batch no. were included. It contains significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059819:Wife case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Headache, Pyrexia
Clinical narrative: Fever of 100; headaches; twitch in my eyelid; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (twitch in my eyelid), PYREXIA (Fever of 100) and HEADACHE (headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced BLEPHAROSPASM (twitch in my eyelid). On an unknown date, the patient experienced PYREXIA (Fever of 100) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, BLEPHAROSPASM (twitch in my eyelid), PYREXIA (Fever of 100) and HEADACHE (headaches) had resolved.            No Concomitant  information was  provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Event outcome was updated.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: patient's back was hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (patient's back was hurting) 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 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced BACK PAIN (patient's back was hurting). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (patient's back was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Somnolence
Clinical narrative: Back pain; Hard time getting up; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and SOMNOLENCE (Hard time getting up) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain) and SOMNOLENCE (Hard time getting up). At the time of the report, BACK PAIN (Back pain) and SOMNOLENCE (Hard time getting up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Lethargy, Pain in extremity, Paraesthesia oral
Clinical narrative: tingling tongue; excessive unquenchable thirst/Really thirsty; dry tongue; been to restroom a lot; disturb sleep; sore arm; lethargic; headache; got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site; got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling tongue), THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), HEADACHE (headache), VACCINATION SITE REACTION (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) and VACCINATION SITE RASH (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site). On 23-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling tongue), THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep). The patient was treated with IBUPROFEN for Rash, at an unspecified dose and frequency. On 25-Mar-2021, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic) and HEADACHE (headache) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling tongue) had not resolved, THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep) outcome was unknown and VACCINATION SITE REACTION (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) and VACCINATION SITE RASH (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) had resolved.            Concomitant medications were not provided. The patient said she did not have any issues after second dose.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: additional adverse events were updated
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Polyuria, Sleep disorder, Thirst, Vaccination site rash, Vaccination site reaction
Clinical narrative: tingling tongue; excessive unquenchable thirst/Really thirsty; dry tongue; been to restroom a lot; disturb sleep; sore arm; lethargic; headache; got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site; got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling tongue), THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), HEADACHE (headache), VACCINATION SITE REACTION (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) and VACCINATION SITE RASH (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site). On 23-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling tongue), THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep). The patient was treated with IBUPROFEN for Rash, at an unspecified dose and frequency. On 25-Mar-2021, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic) and HEADACHE (headache) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling tongue) had not resolved, THIRST (excessive unquenchable thirst/Really thirsty), DRY MOUTH (dry tongue), POLYURIA (been to restroom a lot) and SLEEP DISORDER (disturb sleep) outcome was unknown and VACCINATION SITE REACTION (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) and VACCINATION SITE RASH (got the covid arm about 8 days after first dose. Caller said a big rash of about 5 or 6 inches around injection site) had resolved.            Concomitant medications were not provided. The patient said she did not have any issues after second dose.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: additional adverse events were updated
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: started to lose the sense of smell and taste again; started to lose the sense of smell and taste again; This spontaneous case was reported by a health care professional and describes the occurrence of ANOSMIA (started to lose the sense of smell and taste again) and AGEUSIA (started to lose the sense of smell and taste again) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ANOSMIA (started to lose the sense of smell and taste again) and AGEUSIA (started to lose the sense of smell and taste again). At the time of the report, ANOSMIA (started to lose the sense of smell and taste again) and AGEUSIA (started to lose the sense of smell and taste again) 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.   concomitant medication  included yes but was not given and treatment taken was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness on L arm at the site of injection; L arm of injection hurts a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on L arm at the site of injection) and VACCINATION SITE PAIN (L arm of injection hurts a little) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness on L arm at the site of injection) and VACCINATION SITE PAIN (L arm of injection hurts a little). At the time of the report, VACCINATION SITE ERYTHEMA (Redness on L arm at the site of injection) and VACCINATION SITE PAIN (L arm of injection hurts a little) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; Severe aches on her legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and PAIN IN EXTREMITY (Severe aches on her legs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, 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 PAIN IN EXTREMITY (Arm soreness) and PAIN IN EXTREMITY (Severe aches on her legs). On 11-Mar-2021, PAIN IN EXTREMITY (Arm soreness) and PAIN IN EXTREMITY (Severe aches on her legs) had resolved. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were provided.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-059796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059796:Dose 1
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 10 days apart; A spontaneous report was received from a pharmacist, concerning, a 69- year-old male patient, who received Moderna COVID-19 vaccine (mRNA-1273) 8 days apart from the first dose (Inappropriate schedule of product administration).  The patient's medical history was not reported. Concomitant medication was not reported.  On 26 Feb 2021, prior to onset of events, the patient received his first of the two planned vaccine doses of mRNA-1273 (Lot number:014M20A) via intramuscular route for prophylaxis of COVID-19 infection.  On 08 Mar 2021, prior to onset of events, the patient received his second of the two planned vaccine doses of mRNA-1273 (Lot number:(040A21A) via unknown route for prophylaxis of COVID-19 infection.  On 08 Mar 2021, patient was administered second dose of vaccine, 8 days apart from the first dose. There were no known adverse events experienced.  Laboratory details were not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  On 08 Mar 2021, outcome of the event, received  second dose of vaccine, 8 days apart from the first dose, was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration,  for mRNA-1273, lot #: 040A21A, with no associated AEs.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Erythema, Fatigue
Clinical narrative: sore arm; Headache; coldness in the extremities; dizziness; fatigue; Nausea; itchiness arm; red arm; diarrhea; stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea) and PRURITUS (itchiness arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis (Improved May 2015 when stopped Pantaprazole) since 03-Jan-2013. Concurrent medical conditions included Drug allergy (Pantoprazole (oral) and possibly others in PPI class), Hypothyroidism since 09-Jan-1990 and Migraine since 07-Jan-1968. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 15-Mar-2013 to an unknown date and MONTELUKAST from 15-Mar-2013 to an unknown date for Anaphylaxis, BISACODYL (EQUATE GENTLE LAXATIVE) from 01-Apr-2007 to an unknown date for Constipation, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Sep-1991 to an unknown date for Hypothyroidism.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 15-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea), PRURITUS (itchiness arm), ERYTHEMA (red arm), DIARRHOEA (diarrhea) and FEELING COLD (coldness in the extremities). On 16-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea), PRURITUS (itchiness arm), ERYTHEMA (red arm), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and FEELING COLD (coldness in the extremities) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) had resolved.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-133079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Patient information added, medical history and medication history added. Outcome of the events added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Pain in extremity, Pruritus
Clinical narrative: sore arm; Headache; coldness in the extremities; dizziness; fatigue; Nausea; itchiness arm; red arm; diarrhea; stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea) and PRURITUS (itchiness arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis (Improved May 2015 when stopped Pantaprazole) since 03-Jan-2013. Concurrent medical conditions included Drug allergy (Pantoprazole (oral) and possibly others in PPI class), Hypothyroidism since 09-Jan-1990 and Migraine since 07-Jan-1968. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 15-Mar-2013 to an unknown date and MONTELUKAST from 15-Mar-2013 to an unknown date for Anaphylaxis, BISACODYL (EQUATE GENTLE LAXATIVE) from 01-Apr-2007 to an unknown date for Constipation, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Sep-1991 to an unknown date for Hypothyroidism.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 15-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea), PRURITUS (itchiness arm), ERYTHEMA (red arm), DIARRHOEA (diarrhea) and FEELING COLD (coldness in the extremities). On 16-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Mar-2021, DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (Nausea), PRURITUS (itchiness arm), ERYTHEMA (red arm), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and FEELING COLD (coldness in the extremities) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) had resolved.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-133079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Patient information added, medical history and medication history added. Outcome of the events added.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness
Clinical narrative: felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus, Emphysema (minor Emphysema w/ fibrosis), Blood pressure high and Arthritis. Concomitant products included CARVEDILOL for Hypertension, METFORMIN for Type II diabetes mellitus, ATORVASTATIN CALCIUM (LIPITOR), RAMIPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DIZZINESS (felt dizzy). At the time of the report, DIZZINESS (felt dizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: upto 283 (High) Blood glucose increased Blood sugar went to upto 283 checked again in minutes to be sure the meter was functioning properly and it was 280., 135 (Inconclusive) He drank a gallon or so of water and took a walk; the blood sugar is now 135 (7:46 PM CT). and 195 (Inconclusive) at 6PM glucose was down to 195.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment with water and walk were reported by the patient, pertained to the events .   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25MAY2021, added information about patients medical history and concomitant medications.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Malaise, Pyrexia
Clinical narrative: not feeling good at all; redness is running down the arm; redness; highest temperature of 101 degrees F; horrible headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), ERYTHEMA (redness is running down the arm), MALAISE (not feeling good at all), PYREXIA (highest temperature of 101 degrees F) and HEADACHE (horrible headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 23-Mar-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 23-Mar-2021, the patient experienced ERYTHEMA (redness), PYREXIA (highest temperature of 101 degrees F) and HEADACHE (horrible headache). On 25-Mar-2021, the patient experienced ERYTHEMA (redness is running down the arm). On an unknown date, the patient experienced MALAISE (not feeling good at all). On 25-Mar-2021, PYREXIA (highest temperature of 101 degrees F) had resolved. At the time of the report, ERYTHEMA (redness), ERYTHEMA (redness is running down the arm), MALAISE (not feeling good at all) and HEADACHE (horrible headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were not provided No treatment medications were not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: nose is running; This spontaneous case was reported by a consumer and describes the occurrence of   in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 11-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 11-Feb-2021, the patient experienced FATIGUE (Little tired). On 11-Feb-2021, FATIGUE (Little tired) had resolved. Not Provided          Action taken with mRNA 1273 in response to drug is not applicable . No Concomitant  information was  provided. No Treatment information was  provided. Patient donate blood regularly and on 16MAR2021 before his blood donation, he received a false positive Hep C test. He mainly wanted to report this AE.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Cough, Nasal congestion
Clinical narrative: cough; nasal congestion; back pain; body ache; chills; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), NASAL CONGESTION (nasal congestion), BACK PAIN (back pain), COUGH (cough) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (body ache), BACK PAIN (back pain), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain). On 19-Mar-2021, the patient experienced NASAL CONGESTION (nasal congestion) and COUGH (cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (VICKS NYQUIL) for Nasal congestion and Cough, at an unspecified dose and frequency. On 02-Mar-2021, PAIN (body ache), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain) had resolved. On 14-Mar-2021, BACK PAIN (back pain) had resolved. At the time of the report, NASAL CONGESTION (nasal congestion) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: cough; nasal congestion; back pain; body ache; chills; nausea; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), NASAL CONGESTION (nasal congestion), BACK PAIN (back pain), COUGH (cough) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (body ache), BACK PAIN (back pain), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain). On 19-Mar-2021, the patient experienced NASAL CONGESTION (nasal congestion) and COUGH (cough). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (VICKS NYQUIL) for Nasal congestion and Cough, at an unspecified dose and frequency. On 02-Mar-2021, PAIN (body ache), CHILLS (chills), NAUSEA (nausea) and ARTHRALGIA (joint pain) had resolved. On 14-Mar-2021, BACK PAIN (back pain) had resolved. At the time of the report, NASAL CONGESTION (nasal congestion) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: warm to touch at the injection site; soreness; Redness; swelling; Chills; Headache; Body ache; fever of 101; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and CHILLS (Chills) in a patient of an unknown age and gender 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 was reported.     On 24-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 VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (fever of 101). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (fever of 101) outcome was unknown and MYALGIA (Body ache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to touch at the injection site; soreness; Redness; swelling; Chills; Headache; Body ache; fever of 101; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and CHILLS (Chills) in a patient of an unknown age and gender 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 was reported.     On 24-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 VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body ache) and PYREXIA (fever of 101). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE PAIN (soreness), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (fever of 101) outcome was unknown and MYALGIA (Body ache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided.