chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Erythema, Headache, Insomnia
Clinical narrative: Burning and itching feeling; Couldn't sleep because of the itching; Burning and itching feeling; The redness on my arm, going down my arm; Fever (99.9F); Headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm) and PYREXIA (Fever (99.9F)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm), PYREXIA (Fever (99.9F)) and HEADACHE (Headache). At the time of the report, BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm), PYREXIA (Fever (99.9F)) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.9 (Inconclusive) 99.9 F.         No concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Burning and itching feeling; Couldn't sleep because of the itching; Burning and itching feeling; The redness on my arm, going down my arm; Fever (99.9F); Headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm) and PYREXIA (Fever (99.9F)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm), PYREXIA (Fever (99.9F)) and HEADACHE (Headache). At the time of the report, BURNING SENSATION (Burning and itching feeling), INSOMNIA (Couldn't sleep because of the itching), PRURITUS (Burning and itching feeling), ERYTHEMA (The redness on my arm, going down my arm), PYREXIA (Fever (99.9F)) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.9 (Inconclusive) 99.9 F.         No concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: rashes due to skin lupus have disappeared; achiness; Fever; Nausea; fatigue; headache; rash on the side of injection, which was already present before the vaccine; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash on the side of injection, which was already present before the vaccine), THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared), PAIN (achiness), PYREXIA (Fever) and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash (Patient has had a rash for years on ankles and upper arms) and Cutaneous lupus erythematosus.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash on the side of injection, which was already present before the vaccine), PAIN (achiness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared). At the time of the report, RASH (rash on the side of injection, which was already present before the vaccine) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared), PAIN (achiness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Therapeutic response unexpected
Clinical narrative: rashes due to skin lupus have disappeared; achiness; Fever; Nausea; fatigue; headache; rash on the side of injection, which was already present before the vaccine; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash on the side of injection, which was already present before the vaccine), THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared), PAIN (achiness), PYREXIA (Fever) and NAUSEA (Nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash (Patient has had a rash for years on ankles and upper arms) and Cutaneous lupus erythematosus.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced RASH (rash on the side of injection, which was already present before the vaccine), PAIN (achiness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared). At the time of the report, RASH (rash on the side of injection, which was already present before the vaccine) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (rashes due to skin lupus have disappeared), PAIN (achiness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.  Concomitant products included METHOTREXATE SODIUM (METHOTREXATE [METHOTREXATE SODIUM]), OMEPRAZOLE, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), ATORVASTATIN and FOLIC ACID for an unknown indication.   On 18-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 PYREXIA (fever). At the time of the report, PYREXIA (fever) was resolving.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: felt tender; Swollen; Itchy; Red; I have COVID arm; Hot; bruising - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I have COVID arm), CONTUSION (bruising - left arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PAIN (felt tender) and VACCINATION SITE SWELLING (Swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (bruising - left arm). On 19-Mar-2021, the patient experienced VACCINATION SITE REACTION (I have COVID arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red). On an unknown date, the patient experienced VACCINATION SITE PAIN (felt tender). On 19-Mar-2021, VACCINATION SITE REACTION (I have COVID arm) and CONTUSION (bruising - left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE PAIN (felt tender), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red) had resolved.            Concomitant medications were not provided. Treatment details : Amica Cream for bruising Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: ADR attached. Added patient demographics. Added new events and outcome.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: felt tender; Swollen; Itchy; Red; I have COVID arm; Hot; bruising - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I have COVID arm), CONTUSION (bruising - left arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PAIN (felt tender) and VACCINATION SITE SWELLING (Swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (bruising - left arm). On 19-Mar-2021, the patient experienced VACCINATION SITE REACTION (I have COVID arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red). On an unknown date, the patient experienced VACCINATION SITE PAIN (felt tender). On 19-Mar-2021, VACCINATION SITE REACTION (I have COVID arm) and CONTUSION (bruising - left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE PAIN (felt tender), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red) had resolved.            Concomitant medications were not provided. Treatment details : Amica Cream for bruising Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: ADR attached. Added patient demographics. Added new events and outcome.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue
Clinical narrative: vaccine leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (vaccine leaked out) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-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 19-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (vaccine leaked out). At the time of the report, DEVICE CONNECTION ISSUE (vaccine leaked out) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; fever of 100 degrees Celsius; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) and PYREXIA (fever of 100 degrees Celsius) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN D3, ASCORBIC ACID (VITAMIN C ACID), ZINC, PROBIOTICS NOS, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), METOPROLOL SUCCINATE (TOPROL), PRAVASTATIN, CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN LOW), CLOPIDOGREL BISULFATE (PLAVIX) and LANSOPRAZOLE (PREVACID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19) and PYREXIA (fever of 100 degrees Celsius). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19) and PYREXIA (fever of 100 degrees Celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100 (High) 100 degree Celsius. On 10-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the event was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: arm was more swollen, red and hard at injection site.; arm was more swollen, red and hard at injection site.; arm was more swollen, red and hard at injection site.; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE INDURATION (arm was more swollen, red and hard at injection site.), VACCINATION SITE SWELLING (arm was more swollen, red and hard at injection site.) and VACCINATION SITE ERYTHEMA (arm was more swollen, red and hard at injection site.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Mar-2021, the patient experienced VACCINATION SITE INDURATION (arm was more swollen, red and hard at injection site.), VACCINATION SITE SWELLING (arm was more swollen, red and hard at injection site.) and VACCINATION SITE ERYTHEMA (arm was more swollen, red and hard at injection site.). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE INDURATION (arm was more swollen, red and hard at injection site.), VACCINATION SITE SWELLING (arm was more swollen, red and hard at injection site.) and VACCINATION SITE ERYTHEMA (arm was more swollen, red and hard at injection site.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that the patient was taking concomitant medications but did not specify. No treatment medications were given.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: swelling on his face; rash on the left and right sides of his face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on his face) and RASH (rash on the left and right sides of his face) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SWELLING FACE (swelling on his face) and RASH (rash on the left and right sides of his face). At the time of the report, SWELLING FACE (swelling on his face) and RASH (rash on the left and right sides of his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications provided No relevant treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: A spontaneous report was received from a consumer concerning himself a 67-year-old, male patient who developed injection site swelling and swelling progress down whole arm/ peripheral swelling. The patient's medical history was not provided.  Concomitant product use was unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 021M20A) on 15-FEB-2021. On 16-MAR-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 001321A) for prophylaxis of COVID-19 infection. The patient experienced injection site swelling, swelling progress down to my whole arm like it has blood clot. Treatment for the events included Benadryl. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the event(s) is not applicable. The outcomes of events, Injection site swelling and peripheral swelling were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: She experienced heat at injection site; She experienced swelling at injection site; She experienced redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (She experienced heat at injection site), VACCINATION SITE SWELLING (She experienced swelling at injection site) and VACCINATION SITE ERYTHEMA (She experienced redness at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (She experienced heat at injection site), VACCINATION SITE SWELLING (She experienced swelling at injection site) and VACCINATION SITE ERYTHEMA (She experienced redness at injection site). At the time of the report, VACCINATION SITE WARMTH (She experienced heat at injection site), VACCINATION SITE SWELLING (She experienced swelling at injection site) and VACCINATION SITE ERYTHEMA (She experienced redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-051570 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: Shortness of breath; Body Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and PAIN (Body Pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and PAIN (Body Pain). At the time of the report, DYSPNOEA (Shortness of breath) and PAIN (Body Pain) 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.   No concomitant medications were reported. No treatment medications were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Age 17 1/2; A spontaneous report was received from a consumer, concerning a 17-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) at age 17 1/2 (product administered to patient of inappropriate age).  The patient's medical history includes ulcerative colitis. Concomitant product use was not provided by reporter.  On 19 Mar 2021, patient received herr first of the two planned vaccine doses of mRNA-1273 (lot number: 045A1A) intramuscularly for COVID-19 infection prophylaxis.  On 19 Mar 2021, the patient received vaccine at the age of 171/2.  Action taken with mRNA-1273 in response to the event was not provided.  The event, at age 17 ½, was considered resolved.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 045A1A, with no associated AEs.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative Covid-19 antibody test) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20H) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative Covid-19 antibody test). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Negative Covid-19 antibody test) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Site of injection is itching; developed red rash.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE RASH (developed red rash.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE RASH (developed red rash.). At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE RASH (developed red rash.) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant medication listed. treatment provided was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: very high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003D21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SOMATROPIN, DICYCLOMINE [DICYCLOVERINE], LISINOPRIL and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (very high fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (very high fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 to 101.6 (High) 101.3 F to 101.6 F.         Action taken with mRNA-1273 in response to the event was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Headache, Hyperglycaemia, Pain
Clinical narrative: sugar has been double and triple what it should be; slight aches (body aches); chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (sugar has been double and triple what it should be), PAIN (slight aches (body aches)), CHILLS (chills) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus (on insulin pump).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (slight aches (body aches)), CHILLS (chills) and HEADACHE (headache). On 10-Mar-2021, the patient experienced HYPERGLYCAEMIA (sugar has been double and triple what it should be). On 26-Feb-2021, PAIN (slight aches (body aches)), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, HYPERGLYCAEMIA (sugar has been double and triple what it should be) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood glucose: double (High) sugar has been double and triple than what it should be.         No relevant concomitant medications were reported. The patient did not take any treatment medication. The patient's sugar level had been double and triple than what it should be. She changed to a fresh pump. She was not sure if the blood sugar surge was due to vaccine or not.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: blood pressure issues - had never had high blood pressure before; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure issues - had never had high blood pressure before) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure issues - had never had high blood pressure before). At the time of the report, HYPERTENSION (blood pressure issues - had never had high blood pressure before) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Urticaria, Vaccination site erythema
Clinical narrative: Hives around neck; feels very bad; Headache; Joint pain; Injection site turned red; injection site started to swell; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain) and VACCINATION SITE ERYTHEMA (Injection site turned red) in a 57-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 information was reported.    On 11-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 URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (injection site started to swell). At the time of the report, URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (injection site started to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Hives around neck; feels very bad; Headache; Joint pain; Injection site turned red; injection site started to swell; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain) and VACCINATION SITE ERYTHEMA (Injection site turned red) in a 57-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 information was reported.    On 11-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 URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (injection site started to swell). At the time of the report, URTICARIA (Hives around neck), FEELING ABNORMAL (feels very bad), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (injection site started to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Breast pain, Chest pain, Chills
Clinical narrative: Felt like something hit me in the chest; Difficulty Breathing; Swollen Face and Lips; Anxiety; Sweats; Hurting around Right side (the area of Mastectomy 2019); Eyes and Eyeballs Hurting very bad; Eyes and Eyeballs Hurting very bad; Swollen Face and Lips; Chills; Joint pain; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety) and HYPERHIDROSIS (Sweats) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event, Glaucoma, Arthritis and Mastectomy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the first episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), the second episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the last episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye pain, Hyperhidrosis, Lip swelling, Myalgia
Clinical narrative: Felt like something hit me in the chest; Difficulty Breathing; Swollen Face and Lips; Anxiety; Sweats; Hurting around Right side (the area of Mastectomy 2019); Eyes and Eyeballs Hurting very bad; Eyes and Eyeballs Hurting very bad; Swollen Face and Lips; Chills; Joint pain; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety) and HYPERHIDROSIS (Sweats) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event, Glaucoma, Arthritis and Mastectomy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the first episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), the second episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the last episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Felt like something hit me in the chest; Difficulty Breathing; Swollen Face and Lips; Anxiety; Sweats; Hurting around Right side (the area of Mastectomy 2019); Eyes and Eyeballs Hurting very bad; Eyes and Eyeballs Hurting very bad; Swollen Face and Lips; Chills; Joint pain; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety) and HYPERHIDROSIS (Sweats) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event, Glaucoma, Arthritis and Mastectomy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CLONAZEPAM (KLONOPIN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the first episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), the second episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Felt like something hit me in the chest), DYSPNOEA (Difficulty Breathing), LIP SWELLING (Swollen Face and Lips), ANXIETY (Anxiety), HYPERHIDROSIS (Sweats), BREAST PAIN (Hurting around Right side (the area of Mastectomy 2019)), the last episode of EYE PAIN (Eyes and Eyeballs Hurting very bad), SWELLING FACE (Swollen Face and Lips), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Hot flush, Oropharyngeal pain
Clinical narrative: slight sore throat; hot flashes; sore from head to foot; energy reduced; appetite is reduced; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (slight sore throat), HOT FLUSH (hot flashes), PAIN IN EXTREMITY (sore from head to foot), ASTHENIA (energy reduced) and DECREASED APPETITE (appetite is reduced) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asperger's disorder (body is more sensitive than the general population).    On 17-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 OROPHARYNGEAL PAIN (slight sore throat), HOT FLUSH (hot flashes), PAIN IN EXTREMITY (sore from head to foot), ASTHENIA (energy reduced), DECREASED APPETITE (appetite is reduced) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (slight sore throat), HOT FLUSH (hot flashes), PAIN IN EXTREMITY (sore from head to foot), ASTHENIA (energy reduced), DECREASED APPETITE (appetite is reduced) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slight sore throat; hot flashes; sore from head to foot; energy reduced; appetite is reduced; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (slight sore throat), HOT FLUSH (hot flashes), PAIN IN EXTREMITY (sore from head to foot), ASTHENIA (energy reduced) and DECREASED APPETITE (appetite is reduced) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asperger's disorder (body is more sensitive than the general population).    On 17-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 OROPHARYNGEAL PAIN (slight sore throat), HOT FLUSH (hot flashes), PAIN IN EXTREMITY (sore from head to foot), ASTHENIA (energy reduced), DECREASED APPETITE (appetite is reduced) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (slight sore throat), HOT FLUSH (hot flashes), PAIN IN EXTREMITY (sore from head to foot), ASTHENIA (energy reduced), DECREASED APPETITE (appetite is reduced) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Disorientation, Emotional disorder, Pyrexia
Clinical narrative: Disorientation; Off Balance; Emotionally Off; Shaking; Swollen Injection Site; Fever (Low grade); This spontaneous case was reported by a nurse and describes the occurrence of DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking), VACCINATION SITE SWELLING (Swollen Injection Site) and PYREXIA (Fever (Low grade)). In February 2021, DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking), VACCINATION SITE SWELLING (Swollen Injection Site) and PYREXIA (Fever (Low grade)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication information provided.  No treatment medication information provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vaccination site swelling
Clinical narrative: Disorientation; Off Balance; Emotionally Off; Shaking; Swollen Injection Site; Fever (Low grade); This spontaneous case was reported by a nurse and describes the occurrence of DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking), VACCINATION SITE SWELLING (Swollen Injection Site) and PYREXIA (Fever (Low grade)). In February 2021, DISORIENTATION (Disorientation), BALANCE DISORDER (Off Balance), EMOTIONAL DISORDER (Emotionally Off), TREMOR (Shaking), VACCINATION SITE SWELLING (Swollen Injection Site) and PYREXIA (Fever (Low grade)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication information provided.  No treatment medication information provided.