chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pigmentation disorder, Pruritus
Clinical narrative: little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.; little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) and PIGMENTATION DISORDER (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRURITUS (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) and PIGMENTATION DISORDER (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.). At the time of the report, PRURITUS (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) and PIGMENTATION DISORDER (little dots and they were itchy above my knees, behind my elbows and on my neck. It started above my knees and for about a week, then it started progressing more and it is more itchy and now I have big red spots above my knees.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm; myalgia on side of the leg and foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MYALGIA (myalgia on side of the leg and foot) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-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 PAIN IN EXTREMITY (sore arm) and MYALGIA (myalgia on side of the leg and foot). At the time of the report, PAIN IN EXTREMITY (sore arm) and MYALGIA (myalgia on side of the leg and foot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-073913, MOD-2021-073689, MOD-2021-073650 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-073913:Son case MOD-2021-073689:Wife case MOD-2021-073650:Daughther case
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: nausea/ nauseous; headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea/ nauseous), HEADACHE (headache) and FATIGUE (exhausted) in a 47-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 DIAZEPAM, OLANZAPINE, TRAZODONE, PROPRANOLOL, HYDROXYZINE and IBUPROFEN (IBUPROFEN) 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 NAUSEA (nausea/ nauseous), HEADACHE (headache) and FATIGUE (exhausted). At the time of the report, NAUSEA (nausea/ nauseous), HEADACHE (headache) and FATIGUE (exhausted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information for the events was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI case ,no new information was provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: sore arm; body aches; headache; swollen lymph node; nausea; fatigue; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node) and NAUSEA (nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia and Hypothyroidism.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (mild fever). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. Treatment include Tylenol
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; body aches; headache; swollen lymph node; nausea; fatigue; mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node) and NAUSEA (nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia and Hypothyroidism.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (mild fever). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (body aches), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph node), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. Treatment include Tylenol
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscle spasms, Neuralgia, Pain, Rash
Clinical narrative: Nerve pain; Muscle spasms in my legs, chest/muscle apsams chest, legs; Pretty bad rash on her chest and neck; Really bad dizziness; Severe pain like burning in arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Really bad dizziness), PAIN (Severe pain like burning in arms and legs), MUSCLE SPASMS (Muscle spasms in my legs, chest/muscle apsams chest, legs), RASH (Pretty bad rash on her chest and neck) and NEURALGIA (Nerve pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Hypothyroidism since 07-Jan-2021. Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Anxiety, LEVOTHYROXINE, CITALOPRAM, LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Really bad dizziness), PAIN (Severe pain like burning in arms and legs) and RASH (Pretty bad rash on her chest and neck). On 08-Apr-2021, the patient experienced MUSCLE SPASMS (Muscle spasms in my legs, chest/muscle apsams chest, legs). On an unknown date, the patient experienced NEURALGIA (Nerve pain). The patient was treated with CORTISONE at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; GABAPENTIN (NEURONTIN) at a dose of 1 dosage form and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) at a dose of 1 dosage form. On 19-Apr-2021, DIZZINESS (Really bad dizziness) and RASH (Pretty bad rash on her chest and neck) had resolved. At the time of the report, PAIN (Severe pain like burning in arms and legs), MUSCLE SPASMS (Muscle spasms in my legs, chest/muscle apsams chest, legs) and NEURALGIA (Nerve pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073972 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and contains Non significant information. On 19-Jul-2021: Significant Follow up- Updated patient details, Updated Allergy and concurrent conditions, Updated concomitant and treatment medications, Updated new event and  events start dates and end dates and outcome of the events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Pyrexia
Clinical narrative: severe menstrual bleeding after menopause (8years ago); high fever - 103F; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (severe menstrual bleeding after menopause (8years ago)) and PYREXIA (high fever - 103F) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Menopause since 2013.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (severe menstrual bleeding after menopause (8years ago)) and PYREXIA (high fever - 103F). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (severe menstrual bleeding after menopause (8years ago)) and PYREXIA (high fever - 103F) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment included Advil. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.       On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5. On 06-Mar-2021, the patient experienced LIMB DISCOMFORT (sore arm). On 07-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (severe menstrual bleeding after menopause (8years ago)) (seriousness criterion medically significant) and PYREXIA (high fever - 103F). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-Apr-2021 at an unspecified dose and frequency. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported medication used for second dose reactions is ibuprofen.    This case was linked to MOD-2021-072661 (Patient Link).   This case was linked to MOD-2021-072661 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Illness, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Upper left arm started to hurt very badly), ILLNESS (I felt sick), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Acid reflux (oesophageal), Lisinopril- HCTZ for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol blood excessive, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, GABAPENTIN (NEURONTIN) for Restless leg syndrome, TRAZODONE for Sleep decreased, BUPROPION HYDROCHLORIDE (WELLBUTRIN), ACETYLSALICYLIC ACID (BABY ASPIRIN), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), METOPROLOL SUCCINATE (TOPROL XL), Tumeric, FENOFIBRATE, MULTIVITAMINS & MINERALS PLUS LUTEIN and CALCIUM for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Upper left arm started to hurt very badly), ILLNESS (I felt sick), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak), FATIGUE (Fatigue) and INSOMNIA (I could not sleep). On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Arm was swollen), LYMPH NODE PAIN (pain in my upper arm where I got my shot to my elbow and under my arm where my lymph node) and POLLAKIURIA (I started to urinate a lot). On 11-Apr-2021, ILLNESS (I felt sick) had resolved. At the time of the report, VACCINATION SITE PAIN (Upper left arm started to hurt very badly), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak), FATIGUE (Fatigue), INSOMNIA (I could not sleep), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Arm was swollen), LYMPH NODE PAIN (pain in my upper arm where I got my shot to my elbow and under my arm where my lymph node) and POLLAKIURIA (I started to urinate a lot) 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. Treatment information include Tylenol extra strength.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Muscular weakness, Peripheral swelling, Pollakiuria, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Upper left arm started to hurt very badly), ILLNESS (I felt sick), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for Acid reflux (oesophageal), Lisinopril- HCTZ for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol blood excessive, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, GABAPENTIN (NEURONTIN) for Restless leg syndrome, TRAZODONE for Sleep decreased, BUPROPION HYDROCHLORIDE (WELLBUTRIN), ACETYLSALICYLIC ACID (BABY ASPIRIN), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), METOPROLOL SUCCINATE (TOPROL XL), Tumeric, FENOFIBRATE, MULTIVITAMINS & MINERALS PLUS LUTEIN and CALCIUM for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Upper left arm started to hurt very badly), ILLNESS (I felt sick), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak), FATIGUE (Fatigue) and INSOMNIA (I could not sleep). On 09-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Arm was swollen), LYMPH NODE PAIN (pain in my upper arm where I got my shot to my elbow and under my arm where my lymph node) and POLLAKIURIA (I started to urinate a lot). On 11-Apr-2021, ILLNESS (I felt sick) had resolved. At the time of the report, VACCINATION SITE PAIN (Upper left arm started to hurt very badly), HEADACHE (I had an headache), MUSCULAR WEAKNESS (my legs were weak), FATIGUE (Fatigue), INSOMNIA (I could not sleep), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING (Arm was swollen), LYMPH NODE PAIN (pain in my upper arm where I got my shot to my elbow and under my arm where my lymph node) and POLLAKIURIA (I started to urinate a lot) 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. Treatment information include Tylenol extra strength.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: inadvertently administered with 1.0 ml of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine). On 10-Apr-2021, ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-073944, MOD-2021-073978, MOD-2021-073920 (E2B Linked Report).; Sender's Comments:  MOD-2021-073944:Cross linked case MOD-2021-073978:Cross linked case MOD-2021-073920:Cross linked case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Ocular hyperaemia, Pain in extremity
Clinical narrative: White part of right eye is all red; achy; fatigued; headache; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), OCULAR HYPERAEMIA (White part of right eye is all red), MYALGIA (achy), FATIGUE (fatigued) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), MYALGIA (achy), FATIGUE (fatigued) and HEADACHE (headache). On 06-Mar-2021, the patient experienced OCULAR HYPERAEMIA (White part of right eye is all red). At the time of the report, PAIN IN EXTREMITY (arm was sore), OCULAR HYPERAEMIA (White part of right eye is all red), MYALGIA (achy), FATIGUE (fatigued) and HEADACHE (headache) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Pain
Clinical narrative: Lack of appetite; rash at injection site that was warm and burning; rash at injection site that was warm and burning; rash at injection site that was warm and burning; Joint pain; extremely fatigued; body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), VACCINATION SITE WARMTH (rash at injection site that was warm and burning), DECREASED APPETITE (Lack of appetite), FATIGUE (extremely fatigued) and VACCINATION SITE PAIN (rash at injection site that was warm and burning) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 01-Apr-2021, the patient experienced PAIN (body aches) and CHILLS (Chills). On 02-Apr-2021, the patient experienced FATIGUE (extremely fatigued) and ARTHRALGIA (Joint pain). On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (rash at injection site that was warm and burning), VACCINATION SITE PAIN (rash at injection site that was warm and burning) and VACCINATION SITE RASH (rash at injection site that was warm and burning). On an unknown date, the patient experienced DECREASED APPETITE (Lack of appetite). On 02-Apr-2021, CHILLS (Chills) had resolved. On 03-Apr-2021, PAIN (body aches) had resolved. On 04-Apr-2021, VACCINATION SITE RASH (rash at injection site that was warm and burning) had resolved. On 16-Apr-2021, FATIGUE (extremely fatigued) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (rash at injection site that was warm and burning) and VACCINATION SITE PAIN (rash at injection site that was warm and burning) outcome was unknown.            Concomitant medication was not provided  Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: ADR received, AE updates, additional AE.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: Lack of appetite; rash at injection site that was warm and burning; rash at injection site that was warm and burning; rash at injection site that was warm and burning; Joint pain; extremely fatigued; body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), VACCINATION SITE WARMTH (rash at injection site that was warm and burning), DECREASED APPETITE (Lack of appetite), FATIGUE (extremely fatigued) and VACCINATION SITE PAIN (rash at injection site that was warm and burning) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 01-Apr-2021, the patient experienced PAIN (body aches) and CHILLS (Chills). On 02-Apr-2021, the patient experienced FATIGUE (extremely fatigued) and ARTHRALGIA (Joint pain). On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (rash at injection site that was warm and burning), VACCINATION SITE PAIN (rash at injection site that was warm and burning) and VACCINATION SITE RASH (rash at injection site that was warm and burning). On an unknown date, the patient experienced DECREASED APPETITE (Lack of appetite). On 02-Apr-2021, CHILLS (Chills) had resolved. On 03-Apr-2021, PAIN (body aches) had resolved. On 04-Apr-2021, VACCINATION SITE RASH (rash at injection site that was warm and burning) had resolved. On 16-Apr-2021, FATIGUE (extremely fatigued) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (rash at injection site that was warm and burning) and VACCINATION SITE PAIN (rash at injection site that was warm and burning) outcome was unknown.            Concomitant medication was not provided  Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2021: ADR received, AE updates, additional AE.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness; achy all over the whole body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness) and PAIN (achy all over the whole body) in a 32-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness) and PAIN (achy all over the whole body). At the time of the report, PAIN IN EXTREMITY (soreness) and PAIN (achy all over the whole body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Nerve pain; really bad dizziness; severe pain like burning in arms and legs; Muscle spasm; Burning arms and legs; a pretty bad rash on her chest and neck; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (really bad dizziness), PAIN (severe pain like burning in arms and legs), BURNING SENSATION (Burning arms and legs), MUSCLE SPASMS (Muscle spasm) and NEURALGIA (Nerve pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism since 07-Jan-2010 and Drug allergy (Phenergan). Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, CALCIUM, MULTIVITAMIN [VITAMINS NOS] and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced BURNING SENSATION (Burning arms and legs) and RASH (a pretty bad rash on her chest and neck). On 08-Apr-2021, the patient experienced DIZZINESS (really bad dizziness), PAIN (severe pain like burning in arms and legs) and MUSCLE SPASMS (Muscle spasm). On an unknown date, the patient experienced NEURALGIA (Nerve pain). The patient was treated with CORTISONE at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; GABAPENTIN (NEURONTIN) for Adverse event, at an unspecified dose and frequency and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, DIZZINESS (really bad dizziness) and RASH (a pretty bad rash on her chest and neck) had resolved. At the time of the report, PAIN (severe pain like burning in arms and legs), BURNING SENSATION (Burning arms and legs), MUSCLE SPASMS (Muscle spasm) and NEURALGIA (Nerve pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported the patient visited the ER on 05-Apr-2021 and visited a doctor's office/urgent care on 08-Apr-2021   This case was linked to MOD-2021-073955 (E2B Linked Report). This case was linked to MOD-2021-073955 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated patient demographics, current conditions and concomitant medications.Updated event outcome from unknown to recovered for following events: Rash and dizziness. On 19-Jul-2021: Follow up contains no new information. On 19-Jul-2021: Event outcome updated for muscle spasm, burning, rash and dizziness updated.  New event nerve pain added, treatment medications added.  Sought medical care.; Sender's Comments:  MOD-2021-073955:
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: had vertigo, ran into a wall; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (had vertigo, ran into a wall) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (had vertigo, ran into a wall). At the time of the report, VERTIGO (had vertigo, ran into a wall) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant medication not provided. Treatment medication not provided.  Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Fatigue, Pain
Clinical narrative: aches; needed rest; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), BED REST (needed rest) and FATIGUE (Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (aches), BED REST (needed rest) and FATIGUE (Tired). At the time of the report, PAIN (aches), BED REST (needed rest) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment medication not provided.   This case was linked to MOD-2021-073946 (E2B Linked Report).; Sender's Comments:  MOD-2021-073946:Second dose
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: now he need to wait 2 weeks before getting his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now he need to wait 2 weeks before getting his 2nd dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now he need to wait 2 weeks before getting his 2nd dose). On 11-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now he need to wait 2 weeks before getting his 2nd dose) had resolved. Not Provided          Concomitant medication not provided. Treatment medication not provided.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Incorrect dose administered
Clinical narrative: inadvertently administered with 1.0 ml of the vaccine; inadvertently administered with 1.0 ml of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) and INCORRECT DOSE ADMINISTERED (inadvertently administered with 1.0 ml of the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A,) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). 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, the patient experienced ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) and INCORRECT DOSE ADMINISTERED (inadvertently administered with 1.0 ml of the vaccine). At the time of the report, ACCIDENTAL OVERDOSE (inadvertently administered with 1.0 ml of the vaccine) and INCORRECT DOSE ADMINISTERED (inadvertently administered with 1.0 ml of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Nausea; Swollen arms; Itchiness; Dizzy; Tenderness; Redness; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arms), PRURITUS (Itchiness), DIZZINESS (Dizzy), TENDERNESS (Tenderness) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TENDERNESS (Tenderness), ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at injection site). On 11-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arms), PRURITUS (Itchiness) and DIZZINESS (Dizzy). On 12-Apr-2021, the patient experienced NAUSEA (Nausea). On 03-Apr-2021, TENDERNESS (Tenderness) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arms), PRURITUS (Itchiness), DIZZINESS (Dizzy), ERYTHEMA (Redness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included prednisone 20 mg for five days and Mupirosin 2% ointment three times a day.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: Nausea; Swollen arms; Itchiness; Dizzy; Tenderness; Redness; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arms), PRURITUS (Itchiness), DIZZINESS (Dizzy), TENDERNESS (Tenderness) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced TENDERNESS (Tenderness), ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at injection site). On 11-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arms), PRURITUS (Itchiness) and DIZZINESS (Dizzy). On 12-Apr-2021, the patient experienced NAUSEA (Nausea). On 03-Apr-2021, TENDERNESS (Tenderness) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arms), PRURITUS (Itchiness), DIZZINESS (Dizzy), ERYTHEMA (Redness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included prednisone 20 mg for five days and Mupirosin 2% ointment three times a day.  Company Comment: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Malaise, Pain in extremity
Clinical narrative: sore arm; tiredness; Felt warm; not feeling well; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING HOT (Felt warm), MALAISE (not feeling well), CHILLS (Chills) and FATIGUE (tiredness) 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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING HOT (Felt warm), MALAISE (not feeling well) and CHILLS (Chills). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING HOT (Felt warm), MALAISE (not feeling well), CHILLS (Chills) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication reported.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: New events were added chills,feeling not well and felling warm
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-073992 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073992:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       "Upon internal review on 04-Aug-21, the age units was corrected 66 years."
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical history has been reported.  Concomitant products included FLUVOXAMINE MALEATE (LUVOX), LAMOTRIGINE (LAMICTAL), OLANZAPINE (ZYPREXA), ATORVASTATIN, MELATONIN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LANSOPRAZOLE (PREVACID), TESTOSTERONE, FINASTERIDE (PROSCAR), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), WARFARIN and TRAZODONE 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 24-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight decreased: decreased (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   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 DIARRHOEA (diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided          Concomitant medication not provided.   Treatment medication included immodium.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-073987 (E2B Linked Report). This case was linked to MOD-2021-073987 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073987:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Chills, Fatigue
Clinical narrative: Injection site warm to touch; Injection site pain; Injection site swelling; Fatigue; Chills; Headache; Muscle pain; Joint pain; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, FATIGUE, and CHILLS in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, FATIGUE, CHILLS, HEADACHE, MYALGIA, ARTHRALGIA, and NAUSEA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, FATIGUE, CHILLS, HEADACHE, MYALGIA, ARTHRALGIA, and NAUSEA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/84 (High). On an unknown date, Body temperature: 97.9 (normal). On an unknown date, Heart rate: 82 (normal). On an unknown date, Respiratory rate: 16 (normal).     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 medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter details updated, patient demography updated, first dose details updated, event details were updated, lab data detail updated. On 16-Jul-2021: Email correspondence received and it contains No New Information.