chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy
Clinical narrative: Axillary lymph nodes enlarged; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Axillary lymph nodes enlarged) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Patient had a double mastectomy 2.5 years ago and is a cancer survivor.).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced LYMPHADENOPATHY (Axillary lymph nodes enlarged) and CHILLS (Chills). At the time of the report, LYMPHADENOPATHY (Axillary lymph nodes enlarged) had resolved and CHILLS (Chills) was resolving.            Concomitant product use was unknown by the reporter.  Treatment information was not provided  The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received on 29 April 2021  includes reporter contact details was added and Updated event outcome from unknown to recovered resolved
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Headache) and CHILLS (Chills). On 27-Feb-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No corrective treatment was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Heat (around the injection site); Itching (around the injection site); Redness (around the injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Heat (around the injection site)), INJECTION SITE PRURITUS (Itching (around the injection site)) and INJECTION SITE ERYTHEMA (Redness (around the injection site)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE WARMTH (Heat (around the injection site)), INJECTION SITE PRURITUS (Itching (around the injection site)) and INJECTION SITE ERYTHEMA (Redness (around the injection site)). At the time of the report, INJECTION SITE WARMTH (Heat (around the injection site)), INJECTION SITE PRURITUS (Itching (around the injection site)) and INJECTION SITE ERYTHEMA (Redness (around the injection site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up information was receivcontained non significant information and the reporter information was updated
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: dizziness; little bit of diarrhea; increase fatigue; chills; throwing up; very nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills) and VOMITING (throwing up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea, Thyroid disorder NOS, Cholesterol blood excessive, Anxiety, Arthritis, Osteoporosis, Acid reflux (oesophageal), Pain and Allergy to antibiotic. Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN JR) for Acid reflux (oesophageal), ESCITALOPRAM OXALATE (ESCITALOPRAM [ESCITALOPRAM OXALATE]) for Anxiety, MELOXICAM for Arthritis, ATORVASTATIN for Cholesterol blood excessive, ONDANSETRON for Nausea and Anxiety, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, PARACETAMOL (TYLENOL) for Pain, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) and CENTRUM SILVER +50 for Supplementation therapy, LEVOTHYROXINE for Thyroid disorder NOS.   On 25-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) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills), VOMITING (throwing up) and NAUSEA (very nausea). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills), VOMITING (throwing up) and NAUSEA (very nausea) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to US-MODERNATX, INC.-MOD-2021-162252 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162252:Same reporter
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizziness; little bit of diarrhea; increase fatigue; chills; throwing up; very nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills) and VOMITING (throwing up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea, Thyroid disorder NOS, Cholesterol blood excessive, Anxiety, Arthritis, Osteoporosis, Acid reflux (oesophageal), Pain and Allergy to antibiotic. Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN JR) for Acid reflux (oesophageal), ESCITALOPRAM OXALATE (ESCITALOPRAM [ESCITALOPRAM OXALATE]) for Anxiety, MELOXICAM for Arthritis, ATORVASTATIN for Cholesterol blood excessive, ONDANSETRON for Nausea and Anxiety, ALENDRONATE SODIUM (FOSAMAX) for Osteoporosis, PARACETAMOL (TYLENOL) for Pain, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]) and CENTRUM SILVER +50 for Supplementation therapy, LEVOTHYROXINE for Thyroid disorder NOS.   On 25-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) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills), VOMITING (throwing up) and NAUSEA (very nausea). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), DIARRHOEA (little bit of diarrhea), FATIGUE (increase fatigue), CHILLS (chills), VOMITING (throwing up) and NAUSEA (very nausea) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to US-MODERNATX, INC.-MOD-2021-162252 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162252:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A very sore arm/ He couldn't lift it up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A very sore arm/ He couldn't lift it up) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (A very sore arm/ He couldn't lift it up). At the time of the report, PAIN IN EXTREMITY (A very sore arm/ He couldn't lift it up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Joint swelling, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: swollen area between her neck and the left shoulder joint; Arm hurts; Bluish vein sticking out from her neck; 2 red patches on the area of the injection; Fever (T-100.7 F); Body aches; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection) and PAIN IN EXTREMITY (Arm hurts) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection), PAIN IN EXTREMITY (Arm hurts), JOINT SWELLING (swollen area between her neck and the left shoulder joint) and VEIN DISCOLOURATION (Bluish vein sticking out from her neck). On 25-Feb-2021, PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection), PAIN IN EXTREMITY (Arm hurts), JOINT SWELLING (swollen area between her neck and the left shoulder joint) and VEIN DISCOLOURATION (Bluish vein sticking out from her neck) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vein discolouration
Clinical narrative: swollen area between her neck and the left shoulder joint; Arm hurts; Bluish vein sticking out from her neck; 2 red patches on the area of the injection; Fever (T-100.7 F); Body aches; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection) and PAIN IN EXTREMITY (Arm hurts) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection), PAIN IN EXTREMITY (Arm hurts), JOINT SWELLING (swollen area between her neck and the left shoulder joint) and VEIN DISCOLOURATION (Bluish vein sticking out from her neck). On 25-Feb-2021, PYREXIA (Fever (T-100.7 F)), MYALGIA (Body aches) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (2 red patches on the area of the injection), PAIN IN EXTREMITY (Arm hurts), JOINT SWELLING (swollen area between her neck and the left shoulder joint) and VEIN DISCOLOURATION (Bluish vein sticking out from her neck) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her arm is getting sore now; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is getting sore now) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Her arm is getting sore now). At the time of the report, PAIN IN EXTREMITY (Her arm is getting sore now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Weakness in the arm; Pain in the arm; legs feel weak; aches and pains; the skin in her forearm feels funny; general weakness, a little bit tired; general weakness, a little bit tired; tenderness when she presses on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in the arm), PAIN IN EXTREMITY (Pain in the arm), MUSCULAR WEAKNESS (legs feel weak), PAIN (aches and pains) and SENSORY DISTURBANCE (the skin in her forearm feels funny) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 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 MUSCULAR WEAKNESS (Weakness in the arm), PAIN IN EXTREMITY (Pain in the arm), MUSCULAR WEAKNESS (legs feel weak), PAIN (aches and pains), ASTHENIA (general weakness, a little bit tired), FATIGUE (general weakness, a little bit tired) and VACCINATION SITE PAIN (tenderness when she presses on the injection site). 25-Feb-2021, the patient experienced SENSORY DISTURBANCE (the skin in her forearm feels funny). At the time of the report, MUSCULAR WEAKNESS (Weakness in the arm), PAIN IN EXTREMITY (Pain in the arm), MUSCULAR WEAKNESS (legs feel weak), PAIN (aches and pains), SENSORY DISTURBANCE (the skin in her forearm feels funny), ASTHENIA (general weakness, a little bit tired), FATIGUE (general weakness, a little bit tired) and VACCINATION SITE PAIN (tenderness when she presses on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided. CONCOMITANT INFORMATION WERE NOT PROVIDED.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Vaccination site pain
Clinical narrative: Weakness in the arm; Pain in the arm; legs feel weak; aches and pains; the skin in her forearm feels funny; general weakness, a little bit tired; general weakness, a little bit tired; tenderness when she presses on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in the arm), PAIN IN EXTREMITY (Pain in the arm), MUSCULAR WEAKNESS (legs feel weak), PAIN (aches and pains) and SENSORY DISTURBANCE (the skin in her forearm feels funny) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 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 MUSCULAR WEAKNESS (Weakness in the arm), PAIN IN EXTREMITY (Pain in the arm), MUSCULAR WEAKNESS (legs feel weak), PAIN (aches and pains), ASTHENIA (general weakness, a little bit tired), FATIGUE (general weakness, a little bit tired) and VACCINATION SITE PAIN (tenderness when she presses on the injection site). 25-Feb-2021, the patient experienced SENSORY DISTURBANCE (the skin in her forearm feels funny). At the time of the report, MUSCULAR WEAKNESS (Weakness in the arm), PAIN IN EXTREMITY (Pain in the arm), MUSCULAR WEAKNESS (legs feel weak), PAIN (aches and pains), SENSORY DISTURBANCE (the skin in her forearm feels funny), ASTHENIA (general weakness, a little bit tired), FATIGUE (general weakness, a little bit tired) and VACCINATION SITE PAIN (tenderness when she presses on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided. CONCOMITANT INFORMATION WERE NOT PROVIDED.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site is warm to touch; Injection site developed a itchy arm; Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Injection site developed a itchy arm) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID], HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE), CALCIUM, MAGNESIUM, ZINC (CALCIUM + MAGNESIUM + ZINK), DORZOLAMIDE and LATANOPROST for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Injection site developed a itchy arm) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Injection site developed a itchy arm) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.            Other concomitant medication included centrum.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: body and muscle aches; sore arm; fever 101F; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body and muscle aches), VACCINATION SITE PAIN (sore arm), PYREXIA (fever 101F) and CHILLS (chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (body and muscle aches), VACCINATION SITE PAIN (sore arm), PYREXIA (fever 101F) and CHILLS (chills). On 13-Feb-2021, MYALGIA (body and muscle aches), VACCINATION SITE PAIN (sore arm), PYREXIA (fever 101F) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 101 f (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever of 102 F that lasted for two days; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever of 102 F that lasted for two days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Hypothyroidism. Concomitant products included VITAMIN D NOS, VITAMIN E NOS, CALCIUM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (fever of 102 F that lasted for two days). On 06-Feb-2021, PYREXIA (fever of 102 F that lasted for two days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102 f High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during breast feeding
Clinical narrative: breastfeeding; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and CALCIUM for an unknown indication.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) and HEADACHE (Headache). On 26-Feb-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; short pain and sharp pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (short pain and sharp pain in her arm) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (short pain and sharp pain in her arm). On 26-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (short pain and sharp pain in her arm) and HEADACHE (headache) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.   Reporter did not allow further contact.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: rash on upper body (arms and chest); injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on upper body (arms and chest)) and VACCINATION SITE PAIN (injection site soreness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-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 RASH (rash on upper body (arms and chest)) and VACCINATION SITE PAIN (injection site soreness). At the time of the report, RASH (rash on upper body (arms and chest)) and VACCINATION SITE PAIN (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Hypersensitivity, Magnetic resonance imaging, Migraine
Clinical narrative: intense pain; intense sensitivity; migraines; head feels like shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (intense pain), HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking). On an unknown date, the patient experienced PAIN IN EXTREMITY (intense pain). At the time of the report, PAIN IN EXTREMITY (intense pain), HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal normal. On an unknown date, Magnetic resonance imaging: normal normal.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: intense pain; intense sensitivity; migraines; head feels like shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (intense pain), HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking). On an unknown date, the patient experienced PAIN IN EXTREMITY (intense pain). At the time of the report, PAIN IN EXTREMITY (intense pain), HYPERSENSITIVITY (intense sensitivity), MIGRAINE (migraines) and DIZZINESS (head feels like shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal normal. On an unknown date, Magnetic resonance imaging: normal normal.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and HEADACHE (headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Peripheral swelling
Clinical narrative: Swelling underarm; He experienced mild headaches, swelling under his arm, and pain at injection site.; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling underarm), HEADACHE (He experienced mild headaches, swelling under his arm, and pain at injection site.) and INJECTION SITE PAIN (Pain at injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced HEADACHE (He experienced mild headaches, swelling under his arm, and pain at injection site.) and INJECTION SITE PAIN (Pain at injection site). On 24-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swelling underarm). The patient was treated with IBUPROFEN for Headache, Peripheral swelling and Injection site pain, at an unspecified dose and frequency. On 25-Feb-2021, HEADACHE (He experienced mild headaches, swelling under his arm, and pain at injection site.) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling underarm) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Axillary pain, Breast pain, Diarrhoea, Oropharyngeal pain
Clinical narrative: Urinary tract infection; Sore throat; Soreness of breast; Digestive pain/stomach cramp, loose bowel; loose bowel; Severe armpit pain, still the pain on and off; Soreness at injection site on her left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), OROPHARYNGEAL PAIN (Sore throat), BREAST PAIN (Soreness of breast), ABDOMINAL PAIN UPPER (Digestive pain/stomach cramp, loose bowel) and DIARRHOEA (loose bowel) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site on her left arm). On 22-Feb-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection), OROPHARYNGEAL PAIN (Sore throat), BREAST PAIN (Soreness of breast), ABDOMINAL PAIN UPPER (Digestive pain/stomach cramp, loose bowel), DIARRHOEA (loose bowel) and AXILLARY PAIN (Severe armpit pain, still the pain on and off). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) on 22-Feb-2021 for Armpit pain, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), OROPHARYNGEAL PAIN (Sore throat), BREAST PAIN (Soreness of breast), ABDOMINAL PAIN UPPER (Digestive pain/stomach cramp, loose bowel), DIARRHOEA (loose bowel), AXILLARY PAIN (Severe armpit pain, still the pain on and off) and VACCINATION SITE PAIN (Soreness at injection site on her left arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Other treatment medication included unspecified OTC medicines.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaccination site pain
Clinical narrative: Urinary tract infection; Sore throat; Soreness of breast; Digestive pain/stomach cramp, loose bowel; loose bowel; Severe armpit pain, still the pain on and off; Soreness at injection site on her left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), OROPHARYNGEAL PAIN (Sore throat), BREAST PAIN (Soreness of breast), ABDOMINAL PAIN UPPER (Digestive pain/stomach cramp, loose bowel) and DIARRHOEA (loose bowel) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site on her left arm). On 22-Feb-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection), OROPHARYNGEAL PAIN (Sore throat), BREAST PAIN (Soreness of breast), ABDOMINAL PAIN UPPER (Digestive pain/stomach cramp, loose bowel), DIARRHOEA (loose bowel) and AXILLARY PAIN (Severe armpit pain, still the pain on and off). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) on 22-Feb-2021 for Armpit pain, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), OROPHARYNGEAL PAIN (Sore throat), BREAST PAIN (Soreness of breast), ABDOMINAL PAIN UPPER (Digestive pain/stomach cramp, loose bowel), DIARRHOEA (loose bowel), AXILLARY PAIN (Severe armpit pain, still the pain on and off) and VACCINATION SITE PAIN (Soreness at injection site on her left arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Other treatment medication included unspecified OTC medicines.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site area is hot; Injection site area is hard; Injection site area is itchy; Injection site area is red; Injection site area is raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site area is hot), VACCINATION SITE INDURATION (Injection site area is hard), VACCINATION SITE PRURITUS (Injection site area is itchy), VACCINATION SITE ERYTHEMA (Injection site area is red) and VACCINATION SITE SWELLING (Injection site area is raised) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site area is hot), VACCINATION SITE INDURATION (Injection site area is hard), VACCINATION SITE PRURITUS (Injection site area is itchy), VACCINATION SITE ERYTHEMA (Injection site area is red) and VACCINATION SITE SWELLING (Injection site area is raised). At the time of the report, VACCINATION SITE WARMTH (Injection site area is hot), VACCINATION SITE INDURATION (Injection site area is hard), VACCINATION SITE PRURITUS (Injection site area is itchy), VACCINATION SITE ERYTHEMA (Injection site area is red) and VACCINATION SITE SWELLING (Injection site area is raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Vaccination site mass, Vaccination site rash
Clinical narrative: Lump and Rash Grew and Spread to Left Upper Body; A little Rash Injection Site; Your Vaccine gave me Shingles/contracted Shingles; Lump Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Your Vaccine gave me Shingles/contracted Shingles), VACCINATION SITE MASS (Lump Injection Site), RASH (Lump and Rash Grew and Spread to Left Upper Body) and VACCINATION SITE RASH (A little Rash Injection Site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HERPES ZOSTER (Your Vaccine gave me Shingles/contracted Shingles), VACCINATION SITE MASS (Lump Injection Site) and VACCINATION SITE RASH (A little Rash Injection Site). On 30-Jan-2021, the patient experienced RASH (Lump and Rash Grew and Spread to Left Upper Body). At the time of the report, HERPES ZOSTER (Your Vaccine gave me Shingles/contracted Shingles), VACCINATION SITE MASS (Lump Injection Site), RASH (Lump and Rash Grew and Spread to Left Upper Body) and VACCINATION SITE RASH (A little Rash Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient's doctor confirmed that she had contracted Shingles. She had Shingles on the left upper body: chest, ear, neck, face and head. At the time of report,  She still had shingles on the left Shoulder and a little on the face.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site erythema
Clinical narrative: Headache; Nausea; large red circle about 3 inches in diameter at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (large red circle about 3 inches in diameter at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (large red circle about 3 inches in diameter at the injection site). The patient was treated with IBUPROFEN (EQUATE [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE ERYTHEMA (large red circle about 3 inches in diameter at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID a week later after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID a week later after 1st dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced COVID-19 (COVID a week later after 1st dose). At the time of the report, COVID-19 (COVID a week later after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red spot around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot around injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015AM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red spot around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Swelling
Clinical narrative: Hot; Swellness; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot), SWELLING (Swellness) and MYALGIA (Myalgia) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FEELING HOT (Hot), SWELLING (Swellness) and MYALGIA (Myalgia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Jan-2021, FEELING HOT (Hot), SWELLING (Swellness) and MYALGIA (Myalgia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site swelling
Clinical narrative: Swollen; RASH; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen) and RASH (RASH) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 09-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen) and RASH (RASH). At the time of the report, VACCINATION SITE SWELLING (Swollen) and RASH (RASH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.; Reporter'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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Really itchy rash in the upper arm and legs.; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Really itchy rash in the upper arm and legs.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.  On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced RASH PRURITIC (Really itchy rash in the upper arm and legs.).   At the time of the report, RASH PRURITIC (Really itchy rash in the upper arm and legs.) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.