chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: couldn't sleep last night; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep last night) and VACCINATION SITE PAIN (arm hurts) 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 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced INSOMNIA (couldn't sleep last night) and VACCINATION SITE PAIN (arm hurts). At the time of the report, INSOMNIA (couldn't sleep last night) and VACCINATION SITE PAIN (arm hurts) outcome was unknown.            Concomitant medication history not provided. Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was not applicable. .   This case was linked to MOD-2021-132231 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: feeling weak; headache; sore arm; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (feeling weak), PAIN IN EXTREMITY (sore arm), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS and DOXYCYCLINE for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and CHILLS (chills). On 14-May-2021, the patient experienced ASTHENIA (feeling weak) and HEADACHE (headache). On 14-May-2021, PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, ASTHENIA (feeling weak) and HEADACHE (headache) outcome was unknown and PAIN IN EXTREMITY (sore arm) had not resolved.        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 laboratory details was given. Treatment information was given as the patient took tylenol 500 mg to help with her side effects on 13 May 2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Trigeminal neuralgia
Clinical narrative: Trigeminol Neurlagia; Severe Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TRIGEMINAL NEURALGIA (Trigeminol Neurlagia) and FATIGUE (Severe Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048AZ1A) for COVID-19 immunisation.     Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE, CITALOPRAM, ROSUVASTATIN, PIOGLITAZONE and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Severe Fatigue). On 26-Mar-2021, the patient experienced TRIGEMINAL NEURALGIA (Trigeminol Neurlagia). On 19-Mar-2021, FATIGUE (Severe Fatigue) had resolved. At the time of the report, TRIGEMINAL NEURALGIA (Trigeminol Neurlagia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported went to the emergency department on 26MAR2021 and was diagnosed with Trigeminal Neurlagia. Patient reported that patient received second dose on 15APR2021 and had another episode of Trigeminal Neurlagia on 1MAY2021. Patient also reports having severe fatigued the first night after the first dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant list is provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lymphadenopathy, Mammogram
Clinical narrative: Mammogram found slightly enlarged large lymph nodes on the left side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Mammogram found slightly enlarged large lymph nodes on the left side ) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   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 an unknown date, the patient experienced LYMPHADENOPATHY (Mammogram found slightly enlarged large lymph nodes on the left side ). At the time of the report, LYMPHADENOPATHY (Mammogram found slightly enlarged large lymph nodes on the left side ) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: negative (Negative) 3 months post-vaccine: Negative. On an unknown date, Mammogram: inconclusive (Inconclusive) 3 weeks post vaccine: Large lymph nodes noted and inconclusive (Inconclusive) 3 months post vaccine: Still slightly enlarged lymph nodes noted.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up received contains no new information. Patient declined consent for further follow-up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: Felt lethargic; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Felt lethargic) and ARTHRALGIA (Joint pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No relevant medical history provided.  Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced LETHARGY (Felt lethargic) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Joint pain and Lethargic, at an unspecified dose and frequency. On 13-Apr-2021, LETHARGY (Felt lethargic) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-132381 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Nausea; Shoulder and arm pain -left and right side; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), MYALGIA (Shoulder and arm pain -left and right side) and VOMITING (Vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027BZ1A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (amoxicillin). Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE BESILATE (NORVASC), MULTIVITAMINS [VITAMINS NOS] and BIOTIN for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VOMITING (Vomiting). On 14-May-2021, the patient experienced MYALGIA (Shoulder and arm pain -left and right side). On 15-May-2021, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea), MYALGIA (Shoulder and arm pain -left and right side) and VOMITING (Vomiting) outcome was unknown.            Concomitant medication includes Potassium Chloride pill. No treatment medication was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial was punctured on 7May2021 and given 13May2021; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 14-May-2021. The most recent information was received on 19-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was punctured on 7May2021 and given 13May2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-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 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was punctured on 7May2021 and given 13May2021). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (vial was punctured on 7May2021 and given 13May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not mentioned.  Treatment medications were not mentioned   This case was linked to US-MODERNATX, INC.-MOD-2021-132112 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19 Jul 2021. contains reporter details, patient demographic details, suspect drug details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132112:Same reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Myalgia
Clinical narrative: Chills; Body ache; red dark circle at injection site on next day that was 29Apr2021; I had very bad headache; feeling tired next day after vaccination; fever; all night it goes with hot and chills; My arm was sore on same day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day), CHILLS (Chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.   On 28-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 28-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day) and PYREXIA (fever). On 29-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021), HEADACHE (I had very bad headache) and FATIGUE (feeling tired next day after vaccination). On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day), CHILLS (Chills), PYREXIA (fever), VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021), HEADACHE (I had very bad headache), FATIGUE (feeling tired next day after vaccination) and MYALGIA (Body ache) outcome was unknown.              Patient had cold and sinus infection. She is taking vitamins supplement .    This case was linked to US-MODERNATX, INC.-MOD-2021-064609 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064609:Dose 1
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: Chills; Body ache; red dark circle at injection site on next day that was 29Apr2021; I had very bad headache; feeling tired next day after vaccination; fever; all night it goes with hot and chills; My arm was sore on same day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day), CHILLS (Chills), PYREXIA (fever) and VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.   On 28-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 28-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day) and PYREXIA (fever). On 29-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021), HEADACHE (I had very bad headache) and FATIGUE (feeling tired next day after vaccination). On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (all night it goes with hot and chills), PAIN IN EXTREMITY (My arm was sore on same day), CHILLS (Chills), PYREXIA (fever), VACCINATION SITE ERYTHEMA (red dark circle at injection site on next day that was 29Apr2021), HEADACHE (I had very bad headache), FATIGUE (feeling tired next day after vaccination) and MYALGIA (Body ache) outcome was unknown.              Patient had cold and sinus infection. She is taking vitamins supplement .    This case was linked to US-MODERNATX, INC.-MOD-2021-064609 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064609:Dose 1
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Cognitive disorder, Frustration tolerance decreased, Memory impairment
Clinical narrative: two instances of memory loss, cognitive problems, and forgetfulness; two instances of memory loss, cognitive problems, and forgetfulness; two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating"; really frustrating; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (two instances of memory loss, cognitive problems, and forgetfulness), COGNITIVE DISORDER (two instances of memory loss, cognitive problems, and forgetfulness), MEMORY IMPAIRMENT (two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating") and FRUSTRATION TOLERANCE DECREASED (really frustrating) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (head injury, broken neck, and fractured skull from a car accident in 1986.) in 1986, Head injury in 1986, Broken bones (broken neck) in 1986 and Skull fracture (fractured skull) in 1986. Concurrent medical conditions included Balance difficulty (balance issue from the car accident).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced AMNESIA (two instances of memory loss, cognitive problems, and forgetfulness), COGNITIVE DISORDER (two instances of memory loss, cognitive problems, and forgetfulness), MEMORY IMPAIRMENT (two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating") and FRUSTRATION TOLERANCE DECREASED (really frustrating). At the time of the report, AMNESIA (two instances of memory loss, cognitive problems, and forgetfulness), COGNITIVE DISORDER (two instances of memory loss, cognitive problems, and forgetfulness), MEMORY IMPAIRMENT (two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating") and FRUSTRATION TOLERANCE DECREASED (really frustrating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed 2nd dose of Moderna vaccine on recommended interval; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose of Moderna vaccine on recommended interval) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose of Moderna vaccine on recommended interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose of Moderna vaccine on recommended interval) 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.   Patient had no symptom after first dose vaccine.  No treatment medication were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypotension, Myalgia, Pain
Clinical narrative: headache; muscle ache; fatigue; nonstop terrible pain; blood pressure was very low; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (nonstop terrible pain), HYPOTENSION (blood pressure was very low), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (cashew).   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PAIN (nonstop terrible pain), HYPOTENSION (blood pressure was very low), MYALGIA (muscle ache) and FATIGUE (fatigue). On 09-May-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 500 mg. On 14-May-2021, PAIN (nonstop terrible pain), HYPOTENSION (blood pressure was very low), MYALGIA (muscle ache) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: dizziness and nausea he can't get rid of; dizziness and nausea he can't get rid of; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness and nausea he can't get rid of) and NAUSEA (dizziness and nausea he can't get rid of) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness and nausea he can't get rid of) and NAUSEA (dizziness and nausea he can't get rid of). At the time of the report, DIZZINESS (dizziness and nausea he can't get rid of) and NAUSEA (dizziness and nausea he can't get rid of) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site pain, Palpitations
Clinical narrative: palpitations; the injection area is in pain and is inflamed and red; arm has been super irritated in the injection area; the injection area is in pain and is inflamed and red; the injection area is in pain and is inflamed and red; tachycardia; episodes of fatigue; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (tachycardia), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), PALPITATIONS (palpitations), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red) and FATIGUE (episodes of fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced FATIGUE (episodes of fatigue). On 02-May-2021, the patient experienced TACHYCARDIA (tachycardia). On 09-May-2021, the patient experienced VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red), INJECTION SITE PAIN (the injection area is in pain and is inflamed and red) and INJECTION SITE ERYTHEMA (the injection area is in pain and is inflamed and red). On 14-May-2021, the patient experienced PALPITATIONS (palpitations). At the time of the report, TACHYCARDIA (tachycardia), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), PALPITATIONS (palpitations), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red), FATIGUE (episodes of fatigue), INJECTION SITE PAIN (the injection area is in pain and is inflamed and red) and INJECTION SITE ERYTHEMA (the injection area is in pain and is inflamed and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as ibuprofen.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site irritation
Clinical narrative: palpitations; the injection area is in pain and is inflamed and red; arm has been super irritated in the injection area; the injection area is in pain and is inflamed and red; the injection area is in pain and is inflamed and red; tachycardia; episodes of fatigue; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (tachycardia), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), PALPITATIONS (palpitations), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red) and FATIGUE (episodes of fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced FATIGUE (episodes of fatigue). On 02-May-2021, the patient experienced TACHYCARDIA (tachycardia). On 09-May-2021, the patient experienced VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red), INJECTION SITE PAIN (the injection area is in pain and is inflamed and red) and INJECTION SITE ERYTHEMA (the injection area is in pain and is inflamed and red). On 14-May-2021, the patient experienced PALPITATIONS (palpitations). At the time of the report, TACHYCARDIA (tachycardia), VACCINATION SITE IRRITATION (arm has been super irritated in the injection area), PALPITATIONS (palpitations), INJECTION SITE INFLAMMATION (the injection area is in pain and is inflamed and red), FATIGUE (episodes of fatigue), INJECTION SITE PAIN (the injection area is in pain and is inflamed and red) and INJECTION SITE ERYTHEMA (the injection area is in pain and is inflamed and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as ibuprofen.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Lymphadenopathy, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Sick; she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she; Big red spot on injection site; Swollen lymph node under left arm pit; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), COUGH (Coughing), LYMPHADENOPATHY (Swollen lymph node under left arm pit), VACCINATION SITE ERYTHEMA (Big red spot on injection site) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced COUGH (Coughing). On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under left arm pit). On 23-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red spot on injection site). On an unknown date, the patient experienced ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of 500mg 3 times a day for 1 week; AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), COUGH (Coughing), LYMPHADENOPATHY (Swollen lymph node under left arm pit) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she) outcome was unknown and VACCINATION SITE ERYTHEMA (Big red spot on injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 11-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment for the events methyl prednisone.  Company comment: 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.; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Sick; she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she; Big red spot on injection site; Swollen lymph node under left arm pit; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), COUGH (Coughing), LYMPHADENOPATHY (Swollen lymph node under left arm pit), VACCINATION SITE ERYTHEMA (Big red spot on injection site) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced COUGH (Coughing). On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under left arm pit). On 23-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red spot on injection site). On an unknown date, the patient experienced ILLNESS (Sick) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) at a dose of 500mg 3 times a day for 1 week; AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), COUGH (Coughing), LYMPHADENOPATHY (Swollen lymph node under left arm pit) and PRODUCT DOSE OMISSION ISSUE (she was supposed to receive 2nd dose on 12May2021 but she didn't receive as she) outcome was unknown and VACCINATION SITE ERYTHEMA (Big red spot on injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. On 11-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment for the events methyl prednisone.  Company comment: 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.; 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Erythema, Headache, Malaise
Clinical narrative: Arm turned red; Arm hurting; Tightness in the neck; Developed rash in her arm; Fever with temperature of 101; Chills; Headache; Tightness in her throat; Tightness in her chest; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), ERYTHEMA (Arm turned red) and MUSCLE TIGHTNESS (Tightness in the neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), PYREXIA (Fever with temperature of 101), CHILLS (Chills) and HEADACHE (Headache). On 12-May-2021, the patient experienced RASH (Developed rash in her arm). On 13-May-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in the neck). On 14-May-2021, the patient experienced ERYTHEMA (Arm turned red) and MYALGIA (Arm hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-May-2021, MUSCLE TIGHTNESS (Tightness in the neck) had resolved. At the time of the report, THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), ERYTHEMA (Arm turned red), RASH (Developed rash in her arm), PYREXIA (Fever with temperature of 101), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Arm hurting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-132312 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Pyrexia, Rash, Throat tightness
Clinical narrative: Arm turned red; Arm hurting; Tightness in the neck; Developed rash in her arm; Fever with temperature of 101; Chills; Headache; Tightness in her throat; Tightness in her chest; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), ERYTHEMA (Arm turned red) and MUSCLE TIGHTNESS (Tightness in the neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), PYREXIA (Fever with temperature of 101), CHILLS (Chills) and HEADACHE (Headache). On 12-May-2021, the patient experienced RASH (Developed rash in her arm). On 13-May-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in the neck). On 14-May-2021, the patient experienced ERYTHEMA (Arm turned red) and MYALGIA (Arm hurting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-May-2021, MUSCLE TIGHTNESS (Tightness in the neck) had resolved. At the time of the report, THROAT TIGHTNESS (Tightness in her throat), CHEST DISCOMFORT (Tightness in her chest), MALAISE (Not feeling well), ERYTHEMA (Arm turned red), RASH (Developed rash in her arm), PYREXIA (Fever with temperature of 101), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Arm hurting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-132312 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chronic sinusitis, Hypoaesthesia, Nasal congestion, Paraesthesia oral
Clinical narrative: It's anxiety provoking; nasal congestion for a couple of weeks; chronic sinusitis; lips started to tangle; bit of numbness up above her lips into her nose; Feels a little pressure on her upper cheeks; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose), SKIN DISCOMFORT (Feels a little pressure on her upper cheeks), ANXIETY (It's anxiety provoking) and NASAL CONGESTION (nasal congestion for a couple of weeks) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold sores.    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 PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose) and SKIN DISCOMFORT (Feels a little pressure on her upper cheeks). On 14-Feb-2021, the patient experienced ANXIETY (It's anxiety provoking), NASAL CONGESTION (nasal congestion for a couple of weeks) and CHRONIC SINUSITIS (chronic sinusitis). The patient was treated with PHENYLEPHRINE HCL at a dose of 10 milligram and GUAIFENESIN (GUAFENSIN) at a dose of 400 milligram. At the time of the report, PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose), SKIN DISCOMFORT (Feels a little pressure on her upper cheeks), ANXIETY (It's anxiety provoking), NASAL CONGESTION (nasal congestion for a couple of weeks) and CHRONIC SINUSITIS (chronic sinusitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discomfort
Clinical narrative: It's anxiety provoking; nasal congestion for a couple of weeks; chronic sinusitis; lips started to tangle; bit of numbness up above her lips into her nose; Feels a little pressure on her upper cheeks; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose), SKIN DISCOMFORT (Feels a little pressure on her upper cheeks), ANXIETY (It's anxiety provoking) and NASAL CONGESTION (nasal congestion for a couple of weeks) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold sores.    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 PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose) and SKIN DISCOMFORT (Feels a little pressure on her upper cheeks). On 14-Feb-2021, the patient experienced ANXIETY (It's anxiety provoking), NASAL CONGESTION (nasal congestion for a couple of weeks) and CHRONIC SINUSITIS (chronic sinusitis). The patient was treated with PHENYLEPHRINE HCL at a dose of 10 milligram and GUAIFENESIN (GUAFENSIN) at a dose of 400 milligram. At the time of the report, PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose), SKIN DISCOMFORT (Feels a little pressure on her upper cheeks), ANXIETY (It's anxiety provoking), NASAL CONGESTION (nasal congestion for a couple of weeks) and CHRONIC SINUSITIS (chronic sinusitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Feel worse than when had COVID-19 after the 2nd dose; Diarrhea after the 2nd dose; Fatigued after the 2nd dose; Chills after the 2nd dose; Throwing up after the 2nd dose; Fever of up to 102 F after the 2nd dose; Worst headache ever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose) and VOMITING (Throwing up after the 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. d44d21a and 025c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose), VOMITING (Throwing up after the 2nd dose), PYREXIA (Fever of up to 102 F after the 2nd dose) and HEADACHE (Worst headache ever after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose), VOMITING (Throwing up after the 2nd dose), PYREXIA (Fever of up to 102 F after the 2nd dose) and HEADACHE (Worst headache ever after the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 f (High) 102 F. On an unknown date, SARS-CoV-2 test: positive positive (Positive) positive.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Feel worse than when had COVID-19 after the 2nd dose; Diarrhea after the 2nd dose; Fatigued after the 2nd dose; Chills after the 2nd dose; Throwing up after the 2nd dose; Fever of up to 102 F after the 2nd dose; Worst headache ever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose) and VOMITING (Throwing up after the 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. d44d21a and 025c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose), VOMITING (Throwing up after the 2nd dose), PYREXIA (Fever of up to 102 F after the 2nd dose) and HEADACHE (Worst headache ever after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose), VOMITING (Throwing up after the 2nd dose), PYREXIA (Fever of up to 102 F after the 2nd dose) and HEADACHE (Worst headache ever after the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 f (High) 102 F. On an unknown date, SARS-CoV-2 test: positive positive (Positive) positive.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Vaccination site swelling
Clinical narrative: hard raised area 1 inch, no discoloration, on her arm; Chills; Fatigue; Arm soreness/sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm soreness/sore to touch) and VACCINATION SITE SWELLING (hard raised area 1 inch, no discoloration, on her arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm soreness/sore to touch). On 14-May-2021, the patient experienced VACCINATION SITE SWELLING (hard raised area 1 inch, no discoloration, on her arm). On 06-May-2021, CHILLS (Chills) and FATIGUE (Fatigue) had resolved. On 09-May-2021, PAIN IN EXTREMITY (Arm soreness/sore to touch) had resolved. At the time of the report, VACCINATION SITE SWELLING (hard raised area 1 inch, no discoloration, on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.