chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: feel her heart beating like crazy; temperature of 100; arm swelled up at the injection site; it turned bright red; arm has a lump in it; uncomfortable; very itchy; sore arm; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (uncomfortable), PRURITUS (very itchy), PALPITATIONS (feel her heart beating like crazy), INJECTION SITE MASS (arm has a lump in it) and VACCINATION SITE PAIN (sore arm) in a 67-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 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and FATIGUE (tired). On 26-Feb-2021, the patient experienced FEELING ABNORMAL (uncomfortable), PRURITUS (very itchy), INJECTION SITE MASS (arm has a lump in it), VACCINATION SITE SWELLING (arm swelled up at the injection site) and VACCINATION SITE ERYTHEMA (it turned bright red). On 28-Feb-2021, the patient experienced PYREXIA (temperature of 100). On an unknown date, the patient experienced PALPITATIONS (feel her heart beating like crazy). On 22-Feb-2021, VACCINATION SITE PAIN (sore arm) had resolved. At the time of the report, FEELING ABNORMAL (uncomfortable), PRURITUS (very itchy), PALPITATIONS (feel her heart beating like crazy), INJECTION SITE MASS (arm has a lump in it), VACCINATION SITE SWELLING (arm swelled up at the injection site), VACCINATION SITE ERYTHEMA (it turned bright red), PYREXIA (temperature of 100) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Frequent bowel movements
Clinical narrative: Excessive Bowel Movements; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Excessive Bowel Movements) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FREQUENT BOWEL MOVEMENTS (Excessive Bowel Movements). On 25-Feb-2021, FREQUENT BOWEL MOVEMENTS (Excessive Bowel Movements) 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.   No concomitant medications or treatment details reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine). At the time of the report, VACCINATION SITE PRURITUS (Patient reported itching, redness, little pain and swelling at injection site after receiving 2nd dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for the past 5 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for the past 5 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 24-Feb-2021, the patient experienced HEADACHE (Headache for the past 5 days). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, HEADACHE (Headache for the past 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product administered at inappropriate site
Clinical narrative: swollen lymph nodes at the neck collar of the same arm she got the shot in; vaccine was administered really high in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine was administered really high in the muscle) and LYMPHADENOPATHY (swollen lymph nodes at the neck collar of the same arm she got the shot in) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine was administered really high in the muscle). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes at the neck collar of the same arm she got the shot in). On 16-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine was administered really high in the muscle) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes at the neck collar of the same arm she got the shot in) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Carvedilol. Treatment details were not provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Diarrhea; Dizziness; Pain; Headache; Fatigue; Nausea; Possible fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PAIN (Pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PAIN (Pain), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Possible fever). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PAIN (Pain), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Possible fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Diarrhea; Dizziness; Pain; Headache; Fatigue; Nausea; Possible fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PAIN (Pain), HEADACHE (Headache) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PAIN (Pain), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Possible fever). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), PAIN (Pain), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Possible fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia
Clinical narrative: feels terrible; hasn't slept since receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels terrible) and INSOMNIA (hasn't slept since receiving the vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (feels terrible) and INSOMNIA (hasn't slept since receiving the vaccine). At the time of the report, FEELING ABNORMAL (feels terrible) and INSOMNIA (hasn't slept since receiving the vaccine) outcome was unknown.            No concomitant medications or treatment details reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: rash on leg on same side as injection; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on leg on same side as injection) and VACCINATION SITE PAIN (arm soreness) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     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 2 dosage form. On 25-Feb-2021, the patient experienced RASH (rash on leg on same side as injection) and VACCINATION SITE PAIN (arm soreness). At the time of the report, RASH (rash on leg on same side as injection) and VACCINATION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: irritation in throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (irritation in throat) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (irritation in throat) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL PAIN (irritation in throat) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood pressure increased, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119; My potassium was low; feeling tingling in left arm; nausea; Fever; Aches; very swollen lymp nodes; I was not feeling well; This spontaneous case was reported by a pharmacist and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), BLOOD POTASSIUM DECREASED (My potassium was low), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea) and PYREXIA (Fever) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), BLOOD POTASSIUM DECREASED (My potassium was low), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea), PYREXIA (Fever), MYALGIA (Aches), LYMPHADENOPATHY (very swollen lymp nodes) and MALAISE (I was not feeling well). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea), PYREXIA (Fever) and MALAISE (I was not feeling well) had resolved and BLOOD POTASSIUM DECREASED (My potassium was low), MYALGIA (Aches) and LYMPHADENOPATHY (very swollen lymp nodes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Lab test EKG normal. Cardiac enzymes normal.  potassium  low.ultrasounds and CT's abnormal Treatment medication  Chlorthalidone 25
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pyrexia
Clinical narrative: blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119; My potassium was low; feeling tingling in left arm; nausea; Fever; Aches; very swollen lymp nodes; I was not feeling well; This spontaneous case was reported by a pharmacist and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), BLOOD POTASSIUM DECREASED (My potassium was low), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea) and PYREXIA (Fever) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), BLOOD POTASSIUM DECREASED (My potassium was low), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea), PYREXIA (Fever), MYALGIA (Aches), LYMPHADENOPATHY (very swollen lymp nodes) and MALAISE (I was not feeling well). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure which has been under control for quite some time began to spike/blood pressure climbed to 188/119), PARAESTHESIA (feeling tingling in left arm), NAUSEA (nausea), PYREXIA (Fever) and MALAISE (I was not feeling well) had resolved and BLOOD POTASSIUM DECREASED (My potassium was low), MYALGIA (Aches) and LYMPHADENOPATHY (very swollen lymp nodes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Lab test EKG normal. Cardiac enzymes normal.  potassium  low.ultrasounds and CT's abnormal Treatment medication  Chlorthalidone 25
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain in the arm. It hurts so much; she can't lift it; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain in the arm. It hurts so much; she can't lift it) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain in the arm. It hurts so much; she can't lift it). At the time of the report, MYALGIA (Muscle pain in the arm. It hurts so much; she can't lift it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Contusion, Headache
Clinical narrative: headache; high blood pressure; bruise; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, high blood pressure, and bruise.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced bad headache, high blood pressure and a bruise at injection site.  Treatment details included Amlodipine, pantoprazole.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache was unknown.The outcome of event(s), high blood pressure was unknown.The outcome of event(s), bruise was unknown..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased
Clinical narrative: potassium was low went from 4.2 to 3.2; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event of Blood potassium decreased (potassium was low went from 4.2 to 3.2).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event potassium was low that went from 4.2 to 3.2.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.            No Concomitant medications were provided No Treatment information provided   This case was linked to MOD-2021-030189 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Pyrexia, Tremor
Clinical narrative: headache; fever; chills; shaking; is very cold; A spontaneous report was received from a consumer concerning a 77-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, fever, chills, shaking/tremor, is very cold.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) headache, fever, chills, shaking, is very cold.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, fever, chills, shaking, is very cold was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Sharp increase in glucose reading; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Sharp increase in glucose reading) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Sharp increase in glucose reading). At the time of the report, BLOOD GLUCOSE INCREASED (Sharp increase in glucose reading) outcome was unknown.            Other concomitant medications included medications for blood pressure, atrial fibrillation, and COPD, not otherwise specified. No treatment details provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025-J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (mild fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 12-Feb-2021, PYREXIA (mild fever) had resolved.            No concomitant medications provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-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 27-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) was resolving and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Diarrhoea, Feeding disorder, Headache, Insomnia
Clinical narrative: Pretty harsh reactions; Blurred vision; Lack of sleep; Twitching; Cramping; Unable to eat; Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Pretty harsh reactions), VISION BLURRED (Blurred vision), INSOMNIA (Lack of sleep), MUSCLE TWITCHING (Twitching) and MUSCLE SPASMS (Cramping) in a 31-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Pretty harsh reactions), VISION BLURRED (Blurred vision), INSOMNIA (Lack of sleep), MUSCLE TWITCHING (Twitching), MUSCLE SPASMS (Cramping), FEEDING DISORDER (Unable to eat), DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, ADVERSE REACTION (Pretty harsh reactions), VISION BLURRED (Blurred vision), INSOMNIA (Lack of sleep), MUSCLE TWITCHING (Twitching), MUSCLE SPASMS (Cramping), FEEDING DISORDER (Unable to eat), DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up was received on 22-JUN-2021 contain no significant information
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching, Vision blurred
Clinical narrative: Pretty harsh reactions; Blurred vision; Lack of sleep; Twitching; Cramping; Unable to eat; Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Pretty harsh reactions), VISION BLURRED (Blurred vision), INSOMNIA (Lack of sleep), MUSCLE TWITCHING (Twitching) and MUSCLE SPASMS (Cramping) in a 31-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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Pretty harsh reactions), VISION BLURRED (Blurred vision), INSOMNIA (Lack of sleep), MUSCLE TWITCHING (Twitching), MUSCLE SPASMS (Cramping), FEEDING DISORDER (Unable to eat), DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, ADVERSE REACTION (Pretty harsh reactions), VISION BLURRED (Blurred vision), INSOMNIA (Lack of sleep), MUSCLE TWITCHING (Twitching), MUSCLE SPASMS (Cramping), FEEDING DISORDER (Unable to eat), DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up was received on 22-JUN-2021 contain no significant information
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Headache, Influenza like illness
Clinical narrative: Sore underarm; Flu-like symptoms; Congestion; Sore throat; sore underarm; Chest pain; Congestion; shortness of breath; Vomiting; Vaccination site pain; Pain in her left side of her back.; Nausea/expereinced more nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea/expereinced more nausea), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), BACK PAIN (Pain in her left side of her back.) and MYALGIA (Sore underarm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiomyopathy.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced NAUSEA (Nausea/expereinced more nausea) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), BACK PAIN (Pain in her left side of her back.), DYSPNOEA (shortness of breath) and VOMITING (Vomiting). On an unknown date, the patient experienced MYALGIA (Sore underarm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), the first episode of NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (sore underarm), CHEST PAIN (Chest pain) and the second episode of NASAL CONGESTION (Congestion). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, NAUSEA (Nausea/expereinced more nausea) and HEADACHE (Headache) had resolved. On 26-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) and BACK PAIN (Pain in her left side of her back.) had resolved. On 02-Mar-2021, VOMITING (Vomiting) had resolved. At the time of the report, MYALGIA (Sore underarm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (sore underarm), CHEST PAIN (Chest pain) and the last episode of NASAL CONGESTION (Congestion) had resolved and DYSPNOEA (shortness of breath) had not resolved. experienced more nausea on 9-mar-2021 when she had to get a tetanus shot.          No concomitant medications provided. Other treatment included ginger ale and crackers for nausea.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: new events,outcome of all the events updated
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore underarm; Flu-like symptoms; Congestion; Sore throat; sore underarm; Chest pain; Congestion; shortness of breath; Vomiting; Vaccination site pain; Pain in her left side of her back.; Nausea/expereinced more nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea/expereinced more nausea), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), BACK PAIN (Pain in her left side of her back.) and MYALGIA (Sore underarm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiomyopathy.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced NAUSEA (Nausea/expereinced more nausea) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), BACK PAIN (Pain in her left side of her back.), DYSPNOEA (shortness of breath) and VOMITING (Vomiting). On an unknown date, the patient experienced MYALGIA (Sore underarm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), the first episode of NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (sore underarm), CHEST PAIN (Chest pain) and the second episode of NASAL CONGESTION (Congestion). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, NAUSEA (Nausea/expereinced more nausea) and HEADACHE (Headache) had resolved. On 26-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) and BACK PAIN (Pain in her left side of her back.) had resolved. On 02-Mar-2021, VOMITING (Vomiting) had resolved. At the time of the report, MYALGIA (Sore underarm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (sore underarm), CHEST PAIN (Chest pain) and the last episode of NASAL CONGESTION (Congestion) had resolved and DYSPNOEA (shortness of breath) had not resolved. experienced more nausea on 9-mar-2021 when she had to get a tetanus shot.          No concomitant medications provided. Other treatment included ginger ale and crackers for nausea.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: new events,outcome of all the events updated
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: Sore underarm; Flu-like symptoms; Congestion; Sore throat; sore underarm; Chest pain; Congestion; shortness of breath; Vomiting; Vaccination site pain; Pain in her left side of her back.; Nausea/expereinced more nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea/expereinced more nausea), HEADACHE (Headache), VACCINATION SITE PAIN (Vaccination site pain), BACK PAIN (Pain in her left side of her back.) and MYALGIA (Sore underarm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiomyopathy.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced NAUSEA (Nausea/expereinced more nausea) and HEADACHE (Headache). On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), BACK PAIN (Pain in her left side of her back.), DYSPNOEA (shortness of breath) and VOMITING (Vomiting). On an unknown date, the patient experienced MYALGIA (Sore underarm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), the first episode of NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (sore underarm), CHEST PAIN (Chest pain) and the second episode of NASAL CONGESTION (Congestion). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, NAUSEA (Nausea/expereinced more nausea) and HEADACHE (Headache) had resolved. On 26-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) and BACK PAIN (Pain in her left side of her back.) had resolved. On 02-Mar-2021, VOMITING (Vomiting) had resolved. At the time of the report, MYALGIA (Sore underarm), INFLUENZA LIKE ILLNESS (Flu-like symptoms), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (sore underarm), CHEST PAIN (Chest pain) and the last episode of NASAL CONGESTION (Congestion) had resolved and DYSPNOEA (shortness of breath) had not resolved. experienced more nausea on 9-mar-2021 when she had to get a tetanus shot.          No concomitant medications provided. Other treatment included ginger ale and crackers for nausea.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: new events,outcome of all the events updated
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Diarrhoea, Illness
Clinical narrative: Local pain; Been sick; Diarrhea; No sense of taste or smell; No sense of taste or smell; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell) and AGEUSIA (No sense of taste or smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell), AGEUSIA (No sense of taste or smell), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell), AGEUSIA (No sense of taste or smell), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications or treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Local pain; Been sick; Diarrhea; No sense of taste or smell; No sense of taste or smell; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell) and AGEUSIA (No sense of taste or smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell), AGEUSIA (No sense of taste or smell), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN (Local pain), ILLNESS (Been sick), DIARRHOEA (Diarrhea), ANOSMIA (No sense of taste or smell), AGEUSIA (No sense of taste or smell), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant medications or treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Injection site inflammation
Clinical narrative: Patients experienced inflammation where previous filler (Restylane) was injected following COVID vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE INFLAMMATION (Patients experienced inflammation where previous filler (Restylane) was injected following COVID vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INFLAMMATION (Patients experienced inflammation where previous filler (Restylane) was injected following COVID vaccination). At the time of the report, INJECTION SITE INFLAMMATION (Patients experienced inflammation where previous filler (Restylane) was injected following COVID vaccination) 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: Fatigue, Myalgia
Clinical narrative: muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) and FATIGUE (fatigue) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Insomnia, Myalgia
Clinical narrative: exhausted; weak; couldn't sleep; nausea; body aches; Chills; tenderness at the injection site; swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (weak), INSOMNIA (couldn't sleep), NAUSEA (nausea), FATIGUE (exhausted) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011520A or 011G20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced NAUSEA (nausea), MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 09-Feb-2021, the patient experienced ASTHENIA (weak), INSOMNIA (couldn't sleep) and FATIGUE (exhausted). At the time of the report, ASTHENIA (weak), INSOMNIA (couldn't sleep), NAUSEA (nausea), FATIGUE (exhausted), MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: exhausted; weak; couldn't sleep; nausea; body aches; Chills; tenderness at the injection site; swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (weak), INSOMNIA (couldn't sleep), NAUSEA (nausea), FATIGUE (exhausted) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011520A or 011G20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced NAUSEA (nausea), MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 09-Feb-2021, the patient experienced ASTHENIA (weak), INSOMNIA (couldn't sleep) and FATIGUE (exhausted). At the time of the report, ASTHENIA (weak), INSOMNIA (couldn't sleep), NAUSEA (nausea), FATIGUE (exhausted), MYALGIA (body aches), CHILLS (Chills), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Rash, Vaccination complication
Clinical narrative: Had reaction; Rash; Body aches; Fever; A spontaneous report was received from a consumer concerning a female patient (Unspecified age) who experienced had reaction/vaccination adverse reaction, body aches/myalgia, fever/pyrexia and rash.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date the patient experienced had reaction, body aches, fever and rash.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events had reaction, body aches, fever and rash were unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site warmth
Clinical narrative: Sore; arm is itchy; Hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore), PRURITUS (arm is itchy) and VACCINATION SITE WARMTH (Hot to touch) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (Sore), PRURITUS (arm is itchy) and VACCINATION SITE WARMTH (Hot to touch). At the time of the report, PAIN (Sore), PRURITUS (arm is itchy) and VACCINATION SITE WARMTH (Hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.