chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Paraesthesia, Paraesthesia oral, Swollen tongue, Thirst
Clinical narrative: a little itchiness on the same arm of injection; experienced chills; very bad headaches; felt like she had the flu; bone pain; stay in bed all day; feel very anxious; her hands started to sweat; numbness on face and tongue; tingle on face and tongue like she had anesthesia; tingle on face and tongue like she had anesthesia; tongue was bigger and dryness; tongue was bigger and dryness; thirsty; pressure on chest; dizziness; This spontaneous case was reported by an other caregiver and describes the occurrence of ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia) and PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia), PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia), SWOLLEN TONGUE (tongue was bigger and dryness), TONGUE DRY (tongue was bigger and dryness), THIRST (thirsty), CHEST DISCOMFORT (pressure on chest) and DIZZINESS (dizziness). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), BEDRIDDEN (stay in bed all day), CHILLS (experienced chills), BONE PAIN (bone pain) and HEADACHE (very bad headaches). On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (a little itchiness on the same arm of injection). On 16-Jan-2021, ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia), PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia), SWOLLEN TONGUE (tongue was bigger and dryness), TONGUE DRY (tongue was bigger and dryness), THIRST (thirsty), CHEST DISCOMFORT (pressure on chest) and DIZZINESS (dizziness) had resolved. On 17-Jan-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu), BEDRIDDEN (stay in bed all day), CHILLS (experienced chills), BONE PAIN (bone pain) and HEADACHE (very bad headaches) had resolved. At the time of the report, INJECTION SITE PRURITUS (a little itchiness on the same arm of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue dry
Clinical narrative: a little itchiness on the same arm of injection; experienced chills; very bad headaches; felt like she had the flu; bone pain; stay in bed all day; feel very anxious; her hands started to sweat; numbness on face and tongue; tingle on face and tongue like she had anesthesia; tingle on face and tongue like she had anesthesia; tongue was bigger and dryness; tongue was bigger and dryness; thirsty; pressure on chest; dizziness; This spontaneous case was reported by an other caregiver and describes the occurrence of ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia) and PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia), PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia), SWOLLEN TONGUE (tongue was bigger and dryness), TONGUE DRY (tongue was bigger and dryness), THIRST (thirsty), CHEST DISCOMFORT (pressure on chest) and DIZZINESS (dizziness). On 17-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu), BEDRIDDEN (stay in bed all day), CHILLS (experienced chills), BONE PAIN (bone pain) and HEADACHE (very bad headaches). On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (a little itchiness on the same arm of injection). On 16-Jan-2021, ANXIETY (feel very anxious), HYPERHIDROSIS (her hands started to sweat), HYPOAESTHESIA (numbness on face and tongue), PARAESTHESIA (tingle on face and tongue like she had anesthesia), PARAESTHESIA ORAL (tingle on face and tongue like she had anesthesia), SWOLLEN TONGUE (tongue was bigger and dryness), TONGUE DRY (tongue was bigger and dryness), THIRST (thirsty), CHEST DISCOMFORT (pressure on chest) and DIZZINESS (dizziness) had resolved. On 17-Jan-2021, INFLUENZA LIKE ILLNESS (felt like she had the flu), BEDRIDDEN (stay in bed all day), CHILLS (experienced chills), BONE PAIN (bone pain) and HEADACHE (very bad headaches) had resolved. At the time of the report, INJECTION SITE PRURITUS (a little itchiness on the same arm of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Hardness that was sensitive to touch; Pain at injection site/very sore in left arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (Hardness that was sensitive to touch) and VACCINATION SITE PAIN (Pain at injection site/very sore in left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hardness that was sensitive to touch) and VACCINATION SITE PAIN (Pain at injection site/very sore in left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (Hardness that was sensitive to touch) and VACCINATION SITE PAIN (Pain at injection site/very sore in left arm) 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.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain, Pain in extremity
Clinical narrative: pain in my left arm going down the entire arm into my hand; pain in my neck; pain in my back; pain up my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my left arm going down the entire arm into my hand), NECK PAIN (pain in my neck), BACK PAIN (pain in my back) and ARTHRALGIA (pain up my shoulder) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my left arm going down the entire arm into my hand), NECK PAIN (pain in my neck), BACK PAIN (pain in my back) and ARTHRALGIA (pain up my shoulder). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in my left arm going down the entire arm into my hand), NECK PAIN (pain in my neck), BACK PAIN (pain in my back) and ARTHRALGIA (pain up my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment included heat and cold packs.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Breast tenderness, Heart rate, Hypoaesthesia
Clinical narrative: Breast tenderness; Itching; Hives; Numbness; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Trauma and Hives. Concurrent medical conditions included Bipolar disorder, Depression, Polycystic ovarian syndrome and Drug allergy (Cefidinir) since 02-Aug-2012. Concomitant products included ARIPIPRAZOLE (ABILIFY) from 18-Jun-2020 to an unknown date for Bipolar affective disorder, unspecified.    On 20-Jan-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021 at 12:05 PM, the patient experienced BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) 20-Jan-2021 for Adverse event following immunisation, at a dose of 50 mg once; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intramuscular) 20-Jan-2021 for Adverse event following immunisation, at a dose of 10 mg once and ACETAMINOPHEN (oral) 20-Jan-2021 for Adverse event following immunisation, at a dose of 650 mg once. At the time of the report, BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood pressure measurement (120-80 mmHg): 146/89 mmHg (High) Abnormal. On 20-Jan-2021, Body temperature (36.5-37.5): 36.6 (normal) degree Celsius. On 20-Jan-2021, Heart rate (70-99): 89 (normal) beats per minute. On 20-Jan-2021, Respiratory rate: 18 (normal) other.     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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non Significant Follow-up Append On 21-Jun-2021: Major narrative update, corrections for suspect product, con.meds, treatment, med.history. Added lab data, updated Events and  Causality Assessment
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Respiratory rate, Urticaria
Clinical narrative: Breast tenderness; Itching; Hives; Numbness; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Trauma and Hives. Concurrent medical conditions included Bipolar disorder, Depression, Polycystic ovarian syndrome and Drug allergy (Cefidinir) since 02-Aug-2012. Concomitant products included ARIPIPRAZOLE (ABILIFY) from 18-Jun-2020 to an unknown date for Bipolar affective disorder, unspecified.    On 20-Jan-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021 at 12:05 PM, the patient experienced BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) 20-Jan-2021 for Adverse event following immunisation, at a dose of 50 mg once; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) (intramuscular) 20-Jan-2021 for Adverse event following immunisation, at a dose of 10 mg once and ACETAMINOPHEN (oral) 20-Jan-2021 for Adverse event following immunisation, at a dose of 650 mg once. At the time of the report, BREAST TENDERNESS (Breast tenderness), PRURITUS (Itching), URTICARIA (Hives) and HYPOAESTHESIA (Numbness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood pressure measurement (120-80 mmHg): 146/89 mmHg (High) Abnormal. On 20-Jan-2021, Body temperature (36.5-37.5): 36.6 (normal) degree Celsius. On 20-Jan-2021, Heart rate (70-99): 89 (normal) beats per minute. On 20-Jan-2021, Respiratory rate: 18 (normal) other.     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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non Significant Follow-up Append On 21-Jun-2021: Major narrative update, corrections for suspect product, con.meds, treatment, med.history. Added lab data, updated Events and  Causality Assessment
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Fatigue; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and ARTHRALGIA (Joint Pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (Fatigue) and ARTHRALGIA (Joint Pain). At the time of the report, FATIGUE (Fatigue) and ARTHRALGIA (Joint Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Eye pruritus, Oedema, Urticaria
Clinical narrative: problem with breathing; very itchy eyes; hives increased at inner thigh, under arms; break out rash and hives/hives increased at inner thigh, under arms; edema around his eyes/very itchy eyes; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of URTICARIA (break out rash and hives/hives increased at inner thigh, under arms), OEDEMA (edema around his eyes/very itchy eyes), DYSPNOEA (problem with breathing), EYE PRURITUS (very itchy eyes) and URTICARIA (hives increased at inner thigh, under arms) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cellulitis. Concurrent medical conditions included Drug allergy (Clarithromycin).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Jan-2021, the patient experienced URTICARIA (break out rash and hives/hives increased at inner thigh, under arms), OEDEMA (edema around his eyes/very itchy eyes), EYE PRURITUS (very itchy eyes) and URTICARIA (hives increased at inner thigh, under arms). On 22-Jan-2021, the patient experienced DYSPNOEA (problem with breathing). The patient was treated with PREDNISONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC) at an unspecified dose and frequency. On 26-Jan-2021, URTICARIA (break out rash and hives/hives increased at inner thigh, under arms), OEDEMA (edema around his eyes/very itchy eyes) and DYSPNOEA (problem with breathing) had resolved and EYE PRURITUS (very itchy eyes) and URTICARIA (hives increased at inner thigh, under arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took dalvance as infusion 3 years ago and is using pacemaker at high risk of COVID 19.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site inflammation
Clinical narrative: it is bright pink; Two and a half inches in diameter (it is a circle); the area is pink; tiny itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (tiny itch), ERYTHEMA (the area is pink), ERYTHEMA (it is bright pink) and VACCINATION SITE INFLAMMATION (Two and a half inches in diameter (it is a circle)) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 11-Jan-2021, the patient experienced PRURITUS (tiny itch). On 13-Jan-2021, the patient experienced ERYTHEMA (the area is pink). On 19-Jan-2021, the patient experienced ERYTHEMA (it is bright pink) and VACCINATION SITE INFLAMMATION (Two and a half inches in diameter (it is a circle)). At the time of the report, PRURITUS (tiny itch), ERYTHEMA (the area is pink), ERYTHEMA (it is bright pink) and VACCINATION SITE INFLAMMATION (Two and a half inches in diameter (it is a circle)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.     Treatment details provided include Antihistamine for several days
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site) 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-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site lymphadenopathy
Clinical narrative: pain, like a pinched nerve; swollen lymph node in the arm where she got vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain, like a pinched nerve) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph node in the arm where she got vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen lymph node in the arm where she got vaccine). On 20-Jan-2021, the patient experienced PAIN (pain, like a pinched nerve). At the time of the report, PAIN (pain, like a pinched nerve) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph node in the arm where she got vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Dentist consider her Covid-19 positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Dentist consider her Covid-19 positive) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 18-Jan-2021, the patient experienced COVID-19 (Dentist consider her Covid-19 positive). At the time of the report, COVID-19 (Dentist consider her Covid-19 positive) 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.   As patient experience Covid-19 and dentist denied to treat and had a appointment for a PCR test.  On an unknown date, Blood immunoglobulin G: positive (Positive) Positive. On an unknown date, Blood immunoglobulin M: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.  No relevant concomitant medications were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Really bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Really bad headaches) 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 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Really bad headaches). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for Headache, at an unspecified dose and frequency and METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Really bad headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Updated event outcome to recovered for event headache.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Swelling
Clinical narrative: Chills; a bit of swelling; Headache; Cold; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), SWELLING (a bit of swelling), HEADACHE (Headache) and NASOPHARYNGITIS (Cold) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Hypertension.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced CHILLS (Chills), SWELLING (a bit of swelling), HEADACHE (Headache) and NASOPHARYNGITIS (Cold). At the time of the report, CHILLS (Chills), SWELLING (a bit of swelling), HEADACHE (Headache) and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included anti hypertensives. Treatment details was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Vaccination site inflammation
Clinical narrative: stomach disturbance; minor inflammation on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach disturbance) and VACCINATION SITE INFLAMMATION (minor inflammation on the left arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (minor inflammation on the left arm). On 12-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach disturbance). At the time of the report, ABDOMINAL DISCOMFORT (stomach disturbance) had resolved and VACCINATION SITE INFLAMMATION (minor inflammation on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: rash; headache; fatigue; chills; slight fever; sore arm; hot to touch around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever) and PAIN IN EXTREMITY (sore arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE and ASCORBIC ACID, FERROUS FUMARATE (VITRON C) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (hot to touch around the injection site). On 23-Jan-2021, the patient experienced RASH (rash). At the time of the report, HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever), PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (hot to touch around the injection site) and RASH (rash) outcome was unknown. Not Provided      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 took Lidocaine and Motrin for the symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site warmth
Clinical narrative: rash; headache; fatigue; chills; slight fever; sore arm; hot to touch around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever) and PAIN IN EXTREMITY (sore arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE and ASCORBIC ACID, FERROUS FUMARATE (VITRON C) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE WARMTH (hot to touch around the injection site). On 23-Jan-2021, the patient experienced RASH (rash). At the time of the report, HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills), PYREXIA (slight fever), PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (hot to touch around the injection site) and RASH (rash) outcome was unknown. Not Provided      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 took Lidocaine and Motrin for the symptoms.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Rash
Clinical narrative: I had pain in my arm; Heart palpitations; rash on the front upper body, shoulder and neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Heart palpitations) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.  No medical history was provided by the reporter. . Concomitant products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 23) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations). At the time of the report, PALPITATIONS (Heart palpitations) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No treatment medications provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Intense itching and redness at area and surrounding injection site; Intense itching and redness at area and surrounding injection site; Urticaria; Underlying rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Intense itching and redness at area and surrounding injection site), VACCINATION SITE ERYTHEMA (Intense itching and redness at area and surrounding injection site), URTICARIA (Urticaria) and RASH (Underlying rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's thyroiditis and Sjogren's. Concomitant products included LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Jan-2021 at 9:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Intense itching and redness at area and surrounding injection site), VACCINATION SITE ERYTHEMA (Intense itching and redness at area and surrounding injection site), URTICARIA (Urticaria) and RASH (Underlying rash). At the time of the report, VACCINATION SITE PRURITUS (Intense itching and redness at area and surrounding injection site), VACCINATION SITE ERYTHEMA (Intense itching and redness at area and surrounding injection site), URTICARIA (Urticaria) and RASH (Underlying rash) 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: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm; red arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and PAIN IN EXTREMITY (Sore arm) 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 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red arm) and PAIN IN EXTREMITY (Sore arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As a corrective treatment, patient put ice on the area and has been taking Multim and Benadryl.   No concomitant medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Pain
Clinical narrative: Positive test for Covid-19; pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), FATIGUE (Fatigue) and COVID-19 (Positive test for Covid-19) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN (XARELTO), VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID CHELATE] and VITAMIN D3 for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Jan-2021, the patient experienced PAIN (pain) and FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced COVID-19 (Positive test for Covid-19). On 08-Jan-2021, PAIN (pain) and FATIGUE (Fatigue) had resolved. At the time of the report, COVID-19 (Positive test for Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Vertigo
Clinical narrative: vertigo; dizziness; Could not get of my bed; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness) and BEDRIDDEN (Could not get of my bed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness) and BEDRIDDEN (Could not get of my bed). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness) and BEDRIDDEN (Could not get of my bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema
Clinical narrative: 1 in pink ring around the bruise - this continued until it reached 2 in ring and then stopped; Grape-size bruise with a tail; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (Grape-size bruise with a tail) and VACCINATION SITE ERYTHEMA (1 in pink ring around the bruise - this continued until it reached 2 in ring and then stopped) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Grape-size bruise with a tail). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (1 in pink ring around the bruise - this continued until it reached 2 in ring and then stopped). At the time of the report, VACCINATION SITE BRUISING (Grape-size bruise with a tail) and VACCINATION SITE ERYTHEMA (1 in pink ring around the bruise - this continued until it reached 2 in ring and then stopped) 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.   No Treatment information was provided.  No concomitant medications were included.   Reporter did not allow further contact
Age: 76.0
Sex: M
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 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). In January 2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up TCR is attached : Email id updated. On 24-Apr-2021: ADR form is attached on 24-APR-2021-First dose and Second dose information updated, Patient Race and Ethnicity updated, Event outcome updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Chills, Fatigue, Headache
Clinical narrative: Chills night of vaccine; COVID-19; Lost sense of smell; Severe Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ANOSMIA (Lost sense of smell), HEADACHE (Severe Headache), FATIGUE (Fatigue) and CHILLS (Chills night of vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced CHILLS (Chills night of vaccine). In January 2021, the patient experienced COVID-19 (COVID-19), ANOSMIA (Lost sense of smell), HEADACHE (Severe Headache) and FATIGUE (Fatigue). At the time of the report, COVID-19 (COVID-19), HEADACHE (Severe Headache), FATIGUE (Fatigue) and CHILLS (Chills night of vaccine) had resolved and ANOSMIA (Lost sense of smell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills night of vaccine; COVID-19; Lost sense of smell; Severe Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ANOSMIA (Lost sense of smell), HEADACHE (Severe Headache), FATIGUE (Fatigue) and CHILLS (Chills night of vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced CHILLS (Chills night of vaccine). In January 2021, the patient experienced COVID-19 (COVID-19), ANOSMIA (Lost sense of smell), HEADACHE (Severe Headache) and FATIGUE (Fatigue). At the time of the report, COVID-19 (COVID-19), HEADACHE (Severe Headache), FATIGUE (Fatigue) and CHILLS (Chills night of vaccine) had resolved and ANOSMIA (Lost sense of smell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site area is a few inches out like a "balloon shape" ; rash; redness in the injection site; itching around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around the injection site), RASH (rash), VACCINATION SITE ERYTHEMA (redness in the injection site) and VACCINATION SITE SWELLING (injection site area is a few inches out like a "balloon shape") 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 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the injection site). On 11-Jan-2021, the patient experienced RASH (rash) and VACCINATION SITE ERYTHEMA (redness in the injection site). On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site area is a few inches out like a "balloon shape"). At the time of the report, VACCINATION SITE PRURITUS (itching around the injection site), RASH (rash), VACCINATION SITE ERYTHEMA (redness in the injection site) and VACCINATION SITE SWELLING (injection site area is a few inches out like a "balloon shape") had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Warmth at the injection site; Itchiness at the injection site; Swelling and redness that is present from Left deltoid (Injection site); Swelling and redness that is present from Left deltoid (Injection site); This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE SWELLING (Swelling and redness that is present from Left deltoid (Injection site)) and INJECTION SITE ERYTHEMA (Swelling and redness that is present from Left deltoid (Injection site)) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MOD012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE SWELLING (Swelling and redness that is present from Left deltoid (Injection site)) and INJECTION SITE ERYTHEMA (Swelling and redness that is present from Left deltoid (Injection site)). At the time of the report, INJECTION SITE WARMTH (Warmth at the injection site), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE SWELLING (Swelling and redness that is present from Left deltoid (Injection site)) and INJECTION SITE ERYTHEMA (Swelling and redness that is present from Left deltoid (Injection site)) 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.   No Treatment information was provided. No concomitant medications were included.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pain in arm; Tiredness; A spontaneous report was received from a consumer concerning a 65 Years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain in extremity and Fatigue.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025J20-2A) intramuscularly in the Arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, The patient experienced pain in arm and tiredness.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.   On 09 JAn 2021, the outcome of the events pain in arm and tiredness were resolved.  At the time of this report, the outcome of the event(s) Pain in extremity and Fatigue were considered recovered.; Reporter's Comments: This case concerns a 65 year old female who experienced a nonserious expected events Pain in extremity and Fatigue the same day she received the first dose of mRNA-1273 on 06Jan2021. Both events were reported as recovered/resolved on 09Jan2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: dermal fillers swelling; A spontaneous report was received from a non-heath care professional concerning an unknown patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin swelling.  The patient's medical history included 2 reports of dermal fillers swelling prior to vaccine administration. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received unknown dose of mRNA-1273 for prophylaxis of COVID-19 infection. After 2 days of administration of COVID vaccine, the patient experienced with 3rd episode of dermal fillers swelling. The 1st two dermal fillers swelling were reported prior to vaccine administration.  Laboratory details were not provided.  Treatment details were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   Th outcome of the event at the time of the report were unknown.  The relationship of the reporter assessed event, dermal fillers swelling to the study drug was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded