chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertent administration before age 18; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertent administration before age 18) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertent administration before age 18). On 29-Dec-2020, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inadvertent administration before age 18) 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 were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: initial additional document received 13 Jul 2021 and contains No New Information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: 2.5 inch bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (2.5 inch bruise at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included ENALAPRIL and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (2.5 inch bruise at injection site). At the time of the report, VACCINATION SITE BRUISING (2.5 inch bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Chest pain, Chills, Headache
Clinical narrative: burning in chest; weakness; shaky; fever; chills; achy; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (achy), HEADACHE (headache) and CHEST PAIN (burning in chest) in a 66-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.     The patient's past medical history included COPD and COVID-19 (She did have Covid-19 last May).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (achy) and HEADACHE (headache). On 05-Mar-2021, the patient experienced CHEST PAIN (burning in chest), ASTHENIA (weakness) and NERVOUSNESS (shaky). On 27-Feb-2021, PYREXIA (fever), CHILLS (chills), PAIN (achy) and HEADACHE (headache) had resolved. At the time of the report, CHEST PAIN (burning in chest), ASTHENIA (weakness) and NERVOUSNESS (shaky) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) came back clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain, Pyrexia
Clinical narrative: burning in chest; weakness; shaky; fever; chills; achy; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (achy), HEADACHE (headache) and CHEST PAIN (burning in chest) in a 66-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.     The patient's past medical history included COPD and COVID-19 (She did have Covid-19 last May).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (achy) and HEADACHE (headache). On 05-Mar-2021, the patient experienced CHEST PAIN (burning in chest), ASTHENIA (weakness) and NERVOUSNESS (shaky). On 27-Feb-2021, PYREXIA (fever), CHILLS (chills), PAIN (achy) and HEADACHE (headache) had resolved. At the time of the report, CHEST PAIN (burning in chest), ASTHENIA (weakness) and NERVOUSNESS (shaky) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) came back clear.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site discolouration
Clinical narrative: rash that is itchy; black and blue and is the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash that is itchy) and VACCINATION SITE DISCOLOURATION (black and blue and is the size of a silver dollar) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH (rash that is itchy) and VACCINATION SITE DISCOLOURATION (black and blue and is the size of a silver dollar). At the time of the report, RASH (rash that is itchy) and VACCINATION SITE DISCOLOURATION (black and blue and is the size of a silver dollar) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable. No concomitant medication was mentioned. Treatment  details included hydrocortisone cream.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Headache
Clinical narrative: Could not stand up; Felt so weak; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Could not stand up), ASTHENIA (Felt so weak) and HEADACHE (Slight headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced DYSSTASIA (Could not stand up), ASTHENIA (Felt so weak) and HEADACHE (Slight headache). At the time of the report, DYSSTASIA (Could not stand up), ASTHENIA (Felt so weak) and HEADACHE (Slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness/exhaustion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31M20A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness/exhaustion). At the time of the report, FATIGUE (tiredness/exhaustion) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Vertigo; Vomiting; A spontaneous report was received from a consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vertigo, vomiting.  The patient's medical history was not provided. Concomitant medications reported were lisinopril, amlodipine, letrozole, zometa infusion, vitamin D3, balanced b50 tab, low dose bayer aspirin, calcium citrate for drug use for unknown indication.  On 4 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) via unknown route for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient experienced the event(s) vertigo, vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 6 Mar 2021 the outcome of event(s), vertigo, vomiting was resolved.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: his arm looked like he had a baseball/Swollen/huge; Itching; hard as a rock; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE SWELLING (his arm looked like he had a baseball/Swollen/huge), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE INDURATION (hard as a rock) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (his arm looked like he had a baseball/Swollen/huge), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE INDURATION (hard as a rock). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE SWELLING (his arm looked like he had a baseball/Swollen/huge), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE INDURATION (hard as a rock) had resolved.            No concomitant medications reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever of 102F; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102F) and PAIN IN EXTREMITY (soreness in his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 21-Feb-2021, the patient experienced PYREXIA (fever of 102F). At the time of the report, PYREXIA (fever of 102F) was resolving and PAIN IN EXTREMITY (soreness in his arm) outcome was unknown.            No concomitants and treatment medications were not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza virus test, Malaise
Clinical narrative: Sinus infection; legs cramping; body aches; muscles burn; high fever 103.3 F.; severe headache; chills; felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical histiory).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache). At the time of the report, SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.3 (High) 103.3 F. On 02-Mar-2021, Influenza virus test: negative (Negative) negative. On 02-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.         Very limited information regarding the events has been provided at this time. The events were consistent with infectious process. Company assessed the events to be unlikely related to company product.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sinus infection; legs cramping; body aches; muscles burn; high fever 103.3 F.; severe headache; chills; felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical histiory).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache). At the time of the report, SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.3 (High) 103.3 F. On 02-Mar-2021, Influenza virus test: negative (Negative) negative. On 02-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.         Very limited information regarding the events has been provided at this time. The events were consistent with infectious process. Company assessed the events to be unlikely related to company product.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; legs cramping; body aches; muscles burn; high fever 103.3 F.; severe headache; chills; felt really sick; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical histiory).    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache). At the time of the report, SINUSITIS (Sinus infection), PYREXIA (high fever 103.3 F.) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.3 (High) 103.3 F. On 02-Mar-2021, Influenza virus test: negative (Negative) negative. On 02-Mar-2021, SARS-CoV-2 test: negative (Negative) negative.         Very limited information regarding the events has been provided at this time. The events were consistent with infectious process. Company assessed the events to be unlikely related to company product.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Headache; Fatigue; Fever (Temperature 101.4); Chills; Injection site tenderness; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE PAIN (Injection site tenderness), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol, Tremor and Depression. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Tremor.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site tenderness). On 03-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills). On 03-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills) had resolved. On 04-Mar-2021, INJECTION SITE PAIN (Injection site tenderness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101.4 (High) 101.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include an antidepressant, blood pressure medicine, and a statin for cholesterol. Reported that the patient didn't take any medications for the symptoms.   This case was linked to MOD21-045920 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Fatigue; Fever (Temperature 101.4); Chills; Injection site tenderness; This spontaneous case was reported by a non-health professional and describes the occurrence of INJECTION SITE PAIN (Injection site tenderness), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol, Tremor and Depression. Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Tremor.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site tenderness). On 03-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills). On 03-Mar-2021, HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever (Temperature 101.4)) and CHILLS (Chills) had resolved. On 04-Mar-2021, INJECTION SITE PAIN (Injection site tenderness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 101.4 (High) 101.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include an antidepressant, blood pressure medicine, and a statin for cholesterol. Reported that the patient didn't take any medications for the symptoms.   This case was linked to MOD21-045920 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Red rash 2x3 in size; itchy rash looked like a rectangle; Red rash at the injection site of the left arm; Red rash at the injection site of the left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Red rash 2x3 in size), VACCINATION SITE PRURITUS (itchy rash looked like a rectangle), VACCINATION SITE ERYTHEMA (Red rash at the injection site of the left arm) and VACCINATION SITE RASH (Red rash at the injection site of the left arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Nose congestion.   On 25-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Red rash 2x3 in size), VACCINATION SITE PRURITUS (itchy rash looked like a rectangle), VACCINATION SITE ERYTHEMA (Red rash at the injection site of the left arm) and VACCINATION SITE RASH (Red rash at the injection site of the left arm). On 07-Mar-2021, VACCINATION SITE INDURATION (Red rash 2x3 in size), VACCINATION SITE PRURITUS (itchy rash looked like a rectangle), VACCINATION SITE ERYTHEMA (Red rash at the injection site of the left arm) and VACCINATION SITE RASH (Red rash at the injection site of the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medications was provided   This case was linked to MOD-2021-117037, MOD-2021-036644 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient details updated
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: can't bring the arm up; sore in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (can't bring the arm up) and PAIN IN EXTREMITY (sore in the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can't bring the arm up) and PAIN IN EXTREMITY (sore in the arm). The patient was treated with IBUPROFEN (ADVIL MUSCLE AND JOINT) for Pain in arm, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (can't bring the arm up) and PAIN IN EXTREMITY (sore in the arm) outcome was unknown.            no concomitant medications are provided. Action taken with mRNA-1273 in response to the event was not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash on left arm 9 days after receiving first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed rash on left arm 9 days after receiving first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (Developed rash on left arm 9 days after receiving first dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Developed rash on left arm 9 days after receiving first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching all over body; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over body) and RASH (rash all over body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     No medical information was provided.     On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (itching all over body) and RASH (rash all over body). The patient was treated with CALAMINE for Itching and Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching all over body) and RASH (rash all over body) outcome was unknown.            concomitant medications include blood pressure medications. Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of the event updated from unknown to resolved.
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Tired; Sweating; Vomiting; Can't open your eye; Excruciating pain all over the body; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills) and FATIGUE (Tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025620A and 072A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received second 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. On 07-Feb-2021, the patient experienced VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and HYDROCODONE for Adverse event, at a dose of UNK dosage form. At the time of the report, VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills), FATIGUE (Tired) and HYPERHIDROSIS (Sweating) outcome was unknown.            No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Tired; Sweating; Vomiting; Can't open your eye; Excruciating pain all over the body; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills) and FATIGUE (Tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025620A and 072A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received second 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. On 07-Feb-2021, the patient experienced VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and HYDROCODONE for Adverse event, at a dose of UNK dosage form. At the time of the report, VOMITING (Vomiting), ASTHENOPIA (Can't open your eye), PAIN (Excruciating pain all over the body), CHILLS (Chills), FATIGUE (Tired) and HYPERHIDROSIS (Sweating) outcome was unknown.            No concomitant medications reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lumps underneath her arm pit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lumps underneath her arm pit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Lumps underneath her arm pit). At the time of the report, AXILLARY MASS (Lumps underneath her arm pit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Threw up; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VOMITING (Threw up) and the second episode of VOMITING (Threw up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced the first episode of VOMITING (Threw up). On 06-Mar-2021, the patient experienced the second episode of VOMITING (Threw up). On 06-Mar-2021, last episode of VOMITING (Threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their 1st dose of the Moderna vaccine experienced chills.  On 23-Apr-2021, the patient reported that the symptoms had resolved.  No Concomitant product use was reported. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR Received and Updated the outcome of the event as Resolved.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Black particles in vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Black particles in vaccine vial) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Black particles in vaccine vial). On 04-Mar-2021, POOR QUALITY PRODUCT ADMINISTERED (Black particles in vaccine vial) had resolved. 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.   No relevant concomitant medications were reported.   No treatment information was provided.      This case was linked to MOD-2021-036321 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Headache, Pruritus, Pyrexia, Rash
Clinical narrative: blistering in the upper part of her torso; rash in the upper part of her torso; hands itched; feet itched; fever of 100.4 deg. F; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blistering in the upper part of her torso), RASH (rash in the upper part of her torso), PRURITUS (hands itched), PRURITUS (feet itched) and PYREXIA (fever of 100.4 deg. F) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FAMOTIDINE and Sumatriptopan for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BLISTER (blistering in the upper part of her torso), RASH (rash in the upper part of her torso), PRURITUS (hands itched), PRURITUS (feet itched), PYREXIA (fever of 100.4 deg. F) and HEADACHE (headache). At the time of the report, BLISTER (blistering in the upper part of her torso), RASH (rash in the upper part of her torso), PRURITUS (hands itched), PRURITUS (feet itched), PYREXIA (fever of 100.4 deg. F) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Injection site erythema
Clinical narrative: Extreme Fatigue; Felt Heavy; Severe Headache; Chills; Nausea; Red Injection Site Spread 3.5"; Severe Side Effect; Not Feeling Well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe Side Effect), MALAISE (Not Feeling Well), HEADACHE (Severe Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Severe Side Effect) and MALAISE (Not Feeling Well). On 03-Mar-2021, the patient experienced HEADACHE (Severe Headache), CHILLS (Chills), NAUSEA (Nausea) and INJECTION SITE ERYTHEMA (Red Injection Site Spread 3.5"). On 05-Mar-2021, the patient experienced FATIGUE (Extreme Fatigue) and FEELING ABNORMAL (Felt Heavy). On 06-Mar-2021, VACCINATION COMPLICATION (Severe Side Effect), MALAISE (Not Feeling Well), HEADACHE (Severe Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site Spread 3.5"), FATIGUE (Extreme Fatigue) and FEELING ABNORMAL (Felt Heavy) 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: Malaise, Nausea, Vaccination complication
Clinical narrative: Extreme Fatigue; Felt Heavy; Severe Headache; Chills; Nausea; Red Injection Site Spread 3.5"; Severe Side Effect; Not Feeling Well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe Side Effect), MALAISE (Not Feeling Well), HEADACHE (Severe Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Severe Side Effect) and MALAISE (Not Feeling Well). On 03-Mar-2021, the patient experienced HEADACHE (Severe Headache), CHILLS (Chills), NAUSEA (Nausea) and INJECTION SITE ERYTHEMA (Red Injection Site Spread 3.5"). On 05-Mar-2021, the patient experienced FATIGUE (Extreme Fatigue) and FEELING ABNORMAL (Felt Heavy). On 06-Mar-2021, VACCINATION COMPLICATION (Severe Side Effect), MALAISE (Not Feeling Well), HEADACHE (Severe Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site Spread 3.5"), FATIGUE (Extreme Fatigue) and FEELING ABNORMAL (Felt Heavy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pruritus
Clinical narrative: Itchy arm; Bilateral arm muscle pain; Fatigue; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy arm), MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Itchy arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy arm), MYALGIA (Bilateral arm muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included High Blood Pressure Medications, Antihyperlipidemic Medication.   This case was linked to MOD21-047783 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up received on 03-MAY-2021, new event updated, outcome of the events were updated form unknown to recovered. Treatment details updated.; Sender's Comments:  MOD21-047783:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Difficulty in breathing; Wheezing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing) and WHEEZING (Wheezing) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DYSPNOEA (Difficulty in breathing) and WHEEZING (Wheezing). At the time of the report, DYSPNOEA (Difficulty in breathing) and WHEEZING (Wheezing) 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.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient administered second dose with a 21 day interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose with a 21 day interval) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose with a 21 day interval). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered second dose with a 21 day interval) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications or treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: NNI; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot# 030A21A) with no associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Sep-2020 and the estimated date of delivery was 02-Jul-2021. On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        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: Abdominal discomfort, Pain in extremity, Paraesthesia, Skin exfoliation
Clinical narrative: extremely flaky skin; burning and tingling on her arms, abdomen, and thighs; burning and tingling on her arms, abdomen, and thighs; burning and tingling on her arms, abdomen, and thighs; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (extremely flaky skin), ABDOMINAL DISCOMFORT (burning and tingling on her arms, abdomen, and thighs), PARAESTHESIA (burning and tingling on her arms, abdomen, and thighs) and PAIN IN EXTREMITY (burning and tingling on her arms, abdomen, and thighs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN EXFOLIATION (extremely flaky skin), ABDOMINAL DISCOMFORT (burning and tingling on her arms, abdomen, and thighs), PARAESTHESIA (burning and tingling on her arms, abdomen, and thighs) and PAIN IN EXTREMITY (burning and tingling on her arms, abdomen, and thighs). At the time of the report, SKIN EXFOLIATION (extremely flaky skin), ABDOMINAL DISCOMFORT (burning and tingling on her arms, abdomen, and thighs) and PAIN IN EXTREMITY (burning and tingling on her arms, abdomen, and thighs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick after she took both Moderna COVID-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after she took both Moderna COVID-19 vaccinations.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to arthropod bite (bees and mosquitos).    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 ILLNESS (sick after she took both Moderna COVID-19 vaccinations.). At the time of the report, ILLNESS (sick after she took both Moderna COVID-19 vaccinations.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included neomycin-polymyxin, B-dexamethasone ophthalmic ointment.   This case was linked to US-MODERNATX, INC.-MOD-2021-036583 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036583:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, SARS-CoV-2 test negative
Clinical narrative: Pain under left breast that come and go; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain under left breast that come and go) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included AMLODIPINE and LISINOPRIL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced BREAST PAIN (Pain under left breast that come and go). At the time of the report, BREAST PAIN (Pain under left breast that come and go) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment included Tylenol.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Lab data attached