chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vertigo, Vestibular disorder
Clinical narrative: Unilateral Vestibular Hypofunction in her right ear; Equilibrium Instability; quite sick; Hadn't been well; dizziness; Hadn't been well and didn't get second shot; Nerve Damage; Full episode of vertigo/Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (Nerve Damage), VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick) and VACCINATION COMPLICATION (Hadn't been well) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced NERVE INJURY (Nerve Damage) and VERTIGO (Full episode of vertigo/Vertigo). On an unknown date, the patient experienced VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick), VACCINATION COMPLICATION (Hadn't been well), DIZZINESS (dizziness) and INTENTIONAL DOSE OMISSION (Hadn't been well and didn't get second shot). At the time of the report, NERVE INJURY (Nerve Damage), VESTIBULAR DISORDER (Unilateral Vestibular Hypofunction in her right ear), BALANCE DISORDER (Equilibrium Instability), ILLNESS (quite sick), VACCINATION COMPLICATION (Hadn't been well) and DIZZINESS (dizziness) outcome was unknown and VERTIGO (Full episode of vertigo/Vertigo) and INTENTIONAL DOSE OMISSION (Hadn't been well and didn't get second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Full itchy; rash, broke out again; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Full itchy) and RASH (rash, broke out again) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Patient had heart attack twice from heart racing) and Heart racing (Patient's heart races due to Hashimoto's disease condition). Concurrent medical conditions included Allergy, Eczema, Thyroid disorder (It was not clear whether it was hyperthyroidism or hypothyroidism, because patient mentioned both) and Hashimoto's disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Full itchy) and RASH (rash, broke out again). At the time of the report, PRURITUS (Full itchy) and RASH (rash, broke out again) outcome was unknown.            Patient had rashes from anything, she was even allergic to band-aids, so she didn't not blame the vaccine but rather her own skin.  Since hear attack patient couldn't control it only with thyroid medication cardiologist told her to have aspirin daily as well.   This case was linked to MOD-2021-286205 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination; Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure) and DRUG INEFFECTIVE (Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure). On an unknown date, the patient experienced DRUG INEFFECTIVE (Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination). At the time of the report, COVID-19 (Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure) and DRUG INEFFECTIVE (Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Diagnosed with COVID-19 last week.         Patient went to the ER where treated with an experimental IV cocktail and was discharged to rest and quarantine at home. No concomitant medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Dyspnoea, Illness
Clinical narrative: sick; throat was hurting - sore throat; some shortness of breath; both side of my neck where my lymph nodes are were like golf ball size; Lymph nodes hurt; dry cough when I talk; every now and then, I'll get palpitations; hips were really really sore - painful; whole body hurt, not just on the side where I got the shot - my arms hurt; started getting chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size) and LYMPH NODE PAIN (Lymph nodes hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills). On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia, Oropharyngeal pain, Palpitations
Clinical narrative: sick; throat was hurting - sore throat; some shortness of breath; both side of my neck where my lymph nodes are were like golf ball size; Lymph nodes hurt; dry cough when I talk; every now and then, I'll get palpitations; hips were really really sore - painful; whole body hurt, not just on the side where I got the shot - my arms hurt; started getting chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size) and LYMPH NODE PAIN (Lymph nodes hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills). On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: sick; throat was hurting - sore throat; some shortness of breath; both side of my neck where my lymph nodes are were like golf ball size; Lymph nodes hurt; dry cough when I talk; every now and then, I'll get palpitations; hips were really really sore - painful; whole body hurt, not just on the side where I got the shot - my arms hurt; started getting chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size) and LYMPH NODE PAIN (Lymph nodes hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills). On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick), OROPHARYNGEAL PAIN (throat was hurting - sore throat), DYSPNOEA (some shortness of breath), LYMPHADENOPATHY (both side of my neck where my lymph nodes are were like golf ball size), LYMPH NODE PAIN (Lymph nodes hurt), COUGH (dry cough when I talk), PALPITATIONS (every now and then, I'll get palpitations), ARTHRALGIA (hips were really really sore - painful), MYALGIA (whole body hurt, not just on the side where I got the shot - my arms hurt) and CHILLS (started getting chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information was provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Vaccination site pain
Clinical narrative: chest pain got worse over the week; dizziness got worse over the week; chest heaviness just comes and goes; happens when she is doing something and she gets breathless; Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now; Vaccinated Right upper arm location soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain got worse over the week), DIZZINESS (dizziness got worse over the week), CHEST DISCOMFORT (chest heaviness just comes and goes), DYSPNOEA (happens when she is doing something and she gets breathless) and VACCINATION SITE RASH (Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder, Neuropathy, Back ache and Panic attack. Concurrent medical conditions included Asthma, Allergy, Post-traumatic stress disorder, Rosacea, Depression, Migraine and Irritable bowel syndrome. Concomitant products included Amlodipine; Synthroid; Restasis; Zoloft; Valacyclovir [Valaciclovir]; Symbicort; Astelin [Azelastine Hydrochloride]; Hydroxyzine; Nexium [Esomeprazole Magnesium]; Rizatriptan; Premarin; Baby Aspirin; Vitamin D [Vitamin D Nos]; Oxycodone [Oxycodone Hydrochloride]; Trintellix for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain got worse over the week), DIZZINESS (dizziness got worse over the week), CHEST DISCOMFORT (chest heaviness just comes and goes), DYSPNOEA (happens when she is doing something and she gets breathless), VACCINATION SITE RASH (Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now) and VACCINATION SITE PAIN (Vaccinated Right upper arm location soreness). At the time of the report, CHEST PAIN (chest pain got worse over the week), DIZZINESS (dizziness got worse over the week), CHEST DISCOMFORT (chest heaviness just comes and goes), DYSPNOEA (happens when she is doing something and she gets breathless), VACCINATION SITE RASH (Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now) and VACCINATION SITE PAIN (Vaccinated Right upper arm location soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Historical condition includes : Stomach problem  Concomitant drug includes : Spyrolactine 50mg twice daily Baclicine 10mg once daily Linzness 200 mg once daily Pro air as need Epi Pen as needed   No Treatment information was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: chest pain got worse over the week; dizziness got worse over the week; chest heaviness just comes and goes; happens when she is doing something and she gets breathless; Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now; Vaccinated Right upper arm location soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain got worse over the week), DIZZINESS (dizziness got worse over the week), CHEST DISCOMFORT (chest heaviness just comes and goes), DYSPNOEA (happens when she is doing something and she gets breathless) and VACCINATION SITE RASH (Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder, Neuropathy, Back ache and Panic attack. Concurrent medical conditions included Asthma, Allergy, Post-traumatic stress disorder, Rosacea, Depression, Migraine and Irritable bowel syndrome. Concomitant products included Amlodipine; Synthroid; Restasis; Zoloft; Valacyclovir [Valaciclovir]; Symbicort; Astelin [Azelastine Hydrochloride]; Hydroxyzine; Nexium [Esomeprazole Magnesium]; Rizatriptan; Premarin; Baby Aspirin; Vitamin D [Vitamin D Nos]; Oxycodone [Oxycodone Hydrochloride]; Trintellix for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain got worse over the week), DIZZINESS (dizziness got worse over the week), CHEST DISCOMFORT (chest heaviness just comes and goes), DYSPNOEA (happens when she is doing something and she gets breathless), VACCINATION SITE RASH (Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now) and VACCINATION SITE PAIN (Vaccinated Right upper arm location soreness). At the time of the report, CHEST PAIN (chest pain got worse over the week), DIZZINESS (dizziness got worse over the week), CHEST DISCOMFORT (chest heaviness just comes and goes), DYSPNOEA (happens when she is doing something and she gets breathless), VACCINATION SITE RASH (Vaccinated Right upper arm location her arm broke out in a rash/Vaccinated Right upper arm location rash went away better now) and VACCINATION SITE PAIN (Vaccinated Right upper arm location soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Historical condition includes : Stomach problem  Concomitant drug includes : Spyrolactine 50mg twice daily Baclicine 10mg once daily Linzness 200 mg once daily Pro air as need Epi Pen as needed   No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Infection
Clinical narrative: A breakthrough infection; Started experiencing mild symptoms similar to allergies; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Started experiencing mild symptoms similar to allergies) and INFECTION 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 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced HYPERSENSITIVITY (Started experiencing mild symptoms similar to allergies). On an unknown date, the patient experienced INFECTION. At the time of the report, HYPERSENSITIVITY (Started experiencing mild symptoms similar to allergies) and INFECTION outcome was unknown.            Test was reported to be scheduled on Friday.  No Concomitant use were reported. No Treatment was reported.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Rhinorrhoea
Clinical narrative: a little more painful, sustained pain in the arm; sniffles; a little bit of congestion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little more painful, sustained pain in the arm), RHINORRHOEA (sniffles) and NASAL CONGESTION (a little bit of congestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (a little more painful, sustained pain in the arm) and RHINORRHOEA (sniffles). 04-Mar-2021, the patient experienced NASAL CONGESTION (a little bit of congestion). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 09-Mar-2021, PAIN IN EXTREMITY (a little more painful, sustained pain in the arm) had resolved. On 11-Mar-2021, RHINORRHOEA (sniffles) and NASAL CONGESTION (a little bit of congestion) had resolved.            No concomitant medication information was reported.  The patient was waiting for kidney transplant. The patient enquired whether or not to get a third dose.  No treatment medication information was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days since received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days since received the first dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days since received the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days since received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Condition aggravated
Clinical narrative: received her 2nd dose of the COVID-19 vaccine and her symptoms got worse; Gastrointestinal symptoms; Bloating of the stomach; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (received her 2nd dose of the COVID-19 vaccine and her symptoms got worse), ABDOMINAL DISCOMFORT (Gastrointestinal symptoms) and ABDOMINAL DISTENSION (Bloating of the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (received her 2nd dose of the COVID-19 vaccine and her symptoms got worse), ABDOMINAL DISCOMFORT (Gastrointestinal symptoms) and ABDOMINAL DISTENSION (Bloating of the stomach). At the time of the report, CONDITION AGGRAVATED (received her 2nd dose of the COVID-19 vaccine and her symptoms got worse), ABDOMINAL DISCOMFORT (Gastrointestinal symptoms) and ABDOMINAL DISTENSION (Bloating of the stomach) outcome was unknown.            Concomitant medications were not provided. No Treatment information was provided.   This case was linked to MOD-2021-287626 (Patient Link).
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A single dose of expired Moderna Covid-19 vaccine was given accidentally; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 007D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A single dose of expired Moderna Covid-19 vaccine was given accidentally) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) 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 23-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 PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vaccination complication
Clinical narrative: Experienced normal side effects; Lessergy for 1 or 2 days; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Experienced normal side effects) and ASTHENIA (Lessergy for 1 or 2 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experienced normal side effects) and ASTHENIA (Lessergy for 1 or 2 days). At the time of the report, VACCINATION COMPLICATION (Experienced normal side effects) outcome was unknown and ASTHENIA (Lessergy for 1 or 2 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient had took lots of fluids, Gatorade and had taken rest.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Influenza like illness, Pulmonary congestion, Pyrexia
Clinical narrative: major flu-like symptoms; Congestions in my lungs; A slight fever; Dry cough; I had extreme fatigue; Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (major flu-like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced TENDERNESS (Arm tenderness) and FATIGUE (I had extreme fatigue). On 08-Aug-2021, the patient experienced COUGH (Dry cough). On 10-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (major flu-like symptoms) (seriousness criterion medically significant), PULMONARY CONGESTION (Congestions in my lungs) and PYREXIA (A slight fever). At the time of the report, INFLUENZA LIKE ILLNESS (major flu-like symptoms), PULMONARY CONGESTION (Congestions in my lungs), TENDERNESS (Arm tenderness), COUGH (Dry cough), FATIGUE (I had extreme fatigue) and PYREXIA (A slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) diagnosed Covid-19 positive..         Treatment medication was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-288218 (Patient Link).; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tenderness
Clinical narrative: major flu-like symptoms; Congestions in my lungs; A slight fever; Dry cough; I had extreme fatigue; Arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (major flu-like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced TENDERNESS (Arm tenderness) and FATIGUE (I had extreme fatigue). On 08-Aug-2021, the patient experienced COUGH (Dry cough). On 10-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (major flu-like symptoms) (seriousness criterion medically significant), PULMONARY CONGESTION (Congestions in my lungs) and PYREXIA (A slight fever). At the time of the report, INFLUENZA LIKE ILLNESS (major flu-like symptoms), PULMONARY CONGESTION (Congestions in my lungs), TENDERNESS (Arm tenderness), COUGH (Dry cough), FATIGUE (I had extreme fatigue) and PYREXIA (A slight fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) diagnosed Covid-19 positive..         Treatment medication was not reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-288218 (Patient Link).; 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product JNJ 78436735 for COVID-19 vaccination.    Concurrent medical conditions included Lung disease and Immunocompromised.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of JNJ 78436735 (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (He received both Moderna Covid-19 shots in January & February of 2021 and he got the Johnson & Johnson shot today) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: sore right injection sight arm; headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore right injection sight arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Blood pressure high and Sickle cell trait. Concomitant products included METFORMIN, ATENOLOL, CHLORTALIDONE (ATENOLOL/CHLORTHALIDONE), AMLODIPINE and LEVOTHYROXINE for an unknown indication.    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 SITE PAIN (sore right injection sight arm) and HEADACHE (headache). On 04-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (sore right injection sight arm) outcome was unknown.            No Treatment information were provided by the reporter.  Patient received her second Moderna Covid-19 vaccine on 30MAR2021. The patient reported that had no adverse reactions. Lot number for the second Moderna Covid-19 vaccine 018B21A expiration date was not provided. The patient received both vaccinations in her right arm shoulder deltoid muscle.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown.            No concomitant and treatment medications were provided  Caller was a liver transplant recipient.  He wanted to know the timing of when he should get the 3rd dose booster.  The caller also stated everyone else in the house has had COVID and agent assumed they have had the vaccinations.      The caller stated he also has another daughter who tested positive for COVID after receiving both doses of the Moderna vaccine.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: Full blown migraine; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Full blown migraine), HEADACHE (headache) and NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (since she was 2 years old). Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]), CLONAZEPAM, HYDROCODONE and INSULIN for an unknown indication.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced MIGRAINE (Full blown migraine), HEADACHE (headache) and NAUSEA (Nausea). The patient was treated with UBROGEPANT (UBRELVY) for Migraine, at a dose of 4 tablets max a week. At the time of the report, MIGRAINE (Full blown migraine), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.            Patient state 1-2 hours after getting the vaccine she had a headache and then by 5pm she had a full blown migraine. Patient wanted to note she has suffered from migraines since she was 2 years old. Patient reports she only had 3 to 4 severe migraines a week every week and started to go to a neurologist. Patient reported nausea after the first dose as well.   This case was linked to MOD-2021-288803 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Vaccination complication
Clinical narrative: 2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger; a reaction on her body; very itchy, or itchy like crazy; looks like rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger), VACCINATION COMPLICATION (a reaction on her body), PRURITUS (very itchy, or itchy like crazy) and RASH (looks like rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.   No Medical History information was reported.  Concurrent medical conditions included Drug allergy. Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) and CLONAZEPAM for Product used for unknown indication, LEVOTHYROXINE SODIUM (SYNTHROID) and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 13-Aug-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 ERYTHEMA (2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger), VACCINATION COMPLICATION (a reaction on her body), PRURITUS (very itchy, or itchy like crazy) and RASH (looks like rash). At the time of the report, ERYTHEMA (2 places that are in the size of a silver dollar that are red, the spot on her back was getting larger), VACCINATION COMPLICATION (a reaction on her body), PRURITUS (very itchy, or itchy like crazy) and RASH (looks like rash) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had a lot of allergy to medications (unspecified). The patient put on an itch cream (unspecified) to help treat. The spot on back was getting larger. The patient said spot was not very large in the morning, but it got larger in the afternoon.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nasal congestion, Nasopharyngitis
Clinical narrative: It sounds like he has a cold; pressure headache; congestion stuffy nose; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion stuffy nose), INFLUENZA LIKE ILLNESS (flu-like symptoms), NASOPHARYNGITIS (It sounds like he has a cold) and HEADACHE (pressure headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jul-2021, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced NASAL CONGESTION (congestion stuffy nose), INFLUENZA LIKE ILLNESS (flu-like symptoms) and HEADACHE (pressure headache). On an unknown date, the patient experienced NASOPHARYNGITIS (It sounds like he has a cold). At the time of the report, NASAL CONGESTION (congestion stuffy nose) and NASOPHARYNGITIS (It sounds like he has a cold) outcome was unknown, INFLUENZA LIKE ILLNESS (flu-like symptoms) had not resolved and HEADACHE (pressure headache) had resolved.            No Concomitant Medication was provided.  No treatment  was provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: felt strange; body aches; nausea; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt strange), MYALGIA (body aches), NAUSEA (nausea) and HEADACHE (severe headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced FEELING ABNORMAL (felt strange), MYALGIA (body aches), NAUSEA (nausea) and HEADACHE (severe headache). On 12-Aug-2021, FEELING ABNORMAL (felt strange), MYALGIA (body aches), NAUSEA (nausea) and HEADACHE (severe headache) had resolved.            Concomitant medication included unspecified heartburn pills.  Treatment information was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Haemangioma, Neoplasm, Swelling
Clinical narrative: Tumor; puffiness in the nail under the cuticle of her left thumbnail; Tumor, arterial venous hemangioma under her thumbnail; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM (Tumor), SWELLING (puffiness in the nail under the cuticle of her left thumbnail) and HAEMANGIOMA (Tumor, arterial venous hemangioma under her thumbnail) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included Hemangioma (arterial venous hemangioma under the thumb nail). Concomitant products included LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST SODIUM (SINGULAIR), WOMEN'S DAILY, SERTRALINE, MILK THISTLE [SILYBUM MARIANUM], TEMAZEPAM, NALTREXONE, MAGNESIUM and ROSA CANINA (ROSE HIPS) for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEOPLASM (Tumor), SWELLING (puffiness in the nail under the cuticle of her left thumbnail) and HAEMANGIOMA (Tumor, arterial venous hemangioma under her thumbnail). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, NEOPLASM (Tumor), SWELLING (puffiness in the nail under the cuticle of her left thumbnail) and HAEMANGIOMA (Tumor, arterial venous hemangioma under her thumbnail) outcome was unknown.            In Concomitant medications critical plus d3 was also reported. Patient has underwent a surgery for arterial venous hemangioma  under her thumb nail but the patient thinks it was growing again. After surgery she took Excedrin for the pain.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunocompromised due to steroids).   On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.). On 16-Aug-2021, EXTRA DOSE ADMINISTERED (she received her 3rd dose of the Mdoerna vaccine due to being immunocompromised due to steroids.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient felt that the pharmacy was not following best practice after the vial is punctured.  She stated there was news of a pharmacist who gave saline injection instead of Moderna vaccine but said the saline injection was Moderna vaccine.  Concomitant medication included unspecified steroids.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: Skin blisters; Rash on neck and under her breast; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Skin blisters) and RASH (Rash on neck and under her breast) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (Skin blisters) and RASH (Rash on neck and under her breast). At the time of the report, BLISTER (Skin blisters) and RASH (Rash on neck and under her breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.