chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Little warm; Really itchy; Sizable rash on upper arm; A spontaneous report  was received from a consumer concerning a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Vaccination site rash, vaccination site pruritic,  and vaccination site warmth warm.  The patient's medical history included mild reaction with tetanus shot. No relevant concomitant medications were reported.  The patient received the first of two planned doses of mRNA-1273 (Batch number: unknown) on 03 Feb 2021. On 03 Mar 2021, approximately prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: unknown) in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, after receiving second dose, the patient experienced the event, sizable rash on upper arm, about 5 inches wide and 7 to 8 inches long outside of upper arm, really itchy and little warm. Treatment details included diphenhydramine.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event, vaccination site rash, vaccination site pruritis, and vaccination site warmth was unknown.; Reporter'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: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; 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 HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Retching, Tremor, Vomiting
Clinical narrative: throwing up; dry heaving; really violent shaking; freezing cold; This spontaneous case was reported by a health care professional and describes the occurrence of VOMITING (throwing up), RETCHING (dry heaving), TREMOR (really violent shaking) and FEELING COLD (freezing cold) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history reported.     On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 04-Mar-2021, the patient experienced VOMITING (throwing up), RETCHING (dry heaving), TREMOR (really violent shaking) and FEELING COLD (freezing cold). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 05-Mar-2021, RETCHING (dry heaving), TREMOR (really violent shaking) and FEELING COLD (freezing cold) outcome was unknown. At the time of the report, VOMITING (throwing up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Confusional state, Intentional dose omission, Vision blurred
Clinical narrative: intentional dose omission; Confusion and blurred vision while on way home driving/brain fog; Confusion and blurred vision while on way home driving; couldn't remember her way home and got lost.; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion and blurred vision while on way home driving/brain fog), VISION BLURRED (Confusion and blurred vision while on way home driving), AMNESIA (couldn't remember her way home and got lost.) and INTENTIONAL DOSE OMISSION (intentional dose omission) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    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 CONFUSIONAL STATE (Confusion and blurred vision while on way home driving/brain fog), VISION BLURRED (Confusion and blurred vision while on way home driving) and AMNESIA (couldn't remember her way home and got lost.). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentional dose omission). At the time of the report, CONFUSIONAL STATE (Confusion and blurred vision while on way home driving/brain fog), VISION BLURRED (Confusion and blurred vision while on way home driving), AMNESIA (couldn't remember her way home and got lost.) and INTENTIONAL DOSE OMISSION (intentional dose omission) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Medical history was added, events were updated to recovered, a verbatim was updated.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027AUA) for COVID-19 vaccination.     No medical history provided.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Pain in extremity, Rash
Clinical narrative: sore lymph nodes; rash; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LYMPH NODE PAIN (sore lymph nodes), RASH (rash) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 26-Feb-2021, the patient experienced LYMPH NODE PAIN (sore lymph nodes) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (sore arm), LYMPH NODE PAIN (sore lymph nodes), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shakes; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shakes). At the time of the report, TREMOR (shakes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chromatopsia, Dizziness, Pain, Paraesthesia oral, Rash erythematous
Clinical narrative: dizziness; tingling around their mouth; skin feels like sunburnt with spots around their face and neck that sting and burn; arm has a dull ache between the elbow and the shoulder; a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (dizziness), PARAESTHESIA ORAL (tingling around their mouth), RASH ERYTHEMATOUS (skin feels like sunburnt with spots around their face and neck that sting and burn), PAIN (arm has a dull ache between the elbow and the shoulder) and CHROMATOPSIA (a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, MECLIZINE HCL, OXYCODONE, olmesartan medox hctz, ZOLPIDEM, PANTOPRAZOLE and CELECOXIB for an unknown indication.    On 03-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 DIZZINESS (dizziness), PARAESTHESIA ORAL (tingling around their mouth), RASH ERYTHEMATOUS (skin feels like sunburnt with spots around their face and neck that sting and burn), PAIN (arm has a dull ache between the elbow and the shoulder) and CHROMATOPSIA (a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size). At the time of the report, DIZZINESS (dizziness), PARAESTHESIA ORAL (tingling around their mouth), RASH ERYTHEMATOUS (skin feels like sunburnt with spots around their face and neck that sting and burn), PAIN (arm has a dull ache between the elbow and the shoulder) and CHROMATOPSIA (a vision problem where off to the left of their sight they see a zigzag multicolored pattern quite large, about 1/3 of their eye sight in size) 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 details included meclizine.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: aches; flu like symptoms; fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included TRAZODONE, OMEPRAZOLE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), OXYCODONE and MORPHINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: aches; flu like symptoms; fever; chills; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included TRAZODONE, OMEPRAZOLE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), OXYCODONE and MORPHINE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (aches), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: fever; chills; pain; tenderness; swelling; redness; fatigue; headache; loss of appetite; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE SWELLING (swelling) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TILACTASE (LACTAID), METFORMIN, align                                                          for his stomach and LISINOPRIL 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 PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness), FATIGUE (fatigue), HEADACHE (headache), DECREASED APPETITE (loss of appetite) and MYALGIA (muscle pain). At the time of the report, PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness), FATIGUE (fatigue), HEADACHE (headache), DECREASED APPETITE (loss of appetite) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Patient has been taking tylenol every 3-4 hrs for the fever.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: fever; chills; pain; tenderness; swelling; redness; fatigue; headache; loss of appetite; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE SWELLING (swelling) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TILACTASE (LACTAID), METFORMIN, align                                                          for his stomach and LISINOPRIL 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 PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness), FATIGUE (fatigue), HEADACHE (headache), DECREASED APPETITE (loss of appetite) and MYALGIA (muscle pain). At the time of the report, PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (pain), VACCINATION SITE PAIN (tenderness), VACCINATION SITE SWELLING (swelling), VACCINATION SITE ERYTHEMA (redness), FATIGUE (fatigue), HEADACHE (headache), DECREASED APPETITE (loss of appetite) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Patient has been taking tylenol every 3-4 hrs for the fever.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Fever of 102°F; Pounding headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102°F), HEADACHE (Pounding headache) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25A21A) 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 an unknown date, the patient experienced PYREXIA (Fever of 102°F), HEADACHE (Pounding headache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 102°F), HEADACHE (Pounding headache) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Swelling near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling near Injection Site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-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 09-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swelling near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Swelling of injection site, at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (Swelling near Injection Site) outcome was unknown.            Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dysuria, Fatigue
Clinical narrative: Loss of appetite; Cannot walk; Cannot urinate; Lost all energy; Chills; Vomitting; Ttired; 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 DECREASED APPETITE (Loss of appetite), GAIT DISTURBANCE (Cannot walk), DYSURIA (Cannot urinate), ASTHENIA (Lost all energy) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), GAIT DISTURBANCE (Cannot walk), DYSURIA (Cannot urinate), ASTHENIA (Lost all energy), CHILLS (Chills), VOMITING (Vomitting) and FATIGUE (Ttired). At the time of the report, DECREASED APPETITE (Loss of appetite), GAIT DISTURBANCE (Cannot walk), DYSURIA (Cannot urinate), ASTHENIA (Lost all energy), CHILLS (Chills), VOMITING (Vomitting) and FATIGUE (Ttired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Vomiting
Clinical narrative: Loss of appetite; Cannot walk; Cannot urinate; Lost all energy; Chills; Vomitting; Ttired; 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 DECREASED APPETITE (Loss of appetite), GAIT DISTURBANCE (Cannot walk), DYSURIA (Cannot urinate), ASTHENIA (Lost all energy) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), GAIT DISTURBANCE (Cannot walk), DYSURIA (Cannot urinate), ASTHENIA (Lost all energy), CHILLS (Chills), VOMITING (Vomitting) and FATIGUE (Ttired). At the time of the report, DECREASED APPETITE (Loss of appetite), GAIT DISTURBANCE (Cannot walk), DYSURIA (Cannot urinate), ASTHENIA (Lost all energy), CHILLS (Chills), VOMITING (Vomitting) and FATIGUE (Ttired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling in bicep in opposite arm from injection; swelling is very sore; arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in bicep in opposite arm from injection), VACCINATION SITE PAIN (arm is sore at the injection site) and VACCINATION SITE SWELLING (swelling is very sore) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore at the injection site). On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in bicep in opposite arm from injection) and VACCINATION SITE SWELLING (swelling is very sore). At the time of the report, PERIPHERAL SWELLING (swelling in bicep in opposite arm from injection), VACCINATION SITE PAIN (arm is sore at the injection site) and VACCINATION SITE SWELLING (swelling is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not provided. No treatment medication provided by the reporter.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: pain runs up to the neck; headache; arm got sore but can't even move/arm's been hurtingand can't lift it/Pain at the injected arm; Pain at the injected arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (arm got sore but can't even move/arm's been hurtingand can't lift it/Pain at the injected arm), NECK PAIN (pain runs up to the neck), VACCINATION SITE PAIN (Pain at the injected arm) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (arm got sore but can't even move/arm's been hurtingand can't lift it/Pain at the injected arm) and VACCINATION SITE PAIN (Pain at the injected arm). On 10-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced NECK PAIN (pain runs up to the neck). The patient was treated with PARACETAMOL (TYLENOL) on 10-Mar-2021 at a dose of UNK dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (arm got sore but can't even move/arm's been hurtingand can't lift it/Pain at the injected arm), NECK PAIN (pain runs up to the neck), VACCINATION SITE PAIN (Pain at the injected arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   High blood pressure medication included in concomitant medication.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling hot, Pyrexia, Vomiting
Clinical narrative: Vomited twice; Low grade fever on and off; Doesn't have an appetite; Forehead doesn't have temp but cheeks do; Feeling tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (Doesn't have an appetite), FEELING HOT (Forehead doesn't have temp but cheeks do), FATIGUE (Feeling tired), VOMITING (Vomited twice) and PYREXIA (Low grade fever on and off) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced DECREASED APPETITE (Doesn't have an appetite), FEELING HOT (Forehead doesn't have temp but cheeks do), FATIGUE (Feeling tired) and PYREXIA (Low grade fever on and off). On 06-Mar-2021, the patient experienced VOMITING (Vomited twice). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Doesn't have an appetite), FEELING HOT (Forehead doesn't have temp but cheeks do), FATIGUE (Feeling tired), VOMITING (Vomited twice) and PYREXIA (Low grade fever on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included blood thinners and blood pressure medications.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site mass, Paranasal sinus discomfort, Pyrexia
Clinical narrative: headache; Sinus Pressure; fever; Injection site was red; Lump at injection site; A spontaneous report was received from a consumer concerning a 58-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, sinus pressure / paranasal sinus discomfort , fever/pyrexia, injection site was red/injection site erythema, lump at injection site/injection site mass.  The patient's medical history include diabetes. No relevant concomitant medications were reported.  On 4 Mar 2021, approximately 2 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient experienced the event(s) headache, sinus pressure, fever, injection site was red, lump at injection site.  Treatment details included acetaminophen, Ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), headache, sinus pressure, fever, injection site was red, lump at injection site was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soar arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soar arm / pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received both planned doses of mRNA-1273 (lot/batch: unknown) (unknown route) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) soar arm.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), soar arm was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy rash at the site of injection; Itchy rash at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Itchy rash at the site of injection) and VACCINATION SITE PRURITUS (Itchy rash at the site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (Itchy rash at the site of injection) and VACCINATION SITE PRURITUS (Itchy rash at the site of injection). At the time of the report, VACCINATION SITE RASH (Itchy rash at the site of injection) and VACCINATION SITE PRURITUS (Itchy rash at the site of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient had corona virus 3 days after receiving the first dose of the vaccine; A spontaneous report was received from a pharmacist concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event patient had corona virus 3 days after receiving the first dose of the vaccine./Covid-19.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Patient had corona virus 3 days after receiving the first dose of the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), patient had corona virus 3 days after receiving the first dose of the vaccine was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is a little sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021 at 2:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is a little sore). At the time of the report, PAIN IN EXTREMITY (Arm is a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Event outcome was updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Burning sensation, Herpes zoster, Mammogram, Pain
Clinical narrative: Shingles Rash; Burning; Shooting pain; Pain under left breast; Left side aches really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Left side aches really bad), BREAST PAIN (Pain under left breast), HERPES ZOSTER (Shingles Rash), BURNING SENSATION (Burning) and PAIN (Shooting pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Shingles. Concomitant products included VALACYCLOVIR [VALACICLOVIR], LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE, MULTIVITAMINS [VITAMINS NOS], GLUCOSAMINE and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Left side aches really bad). On 04-Mar-2021, the patient experienced BREAST PAIN (Pain under left breast). On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles Rash), BURNING SENSATION (Burning) and PAIN (Shooting pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Left side aches really bad), BREAST PAIN (Pain under left breast), HERPES ZOSTER (Shingles Rash), BURNING SENSATION (Burning) and PAIN (Shooting pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unspecified date, patient underwent several lab test including mammograms and few other tests which came back fine.  Patient stated she has had shingles before and was prescribed with anti-viral for the rashes.     Reporter did not allow further contact
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced MYALGIA (Achy). At the time of the report, MYALGIA (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching back of knees and abdomen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching back of knees and abdomen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 25-Feb-2021, the patient experienced PRURITUS (Itching back of knees and abdomen). The patient was treated with HYDROCORTISONE for Pruritus, at a dose of UNK, qd; GABAPENTIN for Pruritus, at a dose of UNK dosage form, qd and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Pruritus, at a dose of UNK dosage form, qd. At the time of the report, PRURITUS (Itching back of knees and abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blisters; This spontaneous case was reported by a pharmacist and describes the occurrence of BLISTER (blisters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (blisters). At the time of the report, BLISTER (blisters) 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 relevant concomitant medications were reported.  No treatment information was provided.  The blisters resolved after 2 days   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: NNI received
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 an unknown date and the estimated date of delivery was 10-Jun-2021. On 10-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 10-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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.   Concomitant medication not provided by the reporter.  Treatment information were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Red patch at injection site; Circular oval (2x2 inches) patch at injection site; Soreness at injection site/ Arm of injection developed soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site/ Arm of injection developed soreness), VACCINATION SITE ERYTHEMA (Red patch at injection site) and VACCINATION SITE RASH (Circular oval (2x2 inches) patch at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CALCIUM and VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site/ Arm of injection developed soreness). On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red patch at injection site) and VACCINATION SITE RASH (Circular oval (2x2 inches) patch at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site/ Arm of injection developed soreness), VACCINATION SITE ERYTHEMA (Red patch at injection site) and VACCINATION SITE RASH (Circular oval (2x2 inches) patch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs are not provided by reporter. Antihyperlipidemic and High blood pressure medications are included in concomitant medications.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Hurt all over in her legs/Hurts all over arm and under arm, wrist and elboW/Hurts across her back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurt all over in her legs/Hurts all over arm and under arm, wrist and elboW/Hurts across her back) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (for over 50 years).    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Hurt all over in her legs/Hurts all over arm and under arm, wrist and elboW/Hurts across her back). At the time of the report, PAIN (Hurt all over in her legs/Hurts all over arm and under arm, wrist and elboW/Hurts across her back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. the Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product dose omission issue, Rash, Vaccination site erythema
Clinical narrative: broke out in a rash on her left arm; felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck; didn't receive the second one / scared to get the second dose; arm was very red and there was a print/ mark on it to show where she had the shot.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (broke out in a rash on her left arm), LYMPHADENOPATHY (felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck), VACCINATION SITE ERYTHEMA (arm was very red and there was a print/ mark on it to show where she had the shot.) and PRODUCT DOSE OMISSION ISSUE (didn't receive the second one / scared to get the second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was very red and there was a print/ mark on it to show where she had the shot.). On an unknown date, the patient experienced RASH (broke out in a rash on her left arm), LYMPHADENOPATHY (felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck) and PRODUCT DOSE OMISSION ISSUE (didn't receive the second one / scared to get the second dose). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; TRIAMCINOLONE at a dose of cream 0.1% applied topically twice daily; AZITHROMYCIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Neck pain, at an unspecified dose and frequency. At the time of the report, RASH (broke out in a rash on her left arm) and PRODUCT DOSE OMISSION ISSUE (didn't receive the second one / scared to get the second dose) had resolved and LYMPHADENOPATHY (felt her throat closed / doctor told her those were lymph nodes / pain over both sides of neck) and VACCINATION SITE ERYTHEMA (arm was very red and there was a print/ mark on it to show where she had the shot.) 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.   Other concomitant medications include spray for throat.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up appended. Added reporter details and events (product dose omission issue, rash and lymphadenopathy). On 05-Aug-2021: Non-Significant follow-up appended. Reporter's address added.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: Caller's uncle tested positive 17 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller's uncle tested positive 17 days after receiving 1st dose) in a 69-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) 1 dosage form. On 28-Feb-2021, the patient experienced COVID-19 (Caller's uncle tested positive 17 days after receiving 1st dose). At the time of the report, COVID-19 (Caller's uncle tested positive 17 days after receiving 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, SARS-CoV-1 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.