chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm sore; A bit feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) and PYREXIA (A bit feverish) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and GABAPENTIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore) and PYREXIA (A bit feverish). At the time of the report, PAIN IN EXTREMITY (Arm sore) and PYREXIA (A bit feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Vitamin. The patient did not take any treatment medication.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: pain from back of my hip and going down my leg all the way to foot; severe muscle pain/ pain from back of my hip and going down my leg all the way to foot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe muscle pain/ pain from back of my hip and going down my leg all the way to foot) and BACK PAIN (pain from back of my hip and going down my leg all the way to foot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced MYALGIA (severe muscle pain/ pain from back of my hip and going down my leg all the way to foot) and BACK PAIN (pain from back of my hip and going down my leg all the way to foot). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) on 08-Feb-2021 at a dose of 4 dosage form. At the time of the report, MYALGIA (severe muscle pain/ pain from back of my hip and going down my leg all the way to foot) and BACK PAIN (pain from back of my hip and going down my leg all the way to foot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medication, diabetes medication, Vitamins and cholesterol medication.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness in the upper right arm; Right foot and leg started swelling; She couldn't walk, had to stay out of that foot; Redness in the leg; Fever (max. of 101°F); Extremely tired (the first two days she slept all day) and could not walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in the upper right arm), PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot), ERYTHEMA (Redness in the leg), FATIGUE (Extremely tired (the first two days she slept all day) and could not walk) and PYREXIA (Fever (max. of 101°F)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Blood pressure high. Concomitant products included IRON for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Extremely tired (the first two days she slept all day) and could not walk). On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the upper right arm), PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot), ERYTHEMA (Redness in the leg) and PYREXIA (Fever (max. of 101°F)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 10-Feb-2021, PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot) and ERYTHEMA (Redness in the leg) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness in the upper right arm), FATIGUE (Extremely tired (the first two days she slept all day) and could not walk) and PYREXIA (Fever (max. of 101°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 101 (High) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Soreness in the upper right arm; Right foot and leg started swelling; She couldn't walk, had to stay out of that foot; Redness in the leg; Fever (max. of 101°F); Extremely tired (the first two days she slept all day) and could not walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Soreness in the upper right arm), PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot), ERYTHEMA (Redness in the leg), FATIGUE (Extremely tired (the first two days she slept all day) and could not walk) and PYREXIA (Fever (max. of 101°F)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concurrent medical conditions included Blood pressure high. Concomitant products included IRON for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Extremely tired (the first two days she slept all day) and could not walk). On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the upper right arm), PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot), ERYTHEMA (Redness in the leg) and PYREXIA (Fever (max. of 101°F)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 10-Feb-2021, PERIPHERAL SWELLING (Right foot and leg started swelling; She couldn't walk, had to stay out of that foot) and ERYTHEMA (Redness in the leg) had resolved. At the time of the report, PAIN IN EXTREMITY (Soreness in the upper right arm), FATIGUE (Extremely tired (the first two days she slept all day) and could not walk) and PYREXIA (Fever (max. of 101°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 101 (High) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate increased, Pyrexia, Tremor
Clinical narrative: fast heart beat; body shaking; Fever; Chills; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat), PYREXIA (Fever), CHILLS (Chills), TREMOR (body shaking) and FATIGUE (felt tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEART RATE INCREASED (fast heart beat), PYREXIA (Fever), CHILLS (Chills), TREMOR (body shaking) and FATIGUE (felt tired). On 07-Feb-2021, HEART RATE INCREASED (fast heart beat), PYREXIA (Fever), CHILLS (Chills), TREMOR (body shaking) and FATIGUE (felt tired) had resolved. Not Provided          Concomitant medication was not reported. Treatment medication was not reported. The patient reported that the symptoms stopped after four days.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus got worse; 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 TINNITUS (Tinnitus got worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tinnitus and Hyperacusis.    On 01-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 TINNITUS (Tinnitus got worse). At the time of the report, TINNITUS (Tinnitus got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: discomfort a week later; hive at site 3 to 2 inches wide/raised red hive; itchy; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events discomfort a week later, hive at site 3 to 2 inches wide, raised red hive, itchy..  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: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, she experienced discomfort a week later, hive at site 3 to 2 inches wide, raised red  hive, itchy. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  On an unknown date the outcome of events, discomfort a week later, On an unknown date the outcome of events, hive at site 3 to 2 inches wide, On an unknown date the outcome of events, raised red hive, On an unknown date the outcome of events, itchy. was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: swelling eyelid; A spontaneous report was received from a consumer concerning a male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling eyelid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, 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  swelling eyelid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event swelling eyelid was unknown..
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Illness, Injection site pain, Injection site rash
Clinical narrative: runny nose; shakes; itching; very very sick from this; cough; nauseated; fever; chills; rash around injection site; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), TREMOR (shakes), PRURITUS (itching), ILLNESS (very very sick from this) and COUGH (cough) in a 65-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 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced RHINORRHOEA (runny nose), TREMOR (shakes), PRURITUS (itching), ILLNESS (very very sick from this), COUGH (cough), NAUSEA (nauseated), PYREXIA (fever), CHILLS (chills), INJECTION SITE RASH (rash around injection site) and INJECTION SITE PAIN (soreness at injection site). On 15-Mar-2021, RHINORRHOEA (runny nose), TREMOR (shakes), PRURITUS (itching), ILLNESS (very very sick from this), COUGH (cough), NAUSEA (nauseated), PYREXIA (fever), CHILLS (chills), INJECTION SITE RASH (rash around injection site) and INJECTION SITE PAIN (soreness at injection site) had resolved.            No concomitant medication use was provided by the reporter.  No treatment of events was reported.   This case was linked to MOD-2021-029186 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Details of events and vaccine information were added
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: runny nose; shakes; itching; very very sick from this; cough; nauseated; fever; chills; rash around injection site; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), TREMOR (shakes), PRURITUS (itching), ILLNESS (very very sick from this) and COUGH (cough) in a 65-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 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced RHINORRHOEA (runny nose), TREMOR (shakes), PRURITUS (itching), ILLNESS (very very sick from this), COUGH (cough), NAUSEA (nauseated), PYREXIA (fever), CHILLS (chills), INJECTION SITE RASH (rash around injection site) and INJECTION SITE PAIN (soreness at injection site). On 15-Mar-2021, RHINORRHOEA (runny nose), TREMOR (shakes), PRURITUS (itching), ILLNESS (very very sick from this), COUGH (cough), NAUSEA (nauseated), PYREXIA (fever), CHILLS (chills), INJECTION SITE RASH (rash around injection site) and INJECTION SITE PAIN (soreness at injection site) had resolved.            No concomitant medication use was provided by the reporter.  No treatment of events was reported.   This case was linked to MOD-2021-029186 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Details of events and vaccine information were added
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his foot; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on his foot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, 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 unknown date patient was experienced  rash on his foot.  Treatment details included antibiotics  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, rash on his foot was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 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 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain, Peripheral swelling
Clinical narrative: swollen arm; red arm; from the injection site to her elbow it was red; from the injection site to her elbow it was hot; it was sore; A spontaneous report was received from a Consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a swollen arm, red arm, from the injection site to her elbow it was red, from the injection site to her elbow it was hot, 6 inches long and 4 inch in diameter, it was sore.  The patient's medical history was not provided. Concomitant medications reported were different supplements, simvastatin 40 mg, metoprolol 50 mg, calcium, baby aspirin, multivitamin, Omeprazole, vitamin C, Vitamin D, probiotics for drug use for unknown indication.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the events a swollen arm. red arm, from the injection site to her elbow it was red, from the injection site to her elbow it was hot, 6 inches long and 4 inch in diameter, it was sore.  Treatment details included Achromycin and hot packs.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, a swollen arm, red arm,  from the injection site to her elbow it was red, from the injection site to her elbow it was hot, 6 inches long and 4 inch in diameter, it was sore was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea, Pain
Clinical narrative: Feeling bad; body aches; Nausea; Fever; Headache; muscle soreness; Soreness at the site of injection; A spontaneous report was received from a consumer concerning a 66-year-old,  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle soreness/myalgia, nausea, headache, soreness at the site of injection/vaccination site pain, body ache/pain, fever/pyrexia and feeling bad/feeling abnormal.  The patient's medical history as provided by the reporter included COVID-19. No relevant concomitant medications were reported.  On 08 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced the events, muscle soreness, nausea, headache, arm sore at the site of injection, body ache and fever which she had through the night.  On 09 Feb 2021, the patient reported waking up in the morning feeling bad. T  reatment for the events included prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle soreness, nausea, headache, arm sore at the site of injection, body ache, fever, and feeling abnormal were unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Feeling bad; body aches; Nausea; Fever; Headache; muscle soreness; Soreness at the site of injection; A spontaneous report was received from a consumer concerning a 66-year-old,  female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle soreness/myalgia, nausea, headache, soreness at the site of injection/vaccination site pain, body ache/pain, fever/pyrexia and feeling bad/feeling abnormal.  The patient's medical history as provided by the reporter included COVID-19. No relevant concomitant medications were reported.  On 08 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced the events, muscle soreness, nausea, headache, arm sore at the site of injection, body ache and fever which she had through the night.  On 09 Feb 2021, the patient reported waking up in the morning feeling bad. T  reatment for the events included prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, muscle soreness, nausea, headache, arm sore at the site of injection, body ache, fever, and feeling abnormal were unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia
Clinical narrative: masseter muscle (gum muscle) hurts and is a little redness; hurt the muscular part of the left cheek; A spontaneous report  was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurt the muscular part of the left cheek, masseter muscle (gum muscle) hurts and is a little redness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was provided by the reporter.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event(s) hurt the muscular part of the left cheek . On 17 Feb 2021, the patient experienced the event(s) masseter muscle (gum muscle) hurts and is a little redness.  Treatment details includedthe muscular part of the left cheek, she put ice on it. Now the masseter muscle (gum muscle), hurts and is a little redness., Administration site: left arm, Facility: pharmacy, Consent to follow-up with safety: yes, No doctor aware for follow-up,  no.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hurt the muscular part of the left cheek was unknown.The outcome of event(s), masseter muscle (gum muscle) hurts and is a little redness was unknown..
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site eczema
Clinical narrative: looked like eczema around the right upper arm where she got the vaccine; It became like a systemic rash; rash on arm, leg and torso; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ECZEMA (looked like eczema around the right upper arm where she got the vaccine), RASH (It became like a systemic rash) and RASH (rash on arm, leg and torso) in a 79-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 first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced RASH (It became like a systemic rash) and RASH (rash on arm, leg and torso). On an unknown date, the patient experienced VACCINATION SITE ECZEMA (looked like eczema around the right upper arm where she got the vaccine). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 40 milligram and CLOBETASOL for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ECZEMA (looked like eczema around the right upper arm where she got the vaccine) and RASH (It became like a systemic rash) had not resolved and RASH (rash on arm, leg and torso) had resolved.        For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. Treatment included antihistamine was noted.   This case was linked to MOD-2021-029304 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR form received on 13 Jul 2021  and event and outcomes of event  were updated. Second dose information were included
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: symptoms after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (symptoms after second dose) 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 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (symptoms after second dose). At the time of the report, ADVERSE EVENT (symptoms after second dose) had not resolved.        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.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Myalgia, Ocular discomfort
Clinical narrative: aura of vision; dizziness; vertigo; vomiting; loss of balance; chills; fever; Body aches; A spontaneous report was received from a consumer patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever, body aches, aura of vision, dizziness, vertigo, vomiting, loss of balance.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events chills,fever ,body aches .  On 16 Feb 2021, the patient experienced the events aura of vision, dizziness, vertigo, vomiting and  loss of balance.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, chills, fever, body aches,aura of vision,dizziness vertigo ,vomiting was unknown. The outcome of event, loss of balance was considered resolved.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo, Vomiting
Clinical narrative: aura of vision; dizziness; vertigo; vomiting; loss of balance; chills; fever; Body aches; A spontaneous report was received from a consumer patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever, body aches, aura of vision, dizziness, vertigo, vomiting, loss of balance.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events chills,fever ,body aches .  On 16 Feb 2021, the patient experienced the events aura of vision, dizziness, vertigo, vomiting and  loss of balance.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, chills, fever, body aches,aura of vision,dizziness vertigo ,vomiting was unknown. The outcome of event, loss of balance was considered resolved.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Condition aggravated, Pruritus, Rash
Clinical narrative: big itchy; red/pink patches /rash like bumps in patches/patches on body, side, legs and forearms; had blurry vision but it is worse; blood sugar too high after shot; A spontaneous report was received from a Consumer concerning a 81-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events big itchy(Pruritus ) red pink patches, rash like bumps in patches, patches on body, side, legs and forearms(rash), had blurry vision but it is worse(Condition aggravated), blood sugar too high after shot(Blood glucose increased).  The patient's medical history as provided as type 2 diabetis. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  Patient experienced big itchy red pink patches, rash like bumps in patches, patches on body, side, legs and forearms, had blurry vision but it is worse, blood sugar too high after shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, big itchy red pink patches, rash like bumps in patches, patches on body, side legs and forearms, had blurry vision but it is worse,  blood sugar too high after shot was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: Fever; Chills; Aches; Really bad diarrhea; A spontaneous report was received from a consumer concerning a patient of 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fever, chills, aches and diarrhea.  The patient's medical history, not provided by the reporter.  Concomitant product used was not provided.  On 5 Feb 2021, approximately 1 days prior to the onset of the symptoms the patient received their first of two planned doses of mRNA-1273 (Batch number: 043L20A) unknown route ,injection site- unknown for prophylaxis of COVID-19 infection.    On 08 Feb 2021, the patient developed fever, chills, aches and really bad diarrhea.   Treatment for the event was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event(s) fever, chills, aches got resolved on 9 Feb 2021. The outcome of the event diarrhea was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Memory impairment, Pyrexia
Clinical narrative: Brain fog; chills; Headache; Fatige; Fever of 100.5F; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Brain fog), CHILLS (chills), HEADACHE (Headache), FATIGUE (Fatige) and PYREXIA (Fever of 100.5F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MEMORY IMPAIRMENT (Brain fog), CHILLS (chills), HEADACHE (Headache), FATIGUE (Fatige) and PYREXIA (Fever of 100.5F). At the time of the report, MEMORY IMPAIRMENT (Brain fog), CHILLS (chills), HEADACHE (Headache), FATIGUE (Fatige) and PYREXIA (Fever of 100.5F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient had Tylenol as treatment medication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: outcome of the event has been updated
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: intestinal disturbances; 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 ABDOMINAL DISCOMFORT (intestinal disturbances) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (intestinal disturbances). At the time of the report, ABDOMINAL DISCOMFORT (intestinal disturbances) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up received on 25-May-2021 included no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: big lump on the collarbone on her left shoulder; hurt; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurt, big lump on the collarbone on her left shoulder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) hurt . On 15 Feb 2021, the patient experienced the event(s) big lump on the collarbone on her left shoulder.  Treatment details included Tylenol and ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hurt was unknown.The outcome of event(s), big lump on the collarbone on her left shoulder was unknown..
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral congestion, Diarrhoea, Dizziness, Paraesthesia, Sensory disturbance
Clinical narrative: brain MRI, results were good, just a little congestion; diarrhea this passed few days; he has not diagnosed yet. the tingling is still on going; dizzy; left side of the face started tingling; abnormal sensation she has never experienced before; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizzy), PARAESTHESIA (left side of the face started tingling), SENSORY DISTURBANCE (abnormal sensation she has never experienced before), CEREBRAL CONGESTION (brain MRI, results were good, just a little congestion) and PARAESTHESIA (he has not diagnosed yet. the tingling is still on going) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event since an unknown date.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced DIZZINESS (dizzy), PARAESTHESIA (left side of the face started tingling) and SENSORY DISTURBANCE (abnormal sensation she has never experienced before). On 16-Feb-2021, the patient experienced PARAESTHESIA (he has not diagnosed yet. the tingling is still on going). On an unknown date, the patient experienced CEREBRAL CONGESTION (brain MRI, results were good, just a little congestion) and DIARRHOEA (diarrhea this passed few days). At the time of the report, DIZZINESS (dizzy), PARAESTHESIA (left side of the face started tingling), SENSORY DISTURBANCE (abnormal sensation she has never experienced before), CEREBRAL CONGESTION (brain MRI, results were good, just a little congestion), PARAESTHESIA (he has not diagnosed yet. the tingling is still on going) and DIARRHOEA (diarrhea this passed few days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: Sore arm; Headache felt as if head was coming off; Lingering Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lingering Dizziness), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache felt as if head was coming off) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (said she had vertigo in august) in August 2020. Previously administered products included for Vertigo: Dramamine.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DIZZINESS (Lingering Dizziness) and HEADACHE (Headache felt as if head was coming off). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, DIZZINESS (Lingering Dizziness) and HEADACHE (Headache felt as if head was coming off) was resolving and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itchy; Red; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Red) and RASH (Rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itchy), ERYTHEMA (Red) and RASH (Rash). At the time of the report, PRURITUS (Itchy), ERYTHEMA (Red) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product include methotrexate No treatment was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: lips swelled; right hand swollen; itchy; hives on skin and scalp; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (lips swelled), PERIPHERAL SWELLING (right hand swollen), PRURITUS (itchy) and URTICARIA (hives on skin and scalp) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination.     Concomitant products included CALCIUM and VALSARTAN for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced LIP SWELLING (lips swelled), PERIPHERAL SWELLING (right hand swollen), PRURITUS (itchy) and URTICARIA (hives on skin and scalp). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, LIP SWELLING (lips swelled), PERIPHERAL SWELLING (right hand swollen), PRURITUS (itchy) and URTICARIA (hives on skin and scalp) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Other relevant medication history included vitamin d. No treatment information was provided.    This case was linked to MOD21-022057 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema
Clinical narrative: red large mark; itching; large red mark at the injection site; little itchy; . A spontaneous report was received on 8 Mar 2021, from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events large red mark at the injection site, little itchy, red large mark, itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021,  prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) large red mark at the injection site. little itchy. On 7 Mar 2021, the patient experienced the event(s) red large mark. itching.  Treatment details included, mRNA-1273 mRNA-1273 Safety Clinical Trial, AEs.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), large red mark at the injection site, little itchy,red large mark,itching was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Lip swelling, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Hives all over her body Post Antibiotic; Swollen Lips post Antibiotic; Pain in the left hand; Swollen Left Hand; Red Thumb on the Left Hand (Similar to Gout); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left hand), PERIPHERAL SWELLING (Swollen Left Hand), GOUT (Red Thumb on the Left Hand (Similar to Gout)), URTICARIA (Hives all over her body Post Antibiotic) and LIP SWELLING (Swollen Lips post Antibiotic) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 09-Apr-1998 and Drug allergy (patient remembered that she did have doxycycline about 20 years ago and she had a reaction to the doxycycline about 20 years ago.). Concomitant products included ATENOLOL, PRAVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID] and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D3) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left hand), PERIPHERAL SWELLING (Swollen Left Hand) and GOUT (Red Thumb on the Left Hand (Similar to Gout)). On 04-Feb-2021, the patient experienced URTICARIA (Hives all over her body Post Antibiotic) and LIP SWELLING (Swollen Lips post Antibiotic). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the left hand), PERIPHERAL SWELLING (Swollen Left Hand), GOUT (Red Thumb on the Left Hand (Similar to Gout)), URTICARIA (Hives all over her body Post Antibiotic) and LIP SWELLING (Swollen Lips post Antibiotic) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090658 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: significant follow up received, patient demographics updated, concomitant medication updated
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effects with first shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects with first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects with first shot). At the time of the report, ADVERSE EVENT (Side effects with first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Paraesthesia, Vaccination site pain
Clinical narrative: pain in back of neck; tingling in her extremities; tingling in her fingers/tingling in her toes; pain in her shoulders; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in back of neck), PARAESTHESIA (tingling in her extremities), PARAESTHESIA (tingling in her fingers/tingling in her toes), ARTHRALGIA (pain in her shoulders) and VACCINATION SITE PAIN (soreness at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, PRAVASTATIN, LEVOTHYROXINE, LISINOPRIL, CYCLOBENZAPRINE and GABAPENTIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NECK PAIN (pain in back of neck), PARAESTHESIA (tingling in her extremities), PARAESTHESIA (tingling in her fingers/tingling in her toes), ARTHRALGIA (pain in her shoulders) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, NECK PAIN (pain in back of neck), PARAESTHESIA (tingling in her extremities), PARAESTHESIA (tingling in her fingers/tingling in her toes), ARTHRALGIA (pain in her shoulders) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: TCR, NNI