chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Swelling; Tenderness; Upset Stomach; Fever; Head ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever) and HEADACHE (Head ache) in a female patient of an unknown age 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 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 SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever), HEADACHE (Head ache) and NAUSEA (Nausea). At the time of the report, SWELLING (Swelling), TENDERNESS (Tenderness), ABDOMINAL DISCOMFORT (Upset Stomach), PYREXIA (Fever), HEADACHE (Head ache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  No concomitant medications reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: got a terrible headache for a couple of days after vaccine, stll has slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (got a terrible headache for a couple of days after vaccine, stll has slight headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included PHENYTOIN (DILANTIN [PHENYTOIN]), LORAZEPAM and VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Feb-2021, the patient experienced HEADACHE (got a terrible headache for a couple of days after vaccine, stll has slight headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (got a terrible headache for a couple of days after vaccine, stll has slight headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Mass, Swelling
Clinical narrative: at the the inside crease of the elbow a big bulge the size of a small egg on both arms; swelling; a little heat; This spontaneous case was reported by a consumer and describes the occurrence of MASS (at the the inside crease of the elbow a big bulge the size of a small egg on both arms), SWELLING (swelling) and FEELING HOT (a little heat) 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 No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced MASS (at the the inside crease of the elbow a big bulge the size of a small egg on both arms), SWELLING (swelling) and FEELING HOT (a little heat). At the time of the report, MASS (at the the inside crease of the elbow a big bulge the size of a small egg on both arms), SWELLING (swelling) and FEELING HOT (a little heat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: AE contact information updated
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Achiness; Fever of 101 F, low grage fever next day; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), PYREXIA (Fever of 101 F, low grage fever next day) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, GLIPIZIDE, SAXAGLIPTIN, EMPAGLIFLOZIN, LEVOTHYROXINE, ATENOLOL, ALLOPURINOL and ROSUVASTATIN.    On 15-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 (Achiness), PYREXIA (Fever of 101 F, low grage fever next day) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. On 25-Jan-2021, PAIN (Achiness) and CHILLS (chills) had resolved. At the time of the report, PYREXIA (Fever of 101 F, low grage fever next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 101 (High) Degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-018803 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash seems to be coming back; rash 9 days later, went away in 3 days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash 9 days later, went away in 3 days) and RASH (rash seems to be coming back) 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced RASH (rash 9 days later, went away in 3 days). On 02-Feb-2021, the patient experienced RASH (rash seems to be coming back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Jan-2021 for Rash, at an unspecified dose and frequency. On 29-Jan-2021, RASH (rash 9 days later, went away in 3 days) had resolved. At the time of the report, RASH (rash seems to be coming back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Location of rash not reported and as appeared 9 days after vaccination the event conservatively kept as "rash" rather than coding to vaccination site rash
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pain at the injection site with redness and a kind of ball; Injection site redness; Pain at the injection site; High temperature; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Pain at the injection site with redness and a kind of ball), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (High temperature) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Pain at the injection site with redness and a kind of ball), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (High temperature). At the time of the report, VACCINATION SITE SWELLING (Pain at the injection site with redness and a kind of ball), VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (High temperature) outcome was unknown.        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.  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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Bumpiness(at injection site); Hot to touch((at injection site); Itchy all around injection site, 2-3inches in width; rash (at injection site); redness(around injection site); soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Bumpiness(at injection site)), VACCINATION SITE WARMTH (Hot to touch((at injection site)), VACCINATION SITE PRURITUS (Itchy all around injection site, 2-3inches in width), VACCINATION SITE RASH (rash (at injection site)) and VACCINATION SITE PAIN (soreness at injection site) in a 96-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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 31-Jan-2021, the patient experienced VACCINATION SITE NODULE (Bumpiness(at injection site)), VACCINATION SITE WARMTH (Hot to touch((at injection site)), VACCINATION SITE PRURITUS (Itchy all around injection site, 2-3inches in width), VACCINATION SITE RASH (rash (at injection site)) and VACCINATION SITE ERYTHEMA (redness(around injection site)). At the time of the report, VACCINATION SITE NODULE (Bumpiness(at injection site)), VACCINATION SITE WARMTH (Hot to touch((at injection site)), VACCINATION SITE PRURITUS (Itchy all around injection site, 2-3inches in width), VACCINATION SITE RASH (rash (at injection site)), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (redness(around injection site)) 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. No treatment information was provided.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Bumpiness(at injection site); Hot to touch((at injection site); Itchy all around injection site, 2-3inches in width; rash (at injection site); redness(around injection site); soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Bumpiness(at injection site)), VACCINATION SITE WARMTH (Hot to touch((at injection site)), VACCINATION SITE PRURITUS (Itchy all around injection site, 2-3inches in width), VACCINATION SITE RASH (rash (at injection site)) and VACCINATION SITE PAIN (soreness at injection site) in a 96-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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 31-Jan-2021, the patient experienced VACCINATION SITE NODULE (Bumpiness(at injection site)), VACCINATION SITE WARMTH (Hot to touch((at injection site)), VACCINATION SITE PRURITUS (Itchy all around injection site, 2-3inches in width), VACCINATION SITE RASH (rash (at injection site)) and VACCINATION SITE ERYTHEMA (redness(around injection site)). At the time of the report, VACCINATION SITE NODULE (Bumpiness(at injection site)), VACCINATION SITE WARMTH (Hot to touch((at injection site)), VACCINATION SITE PRURITUS (Itchy all around injection site, 2-3inches in width), VACCINATION SITE RASH (rash (at injection site)), VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (redness(around injection site)) 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. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Nasal dryness, Parosmia, Pruritus, Sneezing
Clinical narrative: It's like I'm smelling like an ammonia-like compound / change in my sense of smell, not loss; my nose is irritated; annoying and itching; sneezing, its been intermittant, worse in the evening; feels burning in his eyes; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (It's like I'm smelling like an ammonia-like compound / change in my sense of smell, not loss), NASAL DRYNESS (my nose is irritated), PRURITUS (annoying and itching), SNEEZING (sneezing, its been intermittant, worse in the evening) and EYE IRRITATION (feels burning in his eyes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (around this time of year).    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 PAROSMIA (It's like I'm smelling like an ammonia-like compound / change in my sense of smell, not loss), NASAL DRYNESS (my nose is irritated), PRURITUS (annoying and itching), SNEEZING (sneezing, its been intermittant, worse in the evening) and EYE IRRITATION (feels burning in his eyes). At the time of the report, PAROSMIA (It's like I'm smelling like an ammonia-like compound / change in my sense of smell, not loss), NASAL DRYNESS (my nose is irritated), PRURITUS (annoying and itching), SNEEZING (sneezing, its been intermittant, worse in the evening) and EYE IRRITATION (feels burning in his eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Patient's contact details were updated. He declined further FU.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: swelling; rash; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) and RASH (rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling) and RASH (rash). At the time of the report, SWELLING (swelling) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-21 included Non significant information
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Decreased appetite, Dizziness, Eyelid pain
Clinical narrative: back hurt; dizziness; hasn't been able to eat much; no energy - just slow; every bone and every muscle and joint ached; kidneys hurt - cannot get comfortable; so weak - couldn't keep head up; could barely get out of bed; even eyelids hurt; headache; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidneys hurt - cannot get comfortable), ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt), MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached) and BACK PAIN (back hurt) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, CALCITRIOL, APIXABAN (ELIQUIS), FUROSEMIDE, LOSARTAN, METOPROLOL, Mutlaq and SPIRONOLACTONE for an unknown indication, CALCIUM and COLECALCIFEROL (VITAMIN D 3).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt) and HEADACHE (headache). On 22-Jan-2021, the patient experienced RENAL PAIN (kidneys hurt - cannot get comfortable) and MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached). On 26-Jan-2021, the patient experienced BACK PAIN (back hurt), DIZZINESS (dizziness), DECREASED APPETITE (hasn't been able to eat much) and FATIGUE (no energy - just slow). At the time of the report, RENAL PAIN (kidneys hurt - cannot get comfortable), ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt), MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached), BACK PAIN (back hurt), DIZZINESS (dizziness), DECREASED APPETITE (hasn't been able to eat much), HEADACHE (headache) and FATIGUE (no energy - just slow) 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.   Very limited information regarding these events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal pain, Renal pain
Clinical narrative: back hurt; dizziness; hasn't been able to eat much; no energy - just slow; every bone and every muscle and joint ached; kidneys hurt - cannot get comfortable; so weak - couldn't keep head up; could barely get out of bed; even eyelids hurt; headache; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidneys hurt - cannot get comfortable), ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt), MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached) and BACK PAIN (back hurt) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, CALCITRIOL, APIXABAN (ELIQUIS), FUROSEMIDE, LOSARTAN, METOPROLOL, Mutlaq and SPIRONOLACTONE for an unknown indication, CALCIUM and COLECALCIFEROL (VITAMIN D 3).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt) and HEADACHE (headache). On 22-Jan-2021, the patient experienced RENAL PAIN (kidneys hurt - cannot get comfortable) and MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached). On 26-Jan-2021, the patient experienced BACK PAIN (back hurt), DIZZINESS (dizziness), DECREASED APPETITE (hasn't been able to eat much) and FATIGUE (no energy - just slow). At the time of the report, RENAL PAIN (kidneys hurt - cannot get comfortable), ASTHENIA (so weak - couldn't keep head up; could barely get out of bed), EYELID PAIN (even eyelids hurt), MUSCULOSKELETAL PAIN (every bone and every muscle and joint ached), BACK PAIN (back hurt), DIZZINESS (dizziness), DECREASED APPETITE (hasn't been able to eat much), HEADACHE (headache) and FATIGUE (no energy - just slow) 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.   Very limited information regarding these events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Lost of appetite; Fatigue; mild headache; Chills; Nausea; Tested positive for COVID-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination), DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu on 25-Jan-2021. Concurrent medical conditions included Blood pressure high, Cholesterol and Prostate ablation. Concomitant products included LISINOPRIL for Blood pressure high, PRAVASTATIN for Cholesterol, POLYCARBOPHIL CALCIUM (FIBER LAXATIVE) for Laxative supportive care, TAMSULOSIN for Prostate ablation, OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination). On an unknown date, the patient experienced DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination) outcome was unknown and DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, COVID-19: Positive. On 25-Jan-2021, Influenza: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       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.   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 the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Nausea, SARS-CoV-2 test positive
Clinical narrative: Lost of appetite; Fatigue; mild headache; Chills; Nausea; Tested positive for COVID-19 after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination), DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Flu on 25-Jan-2021. Concurrent medical conditions included Blood pressure high, Cholesterol and Prostate ablation. Concomitant products included LISINOPRIL for Blood pressure high, PRAVASTATIN for Cholesterol, POLYCARBOPHIL CALCIUM (FIBER LAXATIVE) for Laxative supportive care, TAMSULOSIN for Prostate ablation, OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination). On an unknown date, the patient experienced DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after vaccination) outcome was unknown and DECREASED APPETITE (Lost of appetite), FATIGUE (Fatigue), HEADACHE (mild headache), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, COVID-19: Positive. On 25-Jan-2021, Influenza: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       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.   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 the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling
Clinical narrative: Swelling, at the the inside crease of the elbow a big bulge the size of a small egg on both arms; Little heat; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling, at the the inside crease of the elbow a big bulge the size of a small egg on both arms) and FEELING HOT (Little heat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swelling, at the the inside crease of the elbow a big bulge the size of a small egg on both arms) and FEELING HOT (Little heat). At the time of the report, PERIPHERAL SWELLING (Swelling, at the the inside crease of the elbow a big bulge the size of a small egg on both arms) and FEELING HOT (Little heat) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness below the injection site; Redness below the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness below the injection site) and VACCINATION SITE ERYTHEMA (Redness below the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: legs were not functioning at all,could not feel extremities well,patient could not bend leg; It was all swollen under left knee; extremely sore arm; joint ache in the other knee; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (legs were not functioning at all,could not feel extremities well,patient could not bend leg), PERIPHERAL SWELLING (It was all swollen under left knee), PAIN IN EXTREMITY (extremely sore arm) and ARTHRALGIA (joint ache in the other knee) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041220A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced LIMB DISCOMFORT (legs were not functioning at all,could not feel extremities well,patient could not bend leg), PERIPHERAL SWELLING (It was all swollen under left knee), PAIN IN EXTREMITY (extremely sore arm) and ARTHRALGIA (joint ache in the other knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 16-Jan-2021, LIMB DISCOMFORT (legs were not functioning at all,could not feel extremities well,patient could not bend leg), PERIPHERAL SWELLING (It was all swollen under left knee), PAIN IN EXTREMITY (extremely sore arm) and ARTHRALGIA (joint ache in the other knee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       it was reported that patient takes medication for cholesterol concomitantly.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: Shoulder was also sore the next day; left cheek went numb, has some numb spots(Bell's palsy symptoms); This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (left cheek went numb, has some numb spots(Bell's palsy symptoms)) and ARTHRALGIA (Shoulder was also sore the next day) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included LEVONORGESTREL (MIRENA) and LYSINE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPOAESTHESIA (left cheek went numb, has some numb spots(Bell's palsy symptoms)). On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Shoulder was also sore the next day). On 18-Jan-2021, ARTHRALGIA (Shoulder was also sore the next day) had resolved. At the time of the report, HYPOAESTHESIA (left cheek went numb, has some numb spots(Bell's palsy symptoms)) 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 treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up Information received on 04-JUN-2021  contains no newinformation On 08-Jul-2021: Follow-up received which contains updated outcome of event from not recovered to recovered.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Similar reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Similar reaction) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT (Similar reaction). At the time of the report, ADVERSE EVENT (Similar reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant information provided. No treatment information provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear swelling, Hypoacusis
Clinical narrative: couldn't hear; her left ear canal is swollen; her ear was bothering her; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (her ear was bothering her), HYPOACUSIS (couldn't hear) and EAR SWELLING (her left ear canal is swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, OXYBUTYNIN, LOSARTAN POTASSIUM, RALOXIFENE, OMEPRAZOLE, ATORVASTATIN, COENZYME Q10 [UBIDECARENONE], CETIRIZINE, Vision health and CALCIUM, COLECALCIFEROL, MAGNESIUM (CALCIUM MAGNESIUM + VITAMIN D3) 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 EAR DISCOMFORT (her ear was bothering her). On 16-Feb-2021, the patient experienced HYPOACUSIS (couldn't hear) and EAR SWELLING (her left ear canal is swollen). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN/CLAV POT) on 16-Feb-2021 for Ear swelling, at an unspecified dose and frequency. At the time of the report, EAR DISCOMFORT (her ear was bothering her), HYPOACUSIS (couldn't hear) and EAR SWELLING (her left ear canal is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Vaccination site erythema, Vaccination site induration, Vaccination site inflammation
Clinical narrative: Arm ached; delayed reaction; Warm to touch at injection site; Arm inflammation; Bumps at injection site / beacme inflammed with raised itchy bumps.; severe itching at the vaccination site on left arm; Swollen at injection site; Redness at injection site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021. The most recent information was received on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INFLAMMATION (Arm inflammation) and VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, VITAMIN D NOS for an unknown indication.    On 17-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 (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INFLAMMATION (Arm inflammation), VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.), VACCINATION SITE PRURITUS (severe itching at the vaccination site on left arm), VACCINATION SITE SWELLING (Swollen at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 29-Jan-2021, PAIN (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.), VACCINATION SITE PRURITUS (severe itching at the vaccination site on left arm) and VACCINATION SITE SWELLING (Swollen at injection site) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Arm inflammation) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information  included icepack and antihistamine.  EpiPen was ordered incase of emergency.   This case was linked to MOD-2021-239110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Non Significant follow-up (Reporter's e-mal updated) no new information is added. On 28-Jun-2021: Follow up is significant containing information of patient demographics, concomitant drugs, vaccine batch number, additional event-inflammation(for the first dose of vaccine).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm ached; delayed reaction; Warm to touch at injection site; Arm inflammation; Bumps at injection site / beacme inflammed with raised itchy bumps.; severe itching at the vaccination site on left arm; Swollen at injection site; Redness at injection site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021. The most recent information was received on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INFLAMMATION (Arm inflammation) and VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, VITAMIN D NOS for an unknown indication.    On 17-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 (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INFLAMMATION (Arm inflammation), VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.), VACCINATION SITE PRURITUS (severe itching at the vaccination site on left arm), VACCINATION SITE SWELLING (Swollen at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 29-Jan-2021, PAIN (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.), VACCINATION SITE PRURITUS (severe itching at the vaccination site on left arm) and VACCINATION SITE SWELLING (Swollen at injection site) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Arm inflammation) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information  included icepack and antihistamine.  EpiPen was ordered incase of emergency.   This case was linked to MOD-2021-239110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Non Significant follow-up (Reporter's e-mal updated) no new information is added. On 28-Jun-2021: Follow up is significant containing information of patient demographics, concomitant drugs, vaccine batch number, additional event-inflammation(for the first dose of vaccine).
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 13-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021 at 4:00 AM, the patient experienced PRURITUS (At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas). At the time of the report, PRURITUS (At 4am the next morning she started itching in ankles, scalp, nose, abdomen, it would migrate to different areas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness on her left foot; Felt electric down her left leg; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on her left foot) and PAIN IN EXTREMITY (Felt electric down her left leg) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on her left foot) and PAIN IN EXTREMITY (Felt electric down her left leg). At the time of the report, HYPOAESTHESIA (Numbness on her left foot) had not resolved and PAIN IN EXTREMITY (Felt electric down her left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Pain at the injection site; Redness at the injection site; High temperature; A spontaneous report was received from a Consumer concerning a 50-years-old female  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain at the injection site, redness at the injection site, high temperature.  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 experience pain at the injection site,redness at the injection site, high temperature.  Treatment details were not provided.    Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, pain at the injection site, redness at the injection site, and high temperature was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rhinorrhoea
Clinical narrative: runny nose; chill; Extreme fatigue; This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (runny nose), CHILLS (chill) and FATIGUE (Extreme fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 RHINORRHOEA (runny nose), CHILLS (chill) and FATIGUE (Extreme fatigue). At the time of the report, RHINORRHOEA (runny nose), CHILLS (chill) and FATIGUE (Extreme fatigue) 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. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow-up document received on 04-july-2021. Events outcome was added as Recovered/resolved
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain, Vaccination site warmth
Clinical narrative: Hot/heat at the touch (temperature raise); Stiffness; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot/heat at the touch (temperature raise)), MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Injection site pain) 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 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot/heat at the touch (temperature raise)), MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE WARMTH (Hot/heat at the touch (temperature raise)), MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-022834 (Patient Link).; Sender's Comments: This case concerns a male of unknown age with nonserious events of unexpected musculoskeletal stiffness and injection site warmth and expected injection site pain.  Event onset with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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.