chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Headache, Malaise, Mobility decreased
Clinical narrative: face and eyes are swollen and puffy; swollen and puffy eyes; swollen and puffy eyes; limited movement due to headache; exploding headache; extremely fatigued; sweating all night in their sleep; getting sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (sweating all night in their sleep), SWELLING FACE (face and eyes are swollen and puffy), PERIORBITAL SWELLING (swollen and puffy eyes), EYE SWELLING (swollen and puffy eyes) and MOBILITY DECREASED (limited movement due to headache) in a 33-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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced NIGHT SWEATS (sweating all night in their sleep), MALAISE (getting sick) and FATIGUE (extremely fatigued). On 19-Feb-2021, the patient experienced SWELLING FACE (face and eyes are swollen and puffy), PERIORBITAL SWELLING (swollen and puffy eyes), EYE SWELLING (swollen and puffy eyes), MOBILITY DECREASED (limited movement due to headache) and HEADACHE (exploding headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN (NAP [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (sweating all night in their sleep), SWELLING FACE (face and eyes are swollen and puffy), PERIORBITAL SWELLING (swollen and puffy eyes), EYE SWELLING (swollen and puffy eyes), MOBILITY DECREASED (limited movement due to headache), MALAISE (getting sick), HEADACHE (exploding headache) and FATIGUE (extremely fatigued) outcome was unknown.            No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non- Significant FU, added reporter contact details.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Periorbital swelling, Swelling face
Clinical narrative: face and eyes are swollen and puffy; swollen and puffy eyes; swollen and puffy eyes; limited movement due to headache; exploding headache; extremely fatigued; sweating all night in their sleep; getting sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (sweating all night in their sleep), SWELLING FACE (face and eyes are swollen and puffy), PERIORBITAL SWELLING (swollen and puffy eyes), EYE SWELLING (swollen and puffy eyes) and MOBILITY DECREASED (limited movement due to headache) in a 33-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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced NIGHT SWEATS (sweating all night in their sleep), MALAISE (getting sick) and FATIGUE (extremely fatigued). On 19-Feb-2021, the patient experienced SWELLING FACE (face and eyes are swollen and puffy), PERIORBITAL SWELLING (swollen and puffy eyes), EYE SWELLING (swollen and puffy eyes), MOBILITY DECREASED (limited movement due to headache) and HEADACHE (exploding headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN (NAP [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, NIGHT SWEATS (sweating all night in their sleep), SWELLING FACE (face and eyes are swollen and puffy), PERIORBITAL SWELLING (swollen and puffy eyes), EYE SWELLING (swollen and puffy eyes), MOBILITY DECREASED (limited movement due to headache), MALAISE (getting sick), HEADACHE (exploding headache) and FATIGUE (extremely fatigued) outcome was unknown.            No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Non- Significant FU, added reporter contact details.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Fatigue, Myalgia, Weight decreased
Clinical narrative: feels yucky and bad; 186 lbs. currently; lack of energy; severe body aches; feels fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (feels yucky and bad), WEIGHT DECREASED (186 lbs. currently), ASTHENIA (lack of energy), MYALGIA (severe body aches) and FATIGUE (feels fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Cholesterol high. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DISCOMFORT (feels yucky and bad), WEIGHT DECREASED (186 lbs. currently), ASTHENIA (lack of energy), MYALGIA (severe body aches) and FATIGUE (feels fatigued). At the time of the report, DISCOMFORT (feels yucky and bad), ASTHENIA (lack of energy), MYALGIA (severe body aches) and FATIGUE (feels fatigued) had not resolved and WEIGHT DECREASED (186 lbs. currently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling on my left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on my left arm) in a 71-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling on my left arm). At the time of the report, PERIPHERAL SWELLING (swelling on my left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information include antibiotics.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchiness; rash; raised; pinkish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (raised) and VACCINATION SITE ERYTHEMA (pinkish) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (patient had her Shingle shot 4 or 5 years ago). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, MULTIVITAMINS & MINERALS PLUS LUTEIN and COLECALCIFEROL (VITAMINS D3).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (raised) and VACCINATION SITE ERYTHEMA (pinkish). At the time of the report, VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (raised) and VACCINATION SITE ERYTHEMA (pinkish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment  include applied Hyrocortisone cream.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain in extremity, Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Warm to the touch Injection Site; rash aggravated; Itching sporadically Injection Site; Rash Injection Site (1.5" X 1") Top to Bottom; Arm hurt when lifted the arm (Mild); This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm hurt when lifted the arm (Mild)), INJECTION SITE WARMTH (Warm to the touch Injection Site), RASH (rash aggravated), VACCINATION SITE PRURITUS (Itching sporadically Injection Site) and VACCINATION SITE RASH (Rash Injection Site (1.5" X 1") Top to Bottom) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for an unknown indication.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt when lifted the arm (Mild)). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching sporadically Injection Site) and VACCINATION SITE RASH (Rash Injection Site (1.5" X 1") Top to Bottom). On 23-Jan-2021, the patient experienced RASH (rash aggravated). On 26-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site). At the time of the report, PAIN IN EXTREMITY (Arm hurt when lifted the arm (Mild)), INJECTION SITE WARMTH (Warm to the touch Injection Site), RASH (rash aggravated), VACCINATION SITE PRURITUS (Itching sporadically Injection Site) and VACCINATION SITE RASH (Rash Injection Site (1.5" X 1") Top to Bottom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included benadryl.  No relevant concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Fatigue, Feeling abnormal, Headache, Oropharyngeal pain
Clinical narrative: arm rash; headache; lack of energy; voice is almost gone; feels horrible; sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash), HEADACHE (headache) and FATIGUE (lack of energy). At the time of the report, DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash), HEADACHE (headache) and FATIGUE (lack of energy) outcome was unknown.            No relevant concomitant medications were reported.     Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: arm rash; headache; lack of energy; voice is almost gone; feels horrible; sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash), HEADACHE (headache) and FATIGUE (lack of energy). At the time of the report, DYSPHONIA (voice is almost gone), FEELING ABNORMAL (feels horrible), OROPHARYNGEAL PAIN (sore throat), RASH (arm rash), HEADACHE (headache) and FATIGUE (lack of energy) outcome was unknown.            No relevant concomitant medications were reported.     Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Did not feel good / felt sick; swollen arm and plams; fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel good / felt sick), PERIPHERAL SWELLING (swollen arm and plams) and PYREXIA (fever of 102F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 in December 2020.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MALAISE (Did not feel good / felt sick), PERIPHERAL SWELLING (swollen arm and plams) and PYREXIA (fever of 102F). At the time of the report, MALAISE (Did not feel good / felt sick), PERIPHERAL SWELLING (swollen arm and plams) and PYREXIA (fever of 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient took Tylenol 2 tabs then also fever doesn't subside.    Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore Throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown.            No treatment information was provided. No relevant concomitant medications were reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cold sweat, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Smothering; Blood pressure was so low/read 80/50 mmHg; Clammy; Sweaty; Nauseous; Vomited; A spontaneous report was received from a consumer who was a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  nauseous, vomited, smothering (suffocation feeling), clammy (cold sweat), sweaty (hyperhidrosis), and blood pressure was so low at 80/50 mmHg (hypotension)  The patient's medical history, as provided by the reporter, included that she was a "heart patient."   The patient was "on a lot of regular medications" but did not have a list of them available.  On 23 Jan 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly on her left deltoid for prophylaxis of COVID-19 infection.  On approximately 27 Jan 2021 (reported as 4-5 days post vaccination) she was nauseous, vomited one time, was smothering, clammy and sweaty, and her blood pressure was so low, it read 80/50 mmHg.  She "thought it was a heart attack."  On an unspecified date, the patient was kept overnight for a heart stress test and x-ray (results not provided).  No treatment was given for the events.   Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events of nauseous, smothering, clammy, sweaty, and blood pressure was so low (80/50 mmHg) were unknown at the time of this report.  The event of vomited was considered resolved on approximately 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Suffocation feeling, Vomiting
Clinical narrative: Smothering; Blood pressure was so low/read 80/50 mmHg; Clammy; Sweaty; Nauseous; Vomited; A spontaneous report was received from a consumer who was a 70-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  nauseous, vomited, smothering (suffocation feeling), clammy (cold sweat), sweaty (hyperhidrosis), and blood pressure was so low at 80/50 mmHg (hypotension)  The patient's medical history, as provided by the reporter, included that she was a "heart patient."   The patient was "on a lot of regular medications" but did not have a list of them available.  On 23 Jan 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly on her left deltoid for prophylaxis of COVID-19 infection.  On approximately 27 Jan 2021 (reported as 4-5 days post vaccination) she was nauseous, vomited one time, was smothering, clammy and sweaty, and her blood pressure was so low, it read 80/50 mmHg.  She "thought it was a heart attack."  On an unspecified date, the patient was kept overnight for a heart stress test and x-ray (results not provided).  No treatment was given for the events.   Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events of nauseous, smothering, clammy, sweaty, and blood pressure was so low (80/50 mmHg) were unknown at the time of this report.  The event of vomited was considered resolved on approximately 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his wife has problem sometimes with her hand hurting and it is hurting more today; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his wife has problem sometimes with her hand hurting and it is hurting more today) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Fibromyalgia.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (his wife has problem sometimes with her hand hurting and it is hurting more today). At the time of the report, PAIN IN EXTREMITY (his wife has problem sometimes with her hand hurting and it is hurting more today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included none. No relevant concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Vaccination site pruritus
Clinical narrative: injection site itches; swollen at the injection site; red at the injection site (square of redness); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itches), INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site (square of redness)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historic events reported.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itches), INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site (square of redness)). At the time of the report, VACCINATION SITE PRURITUS (injection site itches) was resolving and INJECTION SITE SWELLING (swollen at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site (square of redness)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was self She applied ice and took a Benadryl oral pill at night. concomitant medications report was not included by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Red itchy patch noted on her right arm (injection site); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Red itchy patch noted on her right arm (injection site)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (Red itchy patch noted on her right arm (injection site)). At the time of the report, PRURITUS (Red itchy patch noted on her right arm (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.   No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to the touch (feverish) of the injection site; injection site itchiing; soreness; injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch (feverish) of the injection site), VACCINATION SITE PRURITUS (injection site itchiing), VACCINATION SITE PAIN (soreness) and VACCINATION SITE RASH (injection site rash) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch (feverish) of the injection site), VACCINATION SITE PRURITUS (injection site itchiing), VACCINATION SITE PAIN (soreness) and VACCINATION SITE RASH (injection site rash). At the time of the report, VACCINATION SITE WARMTH (warm to the touch (feverish) of the injection site), VACCINATION SITE PRURITUS (injection site itchiing), VACCINATION SITE PAIN (soreness) and VACCINATION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.   Reporter did not allow further contact
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomited; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03LL20A) 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) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VOMITING (Vomited). At the time of the report, VOMITING (Vomited) 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.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: arm became bruised; arm became painful and swollen with a rash; arm became painful and swollen with a rash; arm became painful and swollen with a rash; 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 CONTUSION (arm became bruised), PAIN IN EXTREMITY (arm became painful and swollen with a rash), PERIPHERAL SWELLING (arm became painful and swollen with a rash) and RASH (arm became painful and swollen with a rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (arm became bruised), PAIN IN EXTREMITY (arm became painful and swollen with a rash), PERIPHERAL SWELLING (arm became painful and swollen with a rash) and RASH (arm became painful and swollen with a rash). At the time of the report, CONTUSION (arm became bruised), PAIN IN EXTREMITY (arm became painful and swollen with a rash), PERIPHERAL SWELLING (arm became painful and swollen with a rash) and RASH (arm became painful and swollen with a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: swelling around the injection site, about 3 inches; redness around the injection site, about 3 inches; tenderness around the injection site, about 3 inches; Headache; Body ache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.            Treatment included Ice pack. No relevant concomitant medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-018959 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: swelling around the injection site, about 3 inches; redness around the injection site, about 3 inches; tenderness around the injection site, about 3 inches; Headache; Body ache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, INJECTION SITE SWELLING (swelling around the injection site, about 3 inches), INJECTION SITE ERYTHEMA (redness around the injection site, about 3 inches), VACCINATION SITE PAIN (tenderness around the injection site, about 3 inches), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Low grade fever) outcome was unknown.            Treatment included Ice pack. No relevant concomitant medications were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-018959 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red patch that is about 3 inches above the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red patch that is about 3 inches above the injection site) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red patch that is about 3 inches above the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 500 mg. At the time of the report, VACCINATION SITE ERYTHEMA (red patch that is about 3 inches above the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant Medications were reported.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Weakness; Tiredness; redness and swelling of the injection site for 2 days; redness and swelling of the injection site for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Tiredness), VACCINATION SITE SWELLING (redness and swelling of the injection site for 2 days) and VACCINATION SITE ERYTHEMA (redness and swelling of the injection site for 2 days) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE SWELLING (redness and swelling of the injection site for 2 days) and VACCINATION SITE ERYTHEMA (redness and swelling of the injection site for 2 days). On an unknown date, the patient experienced ASTHENIA (Weakness) and FATIGUE (Tiredness). At the time of the report, ASTHENIA (Weakness), FATIGUE (Tiredness), VACCINATION SITE SWELLING (redness and swelling of the injection site for 2 days) and VACCINATION SITE ERYTHEMA (redness and swelling of the injection site for 2 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Headache (Migraine); This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Headache (Migraine)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MIGRAINE (Headache (Migraine)). At the time of the report, MIGRAINE (Headache (Migraine)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: MR-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.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swollen (Injection Site); Itchy (Injection Site); A spontaneous report was received from a consumer concerning a 82-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swollen (injection site), itchy (injection site).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) swollen (injection site), itchy (injection site).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swollen (injection site), itchy (injection site) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills, rigors; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) and CHILLS (chills, rigors) 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 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PYREXIA (fever) and CHILLS (chills, rigors). At the time of the report, PYREXIA (fever) and CHILLS (chills, rigors) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), FATIGUE (feeling tired), CHILLS (chilly) and MUSCULOSKELETAL STIFFNESS (stiff arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included Thyroid disorder NOS, Heartburn, COPD and Heart rate abnormal. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, ATENOLOL for Heart rate, FAMOTIDINE for Heartburn, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ACETYLSALICYLIC ACID (BABY ASPIRIN) for unk. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced FATIGUE (feeling tired). On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 18-Jan-2021, the patient experienced CHILLS (chilly) and MUSCULOSKELETAL STIFFNESS (stiff arm). On 25-Jan-2021, PAIN IN EXTREMITY (sore arm), HEADACHE (headache), FATIGUE (feeling tired), CHILLS (chilly) and MUSCULOSKELETAL STIFFNESS (stiff arm) 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. Patient was treated with Tylenol and using heating pads to warm up. Concomitant products included vitamins. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Vaccination site pain, Vaccination site rash
Clinical narrative: sore throat; headache; rash on on the arm that received the injection; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE RASH (rash on on the arm that received the injection), VACCINATION SITE PAIN (arm hurt) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCORTISONE for an unknown indication.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurt). On 19-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on on the arm that received the injection). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and HEADACHE (headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), VACCINATION SITE RASH (rash on on the arm that received the injection), VACCINATION SITE PAIN (arm hurt) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Peripheral swelling, Pyrexia, Vaccination site dysaesthesia
Clinical narrative: Felt like the gush of the medicine "went into her arm, then it went around her arm"; Mobility is difficult; Arm was swollen to size of golf ball/Swelling seems to be expanding; Arm started to bother her; Warm to touch/It was hot; It is hard; Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger; Fever; Chills; Redness; Injection site was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her) and VACCINATION SITE WARMTH (Warm to touch/It was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-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 DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender). At the time of the report, VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Felt like the gush of the medicine "went into her arm, then it went around her arm"; Mobility is difficult; Arm was swollen to size of golf ball/Swelling seems to be expanding; Arm started to bother her; Warm to touch/It was hot; It is hard; Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger; Fever; Chills; Redness; Injection site was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her) and VACCINATION SITE WARMTH (Warm to touch/It was hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-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 DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender). At the time of the report, VACCINATION SITE DYSAESTHESIA (Felt like the gush of the medicine "went into her arm, then it went around her arm"), VACCINATION SITE MOVEMENT IMPAIRMENT (Mobility is difficult), PERIPHERAL SWELLING (Arm was swollen to size of golf ball/Swelling seems to be expanding), LIMB DISCOMFORT (Arm started to bother her), VACCINATION SITE WARMTH (Warm to touch/It was hot), VACCINATION SITE INDURATION (It is hard), VACCINATION SITE SWELLING (Right arm has large amount of swelling at the site/Inflammed/Injection site area is bigger), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Injection site was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.