chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dry skin, Lip dry, Weight increased
Clinical narrative: Dry mouth; Gain weight; Dry lips; Dry feet; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), WEIGHT INCREASED (Gain weight), LIP DRY (Dry lips) and DRY SKIN (Dry feet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (Dry mouth), WEIGHT INCREASED (Gain weight), LIP DRY (Dry lips) and DRY SKIN (Dry feet). At the time of the report, DRY MOUTH (Dry mouth), WEIGHT INCREASED (Gain weight), LIP DRY (Dry lips) and DRY SKIN (Dry feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and no treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Osteoarthritis
Clinical narrative: The bump on her kneecap was from osteoarthritis; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (The bump on her kneecap was from osteoarthritis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OSTEOARTHRITIS (The bump on her kneecap was from osteoarthritis). At the time of the report, OSTEOARTHRITIS (The bump on her kneecap was from osteoarthritis) 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.  The patient went to urgent care and was told that the bump on their kneecap was from osteoarthritis.  No Concomitant product use was reported. No treatment information was provided..
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: I have a large hard lump a day after my second vaccine; I have a large hard hot lump a day after my second vaccine; There is a swollen lump at the vaccination site; 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 VACCINATION SITE MASS (I have a large hard lump a day after my second vaccine), VACCINATION SITE WARMTH (I have a large hard hot lump a day after my second vaccine) and VACCINATION SITE SWELLING (There is a swollen lump at the vaccination site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (I have a large hard lump a day after my second vaccine), VACCINATION SITE WARMTH (I have a large hard hot lump a day after my second vaccine) and VACCINATION SITE SWELLING (There is a swollen lump at the vaccination site). At the time of the report, VACCINATION SITE MASS (I have a large hard lump a day after my second vaccine), VACCINATION SITE WARMTH (I have a large hard hot lump a day after my second vaccine) and VACCINATION SITE SWELLING (There is a swollen lump at the vaccination site) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events were not applicable.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: My arm to be tight 11 days after the 1st dose; My arm to be tender; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (My arm to be tight 11 days after the 1st dose) and VACCINATION SITE PAIN (My arm to be tender) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (My arm to be tight 11 days after the 1st dose) and VACCINATION SITE PAIN (My arm to be tender). At the time of the report, LIMB DISCOMFORT (My arm to be tight 11 days after the 1st dose) and VACCINATION SITE PAIN (My arm to be tender) 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.  The patient reported that their arm to be tender and tight 11 days post receiving their first dose.  No Concomitant product use was reported. No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feel very tired after 4 days; 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 FATIGUE (feel very tired after 4 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced FATIGUE (feel very tired after 4 days). At the time of the report, FATIGUE (feel very tired after 4 days) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: feel pain in my arm; 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 MYALGIA (feel pain in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced MYALGIA (feel pain in my arm). At the time of the report, MYALGIA (feel pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant Medications were reported. Treatment Information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sluggishness
Clinical narrative: Tiredness,Fatigue; Not as active; 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 FATIGUE (Tiredness,Fatigue) and SLUGGISHNESS (Not as active) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced FATIGUE (Tiredness,Fatigue) and SLUGGISHNESS (Not as active). At the time of the report, FATIGUE (Tiredness,Fatigue) and SLUGGISHNESS (Not as active) outcome was unknown.            Concomitant medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Nausea
Clinical narrative: Pain in the navel Area/feels like her stomach is paralyzed; Nausea; General Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in the navel Area/feels like her stomach is paralyzed), NAUSEA (Nausea) and FATIGUE (General Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 47621A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in the navel Area/feels like her stomach is paralyzed), NAUSEA (Nausea) and FATIGUE (General Fatigue). On 02-Jun-2021, ABDOMINAL PAIN UPPER (Pain in the navel Area/feels like her stomach is paralyzed), NAUSEA (Nausea) and FATIGUE (General Fatigue) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use unknown medication for blood pressure. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR was attached on 09-JUN-2021 contains updated information about events.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased, SARS-CoV-2 test
Clinical narrative: Severe dizziness; Cannot do anything; 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 DIZZINESS (Severe dizziness) and MOBILITY DECREASED (Cannot do anything) 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 COVID-19 (Patient had covid two times prior to the vaccine).    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 DIZZINESS (Severe dizziness) and MOBILITY DECREASED (Cannot do anything). At the time of the report, DIZZINESS (Severe dizziness) and MOBILITY DECREASED (Cannot do anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19 and positive (Positive) Patient had covid two times prior to the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had my first vaccine over 6 weeks ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had my first vaccine over 6 weeks ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had my first vaccine over 6 weeks ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Had my first vaccine over 6 weeks ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       THERE ARE NO CONCOMITENT MEDICATIONS IN THE TREATEMENT
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: gotten your vaccine & tested positive for Covid; 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 COVID-19 (gotten your vaccine & tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (gotten your vaccine & tested positive for Covid). At the time of the report, COVID-19 (gotten your vaccine & tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; Myalgia; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and MYALGIA (Myalgia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (Myalgia). At the time of the report, PYREXIA (fever) and MYALGIA (Myalgia) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: miss 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (miss 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PRODUCT DOSE OMISSION ISSUE (miss 2nd shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (miss 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided.  No laboratory data was provided.  No Treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is hurts at sight and down to fore arm; 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 PAIN IN EXTREMITY (Arm is hurts at sight and down to fore arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is hurts at sight and down to fore arm). At the time of the report, PAIN IN EXTREMITY (Arm is hurts at sight and down to fore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported  Treatment medication information were not reported
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I have a patient who received his second dose after 21 days from first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient who received his second dose after 21 days from first shot) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 047C21A) for COVID-19 vaccination.     No medication history was provided.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient who received his second dose after 21 days from first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have a patient who received his second dose after 21 days from first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information use was unknown
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Arm numbness; 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 HYPOAESTHESIA (Arm numbness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Arm numbness). At the time of the report, HYPOAESTHESIA (Arm numbness) 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. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema
Clinical narrative: pain in the arm; 1 cm diameter redness at the injection site; 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 VACCINATION SITE ERYTHEMA (1 cm diameter redness at the injection site) and MYALGIA (pain in the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U1081282) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (1 cm diameter redness at the injection site) and MYALGIA (pain in the arm). At the time of the report, VACCINATION SITE ERYTHEMA (1 cm diameter redness at the injection site) and MYALGIA (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medications reported. no treatment details 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Malaise
Clinical narrative: chills; sweats; rundown; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HYPERHIDROSIS (sweats) and MALAISE (rundown) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweats) and MALAISE (rundown). At the time of the report, CHILLS (chills), HYPERHIDROSIS (sweats) and MALAISE (rundown) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment details reported. no concomitant products reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; 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 MYALGIA (Muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Insomnia, Myalgia
Clinical narrative: Feeling dizzy; Couldn't sleep; Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Feeling dizzy), INSOMNIA (Couldn't sleep) and MYALGIA (Body aches) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced DIZZINESS (Feeling dizzy), INSOMNIA (Couldn't sleep) and MYALGIA (Body aches). At the time of the report, DIZZINESS (Feeling dizzy), INSOMNIA (Couldn't sleep) and MYALGIA (Body aches) outcome was unknown.            no concomitant and treatment drugs were given
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; 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 AGEUSIA (loss of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: really bad sweats, sweats lasting quite a while; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (really bad sweats, sweats lasting quite a while), PYREXIA (fever) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (really bad sweats, sweats lasting quite a while), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPERHIDROSIS (really bad sweats, sweats lasting quite a while), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medications reported. no treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I'm have a fever of 101 after the 2nd shot of moderna, it's been more than a day; 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 PYREXIA (I'm have a fever of 101 after the 2nd shot of moderna, it's been more than a day) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (I'm have a fever of 101 after the 2nd shot of moderna, it's been more than a day). At the time of the report, PYREXIA (I'm have a fever of 101 after the 2nd shot of moderna, it's been more than a day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) High.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Arm is red but only where he get the shot; 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 VACCINATION SITE ERYTHEMA (Arm is red but only where he get the shot) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm is red but only where he get the shot). At the time of the report, VACCINATION SITE ERYTHEMA (Arm is red but only where he get the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant and treatment details reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Formication
Clinical narrative: Aches in the body/Body aches; Had to crawl into the bed; Weak; Side effects were worse than getting the flu; Did not feel like eating; Chills; Headaches; Fatigue/Hard to get up and go to the bathroom/Still worn out; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu) and DECREASED APPETITE (Did not feel like eating) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 041C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, IRON and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu), DECREASED APPETITE (Did not feel like eating), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue/Hard to get up and go to the bathroom/Still worn out). At the time of the report, MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu), DECREASED APPETITE (Did not feel like eating), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue/Hard to get up and go to the bathroom/Still worn out) outcome was unknown.            No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Myalgia
Clinical narrative: Aches in the body/Body aches; Had to crawl into the bed; Weak; Side effects were worse than getting the flu; Did not feel like eating; Chills; Headaches; Fatigue/Hard to get up and go to the bathroom/Still worn out; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu) and DECREASED APPETITE (Did not feel like eating) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 041C21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, IRON and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu), DECREASED APPETITE (Did not feel like eating), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue/Hard to get up and go to the bathroom/Still worn out). At the time of the report, MYALGIA (Aches in the body/Body aches), FORMICATION (Had to crawl into the bed), ASTHENIA (Weak), INFLUENZA (Side effects were worse than getting the flu), DECREASED APPETITE (Did not feel like eating), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue/Hard to get up and go to the bathroom/Still worn out) outcome was unknown.            No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Sick on and off; Missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Sick on and off) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 ILLNESS (Sick on and off) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, ILLNESS (Sick on and off) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) 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.   It was reported that patient was  sick on and off after first dose of vaccination and she did not received call to get her 2nd dose of MODERNA vaccine so she missed it.   No concomitant medication was reported  No treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of sinusitis (sinus infection) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 034C21A) for COVID-19 immunization. Concurrent medical conditions included sinus infection. On May 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced sinusitis (sinus infection). At the time of the report, sinusitis (sinus infection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: a substantial amount ran down her arm when administered/may have not gotten half of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (a substantial amount ran down her arm when administered/may have not gotten half of the vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced UNDERDOSE (a substantial amount ran down her arm when administered/may have not gotten half of the vaccine). On 21-May-2021, UNDERDOSE (a substantial amount ran down her arm when administered/may have not gotten half of the vaccine) had resolved.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: server muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (server muscle pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (server muscle pain). At the time of the report, MYALGIA (server muscle pain) outcome was unknown.            no treatment information was reported no concomitant medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain in arm/arm still hurting a month after getting the vaccine; 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 VACCINATION SITE PAIN (pain in arm/arm still hurting a month after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in arm/arm still hurting a month after getting the vaccine). At the time of the report, VACCINATION SITE PAIN (pain in arm/arm still hurting a month after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years old, received the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine) 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 product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Chest pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Chest pressure). At the time of the report, CHEST DISCOMFORT (Chest pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain after I've had my vaccine; 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 VACCINATION SITE PAIN (Pain after I've had my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain after I've had my vaccine). At the time of the report, VACCINATION SITE PAIN (Pain after I've had my vaccine) 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.  Treatment information was not provided.    Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received Pfizer vaccine for 2nd dose; Received Moderna vaccine for 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Moderna vaccine for 1st dose) and PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for 2nd dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Moderna vaccine for 1st dose). On 28-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for 2nd dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Moderna vaccine for 1st dose) and PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling
Clinical narrative: Left arm swelling; Hot to the touch; 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 PERIPHERAL SWELLING (Left arm swelling) and FEELING HOT (Hot to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Left arm swelling) and FEELING HOT (Hot to the touch). At the time of the report, PERIPHERAL SWELLING (Left arm swelling) and FEELING HOT (Hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Taste disorder
Clinical narrative: stomach still feels uncomfortable, GI upset; decreased appettite; food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach still feels uncomfortable, GI upset), DECREASED APPETITE (decreased appettite) and TASTE DISORDER (food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach still feels uncomfortable, GI upset), DECREASED APPETITE (decreased appettite) and TASTE DISORDER (food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste). At the time of the report, ABDOMINAL DISCOMFORT (stomach still feels uncomfortable, GI upset), DECREASED APPETITE (decreased appettite) and TASTE DISORDER (food doesn't taste good, even cherries. Salt & vinegar chips taste like cheese; altered taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication reported. no treatment medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a feverish area on my arm about 2 inches below the injection site; 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 PYREXIA (a feverish area on my arm about 2 inches below the injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (a feverish area on my arm about 2 inches below the injection site). At the time of the report, PYREXIA (a feverish area on my arm about 2 inches below the injection site) had not resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site swelling
Clinical narrative: swollen near the site of the injection; severe chills; fever of 102.4/ low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe chills), PYREXIA (fever of 102.4/ low grade fever) and VACCINATION SITE SWELLING (swollen near the site of the injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced CHILLS (severe chills) and PYREXIA (fever of 102.4/ low grade fever). On 28-May-2021, the patient experienced VACCINATION SITE SWELLING (swollen near the site of the injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-May-2021, CHILLS (severe chills) had resolved. On 27-May-2021, PYREXIA (fever of 102.4/ low grade fever) had resolved. At the time of the report, VACCINATION SITE SWELLING (swollen near the site of the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 102.4 (Inconclusive) fever of 102.4.         no concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; 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 FATIGUE (tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medications reported. no treatment details reported.