chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 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 (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) (Intramuscular) 1 mg. On an unknown date, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: my 2nd Moderna vaccination. I missed it.; 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 PRODUCT DOSE OMISSION ISSUE (my 2nd Moderna vaccination. I missed it.) 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 PRODUCT DOSE OMISSION ISSUE (my 2nd Moderna vaccination. I missed it.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (my 2nd Moderna vaccination. I missed it.) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: severe reaction; got my 1st dose of moderna vaccine February 25th; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my 1st dose of moderna vaccine February 25th) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient suffered from Covid 19 in the month March 2020.) in March 2020. Concurrent medical conditions included Glaucoma.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my 1st dose of moderna vaccine February 25th). At the time of the report, VACCINATION COMPLICATION (severe reaction) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my 1st dose of moderna vaccine February 25th) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administration error
Clinical narrative: interchange of vaccine; a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine) had resolved and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  Patient administered First dose of Moderna Vaccine on 22-JAN-2021 and second  dose Janssen Vaccine on 07-APR-2021 in Left Arm.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-JUN-2021 contains non-significant information.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Illness, Lethargy, Migraine, Myalgia
Clinical narrative: Sick in bed; Feels lethargic; Migraine; She doesn't feel like much eating, only liquids; Feels achy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick in bed), LETHARGY (Feels lethargic), MIGRAINE (Migraine), DECREASED APPETITE (She doesn't feel like much eating, only liquids) and MYALGIA (Feels achy) in a 50-year-old female 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 an unknown date, the patient experienced ILLNESS (Sick in bed), LETHARGY (Feels lethargic), MIGRAINE (Migraine), DECREASED APPETITE (She doesn't feel like much eating, only liquids) and MYALGIA (Feels achy). At the time of the report, ILLNESS (Sick in bed), LETHARGY (Feels lethargic), MIGRAINE (Migraine), DECREASED APPETITE (She doesn't feel like much eating, only liquids) and MYALGIA (Feels achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I've lost taste; (I've lost) smell; 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 (I've lost taste) and ANOSMIA ((I've lost) smell) 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 AGEUSIA (I've lost taste) and ANOSMIA ((I've lost) smell). At the time of the report, AGEUSIA (I've lost taste) and ANOSMIA ((I've lost) smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Peripheral swelling
Clinical narrative: left shoulder to her lower arm is swollen; left breast is swollen.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left shoulder to her lower arm is swollen) and BREAST SWELLING (left breast is swollen.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No relevant medical history was provided.     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 shoulder to her lower arm is swollen) and BREAST SWELLING (left breast is swollen.). At the time of the report, PERIPHERAL SWELLING (left shoulder to her lower arm is swollen) and BREAST SWELLING (left breast is swollen.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: I have been having headaches; feeling 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 HEADACHE (I have been having headaches) and FATIGUE (feeling 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (I have been having headaches) and FATIGUE (feeling tired). At the time of the report, HEADACHE (I have been having headaches) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: Panic attack; 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 PANIC ATTACK (Panic attack) 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 PANIC ATTACK (Panic attack). At the time of the report, PANIC ATTACK (Panic attack) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Wife has a red spot on arm a week after shot; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Wife has a red spot on arm a week after shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ERYTHEMA (Wife has a red spot on arm a week after shot). At the time of the report, ERYTHEMA (Wife has a red spot on arm a week after shot) 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.   ? No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swelling in my lip today; 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 LIP SWELLING (Swelling in my lip today) 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 LIP SWELLING (Swelling in my lip today). At the time of the report, LIP SWELLING (Swelling in my lip today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: dark urine; 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 CHROMATURIA (dark urine) 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) (Intramuscular) dosage form. On an unknown date, the patient experienced CHROMATURIA (dark urine). At the time of the report, CHROMATURIA (dark urine) outcome was unknown.            No concomitant medications or treatment details provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Photopsia, Vaccination complication
Clinical narrative: got for sick for 2-3 days; chills; muscle pain at the site of the shot and all over; muscle pain at the site of the shot and all over; when you're looking at something and you look away, he saw part of that image or flash of that image; weakness; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), VACCINATION COMPLICATION (got for sick for 2-3 days), CHILLS (chills) and VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, SIMVASTATIN, FENOFIBRATE, OMEPRAZOLE, SITAGLIPTIN PHOSPHATE (JANUVIA), ZINC OXIDE (ZINC COMPOUND), PARACETAMOL (TYLENOL), DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), CHILLS (chills), VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) and MYALGIA (muscle pain at the site of the shot and all over). On an unknown date, the patient experienced VACCINATION COMPLICATION (got for sick for 2-3 days). On 27-Apr-2021, PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), CHILLS (chills), VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) and MYALGIA (muscle pain at the site of the shot and all over) had resolved. At the time of the report, VACCINATION COMPLICATION (got for sick for 2-3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: got for sick for 2-3 days; chills; muscle pain at the site of the shot and all over; muscle pain at the site of the shot and all over; when you're looking at something and you look away, he saw part of that image or flash of that image; weakness; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), VACCINATION COMPLICATION (got for sick for 2-3 days), CHILLS (chills) and VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, SIMVASTATIN, FENOFIBRATE, OMEPRAZOLE, SITAGLIPTIN PHOSPHATE (JANUVIA), ZINC OXIDE (ZINC COMPOUND), PARACETAMOL (TYLENOL), DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), CHILLS (chills), VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) and MYALGIA (muscle pain at the site of the shot and all over). On an unknown date, the patient experienced VACCINATION COMPLICATION (got for sick for 2-3 days). On 27-Apr-2021, PHOTOPSIA (when you're looking at something and you look away, he saw part of that image or flash of that image), ASTHENIA (weakness), CHILLS (chills), VACCINATION SITE PAIN (muscle pain at the site of the shot and all over) and MYALGIA (muscle pain at the site of the shot and all over) had resolved. At the time of the report, VACCINATION COMPLICATION (got for sick for 2-3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I am sicker now than when i had 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 ILLNESS (I am sicker now than when i had covid) 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 in January 2021.    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 ILLNESS (I am sicker now than when i had covid). At the time of the report, ILLNESS (I am sicker now than when i had covid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information provided.   This case was linked to MOD-2021-162461.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itchy red spot; itchy red spot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy red spot) and ERYTHEMA (itchy red spot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PRURITUS (itchy red spot) and ERYTHEMA (itchy red spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy and Redness, at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy red spot) was resolving and ERYTHEMA (itchy red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I need to get the second shot; had the first one in February 09/2021. When I returned in March, they were no longer there.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications and treatment medications was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain in extremity
Clinical narrative: Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨; i can not lie down to sleep on that side; is like muscular pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨), INSOMNIA (i can not lie down to sleep on that side) and MYALGIA (is like muscular pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced PAIN IN EXTREMITY (Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨), INSOMNIA (i can not lie down to sleep on that side) and MYALGIA (is like muscular pain). At the time of the report, PAIN IN EXTREMITY (Arm pain ¨it is like muscular pain i can not lie down to sleep on that side¨), INSOMNIA (i can not lie down to sleep on that side) and MYALGIA (is like muscular pain) 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.   No concomitant drugs were reported. No treatment drugs are not provided by reporter.   This case was linked to MOD-2021-163442 (Parent-Child Link).   See case MOD-2021-163442 for details regarding the child case.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have fever today; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (have fever today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PYREXIA (have fever today). At the time of the report, PYREXIA (have fever today) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not want to provide any additional information stated that he really was not feeling well and would just like the answer to his questions. No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant follow-up received contains adverse event outcome changed from Unknown to recovered/resolved
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Hard lump at injection site; feels a warm at the injection site; itchiness at the injection site; Headache; Rash at injection site; Low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Rash at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache), VACCINATION SITE RASH (Rash at injection site), PYREXIA (Low grade fever) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE MASS (Hard lump at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Low grade fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache), VACCINATION SITE RASH (Rash at injection site), PYREXIA (Low grade fever) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Patient plans to use cortisone cream for itching. No Concomitant  information was  provided.   This case was linked to MOD-2021-163443 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Hard lump at injection site; feels a warm at the injection site; itchiness at the injection site; Headache; Rash at injection site; Low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache) and VACCINATION SITE RASH (Rash at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache), VACCINATION SITE RASH (Rash at injection site), PYREXIA (Low grade fever) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE MASS (Hard lump at injection site). The patient was treated with PARACETAMOL (TYLENOL) for Low grade fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Hard lump at injection site), VACCINATION SITE WARMTH (feels a warm at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), HEADACHE (Headache), VACCINATION SITE RASH (Rash at injection site), PYREXIA (Low grade fever) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Patient plans to use cortisone cream for itching. No Concomitant  information was  provided.   This case was linked to MOD-2021-163443 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness and stuff like you are supposed to after 2nd shot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced ILLNESS (Sickness and stuff like you are supposed to after 2nd shot). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness and stuff like you are supposed to after 2nd shot) outcome was unknown.            Treatment details included jergens ultra healing lotion.  Action taken with the mRNA-1273 in response to the event is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: fatigue; body aches; headache; unable to breathe; feel really weak; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (unable to breathe), ASTHENIA (feel really weak), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache) 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 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced DYSPNOEA (unable to breathe) and ASTHENIA (feel really weak). On an unknown date, the patient experienced FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, DYSPNOEA (unable to breathe), ASTHENIA (feel really weak), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Cough, Productive cough, Vaccination site erythema, Vaccination site pain
Clinical narrative: phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs; feels choked; coughs; same red blister for two days; burned; vaccine turned red; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked), COUGH (coughs), VACCINATION SITE VESICLES (same red blister for two days) and VACCINATION SITE PAIN (burned) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (burned) and VACCINATION SITE ERYTHEMA (vaccine turned red). On 04-May-2021, the patient experienced VACCINATION SITE VESICLES (same red blister for two days). On 24-May-2021, the patient experienced PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked) and COUGH (coughs). On 28-Apr-2021, VACCINATION SITE PAIN (burned) and VACCINATION SITE ERYTHEMA (vaccine turned red) had resolved. On 06-May-2021, VACCINATION SITE VESICLES (same red blister for two days) had resolved. At the time of the report, PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked) and COUGH (coughs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.  On 24-May-2021, the patient had an appointment to receive the second dose. It was reported that the patient did not have a fever (temp 97.1).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles
Clinical narrative: phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs; feels choked; coughs; same red blister for two days; burned; vaccine turned red; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked), COUGH (coughs), VACCINATION SITE VESICLES (same red blister for two days) and VACCINATION SITE PAIN (burned) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (burned) and VACCINATION SITE ERYTHEMA (vaccine turned red). On 04-May-2021, the patient experienced VACCINATION SITE VESICLES (same red blister for two days). On 24-May-2021, the patient experienced PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked) and COUGH (coughs). On 28-Apr-2021, VACCINATION SITE PAIN (burned) and VACCINATION SITE ERYTHEMA (vaccine turned red) had resolved. On 06-May-2021, VACCINATION SITE VESICLES (same red blister for two days) had resolved. At the time of the report, PRODUCTIVE COUGH (phlegm/when she coughs, mucus comes out from behind her throat//woke up with a lot of mucus/coughs), CHOKING SENSATION (feels choked) and COUGH (coughs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.  On 24-May-2021, the patient had an appointment to receive the second dose. It was reported that the patient did not have a fever (temp 97.1).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination complication
Clinical narrative: Side effects seem to have cleared up by the 17th; Weird burst of pain on the left side of my head; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects seem to have cleared up by the 17th) and HEADACHE (Weird burst of pain on the left side of my head) 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 13-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 an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects seem to have cleared up by the 17th) and HEADACHE (Weird burst of pain on the left side of my head). On 17-May-2021, VACCINATION COMPLICATION (Side effects seem to have cleared up by the 17th) had resolved. At the time of the report, HEADACHE (Weird burst of pain on the left side of my head) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Diarrhea; brain fog; Fatigue; 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 DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog) and FATIGUE (Fatigue) 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 DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
Clinical narrative: Ache is annoying; Pain is currently deep into shoulder and left hand; Deep muscular pain in left deltoid; Bad stiff neck, couldn't turn it; Pain travelled to vaccine arm/shoulder/back/elbow; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Bad stiff neck, couldn't turn it), PAIN IN EXTREMITY (Pain travelled to vaccine arm/shoulder/back/elbow), PAIN (Ache is annoying), ARTHRALGIA (Pain is currently deep into shoulder and left hand) and MYALGIA (Deep muscular pain in left deltoid) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 0ZZMZ0A) for COVID-19 vaccination.     Concomitant products included MELOXICAM (MOBIC) for Pain in hip.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Bad stiff neck, couldn't turn it) and PAIN IN EXTREMITY (Pain travelled to vaccine arm/shoulder/back/elbow). On 24-May-2021, the patient experienced PAIN (Ache is annoying), ARTHRALGIA (Pain is currently deep into shoulder and left hand) and MYALGIA (Deep muscular pain in left deltoid). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Bad stiff neck, couldn't turn it), PAIN IN EXTREMITY (Pain travelled to vaccine arm/shoulder/back/elbow), PAIN (Ache is annoying), ARTHRALGIA (Pain is currently deep into shoulder and left hand) and MYALGIA (Deep muscular pain in left deltoid) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Followup received on 23-Jun-2021 contains: The reporter still had slight neck, shoulder and arm pain over a month later.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Arms hurt; Neck hurts; 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 (Arms hurt) and NECK PAIN (Neck hurts) 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 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arms hurt) and NECK PAIN (Neck hurts). At the time of the report, PAIN IN EXTREMITY (Arms hurt) and NECK PAIN (Neck hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B1A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information has been provided by the reporter. No concomitant medication information has been provided by the reporter. No lab data has been provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick after getting my shot for two 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 ILLNESS (very sick after getting my shot for two days) 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 ILLNESS (very sick after getting my shot for two days). At the time of the report, ILLNESS (very sick after getting my shot for two days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Rash, Urinary tract infection
Clinical narrative: UTI infection; Yeast infection; Rash all over patient body; This spontaneous case was reported by a pharmacist and describes the occurrence of URINARY TRACT INFECTION (UTI infection), FUNGAL INFECTION (Yeast infection) and RASH (Rash all over patient body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI infection), FUNGAL INFECTION (Yeast infection) and RASH (Rash all over patient body). At the time of the report, URINARY TRACT INFECTION (UTI infection), FUNGAL INFECTION (Yeast infection) and RASH (Rash all over patient body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Lingering Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Lingering 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 (Lingering Headache). At the time of the report, HEADACHE (Lingering Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.   Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Light Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Light Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 (Fever) and HEADACHE (Light Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Light Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.