chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Non-Moderna Manufacturer) 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 28-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient received the Johnson and Johnson Covid-19 Vaccine instead of getting the second dose of the Moderna Covid-19 Vaccine.) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain on 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 VACCINATION SITE PAIN (pain on 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain on my arm). At the time of the report, VACCINATION SITE PAIN (pain on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Pain; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) 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, the patient experienced PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            Concomitant medications were not mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Delayed second dose (not yet administered, missed window); 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second dose (not yet administered, missed window)) 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 16-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second dose (not yet administered, missed window)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed second dose (not yet administered, missed window)) 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.  Patient stated that she had an app on July 6 for the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose (not yet administered) is more than 2 months due after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose (not yet administered) is more than 2 months due after the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose (not yet administered) is more than 2 months due after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose (not yet administered) is more than 2 months due after the first 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.   No relevant concomitant medications were reported. No treatment information was provided.  Patient reported that her family received the first shot at the end of March and went out of town.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Hyperhidrosis, Influenza, Nausea
Clinical narrative: Heart Rate Increased; Menstrual flow very heavy; Menstrual Flow very painful; Sweating; Feel like the flu; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea). On 12-May-2021, the patient experienced TACHYCARDIA (Heart Rate Increased). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 4 mg as necessary. On 08-May-2021, HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea) had resolved. On 16-May-2021, TACHYCARDIA (Heart Rate Increased) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient wanted to report the side effects after receiving the second dose of the Moderna COVID-19 Vaccination. Patient received the first dose of the Moderna COVID-19 Vaccination in her left arm muscle, Expiration date unknown.  Patient received her second dose of the Moderna COVID-19 Vaccine on 01May2021, in the right arm muscle; Lot number 046B21A, Expiration date  unknown.    On 03May2021 patient had her menstrual cycle and then later in the month again.  Each time the menstrual flow was very heavy and painful, increased heart rate, sweating, nausea, feel like the flu.  Was tested for the flu once and it was negative and was tested for COVID-19 twice and both came back negative.  Consent to follow up with her health care provider and Safety. Preferred communication is phone.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Heart Rate Increased; Menstrual flow very heavy; Menstrual Flow very painful; Sweating; Feel like the flu; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea). On 12-May-2021, the patient experienced TACHYCARDIA (Heart Rate Increased). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 4 mg as necessary. On 08-May-2021, HEAVY MENSTRUAL BLEEDING (Menstrual flow very heavy), DYSMENORRHOEA (Menstrual Flow very painful), HYPERHIDROSIS (Sweating), INFLUENZA (Feel like the flu) and NAUSEA (Nausea) had resolved. On 16-May-2021, TACHYCARDIA (Heart Rate Increased) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient wanted to report the side effects after receiving the second dose of the Moderna COVID-19 Vaccination. Patient received the first dose of the Moderna COVID-19 Vaccination in her left arm muscle, Expiration date unknown.  Patient received her second dose of the Moderna COVID-19 Vaccine on 01May2021, in the right arm muscle; Lot number 046B21A, Expiration date  unknown.    On 03May2021 patient had her menstrual cycle and then later in the month again.  Each time the menstrual flow was very heavy and painful, increased heart rate, sweating, nausea, feel like the flu.  Was tested for the flu once and it was negative and was tested for COVID-19 twice and both came back negative.  Consent to follow up with her health care provider and Safety. Preferred communication is phone.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: vaccination site rash; vaccination site erythema; 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 RASH (vaccination site rash) and VACCINATION SITE ERYTHEMA (vaccination site erythema) 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 VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given. No treatment information was given.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; 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 COUGH (Cough) 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 COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: flaking scalp; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (flaking scalp) 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 SKIN EXFOLIATION (flaking scalp). At the time of the report, SKIN EXFOLIATION (flaking scalp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A really bad pain in her left arm  where she got the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A really bad pain in her left arm  where she got the second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     No medical information history.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (A really bad pain in her left arm  where she got the second shot). At the time of the report, VACCINATION SITE PAIN (A really bad pain in her left arm  where she got the second shot) outcome was unknown.            No treatment medication provided. No concomitant medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vials after more than 30 days of refrigeration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vials after more than 30 days of refrigeration) 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 PRODUCT STORAGE ERROR (Administered vials after more than 30 days of refrigeration). At the time of the report, PRODUCT STORAGE ERROR (Administered vials after more than 30 days of refrigeration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 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 PAIN (Pain) 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 PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: continuous 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 (continuous 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 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced HEADACHE (continuous headache). At the time of the report, HEADACHE (continuous headache) outcome was unknown.            Concomitant medications were not provided.  Treatment medications was not given.
Sex: U
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: weight gain; 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 WEIGHT INCREASED (weight gain) 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 WEIGHT INCREASED (weight gain). At the time of the report, WEIGHT INCREASED (weight gain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight increased: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant and treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me; 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 COMPLICATION (I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me) 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 COMPLICATION (I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me). At the time of the report, VACCINATION COMPLICATION (I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder still hurts one month after second moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder still hurts one month after second moderna 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 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 ARTHRALGIA (Shoulder still hurts one month after second moderna shot). At the time of the report, ARTHRALGIA (Shoulder still hurts one month after second moderna shot) outcome was unknown.            AE submitted through chatbot. shoulder still hurts one month after second moderna shot is that normal.   no concomitant medications were not reported.  treatment medications was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Feeling abnormal, Feeling of body temperature change, Lethargy
Clinical narrative: feeling very badly after this dose; low grade fever; fatigue; cold and hot; lethargic; pain in the site that radiates to her arm and chest; pain in the site that radiates to her arm; pain in the site that radiates to her arm and chest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot) and LETHARGY (lethargic) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), LETHARGY (lethargic), VACCINATION SITE PAIN (pain in the site that radiates to her arm and chest), MYALGIA (pain in the site that radiates to her arm) and CHEST PAIN (pain in the site that radiates to her arm and chest). At the time of the report, FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), LETHARGY (lethargic), VACCINATION SITE PAIN (pain in the site that radiates to her arm and chest), MYALGIA (pain in the site that radiates to her arm) and CHEST PAIN (pain in the site that radiates to her arm and chest) outcome was unknown.            No treatment and concomitant medications were reported.     This case was linked to MOD-2021-187135 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: feeling very badly after this dose; low grade fever; fatigue; cold and hot; lethargic; pain in the site that radiates to her arm and chest; pain in the site that radiates to her arm; pain in the site that radiates to her arm and chest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot) and LETHARGY (lethargic) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), LETHARGY (lethargic), VACCINATION SITE PAIN (pain in the site that radiates to her arm and chest), MYALGIA (pain in the site that radiates to her arm) and CHEST PAIN (pain in the site that radiates to her arm and chest). At the time of the report, FEELING ABNORMAL (feeling very badly after this dose), PYREXIA (low grade fever), FATIGUE (fatigue), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), LETHARGY (lethargic), VACCINATION SITE PAIN (pain in the site that radiates to her arm and chest), MYALGIA (pain in the site that radiates to her arm) and CHEST PAIN (pain in the site that radiates to her arm and chest) outcome was unknown.            No treatment and concomitant medications were reported.     This case was linked to MOD-2021-187135 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: I got covid after my first dose on april 6,.; and I still havent gotten second dose. When should i get the second dose? (35 days have crossed); 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 (I got covid after my first dose on april 6,.) and PRODUCT DOSE OMISSION ISSUE (and I still havent gotten second dose. When should i get the second dose? (35 days have crossed)) 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 06-Apr-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 COVID-19 (I got covid after my first dose on april 6,.) and PRODUCT DOSE OMISSION ISSUE (and I still havent gotten second dose. When should i get the second dose? (35 days have crossed)). At the time of the report, COVID-19 (I got covid after my first dose on april 6,.) and PRODUCT DOSE OMISSION ISSUE (and I still havent gotten second dose. When should i get the second dose? (35 days have crossed)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided   Reporter did not allow further contact
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Body temperature increased) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 BODY TEMPERATURE INCREASED (Body temperature increased). At the time of the report, BODY TEMPERATURE INCREASED (Body temperature increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: week of feeling like an old lady; extremely fatigued; achy joints; slight headache; chills; nerve issue; 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 ASTHENIA (week of feeling like an old lady), FATIGUE (extremely fatigued), ARTHRALGIA (achy joints), HEADACHE (slight headache) 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. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ASTHENIA (week of feeling like an old lady), FATIGUE (extremely fatigued), ARTHRALGIA (achy joints), HEADACHE (slight headache), CHILLS (chills) and NERVE INJURY (nerve issue   ). At the time of the report, ASTHENIA (week of feeling like an old lady), FATIGUE (extremely fatigued), ARTHRALGIA (achy joints), HEADACHE (slight headache), CHILLS (chills) and NERVE INJURY (nerve issue   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported  no concomitant medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: week of feeling like an old lady; extremely fatigued; achy joints; slight headache; chills; nerve issue; 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 ASTHENIA (week of feeling like an old lady), FATIGUE (extremely fatigued), ARTHRALGIA (achy joints), HEADACHE (slight headache) 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. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ASTHENIA (week of feeling like an old lady), FATIGUE (extremely fatigued), ARTHRALGIA (achy joints), HEADACHE (slight headache), CHILLS (chills) and NERVE INJURY (nerve issue   ). At the time of the report, ASTHENIA (week of feeling like an old lady), FATIGUE (extremely fatigued), ARTHRALGIA (achy joints), HEADACHE (slight headache), CHILLS (chills) and NERVE INJURY (nerve issue   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was reported  no concomitant medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received 1 dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and received 1 dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and received 1 dose). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and received 1 dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product were reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: sciatic nerve issues in my left hip running down my hamstrings / nerve issue; nerve pain; chills; headache; joint pains; extremely fatigued; weak of feeling like an old lady; 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 SCIATICA (sciatic nerve issues in my left hip running down my hamstrings / nerve issue), NEURALGIA (nerve pain), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, 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 SCIATICA (sciatic nerve issues in my left hip running down my hamstrings / nerve issue), NEURALGIA (nerve pain), CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pains), FATIGUE (extremely fatigued) and ASTHENIA (weak of feeling like an old lady). At the time of the report, SCIATICA (sciatic nerve issues in my left hip running down my hamstrings / nerve issue), NEURALGIA (nerve pain), CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pains), FATIGUE (extremely fatigued) and ASTHENIA (weak of feeling like an old lady) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications and treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia, SARS-CoV-2 test, Sciatica
Clinical narrative: sciatic nerve issues in my left hip running down my hamstrings / nerve issue; nerve pain; chills; headache; joint pains; extremely fatigued; weak of feeling like an old lady; 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 SCIATICA (sciatic nerve issues in my left hip running down my hamstrings / nerve issue), NEURALGIA (nerve pain), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, 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 SCIATICA (sciatic nerve issues in my left hip running down my hamstrings / nerve issue), NEURALGIA (nerve pain), CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pains), FATIGUE (extremely fatigued) and ASTHENIA (weak of feeling like an old lady). At the time of the report, SCIATICA (sciatic nerve issues in my left hip running down my hamstrings / nerve issue), NEURALGIA (nerve pain), CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pains), FATIGUE (extremely fatigued) and ASTHENIA (weak of feeling like an old lady) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications and treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pis and needles sensation all over body; 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 PARAESTHESIA (Pis and needles sensation all over body) 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 PARAESTHESIA (Pis and needles sensation all over body). At the time of the report, PARAESTHESIA (Pis and needles sensation all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Ulcer
Clinical narrative: Ulcers; Acid reflux; 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 ULCER (Ulcers) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) 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 ULCER (Ulcers) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). At the time of the report, ULCER (Ulcers) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Treatment details was not reported .   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Pulpitis dental, Tenderness
Clinical narrative: Right behind his teeth was swollen and inflamed; Behind his teeth was tender and sore; Swelling of the lymph nodes in his mouth; Soreness in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PULPITIS DENTAL (Right behind his teeth was swollen and inflamed), TENDERNESS (Behind his teeth was tender and sore), LYMPHADENOPATHY (Swelling of the lymph nodes in his mouth) and ARTHRALGIA (Soreness in the shoulder) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE) for Blood pressure management, VITAMIN D [VITAMIN D NOS] for Supplementation therapy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PULPITIS DENTAL (Right behind his teeth was swollen and inflamed), LYMPHADENOPATHY (Swelling of the lymph nodes in his mouth) and ARTHRALGIA (Soreness in the shoulder). 30-Apr-2021, the patient experienced TENDERNESS (Behind his teeth was tender and sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PULPITIS DENTAL (Right behind his teeth was swollen and inflamed) and LYMPHADENOPATHY (Swelling of the lymph nodes in his mouth) outcome was unknown and TENDERNESS (Behind his teeth was tender and sore) and ARTHRALGIA (Soreness in the shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included steroid intravenously was noted.   This case was linked to MOD-2021-186979 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: he doesn't feel okay; tired; chills; fever; body pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (he doesn't feel okay), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and MYALGIA (body pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 27-May-2021, the patient experienced MALAISE (he doesn't feel okay), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and MYALGIA (body pain). At the time of the report, MALAISE (he doesn't feel okay), FATIGUE (tired), CHILLS (chills), PYREXIA (fever) and MYALGIA (body pain) had resolved.            No concomitant medication provided by reporter. No treatment medication provided by reporter. Action taken with mRNA 1273 in response to event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR received and Updated the Event outcome to Recovered/Resolved
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; 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 (fever) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation down your injection 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 PARAESTHESIA (Tingling sensation down your injection 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 29-May-2021 at 12:45 PM, 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 PARAESTHESIA (Tingling sensation down your injection arm). At the time of the report, PARAESTHESIA (Tingling sensation down your injection arm) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; 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 (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were given by the reporter. No treatment information were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: stomach issues; 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 issues) 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 ABDOMINAL DISCOMFORT (stomach issues). At the time of the report, ABDOMINAL DISCOMFORT (stomach issues) 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.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Mouth swelling
Clinical narrative: Right behind his teeth was swollen and inflamed after the 1st dose; More severe soreness in the shoulder after the 1st dose; Swelling of the lymph nodes in his mouth after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Right behind his teeth was swollen and inflamed after the 1st dose), ARTHRALGIA (More severe soreness in the shoulder after the 1st dose) and LYMPH NODE PAIN (Swelling of the lymph nodes in his mouth after the 1st dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     no medical history reported.  Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE) for Blood pressure.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced MOUTH SWELLING (Right behind his teeth was swollen and inflamed after the 1st dose), ARTHRALGIA (More severe soreness in the shoulder after the 1st dose) and LYMPH NODE PAIN (Swelling of the lymph nodes in his mouth after the 1st dose). On 04-May-2021, ARTHRALGIA (More severe soreness in the shoulder after the 1st dose) had resolved. At the time of the report, MOUTH SWELLING (Right behind his teeth was swollen and inflamed after the 1st dose) and LYMPH NODE PAIN (Swelling of the lymph nodes in his mouth after the 1st 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.   Concomitant medication included Vitamin D 50000 IU