chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: rash about 4 inches long by 2 inches, begins at the injection site and travels from  there; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (rash about 4 inches long by 2 inches, begins at the injection site and travels from  there) 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 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (rash about 4 inches long by 2 inches, begins at the injection site and travels from  there). At the time of the report, VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (rash about 4 inches long by 2 inches, begins at the injection site and travels from  there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant and recieved the moderna covid vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and recieved the moderna covid vaccine) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form(s) at an unspecified frequency. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and recieved the moderna covid vaccine). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and recieved the moderna covid vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       This case concerns a female subject who reported pregnancy after the first dose of  COVID-19 vaccine (mRNA-1273) .No other information was provided regarding last menstrual period , date of conception, and estimated due date.; Reporter's Comments: This case concerns a female subject who reported pregnancy after the first dose of  COVID-19 vaccine (mRNA-1273) .No other information was provided regarding last menstrual period , date of conception, and estimated due date.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Lymphadenopathy, Platelet count normal
Clinical narrative: Swelling of the lymph nodes on her throat,; Had nose bleeding ,twice; Based on the current case data, this case has been classified as invalid. This invalid case case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Swelling of the lymph nodes on her throat,) and EPISTAXIS (Had nose bleeding ,twice) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    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 LYMPHADENOPATHY (Swelling of the lymph nodes on her throat,) and EPISTAXIS (Had nose bleeding ,twice). At the time of the report, LYMPHADENOPATHY (Swelling of the lymph nodes on her throat,) and EPISTAXIS (Had nose bleeding ,twice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count normal: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin reaction
Clinical narrative: delayed severe swelling with progression; initial itch; Localised Swelling; Localised Erythema; Localised Pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (delayed severe swelling with progression), INJECTION SITE PRURITUS (initial itch), INJECTION SITE SWELLING (Localised Swelling), INJECTION SITE ERYTHEMA (Localised Erythema) and INJECTION SITE PAIN (Localised Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (delayed severe swelling with progression), INJECTION SITE PRURITUS (initial itch), INJECTION SITE SWELLING (Localised Swelling), INJECTION SITE ERYTHEMA (Localised Erythema) and INJECTION SITE PAIN (Localised Pain). At the time of the report, SKIN REACTION (delayed severe swelling with progression), INJECTION SITE PRURITUS (initial itch), INJECTION SITE SWELLING (Localised Swelling), INJECTION SITE ERYTHEMA (Localised Erythema) and INJECTION SITE PAIN (Localised 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 medication were reported. No treatment information was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: looks like lymphedema; stomach wasnt bad enough to feel like throwning up; progressing and getting worse, not getting any better; right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm; really tired / fatigue; HEADACHE / sever headche; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (looks like lymphedema), ABDOMINAL DISCOMFORT (stomach wasnt bad enough to feel like throwning up), CONDITION AGGRAVATED (progressing and getting worse, not getting any better), PAIN IN EXTREMITY (right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm) and FATIGUE (really tired / fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Metastatic breast cancer (Start date  on 10-??-2021). Previously administered products included for an unreported indication: XGEVA on 31-Mar-2021 and FASLODEX on 31-Mar-2021. Concurrent medical conditions included Blood pressure, High cholesterol and Diabetes (Diabetes-type 2). Concomitant products included ESTRADIOL (ESTROGEN), PALBOCICLIB (IBRANCE), METFORMIN, DENOSUMAB (XGEVA), LISINOPRIL, ROSUVASTATIN and FULVESTRANT (FASLODEX) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (really tired / fatigue) and HEADACHE (HEADACHE / sever headche). On 17-Mar-2021, the patient experienced LYMPHOEDEMA (looks like lymphedema), ABDOMINAL DISCOMFORT (stomach wasnt bad enough to feel like throwning up), CONDITION AGGRAVATED (progressing and getting worse, not getting any better) and PAIN IN EXTREMITY (right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm). On 16-Mar-2021, HEADACHE (HEADACHE / sever headche) had resolved. At the time of the report, LYMPHOEDEMA (looks like lymphedema), ABDOMINAL DISCOMFORT (stomach wasnt bad enough to feel like throwning up), CONDITION AGGRAVATED (progressing and getting worse, not getting any better), PAIN IN EXTREMITY (right arm between her thumb and index finger is swollen and painful / swelling in hand and traveling thru arm) and FATIGUE (really tired / fatigue) outcome was unknown. Not Provided      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.   Treatment includes softly massaging those areas.  For metastatic breast cancer CT scan was performed and showing changes.   This case was linked to MOD-2021-280024 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant follow-up received on 06-AUG-2021 and added Race information, Ethnic group, Medical history and concomitant medication
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history ).    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Missed the correct interval inter doses; Contracted covid-19 after the 1st 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 (Missed the correct interval inter doses) and COVID-19 (Contracted covid-19 after the 1st dose) 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 (Treated with monoclonal antibodies.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the correct interval inter doses) and COVID-19 (Contracted covid-19 after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the correct interval inter doses) and COVID-19 (Contracted covid-19 after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  It was reported that the first patient, on December got covid-19 and got a treatment with monoclonal antibodies. Two patients got the 1st dose of the moderna covid-19 vaccine on 25 Feb-2021 and the other got the 1st on 4-Mar-2021 and got covid-19 vaccine and did not get yet the 2nd.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up document contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: I was wondering about possible side effects that I need to be looking out for; 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 ADVERSE EVENT (I was wondering about possible side effects that I need to be looking out for) 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 ADVERSE EVENT (I was wondering about possible side effects that I need to be looking out for). At the time of the report, ADVERSE EVENT (I was wondering about possible side effects that I need to be looking out for) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment information were reported
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on fingers; 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 RASH (rash on fingers) 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 RASH (rash on fingers). At the time of the report, RASH (rash on fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had my first vaccine on Friday and just wondering how long I can expect the symptoms to last; 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 first vaccine on Friday and just wondering how long I can expect the symptoms to last) 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 VACCINATION COMPLICATION (I had my first vaccine on Friday and just wondering how long I can expect the symptoms to last). At the time of the report, VACCINATION COMPLICATION (I had my first vaccine on Friday and just wondering how long I can expect the symptoms to last) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia, Vaccination site lymphadenopathy
Clinical narrative: Armpit is still a bit swollen; Entire body was achy; Armpit is still a bit swollen and have pain sometimes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Armpit is still a bit swollen), MYALGIA (Entire body was achy) and AXILLARY PAIN (Armpit is still a bit swollen and have pain sometimes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Armpit is still a bit swollen), MYALGIA (Entire body was achy) and AXILLARY PAIN (Armpit is still a bit swollen and have pain sometimes). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Armpit is still a bit swollen) had not resolved and MYALGIA (Entire body was achy) and AXILLARY PAIN (Armpit is still a bit swollen and have pain sometimes) outcome was unknown. Not Provided          Patient was on antibiotics for the HCG done for infertility.  No concomitant medications were reported.  No treatment medication was reported by reporter.   This case was linked to MOD-2021-248035 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: upgraded to valid case- patient demographics added, suspect drug details added, events added.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Sore shoulder joint/Sore arm joints; Hand sore/Fingers sore; 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 ARTHRALGIA (Sore shoulder joint/Sore arm joints) and PAIN IN EXTREMITY (Hand sore/Fingers sore) 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 ARTHRALGIA (Sore shoulder joint/Sore arm joints) and PAIN IN EXTREMITY (Hand sore/Fingers sore). At the time of the report, ARTHRALGIA (Sore shoulder joint/Sore arm joints) and PAIN IN EXTREMITY (Hand sore/Fingers sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Extremely light headed/Feel like gonna pass out when I stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely light headed/Feel like gonna pass out when I stand up) 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 DIZZINESS (Extremely light headed/Feel like gonna pass out when I stand up). At the time of the report, DIZZINESS (Extremely light headed/Feel like gonna pass out when I stand up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Will I experience hair loss because of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Will I experience hair loss because of the vaccine) 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. On an unknown date, the patient experienced ALOPECIA (Will I experience hair loss because of the vaccine). At the time of the report, ALOPECIA (Will I experience hair loss because of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect that can be spread to member  inside a family who did not recieve the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect that can be spread to member  inside a family who did not recieve the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect that can be spread to member  inside a family who did not recieve the vaccine). At the time of the report, VACCINATION COMPLICATION (Side effect that can be spread to member  inside a family who did not recieve the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  The patient reported a side effect that can be spread to member inside a family who did not receive the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: vaccine administered to patient after excursion; 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 TEMPERATURE EXCURSION ISSUE (vaccine administered to patient after excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine administered to patient after excursion). On 21-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine administered to patient after excursion) had resolved.        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.   Reporter stated that the vaccine was pulled from the refrigerator at 6:25 AM at 4.3C and was placed in a vericooler at 2.2C. The cooler bricks were left in the freezer overnight, but the vaccine coordinator thought they were ok since the initial reading was 2.2C. While in transport to the site from the Health Department, the temperature had dropped to -3.4C at 6:28 AM and continued to drop until the bottom brick was removed from the cooler at 6:50AM. Vaccine was removed from the cooler at this time also and was at room temperature until 7:53AM when the DDL was reattached and the cooler temperature was at 5.3F. DDL data was attached with excursion temperature. Concomitant medications were not provided. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received and contained no new information On 27-Jul-2021: Non-Significant follow up received.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021) 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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 23Apr2021 and 2nd dose on 26Jun2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up received contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Chest discomfort, Chills, Headache, Heart rate
Clinical narrative: I dont have a taste no more; Chest feels tighten; I keep getting chills; My head is still being hurting; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I dont have a taste no more), CHEST DISCOMFORT (Chest feels tighten), CHILLS (I keep getting chills) and HEADACHE (My head is still being hurting) 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-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (I dont have a taste no more), CHEST DISCOMFORT (Chest feels tighten), CHILLS (I keep getting chills) and HEADACHE (My head is still being hurting). At the time of the report, AGEUSIA (I dont have a taste no more), CHEST DISCOMFORT (Chest feels tighten), CHILLS (I keep getting chills) and HEADACHE (My head is still being hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: was in bed for a day; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (was in bed for a day) 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 BEDRIDDEN (was in bed for a day). At the time of the report, BEDRIDDEN (was in bed for a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment and concomitant medication information provided
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: A little chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (A little chills) and FATIGUE (Tiredness) 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 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 CHILLS (A little chills) and FATIGUE (Tiredness). At the time of the report, CHILLS (A little chills) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were provided. No treatments were provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain, Vaccination site rash
Clinical narrative: left arm swelled up; rash at the injection site; very painful; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jul-2021 and was forwarded to Moderna on 01-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swelled up), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PAIN (very painful) in a 73-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left arm swelled up), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PAIN (very painful). At the time of the report, PERIPHERAL SWELLING (left arm swelled up), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE PAIN (very painful) outcome was unknown.            No concomitant medications were reported No treatment Information was provided
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Two children below 18 year and received the Moderna covid-19 vaccine (second dose); 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two children below 18 year and received the Moderna covid-19 vaccine (second 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 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two children below 18 year and received the Moderna covid-19 vaccine (second dose)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Two children below 18 year and received the Moderna covid-19 vaccine (second dose)) had resolved.            This case was linked to MOD-2021-062204 (Patient Link).   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) in a 67-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 NECK PAIN (Neck pain). At the time of the report, NECK PAIN (Neck pain) outcome was unknown.            No concomitant medications reported by the reporter No treatment medications reported by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Gait disturbance, Headache, Pain
Clinical narrative: can't walk; can't eat; the arm of the injection is hurting and can't raise it up; chills; severe headache; fever; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat), PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PAIN (pain), CHILLS (chills), HEADACHE (severe headache) and PYREXIA (fever). On an unknown date, the patient experienced GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat) and PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (pain), GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat), PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up), CHILLS (chills), HEADACHE (severe headache) and PYREXIA (fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided.  The patient reported feeling better after taking paracetamol (Tylenol).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: can't walk; can't eat; the arm of the injection is hurting and can't raise it up; chills; severe headache; fever; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat), PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PAIN (pain), CHILLS (chills), HEADACHE (severe headache) and PYREXIA (fever). On an unknown date, the patient experienced GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat) and PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (pain), GAIT DISTURBANCE (can't walk), FEEDING DISORDER (can't eat), PAIN IN EXTREMITY (the arm of the injection is hurting and can't raise it up), CHILLS (chills), HEADACHE (severe headache) and PYREXIA (fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided.  The patient reported feeling better after taking paracetamol (Tylenol).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine which has been punctured for about 19 hours has been administered to a patient/ First dose was administered on 30June2021 of an expired vial. Vial was first punctured at 5:30 PM on 29June2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine which has been punctured for about 19 hours has been administered to a patient/ First dose was administered on 30June2021 of an expired vial. Vial was first punctured at 5:30 PM on 29June2021) 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 30-Jun-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 EXPIRED PRODUCT ADMINISTERED (vaccine which has been punctured for about 19 hours has been administered to a patient/ First dose was administered on 30June2021 of an expired vial. Vial was first punctured at 5:30 PM on 29June2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine which has been punctured for about 19 hours has been administered to a patient/ First dose was administered on 30June2021 of an expired vial. Vial was first punctured at 5:30 PM on 29June2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by reporter. Treatment information was not provided.   This case was linked to MOD-2021-117613, MOD-2021-117667 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Added patient initials, Vaccine start date and dose number added.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Discomfort, Pharyngeal swelling, Pyrexia
Clinical narrative: Burning in legs; Body feels heavy; Doctor did notice a little swelling in throat; Steady low fever hasn't gone away; Many side effects complete with chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in legs), DISCOMFORT (Body feels heavy), PHARYNGEAL SWELLING (Doctor did notice a little swelling in throat), PYREXIA (Steady low fever hasn't gone away) and CHILLS (Many side effects complete with chills) 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 24-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning in legs), DISCOMFORT (Body feels heavy), PHARYNGEAL SWELLING (Doctor did notice a little swelling in throat), PYREXIA (Steady low fever hasn't gone away) and CHILLS (Many side effects complete with chills). At the time of the report, BURNING SENSATION (Burning in legs), DISCOMFORT (Body feels heavy), PHARYNGEAL SWELLING (Doctor did notice a little swelling in throat), PYREXIA (Steady low fever hasn't gone away) and CHILLS (Many side effects complete with chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  On 24-JUN-2021 Thursday, patient had vaccine and went back to doctor on Tuesday. Doctor had noticed a little swelling on throat and gave him PII(32):AZhSxbiTvtSUG8K0iJLneHEnKB0BbXY= packet 4mg.  Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Missed second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 INTENTIONAL PRODUCT USE ISSUE (Missed second dose). The patient was treated with Surgery (Knee surgery) for Intentional product use issue. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Missed second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications were provided. Treatment medications were unknown.  The patient had knee surgery after the first dose.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: falling outside of the 42 days to get the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (falling outside of the 42 days to get the second vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 PRODUCT DOSE OMISSION ISSUE (falling outside of the 42 days to get the second vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (falling outside of the 42 days to get the second vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (1 year ago). Concurrent medical conditions included Type 1 diabetes mellitus and Deaf.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) 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 medications were reported. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: Shakiness in legs; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and TREMOR (Shakiness in legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Weakness). On 01-Jul-2021, the patient experienced TREMOR (Shakiness in legs). At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (Weakness) had not resolved and TREMOR (Shakiness in legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She tested positive) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032Z21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (She tested positive). The patient was treated with COUGH SYRUP [AMMONIUM CHLORIDE;CHLORPHENAMINE MALEATE;DIHYDROCODEINE BITARTRATE;METHYLEPHEDRINE HYDROCHLORIDE-DL] from 26-Jun-2021 to 04-Jul-2021 for Coughing and COVID-19, at a dose of UNK, bid. At the time of the report, COVID-19 (She tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient visited an Urgent Care Center and tested for COVID on 26-JUN-2021.  The patient was told she was positive on 28-JUN-2021. The patient had COVID-19 symptoms as cough, headache, diarrhea, nasal congestion, loss of taste and smell.  On 26-Jun-2021, PCR (Polymerase chain reaction) test was done: No result was provided.  No concomitant medications were reported.  Patient was treated with Steroids (Z pack) from 26-Jun-2021 to 02-JUL-2021.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Folow up was received. Treatment medications and symptoms of COVID-19 were added.