chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: experienced pure pain in both of her arms, pain in hand; cannot exercise; she has been hurting, painful, experienced pain; Uncomfortable; cold; pain comes down in the muscle to across her back; soreness, muscle pain, soreness is never ending, soreness goes and comes back.; pain comes down in the muscle to across her shoulder; Patient received the second dose 22 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand), EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable) and NASOPHARYNGITIS (cold) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eye disorder NOS. Concomitant products included LATANOPROST for Eye disorder NOS, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand), EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable), NASOPHARYNGITIS (cold), BACK PAIN (pain comes down in the muscle to across her back), MYALGIA (soreness, muscle pain, soreness is never ending, soreness goes and comes back.), ARTHRALGIA (pain comes down in the muscle to across her shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 22 days after the 1st dose). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experienced pure pain in both of her arms, pain in hand) had not resolved, EXERCISE TOLERANCE DECREASED (cannot exercise), PAIN (she has been hurting, painful, experienced pain), DISCOMFORT (Uncomfortable), NASOPHARYNGITIS (cold), BACK PAIN (pain comes down in the muscle to across her back), MYALGIA (soreness, muscle pain, soreness is never ending, soreness goes and comes back.) and ARTHRALGIA (pain comes down in the muscle to across her shoulder) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 22 days after the 1st dose) had resolved.            Treatment information was not provided for all the other events.   This case was linked to MOD-2021-296304 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Somnolence, Vaccination site swelling, Vulvovaginal pruritus
Clinical narrative: Severe vaginal itching / itching was really bad; Not feeling good; Weakness; Sleepy / drowsy; Swelling at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VULVOVAGINAL PRURITUS (Severe vaginal itching / itching was really bad), MALAISE (Not feeling good), ASTHENIA (Weakness), SOMNOLENCE (Sleepy / drowsy) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ11A and 03UA21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE), VITAMIN D NOS and RISPERIDONE (RISPERDAL) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (Not feeling good), ASTHENIA (Weakness), SOMNOLENCE (Sleepy / drowsy) and VACCINATION SITE SWELLING (Swelling at the injection site). On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (Severe vaginal itching / itching was really bad). The patient was treated with CLOBETASOL PROPIONATE at a dose of 1 dosage form twice a day. On 13-Apr-2021, MALAISE (Not feeling good), ASTHENIA (Weakness), SOMNOLENCE (Sleepy / drowsy) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, VULVOVAGINAL PRURITUS (Severe vaginal itching / itching was really bad) had not resolved.            Treatment medication also included an unspecified cream.  The patient stated the itching was really bad the first two months and at the time of report it was a little better but it still itches.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: still get second dose 6 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (still get second dose 6 months after 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (still get second dose 6 months after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (still get second dose 6 months after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. Treatment medication not reported. patient had not taken second dose 6 months after the first dose .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Extra dose administered
Clinical narrative: Patient reeived third dose; had an episode where he could not breathe  / could not get air in for about 45 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (had an episode where he could not breathe  / could not get air in for about 45 seconds) and EXTRA DOSE ADMINISTERED (Patient reeived third dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A, 047C21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection, AMLODIPINE, IRBESARTAN, BIOTIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (had an episode where he could not breathe  / could not get air in for about 45 seconds). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient reeived third dose). In April 2021, DYSPNOEA (had an episode where he could not breathe  / could not get air in for about 45 seconds) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (Patient reeived third dose) had resolved.            In concomitant medications, Daily vitamin was also reported. No treatment details were reported.  It has been reported that, caller says it is not true - that he had no issues whatsoever with the vaccine. Agent reviewed with the caller the previous case but he stated that he didn't report anything.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow-up received, updated patient comment into inarrative
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Chills; Fever; 1st dose of the Moderna 23Apr2021 & second dose on 03May2021; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna 23Apr2021 & second dose on 03May2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna 23Apr2021 & second dose on 03May2021). On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna 23Apr2021 & second dose on 03May2021) had resolved. At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant product was provided. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021; period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13) and MENSTRUATION IRREGULAR (she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02HC27A and 626B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced MENSTRUATION DELAYED (period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13). On 09-Jul-2021, the patient experienced MENSTRUATION IRREGULAR (she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021). At the time of the report, MENSTRUATION DELAYED (period MAY 20-24,2021 however, she did not get her period in the month of JUNE, 2021.  She then reported that she got her period again JUL 9-13) and MENSTRUATION IRREGULAR (she got her period again JUL 9-13, 2021 and again AUGUST 25, 2021) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Rib fracture
Clinical narrative: fractured a rib; My wife fell because she tripped - 6 months after she took Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of RIB FRACTURE (fractured a rib) and FALL (My wife fell because she tripped - 6 months after she took Moderna.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 3.   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 RIB FRACTURE (fractured a rib) and FALL (My wife fell because she tripped - 6 months after she took Moderna.). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Rib fracture, at a dose of 1 dosage form. At the time of the report, RIB FRACTURE (fractured a rib) and FALL (My wife fell because she tripped - 6 months after she took Moderna.) outcome was unknown.            No Concomitant medications was provided.  Reporter stated that - There was NO CONNECTION between the fractured rib and the injection. they were very happy with Moderna and the vaccine. The report was wrong.  Reporter asked that - how many days to stop (meds) before taking the vaccine (third dose) for his wife.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated the current condition, New event added and information added in narrative. On 07-Sep-2021: non significant follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: started itching 4 days after receiving second dose; had redness on the neck/flat red patches; swollen, flat red patches; swollen, flat red patches/breaking out with rash on all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started itching 4 days after receiving second dose), ERYTHEMA (had redness on the neck/flat red patches), SWELLING (swollen, flat red patches) and RASH (swollen, flat red patches/breaking out with rash on all over body) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 029M20A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN, BUSPIRONE and BUPROPION for an unknown indication.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PRURITUS (started itching 4 days after receiving second dose) and ERYTHEMA (had redness on the neck/flat red patches). 24-Aug-2021, the patient experienced SWELLING (swollen, flat red patches) and RASH (swollen, flat red patches/breaking out with rash on all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (started itching 4 days after receiving second dose), ERYTHEMA (had redness on the neck/flat red patches), SWELLING (swollen, flat red patches) and RASH (swollen, flat red patches/breaking out with rash on all over body) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had the Moderna shots in March and just had Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had the Moderna shots in March and just had Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had the Moderna shots in March and just had Covid). At the time of the report, COVID-19 (had the Moderna shots in March and just had Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.            No concurrent and treatment medication was reported by patient.   This case was linked to MOD-2021-297362, MOD-2021-297494 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Off label use, Pyrexia
Clinical narrative: her husband had his booster dose yesterday; Temperature of 104.4 degrees Farenheight; Sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (her husband had his booster dose yesterday), PYREXIA (Temperature of 104.4 degrees Farenheight) and INJECTION SITE PAIN (Sore left arm injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 042L20A and 037K20A) 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) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced OFF LABEL USE (her husband had his booster dose yesterday), PYREXIA (Temperature of 104.4 degrees Farenheight) and INJECTION SITE PAIN (Sore left arm injection site). At the time of the report, OFF LABEL USE (her husband had his booster dose yesterday), PYREXIA (Temperature of 104.4 degrees Farenheight) and INJECTION SITE PAIN (Sore left arm injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment product information was not provided. Concomitant product use was not provided.   This case was linked to MOD-2021-297362, MOD-2021-297493 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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 product use was not provided.   Treatment information was not  provided.  The patient was looking for some guidance if the patient should take second vaccine 28 days later.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu like Symptoms; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like Symptoms) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like Symptoms) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like Symptoms) and FATIGUE (Fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication were not reported. Treatment medication were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 y/o received the Moderna 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o received the Moderna 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 y/o received the Moderna vaccine) 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.   No Concomitant medication was reported No treatment Drug was reported
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered to a patient more than 24 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered to a patient more than 24 hours after puncture) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered to a patient more than 24 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered to a patient more than 24 hours after puncture) 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.   No concomitant medications were reported.  Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Pain in extremity
Clinical narrative: Nosebleed; arm was sore; kinda tired; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nosebleed), PAIN IN EXTREMITY (arm was sore) and FATIGUE (kinda tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004CZ1A and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced EPISTAXIS (Nosebleed), PAIN IN EXTREMITY (arm was sore) and FATIGUE (kinda tired). On 08-May-2021, EPISTAXIS (Nosebleed) had resolved. On 10-May-2021, FATIGUE (kinda tired) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.            Patient stated that after he got shot with in 6 to 10 hours, had nose bleed mentioned that he did not take anything for nosebleed,  just put pressure on it with a Kleenex and overtime it clotted  Patient also stated that he is not on any medications and does not have any health conditions. No treatment medications were provided by reporter.   This case was linked to MOD-2021-319561 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: Did not received 2nd dose; tinnitus in both ears but mostly in my right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus in both ears but mostly in my right ear) and PRODUCT DOSE OMISSION ISSUE (Did not received 2nd dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced TINNITUS (tinnitus in both ears but mostly in my right ear). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not received 2nd dose). At the time of the report, TINNITUS (tinnitus in both ears but mostly in my right ear) had not resolved and PRODUCT DOSE OMISSION ISSUE (Did not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient didn't receive second dose of vaccine, expressed concern that the second dose may make tinnitus worse.  Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: has to go for surgery; This spontaneous case was reported by a consumer and describes the occurrence of ILL-DEFINED DISORDER (has to go for surgery) in a 65-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILL-DEFINED DISORDER (has to go for surgery). At the time of the report, ILL-DEFINED DISORDER (has to go for surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported No treatment medication were reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: right arm aching; vertigo; for 3-4 days she had body aches/occasional body aches; headaches on and off; for 3-4 days she had chills; nauseated; dizziness or vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness or vertigo), PAIN IN EXTREMITY (right arm aching), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches) and HEADACHE (headaches on and off) in a 43-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness or vertigo), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches), HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated). On 25-Aug-2021,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PAIN IN EXTREMITY (right arm aching). In August 2021, DIZZINESS (dizziness or vertigo) had not resolved, HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN IN EXTREMITY (right arm aching) and VERTIGO (vertigo) had not resolved and MYALGIA (for 3-4 days she had body aches/occasional body aches) was resolving.            She's a vaccine compromised person, has had vaccine injury. No concomitant medications were provided by reporter. No treatment medications were provided by reporter. Patient received second dose on 13-AUG-2021 and developed nausea, headache on and off, dizzy during first week and 3 to 4 days. By the sixth day she had only dizziness or vertigo and occasional body aches.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: right arm aching; vertigo; for 3-4 days she had body aches/occasional body aches; headaches on and off; for 3-4 days she had chills; nauseated; dizziness or vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness or vertigo), PAIN IN EXTREMITY (right arm aching), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches) and HEADACHE (headaches on and off) in a 43-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness or vertigo), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches), HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated). On 25-Aug-2021,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PAIN IN EXTREMITY (right arm aching). In August 2021, DIZZINESS (dizziness or vertigo) had not resolved, HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN IN EXTREMITY (right arm aching) and VERTIGO (vertigo) had not resolved and MYALGIA (for 3-4 days she had body aches/occasional body aches) was resolving.            She's a vaccine compromised person, has had vaccine injury. No concomitant medications were provided by reporter. No treatment medications were provided by reporter. Patient received second dose on 13-AUG-2021 and developed nausea, headache on and off, dizzy during first week and 3 to 4 days. By the sixth day she had only dizziness or vertigo and occasional body aches.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: my arm is swollen; hurts really bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm is swollen) and PAIN (hurts really bad) 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 PERIPHERAL SWELLING (my arm is swollen) and PAIN (hurts really bad). At the time of the report, PERIPHERAL SWELLING (my arm is swollen) and PAIN (hurts really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Red; Itches terribly; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itches terribly) 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 22-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itches terribly). At the time of the report, VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itches terribly) outcome was unknown.            No concomitant medications reported. No treatment information was reported by reporter   This case was linked to MOD-2021-298578 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Myalgia, Nausea
Clinical narrative: Terrible stomach discomfort; The stomach discomfort was upgraded from discomfort to pain; Diarrhea; Fever; Vomiting; A lot of muscle aches/body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Terrible stomach discomfort), ABDOMINAL PAIN UPPER (The stomach discomfort was upgraded from discomfort to pain), DIARRHOEA (Diarrhea), PYREXIA (Fever) and VOMITING (Vomiting) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALOPURINOL, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, AMLODIPINE and VALSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Terrible stomach discomfort), ABDOMINAL PAIN UPPER (The stomach discomfort was upgraded from discomfort to pain), DIARRHOEA (Diarrhea), PYREXIA (Fever), VOMITING (Vomiting), MYALGIA (A lot of muscle aches/body aches) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Terrible stomach discomfort), ABDOMINAL PAIN UPPER (The stomach discomfort was upgraded from discomfort to pain), DIARRHOEA (Diarrhea), PYREXIA (Fever), VOMITING (Vomiting), MYALGIA (A lot of muscle aches/body aches) and NAUSEA (Nausea) outcome was unknown.            treatment information was reported Tylenol, ondansetron 8 mg Lab data included : Two stomach surgeries in the past: colon surgery and  recent one on February 2020 that was a gallbladder surgery. Patient reported scar tissue which bothered him from time to time.   This case was linked to MOD-2021-299983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-SEP-2021. No new information
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Terrible stomach discomfort; The stomach discomfort was upgraded from discomfort to pain; Diarrhea; Fever; Vomiting; A lot of muscle aches/body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Terrible stomach discomfort), ABDOMINAL PAIN UPPER (The stomach discomfort was upgraded from discomfort to pain), DIARRHOEA (Diarrhea), PYREXIA (Fever) and VOMITING (Vomiting) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALOPURINOL, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, AMLODIPINE and VALSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Terrible stomach discomfort), ABDOMINAL PAIN UPPER (The stomach discomfort was upgraded from discomfort to pain), DIARRHOEA (Diarrhea), PYREXIA (Fever), VOMITING (Vomiting), MYALGIA (A lot of muscle aches/body aches) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Terrible stomach discomfort), ABDOMINAL PAIN UPPER (The stomach discomfort was upgraded from discomfort to pain), DIARRHOEA (Diarrhea), PYREXIA (Fever), VOMITING (Vomiting), MYALGIA (A lot of muscle aches/body aches) and NAUSEA (Nausea) outcome was unknown.            treatment information was reported Tylenol, ondansetron 8 mg Lab data included : Two stomach surgeries in the past: colon surgery and  recent one on February 2020 that was a gallbladder surgery. Patient reported scar tissue which bothered him from time to time.   This case was linked to MOD-2021-299983 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-SEP-2021. No new information
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Insomnia, Paraesthesia
Clinical narrative: not sleeping well; tingling in their feet/pins and needles on their forearm; Inflammation in hands and fingers / Inflammation in feet and toes; Pain behind knee; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation in hands and fingers / Inflammation in feet and toes), INSOMNIA (not sleeping well), PARAESTHESIA (tingling in their feet/pins and needles on their forearm) and ARTHRALGIA (Pain behind knee) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ARTHRALGIA (Pain behind knee). On 25-Aug-2021, the patient experienced INFLAMMATION (Inflammation in hands and fingers / Inflammation in feet and toes) and PARAESTHESIA (tingling in their feet/pins and needles on their forearm). On 27-Aug-2021, the patient experienced INSOMNIA (not sleeping well). On 26-Aug-2021, ARTHRALGIA (Pain behind knee) had resolved. At the time of the report, INFLAMMATION (Inflammation in hands and fingers / Inflammation in feet and toes), INSOMNIA (not sleeping well) and PARAESTHESIA (tingling in their feet/pins and needles on their forearm) 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 provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Arm hurt; Feel yucky; Had the booster about 3 hours ago and have a headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Feel yucky) and HEADACHE (Had the booster about 3 hours ago and have a headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Feel yucky) and HEADACHE (Had the booster about 3 hours ago and have a headache). At the time of the report, PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (Feel yucky) and HEADACHE (Had the booster about 3 hours ago and have a headache) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received on 01-SEP-2021 contains significant information: Event added
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Reduced facial expression
Clinical narrative: Unable to move the left side of her face 3 to 4 times a week; Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of REDUCED FACIAL EXPRESSION (Unable to move the left side of her face 3 to 4 times a week), PAIN (Pain) and CHILLS (Chills) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced REDUCED FACIAL EXPRESSION (Unable to move the left side of her face 3 to 4 times a week), PAIN (Pain) and CHILLS (Chills). At the time of the report, REDUCED FACIAL EXPRESSION (Unable to move the left side of her face 3 to 4 times a week), PAIN (Pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse event after the vaccination; 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 (adverse event after the vaccination) 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 (adverse event after the vaccination). At the time of the report, VACCINATION COMPLICATION (adverse event after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Little soreness in arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little soreness in arm) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included HYDROCHLOROTHIAZIDE and SPIRONOLACTONE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced MYALGIA (Little soreness in arm) and FATIGUE (Tiredness). In January 2021, MYALGIA (Little soreness in arm) and FATIGUE (Tiredness) 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.   No treatment medications were reported.   This case was linked to MOD-2021-301073, MOD-2021-301074 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up contains no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 16-Jul-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 (Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-SEP-2021. No new information