chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: administered 28-hours after a vaccine vial was removed from the refrigerator; administered 28-hours after a vaccine vial was removed from the refrigerator; administered 28-hours after a vaccine vial was removed from the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 28-hours after a vaccine vial was removed from the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (administered 28-hours after a vaccine vial was removed from the refrigerator) and PRODUCT STORAGE ERROR (administered 28-hours after a vaccine vial was removed from the refrigerator) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 28-hours after a vaccine vial was removed from the refrigerator). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administered 28-hours after a vaccine vial was removed from the refrigerator) and PRODUCT STORAGE ERROR (administered 28-hours after a vaccine vial was removed from the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 28-hours after a vaccine vial was removed from the refrigerator), PRODUCT TEMPERATURE EXCURSION ISSUE (administered 28-hours after a vaccine vial was removed from the refrigerator) and PRODUCT STORAGE ERROR (administered 28-hours after a vaccine vial was removed from the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was moved from freezer to refrigerated on 16-May-2022.   Max temperature reached: Room Temperature 72F.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow-up  received significant information  as vaccine administration date and Lot number updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Oct-2021 and removed from the fridge on 08-Oct-2021; administered vaccines past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2021 and removed from the fridge on 08-Oct-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2021 and removed from the fridge on 08-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines past the expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2021 and removed from the fridge on 08-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  On 08-Oct-2021, the vial was removed from fridge.  The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022; Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Reportedly, the vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that one vial was taken out at a time and thawed as they did not thawan entire box.  Vaccine was removed from the fridge on 13 Oct 2021.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022; Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The BUD date was reported as 02-Apr-2022.  The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  Vaccine was removed from fridge on 06-Apr-2022.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-569375 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.; Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02-Apr-2022 and patient administered on 08-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine was expired on 02-Apr-2022 and removed from fridge on 08-Apr-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that patient took vaccine on 08-Apr-2022, after the expiration date i.e on 02-Apr-2022.The BUD date was reported as 02-Apr-2022.  The vaccine was moved from the fridge on 08-Apr-2022.  It was reported that the vaccines were stored in the freezer and only removed as needed to thaw and then administered. The reporter doesn't have the information about the date the vial was 1st moved from the freezer to refrigerator. The vial was taken out at a time and thaw as they don't thaw enter box.  No treatment medication were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose was administered from a vial that had been opened for more than 12 h; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered from a vial that had been opened for more than 12 h) in a 73-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-May-2022 at 1:15 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022 at 1:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered from a vial that had been opened for more than 12 h). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose was administered from a vial that had been opened for more than 12 h) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2021 at 1:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date of 3/24/22, administartion date on 13-MAY-2021 13:50) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The vial  did not undergo any temperature excursions.  All vials were removed from freezer just prior to administration times.   This case was linked to MOD-2022-570980, MOD-2022-570985, MOD-2022-570968 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ODM2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Asthma and Sulfonamide allergy (Sulfa).    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 17-May-2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive rapid antigen test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. It was unknown that patient has taken any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient experienced renewed COVID symptoms and prolonged positive rapid antigen test (until Day 14) after completing 5 day course of PaxlovPfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider. The device date was reported as 18-May-2022.  COMPANY COMMENT:  This spontaneous case concerns a 70-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 1 month after fourth dose mRNA-1273 vaccine Patient was administered with RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19, after the treatment he was prolonged positive ( rapid antigen test) for covid-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 1 month after fourth dose mRNA-1273 vaccine Patient was administered with RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19, after the treatment he was prolonged positive ( rapid antigen test) for covid-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Illness, Immunisation reaction
Clinical narrative: chest tightness; breathlessness; Was sick; In the bed the whole day; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), DYSPNOEA (breathlessness), ILLNESS (Was sick) and IMMUNISATION REACTION (In the bed the whole day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Patient had no COVID plus test or diagnosis. He was tested periodically and he did not have any symptoms.  Concurrent medical conditions included Allergy to antibiotic (Tetracycline).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced CHEST DISCOMFORT (chest tightness), DYSPNOEA (breathlessness), ILLNESS (Was sick) and IMMUNISATION REACTION (In the bed the whole day). In January 2021, ILLNESS (Was sick) and IMMUNISATION REACTION (In the bed the whole day) had resolved. At the time of the report, CHEST DISCOMFORT (chest tightness) and DYSPNOEA (breathlessness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. It was reported that patient thought he was scheduled to get the stress test on 25-Oct-2021. They found out that there was blockage of greater than 70 percent in 5 areas of his heart but he was told that there was no heart damage and only the blood vessels were affected. So they advised him to see a doctor right away and he was already scheduled for his 1st booster dose on 26-Oct-2021. He does not think that this was related to the vaccine. Patient medical history related to mentioned AE and both acute and chronic illness at the time of vaccination.  Cardiac related signs and symptoms: Chest pain/pressure/discomfort/angina pectoris: yes, Dyspnea/shortness of breath/pain with breathing: yes. Symptoms were still ongoing even after quadruple bypass.   This case was linked to MOD-2022-571226, MOD-2022-571162, MOD-2022-571165 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Patient received the second dose beyond the 25-35 days of time interval after first dose; a little soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose beyond the 25-35 days of time interval after first dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) for COVID-19 vaccination.     There was no history of COVID-19 infection reported. There was no history of Myocarditis/pericarditis reported. Patient was not tested or diagnose for Covid-19 as patient was tested periodically and did not had any symptoms.  Concurrent medical conditions included Allergy to antibiotic (Allergy to Tetracycline).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose beyond the 25-35 days of time interval after first dose). In March 2021, the patient experienced PAIN IN EXTREMITY (a little soreness in the arm). At the time of the report, PAIN IN EXTREMITY (a little soreness in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose beyond the 25-35 days of time interval after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2022-571226, MOD-2022-571142, MOD-2022-571165 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal tenderness, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: He lost 11 lbs; muscle pain; fatigue; nauseous; The strange taste in his mouth; abdomen area is also tender to touch; he started having (horrific) diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (he started having (horrific) diarrhea), WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue) and NAUSEA (nauseous) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 015M20A, 038A21A and 959904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tetracycline).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced DIARRHOEA (he started having (horrific) diarrhea). On an unknown date, the patient experienced WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue), NAUSEA (nauseous), TASTE DISORDER (The strange taste in his mouth) and ABDOMINAL TENDERNESS (abdomen area is also tender to touch). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 16-May-2022, DIARRHOEA (he started having (horrific) diarrhea) had resolved. At the time of the report, WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue), NAUSEA (nauseous) and ABDOMINAL TENDERNESS (abdomen area is also tender to touch) outcome was unknown and TASTE DISORDER (The strange taste in his mouth) had not resolved.            No concomitant medications was reported.   This case was linked to MOD-2022-571226, MOD-2022-571142, MOD-2022-571162 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Weight decreased
Clinical narrative: He lost 11 lbs; muscle pain; fatigue; nauseous; The strange taste in his mouth; abdomen area is also tender to touch; he started having (horrific) diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (he started having (horrific) diarrhea), WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue) and NAUSEA (nauseous) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 015M20A, 038A21A and 959904) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tetracycline).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced DIARRHOEA (he started having (horrific) diarrhea). On an unknown date, the patient experienced WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue), NAUSEA (nauseous), TASTE DISORDER (The strange taste in his mouth) and ABDOMINAL TENDERNESS (abdomen area is also tender to touch). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 16-May-2022, DIARRHOEA (he started having (horrific) diarrhea) had resolved. At the time of the report, WEIGHT DECREASED (He lost 11 lbs), MYALGIA (muscle pain), FATIGUE (fatigue), NAUSEA (nauseous) and ABDOMINAL TENDERNESS (abdomen area is also tender to touch) outcome was unknown and TASTE DISORDER (The strange taste in his mouth) had not resolved.            No concomitant medications was reported.   This case was linked to MOD-2022-571226, MOD-2022-571142, MOD-2022-571162 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive antigen test 1 week after finishing full course of Paxlovid.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Positive antigen test 1 week after finishing full course of Paxlovid.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Concurrent medical conditions included Allergy.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 17-May-2022, the patient experienced COVID-19 (Positive antigen test 1 week after finishing full course of Paxlovid.). At the time of the report, COVID-19 (Positive antigen test 1 week after finishing full course of Paxlovid.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  On 17-May-2022: patient experienced return of cold-like symptoms (no fever) and positive antigen test 1 week after finishing full course of Paxlovid.  No treatment information provided.  Device date reported as 18-May-2022. COMPANY COMMENT: This is an spontaneous case concerning an 70-years-old male patient with  medical history of PAXLOVID on May, 7-2022 for 5 days who experienced the unexpected AESI event of COVID-19 unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 70-years-old male patient with  medical history of PAXLOVID on May, 7-2022 for 5 days who experienced the unexpected AESI event of COVID-19 unknown days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 39.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: symptoms grew much worse again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (symptoms grew much worse again) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (Sulfa drugs).   On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 13-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (symptoms grew much worse again). At the time of the report, COVID-19 (symptoms grew much worse again) was resolving. Not Provided          No concomitant medications were reported  Patient did not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Device date was reported as 18-May-2022  After a few days of improved symptoms after finishing the Paxlovid course, patient's symptoms grew much worse again about 9-10 days later. COMPANY COMMENT: This is an spontaneous case concerning an 39-years-old male patient with  medical history of PAXLOVID on 29-Apr-2022 who experienced the unexpected AESI event of COVID-19 180 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 39-years-old male patient with  medical history of PAXLOVID on 29-Apr-2022 who experienced the unexpected AESI event of COVID-19 180 days after  receiving the  3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Rhinorrhoea
Clinical narrative: Congestion Runny nose Fatigue; Congestion Runny nose Fatigue; Congestion Runny nose Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion Runny nose Fatigue), RHINORRHOEA (Congestion Runny nose Fatigue) and FATIGUE (Congestion Runny nose Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057MZ1A, 071FZ1A, 044BZ1A and 007BZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Pencillin. Past adverse reactions to the above products included Allergy with Pencillin. Concurrent medical conditions included Cardiovascular disease, unspecified.   On 24-Mar-2021 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021 at 4:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022 at 2:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 17-May-2022 at 1:00 PM, the patient experienced NASAL CONGESTION (Congestion Runny nose Fatigue), RHINORRHOEA (Congestion Runny nose Fatigue) and FATIGUE (Congestion Runny nose Fatigue). At the time of the report, NASAL CONGESTION (Congestion Runny nose Fatigue), RHINORRHOEA (Congestion Runny nose Fatigue) and FATIGUE (Congestion Runny nose Fatigue) had not resolved. Not Provided          The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  The patient was not hospitalized and not received treatment.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Chest discomfort, Cough, Dyspnoea, Gait disturbance
Clinical narrative: so sick; breathing difficulties having to take a nebulizer; trouble breathing with a bad cough; hasn't been able to work or get out of the house; can hardly walk; it's really kicking her butt; Her bones ache; chest congestion; fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house) and GAIT DISTURBANCE (can hardly walk) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 026D21A, 027A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no COVID positive test or diagnosis.  Concurrent medical conditions included Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever). At the time of the report, ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever) had not resolved.            No concomitant medication was reported. It was reported that the patient did not receive any other vaccine 1 month prior to Moderna vaccine. Treatment included nebulizer for breathing difficulties.   This case was linked to MOD-2022-571279 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Musculoskeletal pain, Pyrexia
Clinical narrative: so sick; breathing difficulties having to take a nebulizer; trouble breathing with a bad cough; hasn't been able to work or get out of the house; can hardly walk; it's really kicking her butt; Her bones ache; chest congestion; fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house) and GAIT DISTURBANCE (can hardly walk) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 026D21A, 027A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no COVID positive test or diagnosis.  Concurrent medical conditions included Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever). At the time of the report, ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever) had not resolved.            No concomitant medication was reported. It was reported that the patient did not receive any other vaccine 1 month prior to Moderna vaccine. Treatment included nebulizer for breathing difficulties.   This case was linked to MOD-2022-571279 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: so sick; breathing difficulties having to take a nebulizer; trouble breathing with a bad cough; hasn't been able to work or get out of the house; can hardly walk; it's really kicking her butt; Her bones ache; chest congestion; fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house) and GAIT DISTURBANCE (can hardly walk) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 026D21A, 027A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no COVID positive test or diagnosis.  Concurrent medical conditions included Seasonal allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever). At the time of the report, ILLNESS (so sick), DYSPNOEA (breathing difficulties having to take a nebulizer), COUGH (trouble breathing with a bad cough), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hasn't been able to work or get out of the house), GAIT DISTURBANCE (can hardly walk), MUSCULOSKELETAL PAIN (it's really kicking her butt), BONE PAIN (Her bones ache), CHEST DISCOMFORT (chest congestion) and PYREXIA (fever) had not resolved.            No concomitant medication was reported. It was reported that the patient did not receive any other vaccine 1 month prior to Moderna vaccine. Treatment included nebulizer for breathing difficulties.   This case was linked to MOD-2022-571279 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Chest discomfort, Cough, Dyspnoea, Gait disturbance
Clinical narrative: The second shot hit her hard but only lasted a couple days; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Seasonal allergies; Recent change in status: patient did not experience any at the time of reporting).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days). At the time of the report, IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's height was reported as 5 feet. Patient did not ever tested or diagnosed with COVID. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were reported. Patient did not seek any medical care. Patient experienced similar event in the past. No treatment details were reported.   This case was linked to MOD-2022-571261 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Musculoskeletal pain, Pyrexia
Clinical narrative: The second shot hit her hard but only lasted a couple days; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Seasonal allergies; Recent change in status: patient did not experience any at the time of reporting).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days). At the time of the report, IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's height was reported as 5 feet. Patient did not ever tested or diagnosed with COVID. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were reported. Patient did not seek any medical care. Patient experienced similar event in the past. No treatment details were reported.   This case was linked to MOD-2022-571261 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: The second shot hit her hard but only lasted a couple days; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Seasonal allergies; Recent change in status: patient did not experience any at the time of reporting).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days). At the time of the report, IMMUNISATION REACTION (The second shot hit her hard but only lasted a couple days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's height was reported as 5 feet. Patient did not ever tested or diagnosed with COVID. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were reported. Patient did not seek any medical care. Patient experienced similar event in the past. No treatment details were reported.   This case was linked to MOD-2022-571261 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Ulcerative colitis and Drug allergy (Name of the drug was reported as Mo).   On 16-Nov-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative). On 12-May-2022, COVID-19 (Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine  No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Company comment: This spontaneous case concerns a patient of a 36-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 6 months after an unspecified dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced milder Covid after treatment with Paxlovid (ritonavir) and tested positive having previously had a negative test. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of a 36-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 6 months after an unspecified dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced milder Covid after treatment with Paxlovid (ritonavir) and tested positive having previously had a negative test. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: Pain; Flu like symptoms; Headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and FATIGUE (fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ulcerative colitis.    Concurrent medical conditions included Psoriatic arthritis and Ulcerative colitis (moderate to severe).   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and FATIGUE (fatigue). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication were reported.  It was not known weather the patient was enrolled in covid-19 vaccine trail.  The Daily dose of Humira was reported as Citrate Free.   No treatment medication were reported.