chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Hypersomnia, SARS-CoV-2 test
Clinical narrative: knocked out and just slept for the next two days; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (knocked out and just slept for the next two days) and COVID-19 (covid-19) in a 5-decade-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Fever in January 2020, Chills in January 2020, Cough in January 2020, Ache in January 2020, Mucus discharge (required antibiotic to clear up) in January 2020 and Feeling unwell (very sudden, mysterious something) in January 2020.   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 HYPERSOMNIA (knocked out and just slept for the next two days) and COVID-19 (covid-19). At the time of the report, HYPERSOMNIA (knocked out and just slept for the next two days) had resolved and COVID-19 (covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Company comment: This is a spontaneous case concerning a 5-decade-old patient of an unknown gender with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient experienced mild symptoms without hospitalization. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Concomitant product use was not provided by the reporter.  It was reported that patient was doubly vaccinated over 6 months ago, but not boosted.  Patient had tons of snot for the first two days and a cough caused by that. Ptaient was knocked out and just slept for the next two days, with a headache and body aches then just tired the day after.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a 5-decade-old patient of an unknown gender with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test was performed with positive result. Patient experienced mild symptoms without hospitalization. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Lymphadenopathy, Musculoskeletal discomfort, Pain, Pyrexia
Clinical narrative: Joint range of motion decreased cervical spine; Pain; Swollen lymph nodes; Feverish; could not move the neck; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased cervical spine), PAIN (Pain), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Feverish) and MUSCULOSKELETAL DISCOMFORT (could not move the neck) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Chronic disease.    Concurrent medical conditions included Asthma chronic (almost died from), Non-smoker and Abstains from alcohol.   In December 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased cervical spine), PAIN (Pain), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Feverish) and MUSCULOSKELETAL DISCOMFORT (could not move the neck). In April 2021, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased cervical spine), PAIN (Pain), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Feverish) and MUSCULOSKELETAL DISCOMFORT (could not move the neck) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Action taken of co-suspect HUMIRA40MG/0.4ML(ADALIMUMAB)  was unknown with respect to all the events.  Treatment information was not provided.  The reporter's causality for the events of Joint range of motion decreased cervical spine, swelling of lymph nodes, could not move the neck, feverish, fever and pain with HUMIRA40MG/0.4ML(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-626070 (Patient Link).   Reporter did not allow further contact
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeding disorder, Lethargy, Malabsorption
Clinical narrative: not able to eat; Lethargic; nutrients not absorbing in body; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (not able to eat), LETHARGY (Lethargic), MALABSORPTION (nutrients not absorbing in body) and ABDOMINAL PAIN UPPER (Stomach pain) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 028A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Asthma chronic (almost died from), Non-smoker and Abstains from alcohol.   In December 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. In August 2021, the patient experienced FEEDING DISORDER (not able to eat), LETHARGY (Lethargic), MALABSORPTION (nutrients not absorbing in body) and ABDOMINAL PAIN UPPER (Stomach pain). In August 2021, FEEDING DISORDER (not able to eat), LETHARGY (Lethargic), MALABSORPTION (nutrients not absorbing in body) and ABDOMINAL PAIN UPPER (Stomach pain) had resolved.            Concomitant product use was not provided by the reporter.  Action taken of ADALIMUMAB (HUMIRA) was reported as unknown.  Treatment information was not provided.  The reporter's causality for the events of not feeling well, not able to eat, lethargic, nutrients not absorbing in body and stomach pain with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-625949, MOD-2022-626091 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Macular degeneration
Clinical narrative: Macular degeneration; reaction to COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MACULAR DEGENERATION (Macular degeneration) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2021, received third 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) 1 dosage form. On an unknown date, the patient experienced MACULAR DEGENERATION (Macular degeneration) (seriousness criteria hospitalization and medically significant) and IMMUNISATION REACTION (reaction to COVID-19 vaccine). At the time of the report, MACULAR DEGENERATION (Macular degeneration) and IMMUNISATION REACTION (reaction to COVID-19 vaccine) outcome was unknown.            No concomitant medication information was reported.  The patient was missed a dose of humira therapy due to being hospitalized. She had Macular degeneration and reaction to COVID-19 vaccine.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Company Comment: This is a spontaneous case concerning an elderly patient of unknown gender with no relevant medical history, who was hospitalized due to the unexpected, serious (medically significant) event of Macular degeneration, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly patient of unknown gender with no relevant medical history, who was hospitalized due to the unexpected, serious (medically significant) event of Macular degeneration, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Inflammation, Uveitis
Clinical narrative: Possible uveitis flare up; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Possible uveitis flare up) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Panuveitis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE) and Panuveitis (NON-INFECTIOUS INTERMEDIATE POSTERIOR AND PANUVEITIS).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced UVEITIS (Possible uveitis flare up) (seriousness criterion medically significant) and INFLAMMATION (Inflammation). At the time of the report, UVEITIS (Possible uveitis flare up) outcome was unknown and INFLAMMATION (Inflammation) had not resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. No treatment information mentioned.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an elderly female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as possible uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event Uveitis was unknown. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for possible uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly female patient with relevant medical condition of Non-infectious intermediate, posterior and panuveitis, who experienced the unexpected serious (medically significant) event of Uveitis, reported as possible uveitis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event Uveitis was unknown. The medical condition of Non-infectious intermediate, posterior, and panuveitis remains as a confounder for possible uveitis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Fatigue, Feeling abnormal, Hyperglycaemia, Weight
Clinical narrative: I feel very bad; High blood sugar always; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I feel very bad), HYPERGLYCAEMIA (High blood sugar always) and FATIGUE (extreme fatigue) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    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 FEELING ABNORMAL (I feel very bad), HYPERGLYCAEMIA (High blood sugar always) and FATIGUE (extreme fatigue). At the time of the report, FEELING ABNORMAL (I feel very bad), HYPERGLYCAEMIA (High blood sugar always) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: High blood sugar always. On an unknown date, Weight: lost a lot of weight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Uveitis
Clinical narrative: Non-infectious intermediate posterior and panuveitis; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Non-infectious intermediate posterior and panuveitis) in a 63-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concurrent medical conditions included Panuveitis. Concomitant products included PREDNISONE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Oct-2021, received third 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) at an unspecified dose. On an unknown date, the patient experienced UVEITIS (Non-infectious intermediate posterior and panuveitis) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm). At the time of the report, UVEITIS (Non-infectious intermediate posterior and panuveitis) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No treatment information mentioned.  Patient experienced pan uveitis flare up and sore arm on an unknown date.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 63-year-old female patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with medical history of uveitis, who experienced the unexpected, serious (medically significant) event of uveitis an unknown time after a dose of mRNA-1273. The event was described as a flare up. Uveitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 23.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Nausea, Pain in extremity
Clinical narrative: Chills; Fatigue; Nausea; Fever; Pain in arm; 1st dose 09-FEB-2021 2nd dose 19-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third 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) 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021). On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.            No concomitant medication was reported by reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was unsuccessful.  Co-suspect Humira was given by Solution for injection in pre-filled pen.   The reporter's causality for the event(s) of CHILLS, FATIGUE, NAUSEA, FEVER and ARM PAIN was not provided.  No treatment medication was reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 23.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Chills; Fatigue; Nausea; Fever; Pain in arm; 1st dose 09-FEB-2021 2nd dose 19-MAR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third 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) 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021). On an unknown date, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 09-FEB-2021 2nd dose 19-MAR-2021), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown.            No concomitant medication was reported by reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was unsuccessful.  Co-suspect Humira was given by Solution for injection in pre-filled pen.   The reporter's causality for the event(s) of CHILLS, FATIGUE, NAUSEA, FEVER and ARM PAIN was not provided.  No treatment medication was reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Pyrexia
Clinical narrative: FEVER; ANKYLOSING SPONDYLITIS FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2022, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (FEVER). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS FLARE UP) had not resolved and PYREXIA (FEVER) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case concerning an adult male patient with Ankylosing spondylitis, who experienced the serious (medically significant) unexpected AESI Ankylosing spondylitis flare up, on an unknown date after receiving an unspecified dose of mRNA-1273. Pyrexia was also reported as a non-serious event. Clinical findings, diagnostic tests and treatment details were not provided. Patient´s medical condition remains a contributor factor for the event. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult male patient with Ankylosing spondylitis, who experienced the serious (medically significant) unexpected AESI Ankylosing spondylitis flare up, on an unknown date after receiving an unspecified dose of mRNA-1273. Pyrexia was also reported as a non-serious event. Clinical findings, diagnostic tests and treatment details were not provided. Patient´s medical condition remains a contributor factor for the event. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021) and NO ADVERSE EVENT (No Adverse Event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe). Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 02-Feb-2021 and second dose of vaccine administered on 26-Feb-2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of moderna vaccine given one in once. Humira was citrate free.  No treatment information was provided.   This case was linked to MOD-2022-624399 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: First dose of vaccine administered on 12-Oct-2021 and second dose of vaccine administered on 27-Oct-2021; FEVERS AFTER EACH VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVERS AFTER EACH VACCINE) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 12-Oct-2021 and second dose of vaccine administered on 27-Oct-2021) in a 64-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) solution for injection for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult) and Ulcerative colitis (Moderate to severe).   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-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) at an unspecified dose. On 12-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (FEVERS AFTER EACH VACCINE). On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 12-Oct-2021 and second dose of vaccine administered on 27-Oct-2021). In January 2022, PYREXIA (FEVERS AFTER EACH VACCINE) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of vaccine administered on 12-Oct-2021 and second dose of vaccine administered on 27-Oct-2021) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of moderna vaccine given one in once.   No treatment information was provided.  The reporter's causality for the event of fevers after each vaccine with Humira (Adalimumab) was not provided.   This case was linked to MOD-2022-624407 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 61-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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the event of fever was not reported for cosuspect humira. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621576 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Psoriasis
Clinical narrative: Plaque psoriasis flare up/ Occasional spots on buttocks; Moderna vaccine caused brain fog; Moderna vaccine caused fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis flare up/ Occasional spots on buttocks), FEELING ABNORMAL (Moderna vaccine caused brain fog) and FATIGUE (Moderna vaccine caused fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis flare up/ Occasional spots on buttocks), FEELING ABNORMAL (Moderna vaccine caused brain fog) and FATIGUE (Moderna vaccine caused fatigue). At the time of the report, PSORIASIS (Plaque psoriasis flare up/ Occasional spots on buttocks) had not resolved and FEELING ABNORMAL (Moderna vaccine caused brain fog) and FATIGUE (Moderna vaccine caused fatigue) outcome was unknown.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  The reporter causality for the events of Moderna vaccine caused fatigue, Moderna vaccine caused brain fog with co-suspect Skyrizi was no reasonable possibility. The reporter causality for the event plaque psoriasis flare up/ occasional spots on buttocks with co-suspect Skyrizi was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-619486 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Mild fever; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Mild fever) and VACCINATION SITE PAIN (Sore arm) in a 30-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Mild fever) and VACCINATION SITE PAIN (Sore arm). At the time of the report, PYREXIA (Mild fever) and VACCINATION SITE PAIN (Sore arm) had resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  The reporter's causality for the events second vaccine caused sore arm and fever was not provided with Skyrizi.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621007.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Pain, Psoriasis, Stress
Clinical narrative: Psoriasis flare-up/Chronic plaque psoriasis flare up; Stress; Vaccination site lump/Lump at injection site; Vaccination site swelling/Swollen over a week; Pain; Discomfort; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up), STRESS (Stress), PAIN (Pain), DISCOMFORT (Discomfort) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE MASS (Vaccination site lump/Lump at injection site). In 2021, the patient experienced PAIN (Pain), DISCOMFORT (Discomfort), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling/Swollen over a week). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up) and STRESS (Stress). At the time of the report, PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up) and STRESS (Stress) had not resolved and PAIN (Pain), DISCOMFORT (Discomfort), FATIGUE (Fatigue), VACCINATION SITE MASS (Vaccination site lump/Lump at injection site) and VACCINATION SITE SWELLING (Vaccination site swelling/Swollen over a week) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. The patient had plaques on legs, stomach and back of scalp. His left ankle affected the most of legs. His stress and cold weather caused chronic plaque psoriasis flare ups. He had scaling on scalp close to left ear and left ankle. He had Moderna vaccine and first dose caused fatigue, swelling in arm with hot feeling and inflammation. His second dose caused a lump at injection site, the size of large egg that was swollen over a week. The second and booster dose caused pain and discomfort with fatigue.   This case was linked to MOD-2022-630475, MOD-2022-619152 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: Psoriasis flare-up/Chronic plaque psoriasis flare up; Stress; Vaccination site lump/Lump at injection site; Vaccination site swelling/Swollen over a week; Pain; Discomfort; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up), STRESS (Stress), PAIN (Pain), DISCOMFORT (Discomfort) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced VACCINATION SITE MASS (Vaccination site lump/Lump at injection site). In 2021, the patient experienced PAIN (Pain), DISCOMFORT (Discomfort), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Vaccination site swelling/Swollen over a week). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up) and STRESS (Stress). At the time of the report, PSORIASIS (Psoriasis flare-up/Chronic plaque psoriasis flare up) and STRESS (Stress) had not resolved and PAIN (Pain), DISCOMFORT (Discomfort), FATIGUE (Fatigue), VACCINATION SITE MASS (Vaccination site lump/Lump at injection site) and VACCINATION SITE SWELLING (Vaccination site swelling/Swollen over a week) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided. No treatment medication was provided. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. The patient had plaques on legs, stomach and back of scalp. His left ankle affected the most of legs. His stress and cold weather caused chronic plaque psoriasis flare ups. He had scaling on scalp close to left ear and left ankle. He had Moderna vaccine and first dose caused fatigue, swelling in arm with hot feeling and inflammation. His second dose caused a lump at injection site, the size of large egg that was swollen over a week. The second and booster dose caused pain and discomfort with fatigue.   This case was linked to MOD-2022-630475, MOD-2022-619152 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; 01-OCT-2021-Dose 1,19-NOV-2021-Dose 2; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01-OCT-2021-Dose 1,19-NOV-2021-Dose 2) and NO ADVERSE EVENT (No Adverse Event) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-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 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01-OCT-2021-Dose 1,19-NOV-2021-Dose 2). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01-OCT-2021-Dose 1,19-NOV-2021-Dose 2) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621582 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Nasopharyngitis, Pyrexia
Clinical narrative: Increased TSH level; Colds; high fever; This spontaneous case was reported by a patient and describes the occurrence of BLOOD THYROID STIMULATING HORMONE INCREASED (Increased TSH level), NASOPHARYNGITIS (Colds) and PYREXIA (high fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013120A and 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    No Medical History information was reported.   In 2004, the patient started LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) 125 mcg (125 mcg,1 in 1 D). In 2005, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 112 mcg (112 mcg,1 in 1 D). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 88 mcg for three days and 100 mcg for four days (88 mcg,1 in 1 D). In January 2022, LEVOTHYROXINE SODIUM (SYNTHROID) (Oral) dosage was changed to 100 mcg (100 mcg,1 in 1 D). In March 2021, the patient experienced PYREXIA (high fever). In September 2021, the patient experienced BLOOD THYROID STIMULATING HORMONE INCREASED (Increased TSH level) and NASOPHARYNGITIS (Colds). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In March 2021, PYREXIA (high fever) had resolved. In September 2021, NASOPHARYNGITIS (Colds) had resolved. At the time of the report, BLOOD THYROID STIMULATING HORMONE INCREASED (Increased TSH level) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Blood thyroid stimulating hormone: Increased.         No concomitant medications were reported.  The reporter's causality for the event of increased TSH level with Synthroid (levothyroxine) was a reasonable possibility. The reporter's causality for the events of high fever onset in March 2021 and colds with Synthroid (levothyroxine) was no reasonable possibility.  In Feb-2022, Blood thyroid stimulating hormone: results not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-630557, MOD-2022-621238 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Accident, Injury
Clinical narrative: Accident; Injury; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT (Accident) and INJURY (Injury) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In June 2021, the patient experienced ACCIDENT (Accident) and INJURY (Injury). At the time of the report, ACCIDENT (Accident) was resolving and INJURY (Injury) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  In 2021, the patient had accident and had to learn to walk again from injuries. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623063, MOD-2022-631095 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Live Follow Up contains no new information.