chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Injection site erythema, Injection site pain, Injection site swelling, Psoriasis
Clinical narrative: Vertigo; Psoriasis flare up; COVID-19; Swelling arm at injection site; Red line arm at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site) and INJECTION SITE ERYTHEMA (Red line arm at injection site) in an adult 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   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 ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site), INJECTION SITE ERYTHEMA (Red line arm at injection site) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site), INJECTION SITE ERYTHEMA (Red line arm at injection site) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported.  On unknown dates, the patient experienced COVID-19, psoriasis flare up, vertigo, swelling arm at injection site, red line arm at injection site and pain at injection site.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of COVID-19, psoriasis flare up, vertigo, swelling arm at injection site, red line arm at injection site and pain at injection site was not provided for Humira.  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: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: Vertigo; Psoriasis flare up; COVID-19; Swelling arm at injection site; Red line arm at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site) and INJECTION SITE ERYTHEMA (Red line arm at injection site) in an adult 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   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 ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site), INJECTION SITE ERYTHEMA (Red line arm at injection site) and INJECTION SITE PAIN (Pain at injection site). At the time of the report, VERTIGO (Vertigo), PSORIASIS (Psoriasis flare up), COVID-19 (COVID-19), INJECTION SITE SWELLING (Swelling arm at injection site), INJECTION SITE ERYTHEMA (Red line arm at injection site) and INJECTION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported. No treatment medication was reported.  On unknown dates, the patient experienced COVID-19, psoriasis flare up, vertigo, swelling arm at injection site, red line arm at injection site and pain at injection site.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of COVID-19, psoriasis flare up, vertigo, swelling arm at injection site, red line arm at injection site and pain at injection site was not provided for Humira.  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: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Illness
Clinical narrative: hair loss/loosing hair in front and top of forehead; sick after second dose and booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick after second dose and booster shot) and ALOPECIA (hair loss/loosing hair in front and top of forehead) in a 56-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 Crohn's disease.    No Medical History information was reported.   On 02-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 02-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) at an unspecified dose. In March 2021, the patient experienced ILLNESS (sick after second dose and booster shot). On an unknown date, the patient experienced ALOPECIA (hair loss/loosing hair in front and top of forehead). At the time of the report, ILLNESS (sick after second dose and booster shot) had resolved and ALOPECIA (hair loss/loosing hair in front and top of forehead) had not resolved.      No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events of sick after second dose and booster shot with Humira(adalimumab) was no reasonable possibility. The reporter causality for the events of hair loss/loosing hair in front and top of forehead with Humira(adalimumab) was a reasonable possibility.  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.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Attention deficit hyperactivity disorder, Fatigue, Vaccination site pain
Clinical narrative: Attention deficit-hyperactivity disorder; Anxiety; Vaccination site pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder), ANXIETY (Anxiety), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness) in a 22-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.    No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled syringe. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Tiredness). On an unknown date, the patient experienced ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety). The patient was treated with SERTRALINE HYDROCHLORIDE (ZOLOFT) at an unspecified dose and frequency. In April 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 23-Apr-2021, FATIGUE (Tiredness) had resolved. At the time of the report, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit-hyperactivity disorder) and ANXIETY (Anxiety) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported.  On unknown date, the patient experienced attention deficit hyperactivity disorder and anxiety. On 21 Apr 2021, the patient experienced tired and arm hurt after covid vaccination. On 23 Apr 2021, the tired resolved. In April 2021, the arm hurt after covid vaccination resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB):The reporter's causality for the events of attention deficit hyperactivity disorder, arm hurt after covid vaccination, tired, anxiety 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.   This case was linked to MOD-2022-624462 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain
Clinical narrative: A little achy getting the booster shot; Not feeling well from the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little achy getting the booster shot) and IMMUNISATION REACTION (Not feeling well from the booster shot) in a 57-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 Psoriatic arthritis and Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 06-May-2021 to an unknown date for COVID-19 vaccination. On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Jan-2022, the patient experienced PAIN (A little achy getting the booster shot). In January 2022, the patient experienced IMMUNISATION REACTION (Not feeling well from the booster shot). At the time of the report, PAIN (A little achy getting the booster shot) and IMMUNISATION REACTION (Not feeling well from the booster shot) was resolving.     No treatment medication information 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021) in a 69-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 Plaque psoriasis.    No Medical History information was reported.   On 04-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 08-Apr-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) citrate free. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021). In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 01-APR-2021, third dose taken on 08-APR-2021) outcome was unknown.            No concomitant medications were reported.  In 2021, the patient experienced sore arm after covid 19 injection. On an unknown date, sore arm after covid 19 injection resolved. Moderna was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication 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.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Memory impairment
Clinical narrative: Dose 2 administered in 17 days after 1st dose; Memory impairment; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impairment) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered in 17 days after 1st dose) in a 61-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) solution for injection for Ulcerative colitis.    The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Ulcerative colitis.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, received first 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. In 2021, the patient experienced MEMORY IMPAIRMENT (Memory impairment). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered in 17 days after 1st dose). At the time of the report, MEMORY IMPAIRMENT (Memory impairment) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 administered in 17 days after 1st dose) outcome was unknown.            Concomitant products were not provided. Treatment medication were not 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.  On an unknown date in March 2021, the patient experienced COVID-19. It was unknown if patient was enrolled in COVID-19 Vaccine Trial. The reporter's causality for the event (s) a. of MEMORY FOG was not provided. The reporter's causality for the event of COVID-19 with HUMIRA (ADALIMUMAB) was no reasonable possibility.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE UP; COVID-19; AFTER THE FIRST MODERNA VACCINATION EXPERIENCED FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    There was no reported medical history.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) (seriousness criterion medically significant), COVID-19 (COVID-19) and FATIGUE (AFTER THE FIRST MODERNA VACCINATION EXPERIENCED FATIGUE). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP) and COVID-19 (COVID-19) was resolving and FATIGUE (AFTER THE FIRST MODERNA VACCINATION EXPERIENCED FATIGUE) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) 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  Concomitant medications were not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial. Treatment medications were not reported.   The reporter's causality for the event(s) of after the first Moderna vaccination experienced fatigue, covid 19 and rheumatoid arthritis flare up with Humira(adalimumab) was no reasonable possibility.  Company comment: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) and non-serious COVID-19 (AESI) an unknown time after a dose of mRNA-1273. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) and non-serious COVID-19 (AESI) an unknown time after a dose of mRNA-1273. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: heavy hemorrhaging; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (heavy hemorrhaging) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (heavy hemorrhaging) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (heavy hemorrhaging) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the 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  Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhage after receiving a dose mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of the event were not provided. Clinical course and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Non-significant follow Up; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhage after receiving a dose mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of the event were not provided. Clinical course and treatment details were not reported. The outcome of event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Malaise, Pain
Clinical narrative: got sick after each one of her covid vaccines; body aches; not feeling well; dose1 12-OCT-2021/ dose-2  27-OCT-2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after each one of her covid vaccines), PAIN (body aches), MALAISE (not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose1 12-OCT-2021/ dose-2  27-OCT-2021) in a 65-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 Ulcerative colitis and Crohn's disease.    Previously administered products included for Fibromyalgia: Cymbalta; for Depression: Cymbalta. Past adverse reactions to the above products included No adverse event with Cymbalta and Cymbalta. Concurrent medical conditions included Ulcerative colitis and Crohn's disease.   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 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose1 12-OCT-2021/ dose-2  27-OCT-2021). On an unknown date, the patient experienced ILLNESS (got sick after each one of her covid vaccines), PAIN (body aches) and MALAISE (not feeling well). At the time of the report, ILLNESS (got sick after each one of her covid vaccines) was resolving and PAIN (body aches), MALAISE (not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose1 12-OCT-2021/ dose-2  27-OCT-2021) outcome was unknown.            The patient got sick after each one of her covid vaccines also had body aches and she was not feeling well.   No Concomitant 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-2022-623271, MOD-2022-624654 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2022: Significant live follow-up appended-Update in medical history received
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) in a 65-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 Psoriatic arthritis. Concurrent medical conditions included Psoriatic arthritis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled syringe. In 2021, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis flare up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. No treatment information mentioned. In 2021, patient experienced a psoriatic arthritis flare up. Reporters causality of events with Humira 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. Company Comment: This is a spontaneous case, reported by a consumer, concerning a 65-year-old male patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, reported as psoriatic arthritis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The medical condition of Psoriatic arthritis remains as a confounder for the event. 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 a 65-year-old male patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Psoriatic arthropathy, reported as psoriatic arthritis flare up, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the vaccination date nor the exact event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The medical condition of Psoriatic arthritis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Have deep calf pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Have deep calf pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Have deep calf pain). At the time of the report, PAIN IN EXTREMITY (Have deep calf pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Relevant concomitant medications were not reported.  It was reported that the patient had deep calf pain and it has been 5 months since the patient got the first dose of Moderna COVID-19 vaccine.  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.   This case was linked to MOD-2022-624231 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Hypersensitivity
Clinical narrative: UNSPECIFIED BOWEL ISSUES; ALLERGIES GETTING WORSE; This spontaneous case was reported by a health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (UNSPECIFIED BOWEL ISSUES) and HYPERSENSITIVITY (ALLERGIES GETTING WORSE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included SILDENAFIL CITRATE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 200 microgram twice a day. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (UNSPECIFIED BOWEL ISSUES) and HYPERSENSITIVITY (ALLERGIES GETTING WORSE). At the time of the report, GASTROINTESTINAL DISORDER (UNSPECIFIED BOWEL ISSUES) and HYPERSENSITIVITY (ALLERGIES GETTING WORSE) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rashes and hives with the booster dose; Rashes and hives with the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes and hives with the booster dose) and URTICARIA (Rashes and hives with the booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 05-Jan-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. 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 RASH (Rashes and hives with the booster dose) and URTICARIA (Rashes and hives with the booster dose). At the time of the report, RASH (Rashes and hives with the booster dose) and URTICARIA (Rashes and hives with the booster dose) outcome was unknown.            Concomitant medication was not provided.  It was stated that one twin was fine and other twin had rashes two days after the vaccine. Stated that on 07 Jan or 08 Jan 2022 that he had rashes on his body and tummy. Stated that he got itchy legs and had rashes in middle of night and applied coconut oil. Stated that he was itchy because of the weather. Stated that he was in the cold and snow and two the three hours later his son showed him some rashes and he thought maybe the temperature could be causing the itchiness. Stated that later in the night that his hands and legs were itchy and it went away. Stated that there were patches which were itchy also. Stated that the rash on his body subsided in 8-10 hours. Stated that the rash on his legs subsided in a couple of hours. Stated that the rash on his tummy and back started first and subsided the same day. Stated that he had Covid testing before the vaccine on 29-Dec-2021 or 30-Dec-2021. Later clarified that it was Pfizer Pediatric Covid vaccine received by one of the twin.  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: F
Vaccine: COVID19
Symptoms: Crohn's disease, Haemorrhage
Clinical narrative: Microscopic blood found; Crohns disease flare up; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Microscopic blood found) and CROHN'S DISEASE (Crohns disease flare up) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HAEMORRHAGE (Microscopic blood found) (seriousness criterion medically significant) and CROHN'S DISEASE (Crohns disease flare up) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Microscopic blood found) and CROHN'S DISEASE (Crohns disease flare up) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient experienced a microscopic bleed and flare up of Crohn's disease.  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 an elderly female patient of unspecified aged with relevant medical history of Crohn's disease reported, who experienced the unexpected serious (medically significant) events of Crohn's disease (Crohn's aggravated) and Haemorrhage that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns an elderly female patient of unspecified aged with relevant medical history of Crohn's disease reported, who experienced the unexpected serious (medically significant) events of Crohn's disease (Crohn's aggravated) and Haemorrhage that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased, Hypertension, Rash
Clinical narrative: Blood pressures of 200 and 207; RASH; temperatures of about 102 and 102.3; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood pressures of 200 and 207), RASH (RASH) and BODY TEMPERATURE INCREASED (temperatures of about 102 and 102.3) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood pressures of 200 and 207), RASH (RASH) and BODY TEMPERATURE INCREASED (temperatures of about 102 and 102.3). At the time of the report, HYPERTENSION (Blood pressures of 200 and 207), RASH (RASH) and BODY TEMPERATURE INCREASED (temperatures of about 102 and 102.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Blood pressures of 200 and 207. On an unknown date, Body temperature: temperatures of about 102 and 102.3.         Relevant concomitant medications were not reported.  On an unknown date, patient had 2 shots of the Moderna COVID-19 vaccine and experienced rash, Blood pressures of 200 and 207 and temperatures of about 102 and 102.3.  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.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Bone pain, Drug hypersensitivity, Fatigue, Food allergy
Clinical narrative: Autoimmune disorder; Bone pain; Food allergy; Lung disorder; Lethargic; Fatigue; Penicillin allergy; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disorder) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and PENICILLIN NOS for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and PENICILLIN NOS (unknown route) at an unspecified dose. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disorder) (seriousness criterion medically significant), BONE PAIN (Bone pain), FOOD ALLERGY (Food allergy), LUNG DISORDER (Lung disorder), LETHARGY (Lethargic), FATIGUE (Fatigue) and DRUG HYPERSENSITIVITY (Penicillin allergy). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disorder), FOOD ALLERGY (Food allergy) and LUNG DISORDER (Lung disorder) had not resolved, BONE PAIN (Bone pain) outcome was unknown and LETHARGY (Lethargic), FATIGUE (Fatigue) and DRUG HYPERSENSITIVITY (Penicillin allergy) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and 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  Company Comment: This is a spontaneous case concerning an adult female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Autoimmune disorder, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Autoimmune disorder, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Lung disorder
Clinical narrative: Autoimmune disorder; Bone pain; Food allergy; Lung disorder; Lethargic; Fatigue; Penicillin allergy; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Autoimmune disorder) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and PENICILLIN NOS for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and PENICILLIN NOS (unknown route) at an unspecified dose. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune disorder) (seriousness criterion medically significant), BONE PAIN (Bone pain), FOOD ALLERGY (Food allergy), LUNG DISORDER (Lung disorder), LETHARGY (Lethargic), FATIGUE (Fatigue) and DRUG HYPERSENSITIVITY (Penicillin allergy). At the time of the report, AUTOIMMUNE DISORDER (Autoimmune disorder), FOOD ALLERGY (Food allergy) and LUNG DISORDER (Lung disorder) had not resolved, BONE PAIN (Bone pain) outcome was unknown and LETHARGY (Lethargic), FATIGUE (Fatigue) and DRUG HYPERSENSITIVITY (Penicillin allergy) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant and 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  Company Comment: This is a spontaneous case concerning an adult female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Autoimmune disorder, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning an adult female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Autoimmune disorder, after receiving the booster dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: she had a little problem; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (she had a little problem) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had a little problem). At the time of the report, IMMUNISATION REACTION (she had a little problem) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Patient's sister reported that on an unknown date, patient received Moderna COVID-19 vaccine and had a little problem.  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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, COVID-19, Chills, Hidradenitis, Illness
Clinical narrative: Sickness; COVID-19; Laryngitis; Cold; Loss of voice; Hidradenitis suppurativa; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), COVID-19 (COVID-19), LARYNGITIS (Laryngitis), NASOPHARYNGITIS (Cold) and APHONIA (Loss of voice) in an adult 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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-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 ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate free). On an unknown date, the patient experienced ILLNESS (Sickness), COVID-19 (COVID-19), LARYNGITIS (Laryngitis), NASOPHARYNGITIS (Cold), APHONIA (Loss of voice), HIDRADENITIS (Hidradenitis suppurativa), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ILLNESS (Sickness), COVID-19 (COVID-19) and HIDRADENITIS (Hidradenitis suppurativa) had resolved, LARYNGITIS (Laryngitis), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and NASOPHARYNGITIS (Cold) and APHONIA (Loss of voice) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Mycobacterium tuberculosis complex test: Result not provided.         No concomitant medications were reported. 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-2022-624365 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Significant Live follow-up appended included Medical history, Events were added.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Mycobacterium tuberculosis complex test, Nasopharyngitis, Pyrexia
Clinical narrative: Sickness; COVID-19; Laryngitis; Cold; Loss of voice; Hidradenitis suppurativa; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), COVID-19 (COVID-19), LARYNGITIS (Laryngitis), NASOPHARYNGITIS (Cold) and APHONIA (Loss of voice) in an adult 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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-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 ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate free). On an unknown date, the patient experienced ILLNESS (Sickness), COVID-19 (COVID-19), LARYNGITIS (Laryngitis), NASOPHARYNGITIS (Cold), APHONIA (Loss of voice), HIDRADENITIS (Hidradenitis suppurativa), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, ILLNESS (Sickness), COVID-19 (COVID-19) and HIDRADENITIS (Hidradenitis suppurativa) had resolved, LARYNGITIS (Laryngitis), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and NASOPHARYNGITIS (Cold) and APHONIA (Loss of voice) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Mycobacterium tuberculosis complex test: Result not provided.         No concomitant medications were reported. 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-2022-624365 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Significant Live follow-up appended included Medical history, Events were added.