chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-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, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and HERPES ZOSTER (Shingles). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and HERPES ZOSTER (Shingles) had not resolved.            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.  Company comment: This spontaneous case concerns a 50-years-old female patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up). The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a 50-years-old female patient with relevant concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up). The event occurred on an unknown date in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was not resolved. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE ).   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-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, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medication information was reported. No treatment medication information was reported. Formulation of Humira was reported as Solution for injection in pre-filled pen. 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 spontaneous case concerns adult female patient of unspecified age, with medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. The medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns adult female patient of unspecified age, with medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA), who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to second dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was resolving. The medical history of Rheumatoid arthritis treated with ADALIMUMAB (HUMIRA) could be the risk factor for the event. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a 41-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.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. In January 2022, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported No treatment medications were 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Inflammation of wound, Pyrexia
Clinical narrative: Dizziness; Fatigue; Headache; Fever; resistant wounds in front of crease of armpit and shoulder/inflamed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever) and INFLAMMATION OF WOUND (resistant wounds in front of crease of armpit and shoulder/inflamed) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever) and INFLAMMATION OF WOUND (resistant wounds in front of crease of armpit and shoulder/inflamed). At the time of the report, DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever) had resolved and INFLAMMATION OF WOUND (resistant wounds in front of crease of armpit and shoulder/inflamed) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Action taken was reported as unknown for  co-suspect ADALIMUMAB (HUMIRA) with respect to all the events.  Treatment information was not provided.  The reporter's causality for the event of resistant wounds in front of crease of armpit and shoulder/inflamed with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of fatigue, dizziness, headache and fever with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Weakness; chills; fever; headache; muscle ache; extreme body exausion/ Fatigue and exhaustion; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (Weakness), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 21-May-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-May-2021, the patient experienced ASTHENIA (Weakness), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (extreme body exausion/ Fatigue and exhaustion). On 24-May-2021 at 7:00 AM, ASTHENIA (Weakness), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (extreme body exausion/ Fatigue and exhaustion) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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 medication was not provided.  No information regarding treatment medication was provided.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Weakness; chills; fever; headache; muscle ache; extreme body exausion/ Fatigue and exhaustion; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (Weakness), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 21-May-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-May-2021, the patient experienced ASTHENIA (Weakness), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (extreme body exausion/ Fatigue and exhaustion). On 24-May-2021 at 7:00 AM, ASTHENIA (Weakness), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle ache) and FATIGUE (extreme body exausion/ Fatigue and exhaustion) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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 medication was not provided.  No information regarding treatment medication was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: first dose  06-JAN-2021 , Second dose 14-FEB-2021; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose  06-JAN-2021 , Second dose 14-FEB-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-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. In 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose  06-JAN-2021 , Second dose 14-FEB-2021). At the time of the report, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose  06-JAN-2021 , Second dose 14-FEB-2021) outcome was unknown.            No concomitant medications were reported No treatment medications were 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.
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Diarrhoea, Infected cyst
Clinical narrative: ULCERATIVE COLITIS FLARE UP; PRIMORDIAL CYST BECAME INFECTED; LOOSE STOOLS; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ULCERATIVE COLITIS 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 Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) (seriousness criterion medically significant), INFECTED CYST (PRIMORDIAL CYST BECAME INFECTED) and DIARRHOEA (LOOSE STOOLS). At the time of the report, COLITIS ULCERATIVE (ULCERATIVE COLITIS FLARE UP) outcome was unknown, INFECTED CYST (PRIMORDIAL CYST BECAME INFECTED) had resolved and DIARRHOEA (LOOSE STOOLS) had not resolved.            No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of PRIMORDIAL CYST BECAME INFECTED, LOOSE STOOLS and ULCERATIVE CLOITIS FLARE UP with Humira was not provided.  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.  Company comment: This spontaneous case concerns an adult male patient with medical history of ulcerative colitis, who experienced the unexpected, serious (medically significant) event of ulcerative colitis an unknown time after the third dose of mRNA-1273. The event was described as a flare up. Ulcerative colitis 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 unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with medical history of ulcerative colitis, who experienced the unexpected, serious (medically significant) event of ulcerative colitis an unknown time after the third dose of mRNA-1273. The event was described as a flare up. Ulcerative colitis 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 unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Therapeutic response shortened, Vaccination site pain
Clinical narrative: Pain; Wearing off effect; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) and VACCINATION SITE PAIN (Vaccination site pain) in a 52-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-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. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced PAIN (Pain) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect). At the time of the report, PAIN (Pain) and THERAPEUTIC RESPONSE SHORTENED (Wearing off effect) had not resolved and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medications were reported. No treatment medication was reported.  In 2021, the patient experienced PAIN after receiving Moderna Vaccine, the week patient did not take her Humira and when took Humira shot the pain went away with Humira which was resolved on an unknown date. 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Psoriasis, Taste disorder
Clinical narrative: Psoriasis flare-up/back starts to get itchy couple days before injection; Taste disorder; Chills; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up/back starts to get itchy couple days before injection), TASTE DISORDER (Taste disorder), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (Chills) in a male patient of an unknown age 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 Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-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 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/back starts to get itchy couple days before injection), TASTE DISORDER (Taste disorder) and CHILLS (Chills). At the time of the report, PSORIASIS (Psoriasis flare-up/back starts to get itchy couple days before injection) had not resolved and TASTE DISORDER (Taste disorder), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (Chills) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-620439 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Incorrect dose administered, Stress, Unevaluable event
Clinical narrative: Stress; Unevaluable event; Inappropriate dose of drug administered; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), STRESS (Stress), UNEVALUABLE EVENT (Unevaluable event) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced STRESS (Stress), UNEVALUABLE EVENT (Unevaluable event) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered). In January 2022, COVID-19 (COVID-19) had resolved. At the time of the report, STRESS (Stress) and UNEVALUABLE EVENT (Unevaluable event) had not resolved and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication were reported. No treatment details were reported. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of COVID with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event(s) of STRESS and SPOTS was not provided. The reporter's causality for the event(s) of RECEIVED SKYRIZI AND A PORTION OF IT WAS OUT with SKYRIZI(RISANKIZUMAB) 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.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Inappropriate schedule of vaccine administered; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 29-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 Hidradenitis suppurativa.    No Medical History information was reported.   On 05-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 05-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 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 05-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  In 2021, patient experienced flu like symptoms. Patient took second dose on 19MAR2021 and booster on 05DEC2021.  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: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Pain
Clinical narrative: Side effects from 1st dose of COVID vaccine; Pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects from 1st dose of COVID vaccine) and PAIN (Pain) in a 65-year-old patient of an unknown gender 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 14-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) 40 milligram. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects from 1st dose of COVID vaccine) and PAIN (Pain). At the time of the report, IMMUNISATION REACTION (Side effects from 1st dose of COVID vaccine) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment medications were not provided.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Sinusitis
Clinical narrative: Middle finger on right hand and on left hand ring finger became bit swollen and bit painful; Middle finger on right hand and on left hand ring finger became bit swollen and bit painful; Knee pain; Sinus infection; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (Sinus infection), PERIPHERAL SWELLING (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful), PAIN IN EXTREMITY (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) and ARTHRALGIA (Knee pain) in a 51-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 Rheumatoid arthritis.    No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2022, ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In March 2022, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced PERIPHERAL SWELLING (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful), PAIN IN EXTREMITY (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) and ARTHRALGIA (Knee pain). At the time of the report, SINUSITIS (Sinus infection), PERIPHERAL SWELLING (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) and PAIN IN EXTREMITY (Middle finger on right hand and on left hand ring finger became bit swollen and bit painful) was resolving and ARTHRALGIA (Knee pain) had resolved.            No concomitant medications were provided. No treatment medications were 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: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) 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 VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported. Consumer did not wish to be contacted any further.  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: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    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 20-Sep-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2022, the patient experienced SOMNOLENCE (Sleepy). At the time of the report, SOMNOLENCE (Sleepy) had not resolved.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Humira was not as effective when started treatment.  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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 3 Pfizer and 3 Moderna; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 Pfizer and 3 Moderna) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form., second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 Pfizer and 3 Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 Pfizer and 3 Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  Reportedly, patient got 3 Pfizer COVID-19 vaccines and 3 Moderna. He mentioned that he felt good.  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.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: White blood count high on the high end of normal; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (White blood count high on the high end of normal) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Plaque psoriasis.    No Medical History information was reported.   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 WHITE BLOOD CELL COUNT INCREASED (White blood count high on the high end of normal). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (White blood count high on the high end of normal) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: High end of normal.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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, Solution for injection in pre-filled pen. On 03-Jan-2022, the patient experienced COVID-19 (COVID-19). In January 2022, COVID-19 (COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. No treatment medications were 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 spontaneous case concerns a 36 year old female patient, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 3 months and 2 days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. She received the second dose with the same vaccine according to the recommended schedule. She tested positive for SARS COV 2 test. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event recovered. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36 year old female patient, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 3 months and 2 days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. She received the second dose with the same vaccine according to the recommended schedule. She tested positive for SARS COV 2 test. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event recovered. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Moderna has slow down his process with Hidradenitis suppurativa; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Moderna has slow down his process with Hidradenitis suppurativa) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Moderna has slow down his process with Hidradenitis suppurativa). At the time of the report, IMMUNISATION REACTION (Moderna has slow down his process with Hidradenitis suppurativa) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient felt that the Moderna vaccine has slowed down process with Hidradenitis suppurativa.  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: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved. 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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   Humira was citrate free.  No treatment information was provided.  The reporter's causality for the event of rheumatoid arthritis flare up with Humira (Adalimumab) was no reasonable possibility.  Company comment  This spontaneous case reported by a consumer, concerns an adult male patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an adult male patient, with no relevant medical history reported, who experienced the unexpected, serious, (medically significant) AESI of Rheumatoid arthritis (Rheumatoid arthritis flare up) unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Concurrent medical conditions included Rheumatoid arthritis. On an unknown date, the patient had received ADALIMUMAB for Rheumatoid Arthritis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, labs, diagnostics, concomitant medications and treatment details were reported. The event was reported as resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: Feeling bad; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) and CHILLS (Shivering) in a 54-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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth 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 14-Apr-2022, the patient experienced FEELING ABNORMAL (Feeling bad) and CHILLS (Shivering). At the time of the report, FEELING ABNORMAL (Feeling bad) and CHILLS (Shivering) was resolving.     No concomitant medication information was reported. No treatment medication information 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: F
Vaccine: COVID19
Symptoms: Inflammation, Influenza like illness
Clinical narrative: HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS; 1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS) and INFLUENZA LIKE ILLNESS (1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INFLAMMATION (HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS) and INFLUENZA LIKE ILLNESS (1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS). At the time of the report, INFLAMMATION (HAD SOME INFLAMMATION IN HER BIG TOE AND HANDS) had not resolved and INFLUENZA LIKE ILLNESS (1ST VACCINE CAUSED MILD FLU LIKE SYMPTOMS) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of INFLAMMATION and INFLUENZA LIKE ILLNESS with Humira was not provided.  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-2022-634801 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: Muscle weakness; Pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness) and PAIN (Pain) in an adult 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 Psoriatic arthritis.    Concomitant products included GABAPENTIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-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 once a day. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) and PAIN (Pain). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) and PAIN (Pain) had not resolved.            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.