chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in an elderly 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 adult Crohn's disease). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In 2021, 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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bone densitometry: Bone density loss, (Bone density decreased).         The patient had received Booster dose of Moderna vaccine.  The patient had experienced Bone density loss. The reporter's causality for events of Bone density loss and Sick with Humira was no reasonable possibility.  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: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza
Clinical narrative: FLU REACTION; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (FLU REACTION) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, 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 (1 in 2 wk). In 2022, the patient experienced INFLUENZA (FLU REACTION). At the time of the report, INFLUENZA (FLU REACTION) outcome was unknown.            Formulation of Humira was reported as Solution for injection in pre-filled pen.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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: F
Vaccine: COVID19
Symptoms: Cardiac discomfort
Clinical narrative: Heart problems; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (Heart problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Autoimmune disorder (Has an auto immune disease and a couple of other things.).    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, the patient experienced CARDIAC DISCOMFORT (Heart problems). At the time of the report, CARDIAC DISCOMFORT (Heart problems) outcome 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.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Seizure
Clinical narrative: Hearing loss; Seizures; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) and SEIZURE (Seizures) in a 67-year-old female patient who received mRNA-1273 (Spikevax) 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 an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK. On 20-Mar-2022, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant) and SEIZURE (Seizures) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Hearing loss) and SEIZURE (Seizures) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. On 20-Mar-2022 and 21-Mar-2022 patient experienced seizures and hearing loss. Patient stated that it was possible hearing loss could have came from covid shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of Humira as per reporter for event seizures and hearing loss was not 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.  Company comment: This spontaneous case concerns a 67 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Deafness and Seizure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date and dose of vaccination was available in the report. Co suspect adalimumab could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67 year old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Deafness and Seizure (AESI), unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on detailed clinical course, relevant investigations, treatment, exact date and dose of vaccination was available in the report. Co suspect adalimumab could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after COVID-19 vaccination) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after COVID-19 vaccination). At the time of the report, VACCINATION SITE PAIN (Sore arm after COVID-19 vaccination) had resolved.            Concomitant drugs were not reported.  The patient had received first booster dose and second booster dose of Moderna vaccine.  The reporter's causality for event sore arm after vaccination with Skyrizi  was reasonable possibility.  It was unknown date 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: 36 hours of slight symptoms; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (36 hours of slight symptoms) in a  patient of an unknown age and gender 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 an unknown indication.    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 and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (36 hours of slight symptoms). At the time of the report, IMMUNISATION REACTION (36 hours of slight symptoms) had resolved.            No concomitant medication was reported.   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: M
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 a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    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) (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) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19 vaccine clinical trial.  The reporter causality for events of COVID-19 with Humira was no 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.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Antibody test, Vaccine induced antibody absent
Clinical narrative: low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2; patient had low immunity and patient received Booster dose after two primary dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE INDUCED ANTIBODY ABSENT (low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2) and ACCIDENTAL UNDERDOSE (patient had low immunity and patient received Booster dose after two primary dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included CYCLOPHOSPHAMIDE, DOXORUBICIN HYDROCHLORIDE, PREDNISONE, RITUXIMAB, VINCRISTINE SULFATE (R CHOP) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINE INDUCED ANTIBODY ABSENT (low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2) and ACCIDENTAL UNDERDOSE (patient had low immunity and patient received Booster dose after two primary dose). At the time of the report, VACCINE INDUCED ANTIBODY ABSENT (low immunity after three doses of Moderna Vaccine/has no circulating antibodies against SARS-CoV-2) and ACCIDENTAL UNDERDOSE (patient had low immunity and patient received Booster dose after two primary dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: has no circulating antibodies against SARS-CoV-2, no antibodies and no antibodies.         No concomitant medication was reported. The patient had two doses of the Moderna COVID-19 vaccine and then was administered chemotherapy. After the chemotherapy ended, he got the booster dose of the Moderna vaccine and, according to an antbody test, he has no circulating antibodies against SARS-CoV-2. The oncologist recommends the patient to get a 4th dose, but that this time be from Pfizer-BioNtech. 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: Chills, Nasopharyngitis, Pain
Clinical narrative: Had been achy more; Cold; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Had been achy more), NASOPHARYNGITIS (Cold) and CHILLS (Chills) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Had been achy more), NASOPHARYNGITIS (Cold) and CHILLS (Chills). At the time of the report, PAIN (Had been achy more) outcome was unknown and NASOPHARYNGITIS (Cold) and CHILLS (Chills) had resolved.            Patient had no known allergies. No concomitant drugs were taken.  The patient took vaccine and had chills and cold. As of 08-Apr-2022, patient had bone marrow test, results not provide and checked inflammation. Treatment details not 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: Inappropriate schedule of product administration, Vaccination site papule, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Inappropriate schedule of vaccine administered; VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT; VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT; VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), VACCINATION SITE PRURITUS (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT), VACCINATION SITE RASH (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT) and VACCINATION SITE PAPULE (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT) 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), VACCINATION SITE PRURITUS (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT), VACCINATION SITE RASH (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT) and VACCINATION SITE PAPULE (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered), VACCINATION SITE PRURITUS (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT), VACCINATION SITE RASH (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT) and VACCINATION SITE PAPULE (VACCINE SITE RATION/ SMAL RASH RAISED A LITTLE ITCHY ON RIGHT SIDE MORE THAN LEFT) outcome was unknown.            Concomitant drug was not reported. Treatment details were not 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; First dose-15-Jan-21 Second dose-04-Feb-21; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-15-Jan-21 Second dose-04-Feb-21) and NO ADVERSE EVENT (No Adverse Event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe). Concomitant products included ADALIMUMAB (HUMIRA) for 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 04-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-15-Jan-21 Second dose-04-Feb-21). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose-15-Jan-21 Second dose-04-Feb-21) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Both the doses of vaccine received one in once. Humira was citrate free.  No treatment information was provided.   This case was linked to MOD-2022-624296 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Aug-2022: Live Follow up received. Added concomitant batch number.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Heart disease, unspecified and Heart failure.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) 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. The patient had been vaccinated and boosted with the Moderna Covid-19 vaccine and was Covid positive. Patient was suggested by doctor to take Paxlovid however several doctors had told that they do not know where to get it. 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.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 test, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. 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 male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive COVID-19 test, in the context of the 3 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Body Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Body Chills) 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 01-Mar-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) at an unspecified dose. In 2021, the patient experienced CHILLS (Body Chills). At the time of the report, CHILLS (Body Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment medications 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.   This case was linked to MOD-2022-624376, MOD-2022-624175 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PLAQUE PSORIASIS FLARE UPS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PLAQUE PSORIASIS FLARE UPS) 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 Plaque psoriasis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PSORIASIS (PLAQUE PSORIASIS FLARE UPS). At the time of the report, PSORIASIS (PLAQUE PSORIASIS FLARE UPS) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the event of PLAQUE PSORIASIS FLARE UPS was not provided.   No treatment medication 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company productB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-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) Citrate Free. In 2022, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) had not resolved.            No concomitant medication was reported.  The co--suspect Humira formulation was reported as solution for injection in pre-filled pen. On 19-Nov-2021, the patient received the Booster dose of Moderna COVID-19 vaccine. It was unknown if patient was enrolled in COVID-19 Vaccine   No treatment information was reported.  The reporter causality for event sinus infection with co-suspect Humira 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.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Visual impairment
Clinical narrative: EYESIGHT GOT WORSE; BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (EYESIGHT GOT WORSE) and URTICARIA (BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and Ulcerative colitis.    Concurrent medical conditions included Panuveitis (Non-infectious intermediate posterior), Ulcerative colitis (Moderate to severe) and Vision abnormal.   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) at an unspecified dose. On an unknown date, the patient experienced VISUAL IMPAIRMENT (EYESIGHT GOT WORSE) and URTICARIA (BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION). At the time of the report, VISUAL IMPAIRMENT (EYESIGHT GOT WORSE) had not resolved and URTICARIA (BROKE OUT INTO HIVES AFTER SECOND DOSE OF COVID VACCINATION) outcome was unknown.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant product use was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  All doses of vaccine was taken one in once. Humira was citrate free.  No treatment information was provided.  The reporter's causality for the event of eyesight got worse with Humira (Adalimumab) was a reasonable possibility. The reporter's causality with Humira (Adalimumab) for the event of broke out into hives after second dose of covid vaccination was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cancer fatigue, Joint range of motion decreased, Neck injury, Neck pain
Clinical narrative: Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS; Neck pain; Neck injury; Joint range of motion decreased/LACK OF MOBILITY; This spontaneous case was reported by a consumer and describes the occurrence of CANCER FATIGUE (Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Breast cancer female since 1992.    On 15-Nov-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CANCER FATIGUE (Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS) (seriousness criterion medically significant), NECK PAIN (Neck pain), NECK INJURY (Neck injury) and JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/LACK OF MOBILITY). At the time of the report, CANCER FATIGUE (Chemotherapy fatigue/DIFFERENT FATIGUE THAN JUST TIREDNESS), NECK PAIN (Neck pain), NECK INJURY (Neck injury) and JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased/LACK OF MOBILITY) had not resolved.            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.  Company comment: This spontaneous case concerns a 64 year old female patient with concurrent condition of breast cancer, who experienced the unexpected serious (medically significant) event of Cancer fatigue  (reported as Chemotherapy fatigue/different fatigue than just tiredness), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the event was available in the report.  Concurrent condition of breast cancer could be contributory to the event.  The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-628644 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64 year old female patient with concurrent condition of breast cancer, who experienced the unexpected serious (medically significant) event of Cancer fatigue  (reported as Chemotherapy fatigue/different fatigue than just tiredness), unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. No information on exact date of the event, detailed clinical course, relevant investigations and treatment of the event was available in the report.  Concurrent condition of breast cancer could be contributory to the event.  The event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
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 male patient who received mRNA-1273 (Spikevax) 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 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and treatment information was provided.  The reporter's causality for the event of covid-19 with Humira was reported as 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Spinal osteoarthritis
Clinical narrative: HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER; HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) and SPINAL OSTEOARTHRITIS (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, 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 an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient experienced PAIN (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) and SPINAL OSTEOARTHRITIS (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER). At the time of the report, PAIN (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) had not resolved and SPINAL OSTEOARTHRITIS (HAD PAIN OVER BODY MOSTLY IN NECK/NECK PAIN BONES RUBBING TOGETHER) outcome was unknown.            It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and 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-2022-628604 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: got sick with fever for two three days; Shivers; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (got sick with fever for two three days), CHILLS (Shivers) and MYALGIA (Body aches) 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.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (got sick with fever for two three days), CHILLS (Shivers) and MYALGIA (Body aches). At the time of the report, PYREXIA (got sick with fever for two three days) had resolved and CHILLS (Shivers) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Between 102 to 103.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and 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-2022-628648 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Rheumatoid arthritis
Clinical narrative: Migraine; Rheumatoid arthritis flare up; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In March 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant products were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.   No treatment information was reported 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 65-year-old female patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant ) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient received a 2-dose primary series of mRNA-1273 vaccine given on unknown dates, at an unknown interval.  The relevant medical history of Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with relevant medical history of Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant ) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as vaccination date and event onset date were not disclosed. Patient received a 2-dose primary series of mRNA-1273 vaccine given on unknown dates, at an unknown interval.  The relevant medical history of Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Face rash/neck rash; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 63-year-old male 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In 2021, the patient experienced RASH (Face rash/neck rash). In 2021, RASH (Face rash/neck rash) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved.            No concomitant products were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.   No treatment information was reported 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 concerns a 63-year-old male patient with concurrent Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) 13 days after receiving the first dose of mRNA-1273 vaccine.  Patient was treated with Upadacitinib (Rinvoq).  Outcome of the event was reported as resolved. Patient subsequently received a 2nd dose of mRNA-1273 vaccine  28 days after the first dose.  The concurrent Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous concerns a 63-year-old male patient with concurrent Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) 13 days after receiving the first dose of mRNA-1273 vaccine.  Patient was treated with Upadacitinib (Rinvoq).  Outcome of the event was reported as resolved. Patient subsequently received a 2nd dose of mRNA-1273 vaccine  28 days after the first dose.  The concurrent Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick after covid booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after covid booster shot) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ILLNESS (Sick after covid booster shot). At the time of the report, ILLNESS (Sick after covid booster shot) was resolving.            It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and treatment information was provided.  The reporter's causality for the event of sick after co id booster shot with Humira (adalimumab) was no reasonable possibility.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Neck pain, Pyrexia
Clinical narrative: Neck pain; Shoulder pain; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), COVID-19 (COVID-19), ARTHRALGIA (Shoulder pain) and PYREXIA (Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease and Ulcerative colitis.   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 26-Jan-2022, 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 COVID-19 (COVID-19). On 12-Oct-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain). In January 2022, PYREXIA (Fever) had resolved. At the time of the report, NECK PAIN (Neck pain), COVID-19 (COVID-19) and ARTHRALGIA (Shoulder pain) was resolving.            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-2022-628692 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Yeast under armpits; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast under armpits) in an adult female patient who received mRNA-1273 (Spikevax) 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.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced FUNGAL INFECTION (Yeast under armpits). At the time of the report, FUNGAL INFECTION (Yeast under armpits) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a covid-19 vaccine trial   No concomitant medication and 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