chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Memory impairment
Clinical narrative: Forgetfulness; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Forgetfulness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 72-year-old 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 Psoriasis.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 15-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Forgetfulness). At the time of the report, MEMORY IMPAIRMENT (Forgetfulness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed the event of forgetfulness as possibly related to Moderna vaccine and as not reasonably possible with Skyrizi.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: BREAK THROUGH COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (BREAK THROUGH COVID-19) in a 66-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 19-Aug-2021, the patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In January 2022, the patient experienced COVID-19 (BREAK THROUGH COVID-19). At the time of the report, COVID-19 (BREAK THROUGH COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Positive.         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.
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: ulcerative colitis flare up; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ulcerative colitis flare up) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COLITIS ULCERATIVE (ulcerative colitis flare up) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (ulcerative colitis flare up) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of ulcerative colitis flare up 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.  Company Comment:  This is a spontaneous case, reported by a consumer concerning an elderly male patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) adverse event of special interest Colitis ulcerative, reported as ulcerative colitis flare up, in the context of the a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event had resolved. The medical condition of moderate to severe Ulcerative colitis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer concerning an elderly male patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) adverse event of special interest Colitis ulcerative, reported as ulcerative colitis flare up, in the context of the a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event had resolved. The medical condition of moderate to severe Ulcerative colitis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dental implantation, Illness, Infection
Clinical narrative: Dental implantation; Infection; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL IMPLANTATION (Dental implantation), ILLNESS (Sickness) and INFECTION (Infection) 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 Psoriasis.    Concurrent medical conditions included Psoriasis.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-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) 40 milligram once a week. On 11-Nov-2021, the patient experienced ILLNESS (Sickness). On 27-Jan-2022, the patient experienced DENTAL IMPLANTATION (Dental implantation). In 2022, the patient experienced INFECTION (Infection). At the time of the report, DENTAL IMPLANTATION (Dental implantation) and ILLNESS (Sickness) had resolved and INFECTION (Infection) outcome was unknown.            No concomitant medications were reported.  In 2022, the patient experienced sick and infection. The sick was resolved.  She had dental implant on 27-Jan-2022 then she developed an infection and was sick for 6 weeks, took antibiotics.  She had to use intravenous, the intravenous was removed on 17-Apr-2022.  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: F
Vaccine: COVID19
Symptoms: Back pain, Cervicitis, Smear cervix, Vaccination site pain
Clinical narrative: COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE; Abnormal pap and sore; FELT LIKE PATIENT BROKE HER BACK; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE), CERVICITIS (Abnormal pap and sore) and BACK PAIN (FELT LIKE PATIENT BROKE HER BACK) in a female 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 Crohn's disease.    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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third 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 VACCINATION SITE PAIN (COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE), CERVICITIS (Abnormal pap and sore) and BACK PAIN (FELT LIKE PATIENT BROKE HER BACK). At the time of the report, VACCINATION SITE PAIN (COVID-19 VACCINATIONS ARM WAS SORE AT INJECTION SITE) and CERVICITIS (Abnormal pap and sore) outcome was unknown and BACK PAIN (FELT LIKE PATIENT BROKE HER BACK) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear cervix: abnormal.         No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event back pain 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: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Hypersensitivity, Pyrexia, Urinary tract infection
Clinical narrative: UTI; Allergies; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), HYPERSENSITIVITY (Allergies), PYREXIA (Fever) and COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), HYPERSENSITIVITY (Allergies) and PYREXIA (Fever). At the time of the report, URINARY TRACT INFECTION (UTI) had not resolved and HYPERSENSITIVITY (Allergies), PYREXIA (Fever) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 for one day after receiving her second COVID vaccine..         The patient had other concomitant therapy of unspecified antibiotics.  Action taken was reported as dose not changed for the co-suspect drug UPADACITINIB (RINVOQ) with respect to all the events.  It was reported that patient had unspecified antibiotics for Urinary tract infection. patient had started taking an unspecified inhaler and allergy medication for her allergies.   Patient did not agree to had physician contacted.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of UTI was not provided. The reporter's causality for the events of covid-19, allergies and fever after covid vaccine with RINVOQ(UPADACITINIB) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First JANSSEN, booster moderna nowpfizer; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First JANSSEN, booster moderna nowpfizer) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication and 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, first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First JANSSEN, booster moderna nowpfizer) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First JANSSEN, booster moderna nowpfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hidradenitis, Psoriasis
Clinical narrative: HIDRADENITIS SUPPURATIVA FLARE; Psoriasis flare; COVID DIAGNOSIS; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), PSORIASIS (Psoriasis flare) and COVID-19 (COVID DIAGNOSIS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Hidradenitis suppurativa.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), PSORIASIS (Psoriasis flare) and COVID-19 (COVID DIAGNOSIS). At the time of the report, HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE), PSORIASIS (Psoriasis flare) and COVID-19 (COVID DIAGNOSIS) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. On unknown dates, the patient experienced COVID DIAGNOSIS, HIDRADENITIS SUPPURATIVA FLARE and PSORIASIS FLARE. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID DIAGNOSIS with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of HIDRADENITIS SUPPURATIVA FLARE and PSORIASIS FLARE 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: Influenza, Psoriasis
Clinical narrative: Minor psoriasis on feet; Second Moderna vaccine gave flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Minor psoriasis on feet) and INFLUENZA (Second Moderna vaccine gave flu symptoms) in an elderly 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.    No Medical History information was reported.   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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Minor psoriasis on feet) and INFLUENZA (Second Moderna vaccine gave flu symptoms). At the time of the report, PSORIASIS (Minor psoriasis on feet) had not resolved and INFLUENZA (Second Moderna vaccine gave flu symptoms) had resolved.            Concomitant drugs were not reported. Patient had received the booster dose, second dose and first dose of Moderna vaccine.  Patient had stated itching had gone away however she still had some minor psoriasis on her feet. The reporter's causality for the event of Minor psoriasis on feet with SKYRIZI (Risankizumab) was a reasonable possibility.  Treatment medications were not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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: F
Vaccine: COVID19
Symptoms: Influenza, Psoriasis
Clinical narrative: Psoriasis flare-up; Flu; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and INFLUENZA (Flu) in an elderly 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.    No Medical History information was reported.   On an unknown date, the patient received 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 PSORIASIS (Psoriasis flare-up) and INFLUENZA (Flu). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved and INFLUENZA (Flu) 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.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received an expired shot of the Moderna; No adverse event; This spontaneous case was reported by an attorney and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired shot of the Moderna) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired shot of the Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired shot of the Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Relevant concomitant medications were not reported.  It was reported that patient had received an expired shot of the Moderna COVID-19 vaccine.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Increase tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Increase tinnitus) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Increase tinnitus). At the time of the report, TINNITUS (Increase tinnitus) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONTRACTED COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CONTRACTED COVID) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (CONTRACTED COVID). At the time of the report, COVID-19 (CONTRACTED COVID) was resolving.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality of humira as per reporter for event COVID-19 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: Tiredness; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive) and FATIGUE (Tiredness) in a 60-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 Ankylosing spondylitis and Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 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) 1 dosage form. On 04-Jan-2021, the patient experienced COVID-19 (COVID-19 virus test positive). On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, COVID-19 (COVID-19 virus test positive) was resolving and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  Patient received Humira (1158135).  No treatment medications were reported.  The reporter assessed the events as possibly related to Moderna vaccine.  The reporter did not provide any causality assessment for the event of tiredness with Humira. The reporter assessed the event of Covid-19 virus test positive as reasonably possible with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Chronic fatigue) 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 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 TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Chronic fatigue). At the time of the report, FATIGUE (Chronic fatigue) outcome was unknown. 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   Patient reported had a chronic fatigue since vaccinated. But I also must disclose that I did have COVID months before vaccinated. So, I have been attributing my fatigue symptoms to so called long COVID. The LONG COVID just taxing our bodys resources or something. Its been nearly 6 months since my booster (4th dose). Fist two series were Moderna, booster was Pfizer, but both are same mRNA protein building vax. I am seriously considering skipping the 2nd booster 4th) short. Especially since active substance coun-19Just might be taking our system. I don't mean hurting or harming us like cancer or anything. But t numbers are down and relatively pretty low.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Swelling face
Clinical narrative: Face swelling/ Swelling face; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelling/ Swelling face) and PYREXIA (Fever) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    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) Citrate Free. On an unknown date, the patient experienced SWELLING FACE (Face swelling/ Swelling face) and PYREXIA (Fever). At the time of the report, SWELLING FACE (Face swelling/ Swelling face) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: High (Fever).     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  On an unknown date, patient experienced face swelling and fever and it got resolved.  On an unknown date, body temperature was measured but the exact temperature was not provided but it was reported that patient had fever.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of face swelling and fever with HUMIRA 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: Unevaluable event
Clinical narrative: LITTLE ROUGH/PATIENT WAS OFF DUE TO TAKING BOOSTER FOR COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (LITTLE ROUGH/PATIENT WAS OFF DUE TO TAKING BOOSTER FOR COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (LITTLE ROUGH/PATIENT WAS OFF DUE TO TAKING BOOSTER FOR COVID-19). At the time of the report, UNEVALUABLE EVENT (LITTLE ROUGH/PATIENT WAS OFF DUE TO TAKING BOOSTER FOR COVID-19) had not resolved.            No concomitant medication was reported. On an unknown date, the patient experienced LITTLE ROUGH/PATIENT WAS OFF DUE TO TAKING BOOSTER FOR COVID-19. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.  Patient was little rough being off due to taking Booster for covid-19. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of LITTLE ROUGH/PATIENT WAS OFF DUE TO TAKING BOOSTER FOR COVID-19 with RINVOQ(UPADACITINIB) 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: My eyes started matting up very badly. The left eye wants to stay shut; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (My eyes started matting up very badly. The left eye wants to stay shut) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058f21a, 031A21A and 022M20A) for COVID-19 prophylaxis.   Concurrent medical conditions included Blood pressure high, High cholesterol and Drug allergy (Unspecified drug). Concomitant products included AMLODIPINE, PANTOPRAZOLE, LEVOTHYROXINE, COLESEVELAM, METOPROLOL, LOSARTAN and PAROXETINE for an unknown indication, APIXABAN (ELIQUIS).   On 22-Feb-2021 at 1:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021 at 3:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 2:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022 at 4:45 PM, the patient experienced OCULAR DISCOMFORT (My eyes started matting up very badly. The left eye wants to stay shut). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 16-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (My eyes started matting up very badly. The left eye wants to stay shut) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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 .  The patient taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine.   Device Date: 17-Apr-2022
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Labyrinthitis, Pain
Clinical narrative: after booster covid vaccine felt achy and flu like; after booster covid vaccine felt achy and flu like; had an infection behind his eardrum; had cough and he had been plugged up for a month; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (after booster covid vaccine felt achy and flu like), PAIN (after booster covid vaccine felt achy and flu like), LABYRINTHITIS (had an infection behind his eardrum) and COUGH (had cough and he had been plugged up for a month) 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) for Crohn's disease.    The patient's past medical history included Ear tube insertion. Concurrent medical conditions included Nasal passage irritation (terrible nasal passages) and Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   On 19-Nov-2021, the patient 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 first 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 ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (after booster covid vaccine felt achy and flu like), PAIN (after booster covid vaccine felt achy and flu like), LABYRINTHITIS (had an infection behind his eardrum) and COUGH (had cough and he had been plugged up for a month). At the time of the report, INFLUENZA LIKE ILLNESS (after booster covid vaccine felt achy and flu like), PAIN (after booster covid vaccine felt achy and flu like) and COUGH (had cough and he had been plugged up for a month) outcome was unknown and LABYRINTHITIS (had an infection behind his eardrum) had not resolved.            No concomitant drug was reported. Humira was used for the indication of moderate to severe adult crohn's disease. No treatment drug was reported. Causality for HUMIRA(Solution for injection in pre-filled pen): The reporter's causality for the event(s) of tubes in ear and cough was not provided. the reporter's causality for the event(s)of infection behind eardrum, after booster covid vaccine felt achy and flu like unknown onset and after booster covid vaccine felt achy and flu like unknown onset 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Nausea
Clinical narrative: Body aches and joint aches; Backache; joint aches; Fatigue; Severe chills/ shivering; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and joint aches), BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue) and CHILLS (Severe chills/ shivering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (COVID-19 Vaccine). Past adverse reactions to the above products included No adverse event with Pfizer (COVID-19 Vaccine).    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Body aches and joint aches). an unknown date, the patient experienced BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue), CHILLS (Severe chills/ shivering) and NAUSEA (Nausea). At the time of the report, PAIN (Body aches and joint aches), BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue), CHILLS (Severe chills/ shivering) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not reported.  The patient got 3rd COVID-19 Booster shot and 2 days later started having the normal things like just like body aches, fatigue while in the next day severe chills, nausea, joint aches and then the previous day she felt pretty fine last night. The 3rd one she had done Moderna Booster (COVID-19 Vaccine) and the first time she had for the Pfizer (COVID-19 Vaccine).  Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches and joint aches; Backache; joint aches; Fatigue; Severe chills/ shivering; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and joint aches), BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue) and CHILLS (Severe chills/ shivering) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer (COVID-19 Vaccine). Past adverse reactions to the above products included No adverse event with Pfizer (COVID-19 Vaccine).    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Body aches and joint aches). an unknown date, the patient experienced BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue), CHILLS (Severe chills/ shivering) and NAUSEA (Nausea). At the time of the report, PAIN (Body aches and joint aches), BACK PAIN (Backache), ARTHRALGIA (joint aches), FATIGUE (Fatigue), CHILLS (Severe chills/ shivering) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication was not reported.  The patient got 3rd COVID-19 Booster shot and 2 days later started having the normal things like just like body aches, fatigue while in the next day severe chills, nausea, joint aches and then the previous day she felt pretty fine last night. The 3rd one she had done Moderna Booster (COVID-19 Vaccine) and the first time she had for the Pfizer (COVID-19 Vaccine).  Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Skin plaque
Clinical narrative: PLAQUES WAS COMING BACK ON THE BACK OF HEAD; FLUISH REACTION TO THE COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (PLAQUES WAS COMING BACK ON THE BACK OF HEAD) and INFLUENZA (FLUISH REACTION TO THE COVID VACCINE) 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) for Psoriatic arthritis.    No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SKIN PLAQUE (PLAQUES WAS COMING BACK ON THE BACK OF HEAD) and INFLUENZA (FLUISH REACTION TO THE COVID VACCINE). At the time of the report, SKIN PLAQUE (PLAQUES WAS COMING BACK ON THE BACK OF HEAD) outcome was unknown and INFLUENZA (FLUISH REACTION TO THE COVID VACCINE) had resolved.            No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of PLAQUES WAS COMING BACK ON THE BACK OF HEAD and FLUISH REACTION TO THE COVID VACCINE with the 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.
Age: 41.0
Sex: M
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 41-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Psoriatic arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Psoriatic arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced COVID-19 (COVID-19). In March 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  In 2022, patient was positive for COVID. In MAR2022, it resolved.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.) and NO ADVERSE EVENT (No adverse event) 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 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It's been two month since the expiration date, the moderna company has prolonged the expiration date of the vaccine they have in stock.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Patient was concern about the vaccination, received the first dose and going to receive second one. It was reported that they don't have new batch of vaccine, there was all overdue vaccines.  Although It's been two months since the expiration date, they prolonged the expiration date of the vaccine in stock and give the patient.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: ALLERGIC TO COVID VACCINE; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (ALLERGIC TO COVID VACCINE) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ALLERGY TO VACCINE (ALLERGIC TO COVID VACCINE). At the time of the report, ALLERGY TO VACCINE (ALLERGIC TO COVID VACCINE) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. On an unknown date, the patient experienced ALLERGIC TO COVID VACCINE. MODERNA. Physician stated that patient was allergic to Covid-19 vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of ALLERGIC TO COVID VACCINE was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Vaccination site erythema
Clinical narrative: Body aches; Reddish skin at Moderna vaccine injection site; Off label use in unapproved indication; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VACCINATION SITE ERYTHEMA (Reddish skin at Moderna vaccine injection site) and OFF LABEL USE (Off label use in unapproved indication) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Osteoarthritis and Ankylosing spondylitis.    Concurrent medical conditions included Osteoarthritis and Ankylosing spondylitis.   On 19-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 an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Body aches), VACCINATION SITE ERYTHEMA (Reddish skin at Moderna vaccine injection site) and OFF LABEL USE (Off label use in unapproved indication). At the time of the report, PAIN (Body aches), VACCINATION SITE ERYTHEMA (Reddish skin at Moderna vaccine injection site) and OFF LABEL USE (Off label use in unapproved indication) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient reported off label use of unknown indication, reddish skin at moderna vaccine injection site and body aches.  Reporters causality of event off label use with 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