chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 67-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 Plaque psoriasis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 05-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome 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-2022-623209 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID-19; This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough COVID-19) 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 NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough COVID-19). At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2022, SARS-CoV-2 test: (Positive) Positive. On 23-Feb-2022, SARS-CoV-2 test: (Positive) Positive. On 25-Feb-2022, SARS-CoV-2 test: (Negative) Negative. On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications was reported. Patient was a breakthrough case since had two Moderna shots and a booster. Doctor prescribed Paxlovid, and within twelve hours of the first dose, patient felt 100% better.  No treatment medications was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: Covid-19; Soreness of arm at injection site after vaccinated for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and VACCINATION SITE PAIN (Soreness of arm at injection site after vaccinated for Covid-19) 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 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 ADALIMUMAB (HUMIRA) (Subcutaneous) Pre-filled pen. On an unknown date, the patient experienced COVID-19 (Covid-19) and VACCINATION SITE PAIN (Soreness of arm at injection site after vaccinated for Covid-19). At the time of the report, COVID-19 (Covid-19) was resolving and VACCINATION SITE PAIN (Soreness of arm at injection site after vaccinated for Covid-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19
Clinical narrative: Covid-19; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In January 2022, the patient experienced COVID-19 (Covid-19) and ARTHRALGIA (Joint pain). At the time of the report, COVID-19 (Covid-19) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medication was reported. The patient had joint pain due to discontinuation of all medications. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient experienced after second covid shot had a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Patient experienced after second covid shot had a headache) in a 44-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 Ulcerative colitis.  No Medical History information was reported.  In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HEADACHE (Patient experienced after second covid shot had a headache). In 2021, HEADACHE (Patient experienced after second covid shot had a headache) had resolved.   Patient had colonoscopy on 11-Jan-2022 and results were unknown. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe ).   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 NASOPHARYNGITIS (Cold symptoms). At the time of the report, NASOPHARYNGITIS (Cold symptoms) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COLD SYMPTOMS 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: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case, reported by a consumer, concerning an adult male patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest SARS-CoV-2 test positive, reported as COVID-19 virus test positive, 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 was not resolved. The co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. 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 adult male patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest SARS-CoV-2 test positive, reported as COVID-19 virus test positive, 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 was not resolved. The co-suspect drug Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immunisation reaction, Psoriasis
Clinical narrative: Has about five percent Psoriasis/small amount of Psoriasis; COVID vaccine issues; left hip pain; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Has about five percent Psoriasis/small amount of Psoriasis), IMMUNISATION REACTION (COVID vaccine issues) and ARTHRALGIA (left hip pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   In February 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) Dose 1. In March 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to Dose 2. In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In February 2021, the patient experienced ARTHRALGIA (left hip pain). On an unknown date, the patient experienced PSORIASIS (Has about five percent Psoriasis/small amount of Psoriasis) and IMMUNISATION REACTION (COVID vaccine issues). At the time of the report, PSORIASIS (Has about five percent Psoriasis/small amount of Psoriasis) had not resolved and IMMUNISATION REACTION (COVID vaccine issues) and ARTHRALGIA (left hip pain) had resolved.            No relevant concomitant medications were reported. The COVID vaccine issue left hip pain for two months following vaccine. Small amount pf psoriaisis stated that she still had about five percent psoriasis. No treatment medication reported. It was unknown if patient was enrolled in a Covid-19 Vaccine trial.  The reporters causality for the events left hip pain, COVID vaccine issues and Has about five percent Psoriasis/small amount of Psoriasis with SKYRIZI was not provided. The reporters causality for the events left hip pain, COVID vaccine issues and Has about five percent Psoriasis/small amount of Psoriasis with Pfizer was provided as possible.  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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes) in an 85-year-old female patient 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 RASH (Rashes). At the time of the report, RASH (Rashes) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not reported.  Patient developed symptoms (rashes) after vaccination with the Moderna vaccine. Treatment details were not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis, Nerve compression, Vaccination site pain
Clinical narrative: Kidney stone; Pinched nerve; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis.    Concurrent medical conditions included Psoriatic arthritis and Rheumatoid arthritis.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant), NERVE COMPRESSION (Pinched nerve) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, NEPHROLITHIASIS (Kidney stone) and NERVE COMPRESSION (Pinched nerve) had resolved and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medications were reported.  Patient received Humira.  No treatment medications were reported.  The reporter did not provide any causality assessment for the event of vaccination site pain with Humira and assessed rest of the events as not reasonably possible to Humira.  The reporter assessed vaccination site pain as related to Moderna vaccine and did not provide any causality assessment for rest of the events with Moderna vaccine.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Nephrolithiasis, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Nephrolithiasis, after receiving the third dose of mRNA-1273 vaccine. Exact onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Nasopharyngitis, Productive cough
Clinical narrative: Phlegm; Bronchitis; Head cold; This spontaneous case was reported by a non-health professional and describes the occurrence of NASOPHARYNGITIS (Head cold), PRODUCTIVE COUGH (Phlegm) and BRONCHITIS (Bronchitis) in a 69-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 Penicillin allergy and Drug allergy.   On 01-Jan-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2022, the patient experienced NASOPHARYNGITIS (Head cold) and BRONCHITIS (Bronchitis). On an unknown date, the patient experienced PRODUCTIVE COUGH (Phlegm). At the time of the report, NASOPHARYNGITIS (Head cold) and BRONCHITIS (Bronchitis) had resolved and PRODUCTIVE COUGH (Phlegm) 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. Primary reporter did not have the lot number information, because the packaging. was discarded.  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: Arthralgia, Blood cholesterol, Blood cholesterol increased, Dizziness, Nasopharyngitis
Clinical narrative: Cold; High cholesterol; Light headed; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), BLOOD CHOLESTEROL INCREASED (High cholesterol), DIZZINESS (Light headed) and ARTHRALGIA (Sore shoulder) 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 Ankylosing spondylitis.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), BLOOD CHOLESTEROL INCREASED (High cholesterol), DIZZINESS (Light headed) and ARTHRALGIA (Sore shoulder). At the time of the report, NASOPHARYNGITIS (Cold), DIZZINESS (Light headed) and ARTHRALGIA (Sore shoulder) had resolved and BLOOD CHOLESTEROL INCREASED (High cholesterol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: High.         Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality with Humira for the events of high cholesterol, sore shoulder, light headed and cold was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623266, MOD-2022-623262 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Blood glucose increased, Dizziness
Clinical narrative: High sugar; Just felt light headed; Just felt sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High sugar), DIZZINESS (Just felt light headed) and ARTHRALGIA (Just felt sore shoulder) 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 Ankylosing spondylitis.  No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (High sugar), DIZZINESS (Just felt light headed) and ARTHRALGIA (Just felt sore shoulder). At the time of the report, BLOOD GLUCOSE INCREASED (High sugar) outcome was unknown and DIZZINESS (Just felt light headed) and ARTHRALGIA (Just felt sore shoulder) had resolved.     No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623259, MOD-2022-623266.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (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) 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) (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) 1 dosage form once a week. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.            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.  Company comment: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and event onset date was not provided. Patient received 3 doses of mRNA-1273 vaccine on unknown dates. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. On unknown date, patient received Adalimumab which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of an unknown age, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred on an unknown date in the context of receiving a dose of mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and event onset date was not provided. Patient received 3 doses of mRNA-1273 vaccine on unknown dates. Clinical course and treatment details were not reported. The outcome of event was reported as unknown. On unknown date, patient received Adalimumab which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Headache
Clinical narrative: second dose of vaccine had cold sweats; second dose of vaccine had headache; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (second dose of vaccine had cold sweats) and HEADACHE (second dose of vaccine had headache) in a 38-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.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COLD SWEAT (second dose of vaccine had cold sweats) and HEADACHE (second dose of vaccine had headache). At the time of the report, COLD SWEAT (second dose of vaccine had cold sweats) and HEADACHE (second dose of vaccine had headache) had resolved.      No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   The reporter causality for the events of second dose of vaccine had cold sweats and second dose of vaccine had headache was not provided.  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-2022-623259, MOD-2022-623262 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Conjunctivitis, Inappropriate schedule of product administration
Clinical narrative: Conjunctivitis; First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of CONJUNCTIVITIS (Conjunctivitis), COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced CONJUNCTIVITIS (Conjunctivitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.). At the time of the report, CONJUNCTIVITIS (Conjunctivitis) and COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 11-NOV-2021 and second dose on 15-JAN-2022 and second dose on 15-JAN-2022 and Third dose on 15-MAR-2022.) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  No treatment medications were reported.  The reporter's causality for the events of Conjunctivitis and COVID-19 with RINVOQ was 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: Blood test, Heavy menstrual bleeding, Menstruation delayed, Pregnancy test, Ultrasound scan
Clinical narrative: I received the Moderna vaccine in January and February I didn't get my period for 3 months; Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUATION DELAYED (I received the Moderna vaccine in January and February I didn't get my period for 3 months) and HEAVY MENSTRUAL BLEEDING (Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In February 2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop). On an unknown date, the patient experienced MENSTRUATION DELAYED (I received the Moderna vaccine in January and February I didn't get my period for 3 months). At the time of the report, MENSTRUATION DELAYED (I received the Moderna vaccine in January and February I didn't get my period for 3 months) had resolved and HEAVY MENSTRUAL BLEEDING (Finally on April 4 I got my period and it's been super heavy for the past 22 days non-stop) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Normal. On an unknown date, Pregnancy test: Normal. On an unknown date, Ultrasound scan: Normal.         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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Pain
Clinical narrative: colds; Feeling sick; body ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), PAIN (body ache) and NASOPHARYNGITIS (colds) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    no known allergies were reported.  The patient's past medical history included Bronchitis, Joint swelling from July 2020 to September 2020, COVID-19 from July 2020 to September 2020, Arthritic pains from July 2020 to September 2020, Body temperature (104 F) in July 2020 and COVID-19 PCR test in July 2020. Concurrent medical conditions included Asthma, Non-smoker and Alcohol use (one to two drinks a year).   In September 2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 17-Apr-2021, the patient experienced MALAISE (Feeling sick). 17-Apr-2021, the patient experienced PAIN (body ache). In December 2021, the patient experienced NASOPHARYNGITIS (colds). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, ETHANOL, GUAIFENESIN (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Apr-2021, MALAISE (Feeling sick) and PAIN (body ache) had resolved. In December 2021, NASOPHARYNGITIS (colds) had resolved.            Concomitant product use was not provided by the reporter.  Action was drug withdrawal for all the events with respect to co-suspect drug  ADALIMUMAB (HUMIRA).  The reporter's causality for the events of felt sick, colds and general body pain  with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) 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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were 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 PLAQUE PSORIASIS FLARE UP was not provided.  No treatment medications were provided by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: DIABETIC; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (DIABETIC) 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 an unknown indication.    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 DIABETES MELLITUS (DIABETIC) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (DIABETIC) outcome was unknown.            Company comment: This is a spontaneous case concerning an adult female patient on treatment with Adalimumab for an unknown indication, who experienced the serious (medically significant) unexpected event Diabetic, on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Risankizumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   All doses of vaccine including booster taken one in once.   No treatment information was provided.  The reporter's causality with Skyrizi (Risankizumab) for the event of Diabetic was not provided.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult female patient on treatment with Adalimumab for an unknown indication, who experienced the serious (medically significant) unexpected event Diabetic, on an unknown date after the third dose of mRNA-1273.  Clinical course, diagnostic tests and treatment details were not provided. Risankizumab was reported as a co-suspect product. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Low white blood count; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (Low white blood count) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VENETOCLAX (VENCLEXTA) for an unknown indication.    No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-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 VENETOCLAX (VENCLEXTA) (Oral) at an unspecified dose. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT DECREASED (Low white blood count). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (Low white blood count) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Low.         No relevant concomitant medications were reported. The patient was taking VENCLEXTA, however physician took her off temporarily due to low white blood cell count. No treatment medication reported.   It was unknown if patient was enrolled in Covid-10 Vaccine trial.  The reporters causality for the event with VENCLEXTA was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever/ slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever/ slight fever) in an 85-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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 05-May-2022, 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 UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On 05-May-2022, the patient experienced CHILLS (Chills) and PYREXIA (Fever/ slight fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever/ slight fever) was resolving.            No concomitant medications were reported.  Patient stated that she received her Covid booster dose on 05-May-2022 and had chills and a slight fever. 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.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Intervertebral disc protrusion
Clinical narrative: Moderna Vaccine had side effects; Herniated disc; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Moderna Vaccine had side effects) and INTERVERTEBRAL DISC PROTRUSION (Herniated disc) in a 42-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 Psoriasis.    The patient's past medical history included Hip replacement in 2012. Concurrent medical conditions included Psoriasis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) (1 in 1 Once). On an unknown date, the patient experienced IMMUNISATION REACTION (Moderna Vaccine had side effects) and INTERVERTEBRAL DISC PROTRUSION (Herniated disc). At the time of the report, IMMUNISATION REACTION (Moderna Vaccine had side effects) and INTERVERTEBRAL DISC PROTRUSION (Herniated disc) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient still had psoriasis scarring after taking Skyrizi.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient stated Skyrizi was a miracle drug, he was always so embarrassed of being covered 95 percent still had some scaring and had herniated disc and other health Issues. He had Side effects he said it Knocked him down. 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) CF. In March 2022, the patient experienced COVID-19 (COVID-19). In 2022, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The reporter causality for the events of COVID 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.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: rash off and on and it's located down his legs/it is now back and worse/get rashes in the fall because of his allergies/rash mainly in ears, and scalp; This spontaneous case was reported by a patient and describes the occurrence of DERMATITIS ALLERGIC (rash off and on and it's located down his legs/it is now back and worse/get rashes in the fall because of his allergies/rash mainly in ears, and scalp) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Asthma.    Concurrent medical conditions included Rash (mainly around eyes, in ears, and scalp), Asthma (COPD(chronic obstructive pulmonary disease) and Allergy (Not specified). Concomitant products included PREDNISONE for Rash, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]), VITAMIN C [ASCORBIC ACID], IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL), SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA), CYANOCOBALAMIN (VITAMIN B-12), FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), CYCLOBENZAPRINE HCL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), MELOXICAM and OXYGEN for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) 200 milligram every two weeks. In October 2021, the patient experienced DERMATITIS ALLERGIC (rash off and on and it's located down his legs/it is now back and worse/get rashes in the fall because of his allergies/rash mainly in ears, and scalp). In February 2022, DERMATITIS ALLERGIC (rash off and on and it's located down his legs/it is now back and worse/get rashes in the fall because of his allergies/rash mainly in ears, and scalp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.