chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pruritus, Rash erythematous, Rash macular, Vaccination site rash
Clinical narrative: rash at the injection site from that booster shot; Patient had increased blotchy, itchy, red rash on his face; Patient had increased blotchy, itchy, red rash on his face; Patient had increased blotchy, itchy, red rash on his face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient had increased blotchy, itchy, red rash on his face), RASH MACULAR (Patient had increased blotchy, itchy, red rash on his face), RASH ERYTHEMATOUS (Patient had increased blotchy, itchy, red rash on his face) and VACCINATION SITE RASH (rash at the injection site from that booster shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Nasal polyps.    No Medical History information was reported.   On 25-May-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRURITUS (Patient had increased blotchy, itchy, red rash on his face), RASH MACULAR (Patient had increased blotchy, itchy, red rash on his face) and RASH ERYTHEMATOUS (Patient had increased blotchy, itchy, red rash on his face). On 04-Nov-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site from that booster shot). At the time of the report, PRURITUS (Patient had increased blotchy, itchy, red rash on his face), RASH MACULAR (Patient had increased blotchy, itchy, red rash on his face) and RASH ERYTHEMATOUS (Patient had increased blotchy, itchy, red rash on his face) had not resolved and VACCINATION SITE RASH (rash at the injection site from that booster shot) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported.  It was reported that patient had increased blotchy, itchy, red rash on his face.  The reporter's causality was not provided for the all events.  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: Drug hypersensitivity, Pruritus
Clinical narrative: Developed some itching after Moderna Covid Vaccine; allergy to Propylene glycol; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Developed some itching after Moderna Covid Vaccine) and DRUG HYPERSENSITIVITY (allergy to Propylene glycol) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Developed some itching after Moderna Covid Vaccine) and DRUG HYPERSENSITIVITY (allergy to Propylene glycol). At the time of the report, PRURITUS (Developed some itching after Moderna Covid Vaccine) and DRUG HYPERSENSITIVITY (allergy to Propylene glycol) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.  Patient was allergic to propylene glycol and not polyethylene glycol.  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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Significant follow-up received included narrative information updated.
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides, Blood triglycerides increased, Fatigue, Immunisation reaction, Weight decreased
Clinical narrative: Vaccination related malaise; Triglycerides high; Lost weight; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination related malaise), BLOOD TRIGLYCERIDES INCREASED (Triglycerides high), WEIGHT DECREASED (Lost weight) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination related malaise), BLOOD TRIGLYCERIDES INCREASED (Triglycerides high), WEIGHT DECREASED (Lost weight) and FATIGUE (Fatigue). At the time of the report, IMMUNISATION REACTION (Vaccination related malaise), BLOOD TRIGLYCERIDES INCREASED (Triglycerides high), WEIGHT DECREASED (Lost weight) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood triglycerides: Triglycerides were crazy/high.         No concomitant medications were reported  No treatment medications were reported.  The reporter considered all the events as not related to Moderna vaccine.  The reporter did not provide any causality assessment for the events 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: 38.0
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 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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 12-Sep-2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) outcome was unknown.        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.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 38-year-old female patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date was not provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. 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 a 38-year-old female patient with current medication of Adalimumab, who experienced the unexpected non-serious adverse event of special interest COVID-19, in the context of the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date was not provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Colectomy
Clinical narrative: Colectomy; This spontaneous case was reported by a consumer and describes the occurrence of COLECTOMY (Colectomy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLECTOMY (Colectomy) (seriousness criterion medically significant). At the time of the report, COLECTOMY (Colectomy) was resolving.  The case level outcome was reported as recovering/resolving. She felt humira was giving her side effects and doctor took her off humira and placed her on entivio.  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. It was reported that there is no reasonable possibility that the event of HAD SURGERY TO REMOVE COLON is related to HUMIRA(ADALIMUMAB). 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. A 51-year-old female patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days and experienced medically significant event of colectomy 3 months 19 days after receiving second dose. Relevant concurrent medical condition included ulcerative colitis treated with Adalimumab that was switched to Entivio because Humira was giving her side effects. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of ulcerative colitis is a risk factor for colectomy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 51-year-old female patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days and experienced medically significant event of colectomy 3 months after receiving second dose. Relevant concurrent medical condition included ulcerative colitis treated with Adalimumab that was switched to Entivio because Humira was giving her side effects. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of ulcerative colitis is a risk factor for colectomy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blister, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: blister has come up on her lower hip; ITCHINESS ON SCALP; ITCHINESS AROUND MOUTH; Upset stomach; FEELING LIKE CANNOT CATCH HER BREATH; Diarrhoea; WOOZINESS/DIZZINESS; ALLERGIES WORSENED; FEVER; This spontaneous case was reported by a health care professional and describes the occurrence of BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach) and DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included AMBRISENTAN, DILTIAZEM and SILDENAFIL CITRATE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and SELEXIPAG (Oral) 200 microgram twice a day. On an unknown date, the patient experienced BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH), DIARRHOEA (Diarrhoea), DIZZINESS (WOOZINESS/DIZZINESS), HYPERSENSITIVITY (ALLERGIES WORSENED) and PYREXIA (FEVER). At the time of the report, BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH), DIARRHOEA (Diarrhoea), DIZZINESS (WOOZINESS/DIZZINESS), HYPERSENSITIVITY (ALLERGIES WORSENED) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Oral pruritus, Pruritus, Pyrexia
Clinical narrative: blister has come up on her lower hip; ITCHINESS ON SCALP; ITCHINESS AROUND MOUTH; Upset stomach; FEELING LIKE CANNOT CATCH HER BREATH; Diarrhoea; WOOZINESS/DIZZINESS; ALLERGIES WORSENED; FEVER; This spontaneous case was reported by a health care professional and describes the occurrence of BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach) and DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH) in a 77-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension.    Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included AMBRISENTAN, DILTIAZEM and SILDENAFIL CITRATE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and SELEXIPAG (Oral) 200 microgram twice a day. On an unknown date, the patient experienced BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH), DIARRHOEA (Diarrhoea), DIZZINESS (WOOZINESS/DIZZINESS), HYPERSENSITIVITY (ALLERGIES WORSENED) and PYREXIA (FEVER). At the time of the report, BLISTER (blister has come up on her lower hip), PRURITUS (ITCHINESS ON SCALP), ORAL PRURITUS (ITCHINESS AROUND MOUTH), ABDOMINAL DISCOMFORT (Upset stomach), DYSPNOEA (FEELING LIKE CANNOT CATCH HER BREATH), DIARRHOEA (Diarrhoea), DIZZINESS (WOOZINESS/DIZZINESS), HYPERSENSITIVITY (ALLERGIES WORSENED) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) was resolving.            Concomitant Drugs Not Reported.  The reporter's causality for the event(s) of stiffness with Hmira(adalimumab) was no reasonable possibility.  Treatment Drugs 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, UNK
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Arthritis.    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 UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed the event as not related to Moderna vaccine and as not reasonably possible with Rinvoq.  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, UNK
Symptoms: Arthralgia, Pain, Vaccination complication
Clinical narrative: Vaccination adverse reaction; Pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) 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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Plaque psoriasis.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and ARTHRALGIA (Joint pain). In 2021, VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and ARTHRALGIA (Joint pain) had resolved.            No concomitant medications were reported.  Patient received Humira (1149378).  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, UNK
Symptoms: Gout
Clinical narrative: Gout flare; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flare) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Gout.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout flare). At the time of the report, GOUT (Gout flare) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  The patient had gout before going on Skyrizi. He was getting gout flare ups. He had received Covid vaccination but was anti vaccine. He would not be surprised if flare up was related to vaccine. He got vaccine in Mar-2021 and then the flare ups began. His physician wanted him to see a rheumatologist to see if he had rheumatoid arthritis.   No treatment medications were reported.  The reporter assessed the event of gout flare as possibly related to Moderna vaccine and as not reasonably possible to Humira.  Patient did not agree to have physician to be contacted.  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-2021-624353 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Hidradenitis, Night sweats
Clinical narrative: Night sweat; Headache; Hidradenitis suppurativa; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweat), HIDRADENITIS (Hidradenitis suppurativa) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for 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) 1 dosage form. In 2020, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). On an unknown date, the patient experienced NIGHT SWEATS (Night sweat) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Night sweat) and HEADACHE (Headache) was resolving and HIDRADENITIS (Hidradenitis suppurativa) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant Drugs Not Reported.  The reporter's causality for the event(s) of night sweat and headaches after booster injection unknown onset, hidradenitis suppurativa breakouts and night sweat and headaches after booster injection unknown onset with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cough, Migraine, Rash
Clinical narrative: Cough; Migraine; Localised rash; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), MIGRAINE (Migraine) and RASH (Localised rash) in an adult 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 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 COUGH (Cough), MIGRAINE (Migraine) and RASH (Localised rash). At the time of the report, COUGH (Cough), MIGRAINE (Migraine) and RASH (Localised rash) was resolving.            It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  Concomitant Drugs Not Reported  Treatment Drugs Not Reported  The reporter's causality for the event(s) of cough, migraine and foot rash with Skyrizi 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic sinusitis, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SINUSITIS (Chronic sinusitis) and VACCINATION SITE PAIN (Covid booster made arm hurt) in a 62-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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In October 2021, the patient experienced VACCINATION SITE PAIN (Covid booster made arm hurt). In November 2021, the patient experienced CHRONIC SINUSITIS (Chronic sinusitis). At the time of the report, CHRONIC SINUSITIS (Chronic sinusitis) and VACCINATION SITE PAIN (Covid booster made arm hurt) outcome was unknown. Concomitant medication was not provided. Treatment medication information was not provided by the reporter. Primary reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Eczema, Wound
Clinical narrative: Open sores in arm pits; Eczema; This spontaneous case was reported by a consumer and describes the occurrence of WOUND (Open sores in arm pits) and ECZEMA (Eczema) 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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, UNK. On an unknown date, the patient experienced WOUND (Open sores in arm pits) and ECZEMA (Eczema). At the time of the report, WOUND (Open sores in arm pits) and ECZEMA (Eczema) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: SORE ARM WITH FIRST TWO COVID VACCINE SHOT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM WITH FIRST TWO COVID VACCINE SHOT) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM WITH FIRST TWO COVID VACCINE SHOT). In 2021, VACCINATION SITE PAIN (SORE ARM WITH FIRST TWO COVID VACCINE SHOT) had resolved.            No concomitant medication was reported. In 2021, the patient experienced OFF LABEL USE, RIGHT HAND SWOLLEN LIKE A BALLOON/RIGHT HAND COULD NOT CLOSE AND HURTING and SORE ARM WITH FIRST TWO COVID VACCINE SHOT.  On 04 Dec 2021, the patient experienced STOMACH UPSET, SLEPT MOST OF THE DAY AWAY and WAS LOOKING REALLY PALE. In 2021, the SORE ARM WITH FIRST TWO COVID VACCINE SHOT resolved. In December 2021, the STOMACH UPSET, SLEPT MOST OF THE DAY AWAY and WAS LOOKING REALLY PALE resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter contact for lot number information was not available.   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-2021-628605 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigued for 10 hours after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued for 10 hours after 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) solution for injection for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK. On an unknown date, the patient experienced FATIGUE (Fatigued for 10 hours after COVID vaccine). At the time of the report, FATIGUE (Fatigued for 10 hours after COVID vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported. On an unknown date, the patient had device issue, Humira pen misfired/ went to inject the pen, when pressed the spacer was already down/pressed downward/no movement on button/medication spilled out. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event Fatigue was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc degeneration, Radiculopathy, Vaccination site pain
Clinical narrative: DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK; DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK; RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC DEGENERATION (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK), RADICULOPATHY (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) and VACCINATION SITE PAIN (RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced VACCINATION SITE PAIN (RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM). On an unknown date, the patient experienced INTERVERTEBRAL DISC DEGENERATION (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) and RADICULOPATHY (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK). At the time of the report, INTERVERTEBRAL DISC DEGENERATION (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) and RADICULOPATHY (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) had resolved and VACCINATION SITE PAIN (RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM) outcome was unknown.            NO KNOWN ALLERGIES. No relevant medical history. On an unknown date, the patient experienced DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK. In 2021, the patient experienced RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM. On an unknown date, DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK unknown onset was not provided. The reporter's causality for the event(s) of RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM 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: Headache, Nausea, Pyrexia
Clinical narrative: Lowgrade fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Lowgrade fever), HEADACHE (Headache) and NAUSEA (Nausea) 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) for Rheumatoid arthritis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PYREXIA (Lowgrade fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Lowgrade fever), HEADACHE (Headache) and NAUSEA (Nausea) was resolving.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  In 2021, the patient experienced events after took booster shot. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-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) UNK Citrate Free. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). In 2021, PAIN IN EXTREMITY (Pain in arm) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Red blood cell sedimentation rate, Tachycardia
Clinical narrative: Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a 53-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.    Concomitant products included PREDNISONE for COVID-19 vaccination.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2020, the patient experienced TACHYCARDIA (Tachycardia). At the time of the report, TACHYCARDIA (Tachycardia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, Red blood cell sedimentation rate: Increased.         No medical history was reported by the reporter .  Treatment medication information was not provided by the reporter.  In December 2020, the patient experienced tachycardia. On 28-Oct-2021, the patient experienced increased sedimentation rate. In November 2021, the patient experienced achy, inflammation, could not get out of bed for one day and fever. On 01-Nov-2021, the patient experienced very sick after covid booster. In 2021, the very sick after covid booster resolved. The patient had tachycardia after first covid vaccination in Dec 2020. On 28-Oct-2021, blood work showed increased Sedimentation rate. She gave shot of prednisone and her inflammation was better. On 28-Oct-2021 she had taken flu shot. She got sick due to covid booster shot taken on 1-Nov-2021 and could not get out of bed for one day. She was also achy and had fever. 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-2021-628641, MOD-2021-628642 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: General body pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), CHILLS (Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. 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. On 30-Nov-2021, the patient experienced PAIN (General body pain), CHILLS (Chills) and PYREXIA (Fever). On 05-Dec-2021, PAIN (General body pain), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Primary reporter did not have the lot number information, because the packaging was discarded. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Psoriasis, Pyrexia
Clinical narrative: Psoriasis on hands; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis on hands), PYREXIA (Fever) and HEADACHE (Headache) 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 Psoriatic arthritis.    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) UNK Citrate Free. On an unknown date, the patient experienced PSORIASIS (Psoriasis on hands), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PSORIASIS (Psoriasis on hands) had not resolved and PYREXIA (Fever) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Hidradenitis
Clinical narrative: Hidradenitis suppurativa flare up bumps after covid second shot; Hidradenitis suppurativa flare up bumps after covid second shot; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up bumps after covid second shot) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up bumps after covid second shot) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up bumps after covid second shot) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up bumps after covid second shot). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up bumps after covid second shot) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up bumps after covid second shot) was resolving.            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: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) 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) for Rheumatoid arthritis.    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) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On an unknown date, patient received COVID-19 Vaccine manufactured by Moderna, lot number unknown. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication was provided.  Company comment  This spontaneous case reported by a consumer, concerns an elderly female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that on an unknown date, patient also took Adalimumab for Rheumatoid Arthritis, which could be considered as a confounder for the event. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an elderly female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that on an unknown date, patient also took Adalimumab for Rheumatoid Arthritis, which could be considered as a confounder for the event. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.