chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.            No concomitant medication were reported. It was reported that study showed that vaccines of messenger RNA (mRNA) against Covid-19, as the Pfizer and Modern can produce myocarditis after application of the second dose.  No treatment medication were reported. As per "Cardiology", 23 vaccinated patients, between 20 and 51 years old reported acute chest pain. These manifestations occurred within four das after inoculation. The symptoms of the 23 patients were classified as "significantly elevated levels of cardiac troponin", a type of protein found in the muscles of the heart. They suggested that this condition is associated with an inflammatory response. Another vaccine that has been associated with episodes of myocarditis is the one that prevents smallpox.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  company comment This spontaneous case concerns a patient of unknown age and gender and with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of Myocarditis, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that study showed that messenger RNA (mRNA) vaccines of covid 19 can produce myocarditis after application of the second dose.  No further clinical information on comorbidities, risk factors, concomitant medications and treatment details were available in the report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender and with no relevant medical history reported, who experienced the expected, serious, medically significant AESI of Myocarditis, unknown days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that study showed that messenger RNA (mRNA) vaccines of covid 19 can produce myocarditis after application of the second dose.  No further clinical information on comorbidities, risk factors, concomitant medications and treatment details were available in the report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lung disorder, Myalgia, Pain
Clinical narrative: Lung disease; General body pain/body was always in pain in mornings could hardly close hands with Humira; COVID  vaccine caused fatigue; COVID  vaccine caused sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of LUNG DISORDER (Lung disease), PAIN (General body pain/body was always in pain in mornings could hardly close hands with Humira), FATIGUE (COVID  vaccine caused fatigue) and MYALGIA (COVID  vaccine caused sore muscles) 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 LUNG DISORDER (Lung disease), PAIN (General body pain/body was always in pain in mornings could hardly close hands with Humira), FATIGUE (COVID  vaccine caused fatigue) and MYALGIA (COVID  vaccine caused sore muscles). At the time of the report, LUNG DISORDER (Lung disease) and PAIN (General body pain/body was always in pain in mornings could hardly close hands with Humira) had not resolved and FATIGUE (COVID  vaccine caused fatigue) and MYALGIA (COVID  vaccine caused sore muscles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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 of HUMIRA for the event(s) of COVID vaccine caused fatigue and sore muscles unknown onset, lunge disease, body was always in pain in mornings could hardly close hands and COVID vaccine caused fatigue  and sore muscles unknown onset was not provided Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-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) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Renal transplant
Clinical narrative: His wife had a kidney transplant and the vaccine did not work for her; This spontaneous case was reported by a consumer and describes the occurrence of RENAL TRANSPLANT (His wife had a kidney transplant and the vaccine did not work for her) in a female 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 RENAL TRANSPLANT (His wife had a kidney transplant and the vaccine did not work for her). At the time of the report, RENAL TRANSPLANT (His wife had a kidney transplant and the vaccine did not work for her) outcome was unknown.            No concomitant medication was reported. It was reported that the patient had a kidney transplant and the vaccine did not work for her, so they are looking for the studies where people who have get immunized and they had a negative effect.  No treatment medication 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (EXTREMELY FATIGUED) and IMMUNISATION REACTION (SICK AFTER SECOND DOSE OF COVID 19 VACCINE ) in a 40-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 Crohn's disease. 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. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced IMMUNISATION REACTION (SICK AFTER SECOND DOSE OF COVID 19 VACCINE). In August 2021, the patient experienced FATIGUE (EXTREMELY FATIGUED). In 2021, IMMUNISATION REACTION (SICK AFTER SECOND DOSE OF COVID 19 VACCINE) had resolved. At the time of the report, FATIGUE (EXTREMELY FATIGUED) had not resolved. No concomitant products were reported. In April 2021, the patient experienced sick after second dose of Covid 19 vaccine. In August 2021, the patient experienced extremely fatigued. In 2021, the sick after second dose of Covid 19 vaccine resolved. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. In Mar 2021, patient received first dose covid-19 vaccine manufactured by Moderna. On 02-Apr-2021, patient received second dose covid-19 vaccine manufactured by Moderna. The patient was treated with vitamin B.  Causality for Humira (adalimumab). The reporter's causality for the event(s) of extremely fatigued with Humira (adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of sick after second dose of Covid 19 vaccine was not provided. No treatment information was reported by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated
Clinical narrative: Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) had not resolved.            No concomitant 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  No treatment information was reported.      Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP) in an adult 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.    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) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP). At the time of the report, ARTHRALGIA (HANDS AND WRIST JOINT PAIN WHEN FIRST WAKING UP) had resolved.            No concomitant products were reported.  On unknown dates, the patient experienced hands and wrist joint pain when first waking up and after third covid vaccine shot pain and wrist was worst. On an unknown date, hands and wrist joint pain when first waking up resolved. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Patient received 1st dose covid-19 vaccine manufactured by moderna. Patient received 2nd dose covid-19 vaccine manufactured by moderna. Patient received 3rd dose covid-19 vaccine manufactured by moderna.  Causality for humira(adalimumab) The reporter's causality for the event(s) of hands and wrist joint pain when first waking up and after third covid vaccine shot pain and wrist was worst was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt sick). At the time of the report, MALAISE (Felt sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Drugs Not Reported. treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Loss of personal independence in daily activities, Vaccination site pain
Clinical narrative: Sick from COVID vaccine; Still difficult to recover from physical activity like grocery shopping; Pain from covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick from COVID vaccine), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Still difficult to recover from physical activity like grocery shopping) and VACCINATION SITE PAIN (Pain from covid vaccine) in a 41-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 Rheumatoid arthritis and Ankylosing spondylitis.    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 ILLNESS (Sick from COVID vaccine), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Still difficult to recover from physical activity like grocery shopping) and VACCINATION SITE PAIN (Pain from covid vaccine). At the time of the report, ILLNESS (Sick from COVID vaccine) had resolved, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Still difficult to recover from physical activity like grocery shopping) had not resolved and VACCINATION SITE PAIN (Pain from covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache
Clinical narrative: Dull headache behind the right eye; Dull headache behind the right eye; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HEADACHE (Dull headache behind the right eye) and the second episode of HEADACHE (Dull headache behind the right eye) in a 47-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 Rheumatoid arthritis, Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Rheumatoid arthritis, Ankylosing spondylitis and Ulcerative colitis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, UNK. On 31-Jul-2021, the patient experienced the first episode of HEADACHE (Dull headache behind the right eye). On an unknown date, the patient experienced the second episode of HEADACHE (Dull headache behind the right eye). At the time of the report, last episode of HEADACHE (Dull headache behind the right eye) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events with Humira was no reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624118 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Illness, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (HAIR LOSS), ILLNESS (SICK), LYMPHADENOPATHY (LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA), FATIGUE (TIRED) and PYREXIA (FEVER AFTER SECOND COVID SHOT) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis and Ankylosing spondylitis. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ALOPECIA (HAIR LOSS), ILLNESS (SICK), LYMPHADENOPATHY (LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA), FATIGUE (TIRED), PYREXIA (FEVER AFTER SECOND COVID SHOT) and FATIGUE (TIRED AFTER SECOND COVID SHOT). At the time of the report, ALOPECIA (HAIR LOSS) and FATIGUE (TIRED) was resolving, ILLNESS (SICK) had resolved and LYMPHADENOPATHY (LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA), PYREXIA (FEVER AFTER SECOND COVID SHOT) and FATIGUE (TIRED AFTER SECOND COVID SHOT) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. The reporter did not provide causality for the events of TIRED, SICK, LYMPH NODE WAS SWOLLEN/SLIGHTLY BIGGER THAN NORMAL/THE SIZE AS A PEA, TIRED AFTER SECOND COVID, HAIR LOSS and FEVER AFTER SECOND COVID SHOT with Humira and Moderna. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS RETURNED/CAME BACK; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (PSORIASIS RETURNED/CAME BACK) in a 68-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 Plaque psoriasis.    No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced PSORIASIS (PSORIASIS RETURNED/CAME BACK). At the time of the report, PSORIASIS (PSORIASIS RETURNED/CAME BACK) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Patient was off Humira due to COVID vaccine. Patient did not take Humira until got COVID vaccine and psoriasis returned/came back. Treatment details not reported.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Balance disorder, Dizziness, Fall, Frequent bowel movements, Hypersensitivity
Clinical narrative: Frequent bowel movements; Balance disorder; Fluid in middle ear; Fall; Dizziness; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), BALANCE DISORDER (Balance disorder), MIDDLE EAR EFFUSION (Fluid in middle ear), FALL (Fall) and DIZZINESS (Dizziness) in an elderly 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 Ulcerative colitis.    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) Citrate Free. On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), BALANCE DISORDER (Balance disorder), MIDDLE EAR EFFUSION (Fluid in middle ear), FALL (Fall), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy). At the time of the report, FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), BALANCE DISORDER (Balance disorder), MIDDLE EAR EFFUSION (Fluid in middle ear), FALL (Fall), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy) had not resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Middle ear effusion
Clinical narrative: Frequent bowel movements; Balance disorder; Fluid in middle ear; Fall; Dizziness; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), BALANCE DISORDER (Balance disorder), MIDDLE EAR EFFUSION (Fluid in middle ear), FALL (Fall) and DIZZINESS (Dizziness) in an elderly 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 Ulcerative colitis.    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) Citrate Free. On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), BALANCE DISORDER (Balance disorder), MIDDLE EAR EFFUSION (Fluid in middle ear), FALL (Fall), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy). At the time of the report, FREQUENT BOWEL MOVEMENTS (Frequent bowel movements), BALANCE DISORDER (Balance disorder), MIDDLE EAR EFFUSION (Fluid in middle ear), FALL (Fall), DIZZINESS (Dizziness) and HYPERSENSITIVITY (Allergy) had not resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    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 and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient experienced non-serious events tired with RINVOQ(UPADACITINIB).  The patient reported that she was very tired for two to three days after her Covid injection.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event(s) of tired with RINVOQ(UPADACITINIB) was no reasonable possibility.  No treatment medications information were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lactose intolerance
Clinical narrative: Lactose intolerance; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of LACTOSE INTOLERANCE (Lactose intolerance) and DIARRHOEA (Diarrhea) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK Citrate free. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. In 2021, the patient experienced LACTOSE INTOLERANCE (Lactose intolerance) and DIARRHOEA (Diarrhea). At the time of the report, LACTOSE INTOLERANCE (Lactose intolerance) outcome was unknown and DIARRHOEA (Diarrhea) had not resolved.            No concomitant products were reported.  In 2021, the patient experienced lactose intolerance and diarrhea. Covid-19 vaccine moderna (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 27-Feb-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 27-Mar-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna.  Causality for humira (adalimumab) The reporter's causality for the event(s) of lactose intolerance and diarrhea was not provided.   No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Aphasia, Fatigue, Headache, Nausea
Clinical narrative: Aphasia; Tiredness; Headache; Nauseated; This spontaneous case was reported by an other health care professional and describes the occurrence of APHASIA (Aphasia), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseated) 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 Ulcerative colitis.    No Medical History information was reported.   On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In September 2021, the patient experienced FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseated). On an unknown date, the patient experienced APHASIA (Aphasia). In September 2021, NAUSEA (Nauseated) had resolved. At the time of the report, APHASIA (Aphasia), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nauseated) to be related. No further causality assessment was provided for APHASIA (Aphasia).    No concomitant medications were reported.  No treatment medications were reported.  Patient received booster dose.  The reporter assessed the event of nauseated as not reasonably possible with Humira and did not provide any causality assessment for the rest of the events with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Rash
Clinical narrative: RASH ON LEGS AND NECK; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH ON LEGS AND NECK) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.  No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RASH (RASH ON LEGS AND NECK). At the time of the report, RASH (RASH ON LEGS AND NECK) was resolving.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: blood work was good.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was provided.  The patient had not psoriasis but a rash legs and neck. The patient buy a new necklace and after it wore it was a rash. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Skin plaque
Clinical narrative: RAISED SPOT OF PLAQUE and FATIGUE; RAISED SPOT OF PLAQUE and FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (RAISED SPOT OF PLAQUE and FATIGUE) and FATIGUE (RAISED SPOT OF PLAQUE and 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 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 SKIN PLAQUE (RAISED SPOT OF PLAQUE and FATIGUE) and FATIGUE (RAISED SPOT OF PLAQUE and FATIGUE). At the time of the report, SKIN PLAQUE (RAISED SPOT OF PLAQUE and FATIGUE) had not resolved and FATIGUE (RAISED SPOT OF PLAQUE and FATIGUE) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  No concomitant medication information was provided.  The patient had raised spot of plaque that did not itch on her head. When she took her covid vaccine all she experienced was some fatigue for a day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No treatment medication was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Sinusitis
Clinical narrative: Flare up/had reaction to the Moderna COVID 19 booster shot; Sinus Cold; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Cold) and IMMUNISATION REACTION (Flare up/had reaction to the Moderna COVID 19 booster shot) in a 68-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 Psoriatic arthritis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In November 2021, the patient experienced SINUSITIS (Sinus Cold). On an unknown date, the patient experienced IMMUNISATION REACTION (Flare up/had reaction to the Moderna COVID 19 booster shot). In 2021, SINUSITIS (Sinus Cold) had resolved. At the time of the report, IMMUNISATION REACTION (Flare up/had reaction to the Moderna COVID 19 booster shot) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: Big lumpy area after injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Big lumpy area after injection) in a 24-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 an unknown indication.    No Medical History information was reported.   On 15-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Oct-2021, the patient experienced INJECTION SITE MASS (Big lumpy area after injection). At the time of the report, INJECTION SITE MASS (Big lumpy area after injection) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Nervousness, Pain in extremity
Clinical narrative: Headache; Pain in arm; Fatigue; Nervous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and NERVOUSNESS (Nervous) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CITRATE FREE. On an unknown date, the patient experienced HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Fatigue) and NERVOUSNESS (Nervous). At the time of the report, HEADACHE (Headache), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) had resolved and NERVOUSNESS (Nervous) outcome was unknown. Not Provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medication information provided No concomitant medication information provided It was unknown if patient was enrolled in a COVID-19 Vaccine Trial
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Skin laceration, Vaccination site pain, Wound infection
Clinical narrative: Laceration of foot; Wound infection; Vaccination site pain; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (Laceration of foot), WOUND INFECTION (Wound infection), VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (Fever) and FATIGUE (Fatigue) 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 Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced SKIN LACERATION (Laceration of foot), WOUND INFECTION (Wound infection), VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (Fever) and FATIGUE (Fatigue). The patient was treated with BACITRACIN ZINC, POLYMYXIN B SULFATE (ANTIBIOTIC OINTMENT) at an unspecified dose and frequency; DOXYCYCLINE at an unspecified dose and frequency and MUPIROCIN at an unspecified dose and frequency. At the time of the report, SKIN LACERATION (Laceration of foot), WOUND INFECTION (Wound infection), VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.            No concomitant medications were reported. Patient was not 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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      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) (Unknown) was unknown.       No concomitant medications were reported. Reporter stated that his wife and two friends tested positive for covid over the weekend. All were fully vaccinated. Reporter stated one of them took moderna. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive on unspecified date. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non serious AESI of COVID-19, that occurred in context to a dose with mRNA-1273 vaccine (unknown dose number and schedule of vaccination). SARS-CoV-2 test was positive on unspecified date. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event outcome was unknown. Ongoing COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Psoriasis
Clinical narrative: Plaque psoriasis flare up on scalp flakey/faint; Sore arm; fatigued with skyrizi; Achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), PSORIASIS (Plaque psoriasis flare up on scalp flakey/faint ), PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigued with skyrizi) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 03-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 an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (Achiness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigued with skyrizi). On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis flare up on scalp flakey/faint ). At the time of the report, PAIN (Achiness), PAIN IN EXTREMITY (Sore arm) and FATIGUE (fatigued with skyrizi) outcome was unknown and PSORIASIS (Plaque psoriasis flare up on scalp flakey/faint ) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The reporter causality for the events Pain in arm, Ache, Fatigue with respect to skyrizi (risankizumab) was reported as no reasonable possibility. And the causality for the event of Psoriasis flares-up with respect to skyrizi (risankizumab) was reported as reasonable possibility.  The treatment medication was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    Concurrent medical conditions included Psoriasis.   In 2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In 2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 24-Sep-2021, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram. On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRURITUS (Itching). On 09-Nov-2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing), CHILLS (Chills), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness). On 10-Nov-2021, IMMUNISATION REACTION (Vaccination adverse reaction), COUGH (Coughing), PYREXIA (Fever), WHEEZING (Wheezing), CHILLS (Chills), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness) had resolved. At the time of the report, PRURITUS (Itching) outcome was unknown. Not Provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: Fever.         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 information provided No concomitant medication information provided  It was unknown if patient was enrolled in a covid-19 vaccine trial.