chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic rupture
Clinical narrative: Aortic rupture; This spontaneous case was reported by a consumer and describes the occurrence of AORTIC RUPTURE (Aortic rupture) 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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced AORTIC RUPTURE (Aortic rupture) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 21 days due to AORTIC RUPTURE. The patient was treated with Surgery for Aortic rupture. At the time of the report, AORTIC RUPTURE (Aortic rupture) was resolving.            No concomitant medication provided. No treatment information mentioned.  The patient was in the hospital for 3 weeks, had surgery due to tear in aorta. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporters causality for events with HUMIRA was not provided, but sender is of opinion there is no reasonable possibility of relation.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case concerning a 59-year-old female patient with medical history of plaque psoriasis, who experienced the serious unexpected event aortic rupture, on an unknown date after the second dose of mRNA-1273.  The patient was hospitalized for three weeks and had surgery due to tear in aorta. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 59-year-old female patient with medical history of plaque psoriasis, who experienced the serious unexpected event aortic rupture, on an unknown date after the second dose of mRNA-1273.  The patient was hospitalized for three weeks and had surgery due to tear in aorta. Clinical course, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Psoriasis
Clinical narrative: Psoriasis flare up on back of head, on arms above elbow; Reaction/stiff arm after first covid-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Reaction/stiff arm after first covid-19 vaccination) and PSORIASIS (Psoriasis flare up on back of head, on arms above elbow) in a 56-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.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Reaction/stiff arm after first covid-19 vaccination). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare up on back of head, on arms above elbow). At the time of the report, MUSCULOSKELETAL STIFFNESS (Reaction/stiff arm after first covid-19 vaccination) outcome was unknown and PSORIASIS (Psoriasis flare up on back of head, on arms above elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624067 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Reaction/second covid-19 vaccination injection felt like had flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Reaction/second covid-19 vaccination injection felt like had flu) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Reaction/second covid-19 vaccination injection felt like had flu). At the time of the report, INFLUENZA LIKE ILLNESS (Reaction/second covid-19 vaccination injection felt like had flu) outcome was unknown.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624066 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Unknown event/ Brother died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Unknown event/ Brother died) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Heart disorder (Heart problems).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   Reporters brother died and does not know what happened to him. They did not do an autopsy or anything. Reporter stated her brother had Moderna.   No treatment medication 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.  Company Comment: This spontaneous case concerns a 79-year-old, male patient with medical history of Heart problems (unspecified), who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. The reporter stated that the patient (her brother) died after Mother's Day and the reporter did not know what happened to the patient. No further details were provided. The cause of death was not provided. An autopsy was not performed. The medical history of Heart problems (unspecified) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old, male patient with medical history of Heart problems (unspecified), who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. The reporter stated that the patient (her brother) died after Mother's Day and the reporter did not know what happened to the patient. No further details were provided. The cause of death was not provided. An autopsy was not performed. The medical history of Heart problems (unspecified) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to Moderna vaccination; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (Allergic to Moderna vaccination) 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 ALLERGY TO VACCINE (Allergic to Moderna vaccination). At the time of the report, ALLERGY TO VACCINE (Allergic to Moderna vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Rash macular
Clinical narrative: Skin blotches/flare up/dry spots; Feeling unwell; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), FATIGUE (Fatigue) and RASH MACULAR (Skin blotches/flare up/dry spots) in a 39-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 Plaque psoriasis.    There was no reported medical history.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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) Citrate free. In 2021, the patient experienced MALAISE (Feeling unwell) and FATIGUE (Fatigue). On an unknown date, the patient experienced RASH MACULAR (Skin blotches/flare up/dry spots). At the time of the report, MALAISE (Feeling unwell) and FATIGUE (Fatigue) outcome was unknown and RASH MACULAR (Skin blotches/flare up/dry spots) had not resolved.      No concomitant medication details were provided. No treatment medication details were provided.  The reporter's causality for the events fatigue and malaise with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of rash macular with HUMIRA(ADALIMUMAB) was a reasonable possibility.  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: M
Vaccine: COVID19
Symptoms: Accident, Loss of personal independence in daily activities
Clinical narrative: Sports accident; Activities of daily living impaired; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT (Sports accident) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) in an elderly 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ACCIDENT (Sports accident) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired). At the time of the report, ACCIDENT (Sports accident) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) was resolving.            No concomitant medications were reported.   On an unknown date, the patient experienced not felt 100 percent because when participating in an activity such as golf had accidentals. Moderna was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Psoriatic arthropathy
Clinical narrative: Psoriatic arthritis; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic ).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant) and FATIGUE (Fatigue). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication provided. No treatment information mentioned. Causality for Skyrizi(risankizumab): the reporter's causality for the event(s) of psoriatic arthritis and second dose of Moderna vaccination caused fatigue was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment:  This spontaneous case concerns a 64-year-old female patient with relevant medical history of Chronic plaque psoriasis, who experienced the unexpected, serious  (medically significant) event of Psoriatic arthropathy (Psoriatic arthritis)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as event onset date was not provided. Patient was treated with Risankizumab.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 29 days apart.  The relevant medical history of Chronic plaque psoriasis remains a confounder as 1 in 3 people will likely develop psoriatic arthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with relevant medical history of Chronic plaque psoriasis, who experienced the unexpected, serious  (medically significant) event of Psoriatic arthropathy (Psoriatic arthritis)  on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as event onset date was not provided. Patient was treated with Risankizumab.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 29 days apart.  The relevant medical history of Chronic plaque psoriasis remains a confounder as 1 in 3 people will likely develop psoriatic arthritis.   The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: He had a stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (He had a stroke) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had some of the issues in regards to medical conditions.     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 CEREBROVASCULAR ACCIDENT (He had a stroke) (seriousness criteria death and medically significant). The patient died on 16-Apr-2021. The reported cause of death was he had a stroke. It is unknown if an autopsy was performed.            Concomitant drugs reported included unknown blood thinner.  Patient died, reporter wants to say 16-Apr-2021 and he had a stroke. Reporter knows her male friend had Moderna. Reporter did not have any further information to provide.   No treatment medication 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.  Company comment.  This fatal spontaneous case concerns an elderly male patient, with no specific medical history reported, with blood thinner as concomitant medication, who received a dose of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of cerebrovascular accident. Vaccination date was not reported; hence latency and temporal association between vaccination and death date, cannot be properly assessed. The reporter mentioned the patient had a stroke and died. No further information regarding the event, the onset date, and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Patient´s age and concomitant use of blood thinner remains as risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns an elderly male patient, with no specific medical history reported, with blood thinner as concomitant medication, who received a dose of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of cerebrovascular accident. Vaccination date was not reported; hence latency and temporal association between vaccination and death date, cannot be properly assessed. The reporter mentioned the patient had a stroke and died. No further information regarding the event, the onset date, and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Patient´s age and concomitant use of blood thinner remains as risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: He had a stroke
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Malaise
Clinical narrative: After COVID-19 vaccine shot not feeling well; Tied and pooping; Tied and pooping; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (After COVID-19 vaccine shot not feeling well), DIARRHOEA (Tied and pooping) and FATIGUE (Tied and pooping) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In October 2021, the patient experienced MALAISE (After COVID-19 vaccine shot not feeling well), DIARRHOEA (Tied and pooping) and FATIGUE (Tied and pooping). At the time of the report, MALAISE (After COVID-19 vaccine shot not feeling well), DIARRHOEA (Tied and pooping) and FATIGUE (Tied and pooping) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication provided. No treatment information mentioned.  Patient was not feeling well, tired and pooping after COVID vaccine shot.  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: Adverse drug reaction
Clinical narrative: had problems for one night and one day; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had problems for one night and one day) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (had problems for one night and one day). At the time of the report, ADVERSE DRUG REACTION (had problems for one night and one day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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.  It was reported that unspecified moderna product manufacturer, not provided Investigation assessment. And also stated that her roommate took the moderna one and only had problems for one night and one day. Patient missed one day of work.   Patient thought that he was going to die and did not work the next day. Patient was not allergic and he did not have to worry about it.   Patient  doesn't have sympathy. Men can be single handedly stubborn. Patient had a sprained thumb right now. It was 3 weeks later and he was walking around with ice on it. He said that icing made it feel better.  No treatment medication information was provided
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic, Diarrhoea, Pain in extremity
Clinical narrative: Atopic dermatitis flare; looser stool after receiving moderna covid vaccine; sore arm after receiving moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ATOPIC (Atopic dermatitis flare), DIARRHOEA (looser stool after receiving moderna covid vaccine) and PAIN IN EXTREMITY (sore arm after receiving moderna covid vaccine) in a 66-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 Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis. Concomitant products included FLUTICASONE PROPIONATE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   In February 2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis flare), DIARRHOEA (looser stool after receiving moderna covid vaccine) and PAIN IN EXTREMITY (sore arm after receiving moderna covid vaccine). At the time of the report, DERMATITIS ATOPIC (Atopic dermatitis flare), DIARRHOEA (looser stool after receiving moderna covid vaccine) and PAIN IN EXTREMITY (sore arm after receiving moderna covid vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported. It was reported patient having missed a dupixent dose in the past and had a minor flare up of atomic dermatitis. 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Headache; Pain in the patella of the right knee; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in the patella of the right knee) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product (HUMIRA) for Ankylosing spondylitis and Crohn's disease.    Concurrent medical conditions included Ankylosing spondylitis and Crohn's disease.   On 12-Jan-2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced ARTHRALGIA (Pain in the patella of the right knee). In September 2021, the patient experienced HEADACHE (Headache). At the time of the report, ARTHRALGIA (Pain in the patella of the right knee) was resolving and HEADACHE (Headache) had resolved.            No concomitant medication information was reported.  No treatment medication was reported.  I Primary reporter did not have the lot number information, because the packaging was discarded.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna .
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Malaise, Nodule, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) in a 60-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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In August 2021, the patient experienced MALAISE (DID NOT FEEL WELL) and PAIN (WORST PAIN). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) (seriousness criterion medically significant), NODULE (NODULE ON BIG TOE), HERPES ZOSTER (Shingles) and ARTHRALGIA (SHOULDER PAIN/HURT SHOULDER). In August 2021, MALAISE (DID NOT FEEL WELL) and PAIN (WORST PAIN) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) and ARTHRALGIA (SHOULDER PAIN/HURT SHOULDER) was resolving, NODULE (NODULE ON BIG TOE) had not resolved and HERPES ZOSTER (Shingles) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The reporters causality for the event of nodule on big toe, did not feel well, shingles, shoulder pain/hurt shoulder, rheumatoid arthritis flare ups and worst pain with Humira was not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses and flare ups as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses and flare ups as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) in a 60-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 ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In August 2021, the patient experienced MALAISE (DID NOT FEEL WELL) and PAIN (WORST PAIN). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) (seriousness criterion medically significant), NODULE (NODULE ON BIG TOE), HERPES ZOSTER (Shingles) and ARTHRALGIA (SHOULDER PAIN/HURT SHOULDER). In August 2021, MALAISE (DID NOT FEEL WELL) and PAIN (WORST PAIN) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UPS) and ARTHRALGIA (SHOULDER PAIN/HURT SHOULDER) was resolving, NODULE (NODULE ON BIG TOE) had not resolved and HERPES ZOSTER (Shingles) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The reporters causality for the event of nodule on big toe, did not feel well, shingles, shoulder pain/hurt shoulder, rheumatoid arthritis flare ups and worst pain with Humira was not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses and flare ups as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 60-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of rheumatoid arthritis (AESI) an unknown time after the first dose of mRNA-1273. Rheumatoid arthritis can present relapses and flare ups as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: High blood sugars; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD GLUCOSE INCREASED (High blood sugars) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 prophylaxis. Co-suspect product included non-company product SELEXIPAG tablet for Primary pulmonary hypertension. Concurrent medical conditions included Primary pulmonary hypertension, Non-smoker, Alcohol use and Abstains from recreational drugs. Concomitant products included AMLODIPINE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter and SELEXIPAG (Oral) 1600 microgram twice a day. On 01-Jun-2021, the patient experienced BLOOD GLUCOSE INCREASED (High blood sugars) (seriousness criterion hospitalization). The patient was hospitalized from 01-Jun-2021 to 04-Jun-2021 due to BLOOD GLUCOSE INCREASED. At the time of the report, BLOOD GLUCOSE INCREASED (High blood sugars) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood glucose: high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BLOOD GLUCOSE INCREASED (High blood sugars) to be related.    Company comment: This is a spontaneous case concerning a 76-year-old male patient with primary pulmonary hypertension, who experienced the serious unexpected event blood glucose increased, on an unknown date after receiving an unspecified dose of mRNA-1273. Patient was hospitalized for 3 days due to event. Clinical course, diagnostic tests and treatment details were not provided. Selexipag was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. The patient had no known allergies. No treatment medication were reported.; Sender's Comments: Company comment: This is a spontaneous case concerning a 76-year-old male patient with primary pulmonary hypertension, who experienced the serious unexpected event blood glucose increased, on an unknown date after receiving an unspecified dose of mRNA-1273. Patient was hospitalized for 3 days due to event. Clinical course, diagnostic tests and treatment details were not provided. Selexipag was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain, Psoriasis
Clinical narrative: Psoriasis flare-up; Second COVID vaccination had body aches; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and PAIN (Second COVID vaccination had body aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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) at an unspecified dose. In 2021, the patient experienced PAIN (Second COVID vaccination had body aches). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved and PAIN (Second COVID vaccination had body aches) had resolved.            No concomitant medication provided. No treatment information mentioned.  Patient experienced psoriasis flare. Patient experienced body aches after second dose of vaccine.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaccination site pain, Vaccination site rash
Clinical narrative: SEVERAL URINARY TRACT INFECTION; SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT; SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (SEVERAL URINARY TRACT INFECTION), VACCINATION SITE PAIN (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) and VACCINATION SITE RASH (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Penicillin allergy and Drug allergy.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) and VACCINATION SITE RASH (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT). In August 2021, the patient experienced URINARY TRACT INFECTION (SEVERAL URINARY TRACT INFECTION). In 2021, URINARY TRACT INFECTION (SEVERAL URINARY TRACT INFECTION), VACCINATION SITE PAIN (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) and VACCINATION SITE RASH (SORE ARM AND RASH REACTION TO BOOSTER COVID SHOT) had resolved.            No relevant concomitant medications were reported.   The patient took booster covid shot.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of sore arm and rash reaction to booster covid shot, sore arm and rash reaction to booster covid shot and several urinary tract infection with humira(adalimumab) was no reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic product effect decreased
Clinical narrative: Patient experienced HUMIRA STOPPED WORKING; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (Patient experienced HUMIRA STOPPED WORKING) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (Patient experienced HUMIRA STOPPED WORKING). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (Patient experienced HUMIRA STOPPED WORKING) 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.  Company comment: This spontaneous case concerns an elderly female patient with reported non serious event of Therapeutic product effect decreased (reported as Patient experienced HUMIRA STOPPED WORKING), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose after a month. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient with reported non serious event of Therapeutic product effect decreased (reported as Patient experienced HUMIRA STOPPED WORKING), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second dose after a month. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Daughter had the Moderna vaccine and were out for four days; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (Daughter had the Moderna vaccine and were out for four days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   The patient's past medical history included Breast cancer (Had breast cancer and had a really bad several years.).  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 IMMUNISATION REACTION (Daughter had the Moderna vaccine and were out for four days). At the time of the report, IMMUNISATION REACTION (Daughter had the Moderna vaccine and were out for four days) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  This case was linked to US-MODERNATX, INC.-MOD-2021-624117 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624117:Same reporter
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Second moderna injection made breathing worse; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Second moderna injection made breathing worse) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma.    Concurrent medical conditions included Asthma.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On an unknown date, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram every two weeks. On an unknown date, the patient experienced DYSPNOEA (Second moderna injection made breathing worse). At the time of the report, DYSPNOEA (Second moderna injection made breathing worse) outcome was unknown.            No concomitant medications were reported.  The second Moderna injection made his breathing worse and needed to use his nebulizer today, 06Aug2021  This Case was Identified as part of retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation #QE-019993.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in 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 Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On an unknown date, the patient experienced plaque psoriasis flare up. Moderna vaccine was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown date, patient received COVID-19 Vaccine manufactured by Moderna.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: The whole school had the Moderna vaccine and were out for four days; This spontaneous case was reported by a nurse and describes the occurrence of IMMUNISATION REACTION (The whole school had the Moderna vaccine and were out for four days) 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 IMMUNISATION REACTION (The whole school had the Moderna vaccine and were out for four days). At the time of the report, IMMUNISATION REACTION (The whole school had the Moderna vaccine and were out for four days) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2021-624107 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-624107:Same reporter (Daughter case)