chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Rash
Clinical narrative: itch; diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso; red spot on her right leg; a reaction to the moderna vaccine; rash; headache; tiredness; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine) and RASH (rash) in an 83-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Asthma.    Concurrent medical conditions included Asthma.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (unknown route) administered at loading dose of 600 mg once followed by 300 mg every other week. On an unknown date, the patient experienced PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine), RASH (rash), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PRURITUS (itch), PSORIASIS (diagnosed with psoriasis with affected area under both of her breasts and the crease of her right leg/ psoriasis on her chest, back, leg, bra line/developed psoriasis/breaks on most of her upper torso), ERYTHEMA (red spot on her right leg), IMMUNISATION REACTION (a reaction to the moderna vaccine), RASH (rash), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that dupilumab administered at loading dose of 600 mg once followed by 300 mg every other week for asthma  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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Generalized aching/body aches; Fever; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Generalized aching/body aches), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PANCREATIN capsule for Pancreatic insufficiency.    Concurrent medical conditions included Pancreatic necrosis (pancreatic insufficiency), Non-smoker and Abstains from alcohol. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), VITAMIN B COMPLEX and VITAMIN A [RETINOL] for an unknown indication.   In 2011, the patient PANCREATIN (Oral) dosage was changed to at an unspecified dose four times per day. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 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 PANCREATIN (Oral) at an unspecified dose once a week. In May 2021, the patient experienced PAIN (Generalized aching/body aches), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In May 2021, PAIN (Generalized aching/body aches), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The daily dose for Co-suspect Pancreatin was reported as 2 with each meal and 1 with snack.  Patient had flu like symptoms after her second covid-19 vaccine and experienced fever, body aches, nausea, and headache for two days and it went away. She was taking an unknown blood pressure medication.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Action taken with Co-suspect Pancreatin was reported as Dose not changed.  The reporter's causality for the Co-suspect Pancreatin and event(s) of fever, body aches, nausea, headaches, and flu like symptoms after second covid 19 vaccine was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620271 (Patient Link).   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Drug interaction
Clinical narrative: RHEUMATOID ARTHRITIS NOT HELP BY HUMIRA/LACK OF EFFECT AFTER COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (RHEUMATOID ARTHRITIS NOT HELP BY HUMIRA/LACK OF EFFECT AFTER COVID VACCINE) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 DRUG INTERACTION (RHEUMATOID ARTHRITIS NOT HELP BY HUMIRA/LACK OF EFFECT AFTER COVID VACCINE). At the time of the report, DRUG INTERACTION (RHEUMATOID ARTHRITIS NOT HELP BY HUMIRA/LACK OF EFFECT AFTER COVID VACCINE) outcome was unknown.            No concomitant medication was reported. In 2021, the patient experienced RHEUMATOID ARTHRITIS NOT HELP BY HUMIRA/LACK OF EFFECT AFTER COVID VACCINE. 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.  No treatment medication was reported.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of RHEUMATOID ARTHRITIS NOT HELP BY HUMIRA/LACK OF EFFECT AFTER COVID VACCINE was not provided.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: Sickness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and CHILLS (Chills) in a 65-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 Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-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) Citrate Free. In February 2021, the patient experienced ILLNESS (Sickness) and CHILLS (Chills). At the time of the report, ILLNESS (Sickness) and CHILLS (Chills) outcome was unknown.     No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Foot deformity, Illness, Nasopharyngitis, Pain
Clinical narrative: Flat feet; Cold; Pain in the body which has worsened by the winter; Issues with knee/pain; Sore arm after covid vaccines and flu shots; Sick; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), RHINORRHOEA (Runny nose), PAIN (Pain in the body which has worsened by the winter) and ILLNESS (Sick) in a 71-year-old female 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced RHINORRHOEA (Runny nose) and ILLNESS (Sick). On an unknown date, the patient experienced FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), PAIN (Pain in the body which has worsened by the winter), ARTHRALGIA (Issues with knee/pain) and VACCINATION SITE PAIN (Sore arm after covid vaccines and flu shots). In 2022, ILLNESS (Sick) had resolved. At the time of the report, FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), RHINORRHOEA (Runny nose), PAIN (Pain in the body which has worsened by the winter), ARTHRALGIA (Issues with knee/pain) and VACCINATION SITE PAIN (Sore arm after covid vaccines and flu shots) had not resolved.            No concomitant medication provided. No treatment information mentioned.  Patient reported on an unknown date, issues with knee and pain, flat feet, sore arm after COVID vaccine and flu shots, cold and pain in the body worsened. On 23AUG2021, patient underwent surgery for right knee due to ongoing pain, was recovering from it. In Jan 2022, patient got sick and had a runny nose. Reported burning occurring for 5 minutes after injecting with Humira. Had pain in the body due to winter weather.  Reporters causality for events of burning with Humira is reasonable possibility to Humira suspect.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-632050.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rhinorrhoea, Vaccination site pain
Clinical narrative: Flat feet; Cold; Pain in the body which has worsened by the winter; Issues with knee/pain; Sore arm after covid vaccines and flu shots; Sick; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), RHINORRHOEA (Runny nose), PAIN (Pain in the body which has worsened by the winter) and ILLNESS (Sick) in a 71-year-old female 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 Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced RHINORRHOEA (Runny nose) and ILLNESS (Sick). On an unknown date, the patient experienced FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), PAIN (Pain in the body which has worsened by the winter), ARTHRALGIA (Issues with knee/pain) and VACCINATION SITE PAIN (Sore arm after covid vaccines and flu shots). In 2022, ILLNESS (Sick) had resolved. At the time of the report, FOOT DEFORMITY (Flat feet), NASOPHARYNGITIS (Cold), RHINORRHOEA (Runny nose), PAIN (Pain in the body which has worsened by the winter), ARTHRALGIA (Issues with knee/pain) and VACCINATION SITE PAIN (Sore arm after covid vaccines and flu shots) had not resolved.            No concomitant medication provided. No treatment information mentioned.  Patient reported on an unknown date, issues with knee and pain, flat feet, sore arm after COVID vaccine and flu shots, cold and pain in the body worsened. On 23AUG2021, patient underwent surgery for right knee due to ongoing pain, was recovering from it. In Jan 2022, patient got sick and had a runny nose. Reported burning occurring for 5 minutes after injecting with Humira. Had pain in the body due to winter weather.  Reporters causality for events of burning with Humira is reasonable possibility to Humira suspect.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2022-632050.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD HEADACHES; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (BAD HEADACHES) 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 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. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (BAD HEADACHES). At the time of the report, HEADACHE (BAD HEADACHES) was resolving.     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 for the event of bad headaches with Humira (Adalimumab) was a reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out into a major rash/rash with COVID-19 booster; This spontaneous case was reported by a patient and describes the occurrence of RASH (Broke out into a major rash/rash with COVID-19 booster) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for Dermatitis atopic and COVID-19 VACCINE for an unknown indication.    Concurrent medical conditions included Dermatitis atopic.   In October 2020, 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 and dose of COVID-19 VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Broke out into a major rash/rash with COVID-19 booster). At the time of the report, RASH (Broke out into a major rash/rash with COVID-19 booster) outcome was unknown.            The patient's medical treatments and family history were not provided. No concomitant medication was reported.  The co-suspect Dupixent delivered via dupilumab pre-filled syringe.  It was not reported if the patient received a corrective treatment for the event.  The reporter causality for event broke out into a major rash/rash with COVID-19 booster with co-suspect Dupixent  and COVID-19 vaccine was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN capsule for Pancreatic insufficiency.    Concurrent medical conditions included Pancreatic necrosis, Non-smoker and Abstains from alcohol. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN B COMPLEX and VITAMIN A [RETINOL] for an unknown indication.   In 2011, the patient PANCREATIN (Oral) dosage was changed to at an unspecified dose four times per day. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PANCREATIN (Oral) at an unspecified dose four times per day. In February 2022, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with SERUM DERIVED BOVINE IG/PROTEIN ISOLATE (ENTERAGAM) at a dose of Unknown, prn. On 03-Feb-2022, DIARRHOEA (Diarrhea) had resolved.            Patient had no known allergies.  Patient received third dose of Moderna vaccine on unknown date in Dec-2021 or Jan-2022.  The daily dose for Co-suspect Pancreatin was reported as 2 with each meal and 1 with snack. The patient had a full day of diarrhea on tuesday or wednesday in Feb-2022. She was taking Enteragam as needed and it stopped the diarrhea.  She was taking an unknown blood pressure medication.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of diarrhoea with PANCREATIN 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-2022-620234 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            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 for the event of COVID-19 with Humira (Adalimumab) was no reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns a 55-year-old female patient with use of Adalimumab (Humira) for rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. SARS-CoV-2  test, and treatment were not reported.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart.  Adalimumab (Humira) is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with use of Adalimumab (Humira) for rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of event onset was not provided. SARS-CoV-2  test, and treatment were not reported.  Patient received a 2-dose primary series of mRNA-1273 vaccine given 28 days apart.  Adalimumab (Humira) is an immunosuppressant that may lower the immune system of the body and affect immune response to mRNA-1273 vaccine predisposing to COVID-19 infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive) in an adult male patient who received mRNA-1273 (Spikevax) 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 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced COVID-19 (COVID-19 virus test positive). At the time of the report, COVID-19 (COVID-19 virus test positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.  The action taken with mRNA-1273 (Spikevax) (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 for the event of COVID POSITIVE with Humira (Adalimumab) was no reasonable possibility.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant products were reported.  On an unknown date, patients mother reported that her son died suddenly three months ago after taking the second dose of the Moderna vaccine and she has been devastated.  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.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the second 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. No information was available regarding the first vaccine dose. It was reported that the patient suddenly died after receiving the second dose of the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the second 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. No information was available regarding the first vaccine dose. It was reported that the patient suddenly died after receiving the second dose of the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   In January 2022, 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) at an unspecified dose. In January 2022, the patient experienced INFECTION (Infection). In 2022, INFECTION (Infection) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality with Humira for the event INFECTION was not provided. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Menopause, Pain in extremity
Clinical narrative: Menopause; Inflammation drained from right thumb; Pain in right thumb; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (Menopause), INFLAMMATION (Inflammation drained from right thumb) and PAIN IN EXTREMITY (Pain in right thumb) 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.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In January 2022, the patient experienced MENOPAUSE (Menopause), INFLAMMATION (Inflammation drained from right thumb) and PAIN IN EXTREMITY (Pain in right thumb). At the time of the report, MENOPAUSE (Menopause) and PAIN IN EXTREMITY (Pain in right thumb) outcome was unknown and INFLAMMATION (Inflammation drained from right thumb) had resolved.            Concomitant Medication use information was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event(s) of menopaus and inflammation drained from right thumb   with humira(adalimumab) was no reasonable possibility. Also, for the event of pain in right thumb was not provided.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620479 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Generalized aching; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), PYREXIA (Fever) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Plaque psoriasis.  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced PAIN (Generalized aching), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, PAIN (Generalized aching), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. Not Provided    mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.    No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the event(s) of BODY ACHES, FEVER and FATIGUE with HUMIRA(ADALIMUMAB) was no  reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Eczema, Gastrooesophageal reflux disease, Sinus disorder
Clinical narrative: Acid reflux; Mouth dry aggravated/Dry mouth flare; Dry eyes aggravated/Dry eyes Flare; Eczema aggravated/Eczema Flare; Sinus disorder/Sinus issues; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (Sinus disorder/Sinus issues), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), DRY MOUTH (Mouth dry aggravated/Dry mouth flare), DRY EYE (Dry eyes aggravated/Dry eyes Flare) and ECZEMA (Eczema aggravated/Eczema Flare) in a 69-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis), Dry mouth, Dry eyes and Eczema.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, first dose. In 2021, the patient experienced SINUS DISORDER (Sinus disorder/Sinus issues), DRY MOUTH (Mouth dry aggravated/Dry mouth flare), DRY EYE (Dry eyes aggravated/Dry eyes Flare) and ECZEMA (Eczema aggravated/Eczema Flare). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). At the time of the report, SINUS DISORDER (Sinus disorder/Sinus issues), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), DRY MOUTH (Mouth dry aggravated/Dry mouth flare), DRY EYE (Dry eyes aggravated/Dry eyes Flare) and ECZEMA (Eczema aggravated/Eczema Flare) outcome was unknown.        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 acid reflux. in 2021, the patient experienced sinus issues since covid booster, dry mouth flare, dry eyes flare and eczema flare.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality for the co-suspect Humira with respect to all the events were 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2022: Additional information received on 24-Mar-2022 and included patient demographics, new events information, reporter opinion of causality, suspect drug information and narrative description were added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Immunisation reaction, Papule
Clinical narrative: Dry skin aggravated; Papule; Skin red; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin aggravated), PAPULE (Papule), ERYTHEMA (Skin red) and IMMUNISATION REACTION (Vaccination adverse reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 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 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DRY SKIN (Dry skin aggravated), PAPULE (Papule), ERYTHEMA (Skin red) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, DRY SKIN (Dry skin aggravated), PAPULE (Papule), ERYTHEMA (Skin red) and IMMUNISATION REACTION (Vaccination adverse reaction) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No information on concomitant medication were reported. No treatment details were reported. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of DRY SKIN LIKE A RASH ON FACE/STARTED AROUND MOUTH, BUT NOW IT WAS MORE ALL OVER FACE/SOMETIMES RED AND RAISED unknown onset, DRY SKIN LIKE A RASH ON FACE/STARTED AROUND MOUTH, BUT NOW IT WAS MORE ALL OVER FACE/SOMETIMES RED AND RAISED unknown onset, DRY SKIN LIKE A RASH ON FACE/STARTED  AROUND MOUTH, BUT NOW IT WAS MORE ALL OVER FACE/SOMETIMES RED AND RAISED unknown onset and POSSIBLE REACTION TO COVID VACCINE with HUMIRA(ADALIMUMAB) was a reasonable possibility.This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: Fatigue; Second dose 14-APR-2021/ Booster 1 19-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 14-APR-2021/ Booster 1 19-AUG-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth 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 19-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 14-APR-2021/ Booster 1 19-AUG-2021). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 14-APR-2021/ Booster 1 19-AUG-2021) outcome was unknown.            No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: Tooth infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (Tooth infection) 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 Hidradenitis suppurativa and Crohn's disease.    No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced TOOTH INFECTION (Tooth infection). The patient was treated with CLINDAMYCIN for Adverse event, at a dose of Unknown. At the time of the report, TOOTH INFECTION (Tooth infection) had not resolved. Not Provided          No concomitant medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporters causality for the event(s) of BAD TOOTH/TOOTH 29 INFECTED with HUMIRA(ADALIMUMAB) was a  reasonable possibility. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Unevaluable event
Clinical narrative: Unevaluable event; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and UNEVALUABLE EVENT (Unevaluable event) in a 32-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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (MODERATE TO SEVERE).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On 31-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, COVID-19 (COVID-19) was resolving and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  On an unknown date, the patient experienced congestion. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of COVID-19 was no reasonable possibility and the reporter's causality for the event of unevaluable event was not provided with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Pain in extremity, Platelet count, Pyrexia, Weight
Clinical narrative: Gained one pound; Feverish; Right arm soreness; Hardly able to eat; This spontaneous case was reported by an other health care professional and describes the occurrence of FEEDING DISORDER (Hardly able to eat), WEIGHT INCREASED (Gained one pound), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness) 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 PALBOCICLIB (IBRANCE) for Breast cancer.    Concomitant products included EXEMESTANE (AROMASIN) for an unknown indication.   On 09-Sep-2021, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. On 22-Oct-2021, PALBOCICLIB (IBRANCE) (Oral) dosage was changed to 100 milligram once a day. In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEEDING DISORDER (Hardly able to eat), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness). On an unknown date, the patient experienced WEIGHT INCREASED (Gained one pound). In January 2022, FEEDING DISORDER (Hardly able to eat), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness) had resolved. At the time of the report, WEIGHT INCREASED (Gained one pound) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Platelet count: 191. On an unknown date, Weight: gained one pound.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Recommended dose per prescribing information was 125 mg. Current dose prescription per file was 100 mg 21 days on/ 7 days off, patient reported on and off week of 125 mg dose. Patients platelets dropped down relay low from 17 to 7, so did hemoglobin. The patient was sent to the emergency room to received a blood and platelet transfusion. Patient was instructed to hold Ibrance for 7 days after off week and resume therapy at lower 100 mg dose, while off therapy patient experienced the following "nasal allergy, could not breath, it was not sinusitis like patient thought before. Physician started patient on a nasal spray (Azelastine), patient was weak, hard to talk, rashes all over, bruises and had no energy". Since restarting Ibrance 100mg dose, patient felt a little more energy, improved appetite and still felt a little weak.  Patient received Moderna booster dose. Other labs everything was ok according to physician.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Gained one pound; Feverish; Right arm soreness; Hardly able to eat; This spontaneous case was reported by an other health care professional and describes the occurrence of FEEDING DISORDER (Hardly able to eat), WEIGHT INCREASED (Gained one pound), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness) 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 PALBOCICLIB (IBRANCE) for Breast cancer.    Concomitant products included EXEMESTANE (AROMASIN) for an unknown indication.   On 09-Sep-2021, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. On 22-Oct-2021, PALBOCICLIB (IBRANCE) (Oral) dosage was changed to 100 milligram once a day. In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEEDING DISORDER (Hardly able to eat), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness). On an unknown date, the patient experienced WEIGHT INCREASED (Gained one pound). In January 2022, FEEDING DISORDER (Hardly able to eat), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness) had resolved. At the time of the report, WEIGHT INCREASED (Gained one pound) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Platelet count: 191. On an unknown date, Weight: gained one pound.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Recommended dose per prescribing information was 125 mg. Current dose prescription per file was 100 mg 21 days on/ 7 days off, patient reported on and off week of 125 mg dose. Patients platelets dropped down relay low from 17 to 7, so did hemoglobin. The patient was sent to the emergency room to received a blood and platelet transfusion. Patient was instructed to hold Ibrance for 7 days after off week and resume therapy at lower 100 mg dose, while off therapy patient experienced the following "nasal allergy, could not breath, it was not sinusitis like patient thought before. Physician started patient on a nasal spray (Azelastine), patient was weak, hard to talk, rashes all over, bruises and had no energy". Since restarting Ibrance 100mg dose, patient felt a little more energy, improved appetite and still felt a little weak.  Patient received Moderna booster dose. Other labs everything was ok according to physician.  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.