chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Seizure
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of SEIZURE (Seizures) in a 61-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. 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 SEIZURE (Seizures) (seriousness criterion medically significant) and MALAISE (not looking good). At the time of the report, SEIZURE (Seizures) and MALAISE (not looking good) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient Ethnicity was reported as Private. No prior vaccination taken within 4 weeks. Reporter stated that it was sometime in May (unspecified year), patient got Moderna vaccine because she was afraid to get Pfizer because reporter's grandmother died three hours after Pfizer (her lungs started filling with fluid and turned blue). When reporter saw the patient, she was not looking good and started having seizures. No concomitant product was reported. No treatment 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. Company Comment: This is a spontaneous case, reported by a patient, concerning a 61-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Seizure, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 61-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Seizure, in the context of a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Really tired; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired), PYREXIA (Fever) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK. On an unknown date, the patient experienced FATIGUE (Really tired), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FATIGUE (Really tired) outcome was unknown and PYREXIA (Fever) and HEADACHE (Headache) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Gait inability, Headache, Injection site pain, Pain in extremity
Clinical narrative: Stomach hurts very bad; Hard time in morning when gets up legs hurt and cannot walk; Hard time in morning when gets up legs hurt and cannot walk; Arm hurt from injection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurts very bad), GAIT INABILITY (Hard time in morning when gets up legs hurt and cannot walk), PAIN IN EXTREMITY (Hard time in morning when gets up legs hurt and cannot walk), INJECTION SITE PAIN (Arm hurt from injection) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Back pain (Pain from past health issues with back).   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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurts very bad), GAIT INABILITY (Hard time in morning when gets up legs hurt and cannot walk), PAIN IN EXTREMITY (Hard time in morning when gets up legs hurt and cannot walk) and INJECTION SITE PAIN (Arm hurt from injection). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurts very bad), GAIT INABILITY (Hard time in morning when gets up legs hurt and cannot walk), PAIN IN EXTREMITY (Hard time in morning when gets up legs hurt and cannot walk) and INJECTION SITE PAIN (Arm hurt from injection) outcome was unknown and HEADACHE (Headache) had not resolved.            This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  No concomitant medication was reported.  Primary reporter contact for lot number information was not available.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of hard time in morning when gets up legs hurt and cannot walk unknown onset, hard time in morning when gets up legs hurt and cannot walk unknown onset, stomach hurts very bad and arm hurt from injection was not provided. The reporter's causality for the events of headache was not reported for co-suspect Humira.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Rushed to the hospital after Moderna Vaccine) 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 IMMUNISATION REACTION (Rushed to the hospital after Moderna Vaccine) (seriousness criterion hospitalization prolonged). At the time of the report, IMMUNISATION REACTION (Rushed to the hospital after Moderna Vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. 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 male patient of unspecified age with no medical history reported, who experienced the unexpected serious (Hospitalization) event of Immunisation reaction that occurred in the context of a dose (reported as 1 dosage) of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient was rushed to the hospital after Moderna Vaccine. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow-up received contains no new information (NNI). Sender's Comments: This spontaneous case concerns a male patient of unspecified age with no medical history reported, who experienced the unexpected serious (Hospitalization) event of Immunisation reaction that occurred in the context of a dose (reported as 1 dosage) of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient was rushed to the hospital after Moderna Vaccine. No further information on risk factors, clinical course, investigations and treatment received was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Ultrasound abdomen
Clinical narrative: Abdominal pain/ She had severe, intermittent abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain/ She had severe, intermittent abdominal pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Kidney disorder.   On 01-Apr-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ABDOMINAL PAIN (Abdominal pain/ She had severe, intermittent abdominal pain). At the time of the report, ABDOMINAL PAIN (Abdominal pain/ She had severe, intermittent abdominal pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: it was fine.         No concomitant medications were reported No treatment medications were reported Patients physician had thought that the vaccines caused the abdominal pain but he was stopping Rinvoq for one month to see if that might be the cause despite the pain commencing prior to initiating Rinvoq.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporters causality for the event(s) of SEVERE, INTERMITTENT ABDOMINAL PAIN with RINVOQ(UPADACITINIB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.     No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pyrexia, Vaccination site erythema
Clinical narrative: Redness at injection site; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Fever) had resolved.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Duration of event fever was 24 hour. 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: Influenza like illness, Psoriasis
Clinical narrative: Psoriasis flare-up; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  Patient had flare ups with Scaling and Itchiness and Experienced flu like  symptoms after receiving the second Moderna vaccination. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: feeling sick; fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick) and PYREXIA (fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic vaccination.    Concurrent medical conditions included Atopic dermatitis. Concomitant products included DUPILUMAB (DUPIXENT) from 23-Mar-2018 to an unknown date for Atopic dermatitis.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced MALAISE (feeling sick) and PYREXIA (fever). At the time of the report, MALAISE (feeling sick) and PYREXIA (fever) outcome was unknown.        Patient experienced similar event after second COVID-19 vaccine.  No treatment medication 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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Significant follow up- patient age, suspect product information updated. On 10-Jan-2022: Significant follow up-concomitant medication DUPIXENT added.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: Arthritic pains; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Arthritic pains) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.  No Medical History information was reported.  On 22-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) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Arthritic pains). At the time of the report, ARTHRALGIA (Arthritic pains) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Illness, Pain
Clinical narrative: COVID-19; Sick after eating; Miserable and some days just could not do it; Sore/ achy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after eating), FEELING ABNORMAL (Miserable and some days just could not do it), PAIN (Sore/ achy), FATIGUE (Tiredness) and COVID-19 (COVID-19) in a 74-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 Ankylosing spondylitis.    No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced ILLNESS (Sick after eating), FEELING ABNORMAL (Miserable and some days just could not do it), PAIN (Sore/ achy) and FATIGUE (Tiredness). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, ILLNESS (Sick after eating), FEELING ABNORMAL (Miserable and some days just could not do it), PAIN (Sore/ achy) and FATIGUE (Tiredness) outcome was unknown and COVID-19 (COVID-19) had resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was reported.  The reporter's causality for the event of tired, sick after eating, miserable and some days just could not do it, sore/achy and COVID was not provided for co-suspect drug Humira.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included AZATHIOPRINE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK CF. In 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            No medical history was reported by the reporter.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Psoriasis
Clinical narrative: RETURN OF PLAQUE PSORIASIS SYMPTOMS; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (RETURN OF PLAQUE PSORIASIS SYMPTOMS) and FATIGUE (Fatigue) 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 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 ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (RETURN OF PLAQUE PSORIASIS SYMPTOMS) and FATIGUE (Fatigue). At the time of the report, PSORIASIS (RETURN OF PLAQUE PSORIASIS SYMPTOMS) had not resolved and FATIGUE (Fatigue) had resolved.            Concomitant medication was not reported.  On an unknow date, patient experienced fatigue after second dose of COVID-19 vaccine. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: 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 63-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.    Concurrent medical conditions included Ulcerative colitis and Plaque psoriasis. Concomitant products included MESALAMINE for Ulcerative colitis.   In February 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) UNK, Citrate Free. In February 2021, the patient experienced COVID-19 (COVID-19). In 2021, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Humira causality as per reporter was reasonable possibility for event COVID-19. 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 is a spontaneous case concerning a 63-year-old male patient with Plaque psoriasis and ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected AESI COVID-19, on the same month after the first dose of mRNA-1273.  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 63-year-old male patient with Plaque psoriasis and ulcerative colitis on treatment with Adalimumab, who experienced the non-serious unexpected AESI COVID-19, on the same month after the first dose of mRNA-1273.  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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pruritus
Clinical narrative: Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    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) Citrate Free, Solution for injection in pre-filled syringe. On an unknown date, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. On an unknown date, the patient experienced ITCHY.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Primary reporter declined to provide lot number information.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of ITCHY was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Sleepy; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain) 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 Crohn's disease.  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. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain). In 2021, SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.   No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Tiredness; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concomitant products included LOSARTAN POTASSIUM, ATORVASTATIN and HYDROCHLOROTHIAZIDE for Blood pressure high.   On 28-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.            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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Injection site pain
Clinical narrative: Injection site pain; Blood pressure high; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure high) and INJECTION SITE PAIN (Injection site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055C21A, 015M20A and 027L20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Aug-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 07-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced HYPERTENSION (Blood pressure high). On 17-Aug-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 17-Aug-2021, INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, HYPERTENSION (Blood pressure high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: Blood pressure high.         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 pain at injection site with humira(adalimumab) was no reasonable possibility and the event of high blood pressure 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.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: 2 dose of moderna I experienced the worst ear ache; This spontaneous case was reported by a patient and describes the occurrence of EAR PAIN (2 dose of moderna I experienced the worst ear ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (2 dose of moderna I experienced the worst ear ache). At the time of the report, EAR PAIN (2 dose of moderna I experienced the worst ear ache) had not resolved. No concomitant medications were reported. Patient received 2 dose of moderna and experienced the worst ear ache ever. Since then patient saw her ear Dr. Patient have same constant ear ache. It goes on for hours and days. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Psoriatic arthropathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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. Company comment: This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the Covid 19 vaccination series. It was reported that on an unknown date, patient also took Adalimumab for Psoriatic Arthropathy, which could be considered as a confounder for the flare up. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the Covid 19 vaccination series. It was reported that on an unknown date, patient also took Adalimumab for Psoriatic Arthropathy, which could be considered as a confounder for the flare up. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE) in a 31-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.   On 08-Jul-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) Citrate Free. On an unknown date, the patient experienced COVID-19 (FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE). At the time of the report, COVID-19 (FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.  On an unknown date, the patient experienced HAD COVID FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE. MODERNA COVID-19 VACCINE (COVID-19 VACCINE MRNA (MRNA1273)) was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of HAD COVID FEW WEEKS AFTER GETTING FIRST DOSE OF VACCINE 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.  Company Comment: This is a spontaneous case concerning a 31-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, few weeks after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 31-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, few weeks after receiving the first dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollenness/soreness in thigh; Swollenness/soreness in thigh; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Swollenness/soreness in thigh) and INJECTION SITE SWELLING (Swollenness/soreness in thigh) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (Swollenness/soreness in thigh) and INJECTION SITE SWELLING (Swollenness/soreness in thigh). At the time of the report, INJECTION SITE PAIN (Swollenness/soreness in thigh) and INJECTION SITE SWELLING (Swollenness/soreness in thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. Case level outcome was reported as unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Unevaluable event
Clinical narrative: patient had problem when missed humira for not getting prescription when ran out of medication.; Pain; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (patient had problem when missed humira for not getting prescription when ran out of medication.), PAIN (Pain), CHILLS (Chills) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen. On an unknown date, the patient experienced UNEVALUABLE EVENT (patient had problem when missed humira for not getting prescription when ran out of medication.), PAIN (Pain), CHILLS (Chills) and PYREXIA (Low grade fever). At the time of the report, UNEVALUABLE EVENT (patient had problem when missed humira for not getting prescription when ran out of medication.) outcome was unknown and PAIN (Pain), CHILLS (Chills) and PYREXIA (Low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Low grade fever.         Concomitant product use was not provided by the reporter.  Action taken was reported as unknown for the co-suspect ADALIMUMAB (HUMIRA) with respect to all the events.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  The reporter's causality for the event(s) of chills, low grade fever and pain with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of patient had problem when missed humira for not getting prescription when ran out of medication 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.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Insomnia, Skin exfoliation, Therapeutic product effect decreased
Clinical narrative: Condition aggravated; Difficulty sleeping; Drug effect decreased; Localised exfoliation; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), INSOMNIA (Difficulty sleeping), THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) and SKIN EXFOLIATION (Localised exfoliation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Rheumatoid arthritis aggravated. No Medical History information was reported. 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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (Localized exfoliation). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), INSOMNIA (Difficulty sleeping) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). In 2021, SKIN EXFOLIATION (Localized exfoliation) had resolved. At the time of the report, CONDITION AGGRAVATED (Condition aggravated), INSOMNIA (Difficulty sleeping) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) had not resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use information was not provided by reporter. On unknown dates, the patient experienced humira helped first but now arms flared up again felt like humira was not working anymore, peeling hands and can not sleep at night with Humira. On 15Mar2021, the patient experienced peeling hands and in 2021, the peeling hands resolved. It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for the event(s) of humira helped first but now arms flared up again felt like humira was not working anymore unknown onset, peeling hands and can not sleep at night was not provided. The reporter causality of the Humira for the event of drug effect decreased was a reasonable possibility. 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.   Reporter did not allow further contact.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE; TINGLING AFTER FIRST COVID INJECTION; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE) and PARAESTHESIA (TINGLING AFTER FIRST COVID INJECTION) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 30-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) at an unspecified dose. In 2021, the patient experienced PARAESTHESIA (TINGLING AFTER FIRST COVID INJECTION). On an unknown date, the patient experienced MOBILITY DECREASED (LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE). In 2021, PARAESTHESIA (TINGLING AFTER FIRST COVID INJECTION) had resolved. At the time of the report, MOBILITY DECREASED (LACK OF MOBILITY/COUD NOT MOVE AS WELL AS BEFORE) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medications were reported.