chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Stress
Clinical narrative: Stress; cramps in the stomach; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (Stress) and ABDOMINAL PAIN UPPER (cramps in the stomach) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced STRESS (Stress) and ABDOMINAL PAIN UPPER (cramps in the stomach). At the time of the report, STRESS (Stress) outcome was unknown and ABDOMINAL PAIN UPPER (cramps in the stomach) had not resolved.            No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event of stress was not provided. The reporter's causality for the event of cramps in the stomach with Humira (adalimumab) was no reasonable possibility. The reporter assessed events of stress and cramps in the stomach as possibly related to Moderna COVID-19 vaccine.  No treatment details 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: Illness
Clinical narrative: got a little sick after her 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got a little sick after her 2nd shot) in a female 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. On an unknown date, the patient experienced ILLNESS (got a little sick after her 2nd shot). At the time of the report, ILLNESS (got a little sick after her 2nd shot) outcome was unknown.            Concomitant medications details were not 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.   This case was linked to MOD-2022-620750 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Gait disturbance, Injection site pain, Speech disorder
Clinical narrative: FELT FOGGY BRAINED; COULD BARELY WALK; COULD BARELY TALK; HUMIRA WHICH HURT LIKE BEE STING; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (FELT FOGGY BRAINED), GAIT DISTURBANCE (COULD BARELY WALK), SPEECH DISORDER (COULD BARELY TALK) and INJECTION SITE PAIN (HUMIRA WHICH HURT LIKE BEE STING) 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.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-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 16-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. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to CF40MG/0.4ML in 1 wk. On an unknown date, the patient experienced FEELING ABNORMAL (FELT FOGGY BRAINED), GAIT DISTURBANCE (COULD BARELY WALK), SPEECH DISORDER (COULD BARELY TALK) and INJECTION SITE PAIN (HUMIRA WHICH HURT LIKE BEE STING). At the time of the report, FEELING ABNORMAL (FELT FOGGY BRAINED), GAIT DISTURBANCE (COULD BARELY WALK) and SPEECH DISORDER (COULD BARELY TALK) outcome was unknown and INJECTION SITE PAIN (HUMIRA WHICH HURT LIKE BEE STING) had resolved.            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 FELT FOGGY BRAINED, COULD BARELY WALK/TALK unknown onset, COULD BARELY WALK/TALK unknown onset and HUMIRA WHICH HURT LIKE BEE STING was not provided.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB): The reporter's causality for the event(s) of FELT FOGGY BRAINED, COULD BARELY WALK/TALK unknown onset, COULD BARELY WALK/TALK unknown onset and HUMIRA WHICH HURT LIKE BEE STING was not provided. No information on concomitant medication were reported. No treatment details 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: Hypersensitivity, Limb injury, Sinus disorder
Clinical narrative: Sinus disorder/ sinus issues; Foot injury/ dropped canned food on her big toe and hurt foot; Allergies; This spontaneous case was reported by a patient and describes the occurrence of SINUS DISORDER (Sinus disorder/ sinus issues), LIMB INJURY (Foot injury/ dropped canned food on her big toe and hurt foot) and HYPERSENSITIVITY (Allergies) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult crohn's disease).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SINUS DISORDER (Sinus disorder/ sinus issues), LIMB INJURY (Foot injury/ dropped canned food on her big toe and hurt foot) and HYPERSENSITIVITY (Allergies). At the time of the report, SINUS DISORDER (Sinus disorder/ sinus issues) and HYPERSENSITIVITY (Allergies) had not resolved and LIMB INJURY (Foot injury/ dropped canned food on her big toe and hurt foot) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) 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.  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, Intervertebral disc protrusion, Vaccination site pain, Weight, Weight decreased
Clinical narrative: Weight loss; Herniated disc; Fatigue; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC PROTRUSION (Herniated disc), WEIGHT DECREASED (Weight loss), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) 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) for Crohn's disease.    No Medical History information was reported.   On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In May 2021, the patient experienced INTERVERTEBRAL DISC PROTRUSION (Herniated disc). In 2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced WEIGHT DECREASED (Weight loss). At the time of the report, INTERVERTEBRAL DISC PROTRUSION (Herniated disc), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown and WEIGHT DECREASED (Weight loss) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: FORTY FIVE POUND WEIGHT LOSS.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  Treatment Drugs Not Reported.  The reporter's causality for the event(s) of HERNIATED DISCS, FORTY FIVE POUND WEIGHT LOSS, FATIGUE AND SOREARM FOLLOWING VACCINES onset in 2021 and FATIGUE AND SOREARM FOLLOWING VACCINES onset in 2021 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, COVID-19 (COVID-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication provided. No treatment information mentioned.  Patient experienced COVID. Took first dose in April and second dose in July.  The reporters causality for event with Rinvoq 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Plaque psoriasis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    There was no reported medical history.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Plaque psoriasis). At the time of the report, PSORIASIS (Plaque psoriasis) had not resolved.     No concomitant medications were reported.  The patient did not have plaque psoriasis until she took covid vaccination in Jan-2021. It started as something on leg and then arm.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis
Clinical narrative: Unilateral upper right side lip droop/ weakness; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARESIS (Unilateral upper right side lip droop/ weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022, the patient experienced FACIAL PARESIS (Unilateral upper right side lip droop/ weakness). The patient was treated with HYALURONIC ACID (RESTYLANE) on 27-Jan-2022 at a dose of Restylane Lyft; HYALURONIC ACID (RESTYLANE) in May 2021 at a dose of Restylane Kysse and HYALURONIC ACID, LIDOCAINE (RESTYLANE L) on 24-Nov-2021 at an unspecified dose and frequency. At the time of the report, FACIAL PARESIS (Unilateral upper right side lip droop/ weakness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The patient had unilateral upper right side lip droop or weakness. Only top right side. Lips injected with Restylane Kysse in May 2021, Restylane L injected on 24-Nov-2021. Cheeks done with Restylane Lyft on 27-Jan-22. Event started 8-Feb-2022 and was ongoing. 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Fatigue, Pain
Clinical narrative: Itching in eyes; Little pain; Felt tired; This spontaneous case was reported by a patient and describes the occurrence of EYE PRURITUS (Itching in eyes), PAIN (Little pain) and FATIGUE (Felt tired) in a 55-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 Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 22-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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) Citrate Free. On 22-Feb-2022, the patient experienced EYE PRURITUS (Itching in eyes), PAIN (Little pain) and FATIGUE (Felt tired). At the time of the report, EYE PRURITUS (Itching in eyes), PAIN (Little pain) and FATIGUE (Felt tired) outcome was unknown.            No concomitant medications were provided. 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: COVID-19, Eye infection
Clinical narrative: COVID; EYE INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and EYE INFECTION (EYE INFECTION) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID) and EYE INFECTION (EYE INFECTION). At the time of the report, COVID-19 (COVID) and EYE INFECTION (EYE INFECTION) was resolving.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  Reportedly, the patient had COVID and eye infection, off for 15 days.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COVID and EYE INFECTION with RINVOQ(UPADACITINIB) was a reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Flare up; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Flare up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Flare up). At the time of the report, CONDITION AGGRAVATED (Flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient experienced a flare up post taking the booster dose.  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: Ageusia, Arthropathy, Muscle fatigue
Clinical narrative: Joints could not keep up; Muscle/joint fatigue; Side effects with COVID vaccination/lost taste; This spontaneous case was reported by a patient and describes the occurrence of ARTHROPATHY (Joints could not keep up), MUSCLE FATIGUE (Muscle/joint fatigue) and AGEUSIA (Side effects with COVID vaccination/lost taste) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for an unknown indication.   In March 2021, the patient 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 and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ARTHROPATHY (Joints could not keep up), MUSCLE FATIGUE (Muscle/joint fatigue) and AGEUSIA (Side effects with COVID vaccination/lost taste). At the time of the report, ARTHROPATHY (Joints could not keep up) and MUSCLE FATIGUE (Muscle/joint fatigue) outcome was unknown and AGEUSIA (Side effects with COVID vaccination/lost taste) was resolving.            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: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient had no known drug allergies.  Concurrent medical conditions included Rheumatoid arthritis.   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). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient did not take any concomitant drugs.   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. The reporter assessed events of COVID-19 as possibly related to Moderna COVID-19 vaccine.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) 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 dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant product was reported. On an unknown date, the patient felt that Humira was not working. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns an adult, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. No symptoms were reported and treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult, female patient with medical history of Moderate-to-severe Rheumatoid Arthritis treated with the co-suspect product Humira (adalimumab), who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving Humira. Of note, the administration date of Humira was not provided, hence, the onset latency could not be assessed. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. No symptoms were reported and treatment information was not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Stress; COVID-19 recurrent; Fatigue; body aches; Headache; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), STRESS (Stress), COVID-19 (COVID-19 recurrent), FATIGUE (Fatigue) and MYALGIA (body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 11-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 1 wk). In August 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (body aches) and HEADACHE (Headache). On an unknown date, the patient experienced STRESS (Stress) and COVID-19 (COVID-19 recurrent). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (body aches) and HEADACHE (Headache) had resolved. At the time of the report, STRESS (Stress) and COVID-19 (COVID-19 recurrent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On unknown dates, the patient experienced stress and covid twice. in august 2021, the patient experienced fatigue after covid vaccine, body aches after covid vaccine, headaches after covid vaccine and felt like had flu after covid vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for Humira (adalimumab) for the events of fatigue after covid vaccine, stress, covid twice, body aches after covid vaccine, headaches after covid vaccine and felt like had flu after covid vaccine was not provided.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Stress; COVID-19 recurrent; Fatigue; body aches; Headache; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), STRESS (Stress), COVID-19 (COVID-19 recurrent), FATIGUE (Fatigue) and MYALGIA (body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 11-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 1 wk). In August 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (body aches) and HEADACHE (Headache). On an unknown date, the patient experienced STRESS (Stress) and COVID-19 (COVID-19 recurrent). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (body aches) and HEADACHE (Headache) had resolved. At the time of the report, STRESS (Stress) and COVID-19 (COVID-19 recurrent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On unknown dates, the patient experienced stress and covid twice. in august 2021, the patient experienced fatigue after covid vaccine, body aches after covid vaccine, headaches after covid vaccine and felt like had flu after covid vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for Humira (adalimumab) for the events of fatigue after covid vaccine, stress, covid twice, body aches after covid vaccine, headaches after covid vaccine and felt like had flu after covid vaccine was not provided.  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: Eye inflammation, Fatigue
Clinical narrative: Eye inflamed; Worn out; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFLAMMATION (Eye inflamed) and FATIGUE (Worn out) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Panuveitis.    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 and third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced EYE INFLAMMATION (Eye inflamed) and FATIGUE (Worn out). At the time of the report, EYE INFLAMMATION (Eye inflamed) and FATIGUE (Worn out) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On unknown dates, the patient experienced eyes got inflamed close to when it was time for Humira injection and patient was wore out. 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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Pruritus, Rash, Rebound eczema, SARS-CoV-2 antibody test
Clinical narrative: eczema are back; itching; minor rashes, rashes are back; This spontaneous case was reported by a patient and describes the occurrence of REBOUND ECZEMA (eczema are back), PRURITUS (itching) and RASH (minor rashes, rashes are back) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    No Medical History information was reported.   On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram once a day. In 2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 27-Aug-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced REBOUND ECZEMA (eczema are back), PRURITUS (itching) and RASH (minor rashes, rashes are back). At the time of the report, REBOUND ECZEMA (eczema are back), PRURITUS (itching) and RASH (minor rashes, rashes are back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: showed 3 out of 20. In April 2021, SARS-CoV-2 antibody test: antibodies were low.         No concomitant medications were reported.It was reported that once patient started on Dupixent, it was amazing, felt 100 percent better but the dose was late so started having slight itching (pruritus) and minor rashes (rash), but they were minor and patient was 90 to 95 percent better since starting on Dupixent. Patient got booster dose of Moderna on 27-Aug-2021.Patient was advised to take 2 to 3 weeks before taking his Dupixent again, eczema and rashes disappeared 100%, now his rash (rash) and eczema (eczema rebound) are back, wanting to restart, and unsure if Dupixent shot made his antibodies low.  It was not reported if the patient received a corrective treatment for the events.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWOLLEN HANDS; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (SWOLLEN HANDS) 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 Rheumatoid arthritis.    No Medical History information was reported.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (SWOLLEN HANDS). At the time of the report, PERIPHERAL SWELLING (SWOLLEN HANDS) had not resolved.            No concomitant medication was reported.  The patient had swelling hands due to lack of medication.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of SWOLLEN HANDS with SKYRIZI(RISANKIZUMAB) was a reasonable possibility.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration, Malaise, Pain
Clinical narrative: Pain; Feeling abnormal/ patient experienced spaciness; Fatigue; Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021; Feeling unwell /Not feeling good; Fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell /Not feeling good), FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness), PAIN (Pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021). In May 2021, the patient experienced MALAISE (Feeling unwell /Not feeling good) and PYREXIA (Fever). In October 2021, the patient experienced FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Pain). At the time of the report, MALAISE (Feeling unwell /Not feeling good), FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness), PAIN (Pain), PYREXIA (Fever), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021) outcome was unknown.            No concomitant medications were reported.  on 11-OCT-2021, patient received Booster dose of Moderna vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for Humira (adalimumab) for the events of fever, not feeling good, spaciness, fatigue and pain was not provided.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain; Feeling abnormal/ patient experienced spaciness; Fatigue; Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021; Feeling unwell /Not feeling good; Fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell /Not feeling good), FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness), PAIN (Pain), PYREXIA (Fever) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021). In May 2021, the patient experienced MALAISE (Feeling unwell /Not feeling good) and PYREXIA (Fever). In October 2021, the patient experienced FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Pain). At the time of the report, MALAISE (Feeling unwell /Not feeling good), FEELING ABNORMAL (Feeling abnormal/ patient experienced spaciness), PAIN (Pain), PYREXIA (Fever), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 02-APR-2021 and Dose 2 on 11-MAY-2021) outcome was unknown.            No concomitant medications were reported.  on 11-OCT-2021, patient received Booster dose of Moderna vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter causality for Humira (adalimumab) for the events of fever, not feeling good, spaciness, fatigue and pain was not provided.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dyspnoea
Clinical narrative: Breathing restricted/air way issues/felt restricted; Broke out with blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Broke out with blisters) and DYSPNOEA (Breathing restricted/air way issues/felt restricted) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In 2006, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 19-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 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced BLISTER (Broke out with blisters). On an unknown date, the patient experienced DYSPNOEA (Breathing restricted/air way issues/felt restricted). At the time of the report, BLISTER (Broke out with blisters) and DYSPNOEA (Breathing restricted/air way issues/felt restricted) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inflammation, Migraine, Pain in extremity
Clinical narrative: Pain in spine; Migraine; ELEVATED INFLAMMATION; Headache/slight headache; Pain in arm/sorearm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pain in spine), MIGRAINE (Migraine), INFLAMMATION (ELEVATED INFLAMMATION), HEADACHE (Headache/slight headache) and PAIN IN EXTREMITY (Pain in arm/sorearm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-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. On 25-Jan-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 25-Jan-2022, the patient experienced HEADACHE (Headache/slight headache), PAIN IN EXTREMITY (Pain in arm/sorearm) and FATIGUE (Fatigue). On an unknown date, the patient experienced SPINAL PAIN (Pain in spine), MIGRAINE (Migraine) and INFLAMMATION (ELEVATED INFLAMMATION). At the time of the report, SPINAL PAIN (Pain in spine), MIGRAINE (Migraine), INFLAMMATION (ELEVATED INFLAMMATION), HEADACHE (Headache/slight headache), PAIN IN EXTREMITY (Pain in arm/sorearm) and FATIGUE (Fatigue) 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.  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 29-Aug-2022: Events Pain in spine, Migraine and Inflammation added. Dose regimen for non-company suspect drug added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Pain in spine; Migraine; ELEVATED INFLAMMATION; Headache/slight headache; Pain in arm/sorearm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pain in spine), MIGRAINE (Migraine), INFLAMMATION (ELEVATED INFLAMMATION), HEADACHE (Headache/slight headache) and PAIN IN EXTREMITY (Pain in arm/sorearm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-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. On 25-Jan-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 25-Jan-2022, the patient experienced HEADACHE (Headache/slight headache), PAIN IN EXTREMITY (Pain in arm/sorearm) and FATIGUE (Fatigue). On an unknown date, the patient experienced SPINAL PAIN (Pain in spine), MIGRAINE (Migraine) and INFLAMMATION (ELEVATED INFLAMMATION). At the time of the report, SPINAL PAIN (Pain in spine), MIGRAINE (Migraine), INFLAMMATION (ELEVATED INFLAMMATION), HEADACHE (Headache/slight headache), PAIN IN EXTREMITY (Pain in arm/sorearm) and FATIGUE (Fatigue) 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.  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 29-Aug-2022: Events Pain in spine, Migraine and Inflammation added. Dose regimen for non-company suspect drug added.