chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammation
Clinical narrative: Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Panuveitis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation). At the time of the report, INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) 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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter. .  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-622823 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021; COVID-19; COVID-19 aggravated / COVID-19 worse; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021), COVID-19 (COVID-19) and COVID-19 (COVID-19 aggravated / COVID-19 worse) 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 ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021), COVID-19 (COVID-19) and COVID-19 (COVID-19 aggravated / COVID-19 worse). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had dose 1 0n 01 Sep 2021 and dose 2 on 20 Sep 2021) outcome was unknown, COVID-19 (COVID-19) was resolving and COVID-19 (COVID-19 aggravated / COVID-19 worse) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Pain
Clinical narrative: Acid reflux (esophageal); Pain/Aches; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and PAIN (Pain/Aches) 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 Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and PAIN (Pain/Aches). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and PAIN (Pain/Aches) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received booster dose COVID-19 Vaccine manufactured by Moderna. Primary reporter contact for lot number information was unsuccessful.  The reporter's causality for the events of gastroesophageal reflux disease and pain with HUMIRA (ADALIMUMAB) was no reasonable possibility.  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: M
Vaccine: COVID19
Symptoms: Adverse food reaction, Fatigue, Flushing
Clinical narrative: Flushing of face; Adverse food reaction; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing of face), ADVERSE FOOD REACTION (Adverse food reaction) 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 Rheumatoid arthritis.    No Medical History information was reported.   In 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUSHING (Flushing of face), ADVERSE FOOD REACTION (Adverse food reaction) and FATIGUE (Fatigue). At the time of the report, FLUSHING (Flushing of face) and FATIGUE (Fatigue) had resolved and ADVERSE FOOD REACTION (Adverse food reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment Drug was 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.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 24-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 Crohn's disease.    The patient's past medical history included COVID-19 in January 2020. Concurrent medical conditions included Crohn's disease.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 22-Dec-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome 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.  Concomitant Medication use information was not provided by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment Medication use information was not provided by reporter.  Company Comment: This is a spontaneous case concerning a 24-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the second dose of mRNA-1273 vaccine. Drug ineffective was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved 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 24-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 8 months after receiving the second dose of mRNA-1273 vaccine. Drug ineffective was also reported as an additional event. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: a cluster of hemangiomas like a big thick red blood-like area around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a cluster of hemangiomas like a big thick red blood-like area around the injection site) in a 92-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Bruise.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (a cluster of hemangiomas like a big thick red blood-like area around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (a cluster of hemangiomas like a big thick red blood-like area around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.   The caller stated that patient, bruises easily and this could be contributing to her injection site issues. Caller stated that she had been seen by her PCP and a dermatologist.  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: 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 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) solution for injection for an unknown indication.    No Medical History information was reported.   On 06-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) Solution for injection in pre-filled pen. In August 2021, the patient experienced COVID-19 (COVID-19). In September 2021, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported by reporter. 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 where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 62 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days (however, in the same month) after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event recovered. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old female patient, with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days (however, in the same month) after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No further information on risk factors, co morbidities, investigations and treatment was available in the report. The event recovered. Co suspect adalimumab could be a risk factor for the event. COVID-19 pandemia could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: She had an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had an adverse reaction) in a female patient of an unknown age who received mRNA-1273  for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273  (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (She had an adverse reaction). At the time of the report, IMMUNISATION REACTION (She had an adverse reaction) outcome was unknown.        The action taken with mRNA-1273(Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.    This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: She had very bad reaction to covid shot; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She had very bad reaction to covid shot) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product METHYLPREDNISOLONE ACETATE (DEPO MEDROL) for an unknown indication.    Concurrent medical conditions included Drug allergy (Allergy to chemical in glycol propylate).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and METHYLPREDNISOLONE ACETATE (DEPO MEDROL) (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (She had very bad reaction to covid shot). At the time of the report, IMMUNISATION REACTION (She had very bad reaction to covid shot) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient had a bad reaction to COVID shot. They found out about an allergy to glycol propylate cause of the reaction that occurred. Now has health issues that include a possible surgery. Its a sinus thing to have polyps removed so she was given steroids to shrink that and that's when they found out has a reaction to the chemical. Has had a reaction to the shot and has reported to Moderna.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, SARS-CoV-2 test
Clinical narrative: Feeling way better, Paxlovid has alleviated her COVID; Very sour taste in her mouth that was initially a metallic; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Feeling way better, Paxlovid has alleviated her COVID) and DYSGEUSIA (Very sour taste in her mouth that was initially a metallic) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    No Medical History information was reported.   On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose twice a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient experienced COVID-19 (Feeling way better, Paxlovid has alleviated her COVID). 26-Apr-2022, the patient experienced DYSGEUSIA (Very sour taste in her mouth that was initially a metallic). At the time of the report, COVID-19 (Feeling way better, Paxlovid has alleviated her COVID) and DYSGEUSIA (Very sour taste in her mouth that was initially a metallic) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Patient felt way better regarding COVID, it feels like a cold instead of a really bad flu. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Psoriasis, Skin disorder
Clinical narrative: Some spots on underside of hands; Psoriasis flare-up; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Some spots on underside of hands), PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB for Plaque psoriasis.    No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (Some spots on underside of hands), PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue). At the time of the report, SKIN DISORDER (Some spots on underside of hands) and PSORIASIS (Psoriasis flare-up) had not resolved and FATIGUE (Fatigue) 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA/WATERY STOOLS/LOOSE STOOLS; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (DIARRHEA/WATERY STOOLS/LOOSE STOOLS) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-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 DIARRHOEA (DIARRHEA/WATERY STOOLS/LOOSE STOOLS). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (DIARRHEA/WATERY STOOLS/LOOSE STOOLS) had resolved.            No concomitant medication was reported. Patient reported that she had watery, loose stools for about 5 days after her first injection. She had no other symptoms or other complaints of issues. She states that the diarrhea went away. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Pain with arthritis; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ARTHRALGIA (Pain with arthritis) and PAIN IN EXTREMITY (Sore arm) in an adult patient of an unknown gender 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue), ARTHRALGIA (Pain with arthritis) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved and ARTHRALGIA (Pain with arthritis) had not 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Dry skin, Fatigue
Clinical narrative: Flare up; Dry patches/ dry skin on lower legs; More fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Flare up), DRY SKIN (Dry patches/ dry skin on lower legs), FATIGUE (More fatigue) and ARTHRALGIA (Joint pain) 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 Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-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 CONDITION AGGRAVATED (Flare up), DRY SKIN (Dry patches/ dry skin on lower legs), FATIGUE (More fatigue) and ARTHRALGIA (Joint pain). At the time of the report, CONDITION AGGRAVATED (Flare up) and DRY SKIN (Dry patches/ dry skin on lower legs) had not resolved and FATIGUE (More fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality with Humira for the event of flare up was a reasonable possibility and for the events of dry patches/ dry skin on lower legs, more fatigue and joint pain was not 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Magnetic resonance imaging, Mobility decreased, Vaccination site pain
Clinical narrative: Back pain; Mobility issues; Sore arm after all covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues) and VACCINATION SITE PAIN (Sore arm after all covid vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Solution for injection in pre-filled pen. On an unknown date, the patient experienced BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues) and VACCINATION SITE PAIN (Sore arm after all covid vaccine). At the time of the report, BACK PAIN (Back pain), MOBILITY DECREASED (Mobility issues) and VACCINATION SITE PAIN (Sore arm after all covid vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Magnetic resonance imaging: bone spurs.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On 29-Mar-2021, the patient experienced bone spurs. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to US-MODERNATX, INC.-MOD-2022-622380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-622380:Dose 2
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feeling of light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling of light headedness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and 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 DIZZINESS (Feeling of light headedness). At the time of the report, DIZZINESS (Feeling of light headedness) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  The reporter causality for the event of light headedness was not provided.  It was unknown if patient was enrolled in the COVID-19 vaccine clinical 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic enzyme increased, Illness
Clinical narrative: Elevated liver enzymes; Sick after COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after COVID-19 Vaccine) and HEPATIC ENZYME INCREASED (Elevated liver enzymes) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and METHOTREXATE for an unknown indication.    No Medical History information was reported.   On 19-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and METHOTREXATE (unknown route) at an unspecified dose. On 19-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced ILLNESS (Sick after COVID-19 Vaccine). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Elevated liver enzymes). On 21-Mar-2022, ILLNESS (Sick after COVID-19 Vaccine) had resolved. At the time of the report, HEPATIC ENZYME INCREASED (Elevated liver enzymes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme increased: elevated.   The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19 vaccine clinical trial.  The reporter causality for events of sick after COVID vaccine and elevated liver enzymes most likely from methotrexate with Humira was no reasonable possibility.  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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in an 85-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.    The patient's past medical history included Breast cancer in 2012 and Mastectomy bilateral (She had both breast removed.) in 2012.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) had resolved. No concomitant medications was reported. No treatment medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. This case was linked to MOD-2022-624208 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Condition aggravated; Feeling bad; Ache; Skin red; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated), FEELING ABNORMAL (Feeling bad), PAIN (Ache), ERYTHEMA (Skin red) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 01-Mar-2021 to an unknown date for COVID-19 vaccination.   On 01-Jan-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2022, the patient experienced CONDITION AGGRAVATED (Condition aggravated), FEELING ABNORMAL (Feeling bad), PAIN (Ache), ERYTHEMA (Skin red) and PYREXIA (Fever). At the time of the report, CONDITION AGGRAVATED (Condition aggravated), FEELING ABNORMAL (Feeling bad), PAIN (Ache), ERYTHEMA (Skin red) and PYREXIA (Fever) had not resolved.            On 13 Apr 2022, the patient experienced skin all red and flared up, feeling terrible, fever, severe aches and skin all red. Moderna COVID-19 vaccine (Elasomeran) was also considered suspect.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Treatment medication 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue after his Covid Vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue after his Covid Vaccinations) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In 2020, the patient RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram once a day. On 14-Mar-2022, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram once a day. On an unknown date, the patient experienced FATIGUE (fatigue after his Covid Vaccinations). At the time of the report, FATIGUE (fatigue after his Covid Vaccinations) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 44.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis, Pyrexia
Clinical narrative: plaque psoriasis came back; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (plaque psoriasis came back) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PSORIASIS (plaque psoriasis came back). In 2021, PYREXIA (Fever) had resolved. At the time of the report, PSORIASIS (plaque psoriasis came back) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   Patient stopped taking Skyrizi then plaque psoriasis came back then patient started back taking Skyrizi in Nov-2021 and plaque psoriasis cleared up again.  The reporter causality for the events of fever and plaque psoriasis came back 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: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not 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. No concomitant medications were reported. No treatment medications were reported. Company comment-This spontaneous case concerns an adult female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date after a dose (dose number not specified)of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement  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.; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with no relevant medical history reported, who experienced the unexpected non serious AESI event of COVID-19 on unknown date after a dose (dose number not specified)of mRNA-1273 vaccination.  Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations
Clinical narrative: Had some light headaches/ Headache; Herat was racing/ Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Herat was racing/ Heart racing) and HEADACHE (Had some light headaches/ Headache) in a 66-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 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2022, the patient started UPADACITINIB (RINVOQ) (Oral) 15 Tablet (15 Tablet, 1 in 1 D). In May 2022, the patient experienced PALPITATIONS (Herat was racing/ Heart racing). On an unknown date, the patient experienced HEADACHE (Had some light headaches/ Headache). At the time of the report, PALPITATIONS (Herat was racing/ Heart racing) had not resolved and HEADACHE (Had some light headaches/ Headache) outcome was unknown.            Relevant concomitant medications were not reported.  The patient reported that her heart was racing, like when drink too much caffeine. She took at 11 am and the racing did not stop until 3 pm. She had some light headaches.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  The reporter's causality for the event of heart was racing and headaches with RINVOQ was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Excessively tired from covid booster; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Excessively tired from covid booster) 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) injection for Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Excessively tired from covid booster). At the time of the report, FATIGUE (Excessively tired from covid booster) was resolving.            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 provided.  No treatment medication was provided. It was unknown if the patient was enrolled in COVID-19 vaccine trial.