chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rheumatoid arthritis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP IN HIP) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) 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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP IN HIP) (seriousness criterion medically significant) and PERIPHERAL SWELLING (SWOLLEN HAND). At the time of the report, RHEUMATOID ARTHRITIS (RHEUMATOID ARTHRITIS FLARE UP IN HIP) and PERIPHERAL SWELLING (SWOLLEN HAND) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication was reported. Reportedly, the patient's right hip to keep hurting, thinking it was the rheumatoid, no pain since Aug until now and hand was swollen, no pain all last week but now feeling better. The reporter causality for an events of RHEUMATOID ARTHRITIS and PERIPHERAL SWELLING with the RINVOQ was no reasonable possibility. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company Comment: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Malaise
Clinical narrative: joint pain everywhere; MENTAL FOGGINESS; NOT FEELING GOOD; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain everywhere), FATIGUE (Fatigue), FEELING ABNORMAL (MENTAL FOGGINESS) and MALAISE (NOT FEELING GOOD) in a 59-year-old male 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.    Concomitant products included METHOTREXATE SODIUM (METOTREXATE) for Joint pain.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 28-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (joint pain everywhere), FEELING ABNORMAL (MENTAL FOGGINESS) and MALAISE (NOT FEELING GOOD). At the time of the report, ARTHRALGIA (joint pain everywhere), FATIGUE (Fatigue) and FEELING ABNORMAL (MENTAL FOGGINESS) had not resolved and MALAISE (NOT FEELING GOOD) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of JOINT PAIN, MENTAL FOGGINESS and NOT FEELING GOOD was not provided. The reporter's causality for the event(s) of FATIGUE with RINVOQ(UPADACITINIB) was a reasonable possibility. 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.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Arthralgia, Back pain, Pain in extremity, Psoriasis
Clinical narrative: Plaque psoriasis; Back pain/pain in back; arthritis pain/pain in elbows; Pain in fingers; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Plaque psoriasis), BACK PAIN (Back pain/pain in back), ARTHRALGIA (arthritis pain/pain in elbows) and PAIN IN EXTREMITY (Pain in fingers) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication. No Medical History information was reported.   On 01-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. In 2021, received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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), BACK PAIN (Back pain/pain in back), ARTHRALGIA (arthritis pain/pain in elbows) and PAIN IN EXTREMITY (Pain in fingers). At the time of the report, PSORIASIS (Plaque psoriasis) was resolving and BACK PAIN (Back pain/pain in back), ARTHRALGIA (arthritis pain/pain in elbows) and PAIN IN EXTREMITY (Pain in fingers) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient complained of pain in his back, fingers, and elbows without any arthritis inflammation with Skyrizi, his plaque psoriasis was better. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment details were reported.  The reporter's causality for the event(s) of arthritis pain/pain in elbows, pain in back, pain in fingers and plaque psoriasis with Janssen Covid Vaccine was possible. The reporter's causality for the event(s) of arthritis pain/pain in elbows with skyrizi(risankizumab) was no reasonable possibility. the reporter's causality for the event(s) of pain in back, pain in fingers and plaque psoriasis 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
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic product effect decreased
Clinical narrative: HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE) 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 Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE) 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 spontaneous case concerns an adult male patient with concurrent condition of ankylosing spondylitis and reported non serious event of Therapeutic product effect decreased (reported as HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second and booster doses with the same vaccine on unknown dates. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with concurrent condition of ankylosing spondylitis and reported non serious event of Therapeutic product effect decreased (reported as HUMIRA NOT AS EFFECTIVE SINCE GETTING MODERNA COVID VACCINE), unknown days after receiving the first dose of mRNA-1273 vaccine. The patient received the second and booster doses with the same vaccine on unknown dates. No information on detailed clinical course including whether the patient was diagnosed with COVID 19 was available in the report.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Paranasal sinus discomfort
Clinical narrative: Fatigue; Chills; Sinus pressure; Cold; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), PARANASAL SINUS DISCOMFORT (Sinus pressure) and NASOPHARYNGITIS (Cold) 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) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to Severe).   On 20-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 20-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, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), PARANASAL SINUS DISCOMFORT (Sinus pressure) and NASOPHARYNGITIS (Cold). At the time of the report, FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and PARANASAL SINUS DISCOMFORT (Sinus pressure) and NASOPHARYNGITIS (Cold) was resolving.        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.  No treatment details were reported.  The reporter's causality for the event(s) of fatigue, chills, sinus pressure and cold with humira(adalimumab) was no reasonable possibility  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain in extremity, Product storage error
Clinical narrative: Product storage error/Refrigerator door left open for six hours/had three syringes; Fatigue; Injection site pain/Sore at injection site; Pain in arm/Entire arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error/Refrigerator door left open for six hours/had three syringes), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site pain/Sore at injection site) and PAIN IN EXTREMITY (Pain in arm/Entire arm) 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 Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error/Refrigerator door left open for six hours/had three syringes), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site pain/Sore at injection site) and PAIN IN EXTREMITY (Pain in arm/Entire arm). At the time of the report, PRODUCT STORAGE ERROR (Product storage error/Refrigerator door left open for six hours/had three syringes) and FATIGUE (Fatigue) outcome was unknown and INJECTION SITE PAIN (Injection site pain/Sore at injection site) and PAIN IN EXTREMITY (Pain in arm/Entire arm) 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. On unknown date, she received first dose COVID-19 Vaccine manufactured by Moderna. The reporter's causality for the event of product storage error was a reasonable possibility and the reporter's causality for the events of fatigue, Injection site pain and in in extremity was no reasonable possibility with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Fall, Head injury, Lethargy, Pruritus
Clinical narrative: Fell and hit her head on the door frame had concussion; Fell and hit her head on the door frame had concussion; Covid-19 vaccination fourth day very lethargic; Itchy arm with first covid-19 vaccine; Fell and hit her head on the door frame had concussion; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Covid-19 vaccination fourth day very lethargic), PRURITUS (Itchy arm with first covid-19 vaccine), FALL (Fell and hit her head on the door frame had concussion), HEAD INJURY (Fell and hit her head on the door frame had concussion) and CONCUSSION (Fell and hit her head on the door frame had concussion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 06-Mar-2021, the patient experienced LETHARGY (Covid-19 vaccination fourth day very lethargic) and PRURITUS (Itchy arm with first covid-19 vaccine). In March 2021, the patient experienced CONCUSSION (Fell and hit her head on the door frame had concussion). On 24-Mar-2021, the patient experienced FALL (Fell and hit her head on the door frame had concussion) and HEAD INJURY (Fell and hit her head on the door frame had concussion). In March 2021, LETHARGY (Covid-19 vaccination fourth day very lethargic) and PRURITUS (Itchy arm with first covid-19 vaccine) had resolved. At the time of the report, FALL (Fell and hit her head on the door frame had concussion) and CONCUSSION (Fell and hit her head on the door frame had concussion) was resolving and HEAD INJURY (Fell and hit her head on the door frame had concussion) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of covid-19 vaccination fourth day very lethargic, fell and hit her head on the door frame had concussion onset 24 Mar 2022, fell and hit her head on the door frame had concussion onset in March 2022, fell and hit her head on the door frame had concussion onset 24 Mar 2022 and itchy arm with first covid-19 vaccine with Humira 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dry skin, Skin discolouration, Skin ulcer, Vaccination site pain
Clinical narrative: COVID-19; SORE ON REAR SIDE OF LEFT; SKIN BECAME DRY; STARTED TURNING DARK; FIRST VACCINATION MADE ARM SORE AT; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SKIN ULCER (SORE ON REAR SIDE OF LEFT), DRY SKIN (SKIN BECAME DRY), SKIN DISCOLOURATION (STARTED TURNING DARK) and VACCINATION SITE PAIN (FIRST VACCINATION MADE ARM SORE AT) in a 70-year-old 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.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) unknown. In December 2021, the patient experienced COVID-19 (COVID-19), SKIN ULCER (SORE ON REAR SIDE OF LEFT), DRY SKIN (SKIN BECAME DRY), SKIN DISCOLOURATION (STARTED TURNING DARK) and VACCINATION SITE PAIN (FIRST VACCINATION MADE ARM SORE AT). At the time of the report, COVID-19 (COVID-19), SKIN ULCER (SORE ON REAR SIDE OF LEFT), DRY SKIN (SKIN BECAME DRY), SKIN DISCOLOURATION (STARTED TURNING DARK) and VACCINATION SITE PAIN (FIRST VACCINATION MADE ARM SORE AT) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of SORE ON REAR SIDE OF LEFT LEG AND SKIN BECAME DRY AND STARTED TURNING DARK unknown onset, FIRST VACCINATION MADE ARM SORE AT INJECTION SIGHT, COVID-19, SORE ON REAR SIDE OF LEFT LEG AND SKIN BECAME DRY AND STARTED TURNING DARK unknown onset and SORE ON REAR SIDE OF LEFT LEG AND SKIN  BECAME DRY AND STARTED TURNING DARK unknown onset with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. 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.
Age: 64.0
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 a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.  No Medical History information was reported.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COVID was not provided.  No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: Hospitalization; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (Hospitalization) 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) solution for injection for an unknown indication.    Concomitant products included PREDNISONE, MESALAZINE (ASACOL HD) and BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) for an unknown indication, MONTELUKAST SODIUM.   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 every two weeks. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization). At the time of the report, HOSPITALISATION (Hospitalization) outcome was unknown.            Treatment medication was not provided by the reporter.  Patient's medication was working well. The Covid booster put him in the hospital. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with humira for the event(s) of hospitalization was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning an elderly male patient with no medical history reported, who was hospitalized due to the unexpected serious event of Hospitalisation, in the context of a dose of mRNA-1273 as booster dose of COVID-19 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning an elderly male patient with no medical history reported, who was hospitalized due to the unexpected serious event of Hospitalisation, in the context of a dose of mRNA-1273 as booster dose of COVID-19 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: BLOOD CLOT IN LEGS/DVT; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (BLOOD CLOT IN LEGS/DVT) 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 Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   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 DEEP VEIN THROMBOSIS (BLOOD CLOT IN LEGS/DVT) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (BLOOD CLOT IN LEGS/DVT) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns an adult male patient with use of Adalimumab for Ulcerative colitis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Deep vein thrombosis (reported as blood clot in legs/DVT) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as the vaccination date and  date of event onset were not provided. No information on any other doses of COVID-19 vaccination was provided. The use of Adalimumab  could be considered confounding to the case as leg thrombosis was reported to be one of its serious hematologic adverse effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with use of Adalimumab for Ulcerative colitis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Deep vein thrombosis (reported as blood clot in legs/DVT) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as the vaccination date and  date of event onset were not provided. No information on any other doses of COVID-19 vaccination was provided. The use of Adalimumab  could be considered confounding to the case as leg thrombosis was reported to be one of its serious hematologic adverse effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 05-May-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, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) had not resolved.            She was given several cortisone treatments but that did not help the problem. The doctor was talking about another medication switch but was undecided.  The flare ups might had gotten worse since getting Covid-19 vaccination but she was not sure. 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: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Fatigue; Acid reflux (esophageal); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) 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) 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 FATIGUE (Fatigue) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)). At the time of the report, FATIGUE (Fatigue) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Ligament sprain
Clinical narrative: Sprained ankle/Sprained right ankle; 01 Feb 2021, patient received 1st dose COVID-19 Vaccine and on 1-Apr 2021, patient received 2nd dose COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (Sprained ankle/Sprained right ankle) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01 Feb 2021, patient received 1st dose COVID-19 Vaccine and on 1-Apr 2021, patient received 2nd dose COVID-19 Vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concomitant products included COVID-19 VACCINE for COVID-19 vaccination, HYDROXYCHLOROQUINE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-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) 40 milligram. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01 Feb 2021, patient received 1st dose COVID-19 Vaccine and on 1-Apr 2021, patient received 2nd dose COVID-19 Vaccine). On an unknown date, the patient experienced LIGAMENT SPRAIN (Sprained ankle/Sprained right ankle). At the time of the report, LIGAMENT SPRAIN (Sprained ankle/Sprained right ankle) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01 Feb 2021, patient received 1st dose COVID-19 Vaccine and on 1-Apr 2021, patient received 2nd dose COVID-19 Vaccine) outcome was unknown.            No Medical History information was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of ligament sprain was no reasonable possibility with HUMIRA(ADALIMUMAB).  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: SICK/FELT LIKE DYING AFTER COVID BOOSTER; FEVER AFTER COVID BOOSTER; THROWING UP AFTER COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (SICK/FELT LIKE DYING AFTER COVID BOOSTER), PYREXIA (FEVER AFTER COVID BOOSTER) and VOMITING (THROWING UP AFTER COVID BOOSTER) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for an unknown indication and COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In January 2022, the patient experienced MALAISE (SICK/FELT LIKE DYING AFTER COVID BOOSTER), PYREXIA (FEVER AFTER COVID BOOSTER) and VOMITING (THROWING UP AFTER COVID BOOSTER). At the time of the report, MALAISE (SICK/FELT LIKE DYING AFTER COVID BOOSTER) had not resolved and PYREXIA (FEVER AFTER COVID BOOSTER) and VOMITING (THROWING UP AFTER COVID BOOSTER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, No adverse event
Clinical narrative: EXPOSED TO COVID; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (EXPOSED TO COVID) and NO ADVERSE EVENT (No adverse event) 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 Ulcerative colitis.    NO KNOWN ALLERGIES.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-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, the patient experienced EXPOSURE TO SARS-COV-2 (EXPOSED TO COVID) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPOSURE TO SARS-COV-2 (EXPOSED TO COVID) had not resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported. Treatment detail was not 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: Productive cough
Clinical narrative: Currently had phlegm; This spontaneous case was reported by a patient and describes the occurrence of PRODUCTIVE COUGH (Currently had phlegm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Bone cancer.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (Currently had phlegm). At the time of the report, PRODUCTIVE COUGH (Currently had phlegm) outcome was unknown.            The concomitant medication was not reported by reporter. It was stated that patient had both doses of the Moderna COVID vaccine. He currently had phlegm, but it was clear. Patient was not taking chemotherapy right now because his last one had a bad outcome. He had been on 6 of them (chemotherapies). 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Vaccination site pain
Clinical narrative: STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS; VERY MINOR FATIGUE; ACHY ARM AFTER COVID VACCINES; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS), FATIGUE (VERY MINOR FATIGUE) and VACCINATION SITE PAIN (ACHY ARM AFTER COVID VACCINES) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PRURITUS (STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS), FATIGUE (VERY MINOR FATIGUE) and VACCINATION SITE PAIN (ACHY ARM AFTER COVID VACCINES). At the time of the report, PRURITUS (STILL HAD A LOT OF ITCHY SPOTS/LITTLE IMPROVEMENT ON ELBOWS BUT NONE ON LEGS), FATIGUE (VERY MINOR FATIGUE) and VACCINATION SITE PAIN (ACHY ARM AFTER COVID VACCINES) outcome was unknown.            Concomitant medication was not reported.  Patient might have experienced very minor fatigue, achy arm after COVID vaccines. Patient had very minimal improvement since being on Humira. Still had a lot of itchy spots. Little improvement on elbows but none on legs. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Bad reactions to covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Bad reactions to covid-19 vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced IMMUNISATION REACTION (Bad reactions to covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (Bad reactions to covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient had last surgery on hand. She was recovering from surgery and stitches. 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: Back pain, Chills, Myalgia, Pyrexia
Clinical narrative: Back pain; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) 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 Ankylosing spondylitis.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 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) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (Back pain), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, BACK PAIN (Back pain), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) 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.  On unknown dates, the patient experienced chills after getting second Covid vaccine, fever after getting second Covid vaccine and body aches after getting second Covid vaccine.  No treatment information was provided.  The reporter's causality with Humira for the events of chills, back pain, fever and body aches 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and NAUSEA (Nausea) in a 21-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 Ulcerative colitis.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In October 2021, the patient experienced FATIGUE (Fatigue) and NAUSEA (Nausea). In October 2021, FATIGUE (Fatigue) and NAUSEA (Nausea) had 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 events of fatigue and nausea with HUMIRA (ADALIMUMAB) was a 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: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Feverish; Ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish) and PAIN (Ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) Unknown. On an unknown date, the patient experienced PYREXIA (Feverish) and PAIN (Ache). At the time of the report, PYREXIA (Feverish) and PAIN (Ache) had resolved.            No concomitant medications were reported.  The patient had no side effects on the first dose of Moderna but felt feverish and achy on second and third dose. It passed after about a day and was fine.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of pyrexia and pain was not provided with SKYRIZI(RISANKIZUMAB).  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, UNK
Symptoms: Arthralgia, Insomnia, Musculoskeletal stiffness, Pain, Skin discolouration
Clinical narrative: Color of skin was changing possibly from varicose veins; Color of skin was changing possibly from varicose veins; Loses sleep; Stiff; Aching down legs/ thigh/ behind the knee hurts bad and in front; Aching down legs/ thigh/ behind the knee hurts bad and in front; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front), SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep) and MUSCULOSKELETAL STIFFNESS (Stiff) in a 58-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.    No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 07-Dec-2021, the patient experienced PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front) and ARTHRALGIA (Aching down legs/ thigh/ behind the knee hurts bad and in front). On an unknown date, the patient experienced SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep) and MUSCULOSKELETAL STIFFNESS (Stiff). At the time of the report, PAIN (Aching down legs/ thigh/ behind the knee hurts bad and in front), SKIN DISCOLOURATION (Color of skin was changing possibly from varicose veins), VARICOSE VEIN (Color of skin was changing possibly from varicose veins), INSOMNIA (Loses sleep), MUSCULOSKELETAL STIFFNESS (Stiff) and ARTHRALGIA (Aching down legs/ thigh/ behind the knee hurts bad and in front) 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 for the events of aching down legs/ thigh/ behind the knee hurts bad and in front with Humira was no reasonable possibility, for the events of color of skin was changing possibly from varicose vein, loses sleep and stiff 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.